User login
Phone monitoring program helps cut chemotherapy symptom severity
AMSTERDAM – A telephone-based system to monitor chemotherapy-induced symptoms when patients are home and facilitate interventions as needed led to significant cuts in symptom burden in a single-center, randomized trial with 152 breast cancer patients.
“Symptom care at home gives patients symptom care when and where they need it,” Kathi H. Mooney, Ph.D., said at the European Breast Cancer Conference. “Rarely is symptom monitoring extended to when patients are home, but that is when symptoms are most problematic for patients.”
The 30-day program was linked with significant cuts in the number of days with any of seven chemotherapy-induced symptoms. In addition, overall days with any severe symptom fell by 48% (P = .006) and the number of days with any moderate symptoms fell by 38% (P = .011), reported Dr. Mooney, professor of nursing at the University of Utah, Salt Lake City.
She and her associates designed a telephone-based system to address the usual reticence that chemotherapy patients have to report their symptoms. Prior study results had documented that patients with moderate or severe symptoms initiated calls for about 5% of episodes, even when explicitly told to report symptoms. This led the Utah researchers to develop an automated, interactive system that phoned patients daily.
The enrolled patients spanned the full spectrum of breast cancer stages; the average age was 53 years. All patients received a daily, automated call that prompted them to rate each of 11 chemotherapy symptoms on a scale of 0-10.
The calls also provided automated, self-management coaching for problematic symptoms. The investigational Symptom Care at Home intervention involved a nurse practitioner getting back to patients who reported poorly-controlled symptoms. These follow-up calls averaged just under 7 minutes in length, and on average each patient received 11 calls during the 30 days of the intervention.
After 30 days, the 83 patients in the Symptom Care at Home program had statistically-significant reductions in days with moderate or worse episodes for 7 of the 11 symptoms tallied: numbness or tingling, anxiety, nausea, pain, depressed mood, sore mouth, and fatigue. The most robust effects were a 72% drop in days with moderate or worse numbness or tingling, a 66% reduction in anxiety days, and a 61% cut in nausea days.
“I like the intervention used in this study. I think it shows what can happen when you collect symptom information in a way that is patient friendly,” said Dr. Robert Mansel, professor at the Institute of Cancer & Genetics at Cardiff University, South Wales. “I was delighted to see that this intervention really made a difference. The findings show that patients often suffer a lot more from treatment than they are usually prepared to tell us.”
In addition to the efficacy of this intervention, “patients told us that they liked having someone to talk with about their symptoms,” Dr. Mooney said in an interview. “Patients are concerned about their symptoms.”
One aspect of the Symptom Care at Home program that has not yet been analyzed is its cost efficacy. The University of Utah’s Huntsman Cancer Institute, where the program was developed, is awaiting results from a cost-benefit analysis before deciding whether to make the telephone system part of routine practice, she said.
Dr. Mooney and Dr. Mansel reported having no financial disclosures.
On Twitter @mitchelzoler
AMSTERDAM – A telephone-based system to monitor chemotherapy-induced symptoms when patients are home and facilitate interventions as needed led to significant cuts in symptom burden in a single-center, randomized trial with 152 breast cancer patients.
“Symptom care at home gives patients symptom care when and where they need it,” Kathi H. Mooney, Ph.D., said at the European Breast Cancer Conference. “Rarely is symptom monitoring extended to when patients are home, but that is when symptoms are most problematic for patients.”
The 30-day program was linked with significant cuts in the number of days with any of seven chemotherapy-induced symptoms. In addition, overall days with any severe symptom fell by 48% (P = .006) and the number of days with any moderate symptoms fell by 38% (P = .011), reported Dr. Mooney, professor of nursing at the University of Utah, Salt Lake City.
She and her associates designed a telephone-based system to address the usual reticence that chemotherapy patients have to report their symptoms. Prior study results had documented that patients with moderate or severe symptoms initiated calls for about 5% of episodes, even when explicitly told to report symptoms. This led the Utah researchers to develop an automated, interactive system that phoned patients daily.
The enrolled patients spanned the full spectrum of breast cancer stages; the average age was 53 years. All patients received a daily, automated call that prompted them to rate each of 11 chemotherapy symptoms on a scale of 0-10.
The calls also provided automated, self-management coaching for problematic symptoms. The investigational Symptom Care at Home intervention involved a nurse practitioner getting back to patients who reported poorly-controlled symptoms. These follow-up calls averaged just under 7 minutes in length, and on average each patient received 11 calls during the 30 days of the intervention.
After 30 days, the 83 patients in the Symptom Care at Home program had statistically-significant reductions in days with moderate or worse episodes for 7 of the 11 symptoms tallied: numbness or tingling, anxiety, nausea, pain, depressed mood, sore mouth, and fatigue. The most robust effects were a 72% drop in days with moderate or worse numbness or tingling, a 66% reduction in anxiety days, and a 61% cut in nausea days.
“I like the intervention used in this study. I think it shows what can happen when you collect symptom information in a way that is patient friendly,” said Dr. Robert Mansel, professor at the Institute of Cancer & Genetics at Cardiff University, South Wales. “I was delighted to see that this intervention really made a difference. The findings show that patients often suffer a lot more from treatment than they are usually prepared to tell us.”
In addition to the efficacy of this intervention, “patients told us that they liked having someone to talk with about their symptoms,” Dr. Mooney said in an interview. “Patients are concerned about their symptoms.”
One aspect of the Symptom Care at Home program that has not yet been analyzed is its cost efficacy. The University of Utah’s Huntsman Cancer Institute, where the program was developed, is awaiting results from a cost-benefit analysis before deciding whether to make the telephone system part of routine practice, she said.
Dr. Mooney and Dr. Mansel reported having no financial disclosures.
On Twitter @mitchelzoler
AMSTERDAM – A telephone-based system to monitor chemotherapy-induced symptoms when patients are home and facilitate interventions as needed led to significant cuts in symptom burden in a single-center, randomized trial with 152 breast cancer patients.
“Symptom care at home gives patients symptom care when and where they need it,” Kathi H. Mooney, Ph.D., said at the European Breast Cancer Conference. “Rarely is symptom monitoring extended to when patients are home, but that is when symptoms are most problematic for patients.”
