Sharon Worcester

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

SAN ANTONIO – Dietary restrictions prescribed for children with food allergies may lead to growth impairment, according to findings from a review of medical records for 245 food-allergic pediatric patients.

The risk of growth impairment was greatest for children whose dietary restrictions required elimination of more than two foods and/or elimination of cow’s milk, Dr. Brian P. Vickery reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

After age 2 years, the food-allergic children had lower mean percentiles for weight (67.5 vs. 72.5) and a lower body mass index (57.6 vs.68.0), than did 4,584 healthy age-matched controls.

Furthermore, the 52 patients with more than two food allergies (and thus more than two food restrictions), compared with 193 patients with one or two food allergies, had significantly lower mean percentiles for height (62.2 vs. 74.8) and weight (55.3 vs. 69.2). The 66 patients with milk allergy, compared with those with other food allergies, had lower mean percentiles for weight (54.5 vs. 70.6) and BMI (48.9 vs. 58.8), according to Dr. Vickery of the University of North Carolina at Chapel Hill.

Milk-allergic children younger than 2 years of age were particularly vulnerable to growth restriction, he said during a press briefing at the meeting.

The food-allergic children in this study, who were aged 1 month to 11 years and who presented to a University of North Carolina outpatient clinic between 2007 and 2011, also were compared with 205 "disease controls," consisting of children with either cystic fibrosis or celiac disease, two conditions that are associated with impaired growth. When children passed their second birthday, the effect of food allergy on growth was very similar to the effect of celiac disease on growth, Dr. Vickery said.

The findings of this study confirm those from a smaller study, conducted more than a decade ago, that also showed that milk allergy and multiple food allergies were associated with growth impairment.

That study is "the most commonly cited previous study to address the growth of food-allergic children in the United States," Dr. Vickery noted.

"The prevalence [of food allergy] has increased over the past 10 years, so we wanted to take another look in a bigger population to kind of reassess the impact of elimination diets on growth," he said.

The current findings demonstrate that a food allergy–associated elimination diet can place children at risk of impaired growth, compared with their healthy peers, regardless of whether they are under age 2 years, or are 2-11 years old, and that after age 2, the effect of food allergy on growth is very similar to that of chronic diseases known to affect growth, he said.

"While awareness of food allergy is increasing along with the prevalence of the disease, it is important to draw attention to the important consequences of elimination diets. We feel that providers should counsel patients and caregivers about the growth-related risks of the elimination diets that are used to treat food allergy, and ensure that families are excluding only the foods that are medically required or otherwise culturally indicated, that nutritional assessment and/or supplementation is provided as needed, and that subspecialty consultation is arranged, especially for children at highest risk," he said.

Dr. Vickery reported having no relevant financial disclosures.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

fpnews@elsevier.com

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

SAN ANTONIO – Dietary restrictions prescribed for children with food allergies may lead to growth impairment, according to findings from a review of medical records for 245 food-allergic pediatric patients.

The risk of growth impairment was greatest for children whose dietary restrictions required elimination of more than two foods and/or elimination of cow’s milk, Dr. Brian P. Vickery reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

After age 2 years, the food-allergic children had lower mean percentiles for weight (67.5 vs. 72.5) and a lower body mass index (57.6 vs.68.0), than did 4,584 healthy age-matched controls.

Furthermore, the 52 patients with more than two food allergies (and thus more than two food restrictions), compared with 193 patients with one or two food allergies, had significantly lower mean percentiles for height (62.2 vs. 74.8) and weight (55.3 vs. 69.2). The 66 patients with milk allergy, compared with those with other food allergies, had lower mean percentiles for weight (54.5 vs. 70.6) and BMI (48.9 vs. 58.8), according to Dr. Vickery of the University of North Carolina at Chapel Hill.

Milk-allergic children younger than 2 years of age were particularly vulnerable to growth restriction, he said during a press briefing at the meeting.

The food-allergic children in this study, who were aged 1 month to 11 years and who presented to a University of North Carolina outpatient clinic between 2007 and 2011, also were compared with 205 "disease controls," consisting of children with either cystic fibrosis or celiac disease, two conditions that are associated with impaired growth. When children passed their second birthday, the effect of food allergy on growth was very similar to the effect of celiac disease on growth, Dr. Vickery said.

The findings of this study confirm those from a smaller study, conducted more than a decade ago, that also showed that milk allergy and multiple food allergies were associated with growth impairment.

That study is "the most commonly cited previous study to address the growth of food-allergic children in the United States," Dr. Vickery noted.

"The prevalence [of food allergy] has increased over the past 10 years, so we wanted to take another look in a bigger population to kind of reassess the impact of elimination diets on growth," he said.

The current findings demonstrate that a food allergy–associated elimination diet can place children at risk of impaired growth, compared with their healthy peers, regardless of whether they are under age 2 years, or are 2-11 years old, and that after age 2, the effect of food allergy on growth is very similar to that of chronic diseases known to affect growth, he said.

"While awareness of food allergy is increasing along with the prevalence of the disease, it is important to draw attention to the important consequences of elimination diets. We feel that providers should counsel patients and caregivers about the growth-related risks of the elimination diets that are used to treat food allergy, and ensure that families are excluding only the foods that are medically required or otherwise culturally indicated, that nutritional assessment and/or supplementation is provided as needed, and that subspecialty consultation is arranged, especially for children at highest risk," he said.

Dr. Vickery reported having no relevant financial disclosures.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

fpnews@elsevier.com

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the post-test.

SAN ANTONIO – Dietary restrictions prescribed for children with food allergies may lead to growth impairment, according to findings from a review of medical records for 245 food-allergic pediatric patients.

The risk of growth impairment was greatest for children whose dietary restrictions required elimination of more than two foods and/or elimination of cow’s milk, Dr. Brian P. Vickery reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

After age 2 years, the food-allergic children had lower mean percentiles for weight (67.5 vs. 72.5) and a lower body mass index (57.6 vs.68.0), than did 4,584 healthy age-matched controls.

Furthermore, the 52 patients with more than two food allergies (and thus more than two food restrictions), compared with 193 patients with one or two food allergies, had significantly lower mean percentiles for height (62.2 vs. 74.8) and weight (55.3 vs. 69.2). The 66 patients with milk allergy, compared with those with other food allergies, had lower mean percentiles for weight (54.5 vs. 70.6) and BMI (48.9 vs. 58.8), according to Dr. Vickery of the University of North Carolina at Chapel Hill.

Milk-allergic children younger than 2 years of age were particularly vulnerable to growth restriction, he said during a press briefing at the meeting.

The food-allergic children in this study, who were aged 1 month to 11 years and who presented to a University of North Carolina outpatient clinic between 2007 and 2011, also were compared with 205 "disease controls," consisting of children with either cystic fibrosis or celiac disease, two conditions that are associated with impaired growth. When children passed their second birthday, the effect of food allergy on growth was very similar to the effect of celiac disease on growth, Dr. Vickery said.

The findings of this study confirm those from a smaller study, conducted more than a decade ago, that also showed that milk allergy and multiple food allergies were associated with growth impairment.

That study is "the most commonly cited previous study to address the growth of food-allergic children in the United States," Dr. Vickery noted.

"The prevalence [of food allergy] has increased over the past 10 years, so we wanted to take another look in a bigger population to kind of reassess the impact of elimination diets on growth," he said.

The current findings demonstrate that a food allergy–associated elimination diet can place children at risk of impaired growth, compared with their healthy peers, regardless of whether they are under age 2 years, or are 2-11 years old, and that after age 2, the effect of food allergy on growth is very similar to that of chronic diseases known to affect growth, he said.

"While awareness of food allergy is increasing along with the prevalence of the disease, it is important to draw attention to the important consequences of elimination diets. We feel that providers should counsel patients and caregivers about the growth-related risks of the elimination diets that are used to treat food allergy, and ensure that families are excluding only the foods that are medically required or otherwise culturally indicated, that nutritional assessment and/or supplementation is provided as needed, and that subspecialty consultation is arranged, especially for children at highest risk," he said.

Dr. Vickery reported having no relevant financial disclosures.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

fpnews@elsevier.com

SAN ANTONIO – Dietary restrictions prescribed for children with food allergies may lead to growth impairment, according to findings from a review of medical records for 245 food-allergic pediatric patients.

The risk of growth impairment was greatest for children whose dietary restrictions required elimination of more than two foods and/or elimination of cow’s milk, Dr. Brian P. Vickery reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

©BananaStock/thinkstockphotos.com

After age 2 years, the food-allergic children had lower mean percentiles for weight (67.5 vs. 72.5) and a lower body mass index (57.6 vs.68.0), than did 4,584 healthy age-matched controls.

Furthermore, the 52 patients with more than two food allergies (and thus more than two food restrictions), compared with 193 patients with one or two food allergies, had significantly lower mean percentiles for height (62.2 vs. 74.8) and weight (55.3 vs. 69.2). The 66 patients with milk allergy, compared with those with other food allergies, had lower mean percentiles for weight (54.5 vs. 70.6) and BMI (48.9 vs. 58.8), according to Dr. Vickery of the University of North Carolina at Chapel Hill.

Milk-allergic children younger than 2 years of age were particularly vulnerable to growth restriction, he said during a press briefing at the meeting.

The food-allergic children in this study, who were aged 1 month to 11 years and who presented to a University of North Carolina outpatient clinic between 2007 and 2011, also were compared with 205 "disease controls," consisting of children with either cystic fibrosis or celiac disease, two conditions that are associated with impaired growth. When children passed their second birthday, the effect of food allergy on growth was very similar to the effect of celiac disease on growth, Dr. Vickery said.

The findings of this study confirm those from a smaller study, conducted more than a decade ago, that also showed that milk allergy and multiple food allergies were associated with growth impairment.

That study is "the most commonly cited previous study to address the growth of food-allergic children in the United States," Dr. Vickery noted.

"The prevalence [of food allergy] has increased over the past 10 years, so we wanted to take another look in a bigger population to kind of reassess the impact of elimination diets on growth," he said.

The current findings demonstrate that a food allergy–associated elimination diet can place children at risk of impaired growth, compared with their healthy peers, regardless of whether they are under age 2 years, or are 2-11 years old, and that after age 2, the effect of food allergy on growth is very similar to that of chronic diseases known to affect growth, he said.

"While awareness of food allergy is increasing along with the prevalence of the disease, it is important to draw attention to the important consequences of elimination diets. We feel that providers should counsel patients and caregivers about the growth-related risks of the elimination diets that are used to treat food allergy, and ensure that families are excluding only the foods that are medically required or otherwise culturally indicated, that nutritional assessment and/or supplementation is provided as needed, and that subspecialty consultation is arranged, especially for children at highest risk," he said.

Dr. Vickery reported having no relevant financial disclosures.

fpnews@elsevier.com

SAN ANTONIO – Dietary restrictions prescribed for children with food allergies may lead to growth impairment, according to findings from a review of medical records for 245 food-allergic pediatric patients.

The risk of growth impairment was greatest for children whose dietary restrictions required elimination of more than two foods and/or elimination of cow’s milk, Dr. Brian P. Vickery reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

©BananaStock/thinkstockphotos.com

After age 2 years, the food-allergic children had lower mean percentiles for weight (67.5 vs. 72.5) and a lower body mass index (57.6 vs.68.0), than did 4,584 healthy age-matched controls.

Furthermore, the 52 patients with more than two food allergies (and thus more than two food restrictions), compared with 193 patients with one or two food allergies, had significantly lower mean percentiles for height (62.2 vs. 74.8) and weight (55.3 vs. 69.2). The 66 patients with milk allergy, compared with those with other food allergies, had lower mean percentiles for weight (54.5 vs. 70.6) and BMI (48.9 vs. 58.8), according to Dr. Vickery of the University of North Carolina at Chapel Hill.

Milk-allergic children younger than 2 years of age were particularly vulnerable to growth restriction, he said during a press briefing at the meeting.

The food-allergic children in this study, who were aged 1 month to 11 years and who presented to a University of North Carolina outpatient clinic between 2007 and 2011, also were compared with 205 "disease controls," consisting of children with either cystic fibrosis or celiac disease, two conditions that are associated with impaired growth. When children passed their second birthday, the effect of food allergy on growth was very similar to the effect of celiac disease on growth, Dr. Vickery said.

The findings of this study confirm those from a smaller study, conducted more than a decade ago, that also showed that milk allergy and multiple food allergies were associated with growth impairment.

That study is "the most commonly cited previous study to address the growth of food-allergic children in the United States," Dr. Vickery noted.

"The prevalence [of food allergy] has increased over the past 10 years, so we wanted to take another look in a bigger population to kind of reassess the impact of elimination diets on growth," he said.

The current findings demonstrate that a food allergy–associated elimination diet can place children at risk of impaired growth, compared with their healthy peers, regardless of whether they are under age 2 years, or are 2-11 years old, and that after age 2, the effect of food allergy on growth is very similar to that of chronic diseases known to affect growth, he said.

"While awareness of food allergy is increasing along with the prevalence of the disease, it is important to draw attention to the important consequences of elimination diets. We feel that providers should counsel patients and caregivers about the growth-related risks of the elimination diets that are used to treat food allergy, and ensure that families are excluding only the foods that are medically required or otherwise culturally indicated, that nutritional assessment and/or supplementation is provided as needed, and that subspecialty consultation is arranged, especially for children at highest risk," he said.

Dr. Vickery reported having no relevant financial disclosures.

fpnews@elsevier.com

SAN ANTONIO – Dietary restrictions prescribed for children with food allergies may lead to growth impairment, according to findings from a review of medical records for 245 food-allergic pediatric patients.

The risk of growth impairment was greatest for children whose dietary restrictions required elimination of more than two foods and/or elimination of cow’s milk, Dr. Brian P. Vickery reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

©BananaStock/thinkstockphotos.com

After age 2 years, the food-allergic children had lower mean percentiles for weight (67.5 vs. 72.5) and a lower body mass index (57.6 vs.68.0), than did 4,584 healthy age-matched controls.

Furthermore, the 52 patients with more than two food allergies (and thus more than two food restrictions), compared with 193 patients with one or two food allergies, had significantly lower mean percentiles for height (62.2 vs. 74.8) and weight (55.3 vs. 69.2). The 66 patients with milk allergy, compared with those with other food allergies, had lower mean percentiles for weight (54.5 vs. 70.6) and BMI (48.9 vs. 58.8), according to Dr. Vickery of the University of North Carolina at Chapel Hill.

