Bruce Jancin

WAIKOLOA, HAWAII  – The use of eflornithine cream may increase the effectiveness of laser hair removal for treating pseudofolliculitis barbae, according to Dr. Andrew F. Alexis.

Laser hair removal has proved to be a game changer in the treatment of pseudofolliculitis barbae, a common chronic, inflammatory dermatosis that’s often been a difficult therapeutic challenge, Dr. Alexis said at the seminar sponsored by Skin Disease Education Foundation (SDEF). And the use of adjunctive eflornithine cream makes laser therapy even more effective, based on a recent study, which is one of the few rigorous studies conducted in pseudofolliculitis barbae (PFB) patients, noted Dr. Alexis, director of the skin of color center at St. Luke’s–Roosevelt Hospital and a dermatologist at Columbia University, New York.

Photo: Dermatologic Clinics 2003;21;629-44

The double-blind placebo controlled study was carried out by U.S. military physicians. PFB, which is predominantly a disorder of black men, has at times been a source of racial tension in the military because the simplest treatment for PFB is to stop shaving and grow a beard, a form of individual expression at odds with regulations.

The study included 27 men with PFB. They received laser therapy once every 4 weeks for 16 weeks. In addition, they applied eflornithine cream to one side of their bearded neck region and placebo to the other side twice daily.

At 16 weeks, the laser plus eflornithine cream side produced a median 99.5% reduction in hair count and inflammatory papules. This was a significantly better result than the median 85% reduction on the laser plus placebo–treated side (J. Am. Acad. Dermatol. 2012 Jan. 8; in press).

The PFB study follows an earlier study by other investigators who demonstrated that eflornithine cream as an adjunct to laser hair removal for facial hirsutism in women was more effective than laser therapy alone (J. Am. Acad. Dermatol. 2007;57:54-9).

Dr. Alexis said performing laser hair removal safely in darker-skinned patients with PFB requires attention to several key principles: longer wavelengths, lower fluences, longer pulse durations, and plenty of epidermal cooling.

"The No. 1 thing is to use longer wavelengths, because the goal is deeper penetration to maximize the ratio of the temperature in the bulb of the follicle to the temperature in the epidermis," he explained.

The long-pulsed 1,064-nm Nd:YAG laser has the lowest rate of associated epidermal burns, hypopigmentation, and other adverse events in darker-skinned patients, as has been shown in a review of a wide assortment of lasers (J. Drugs Dermatol. 2007;6:40-6). It is clearly the safest laser option in patients with skin types IV-VI. The 810-nm diode laser is a reasonable alternative in skin types IV-V, Dr. Alexis said.

In treating patients for PFB with the 1,064-nm Nd:YAG laser, he said that he typically starts with a fluence of 20 J/cm² and a pulse duration of 20-30 milliseconds. After several sessions, as he makes inroads into the initially dense follicular distribution, he said that he might increase the fluence to a maximum of 50 J/cm² in the setting of skin type VI, and as high as 100 J/cm² in skin types IV or V.

Longer pulse durations allow for more efficient epidermal cooling. This minimizes heat injury to melanin-containing epidermal cells. For the 810-nm diode laser, Dr. Alexis said he uses pulse durations of 100 or 400 milliseconds.

Epidermal cooling can be accomplished in several ways. His preferred method is to utilize contact cooling via a sapphire tip or chilled copper plate attached to the laser; the cooling is done before delivering the laser pulse. Alternatively, the epidermal cooling can be done using cold gels, forced air, or spray cooling, although dyschromia can occur in darker skin types if the spray technique isn’t optimal. Another option is to apply an ice pack for 5-10 minutes post treatment.

Laser therapy is expensive, so Dr. Alexis said he likes to give his patients a range of therapeutic options. These include growing a beard, chemical depilation with barium sulfide or calcium thioglycolate every 2-4 days, modification of shaving practices, and salicylic acid chemical peels.

"It’s kind of a long conversation," he said.

Whatever form of therapy the patient decides upon, it’s important that the patient stops tweezing to remove ingrown hairs. This is a common practice that induces trauma and worsens postinflammatory hyperpigmentation.

Dr. Alexis reported that he serves as a consultant to Schick and is on the advisory board for Allergan. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII  – The use of eflornithine cream may increase the effectiveness of laser hair removal for treating pseudofolliculitis barbae, according to Dr. Andrew F. Alexis.

Laser hair removal has proved to be a game changer in the treatment of pseudofolliculitis barbae, a common chronic, inflammatory dermatosis that’s often been a difficult therapeutic challenge, Dr. Alexis said at the seminar sponsored by Skin Disease Education Foundation (SDEF). And the use of adjunctive eflornithine cream makes laser therapy even more effective, based on a recent study, which is one of the few rigorous studies conducted in pseudofolliculitis barbae (PFB) patients, noted Dr. Alexis, director of the skin of color center at St. Luke’s–Roosevelt Hospital and a dermatologist at Columbia University, New York.