The 30-day program was linked with significant cuts in the number of days with any of seven chemotherapy-induced symptoms. In addition, overall days with any severe symptom fell by 48% (P = .006) and the number of days with any moderate symptoms fell by 38% (P = .011), reported Dr. Mooney, professor of nursing at the University of Utah, Salt Lake City.
She and her associates designed a telephone-based system to address the usual reticence that chemotherapy patients have to report their symptoms. Prior study results had documented that patients with moderate or severe symptoms initiated calls for about 5% of episodes, even when explicitly told to report symptoms. This led the Utah researchers to develop an automated, interactive system that phoned patients daily.
The enrolled patients spanned the full spectrum of breast cancer stages; the average age was 53 years. All patients received a daily, automated call that prompted them to rate each of 11 chemotherapy symptoms on a scale of 0-10.
The calls also provided automated, self-management coaching for problematic symptoms. The investigational Symptom Care at Home intervention involved a nurse practitioner getting back to patients who reported poorly-controlled symptoms. These follow-up calls averaged just under 7 minutes in length, and on average each patient received 11 calls during the 30 days of the intervention.
After 30 days, the 83 patients in the Symptom Care at Home program had statistically-significant reductions in days with moderate or worse episodes for 7 of the 11 symptoms tallied: numbness or tingling, anxiety, nausea, pain, depressed mood, sore mouth, and fatigue. The most robust effects were a 72% drop in days with moderate or worse numbness or tingling, a 66% reduction in anxiety days, and a 61% cut in nausea days.
“I like the intervention used in this study. I think it shows what can happen when you collect symptom information in a way that is patient friendly,” said Dr. Robert Mansel, professor at the Institute of Cancer & Genetics at Cardiff University, South Wales. “I was delighted to see that this intervention really made a difference. The findings show that patients often suffer a lot more from treatment than they are usually prepared to tell us.”
In addition to the efficacy of this intervention, “patients told us that they liked having someone to talk with about their symptoms,” Dr. Mooney said in an interview. “Patients are concerned about their symptoms.”
One aspect of the Symptom Care at Home program that has not yet been analyzed is its cost efficacy. The University of Utah’s Huntsman Cancer Institute, where the program was developed, is awaiting results from a cost-benefit analysis before deciding whether to make the telephone system part of routine practice, she said.
Dr. Mooney and Dr. Mansel reported having no financial disclosures.
On Twitter @mitchelzoler
AT EBCC 10
How to beat apremilast-induced diarrhea
MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.
“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.
Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.
Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.
“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.
It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.
Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.
Diphenoxylate/atropine (Lomotil) is another effective prescription option.
Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.
The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.
Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”
Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.
Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.
“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.
He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.
MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.
“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.
Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.
Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.
“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.
It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.
Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.
Diphenoxylate/atropine (Lomotil) is another effective prescription option.
Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.
The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.
Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”
Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.
Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.
“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.
He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.
MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.
“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.
Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.
Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.
“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.
It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.
Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.
Diphenoxylate/atropine (Lomotil) is another effective prescription option.
Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.
The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.
Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”
Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.
Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.
“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.
He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.
EXPERT ANALYSIS FROM RWCS 2016
How to beat apremilast-induced diarrhea
MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.
“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.
Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.
Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.
“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.
It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.
Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.
Diphenoxylate/atropine (Lomotil) is another effective prescription option.
Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.
The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.
Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”
Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.
Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.
“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.
He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.
MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.
“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.
Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.
Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.
“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.
It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.
Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.
Diphenoxylate/atropine (Lomotil) is another effective prescription option.
Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.
The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.
Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”
Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.
Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.
“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.
He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.
MAUI, HAWAII – If you’re going to prescribe apremilast for psoriasis or psoriatic arthritis – and more and more physicians are doing so because of the drug’s exceptional safety profile – you’d better get familiar with the oral phosphodiesterase-4 inhibitor’s gastrointestinal side effects, Dr. George M. Martin advised at the 2016 Rheumatology Winter Clinical Symposium.
“One of the biggest hurdles we have to deal with when we prescribe apremilast is the fact that there are these GI side effects,” said Dr. Martin, a dermatologist practicing in Maui and codirector of the rheumatology symposium.
Celgene, which markets apremilast (Otezla), sponsored an analysis of the pattern of diarrhea that emerged in the pooled results of the phase III ESTEEM 1 and 2 trials of apremilast at 30 mg twice daily for psoriasis and the PALACE 1-3 phase III psoriatic arthritis trials.
Diarrhea occurred in 16%-18% of patients on apremilast, a rate roughly threefold greater than in placebo-treated controls. Diarrhea onset was usually within the first 14 days of therapy. When it occurred, the duration was typically about 2 weeks.
“This you can relay to your patients so they’re not surprised if it happens,” the dermatologist said.
It’s a secretory diarrhea, and it is believed to be a classwide effect for the phosphodiesterase-4 (PDE-4) inhibitors. For example, roflumilast (Daliresp), an oral PDE-4 inhibitor used in the treatment of chronic obstructive pulmonary disease, has the same diarrhea issues. The mechanism has been worked out: The drug increases intracellular cyclic adenosine monophosphate, with resultant activation of chloride channels in crypts in the small bowel, which in turn leads to secretion of chloride ions. It takes the large bowel a couple of weeks to adapt. Caffeine causes diarrhea in some individuals through a similar mechanism.
Apremilast-related diarrhea often responds to the time-tested OTC remedies, including bismuth salicylate or fiber supplements. Alternatively, Dr. Martin said he is a fan of the oral prescription agent crofelemer (Fulyzaq) because of its exceptional safety, tolerability, and effectiveness. Plus, many residents of the garden islands of Hawaii like the idea of using a botanical derived from the latexlike sap – known as ‘dragon’s blood – of a South American tree. Crofelemer’s approved indication is the treatment of diarrhea associated with anti-HIV agents.
Diphenoxylate/atropine (Lomotil) is another effective prescription option.
Nausea and/or vomiting occurred in 15%-17% of apremilast-treated patients in the phase III trials. As with diarrhea, if nausea and/or vomiting is going to happen, it occurs early, within the first week or two. Dr. Martin said he finds in his own practice that the nausea/vomiting is less bothersome for patients than the diarrhea. Drug discontinuation due to any GI side effects is rarely necessary.