Milk-allergic children younger than 2 years of age were particularly vulnerable to growth restriction, he said during a press briefing at the meeting.

The food-allergic children in this study, who were aged 1 month to 11 years and who presented to a University of North Carolina outpatient clinic between 2007 and 2011, also were compared with 205 "disease controls," consisting of children with either cystic fibrosis or celiac disease, two conditions that are associated with impaired growth. When children passed their second birthday, the effect of food allergy on growth was very similar to the effect of celiac disease on growth, Dr. Vickery said.

The findings of this study confirm those from a smaller study, conducted more than a decade ago, that also showed that milk allergy and multiple food allergies were associated with growth impairment.

That study is "the most commonly cited previous study to address the growth of food-allergic children in the United States," Dr. Vickery noted.

"The prevalence [of food allergy] has increased over the past 10 years, so we wanted to take another look in a bigger population to kind of reassess the impact of elimination diets on growth," he said.

The current findings demonstrate that a food allergy–associated elimination diet can place children at risk of impaired growth, compared with their healthy peers, regardless of whether they are under age 2 years, or are 2-11 years old, and that after age 2, the effect of food allergy on growth is very similar to that of chronic diseases known to affect growth, he said.

"While awareness of food allergy is increasing along with the prevalence of the disease, it is important to draw attention to the important consequences of elimination diets. We feel that providers should counsel patients and caregivers about the growth-related risks of the elimination diets that are used to treat food allergy, and ensure that families are excluding only the foods that are medically required or otherwise culturally indicated, that nutritional assessment and/or supplementation is provided as needed, and that subspecialty consultation is arranged, especially for children at highest risk," he said.

Dr. Vickery reported having no relevant financial disclosures.

fpnews@elsevier.com

SAN ANTONIO – Omalizumab diminished the signs and symptoms of chronic idiopathic urticaria in a dose-dependent fashion in a phase III study of 323 patients who failed to respond adequately to H1-antihistamines.

After 12 weeks of treatment with the recombinant humanized monoclonal antibody, improvements from baseline in weekly itch-severity scores were significantly greater in patients randomized to receive three doses of either 300 mg or 150 mg every 4 weeks, compared with placebo (score change of -9.8 and -8.1 vs. -5.1, respectively). The itch-severity score in patients randomized to receive a 75-mg dose changed by -5.9 points, but this did not differ significantly from the change in the placebo group, according to Dr. Marcus Maurer of Charite-Universitatsmedizin, Berlin. The report was published online on Feb. 24 in the New England Journal of Medicine.

The findings from this international double-blind trial were reported simultaneously at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In addition to meeting the primary 12-week response endpoint of change in weekly itch-severity score, patients receiving the 300-mg and 150-mg doses of omalizumab also experienced significant improvements, compared with patients given placebo, on all but one secondary endpoint, including change in the 7-day urticaria activity score (UAS7), change in the score for the weekly number of hives, time until a reduction from baseline of at least 5 points in the weekly itch-severity score (the MID), the proportions of patients with a UAS7 of 6 or less, the number of patients with a weekly MID response in the itch-severity score, the change from baseline in the score for the size of the largest hive, and change from baseline in the overall score on the Dermatology Life Quality Index. Those receiving 300 mg, but not those receiving 150 mg, also experienced significant improvement in the proportion of angioedema-free days from weeks 4-12 (N. Engl. J. Med. 2013 Feb. 24 [doi:10.1056/NEJMoa1215372]).

In a post hoc analysis at 12 weeks, 53%, 23%, 18%, and 10%, of those in the 300-mg, 150-mg, 75-mg, and placebo groups, respectively, were completely free of hives, and 44%, 22%, 16%, and 5%, respectively, were free of both hives and itching.

Of note, many patients experienced extremely rapid improvement, raising questions about a potential, as-yet unidentified and fundamental characteristic of this disease, study coauthors Dr. Thomas B. Casale, professor of medicine and medical microbiology and immunology and chief of allergy/immunology at Creighton University Medical Center, Omaha, Neb., and Dr. Allen P. Kaplan, clinical professor of medicine at the Medical University of South Carolina, Charleston, reported during a press briefing at AAAAI.

They explained that omalizumab, currently approved as an add-on therapy for moderate to severe persistent allergic asthma, is known to bind the allergic antibody immunoglobulin E (IgE). Many patients with chronic urticaria have an antibody that binds to a protein on the surface of histamine-containing cells, and that protein binds IgE.

"Just one injection drops one’s IgE level pretty close to zero ... and we learned that when we drop IgE to rock bottom, the protein on the cell to which it is attached also drops – and that’s the protein that the circulating antibody interacts with. The thinking was that if we drop the surface protein low enough, there’s nothing for the antibody to react with, and the hives would improve," he said.

This was, in fact, the case, as demonstrated in a phase I study of 12 patients, in which 7 patients responded dramatically, 4 responded partially, and 1 had no response. These findings led to the current phase III study, which is one of three such studies that investigators hope will lead to the drug’s approval for chronic idiopathic urticaria, because the high cost of the drug is prohibitive with respect to off-label use.

The same effect was seen in the current study.

This effect, however, takes a couple weeks to become apparent, so the rapid responses that occur in numerous patients suggest there is something more at play.

"This is working even faster than we thought, and probably there is a function of the allergic antibody that we do not yet understand," Dr. Kaplan said. "So this is going to be not only a terrific therapy for the disorder, but will lead to research in the future that probably – we hope – will elucidate the underlying abnormality of chronic urticaria beyond our current understanding of it. It’s very exciting, because it might elucidate some fundamental analogy that we don’t appreciate, and would have implications for allergic disease across the board."

The current study comprised patients aged 12-75 years who had a 6-month or longer history of chronic idiopathic urticaria, the presence of hives associated with itching for at least 8 consecutive weeks at any time prior to enrollment (despite H1-antihistamine use), a UAS7 of 16 or more during a 7-day period, a weekly itch-severity score of at least 8, a score of at least 4 on the UAS on at least one of the screening-visit days, and receipt of a licensed dose of a second-generation H1-antihistamine for at least 3 consecutive days immediately prior to the screening visit. Those with a clearly defined underlying cause for their symptoms were excluded. The doses evaluated in this study were based on a prior dose-ranging study, which showed no additional benefit with doses over 300 mg, the investigators said.

Patients continued to receive stable doses of H1-antihistamines throughout the 12-week treatment period, and were permitted to use diphenhydramine as a rescue medication.

Omalizumab was well tolerated in this study, with a similar number of adverse events occurring across the treatment groups. Serious adverse events occurred more often in the 300-mg group, with 6% of patients in that group experiencing a serious adverse event, compared with 3% of patients in the placebo group, and 1% of patients in the 150-mg and 75-mg groups, but the events were not considered to be related to the study drug.

The duration of response, however, was limited, as noted during a 16-week observation period following the initial 12-week treatment period.

Although the weekly itch-severity scores did not return to baseline during follow-up, they did increase to the levels seen in the placebo group.

The findings are nonetheless encouraging, Dr. Kaplan said, noting that this disease, which can have dramatic adverse effects on quality of life, is not uncommon, and can be difficult to treat, with about half of all patients failing to respond to standard therapy with high dose antihistamines. Alternate treatments used to treat the disease, including steroids and cyclosporine, can be effective, but can be highly toxic, he said.

"For refractory patients we have nothing that matches (omalizumab’s) combination of this kind of efficacy with low side effects, so many of us in the field kind of view this as a game changer for the patients," he said.

This study was sponsored by Genentech and Novartis Pharma. Several study authors made disclosures. A complete list of these disclosures is available with the full text of the article at NEJM.org.

fpnews@elsevier.com

SAN ANTONIO – Omalizumab diminished the signs and symptoms of chronic idiopathic urticaria in a dose-dependent fashion in a phase III study of 323 patients who failed to respond adequately to H1-antihistamines.

After 12 weeks of treatment with the recombinant humanized monoclonal antibody, improvements from baseline in weekly itch-severity scores were significantly greater in patients randomized to receive three doses of either 300 mg or 150 mg every 4 weeks, compared with placebo (score change of -9.8 and -8.1 vs. -5.1, respectively). The itch-severity score in patients randomized to receive a 75-mg dose changed by -5.9 points, but this did not differ significantly from the change in the placebo group, according to Dr. Marcus Maurer of Charite-Universitatsmedizin, Berlin. The report was published online on Feb. 24 in the New England Journal of Medicine.

The findings from this international double-blind trial were reported simultaneously at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In addition to meeting the primary 12-week response endpoint of change in weekly itch-severity score, patients receiving the 300-mg and 150-mg doses of omalizumab also experienced significant improvements, compared with patients given placebo, on all but one secondary endpoint, including change in the 7-day urticaria activity score (UAS7), change in the score for the weekly number of hives, time until a reduction from baseline of at least 5 points in the weekly itch-severity score (the MID), the proportions of patients with a UAS7 of 6 or less, the number of patients with a weekly MID response in the itch-severity score, the change from baseline in the score for the size of the largest hive, and change from baseline in the overall score on the Dermatology Life Quality Index. Those receiving 300 mg, but not those receiving 150 mg, also experienced significant improvement in the proportion of angioedema-free days from weeks 4-12 (N. Engl. J. Med. 2013 Feb. 24 [doi:10.1056/NEJMoa1215372]).

In a post hoc analysis at 12 weeks, 53%, 23%, 18%, and 10%, of those in the 300-mg, 150-mg, 75-mg, and placebo groups, respectively, were completely free of hives, and 44%, 22%, 16%, and 5%, respectively, were free of both hives and itching.

Of note, many patients experienced extremely rapid improvement, raising questions about a potential, as-yet unidentified and fundamental characteristic of this disease, study coauthors Dr. Thomas B. Casale, professor of medicine and medical microbiology and immunology and chief of allergy/immunology at Creighton University Medical Center, Omaha, Neb., and Dr. Allen P. Kaplan, clinical professor of medicine at the Medical University of South Carolina, Charleston, reported during a press briefing at AAAAI.

They explained that omalizumab, currently approved as an add-on therapy for moderate to severe persistent allergic asthma, is known to bind the allergic antibody immunoglobulin E (IgE). Many patients with chronic urticaria have an antibody that binds to a protein on the surface of histamine-containing cells, and that protein binds IgE.

"Just one injection drops one’s IgE level pretty close to zero ... and we learned that when we drop IgE to rock bottom, the protein on the cell to which it is attached also drops – and that’s the protein that the circulating antibody interacts with. The thinking was that if we drop the surface protein low enough, there’s nothing for the antibody to react with, and the hives would improve," he said.

This was, in fact, the case, as demonstrated in a phase I study of 12 patients, in which 7 patients responded dramatically, 4 responded partially, and 1 had no response. These findings led to the current phase III study, which is one of three such studies that investigators hope will lead to the drug’s approval for chronic idiopathic urticaria, because the high cost of the drug is prohibitive with respect to off-label use.

The same effect was seen in the current study.

This effect, however, takes a couple weeks to become apparent, so the rapid responses that occur in numerous patients suggest there is something more at play.

"This is working even faster than we thought, and probably there is a function of the allergic antibody that we do not yet understand," Dr. Kaplan said. "So this is going to be not only a terrific therapy for the disorder, but will lead to research in the future that probably – we hope – will elucidate the underlying abnormality of chronic urticaria beyond our current understanding of it. It’s very exciting, because it might elucidate some fundamental analogy that we don’t appreciate, and would have implications for allergic disease across the board."

The current study comprised patients aged 12-75 years who had a 6-month or longer history of chronic idiopathic urticaria, the presence of hives associated with itching for at least 8 consecutive weeks at any time prior to enrollment (despite H1-antihistamine use), a UAS7 of 16 or more during a 7-day period, a weekly itch-severity score of at least 8, a score of at least 4 on the UAS on at least one of the screening-visit days, and receipt of a licensed dose of a second-generation H1-antihistamine for at least 3 consecutive days immediately prior to the screening visit. Those with a clearly defined underlying cause for their symptoms were excluded. The doses evaluated in this study were based on a prior dose-ranging study, which showed no additional benefit with doses over 300 mg, the investigators said.

Patients continued to receive stable doses of H1-antihistamines throughout the 12-week treatment period, and were permitted to use diphenhydramine as a rescue medication.

Omalizumab was well tolerated in this study, with a similar number of adverse events occurring across the treatment groups. Serious adverse events occurred more often in the 300-mg group, with 6% of patients in that group experiencing a serious adverse event, compared with 3% of patients in the placebo group, and 1% of patients in the 150-mg and 75-mg groups, but the events were not considered to be related to the study drug.

The duration of response, however, was limited, as noted during a 16-week observation period following the initial 12-week treatment period.

Although the weekly itch-severity scores did not return to baseline during follow-up, they did increase to the levels seen in the placebo group.

The findings are nonetheless encouraging, Dr. Kaplan said, noting that this disease, which can have dramatic adverse effects on quality of life, is not uncommon, and can be difficult to treat, with about half of all patients failing to respond to standard therapy with high dose antihistamines. Alternate treatments used to treat the disease, including steroids and cyclosporine, can be effective, but can be highly toxic, he said.

"For refractory patients we have nothing that matches (omalizumab’s) combination of this kind of efficacy with low side effects, so many of us in the field kind of view this as a game changer for the patients," he said.

This study was sponsored by Genentech and Novartis Pharma. Several study authors made disclosures. A complete list of these disclosures is available with the full text of the article at NEJM.org.

fpnews@elsevier.com

SAN ANTONIO – Omalizumab diminished the signs and symptoms of chronic idiopathic urticaria in a dose-dependent fashion in a phase III study of 323 patients who failed to respond adequately to H1-antihistamines.

After 12 weeks of treatment with the recombinant humanized monoclonal antibody, improvements from baseline in weekly itch-severity scores were significantly greater in patients randomized to receive three doses of either 300 mg or 150 mg every 4 weeks, compared with placebo (score change of -9.8 and -8.1 vs. -5.1, respectively). The itch-severity score in patients randomized to receive a 75-mg dose changed by -5.9 points, but this did not differ significantly from the change in the placebo group, according to Dr. Marcus Maurer of Charite-Universitatsmedizin, Berlin. The report was published online on Feb. 24 in the New England Journal of Medicine.

The findings from this international double-blind trial were reported simultaneously at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In addition to meeting the primary 12-week response endpoint of change in weekly itch-severity score, patients receiving the 300-mg and 150-mg doses of omalizumab also experienced significant improvements, compared with patients given placebo, on all but one secondary endpoint, including change in the 7-day urticaria activity score (UAS7), change in the score for the weekly number of hives, time until a reduction from baseline of at least 5 points in the weekly itch-severity score (the MID), the proportions of patients with a UAS7 of 6 or less, the number of patients with a weekly MID response in the itch-severity score, the change from baseline in the score for the size of the largest hive, and change from baseline in the overall score on the Dermatology Life Quality Index. Those receiving 300 mg, but not those receiving 150 mg, also experienced significant improvement in the proportion of angioedema-free days from weeks 4-12 (N. Engl. J. Med. 2013 Feb. 24 [doi:10.1056/NEJMoa1215372]).

In a post hoc analysis at 12 weeks, 53%, 23%, 18%, and 10%, of those in the 300-mg, 150-mg, 75-mg, and placebo groups, respectively, were completely free of hives, and 44%, 22%, 16%, and 5%, respectively, were free of both hives and itching.

Of note, many patients experienced extremely rapid improvement, raising questions about a potential, as-yet unidentified and fundamental characteristic of this disease, study coauthors Dr. Thomas B. Casale, professor of medicine and medical microbiology and immunology and chief of allergy/immunology at Creighton University Medical Center, Omaha, Neb., and Dr. Allen P. Kaplan, clinical professor of medicine at the Medical University of South Carolina, Charleston, reported during a press briefing at AAAAI.

They explained that omalizumab, currently approved as an add-on therapy for moderate to severe persistent allergic asthma, is known to bind the allergic antibody immunoglobulin E (IgE). Many patients with chronic urticaria have an antibody that binds to a protein on the surface of histamine-containing cells, and that protein binds IgE.

"Just one injection drops one’s IgE level pretty close to zero ... and we learned that when we drop IgE to rock bottom, the protein on the cell to which it is attached also drops – and that’s the protein that the circulating antibody interacts with. The thinking was that if we drop the surface protein low enough, there’s nothing for the antibody to react with, and the hives would improve," he said.

This was, in fact, the case, as demonstrated in a phase I study of 12 patients, in which 7 patients responded dramatically, 4 responded partially, and 1 had no response. These findings led to the current phase III study, which is one of three such studies that investigators hope will lead to the drug’s approval for chronic idiopathic urticaria, because the high cost of the drug is prohibitive with respect to off-label use.

The same effect was seen in the current study.

This effect, however, takes a couple weeks to become apparent, so the rapid responses that occur in numerous patients suggest there is something more at play.

"This is working even faster than we thought, and probably there is a function of the allergic antibody that we do not yet understand," Dr. Kaplan said. "So this is going to be not only a terrific therapy for the disorder, but will lead to research in the future that probably – we hope – will elucidate the underlying abnormality of chronic urticaria beyond our current understanding of it. It’s very exciting, because it might elucidate some fundamental analogy that we don’t appreciate, and would have implications for allergic disease across the board."

The current study comprised patients aged 12-75 years who had a 6-month or longer history of chronic idiopathic urticaria, the presence of hives associated with itching for at least 8 consecutive weeks at any time prior to enrollment (despite H1-antihistamine use), a UAS7 of 16 or more during a 7-day period, a weekly itch-severity score of at least 8, a score of at least 4 on the UAS on at least one of the screening-visit days, and receipt of a licensed dose of a second-generation H1-antihistamine for at least 3 consecutive days immediately prior to the screening visit. Those with a clearly defined underlying cause for their symptoms were excluded. The doses evaluated in this study were based on a prior dose-ranging study, which showed no additional benefit with doses over 300 mg, the investigators said.

Patients continued to receive stable doses of H1-antihistamines throughout the 12-week treatment period, and were permitted to use diphenhydramine as a rescue medication.

Omalizumab was well tolerated in this study, with a similar number of adverse events occurring across the treatment groups. Serious adverse events occurred more often in the 300-mg group, with 6% of patients in that group experiencing a serious adverse event, compared with 3% of patients in the placebo group, and 1% of patients in the 150-mg and 75-mg groups, but the events were not considered to be related to the study drug.

The duration of response, however, was limited, as noted during a 16-week observation period following the initial 12-week treatment period.

Although the weekly itch-severity scores did not return to baseline during follow-up, they did increase to the levels seen in the placebo group.

The findings are nonetheless encouraging, Dr. Kaplan said, noting that this disease, which can have dramatic adverse effects on quality of life, is not uncommon, and can be difficult to treat, with about half of all patients failing to respond to standard therapy with high dose antihistamines. Alternate treatments used to treat the disease, including steroids and cyclosporine, can be effective, but can be highly toxic, he said.

"For refractory patients we have nothing that matches (omalizumab’s) combination of this kind of efficacy with low side effects, so many of us in the field kind of view this as a game changer for the patients," he said.

This study was sponsored by Genentech and Novartis Pharma. Several study authors made disclosures. A complete list of these disclosures is available with the full text of the article at NEJM.org.

fpnews@elsevier.com

SAN ANTONIO – Omalizumab diminished the signs and symptoms of chronic idiopathic urticaria in a dose-dependent fashion in a phase III study of 323 patients who failed to respond adequately to H1-antihistamines.

After 12 weeks of treatment with the recombinant humanized monoclonal antibody, improvements from baseline in weekly itch-severity scores were significantly greater in patients randomized to receive three doses of either 300 mg or 150 mg every 4 weeks, compared with placebo (score change of -9.8 and -8.1 vs. -5.1, respectively). The itch-severity score in patients randomized to receive a 75-mg dose changed by -5.9 points, but this did not differ significantly from the change in the placebo group, according to Dr. Marcus Maurer of Charite-Universitatsmedizin, Berlin. The report was published online on Feb. 24 in the New England Journal of Medicine.

The findings from this international double-blind trial were reported simultaneously at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In addition to meeting the primary 12-week response endpoint of change in weekly itch-severity score, patients receiving the 300-mg and 150-mg doses of omalizumab also experienced significant improvements, compared with patients given placebo, on all but one secondary endpoint, including change in the 7-day urticaria activity score (UAS7), change in the score for the weekly number of hives, time until a reduction from baseline of at least 5 points in the weekly itch-severity score (the MID), the proportions of patients with a UAS7 of 6 or less, the number of patients with a weekly MID response in the itch-severity score, the change from baseline in the score for the size of the largest hive, and change from baseline in the overall score on the Dermatology Life Quality Index. Those receiving 300 mg, but not those receiving 150 mg, also experienced significant improvement in the proportion of angioedema-free days from weeks 4-12 (N. Engl. J. Med. 2013 Feb. 24 [doi:10.1056/NEJMoa1215372]).

In a post hoc analysis at 12 weeks, 53%, 23%, 18%, and 10%, of those in the 300-mg, 150-mg, 75-mg, and placebo groups, respectively, were completely free of hives, and 44%, 22%, 16%, and 5%, respectively, were free of both hives and itching.

Of note, many patients experienced extremely rapid improvement, raising questions about a potential, as-yet unidentified and fundamental characteristic of this disease, study coauthors Dr. Thomas B. Casale, professor of medicine and medical microbiology and immunology and chief of allergy/immunology at Creighton University Medical Center, Omaha, Neb., and Dr. Allen P. Kaplan, clinical professor of medicine at the Medical University of South Carolina, Charleston, reported during a press briefing at AAAAI.

They explained that omalizumab, currently approved as an add-on therapy for moderate to severe persistent allergic asthma, is known to bind the allergic antibody immunoglobulin E (IgE). Many patients with chronic urticaria have an antibody that binds to a protein on the surface of histamine-containing cells, and that protein binds IgE.

"Just one injection drops one’s IgE level pretty close to zero ... and we learned that when we drop IgE to rock bottom, the protein on the cell to which it is attached also drops – and that’s the protein that the circulating antibody interacts with. The thinking was that if we drop the surface protein low enough, there’s nothing for the antibody to react with, and the hives would improve," he said.

This was, in fact, the case, as demonstrated in a phase I study of 12 patients, in which 7 patients responded dramatically, 4 responded partially, and 1 had no response. These findings led to the current phase III study, which is one of three such studies that investigators hope will lead to the drug’s approval for chronic idiopathic urticaria, because the high cost of the drug is prohibitive with respect to off-label use.

The same effect was seen in the current study.

This effect, however, takes a couple weeks to become apparent, so the rapid responses that occur in numerous patients suggest there is something more at play.

"This is working even faster than we thought, and probably there is a function of the allergic antibody that we do not yet understand," Dr. Kaplan said. "So this is going to be not only a terrific therapy for the disorder, but will lead to research in the future that probably – we hope – will elucidate the underlying abnormality of chronic urticaria beyond our current understanding of it. It’s very exciting, because it might elucidate some fundamental analogy that we don’t appreciate, and would have implications for allergic disease across the board."

The current study comprised patients aged 12-75 years who had a 6-month or longer history of chronic idiopathic urticaria, the presence of hives associated with itching for at least 8 consecutive weeks at any time prior to enrollment (despite H1-antihistamine use), a UAS7 of 16 or more during a 7-day period, a weekly itch-severity score of at least 8, a score of at least 4 on the UAS on at least one of the screening-visit days, and receipt of a licensed dose of a second-generation H1-antihistamine for at least 3 consecutive days immediately prior to the screening visit. Those with a clearly defined underlying cause for their symptoms were excluded. The doses evaluated in this study were based on a prior dose-ranging study, which showed no additional benefit with doses over 300 mg, the investigators said.

Patients continued to receive stable doses of H1-antihistamines throughout the 12-week treatment period, and were permitted to use diphenhydramine as a rescue medication.

Omalizumab was well tolerated in this study, with a similar number of adverse events occurring across the treatment groups. Serious adverse events occurred more often in the 300-mg group, with 6% of patients in that group experiencing a serious adverse event, compared with 3% of patients in the placebo group, and 1% of patients in the 150-mg and 75-mg groups, but the events were not considered to be related to the study drug.

The duration of response, however, was limited, as noted during a 16-week observation period following the initial 12-week treatment period.

Although the weekly itch-severity scores did not return to baseline during follow-up, they did increase to the levels seen in the placebo group.

The findings are nonetheless encouraging, Dr. Kaplan said, noting that this disease, which can have dramatic adverse effects on quality of life, is not uncommon, and can be difficult to treat, with about half of all patients failing to respond to standard therapy with high dose antihistamines. Alternate treatments used to treat the disease, including steroids and cyclosporine, can be effective, but can be highly toxic, he said.

"For refractory patients we have nothing that matches (omalizumab’s) combination of this kind of efficacy with low side effects, so many of us in the field kind of view this as a game changer for the patients," he said.

This study was sponsored by Genentech and Novartis Pharma. Several study authors made disclosures. A complete list of these disclosures is available with the full text of the article at NEJM.org.

fpnews@elsevier.com

SAN ANTONIO – Omalizumab diminished the signs and symptoms of chronic idiopathic urticaria in a dose-dependent fashion in a phase III study of 323 patients who failed to respond adequately to H1-antihistamines.

After 12 weeks of treatment with the recombinant humanized monoclonal antibody, improvements from baseline in weekly itch-severity scores were significantly greater in patients randomized to receive three doses of either 300 mg or 150 mg every 4 weeks, compared with placebo (score change of -9.8 and -8.1 vs. -5.1, respectively). The itch-severity score in patients randomized to receive a 75-mg dose changed by -5.9 points, but this did not differ significantly from the change in the placebo group, according to Dr. Marcus Maurer of Charite-Universitatsmedizin, Berlin. The report was published online on Feb. 24 in the New England Journal of Medicine.

The findings from this international double-blind trial were reported simultaneously at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In addition to meeting the primary 12-week response endpoint of change in weekly itch-severity score, patients receiving the 300-mg and 150-mg doses of omalizumab also experienced significant improvements, compared with patients given placebo, on all but one secondary endpoint, including change in the 7-day urticaria activity score (UAS7), change in the score for the weekly number of hives, time until a reduction from baseline of at least 5 points in the weekly itch-severity score (the MID), the proportions of patients with a UAS7 of 6 or less, the number of patients with a weekly MID response in the itch-severity score, the change from baseline in the score for the size of the largest hive, and change from baseline in the overall score on the Dermatology Life Quality Index. Those receiving 300 mg, but not those receiving 150 mg, also experienced significant improvement in the proportion of angioedema-free days from weeks 4-12 (N. Engl. J. Med. 2013 Feb. 24 [doi:10.1056/NEJMoa1215372]).

In a post hoc analysis at 12 weeks, 53%, 23%, 18%, and 10%, of those in the 300-mg, 150-mg, 75-mg, and placebo groups, respectively, were completely free of hives, and 44%, 22%, 16%, and 5%, respectively, were free of both hives and itching.

Of note, many patients experienced extremely rapid improvement, raising questions about a potential, as-yet unidentified and fundamental characteristic of this disease, study coauthors Dr. Thomas B. Casale, professor of medicine and medical microbiology and immunology and chief of allergy/immunology at Creighton University Medical Center, Omaha, Neb., and Dr. Allen P. Kaplan, clinical professor of medicine at the Medical University of South Carolina, Charleston, reported during a press briefing at AAAAI.

They explained that omalizumab, currently approved as an add-on therapy for moderate to severe persistent allergic asthma, is known to bind the allergic antibody immunoglobulin E (IgE). Many patients with chronic urticaria have an antibody that binds to a protein on the surface of histamine-containing cells, and that protein binds IgE.

"Just one injection drops one’s IgE level pretty close to zero ... and we learned that when we drop IgE to rock bottom, the protein on the cell to which it is attached also drops – and that’s the protein that the circulating antibody interacts with. The thinking was that if we drop the surface protein low enough, there’s nothing for the antibody to react with, and the hives would improve," he said.

This was, in fact, the case, as demonstrated in a phase I study of 12 patients, in which 7 patients responded dramatically, 4 responded partially, and 1 had no response. These findings led to the current phase III study, which is one of three such studies that investigators hope will lead to the drug’s approval for chronic idiopathic urticaria, because the high cost of the drug is prohibitive with respect to off-label use.

The same effect was seen in the current study.

This effect, however, takes a couple weeks to become apparent, so the rapid responses that occur in numerous patients suggest there is something more at play.