The nausea/vomiting is usually readily managed by encouraging affected patients to make sure that they’re well hydrated, take their apremilast with food, and eat smaller, more frequent meals. OTC diphenhydramine (Benadryl) is often effective, as are the usual prescription antiemetic agents.
Pharmaceutical industry data indicate apremilast has quickly captured a 17% share of the market for systemic psoriasis therapies. There is a good reason for that, according to Dr. Martin: “Dermatologists have historically been risk averse. And apremilast is arguably the safest systemic agent we have to treat psoriasis. The beauty of apremilast is it requires no laboratory monitoring. That makes it attractive to dermatologists who are concerned about systemic therapy. It’s why there has been a huge jump in adoption of apremilast.”
Apremilast is comparable to methotrexate in terms of efficacy as reflected in week 16 PASI-75 response rates of about 35%, meaning 35% of treated patients obtain at least a 75% improvement in Psoriasis Area and Severity Index scores, he continued. Apremilast is particularly effective for scalp and nail psoriasis, making it a good option for patients who have psoriasis at those sites but not extensive involvement elsewhere, which might call for the use of a more potent biologic agent.
Surveys indicate that 20% of dermatologists write 80% of all prescriptions for biologic agents used to treat psoriasis. The thinking was that apremilast would appeal to the 80% of dermatologists who have steered clear of the biologics, and that after becoming comfortable with apremilast, they might become more receptive to using biologics for their patients with an inadequate response to the oral PDE-4 inhibitor. That hasn’t happened yet.
“We’re not seeing apremilast function as the gateway drug we thought it would be. It’s just going to take some time for those prescribers either to refer their patients who aren’t getting a good response to the next doctor who’s more adept at treating with biologic agents, or perhaps they themselves will get more involved,” Dr. Martin predicted.
He reported serving on scientific advisory boards for, and/or as a consultant to, nine pharmaceutical companies.
EXPERT ANALYSIS FROM RWCS 2016
AATS Annual Meeting Registration Packages Still Available
Health Care Professional Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $500 (a savings of $400).
Resident/Fellow and Medical Student Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $300.
Saturday Courses and Sunday Symposia Registration: Register for a Saturday course and/or a Sunday symposia and have access to all other courses/symposia taking place that same day. Note: Registration for the Saturday courses and/or Sunday symposia is separate from the Annual Meeting fee.
Health Care Professional Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $500 (a savings of $400).
Resident/Fellow and Medical Student Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $300.
Saturday Courses and Sunday Symposia Registration: Register for a Saturday course and/or a Sunday symposia and have access to all other courses/symposia taking place that same day. Note: Registration for the Saturday courses and/or Sunday symposia is separate from the Annual Meeting fee.
Health Care Professional Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $500 (a savings of $400).
Resident/Fellow and Medical Student Package: includes registration for the Saturday Courses, Sunday Symposia and the 96th Annual Meeting (Monday-Wednesday). Registration is $300.
Saturday Courses and Sunday Symposia Registration: Register for a Saturday course and/or a Sunday symposia and have access to all other courses/symposia taking place that same day. Note: Registration for the Saturday courses and/or Sunday symposia is separate from the Annual Meeting fee.
See you at AATS Week 2016!
AATS Week 2016 includes Two Terrific Events
AATS Week 2016 Registration & Housing Open!
Aortic Symposium
May 12–13, 2016
New York, NY
(More information below)
96th Annual Meeting
May 14-18, 2016
Baltimore, MD
(More information below)
Register for AATS Week 2016 today & receive a $100 discount off the AATS Aortic Symposium registration fee.
AATS Aortic Symposium
May 12–13, 2016
New York, NY
Course Directors
Joseph S. Coselli
Steven L. Lansman
The 2016 AATS Aortic Symposium is a two-day symposium focused on the pathophysiology, diagnosis and treatment of aortic aneurysms and dissections. The conference is designed for cardiovascular and thoracic surgeons, residents, perfusionists, ICU and OR nurses and others involved in aortic disease patient care. Faculty members include world leaders in the field who will share their experiences treating difficult aortic disease cases.
Be sure to register for a Friday Morning Breakfast Breakout session.
AATS 96th Annual Meeting
May 14-18, 2016
Baltimore, MD
President & Annual Meeting Chair
Joseph S. Coselli
Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones
View Preliminary Program, Speakers, Presentations and Full Abstracts
Don’t miss this year’s exciting program including:
Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions
Sunday Postgraduate Symposia with Legends Luncheons featuring Leonard L. Bailey, Joel D. Cooper and John L. Ochsner
New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)
Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam,” Joseph S. Coselli, Baylor College of Medicine
Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.
Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic
VAD/ECMO SessionMasters of Surgery Video Sessions
AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.
Check Out the AATS Week Video
Learn more about the exciting program planned for the AATS Aortic Symposium and 2016 Annual Meeting.
AATS Week 2016 includes Two Terrific Events
AATS Week 2016 Registration & Housing Open!
Aortic Symposium
May 12–13, 2016
New York, NY
(More information below)
96th Annual Meeting
May 14-18, 2016
Baltimore, MD
(More information below)
Register for AATS Week 2016 today & receive a $100 discount off the AATS Aortic Symposium registration fee.
AATS Aortic Symposium
May 12–13, 2016
New York, NY
Course Directors
Joseph S. Coselli
Steven L. Lansman
The 2016 AATS Aortic Symposium is a two-day symposium focused on the pathophysiology, diagnosis and treatment of aortic aneurysms and dissections. The conference is designed for cardiovascular and thoracic surgeons, residents, perfusionists, ICU and OR nurses and others involved in aortic disease patient care. Faculty members include world leaders in the field who will share their experiences treating difficult aortic disease cases.
Be sure to register for a Friday Morning Breakfast Breakout session.
AATS 96th Annual Meeting
May 14-18, 2016
Baltimore, MD
President & Annual Meeting Chair
Joseph S. Coselli
Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones
View Preliminary Program, Speakers, Presentations and Full Abstracts
Don’t miss this year’s exciting program including:
Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions
Sunday Postgraduate Symposia with Legends Luncheons featuring Leonard L. Bailey, Joel D. Cooper and John L. Ochsner
New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)
Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam,” Joseph S. Coselli, Baylor College of Medicine
Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.
Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic
VAD/ECMO SessionMasters of Surgery Video Sessions
AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.
Check Out the AATS Week Video
Learn more about the exciting program planned for the AATS Aortic Symposium and 2016 Annual Meeting.
AATS Week 2016 includes Two Terrific Events
AATS Week 2016 Registration & Housing Open!
Aortic Symposium
May 12–13, 2016
New York, NY
(More information below)
96th Annual Meeting
May 14-18, 2016
Baltimore, MD
(More information below)
Register for AATS Week 2016 today & receive a $100 discount off the AATS Aortic Symposium registration fee.
AATS Aortic Symposium
May 12–13, 2016
New York, NY
Course Directors
Joseph S. Coselli
Steven L. Lansman
The 2016 AATS Aortic Symposium is a two-day symposium focused on the pathophysiology, diagnosis and treatment of aortic aneurysms and dissections. The conference is designed for cardiovascular and thoracic surgeons, residents, perfusionists, ICU and OR nurses and others involved in aortic disease patient care. Faculty members include world leaders in the field who will share their experiences treating difficult aortic disease cases.
Be sure to register for a Friday Morning Breakfast Breakout session.
AATS 96th Annual Meeting
May 14-18, 2016
Baltimore, MD
President & Annual Meeting Chair
Joseph S. Coselli
Annual Meeting Co-Chairs
Charles D. Fraser
David R. Jones
View Preliminary Program, Speakers, Presentations and Full Abstracts
Don’t miss this year’s exciting program including:
Saturday Skills Courses featuring Combined Luncheon Speaker: Denton A. Cooley, followed by Hands-On Sessions
Sunday Postgraduate Symposia with Legends Luncheons featuring Leonard L. Bailey, Joel D. Cooper and John L. Ochsner
New: Survival Guide for the Cardiothoracic Surgical Team course following by a Hands-On Session (Available to Residents, Fellows and Health Care Professionals Only)
Presidential Address: Competition: Perspiration to Inspiration “Aut viam inveniam aut faciam,” Joseph S. Coselli, Baylor College of Medicine
Honored Guest Lecture: Brian Kelly, Notre Dame Head Football Coach and a veteran of 23 seasons as a collegiate head coach. Brian Kelly brings a championship tradition to his fifth year as the 29th head football coach at the University of Notre Dame.
Emerging Technologies & Techniques For: Adult Cardiac and General Thoracic
VAD/ECMO SessionMasters of Surgery Video Sessions
AATS Learning Center: Featuring cutting-edge case videos of novel procedures and surgical techniques.
Check Out the AATS Week Video
Learn more about the exciting program planned for the AATS Aortic Symposium and 2016 Annual Meeting.
Congratulations to 2016 “Honoring Our Mentors” Fellows
Winners of the F. Griffith Pearson Fellowships and the Mark R. de Leval Fellowship announced.
F. Griffith Pearson Fellowship
Nestor Villamizar Ortiz, MD
Institution: University of Miami
Host Sponsor: Mark Onaitis, MD
Host Institution: Duke University Medical Center
Fellowship Focus: Robotic Surgery for Malignant and Benign Esophageal Pathology
Xiao Li, MD
Institution: Peking University People’s Hospital, Beijing, China
Host Sponsor: Mark K. Ferguson, MD
Host Institution: Department of Thoracic Surgery, University of Chicago
Fellowship Focus: Advanced Minimally Invasive Thoracic Surgery and Robotic Thoracic Surgery
Marc R. de Leval Fellowship
Jeremy Herrmann, MD
Institution: The Children’s Hospital of Philadelphia
Host Sponsor: David Barron, MD
Host Institution: Birmingham Children’s Hospital, UK
Fellowship Focus: Management of ccTGA
Winners of the F. Griffith Pearson Fellowships and the Mark R. de Leval Fellowship announced.
F. Griffith Pearson Fellowship
Nestor Villamizar Ortiz, MD
Institution: University of Miami
Host Sponsor: Mark Onaitis, MD
Host Institution: Duke University Medical Center
Fellowship Focus: Robotic Surgery for Malignant and Benign Esophageal Pathology
Xiao Li, MD
Institution: Peking University People’s Hospital, Beijing, China
Host Sponsor: Mark K. Ferguson, MD
Host Institution: Department of Thoracic Surgery, University of Chicago
Fellowship Focus: Advanced Minimally Invasive Thoracic Surgery and Robotic Thoracic Surgery
Marc R. de Leval Fellowship
Jeremy Herrmann, MD
Institution: The Children’s Hospital of Philadelphia
Host Sponsor: David Barron, MD
Host Institution: Birmingham Children’s Hospital, UK
Fellowship Focus: Management of ccTGA
Winners of the F. Griffith Pearson Fellowships and the Mark R. de Leval Fellowship announced.
F. Griffith Pearson Fellowship
Nestor Villamizar Ortiz, MD
Institution: University of Miami
Host Sponsor: Mark Onaitis, MD
Host Institution: Duke University Medical Center
Fellowship Focus: Robotic Surgery for Malignant and Benign Esophageal Pathology
Xiao Li, MD
Institution: Peking University People’s Hospital, Beijing, China
Host Sponsor: Mark K. Ferguson, MD
Host Institution: Department of Thoracic Surgery, University of Chicago
Fellowship Focus: Advanced Minimally Invasive Thoracic Surgery and Robotic Thoracic Surgery
Marc R. de Leval Fellowship
Jeremy Herrmann, MD
Institution: The Children’s Hospital of Philadelphia
Host Sponsor: David Barron, MD
Host Institution: Birmingham Children’s Hospital, UK
Fellowship Focus: Management of ccTGA
Rash on trunk
The FP diagnosed a varicella infection in this patient. The simultaneous appearance of papules, pustules, and crusted lesions on the patient’s trunk and face was highly suspicious for varicella, especially because there was no history of him receiving the varicella vaccine.
Varicella (chickenpox) is caused by a primary infection with the varicella zoster virus (VZV), which is a double-stranded, linear DNA herpes virus. Transmission occurs via contact with aerosolized droplets from nasopharyngeal secretions or by direct cutaneous contact with vesicle fluid from skin lesions. The incubation period for VZV is approximately 15 days, during which the virus undergoes replication in regional lymph nodes, followed by 2 viremic stages. In the first stage the virus spreads to internal organs, and in the second stage the virus spreads to the skin.
The vesicular rash appears in crops for several days and the lesions start as vesicles on a red base (classically described as a “dew drop on a rose petal”). The lesions gradually develop a pustular component followed by the evolution of crusted papules. The period of infectivity is generally considered to last from 48 hours prior to the onset of the rash until the skin lesions have fully crusted.
New varicella lesions stop forming in approximately 4 days, and most lesions become fully crusted by 7 days. Diagnosis is usually based on classic presentation. A culture of the lesions may provide a definitive diagnosis, but is positive in less than 40% of cases. Direct fluorescent antibody testing has good sensitivity and is more rapid than tissue culture. In this case, the diagnosis was made on clinical grounds.
Adults who get varicella should be assessed for neurologic and pulmonary disease; our patient showed no signs of either complication. Encephalitis is a serious potential complication of chickenpox that can develop toward the end of the first week of the exanthema. One form, acute cerebellar ataxia, occurs mostly in children and is generally followed by a complete recovery. In adults, a diffuse encephalitis can occur, and may produce delirium, seizures, and focal neurologic signs. It has significant rates of long-term neurologic sequelae and death.
Varicella pneumonia accounts for the majority of hospitalizations in adults with chickenpox, where it has up to a 30% mortality rate. It usually develops insidiously within a few days after the rash has appeared, with progressive tachypnea, dyspnea, and dry cough. Chest x-rays will reveal diffuse bilateral infiltrates. Varicella pneumonia requires prompt administration of intravenous acyclovir.
For adults with uncomplicated varicella, oral acyclovir 800 mg 5 times/d for 5 days may be used for treatment if started within the first 24 hours of the rash. The patient in this case denied risk factors for human immunodeficiency virus, and because he lacked health insurance, he did not want any blood tests or medications unless they were absolutely necessary. He wanted to return to work but was told that he needed to wait until all his lesions had crusted over.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ. Chickenpox. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:707-711.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
The FP diagnosed a varicella infection in this patient. The simultaneous appearance of papules, pustules, and crusted lesions on the patient’s trunk and face was highly suspicious for varicella, especially because there was no history of him receiving the varicella vaccine.
Varicella (chickenpox) is caused by a primary infection with the varicella zoster virus (VZV), which is a double-stranded, linear DNA herpes virus. Transmission occurs via contact with aerosolized droplets from nasopharyngeal secretions or by direct cutaneous contact with vesicle fluid from skin lesions. The incubation period for VZV is approximately 15 days, during which the virus undergoes replication in regional lymph nodes, followed by 2 viremic stages. In the first stage the virus spreads to internal organs, and in the second stage the virus spreads to the skin.
The vesicular rash appears in crops for several days and the lesions start as vesicles on a red base (classically described as a “dew drop on a rose petal”). The lesions gradually develop a pustular component followed by the evolution of crusted papules. The period of infectivity is generally considered to last from 48 hours prior to the onset of the rash until the skin lesions have fully crusted.
New varicella lesions stop forming in approximately 4 days, and most lesions become fully crusted by 7 days. Diagnosis is usually based on classic presentation. A culture of the lesions may provide a definitive diagnosis, but is positive in less than 40% of cases. Direct fluorescent antibody testing has good sensitivity and is more rapid than tissue culture. In this case, the diagnosis was made on clinical grounds.
Adults who get varicella should be assessed for neurologic and pulmonary disease; our patient showed no signs of either complication. Encephalitis is a serious potential complication of chickenpox that can develop toward the end of the first week of the exanthema. One form, acute cerebellar ataxia, occurs mostly in children and is generally followed by a complete recovery. In adults, a diffuse encephalitis can occur, and may produce delirium, seizures, and focal neurologic signs. It has significant rates of long-term neurologic sequelae and death.
Varicella pneumonia accounts for the majority of hospitalizations in adults with chickenpox, where it has up to a 30% mortality rate. It usually develops insidiously within a few days after the rash has appeared, with progressive tachypnea, dyspnea, and dry cough. Chest x-rays will reveal diffuse bilateral infiltrates. Varicella pneumonia requires prompt administration of intravenous acyclovir.
For adults with uncomplicated varicella, oral acyclovir 800 mg 5 times/d for 5 days may be used for treatment if started within the first 24 hours of the rash. The patient in this case denied risk factors for human immunodeficiency virus, and because he lacked health insurance, he did not want any blood tests or medications unless they were absolutely necessary. He wanted to return to work but was told that he needed to wait until all his lesions had crusted over.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ. Chickenpox. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:707-711.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
The FP diagnosed a varicella infection in this patient. The simultaneous appearance of papules, pustules, and crusted lesions on the patient’s trunk and face was highly suspicious for varicella, especially because there was no history of him receiving the varicella vaccine.
Varicella (chickenpox) is caused by a primary infection with the varicella zoster virus (VZV), which is a double-stranded, linear DNA herpes virus. Transmission occurs via contact with aerosolized droplets from nasopharyngeal secretions or by direct cutaneous contact with vesicle fluid from skin lesions. The incubation period for VZV is approximately 15 days, during which the virus undergoes replication in regional lymph nodes, followed by 2 viremic stages. In the first stage the virus spreads to internal organs, and in the second stage the virus spreads to the skin.
The vesicular rash appears in crops for several days and the lesions start as vesicles on a red base (classically described as a “dew drop on a rose petal”). The lesions gradually develop a pustular component followed by the evolution of crusted papules. The period of infectivity is generally considered to last from 48 hours prior to the onset of the rash until the skin lesions have fully crusted.
New varicella lesions stop forming in approximately 4 days, and most lesions become fully crusted by 7 days. Diagnosis is usually based on classic presentation. A culture of the lesions may provide a definitive diagnosis, but is positive in less than 40% of cases. Direct fluorescent antibody testing has good sensitivity and is more rapid than tissue culture. In this case, the diagnosis was made on clinical grounds.