"This is working even faster than we thought, and probably there is a function of the allergic antibody that we do not yet understand," Dr. Kaplan said. "So this is going to be not only a terrific therapy for the disorder, but will lead to research in the future that probably – we hope – will elucidate the underlying abnormality of chronic urticaria beyond our current understanding of it. It’s very exciting, because it might elucidate some fundamental analogy that we don’t appreciate, and would have implications for allergic disease across the board."

The current study comprised patients aged 12-75 years who had a 6-month or longer history of chronic idiopathic urticaria, the presence of hives associated with itching for at least 8 consecutive weeks at any time prior to enrollment (despite H1-antihistamine use), a UAS7 of 16 or more during a 7-day period, a weekly itch-severity score of at least 8, a score of at least 4 on the UAS on at least one of the screening-visit days, and receipt of a licensed dose of a second-generation H1-antihistamine for at least 3 consecutive days immediately prior to the screening visit. Those with a clearly defined underlying cause for their symptoms were excluded. The doses evaluated in this study were based on a prior dose-ranging study, which showed no additional benefit with doses over 300 mg, the investigators said.

Patients continued to receive stable doses of H1-antihistamines throughout the 12-week treatment period, and were permitted to use diphenhydramine as a rescue medication.

Omalizumab was well tolerated in this study, with a similar number of adverse events occurring across the treatment groups. Serious adverse events occurred more often in the 300-mg group, with 6% of patients in that group experiencing a serious adverse event, compared with 3% of patients in the placebo group, and 1% of patients in the 150-mg and 75-mg groups, but the events were not considered to be related to the study drug.

The duration of response, however, was limited, as noted during a 16-week observation period following the initial 12-week treatment period.

Although the weekly itch-severity scores did not return to baseline during follow-up, they did increase to the levels seen in the placebo group.

The findings are nonetheless encouraging, Dr. Kaplan said, noting that this disease, which can have dramatic adverse effects on quality of life, is not uncommon, and can be difficult to treat, with about half of all patients failing to respond to standard therapy with high dose antihistamines. Alternate treatments used to treat the disease, including steroids and cyclosporine, can be effective, but can be highly toxic, he said.

"For refractory patients we have nothing that matches (omalizumab’s) combination of this kind of efficacy with low side effects, so many of us in the field kind of view this as a game changer for the patients," he said.

This study was sponsored by Genentech and Novartis Pharma. Several study authors made disclosures. A complete list of these disclosures is available with the full text of the article at NEJM.org.

fpnews@elsevier.com

SAN ANTONIO – Omalizumab diminished the signs and symptoms of chronic idiopathic urticaria in a dose-dependent fashion in a phase III study of 323 patients who failed to respond adequately to H1-antihistamines.

After 12 weeks of treatment with the recombinant humanized monoclonal antibody, improvements from baseline in weekly itch-severity scores were significantly greater in patients randomized to receive three doses of either 300 mg or 150 mg every 4 weeks, compared with placebo (score change of -9.8 and -8.1 vs. -5.1, respectively). The itch-severity score in patients randomized to receive a 75-mg dose changed by -5.9 points, but this did not differ significantly from the change in the placebo group, according to Dr. Marcus Maurer of Charite-Universitatsmedizin, Berlin. The report was published online on Feb. 24 in the New England Journal of Medicine.

The findings from this international double-blind trial were reported simultaneously at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In addition to meeting the primary 12-week response endpoint of change in weekly itch-severity score, patients receiving the 300-mg and 150-mg doses of omalizumab also experienced significant improvements, compared with patients given placebo, on all but one secondary endpoint, including change in the 7-day urticaria activity score (UAS7), change in the score for the weekly number of hives, time until a reduction from baseline of at least 5 points in the weekly itch-severity score (the MID), the proportions of patients with a UAS7 of 6 or less, the number of patients with a weekly MID response in the itch-severity score, the change from baseline in the score for the size of the largest hive, and change from baseline in the overall score on the Dermatology Life Quality Index. Those receiving 300 mg, but not those receiving 150 mg, also experienced significant improvement in the proportion of angioedema-free days from weeks 4-12 (N. Engl. J. Med. 2013 Feb. 24 [doi:10.1056/NEJMoa1215372]).

In a post hoc analysis at 12 weeks, 53%, 23%, 18%, and 10%, of those in the 300-mg, 150-mg, 75-mg, and placebo groups, respectively, were completely free of hives, and 44%, 22%, 16%, and 5%, respectively, were free of both hives and itching.

Of note, many patients experienced extremely rapid improvement, raising questions about a potential, as-yet unidentified and fundamental characteristic of this disease, study coauthors Dr. Thomas B. Casale, professor of medicine and medical microbiology and immunology and chief of allergy/immunology at Creighton University Medical Center, Omaha, Neb., and Dr. Allen P. Kaplan, clinical professor of medicine at the Medical University of South Carolina, Charleston, reported during a press briefing at AAAAI.

They explained that omalizumab, currently approved as an add-on therapy for moderate to severe persistent allergic asthma, is known to bind the allergic antibody immunoglobulin E (IgE). Many patients with chronic urticaria have an antibody that binds to a protein on the surface of histamine-containing cells, and that protein binds IgE.

"Just one injection drops one’s IgE level pretty close to zero ... and we learned that when we drop IgE to rock bottom, the protein on the cell to which it is attached also drops – and that’s the protein that the circulating antibody interacts with. The thinking was that if we drop the surface protein low enough, there’s nothing for the antibody to react with, and the hives would improve," he said.

This was, in fact, the case, as demonstrated in a phase I study of 12 patients, in which 7 patients responded dramatically, 4 responded partially, and 1 had no response. These findings led to the current phase III study, which is one of three such studies that investigators hope will lead to the drug’s approval for chronic idiopathic urticaria, because the high cost of the drug is prohibitive with respect to off-label use.

The same effect was seen in the current study.

This effect, however, takes a couple weeks to become apparent, so the rapid responses that occur in numerous patients suggest there is something more at play.

"This is working even faster than we thought, and probably there is a function of the allergic antibody that we do not yet understand," Dr. Kaplan said. "So this is going to be not only a terrific therapy for the disorder, but will lead to research in the future that probably – we hope – will elucidate the underlying abnormality of chronic urticaria beyond our current understanding of it. It’s very exciting, because it might elucidate some fundamental analogy that we don’t appreciate, and would have implications for allergic disease across the board."

The current study comprised patients aged 12-75 years who had a 6-month or longer history of chronic idiopathic urticaria, the presence of hives associated with itching for at least 8 consecutive weeks at any time prior to enrollment (despite H1-antihistamine use), a UAS7 of 16 or more during a 7-day period, a weekly itch-severity score of at least 8, a score of at least 4 on the UAS on at least one of the screening-visit days, and receipt of a licensed dose of a second-generation H1-antihistamine for at least 3 consecutive days immediately prior to the screening visit. Those with a clearly defined underlying cause for their symptoms were excluded. The doses evaluated in this study were based on a prior dose-ranging study, which showed no additional benefit with doses over 300 mg, the investigators said.

Patients continued to receive stable doses of H1-antihistamines throughout the 12-week treatment period, and were permitted to use diphenhydramine as a rescue medication.

Omalizumab was well tolerated in this study, with a similar number of adverse events occurring across the treatment groups. Serious adverse events occurred more often in the 300-mg group, with 6% of patients in that group experiencing a serious adverse event, compared with 3% of patients in the placebo group, and 1% of patients in the 150-mg and 75-mg groups, but the events were not considered to be related to the study drug.

The duration of response, however, was limited, as noted during a 16-week observation period following the initial 12-week treatment period.

Although the weekly itch-severity scores did not return to baseline during follow-up, they did increase to the levels seen in the placebo group.

The findings are nonetheless encouraging, Dr. Kaplan said, noting that this disease, which can have dramatic adverse effects on quality of life, is not uncommon, and can be difficult to treat, with about half of all patients failing to respond to standard therapy with high dose antihistamines. Alternate treatments used to treat the disease, including steroids and cyclosporine, can be effective, but can be highly toxic, he said.

"For refractory patients we have nothing that matches (omalizumab’s) combination of this kind of efficacy with low side effects, so many of us in the field kind of view this as a game changer for the patients," he said.

This study was sponsored by Genentech and Novartis Pharma. Several study authors made disclosures. A complete list of these disclosures is available with the full text of the article at NEJM.org.

fpnews@elsevier.com

The U.S. Preventive Services Task Force has recommended against vitamin D and calcium supplementation in healthy postmenopausal women, citing research showing that such supplementation increases the risk of kidney stones and does not protect against fractures in this population.

Top:©Kaspri/Fotolia.com; Bottom: ©Elenathewise/fotolia.com

Specifically, the USPSTF recommended – with moderate certainty – against supplementation with doses of vitamin D at 400 IU or less, and calcium at 1,000 IU or less in noninstitutionalized postmenopausal women. The evidence with respect to higher doses is insufficient for making a recommendation, Dr. Virginia A. Moyer reported on behalf of the USPSTF.

The evidence is also insufficient to assess the balance of the benefits and harms of combined vitamin D and calcium supplementation for the primary prevention of fractures in men and in premenopausal women, according to the recommendation statement, which was published online in the Feb. 25 issue of Annals of Internal Medicine (doi:10.7326/
0003-4819-158-9-201305070-00605).

Based on previously released recommendation statements, however, the USPSTF does recommend vitamin D supplementation for the prevention of falls in community-dwelling adults aged 65 years or older who are at increased risk for falls, and recommends that women aged 65 years and older be screened for osteoporosis.

Younger women with a fracture risk that is equal to or greater than that of a 65-year-old white woman with no additional risk factors should also be screened.

The new recommendations apply to noninstitutionalized or community-dwelling asymptomatic adults without a history of fractures; they do not apply to persons with osteoporosis or vitamin D deficiency.

The USPSTF acknowledged that the health burden of fractures is substantial in the older population, with nearly half of all women over age 50 years experiencing an osteoporosis-related fracture during their lifetime, but the task force noted that the increased risk of renal stones demonstrated in participants in the Women’s Health Initiative study who were taking supplemental vitamin D and calcium was also substantial.

"One woman was diagnosed with a urinary tract stone for every 273 women who received supplementation over a 7-year follow-up period," according to the recommendation statement.

In developing the recommendations, the USPSTF commissioned two systematic reviews of the evidence from 16 available randomized controlled trials and an updated meta-analysis of vitamin D supplementation with or without calcium supplementation.

The members of the USPSTF said they had no relevant financial disclosures.

The U.S. Preventive Services Task Force has recommended against vitamin D and calcium supplementation in healthy postmenopausal women, citing research showing that such supplementation increases the risk of kidney stones and does not protect against fractures in this population.

Top:©Kaspri/Fotolia.com; Bottom: ©Elenathewise/fotolia.com

Specifically, the USPSTF recommended – with moderate certainty – against supplementation with doses of vitamin D at 400 IU or less, and calcium at 1,000 IU or less in noninstitutionalized postmenopausal women. The evidence with respect to higher doses is insufficient for making a recommendation, Dr. Virginia A. Moyer reported on behalf of the USPSTF.

The evidence is also insufficient to assess the balance of the benefits and harms of combined vitamin D and calcium supplementation for the primary prevention of fractures in men and in premenopausal women, according to the recommendation statement, which was published online in the Feb. 25 issue of Annals of Internal Medicine (doi:10.7326/
0003-4819-158-9-201305070-00605).

Based on previously released recommendation statements, however, the USPSTF does recommend vitamin D supplementation for the prevention of falls in community-dwelling adults aged 65 years or older who are at increased risk for falls, and recommends that women aged 65 years and older be screened for osteoporosis.

Younger women with a fracture risk that is equal to or greater than that of a 65-year-old white woman with no additional risk factors should also be screened.

The new recommendations apply to noninstitutionalized or community-dwelling asymptomatic adults without a history of fractures; they do not apply to persons with osteoporosis or vitamin D deficiency.

The USPSTF acknowledged that the health burden of fractures is substantial in the older population, with nearly half of all women over age 50 years experiencing an osteoporosis-related fracture during their lifetime, but the task force noted that the increased risk of renal stones demonstrated in participants in the Women’s Health Initiative study who were taking supplemental vitamin D and calcium was also substantial.

"One woman was diagnosed with a urinary tract stone for every 273 women who received supplementation over a 7-year follow-up period," according to the recommendation statement.

In developing the recommendations, the USPSTF commissioned two systematic reviews of the evidence from 16 available randomized controlled trials and an updated meta-analysis of vitamin D supplementation with or without calcium supplementation.

The members of the USPSTF said they had no relevant financial disclosures.

The U.S. Preventive Services Task Force has recommended against vitamin D and calcium supplementation in healthy postmenopausal women, citing research showing that such supplementation increases the risk of kidney stones and does not protect against fractures in this population.

Top:©Kaspri/Fotolia.com; Bottom: ©Elenathewise/fotolia.com

Specifically, the USPSTF recommended – with moderate certainty – against supplementation with doses of vitamin D at 400 IU or less, and calcium at 1,000 IU or less in noninstitutionalized postmenopausal women. The evidence with respect to higher doses is insufficient for making a recommendation, Dr. Virginia A. Moyer reported on behalf of the USPSTF.

The evidence is also insufficient to assess the balance of the benefits and harms of combined vitamin D and calcium supplementation for the primary prevention of fractures in men and in premenopausal women, according to the recommendation statement, which was published online in the Feb. 25 issue of Annals of Internal Medicine (doi:10.7326/
0003-4819-158-9-201305070-00605).

Based on previously released recommendation statements, however, the USPSTF does recommend vitamin D supplementation for the prevention of falls in community-dwelling adults aged 65 years or older who are at increased risk for falls, and recommends that women aged 65 years and older be screened for osteoporosis.

Younger women with a fracture risk that is equal to or greater than that of a 65-year-old white woman with no additional risk factors should also be screened.

The new recommendations apply to noninstitutionalized or community-dwelling asymptomatic adults without a history of fractures; they do not apply to persons with osteoporosis or vitamin D deficiency.

The USPSTF acknowledged that the health burden of fractures is substantial in the older population, with nearly half of all women over age 50 years experiencing an osteoporosis-related fracture during their lifetime, but the task force noted that the increased risk of renal stones demonstrated in participants in the Women’s Health Initiative study who were taking supplemental vitamin D and calcium was also substantial.

"One woman was diagnosed with a urinary tract stone for every 273 women who received supplementation over a 7-year follow-up period," according to the recommendation statement.

In developing the recommendations, the USPSTF commissioned two systematic reviews of the evidence from 16 available randomized controlled trials and an updated meta-analysis of vitamin D supplementation with or without calcium supplementation.