Adults who get varicella should be assessed for neurologic and pulmonary disease; our patient showed no signs of either complication. Encephalitis is a serious potential complication of chickenpox that can develop toward the end of the first week of the exanthema. One form, acute cerebellar ataxia, occurs mostly in children and is generally followed by a complete recovery. In adults, a diffuse encephalitis can occur, and may produce delirium, seizures, and focal neurologic signs. It has significant rates of long-term neurologic sequelae and death.
Varicella pneumonia accounts for the majority of hospitalizations in adults with chickenpox, where it has up to a 30% mortality rate. It usually develops insidiously within a few days after the rash has appeared, with progressive tachypnea, dyspnea, and dry cough. Chest x-rays will reveal diffuse bilateral infiltrates. Varicella pneumonia requires prompt administration of intravenous acyclovir.
For adults with uncomplicated varicella, oral acyclovir 800 mg 5 times/d for 5 days may be used for treatment if started within the first 24 hours of the rash. The patient in this case denied risk factors for human immunodeficiency virus, and because he lacked health insurance, he did not want any blood tests or medications unless they were absolutely necessary. He wanted to return to work but was told that he needed to wait until all his lesions had crusted over.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ. Chickenpox. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:707-711.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
Vemurafenib and Serum Creatinine Elevation
Used to treat advanced melanoma, vemurafenib has been shown to increase serum creatinine; but neither the prevalence nor the mechanism for the increase is known, say researchers from Assistance-Publique-Hôpitaux de Paris. Their study suggests 2 mechanisms are at work.
In their retrospective study of 70 patients, the researchers found that 97% had an immediate—but stable—increase in their creatinine level after starting vemurafenib. At the first visit, 1 month after starting the drug, 68 patients had a significant increase in serum creatinine levels, with a median variation of 22.8%. However, in 44 of 52 patients who discontinued the drug, because the melanoma had progressed, creatinine levels returned to baseline.
Related: Promising Method to Evaluate Response to Treatment
Serum cystatin C levels also rose, although less than that of serum creatinine. Researchers say the increase showed that the creatinine increase was partly a result of renal function impairment. Moreover, renal explorations showed that vemurafenib led to inhibition of creatinine tubular secretion.
According to the researchers, the dual mechanism of both inhibition of creatinine tubular secretion and slight renal function impairment makes interpreting creatinine variations difficult. They offer a decision tree to help clinicians manage creatinine elevations due to the drug. The researchers suggest testing for serum creatinine and cystatin C before beginning the treatment and during monthly follow-ups.
Related: FDA Approves Rescue Drug for Chemotherapy Overdose
The collected data are reassuring. Apart from rare cases of serious adverse events, such as severe acute renal failure, an increase in serum creatinine below 50% and/or moderate signs of tubular dysfunction should not lead to discontinuing treatment if it is otherwise effective.
Source:
Hurabielle C, Pillebout E, Stehlé T, et al. PLoS ONE. 2016;11(3):e0149873. doi:10.1371/journal.pone.0149873.
Used to treat advanced melanoma, vemurafenib has been shown to increase serum creatinine; but neither the prevalence nor the mechanism for the increase is known, say researchers from Assistance-Publique-Hôpitaux de Paris. Their study suggests 2 mechanisms are at work.
In their retrospective study of 70 patients, the researchers found that 97% had an immediate—but stable—increase in their creatinine level after starting vemurafenib. At the first visit, 1 month after starting the drug, 68 patients had a significant increase in serum creatinine levels, with a median variation of 22.8%. However, in 44 of 52 patients who discontinued the drug, because the melanoma had progressed, creatinine levels returned to baseline.
Related: Promising Method to Evaluate Response to Treatment
Serum cystatin C levels also rose, although less than that of serum creatinine. Researchers say the increase showed that the creatinine increase was partly a result of renal function impairment. Moreover, renal explorations showed that vemurafenib led to inhibition of creatinine tubular secretion.
According to the researchers, the dual mechanism of both inhibition of creatinine tubular secretion and slight renal function impairment makes interpreting creatinine variations difficult. They offer a decision tree to help clinicians manage creatinine elevations due to the drug. The researchers suggest testing for serum creatinine and cystatin C before beginning the treatment and during monthly follow-ups.
Related: FDA Approves Rescue Drug for Chemotherapy Overdose
The collected data are reassuring. Apart from rare cases of serious adverse events, such as severe acute renal failure, an increase in serum creatinine below 50% and/or moderate signs of tubular dysfunction should not lead to discontinuing treatment if it is otherwise effective.
Source:
Hurabielle C, Pillebout E, Stehlé T, et al. PLoS ONE. 2016;11(3):e0149873. doi:10.1371/journal.pone.0149873.
Used to treat advanced melanoma, vemurafenib has been shown to increase serum creatinine; but neither the prevalence nor the mechanism for the increase is known, say researchers from Assistance-Publique-Hôpitaux de Paris. Their study suggests 2 mechanisms are at work.
In their retrospective study of 70 patients, the researchers found that 97% had an immediate—but stable—increase in their creatinine level after starting vemurafenib. At the first visit, 1 month after starting the drug, 68 patients had a significant increase in serum creatinine levels, with a median variation of 22.8%. However, in 44 of 52 patients who discontinued the drug, because the melanoma had progressed, creatinine levels returned to baseline.
Related: Promising Method to Evaluate Response to Treatment
Serum cystatin C levels also rose, although less than that of serum creatinine. Researchers say the increase showed that the creatinine increase was partly a result of renal function impairment. Moreover, renal explorations showed that vemurafenib led to inhibition of creatinine tubular secretion.
According to the researchers, the dual mechanism of both inhibition of creatinine tubular secretion and slight renal function impairment makes interpreting creatinine variations difficult. They offer a decision tree to help clinicians manage creatinine elevations due to the drug. The researchers suggest testing for serum creatinine and cystatin C before beginning the treatment and during monthly follow-ups.