The members of the USPSTF said they had no relevant financial disclosures.

MIAMI BEACH – Denervation of the renal arteries improved glucose metabolism and control of drug-resistant hypertension, according to findings from a 2011 pilot study.

"If you thought the impact of renal denervation on hypertension was big, certainly the consideration of renal sympathetic denervation on glucose metabolism raises some real eye-opening opportunities," Dr. Michael R. Jaff said at the International Symposium on Endovascular Therapy 2013.

In 50 patients with drug-resistant hypertension who were enrolled in the pilot study, 37 underwent bilateral renal denervation, and 13 served as controls. Not only did the treated patients experience improvements in blood pressure compared with controls at 3 months (decreases in systolic BP of 32 mm Hg vs. 5 mm Hg, and decreases in diastolic BP of 12 mm Hg vs. 3 mm Hg in treated patients vs. controls, respectively), they also experienced improvements in fasting blood glucose levels.

At 3 months, the treatment group had a 9.4-mg/dL decrease in fasting blood glucose, compared with a 0.9-mg/dL increase in the controls (Circulation 2011;123:1940-6).

"However, I think the most exciting thing is the impact on plasma insulin levels, where there was a real reduction in plasma insulin levels at 1 month and 3 months in patients treated with renal denervation," said Dr. Jaff, who is medical director of the vascular center, the vascular diagnostic laboratory, and the vascular ultrasound core laboratory at Massachusetts General Hospital, Boston.

At 1 month, plasma insulin had decreased by 8.7 mcU/mL in the treated patients, and increased by 6.4 mcU/mL increase in the controls; at 3 months, plasma insulin had decreased by 11.6 mcU/mL in the treated patients, and increased by 0.5 mcU/mL in the controls.

A reduction in the number of patients diagnosed with diabetes and with impaired glucose tolerance was seen at 3 months in the treatment group, while the diabetic cases increased from 23% to 38% and normal glucose tolerance dropped from 31% to 24% in the control group, Dr. Jaff said.

"Admittedly this is a small sample size, but nonetheless, given the basic pathophysiology of this and these early findings, this is a tantalizing impact," he said, adding that if the findings are confirmed, the potential reach of renal denervation is mind-boggling.

"I think the potential is amazing. Could we actually say we could prevent diabetes mellitus in those with resistant hypertension? Could we cure those who already have diabetes? All of this would potentially be on a background of blood pressure control. We’ve all seen these charts that show that the more risk factors you have, it’s almost logarithmic, the impact on atherosclerosis. So being able to manage two major atherosclerotic risk factors with one simple procedure is almost hard to comprehend," he said.

But the "basic pathophysiology" he mentioned offers a plausible path to comprehension of the potential impact of renal sympathetic denervation.

Specifically, sympathetic hyperactivity directly mediates vascular resistance, and increases in vascular resistance shift blood flow from striated muscle to visceral tissues, he said, explaining that visceral tissue is less insulin sensitive than striated muscle.

In one long-term study looking at sympathetic drive in patients with essential hypertension and in normotensive controls, patients with type 2 diabetes had higher sympathetic drive than did controls, and those with hypertension and diabetes had the highest sympathetic drive. The study, which followed patients for 18 years, indicated that sympathetic drive and impaired glucose tolerance were directly related, he said (Metabolism Clin. Exper. 2008;57:1422-7).

"The background on this is that catheter-based denervation has been shown to reduce sympathetic drive as measured by renal norepinephrine spillover at 6 months, with a near 50% reduction in spillover," he said.

The pathophysiology – particularly outflow from the central nervous system and its effect on the clinical symptom of lung congestion – also provides a rationale for multiple other observed and potential "collateral benefits" of renal denervation, such as improvements in obstructive sleep apnea, said Dr. Krishna T. Rocha-Singh, who is director of the Prairie Vascular Institute at St. John’s Hospital, Springfield, Ill.

"Renal sympathetic outflow results in volume reduction and renal blood flow, retention of sodium and volume retention, and can relate to congestion. We can also have an internal reset, if you will, of the chemoreceptors on the brain that can lead to dyspnea and central sleep apnea. And, as [Dr. Jaff] suggested, there can be a reduction in peripheral vascular resistance due to vascular remodeling that improves insulin resistance.

"But more importantly, we have the effect of increased hypertrophy that may induce arrhythmias, oxygen consumption, and promote dyspnea. There’s also a direct connection between that and the brain, again relating to congestion," he said.

Dr. Rocha-Singh said this synergy between two pathophysiological systems – the activation of the sympathetic nervous system and the retention of sodium – relates to vascular resistance and excess volume, and to congestion and the perception of dyspnea.

When a person is in a reclining position, fluid shifts from the legs to the soft tissues. This effect is greater in patients with drug-resistant hypertension than in those with controlled blood pressure, and it occurs irrespective of body mass index and neck circumference, he said.

In a small study of patients who underwent renal denervation, 70% experienced not only blood pressure improvements but also decreases in the severity of sleep apnea as measured using the apnea-hypopnea index at 3 and 6 months’ follow-up, he said.

Additionally, in a small trial involving 27 patients who underwent pulmonary vein isolation or ablation of atrial fibrillation, 69% of those who also underwent renal denervation were free of recurrence of atrial fibrillation at 12 months, compared with only 29% of those who did not undergo renal denervation (J. Am. Coll. Cardiol. 2012;60:1163-70).

These encouraging findings contribute to what Dr. Rocha-Singh called a "tsunami of excitement" surrounding renal denervation. He noted that a quick Internet search identified more than 145 papers that have been published on the topic, and showed that more than 1,700 related provisional patents have been filed.

While, he – like Dr. Jaff – agreed that the enthusiasm must be tempered pending additional procedural and long-term data, he noted that the diversity of the primary and observed collateral benefits of renal denervation is something of a "vuja de" – the opposite of déjà vu.

"We have never experienced anything like this in our professional lives," he said.

Dr. Jaff is a consultant for numerous companies, including Medtronic, the maker of the Symplicity renal denervation device, but he is not compensated by Medtronic. He also has equity in numerous medical device companies, including one – Northwind Medical – that has a renal denervation strategy utilizing a novel mechanism. He is a board member for the nonprofit VIVA Physicians organization. Dr. Rocha-Singh is also a consultant or advisory board member for Medtronic, as well as for CardioSonic.

MIAMI BEACH – Denervation of the renal arteries improved glucose metabolism and control of drug-resistant hypertension, according to findings from a 2011 pilot study.

"If you thought the impact of renal denervation on hypertension was big, certainly the consideration of renal sympathetic denervation on glucose metabolism raises some real eye-opening opportunities," Dr. Michael R. Jaff said at the International Symposium on Endovascular Therapy 2013.

In 50 patients with drug-resistant hypertension who were enrolled in the pilot study, 37 underwent bilateral renal denervation, and 13 served as controls. Not only did the treated patients experience improvements in blood pressure compared with controls at 3 months (decreases in systolic BP of 32 mm Hg vs. 5 mm Hg, and decreases in diastolic BP of 12 mm Hg vs. 3 mm Hg in treated patients vs. controls, respectively), they also experienced improvements in fasting blood glucose levels.

At 3 months, the treatment group had a 9.4-mg/dL decrease in fasting blood glucose, compared with a 0.9-mg/dL increase in the controls (Circulation 2011;123:1940-6).

"However, I think the most exciting thing is the impact on plasma insulin levels, where there was a real reduction in plasma insulin levels at 1 month and 3 months in patients treated with renal denervation," said Dr. Jaff, who is medical director of the vascular center, the vascular diagnostic laboratory, and the vascular ultrasound core laboratory at Massachusetts General Hospital, Boston.

At 1 month, plasma insulin had decreased by 8.7 mcU/mL in the treated patients, and increased by 6.4 mcU/mL increase in the controls; at 3 months, plasma insulin had decreased by 11.6 mcU/mL in the treated patients, and increased by 0.5 mcU/mL in the controls.

A reduction in the number of patients diagnosed with diabetes and with impaired glucose tolerance was seen at 3 months in the treatment group, while the diabetic cases increased from 23% to 38% and normal glucose tolerance dropped from 31% to 24% in the control group, Dr. Jaff said.

"Admittedly this is a small sample size, but nonetheless, given the basic pathophysiology of this and these early findings, this is a tantalizing impact," he said, adding that if the findings are confirmed, the potential reach of renal denervation is mind-boggling.

"I think the potential is amazing. Could we actually say we could prevent diabetes mellitus in those with resistant hypertension? Could we cure those who already have diabetes? All of this would potentially be on a background of blood pressure control. We’ve all seen these charts that show that the more risk factors you have, it’s almost logarithmic, the impact on atherosclerosis. So being able to manage two major atherosclerotic risk factors with one simple procedure is almost hard to comprehend," he said.

But the "basic pathophysiology" he mentioned offers a plausible path to comprehension of the potential impact of renal sympathetic denervation.

Specifically, sympathetic hyperactivity directly mediates vascular resistance, and increases in vascular resistance shift blood flow from striated muscle to visceral tissues, he said, explaining that visceral tissue is less insulin sensitive than striated muscle.

In one long-term study looking at sympathetic drive in patients with essential hypertension and in normotensive controls, patients with type 2 diabetes had higher sympathetic drive than did controls, and those with hypertension and diabetes had the highest sympathetic drive. The study, which followed patients for 18 years, indicated that sympathetic drive and impaired glucose tolerance were directly related, he said (Metabolism Clin. Exper. 2008;57:1422-7).

"The background on this is that catheter-based denervation has been shown to reduce sympathetic drive as measured by renal norepinephrine spillover at 6 months, with a near 50% reduction in spillover," he said.

The pathophysiology – particularly outflow from the central nervous system and its effect on the clinical symptom of lung congestion – also provides a rationale for multiple other observed and potential "collateral benefits" of renal denervation, such as improvements in obstructive sleep apnea, said Dr. Krishna T. Rocha-Singh, who is director of the Prairie Vascular Institute at St. John’s Hospital, Springfield, Ill.

"Renal sympathetic outflow results in volume reduction and renal blood flow, retention of sodium and volume retention, and can relate to congestion. We can also have an internal reset, if you will, of the chemoreceptors on the brain that can lead to dyspnea and central sleep apnea. And, as [Dr. Jaff] suggested, there can be a reduction in peripheral vascular resistance due to vascular remodeling that improves insulin resistance.

"But more importantly, we have the effect of increased hypertrophy that may induce arrhythmias, oxygen consumption, and promote dyspnea. There’s also a direct connection between that and the brain, again relating to congestion," he said.

Dr. Rocha-Singh said this synergy between two pathophysiological systems – the activation of the sympathetic nervous system and the retention of sodium – relates to vascular resistance and excess volume, and to congestion and the perception of dyspnea.

When a person is in a reclining position, fluid shifts from the legs to the soft tissues. This effect is greater in patients with drug-resistant hypertension than in those with controlled blood pressure, and it occurs irrespective of body mass index and neck circumference, he said.

In a small study of patients who underwent renal denervation, 70% experienced not only blood pressure improvements but also decreases in the severity of sleep apnea as measured using the apnea-hypopnea index at 3 and 6 months’ follow-up, he said.

Additionally, in a small trial involving 27 patients who underwent pulmonary vein isolation or ablation of atrial fibrillation, 69% of those who also underwent renal denervation were free of recurrence of atrial fibrillation at 12 months, compared with only 29% of those who did not undergo renal denervation (J. Am. Coll. Cardiol. 2012;60:1163-70).

These encouraging findings contribute to what Dr. Rocha-Singh called a "tsunami of excitement" surrounding renal denervation. He noted that a quick Internet search identified more than 145 papers that have been published on the topic, and showed that more than 1,700 related provisional patents have been filed.

While, he – like Dr. Jaff – agreed that the enthusiasm must be tempered pending additional procedural and long-term data, he noted that the diversity of the primary and observed collateral benefits of renal denervation is something of a "vuja de" – the opposite of déjà vu.

"We have never experienced anything like this in our professional lives," he said.

Dr. Jaff is a consultant for numerous companies, including Medtronic, the maker of the Symplicity renal denervation device, but he is not compensated by Medtronic. He also has equity in numerous medical device companies, including one – Northwind Medical – that has a renal denervation strategy utilizing a novel mechanism. He is a board member for the nonprofit VIVA Physicians organization. Dr. Rocha-Singh is also a consultant or advisory board member for Medtronic, as well as for CardioSonic.

MIAMI BEACH – Denervation of the renal arteries improved glucose metabolism and control of drug-resistant hypertension, according to findings from a 2011 pilot study.

"If you thought the impact of renal denervation on hypertension was big, certainly the consideration of renal sympathetic denervation on glucose metabolism raises some real eye-opening opportunities," Dr. Michael R. Jaff said at the International Symposium on Endovascular Therapy 2013.

In 50 patients with drug-resistant hypertension who were enrolled in the pilot study, 37 underwent bilateral renal denervation, and 13 served as controls. Not only did the treated patients experience improvements in blood pressure compared with controls at 3 months (decreases in systolic BP of 32 mm Hg vs. 5 mm Hg, and decreases in diastolic BP of 12 mm Hg vs. 3 mm Hg in treated patients vs. controls, respectively), they also experienced improvements in fasting blood glucose levels.

At 3 months, the treatment group had a 9.4-mg/dL decrease in fasting blood glucose, compared with a 0.9-mg/dL increase in the controls (Circulation 2011;123:1940-6).

"However, I think the most exciting thing is the impact on plasma insulin levels, where there was a real reduction in plasma insulin levels at 1 month and 3 months in patients treated with renal denervation," said Dr. Jaff, who is medical director of the vascular center, the vascular diagnostic laboratory, and the vascular ultrasound core laboratory at Massachusetts General Hospital, Boston.

At 1 month, plasma insulin had decreased by 8.7 mcU/mL in the treated patients, and increased by 6.4 mcU/mL increase in the controls; at 3 months, plasma insulin had decreased by 11.6 mcU/mL in the treated patients, and increased by 0.5 mcU/mL in the controls.

A reduction in the number of patients diagnosed with diabetes and with impaired glucose tolerance was seen at 3 months in the treatment group, while the diabetic cases increased from 23% to 38% and normal glucose tolerance dropped from 31% to 24% in the control group, Dr. Jaff said.

"Admittedly this is a small sample size, but nonetheless, given the basic pathophysiology of this and these early findings, this is a tantalizing impact," he said, adding that if the findings are confirmed, the potential reach of renal denervation is mind-boggling.

"I think the potential is amazing. Could we actually say we could prevent diabetes mellitus in those with resistant hypertension? Could we cure those who already have diabetes? All of this would potentially be on a background of blood pressure control. We’ve all seen these charts that show that the more risk factors you have, it’s almost logarithmic, the impact on atherosclerosis. So being able to manage two major atherosclerotic risk factors with one simple procedure is almost hard to comprehend," he said.

But the "basic pathophysiology" he mentioned offers a plausible path to comprehension of the potential impact of renal sympathetic denervation.

Specifically, sympathetic hyperactivity directly mediates vascular resistance, and increases in vascular resistance shift blood flow from striated muscle to visceral tissues, he said, explaining that visceral tissue is less insulin sensitive than striated muscle.

In one long-term study looking at sympathetic drive in patients with essential hypertension and in normotensive controls, patients with type 2 diabetes had higher sympathetic drive than did controls, and those with hypertension and diabetes had the highest sympathetic drive. The study, which followed patients for 18 years, indicated that sympathetic drive and impaired glucose tolerance were directly related, he said (Metabolism Clin. Exper. 2008;57:1422-7).

"The background on this is that catheter-based denervation has been shown to reduce sympathetic drive as measured by renal norepinephrine spillover at 6 months, with a near 50% reduction in spillover," he said.

The pathophysiology – particularly outflow from the central nervous system and its effect on the clinical symptom of lung congestion – also provides a rationale for multiple other observed and potential "collateral benefits" of renal denervation, such as improvements in obstructive sleep apnea, said Dr. Krishna T. Rocha-Singh, who is director of the Prairie Vascular Institute at St. John’s Hospital, Springfield, Ill.

"Renal sympathetic outflow results in volume reduction and renal blood flow, retention of sodium and volume retention, and can relate to congestion. We can also have an internal reset, if you will, of the chemoreceptors on the brain that can lead to dyspnea and central sleep apnea. And, as [Dr. Jaff] suggested, there can be a reduction in peripheral vascular resistance due to vascular remodeling that improves insulin resistance.

"But more importantly, we have the effect of increased hypertrophy that may induce arrhythmias, oxygen consumption, and promote dyspnea. There’s also a direct connection between that and the brain, again relating to congestion," he said.

Dr. Rocha-Singh said this synergy between two pathophysiological systems – the activation of the sympathetic nervous system and the retention of sodium – relates to vascular resistance and excess volume, and to congestion and the perception of dyspnea.

When a person is in a reclining position, fluid shifts from the legs to the soft tissues. This effect is greater in patients with drug-resistant hypertension than in those with controlled blood pressure, and it occurs irrespective of body mass index and neck circumference, he said.

In a small study of patients who underwent renal denervation, 70% experienced not only blood pressure improvements but also decreases in the severity of sleep apnea as measured using the apnea-hypopnea index at 3 and 6 months’ follow-up, he said.

Additionally, in a small trial involving 27 patients who underwent pulmonary vein isolation or ablation of atrial fibrillation, 69% of those who also underwent renal denervation were free of recurrence of atrial fibrillation at 12 months, compared with only 29% of those who did not undergo renal denervation (J. Am. Coll. Cardiol. 2012;60:1163-70).

These encouraging findings contribute to what Dr. Rocha-Singh called a "tsunami of excitement" surrounding renal denervation. He noted that a quick Internet search identified more than 145 papers that have been published on the topic, and showed that more than 1,700 related provisional patents have been filed.

While, he – like Dr. Jaff – agreed that the enthusiasm must be tempered pending additional procedural and long-term data, he noted that the diversity of the primary and observed collateral benefits of renal denervation is something of a "vuja de" – the opposite of déjà vu.

"We have never experienced anything like this in our professional lives," he said.

Dr. Jaff is a consultant for numerous companies, including Medtronic, the maker of the Symplicity renal denervation device, but he is not compensated by Medtronic. He also has equity in numerous medical device companies, including one – Northwind Medical – that has a renal denervation strategy utilizing a novel mechanism. He is a board member for the nonprofit VIVA Physicians organization. Dr. Rocha-Singh is also a consultant or advisory board member for Medtronic, as well as for CardioSonic.

MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.

A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.

At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.

The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.

Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.

On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.

The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.

Dr. Lobato reported having no disclosures.

surgerynews@elsevier.com

MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.

A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.

At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.

The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.

Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.

On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.

The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.

Dr. Lobato reported having no disclosures.

surgerynews@elsevier.com

MIAMI BEACH – Hypogastric artery endorevascularization using the sandwich technique was associated with fewer complications than was hypogastric artery exclusion by coil embolization for the treatment of abdominal aortic aneurysm with concomitant bilateral common iliac artery aneurysm in a series of 79 patients.

A total of 158 common iliac artery aneurysms were treated using either the same technique bilaterally or a different technique in each side. In the first group, 40 hypogastric artery endorevascularization procedures were performed using the sandwich technique, including 6 bilateral procedures. In the second group, 118 hypogastric artery exclusion procedures were performed using coil embolization followed by positioning of a limb extension to the external iliac artery, including 45 bilateral procedures, Dr. Armando C. Lobato reported at the International Symposium on Endovascular Therapy 2013.

At a mean of 37 months’ follow-up, permanent buttock claudication rates were significantly higher in group two (12.7% vs. 2.5%), as were late type II endoleak rates (15.5% vs. 2.5%), said Dr. Lobato of the Sao Paulo Vascular and Endovascular Surgery Institute, Beneficencia Portuguesa Hospital, Sao Paulo, Brazil.

The technical success rate was 100% in both groups, and related mortality and postoperative aneurysm rupture rates did not differ significantly between the groups. Early mortality was 0% and 1.4% in groups one and two, respectively; late mortality was 0% and 2.8% in the groups, respectively; and the postoperative aneurysm rupture rate was 0% and 1.4% in the groups, respectively, he said.

Rates of iliac limb migration, late type IB endoleak, type III endoleak, iliac limb occlusion, and reintervention also were similar in the two groups.

On multivariate regression analysis, bilateral hypogastric artery exclusion by coil embolization was significantly associated with permanent buttock claudication and late type II endoleak, he noted.

The findings provide further validation of the sandwich technique, which was developed by Dr. Lobato to overcome anatomical and device-related constraints encountered during endovascular aneurysm repair (EVAR). The technique has shown promise in prior studies and earlier reports from Dr. Lobato’s case series.

Dr. Lobato reported having no disclosures.

surgerynews@elsevier.com

Sixteen cases of acute kidney injury following the use of synthetic cannabinoids were identified in the United States in 2012, according to a report from the Centers for Disease Control and Prevention.

The cases, which occurred in six states and were unrelated in all but two incidents, underscore the importance of awareness on the part of health care providers about renal and other unexpected toxicities from the use of synthetic cannabinoid (SC) compounds, the CDC said in the Feb. 15 issue of the Morbidity and Mortality Weekly Report.

Courtesy DEA

This is particularly true given the increasing use of SCs, also known as synthetic marijuana, "spice," or "K2, and in light of prior reports of toxicities associated with SC.

The initial four cases of acute kidney injury (AKI) following recent SC use were reported in Wyoming in March 2012, and an additional 12 cases were subsequently identified, including 6 in Oregon, 2 in New York, 2 in Oklahoma, and 1 each in Rhode Island and Kansas (MMWR 2013;62:93-8).

The patients – 15 adolescent or adult males aged 15-33 years, and one 15-year-old female – all visited emergency departments complaining of nausea and vomiting within days or hours of SC use; 12 also reported abdominal, flank, and/or back pain, and none had preexisting renal dysfunction or used medications associated with renal problems. All were hospitalized.

"The highest serum creatinine concentrations (creatinine peak) among the 16 patients ranged from 3.3 to 21.0 mg/dL (median: 6.7 mg/dL; normal 0.6-1.3 mg/dL) and occurred 1-6 days after symptom onset (median: 3 days)," according to the report.

Urinalysis results were variable, demonstrating proteinuria in eight patients, casts in five patients, white blood cells in nine patients, and red blood cells in eight patients. Renal ultrasonography in 12 patients showed that 9 had a nonspecific increase in renal cortical echogenicity. None had hydronephrosis.

Renal biopsy in eight patients demonstrated acute tubular injury in six cases, and features of acute interstitial nephritis in three.

Most patients experienced kidney function recovery within 3 days of creatinine peak, but five required hemodialysis, and four received corticosteroids.

Toxicologic analysis of the implicated SC product and clinical specimens were possible in seven cases, and two products were linked with the first three cases. These products contained 3-(1-naphthoyl) indole, a precursor to several aminoalkylindole synthetic cannabinoids, and one also contained AM 2201, a potent SC previously linked to human disease and death, but not to AKI.

With one exception, other product samples and/or blood or urine specimens from patients contained XLR-11 (a previously undescribed fluorinated-derivative of the known SC compound UR-144) either alone or in combination with an N-pentanoic acid metabolite of XLR-11 or UR-144.

These reports of AKI following SC use are concerning given the worldwide distribution of SC products, which are "packaged in colorful wrappers designed to appeal to teens, young adults, and first-time drug users," according to an editorial note in the report, which also states that SCs often are packaged with disingenuous labels claiming the products are not for human consumption, although it is widely known that they are smoked like marijuana.

Despite federal and state regulations prohibiting SC sale and distribution, illicit use continues, and reports of illness are increasing.

"The increasing use of synthetic cannabinoids in adolescents is particularly concerning because these substances can contain multiple active and inactive substances with a variety of short-term and potentially unknown long-term effects," Dr. Joanna S. Cohen said in an interview.

In a case study published last year, Dr. Cohen, of the departments of pediatrics and emergency medicine at George Washington University, Washington, noted the increasing use of SCs among adolescents, the potential dangers of SCs with respect to the developing brain, and the need for providers to become familiar with the presenting signs and symptoms of SC-related intoxication (Pediatrics 2012;129:e1064-7).

According to the MMWR report, SCs are related to the active ingredient in marijuana (delta-9-tetrahydrocannabinol), but are up to three times more likely to be associated with sympathomimetic effects such as tachycardia and hypertension, and about five times more likely to be associated with hallucinations.

An increase in seizure occurrence also has been reported with SC use.

"Given the rapidity with which new SC compounds enter the marketplace and their increasing use in the past 3 years, outbreaks of unexpected toxicity associated with their use are likely to increase," the CDC said.

Furthermore, no antidote currently exists; management of SC toxicity is symptomatic and supportive. All patients in this report of 16 cases of AKI recovered creatinine clearance during their hospital stay, but a risk for long-term kidney sequelae is possible. Findings from recent studies suggest the risk for chronic and end-stage renal disease is increased among patients who experience AKI, regardless of etiology and initial recovery.

The CDC recommends that physicians caring for adolescents and young adults with unexplained AKI inquire about SC use. Cases of suspected SC poisoning should be reported to the appropriate state health department, and to a regional poison center by calling 800-222-1222.

The authors reported on disclosures.

Sixteen cases of acute kidney injury following the use of synthetic cannabinoids were identified in the United States in 2012, according to a report from the Centers for Disease Control and Prevention.

The cases, which occurred in six states and were unrelated in all but two incidents, underscore the importance of awareness on the part of health care providers about renal and other unexpected toxicities from the use of synthetic cannabinoid (SC) compounds, the CDC said in the Feb. 15 issue of the Morbidity and Mortality Weekly Report.

Courtesy DEA

This is particularly true given the increasing use of SCs, also known as synthetic marijuana, "spice," or "K2, and in light of prior reports of toxicities associated with SC.

The initial four cases of acute kidney injury (AKI) following recent SC use were reported in Wyoming in March 2012, and an additional 12 cases were subsequently identified, including 6 in Oregon, 2 in New York, 2 in Oklahoma, and 1 each in Rhode Island and Kansas (MMWR 2013;62:93-8).

The patients – 15 adolescent or adult males aged 15-33 years, and one 15-year-old female – all visited emergency departments complaining of nausea and vomiting within days or hours of SC use; 12 also reported abdominal, flank, and/or back pain, and none had preexisting renal dysfunction or used medications associated with renal problems. All were hospitalized.

"The highest serum creatinine concentrations (creatinine peak) among the 16 patients ranged from 3.3 to 21.0 mg/dL (median: 6.7 mg/dL; normal 0.6-1.3 mg/dL) and occurred 1-6 days after symptom onset (median: 3 days)," according to the report.

Urinalysis results were variable, demonstrating proteinuria in eight patients, casts in five patients, white blood cells in nine patients, and red blood cells in eight patients. Renal ultrasonography in 12 patients showed that 9 had a nonspecific increase in renal cortical echogenicity. None had hydronephrosis.

Renal biopsy in eight patients demonstrated acute tubular injury in six cases, and features of acute interstitial nephritis in three.

Most patients experienced kidney function recovery within 3 days of creatinine peak, but five required hemodialysis, and four received corticosteroids.

Toxicologic analysis of the implicated SC product and clinical specimens were possible in seven cases, and two products were linked with the first three cases. These products contained 3-(1-naphthoyl) indole, a precursor to several aminoalkylindole synthetic cannabinoids, and one also contained AM 2201, a potent SC previously linked to human disease and death, but not to AKI.

With one exception, other product samples and/or blood or urine specimens from patients contained XLR-11 (a previously undescribed fluorinated-derivative of the known SC compound UR-144) either alone or in combination with an N-pentanoic acid metabolite of XLR-11 or UR-144.

These reports of AKI following SC use are concerning given the worldwide distribution of SC products, which are "packaged in colorful wrappers designed to appeal to teens, young adults, and first-time drug users," according to an editorial note in the report, which also states that SCs often are packaged with disingenuous labels claiming the products are not for human consumption, although it is widely known that they are smoked like marijuana.

Despite federal and state regulations prohibiting SC sale and distribution, illicit use continues, and reports of illness are increasing.

"The increasing use of synthetic cannabinoids in adolescents is particularly concerning because these substances can contain multiple active and inactive substances with a variety of short-term and potentially unknown long-term effects," Dr. Joanna S. Cohen said in an interview.

In a case study published last year, Dr. Cohen, of the departments of pediatrics and emergency medicine at George Washington University, Washington, noted the increasing use of SCs among adolescents, the potential dangers of SCs with respect to the developing brain, and the need for providers to become familiar with the presenting signs and symptoms of SC-related intoxication (Pediatrics 2012;129:e1064-7).