Related: FDA Approves Rescue Drug for Chemotherapy Overdose
The collected data are reassuring. Apart from rare cases of serious adverse events, such as severe acute renal failure, an increase in serum creatinine below 50% and/or moderate signs of tubular dysfunction should not lead to discontinuing treatment if it is otherwise effective.
Source:
Hurabielle C, Pillebout E, Stehlé T, et al. PLoS ONE. 2016;11(3):e0149873. doi:10.1371/journal.pone.0149873.
Endovascular surges over surgery for patients hospitalized for CLI
Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.
In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.
The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].
Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.
A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).
Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).
Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.
Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.
In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.
“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.
The authors reported that they had no relevant disclosures.
Many of the unanswered questions regarding the optimal approach to CLI are being addressed by the National Heart, Lung, and Blood Institute–sponsored, multicenter, randomized BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial. The BEST-CLI trial will hopefully be completed in 2017. Until that time, clinicians will continue to rely on the best available data to guide revascularization strategies for the management of CLI.
Consistent with prior investigations, Dr. Agarwal et al. demonstrated a significant reduction in the proportion of patients undergoing surgical revascularization with a concomitant rise in endovascular revascularization during the same time period. This was accompanied by a steady decline in the incidence of in-hospital mortality and major amputation. Endovascular therapy was associated with a shorter mean length of stay and reduced hospital costs, despite a similar rate of in-hospital major amputation. As the authors correctly point out, the decreasing amputation and mortality rates cannot be directly attributable to a rise in endovascular therapy, as these studies cannot provide causal conclusions. Numerous other factors can influence mortality and amputation rates, including better medical care, aggressive risk factor modification, and appropriate wound care. Still, these associations are powerful and hypothesis generating, and they warrant further investigation.
Whether the improving CLI outcomes can be explained by the growth of these endovascular therapies is yet to be proved. We await the results of the landmark BEST-CLI trial to provide clarity regarding this issue and to further clarify the future role of surgical versus endovascular revascularization.
Dr. John R. Laird and Dr. Gagan D. Singh of the University of California, Davis Medical Center, Sacramento, and Dr. Ehrin J. Armstrong of the University of Colorado, Denver, made their comments in an invited editorial published online in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2016.02.041). Dr. Laird has served as a consultant or advisory board member for Bard Peripheral Vascular, Boston Scientific, Cordis, Medtronic, and Abbott Vascular; and has received research support from WL Gore. Dr. Armstrong has served as a consultant or advisory board member for Abbott Vascular, Boston Scientific, Medtronic, Merck, and Spectranetics. Dr. Singh reported that he has no relevant disclosures.
Many of the unanswered questions regarding the optimal approach to CLI are being addressed by the National Heart, Lung, and Blood Institute–sponsored, multicenter, randomized BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial. The BEST-CLI trial will hopefully be completed in 2017. Until that time, clinicians will continue to rely on the best available data to guide revascularization strategies for the management of CLI.
Consistent with prior investigations, Dr. Agarwal et al. demonstrated a significant reduction in the proportion of patients undergoing surgical revascularization with a concomitant rise in endovascular revascularization during the same time period. This was accompanied by a steady decline in the incidence of in-hospital mortality and major amputation. Endovascular therapy was associated with a shorter mean length of stay and reduced hospital costs, despite a similar rate of in-hospital major amputation. As the authors correctly point out, the decreasing amputation and mortality rates cannot be directly attributable to a rise in endovascular therapy, as these studies cannot provide causal conclusions. Numerous other factors can influence mortality and amputation rates, including better medical care, aggressive risk factor modification, and appropriate wound care. Still, these associations are powerful and hypothesis generating, and they warrant further investigation.
Whether the improving CLI outcomes can be explained by the growth of these endovascular therapies is yet to be proved. We await the results of the landmark BEST-CLI trial to provide clarity regarding this issue and to further clarify the future role of surgical versus endovascular revascularization.
Dr. John R. Laird and Dr. Gagan D. Singh of the University of California, Davis Medical Center, Sacramento, and Dr. Ehrin J. Armstrong of the University of Colorado, Denver, made their comments in an invited editorial published online in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2016.02.041). Dr. Laird has served as a consultant or advisory board member for Bard Peripheral Vascular, Boston Scientific, Cordis, Medtronic, and Abbott Vascular; and has received research support from WL Gore. Dr. Armstrong has served as a consultant or advisory board member for Abbott Vascular, Boston Scientific, Medtronic, Merck, and Spectranetics. Dr. Singh reported that he has no relevant disclosures.
Many of the unanswered questions regarding the optimal approach to CLI are being addressed by the National Heart, Lung, and Blood Institute–sponsored, multicenter, randomized BEST-CLI (Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia) trial. The BEST-CLI trial will hopefully be completed in 2017. Until that time, clinicians will continue to rely on the best available data to guide revascularization strategies for the management of CLI.
Consistent with prior investigations, Dr. Agarwal et al. demonstrated a significant reduction in the proportion of patients undergoing surgical revascularization with a concomitant rise in endovascular revascularization during the same time period. This was accompanied by a steady decline in the incidence of in-hospital mortality and major amputation. Endovascular therapy was associated with a shorter mean length of stay and reduced hospital costs, despite a similar rate of in-hospital major amputation. As the authors correctly point out, the decreasing amputation and mortality rates cannot be directly attributable to a rise in endovascular therapy, as these studies cannot provide causal conclusions. Numerous other factors can influence mortality and amputation rates, including better medical care, aggressive risk factor modification, and appropriate wound care. Still, these associations are powerful and hypothesis generating, and they warrant further investigation.
Whether the improving CLI outcomes can be explained by the growth of these endovascular therapies is yet to be proved. We await the results of the landmark BEST-CLI trial to provide clarity regarding this issue and to further clarify the future role of surgical versus endovascular revascularization.
Dr. John R. Laird and Dr. Gagan D. Singh of the University of California, Davis Medical Center, Sacramento, and Dr. Ehrin J. Armstrong of the University of Colorado, Denver, made their comments in an invited editorial published online in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2016.02.041). Dr. Laird has served as a consultant or advisory board member for Bard Peripheral Vascular, Boston Scientific, Cordis, Medtronic, and Abbott Vascular; and has received research support from WL Gore. Dr. Armstrong has served as a consultant or advisory board member for Abbott Vascular, Boston Scientific, Medtronic, Merck, and Spectranetics. Dr. Singh reported that he has no relevant disclosures.
Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.
In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.
The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].
Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.
A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).
Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).
Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.
Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.
In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.
“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.
The authors reported that they had no relevant disclosures.
Even though there was a steady rate of patients with critical limb ischemia (CLI) admitted to hospitals from 2003 to 2011, surgical revascularization decreased and endovascular treatment increased significantly, with concomitant decreases in in-hospital mortality and major amputation, according to the results of an analysis of the Nationwide Inpatient Sample of 642,433 patients hospitalized with CLI.
In addition, despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality, compared with surgical revascularization over the same period, according to a report online in the Journal of the American College of Cardiology.
The annual in-hospital mortality rate decreased from 5.4% in 2003 to 3.4% in 2011 (P less than .001), and the major amputation rate dropped from 16.7% to 10.8%. There also was a significant decrease in length-of-stay (LOS) from 10 days to 8.4 days over the same period (P less than .001); however this did not translate to a significant difference in the cost of hospitalization, according to Dr. Shikhar Agarwal and colleagues at the Cleveland Clinic [doi:10.1016/j.jacc.2016.02.040].
Significant predictive factors of in-hospital mortality after multivariate regression analysis were female sex, older age, emergent admission, a primary indication of septicemia, heart failure, and respiratory disease, as well any stump complications present during admission. In contrast, any form of revascularization was associated with significantly reduced in-hospital mortality.
A comparison of revascularization methods showed that surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%. Also, endovascular revascularization was associated with a significant decrease in in-hospital mortality compared with surgical revascularization over the study period (2.34% vs. 2.73%, respectively; odds ratio = .69). Major amputation rates were not significantly different between the two treatments (6.5% vs. 5.7%; OR = .99).
Length of stay was significantly lower with endovascular treatment compared with surgical (8.7 vs. 10.7 days) as were costs ($31,679 vs. $32,485, respectively).
Women had a higher rate of in-hospital mortality, but a lower rate of major amputation. Although race was not seen as a factor in predicting in-hospital mortality, blacks and other nonwhite races had significantly higher rates of amputation and lower rates of revascularization, compared with whites.
Approximately half of the patients assessed were admitted for primary CLI-related diagnoses. The other, non–CLI-related conditions – such as acute MI, cerebrovascular events, respiratory disease, heart failure, and acute kidney disease – have all been independently associated with increased in-hospital mortality and may be confounding, according to the authors. These are still relevant because CLI patients have an overall elevated cardiovascular risk in multiple vascular beds.
In terms of limitations, the authors noted the possibility of selection bias in the database, the rise of standalone outpatient centers in more recent years, which might funnel off select patients, and the lack of anatomical information in the NIS database, which precludes a determination of the appropriateness of treatment choice. Also, the type and invasiveness of the endovascular therapy cannot be determined. “It is possible that simple lesions were preferentially treated with endovascular therapy, whereas more complex lesions were treated by surgical techniques, leading to obvious differences in outcomes. Alternatively, it may be likely that the findings underestimate the impact of endovascular therapy, as sicker patients with higher comorbidities and poor targets were more likely to undergo endovascular revascularization,” the researchers pointed out.
“Despite similar rates of major amputation, endovascular revascularization was associated with reduced in-hospital mortality, mean LOS, and mean cost of hospitalization. Although the results are encouraging, there remain significant disparities and gaps that must be addressed,” Dr. Agarwal and his colleagues concluded.
The authors reported that they had no relevant disclosures.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point: Surgery in hospitalized CLI patients decreased and endovascular treatment increased from 2003 to 2011 with a concomitant decrease in in-hospital mortality and major amputation.
Major finding: Surgical revascularization significantly decreased from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization increased from 5.1% to 11%.
Data source: A retrospective database analysis of 642,433 patients hospitalized with CLI from 2003 to 2011 who were included in the Nationwide Inpatient Sample.
Disclosures: The authors reported that they had no relevant disclosures.
SHM Student-Resident Program to Tour U.S. Cities
Interested in a career in hospital medicine? Know someone who is? SHM hosts a series of special events for students and residents on campuses throughout the country. These catered networking receptions feature nationally recognized hospitalists speaking on their careers and the many options and opportunities within the hospital medicine specialty.
Don’t miss the opportunity to consider a career choice in medicine’s fastest growing specialty and network with the hospital medicine community. The tentative 2016 schedule includes stops in the following cities:
Spring: Baltimore, San Antonio, Seattle, Tempe, Ariz.
Fall: Atlanta, Chicago, Denver, New York City, Philadelphia, San Francisco, St. Louis
Visit www.futureofhospitalmedicine.org/events to learn more and see updated schedule details.
Interested in a career in hospital medicine? Know someone who is? SHM hosts a series of special events for students and residents on campuses throughout the country. These catered networking receptions feature nationally recognized hospitalists speaking on their careers and the many options and opportunities within the hospital medicine specialty.
Don’t miss the opportunity to consider a career choice in medicine’s fastest growing specialty and network with the hospital medicine community. The tentative 2016 schedule includes stops in the following cities:
Spring: Baltimore, San Antonio, Seattle, Tempe, Ariz.
Fall: Atlanta, Chicago, Denver, New York City, Philadelphia, San Francisco, St. Louis
Visit www.futureofhospitalmedicine.org/events to learn more and see updated schedule details.
Interested in a career in hospital medicine? Know someone who is? SHM hosts a series of special events for students and residents on campuses throughout the country. These catered networking receptions feature nationally recognized hospitalists speaking on their careers and the many options and opportunities within the hospital medicine specialty.
Don’t miss the opportunity to consider a career choice in medicine’s fastest growing specialty and network with the hospital medicine community. The tentative 2016 schedule includes stops in the following cities:
Spring: Baltimore, San Antonio, Seattle, Tempe, Ariz.
Fall: Atlanta, Chicago, Denver, New York City, Philadelphia, San Francisco, St. Louis
Visit www.futureofhospitalmedicine.org/events to learn more and see updated schedule details.