According to the MMWR report, SCs are related to the active ingredient in marijuana (delta-9-tetrahydrocannabinol), but are up to three times more likely to be associated with sympathomimetic effects such as tachycardia and hypertension, and about five times more likely to be associated with hallucinations.

An increase in seizure occurrence also has been reported with SC use.

"Given the rapidity with which new SC compounds enter the marketplace and their increasing use in the past 3 years, outbreaks of unexpected toxicity associated with their use are likely to increase," the CDC said.

Furthermore, no antidote currently exists; management of SC toxicity is symptomatic and supportive. All patients in this report of 16 cases of AKI recovered creatinine clearance during their hospital stay, but a risk for long-term kidney sequelae is possible. Findings from recent studies suggest the risk for chronic and end-stage renal disease is increased among patients who experience AKI, regardless of etiology and initial recovery.

The CDC recommends that physicians caring for adolescents and young adults with unexplained AKI inquire about SC use. Cases of suspected SC poisoning should be reported to the appropriate state health department, and to a regional poison center by calling 800-222-1222.

The authors reported on disclosures.

Sixteen cases of acute kidney injury following the use of synthetic cannabinoids were identified in the United States in 2012, according to a report from the Centers for Disease Control and Prevention.

The cases, which occurred in six states and were unrelated in all but two incidents, underscore the importance of awareness on the part of health care providers about renal and other unexpected toxicities from the use of synthetic cannabinoid (SC) compounds, the CDC said in the Feb. 15 issue of the Morbidity and Mortality Weekly Report.

Courtesy DEA

This is particularly true given the increasing use of SCs, also known as synthetic marijuana, "spice," or "K2, and in light of prior reports of toxicities associated with SC.

The initial four cases of acute kidney injury (AKI) following recent SC use were reported in Wyoming in March 2012, and an additional 12 cases were subsequently identified, including 6 in Oregon, 2 in New York, 2 in Oklahoma, and 1 each in Rhode Island and Kansas (MMWR 2013;62:93-8).

The patients – 15 adolescent or adult males aged 15-33 years, and one 15-year-old female – all visited emergency departments complaining of nausea and vomiting within days or hours of SC use; 12 also reported abdominal, flank, and/or back pain, and none had preexisting renal dysfunction or used medications associated with renal problems. All were hospitalized.

"The highest serum creatinine concentrations (creatinine peak) among the 16 patients ranged from 3.3 to 21.0 mg/dL (median: 6.7 mg/dL; normal 0.6-1.3 mg/dL) and occurred 1-6 days after symptom onset (median: 3 days)," according to the report.

Urinalysis results were variable, demonstrating proteinuria in eight patients, casts in five patients, white blood cells in nine patients, and red blood cells in eight patients. Renal ultrasonography in 12 patients showed that 9 had a nonspecific increase in renal cortical echogenicity. None had hydronephrosis.

Renal biopsy in eight patients demonstrated acute tubular injury in six cases, and features of acute interstitial nephritis in three.

Most patients experienced kidney function recovery within 3 days of creatinine peak, but five required hemodialysis, and four received corticosteroids.

Toxicologic analysis of the implicated SC product and clinical specimens were possible in seven cases, and two products were linked with the first three cases. These products contained 3-(1-naphthoyl) indole, a precursor to several aminoalkylindole synthetic cannabinoids, and one also contained AM 2201, a potent SC previously linked to human disease and death, but not to AKI.

With one exception, other product samples and/or blood or urine specimens from patients contained XLR-11 (a previously undescribed fluorinated-derivative of the known SC compound UR-144) either alone or in combination with an N-pentanoic acid metabolite of XLR-11 or UR-144.

These reports of AKI following SC use are concerning given the worldwide distribution of SC products, which are "packaged in colorful wrappers designed to appeal to teens, young adults, and first-time drug users," according to an editorial note in the report, which also states that SCs often are packaged with disingenuous labels claiming the products are not for human consumption, although it is widely known that they are smoked like marijuana.

Despite federal and state regulations prohibiting SC sale and distribution, illicit use continues, and reports of illness are increasing.

"The increasing use of synthetic cannabinoids in adolescents is particularly concerning because these substances can contain multiple active and inactive substances with a variety of short-term and potentially unknown long-term effects," Dr. Joanna S. Cohen said in an interview.

In a case study published last year, Dr. Cohen, of the departments of pediatrics and emergency medicine at George Washington University, Washington, noted the increasing use of SCs among adolescents, the potential dangers of SCs with respect to the developing brain, and the need for providers to become familiar with the presenting signs and symptoms of SC-related intoxication (Pediatrics 2012;129:e1064-7).

According to the MMWR report, SCs are related to the active ingredient in marijuana (delta-9-tetrahydrocannabinol), but are up to three times more likely to be associated with sympathomimetic effects such as tachycardia and hypertension, and about five times more likely to be associated with hallucinations.

An increase in seizure occurrence also has been reported with SC use.

"Given the rapidity with which new SC compounds enter the marketplace and their increasing use in the past 3 years, outbreaks of unexpected toxicity associated with their use are likely to increase," the CDC said.

Furthermore, no antidote currently exists; management of SC toxicity is symptomatic and supportive. All patients in this report of 16 cases of AKI recovered creatinine clearance during their hospital stay, but a risk for long-term kidney sequelae is possible. Findings from recent studies suggest the risk for chronic and end-stage renal disease is increased among patients who experience AKI, regardless of etiology and initial recovery.

The CDC recommends that physicians caring for adolescents and young adults with unexplained AKI inquire about SC use. Cases of suspected SC poisoning should be reported to the appropriate state health department, and to a regional poison center by calling 800-222-1222.

The authors reported on disclosures.

In many ways, office efficiency and patient satisfaction go hand in hand. Effective communication is one key to achieving both, according to Dr. Roger I. Ceilley.

During a talk at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Ceilley of the University of Iowa, Iowa City, offered several tips for improving patient interactions through such communication.

A good first step is to be prepared.

"Always review the patient record before entering the room," he said, noting that this will provide a quick recall of the patient’s history and will provide the patient with the knowledge that he or she will be receiving informed care. Look for notes from assistants, who may have noted why the patient is being seen and if the patient is upset or has special concerns.

Also, it is fine for a provider to enter the room quickly, but be sure to always leave slowly. Offer a warm handshake, and remember the value and healing power of "laying on hands," he said.

During the visit, make a note of something personal about the patient, and put it in the chart to reference at the next visit. For example, "Patient will celebrate 50th anniversary on June 20."

During the encounter, sit down for a brief time whenever possible, look directly at the patient when speaking, and convey that you care and that you enjoy what you are doing, Dr. Ceilley advised.

Interject humor whenever possible, he added. When used appropriately, humor will further put the patient at ease in what may be an uncomfortable circumstance. Keep in mind that some patients have hearing loss and lip read to some degree and want to see your expressions.

On average, physicians give patients less than 30 seconds to express concerns, and physicians tend to focus on the first problem that a patient mentions. The first one they mention may not be the one of most concern, so take time to hear their other concerns as well, he said.

Be sure to take an inventory of patient expectations and discuss realistic expectations of treatment options available, carefully review the treatment plan and costs, and obtain informed consent prior to any procedure (including disclosure of expectations, side effects, and costs,) he added.

At the close of the visit, supply handouts and provide enough refills until the next visit or for 60-90 days depending on insurance requirements, and ask the patient if there is anything else he or she needs. You may not be able to take care of these needs, but they should be addressed. Then schedule a follow-up appointment, refer the patient, or have the clinical staff assist them, Dr. Ceilley said.

"And remember, patients won’t remember everything exactly as you said or everything that you did, but they will remember how you made them feel," he said.

A few other things that can contribute to patient satisfaction and/or office efficiency are samples and supplies (provided with instructions and quality handouts), a dedicated check-in and check-out process, a communication center (for making appointments, handling referrals, managing faxes and other communications, and triaging patients), and a website to serve as a patient resource.

Dr. Ceilley also offered tips for hiring and training practices that can improve office efficiency and physician, staff, and patient satisfaction. When hiring staff, take your time and don’t settle for less than you need, he advised.

A tiered interviewing process by which prospective employees are interviewed first by management, then by lead staff, and finally by the physician is optimal. The inclusion of at least a few hours of shadowing with staff before a position is offered to a final candidate can help improve the likelihood that the best hiring decision will be made.

Among the factors to consider in a candidate are attitude, intelligence, experience, loyalty, stability, enthusiasm, judgment, and technical ability. Staff efficiency is best achieved with high-quality staff, and that efficiency will more than make up for the extra pay likely required to hire the best, he said.

"One excellent staff [member] at 20% over market rate pay will equal or exceed in work output 1.5 average staff at the market rate – at less cost," Dr. Ceilley said.

To further ensure the highest level of efficiency, consider personally training your assistants, he said, noting that the physician’s role in creating an efficient office environment involves earning the trust of employees – this is where communication also can benefit this aspect of practice. Employees need to know that they won’t be taken unfair advantage of, and this is communicated by demonstrating consistency (which provides a sense that things will be handled in an even and predictable manner every day) and conveying confidence, (which provides a sense that things are under control).

An efficient office with good communication leads to personal and staff satisfaction, patient satisfaction, good quality care, efficient care, and profitable care, he concluded.

Dr. Ceilley reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

sknews@elsevier.com

*This story was updated March 1, 2013.

In many ways, office efficiency and patient satisfaction go hand in hand. Effective communication is one key to achieving both, according to Dr. Roger I. Ceilley.

During a talk at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Ceilley of the University of Iowa, Iowa City, offered several tips for improving patient interactions through such communication.

A good first step is to be prepared.

"Always review the patient record before entering the room," he said, noting that this will provide a quick recall of the patient’s history and will provide the patient with the knowledge that he or she will be receiving informed care. Look for notes from assistants, who may have noted why the patient is being seen and if the patient is upset or has special concerns.

Also, it is fine for a provider to enter the room quickly, but be sure to always leave slowly. Offer a warm handshake, and remember the value and healing power of "laying on hands," he said.

During the visit, make a note of something personal about the patient, and put it in the chart to reference at the next visit. For example, "Patient will celebrate 50th anniversary on June 20."

During the encounter, sit down for a brief time whenever possible, look directly at the patient when speaking, and convey that you care and that you enjoy what you are doing, Dr. Ceilley advised.

Interject humor whenever possible, he added. When used appropriately, humor will further put the patient at ease in what may be an uncomfortable circumstance. Keep in mind that some patients have hearing loss and lip read to some degree and want to see your expressions.

On average, physicians give patients less than 30 seconds to express concerns, and physicians tend to focus on the first problem that a patient mentions. The first one they mention may not be the one of most concern, so take time to hear their other concerns as well, he said.

Be sure to take an inventory of patient expectations and discuss realistic expectations of treatment options available, carefully review the treatment plan and costs, and obtain informed consent prior to any procedure (including disclosure of expectations, side effects, and costs,) he added.

At the close of the visit, supply handouts and provide enough refills until the next visit or for 60-90 days depending on insurance requirements, and ask the patient if there is anything else he or she needs. You may not be able to take care of these needs, but they should be addressed. Then schedule a follow-up appointment, refer the patient, or have the clinical staff assist them, Dr. Ceilley said.

"And remember, patients won’t remember everything exactly as you said or everything that you did, but they will remember how you made them feel," he said.

A few other things that can contribute to patient satisfaction and/or office efficiency are samples and supplies (provided with instructions and quality handouts), a dedicated check-in and check-out process, a communication center (for making appointments, handling referrals, managing faxes and other communications, and triaging patients), and a website to serve as a patient resource.

Dr. Ceilley also offered tips for hiring and training practices that can improve office efficiency and physician, staff, and patient satisfaction. When hiring staff, take your time and don’t settle for less than you need, he advised.

A tiered interviewing process by which prospective employees are interviewed first by management, then by lead staff, and finally by the physician is optimal. The inclusion of at least a few hours of shadowing with staff before a position is offered to a final candidate can help improve the likelihood that the best hiring decision will be made.

Among the factors to consider in a candidate are attitude, intelligence, experience, loyalty, stability, enthusiasm, judgment, and technical ability. Staff efficiency is best achieved with high-quality staff, and that efficiency will more than make up for the extra pay likely required to hire the best, he said.

"One excellent staff [member] at 20% over market rate pay will equal or exceed in work output 1.5 average staff at the market rate – at less cost," Dr. Ceilley said.

To further ensure the highest level of efficiency, consider personally training your assistants, he said, noting that the physician’s role in creating an efficient office environment involves earning the trust of employees – this is where communication also can benefit this aspect of practice. Employees need to know that they won’t be taken unfair advantage of, and this is communicated by demonstrating consistency (which provides a sense that things will be handled in an even and predictable manner every day) and conveying confidence, (which provides a sense that things are under control).

An efficient office with good communication leads to personal and staff satisfaction, patient satisfaction, good quality care, efficient care, and profitable care, he concluded.

Dr. Ceilley reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

sknews@elsevier.com

*This story was updated March 1, 2013.

In many ways, office efficiency and patient satisfaction go hand in hand. Effective communication is one key to achieving both, according to Dr. Roger I. Ceilley.

During a talk at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Ceilley of the University of Iowa, Iowa City, offered several tips for improving patient interactions through such communication.

A good first step is to be prepared.

"Always review the patient record before entering the room," he said, noting that this will provide a quick recall of the patient’s history and will provide the patient with the knowledge that he or she will be receiving informed care. Look for notes from assistants, who may have noted why the patient is being seen and if the patient is upset or has special concerns.

Also, it is fine for a provider to enter the room quickly, but be sure to always leave slowly. Offer a warm handshake, and remember the value and healing power of "laying on hands," he said.

During the visit, make a note of something personal about the patient, and put it in the chart to reference at the next visit. For example, "Patient will celebrate 50th anniversary on June 20."

During the encounter, sit down for a brief time whenever possible, look directly at the patient when speaking, and convey that you care and that you enjoy what you are doing, Dr. Ceilley advised.

Interject humor whenever possible, he added. When used appropriately, humor will further put the patient at ease in what may be an uncomfortable circumstance. Keep in mind that some patients have hearing loss and lip read to some degree and want to see your expressions.

On average, physicians give patients less than 30 seconds to express concerns, and physicians tend to focus on the first problem that a patient mentions. The first one they mention may not be the one of most concern, so take time to hear their other concerns as well, he said.

Be sure to take an inventory of patient expectations and discuss realistic expectations of treatment options available, carefully review the treatment plan and costs, and obtain informed consent prior to any procedure (including disclosure of expectations, side effects, and costs,) he added.

At the close of the visit, supply handouts and provide enough refills until the next visit or for 60-90 days depending on insurance requirements, and ask the patient if there is anything else he or she needs. You may not be able to take care of these needs, but they should be addressed. Then schedule a follow-up appointment, refer the patient, or have the clinical staff assist them, Dr. Ceilley said.

"And remember, patients won’t remember everything exactly as you said or everything that you did, but they will remember how you made them feel," he said.

A few other things that can contribute to patient satisfaction and/or office efficiency are samples and supplies (provided with instructions and quality handouts), a dedicated check-in and check-out process, a communication center (for making appointments, handling referrals, managing faxes and other communications, and triaging patients), and a website to serve as a patient resource.

Dr. Ceilley also offered tips for hiring and training practices that can improve office efficiency and physician, staff, and patient satisfaction. When hiring staff, take your time and don’t settle for less than you need, he advised.

A tiered interviewing process by which prospective employees are interviewed first by management, then by lead staff, and finally by the physician is optimal. The inclusion of at least a few hours of shadowing with staff before a position is offered to a final candidate can help improve the likelihood that the best hiring decision will be made.

Among the factors to consider in a candidate are attitude, intelligence, experience, loyalty, stability, enthusiasm, judgment, and technical ability. Staff efficiency is best achieved with high-quality staff, and that efficiency will more than make up for the extra pay likely required to hire the best, he said.

"One excellent staff [member] at 20% over market rate pay will equal or exceed in work output 1.5 average staff at the market rate – at less cost," Dr. Ceilley said.

To further ensure the highest level of efficiency, consider personally training your assistants, he said, noting that the physician’s role in creating an efficient office environment involves earning the trust of employees – this is where communication also can benefit this aspect of practice. Employees need to know that they won’t be taken unfair advantage of, and this is communicated by demonstrating consistency (which provides a sense that things will be handled in an even and predictable manner every day) and conveying confidence, (which provides a sense that things are under control).

An efficient office with good communication leads to personal and staff satisfaction, patient satisfaction, good quality care, efficient care, and profitable care, he concluded.

Dr. Ceilley reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

sknews@elsevier.com

*This story was updated March 1, 2013.

Office-based dermatologic surgery should always start with a detailed surgery checklist that covers everything a physician needs to ensure a seamless procedure, according to Dr. Roger I. Ceilley.

The focus is on documentation and, ultimately, safety. "Document, document, document," he said during a talk at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

A sample checklist that he shared included the following items:

• Referring physician.

• Who did the biopsy?

• Sign consent.

• Circle surgery site with patient verification.

• Verify and record pacemaker/defibrillator or other electronic implants.

• Review allergies to any anesthesia/antibiotics/latex/bandages.

• Check and record anticoagulants.

• Prophylactic antibiotics needed? If so, why?

• Record blood pressure and pulse – notify provider if elevated or too low.

• Check for special health concerns such as diabetes, etc.

• Buffered and unbuffered anesthesia on the field.

• Mapping card.

• Verify pathology report.

• Photo.

• Miscellaneous patient concerns.

Using such a checklist will ensure that all aspects of the pending procedure have been documented and discussed with the patient and also that the clinical assistant and physician are "on the same page" as to what will be happening before the procedure begins, said Dr. Ceilley of the University of Iowa, Iowa City.

Preoperative photography is a particularly important item on this list, as it can help to prevent wrong-site surgery, he noted, adding that it is also imperative to site confirm with the patient (one of the steps on the checklist) prior to beginning the procedure.

This information should be readily available because of the proper prior documentation. An accurate diagram and measurement also will help, he said.

Dr. Ceilley covered several other topics:

• Surgical equipment needs. A properly preselected, prewrapped, autoclaved pack of surgical instruments is a necessity; it should include a curette, forceps, scalpel blade holder, needle driver, hemostat, iris scissors, and straight scissor, he said.

The surgical tray also should include readily available gauze, cotton swabs, and extra anesthesia, and the equipment should be arranged on a tray in a standard fashion and kept organized during the procedure, with the sharps placed consistently in the same area on the tray.

• Local anesthesia. Dr. Ceilley described alternatives, including diphenhydramine and bacteriostatic saline, for the very rare patient with anesthesia allergies and provided a number of pearls for using local anesthesia. He discussed the use of topical versus subcutaneous lidocaine, the use of ice or alternate refrigerants, and the benefits of rubbing the area after infiltration.

He also noted that a number of other nonpharmacologic measures – including "talk-esthesia" (use of conversation to keep the patient’s mind busy and distracted from some of the more invasive aspects of the procedure), ice packs, accupressure, headphones, and even stuffed animals – that can provide pain relief or comfort for surgical patients.

• Sutureless closures. Among the options for sutureless closures are staples, steri-strips/paper tape, and Dermabond or other tissue glues. Tapes and glues are best for low-tension wounds, he noted.

• Closing tight wound defects. Pinching and stretching the wound can help with closure of tight wounds, as can the use of antitension clamps, he said, adding that a temporary horizontal mattress or pulley stitch also may help stretch tissue and facilitate closure.

• Hemostasis. Stretching, pinching, and applying ring pressure can help with hemostasis, he said.

• Surgical wound dressing. Keep a dressing tray handy and "do them with pride," Dr. Ceilley said of wound dressings.

"You will want to have on-hand items that you have learned are the most useful for wound dressing. These should include tan/skin-colored tapes, mupirocin or petrolatum, Coban (3M), Hypafix, and steri-strips, to name a few. Only use the minimum necessary for proper dressing of any item to ensure the least visibly noticeable appearance for your patient," he said.

Also, provide patients with supplies for dressing changes if possible, or with information on where to obtain the appropriate supplies, and include detailed wound care instructions, he said.

• Postoperative care. In addition to information on wound care and dressing, also provide patients with handouts on various aspects of postoperative care, including information on resuming activities and warnings about swelling, hematoma, drainage, and infection, he advised.

"I can’t overemphasize the importance of attention to detail in all aspects of dermatologic surgery, from evaluation and explanation to procedure, dressing, and postoperative care. The final results bear your signature and enhance or detract from your reputation and that of all dermatologic surgeons," he said.

Dr. Ceilley reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

sknews@elsevier.com

*This story was updated March 1, 2013.

Office-based dermatologic surgery should always start with a detailed surgery checklist that covers everything a physician needs to ensure a seamless procedure, according to Dr. Roger I. Ceilley.

The focus is on documentation and, ultimately, safety. "Document, document, document," he said during a talk at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

A sample checklist that he shared included the following items:

• Referring physician.

• Who did the biopsy?

• Sign consent.

• Circle surgery site with patient verification.

• Verify and record pacemaker/defibrillator or other electronic implants.

• Review allergies to any anesthesia/antibiotics/latex/bandages.

• Check and record anticoagulants.

• Prophylactic antibiotics needed? If so, why?

• Record blood pressure and pulse – notify provider if elevated or too low.

• Check for special health concerns such as diabetes, etc.

• Buffered and unbuffered anesthesia on the field.

• Mapping card.

• Verify pathology report.

• Photo.

• Miscellaneous patient concerns.

Using such a checklist will ensure that all aspects of the pending procedure have been documented and discussed with the patient and also that the clinical assistant and physician are "on the same page" as to what will be happening before the procedure begins, said Dr. Ceilley of the University of Iowa, Iowa City.

Preoperative photography is a particularly important item on this list, as it can help to prevent wrong-site surgery, he noted, adding that it is also imperative to site confirm with the patient (one of the steps on the checklist) prior to beginning the procedure.

This information should be readily available because of the proper prior documentation. An accurate diagram and measurement also will help, he said.

Dr. Ceilley covered several other topics:

• Surgical equipment needs. A properly preselected, prewrapped, autoclaved pack of surgical instruments is a necessity; it should include a curette, forceps, scalpel blade holder, needle driver, hemostat, iris scissors, and straight scissor, he said.

The surgical tray also should include readily available gauze, cotton swabs, and extra anesthesia, and the equipment should be arranged on a tray in a standard fashion and kept organized during the procedure, with the sharps placed consistently in the same area on the tray.

• Local anesthesia. Dr. Ceilley described alternatives, including diphenhydramine and bacteriostatic saline, for the very rare patient with anesthesia allergies and provided a number of pearls for using local anesthesia. He discussed the use of topical versus subcutaneous lidocaine, the use of ice or alternate refrigerants, and the benefits of rubbing the area after infiltration.

He also noted that a number of other nonpharmacologic measures – including "talk-esthesia" (use of conversation to keep the patient’s mind busy and distracted from some of the more invasive aspects of the procedure), ice packs, accupressure, headphones, and even stuffed animals – that can provide pain relief or comfort for surgical patients.

• Sutureless closures. Among the options for sutureless closures are staples, steri-strips/paper tape, and Dermabond or other tissue glues. Tapes and glues are best for low-tension wounds, he noted.

• Closing tight wound defects. Pinching and stretching the wound can help with closure of tight wounds, as can the use of antitension clamps, he said, adding that a temporary horizontal mattress or pulley stitch also may help stretch tissue and facilitate closure.

• Hemostasis. Stretching, pinching, and applying ring pressure can help with hemostasis, he said.

• Surgical wound dressing. Keep a dressing tray handy and "do them with pride," Dr. Ceilley said of wound dressings.

"You will want to have on-hand items that you have learned are the most useful for wound dressing. These should include tan/skin-colored tapes, mupirocin or petrolatum, Coban (3M), Hypafix, and steri-strips, to name a few. Only use the minimum necessary for proper dressing of any item to ensure the least visibly noticeable appearance for your patient," he said.

Also, provide patients with supplies for dressing changes if possible, or with information on where to obtain the appropriate supplies, and include detailed wound care instructions, he said.

• Postoperative care. In addition to information on wound care and dressing, also provide patients with handouts on various aspects of postoperative care, including information on resuming activities and warnings about swelling, hematoma, drainage, and infection, he advised.

"I can’t overemphasize the importance of attention to detail in all aspects of dermatologic surgery, from evaluation and explanation to procedure, dressing, and postoperative care. The final results bear your signature and enhance or detract from your reputation and that of all dermatologic surgeons," he said.

Dr. Ceilley reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

sknews@elsevier.com

*This story was updated March 1, 2013.

Office-based dermatologic surgery should always start with a detailed surgery checklist that covers everything a physician needs to ensure a seamless procedure, according to Dr. Roger I. Ceilley.

The focus is on documentation and, ultimately, safety. "Document, document, document," he said during a talk at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

A sample checklist that he shared included the following items:

• Referring physician.

• Who did the biopsy?

• Sign consent.

• Circle surgery site with patient verification.

• Verify and record pacemaker/defibrillator or other electronic implants.

• Review allergies to any anesthesia/antibiotics/latex/bandages.

• Check and record anticoagulants.

• Prophylactic antibiotics needed? If so, why?

• Record blood pressure and pulse – notify provider if elevated or too low.

• Check for special health concerns such as diabetes, etc.

• Buffered and unbuffered anesthesia on the field.

• Mapping card.

• Verify pathology report.

• Photo.

• Miscellaneous patient concerns.

Using such a checklist will ensure that all aspects of the pending procedure have been documented and discussed with the patient and also that the clinical assistant and physician are "on the same page" as to what will be happening before the procedure begins, said Dr. Ceilley of the University of Iowa, Iowa City.

Preoperative photography is a particularly important item on this list, as it can help to prevent wrong-site surgery, he noted, adding that it is also imperative to site confirm with the patient (one of the steps on the checklist) prior to beginning the procedure.

This information should be readily available because of the proper prior documentation. An accurate diagram and measurement also will help, he said.

Dr. Ceilley covered several other topics:

• Surgical equipment needs. A properly preselected, prewrapped, autoclaved pack of surgical instruments is a necessity; it should include a curette, forceps, scalpel blade holder, needle driver, hemostat, iris scissors, and straight scissor, he said.

The surgical tray also should include readily available gauze, cotton swabs, and extra anesthesia, and the equipment should be arranged on a tray in a standard fashion and kept organized during the procedure, with the sharps placed consistently in the same area on the tray.

• Local anesthesia. Dr. Ceilley described alternatives, including diphenhydramine and bacteriostatic saline, for the very rare patient with anesthesia allergies and provided a number of pearls for using local anesthesia. He discussed the use of topical versus subcutaneous lidocaine, the use of ice or alternate refrigerants, and the benefits of rubbing the area after infiltration.

He also noted that a number of other nonpharmacologic measures – including "talk-esthesia" (use of conversation to keep the patient’s mind busy and distracted from some of the more invasive aspects of the procedure), ice packs, accupressure, headphones, and even stuffed animals – that can provide pain relief or comfort for surgical patients.

• Sutureless closures. Among the options for sutureless closures are staples, steri-strips/paper tape, and Dermabond or other tissue glues. Tapes and glues are best for low-tension wounds, he noted.

• Closing tight wound defects. Pinching and stretching the wound can help with closure of tight wounds, as can the use of antitension clamps, he said, adding that a temporary horizontal mattress or pulley stitch also may help stretch tissue and facilitate closure.

• Hemostasis. Stretching, pinching, and applying ring pressure can help with hemostasis, he said.

• Surgical wound dressing. Keep a dressing tray handy and "do them with pride," Dr. Ceilley said of wound dressings.

"You will want to have on-hand items that you have learned are the most useful for wound dressing. These should include tan/skin-colored tapes, mupirocin or petrolatum, Coban (3M), Hypafix, and steri-strips, to name a few. Only use the minimum necessary for proper dressing of any item to ensure the least visibly noticeable appearance for your patient," he said.

Also, provide patients with supplies for dressing changes if possible, or with information on where to obtain the appropriate supplies, and include detailed wound care instructions, he said.

• Postoperative care. In addition to information on wound care and dressing, also provide patients with handouts on various aspects of postoperative care, including information on resuming activities and warnings about swelling, hematoma, drainage, and infection, he advised.

"I can’t overemphasize the importance of attention to detail in all aspects of dermatologic surgery, from evaluation and explanation to procedure, dressing, and postoperative care. The final results bear your signature and enhance or detract from your reputation and that of all dermatologic surgeons," he said.

Dr. Ceilley reported having no relevant disclosures. SDEF and this news organization are owned by the same parent company.

sknews@elsevier.com

*This story was updated March 1, 2013.