Photo: Dermatologic Clinics 2003;21;629-44

The double-blind placebo controlled study was carried out by U.S. military physicians. PFB, which is predominantly a disorder of black men, has at times been a source of racial tension in the military because the simplest treatment for PFB is to stop shaving and grow a beard, a form of individual expression at odds with regulations.

The study included 27 men with PFB. They received laser therapy once every 4 weeks for 16 weeks. In addition, they applied eflornithine cream to one side of their bearded neck region and placebo to the other side twice daily.

At 16 weeks, the laser plus eflornithine cream side produced a median 99.5% reduction in hair count and inflammatory papules. This was a significantly better result than the median 85% reduction on the laser plus placebo–treated side (J. Am. Acad. Dermatol. 2012 Jan. 8; in press).

The PFB study follows an earlier study by other investigators who demonstrated that eflornithine cream as an adjunct to laser hair removal for facial hirsutism in women was more effective than laser therapy alone (J. Am. Acad. Dermatol. 2007;57:54-9).

Dr. Alexis said performing laser hair removal safely in darker-skinned patients with PFB requires attention to several key principles: longer wavelengths, lower fluences, longer pulse durations, and plenty of epidermal cooling.

"The No. 1 thing is to use longer wavelengths, because the goal is deeper penetration to maximize the ratio of the temperature in the bulb of the follicle to the temperature in the epidermis," he explained.

The long-pulsed 1,064-nm Nd:YAG laser has the lowest rate of associated epidermal burns, hypopigmentation, and other adverse events in darker-skinned patients, as has been shown in a review of a wide assortment of lasers (J. Drugs Dermatol. 2007;6:40-6). It is clearly the safest laser option in patients with skin types IV-VI. The 810-nm diode laser is a reasonable alternative in skin types IV-V, Dr. Alexis said.

In treating patients for PFB with the 1,064-nm Nd:YAG laser, he said that he typically starts with a fluence of 20 J/cm² and a pulse duration of 20-30 milliseconds. After several sessions, as he makes inroads into the initially dense follicular distribution, he said that he might increase the fluence to a maximum of 50 J/cm² in the setting of skin type VI, and as high as 100 J/cm² in skin types IV or V.

Longer pulse durations allow for more efficient epidermal cooling. This minimizes heat injury to melanin-containing epidermal cells. For the 810-nm diode laser, Dr. Alexis said he uses pulse durations of 100 or 400 milliseconds.

Epidermal cooling can be accomplished in several ways. His preferred method is to utilize contact cooling via a sapphire tip or chilled copper plate attached to the laser; the cooling is done before delivering the laser pulse. Alternatively, the epidermal cooling can be done using cold gels, forced air, or spray cooling, although dyschromia can occur in darker skin types if the spray technique isn’t optimal. Another option is to apply an ice pack for 5-10 minutes post treatment.

Laser therapy is expensive, so Dr. Alexis said he likes to give his patients a range of therapeutic options. These include growing a beard, chemical depilation with barium sulfide or calcium thioglycolate every 2-4 days, modification of shaving practices, and salicylic acid chemical peels.

"It’s kind of a long conversation," he said.

Whatever form of therapy the patient decides upon, it’s important that the patient stops tweezing to remove ingrown hairs. This is a common practice that induces trauma and worsens postinflammatory hyperpigmentation.

Dr. Alexis reported that he serves as a consultant to Schick and is on the advisory board for Allergan. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII  – The use of eflornithine cream may increase the effectiveness of laser hair removal for treating pseudofolliculitis barbae, according to Dr. Andrew F. Alexis.

Laser hair removal has proved to be a game changer in the treatment of pseudofolliculitis barbae, a common chronic, inflammatory dermatosis that’s often been a difficult therapeutic challenge, Dr. Alexis said at the seminar sponsored by Skin Disease Education Foundation (SDEF). And the use of adjunctive eflornithine cream makes laser therapy even more effective, based on a recent study, which is one of the few rigorous studies conducted in pseudofolliculitis barbae (PFB) patients, noted Dr. Alexis, director of the skin of color center at St. Luke’s–Roosevelt Hospital and a dermatologist at Columbia University, New York.

Photo: Dermatologic Clinics 2003;21;629-44

The double-blind placebo controlled study was carried out by U.S. military physicians. PFB, which is predominantly a disorder of black men, has at times been a source of racial tension in the military because the simplest treatment for PFB is to stop shaving and grow a beard, a form of individual expression at odds with regulations.

The study included 27 men with PFB. They received laser therapy once every 4 weeks for 16 weeks. In addition, they applied eflornithine cream to one side of their bearded neck region and placebo to the other side twice daily.

At 16 weeks, the laser plus eflornithine cream side produced a median 99.5% reduction in hair count and inflammatory papules. This was a significantly better result than the median 85% reduction on the laser plus placebo–treated side (J. Am. Acad. Dermatol. 2012 Jan. 8; in press).

The PFB study follows an earlier study by other investigators who demonstrated that eflornithine cream as an adjunct to laser hair removal for facial hirsutism in women was more effective than laser therapy alone (J. Am. Acad. Dermatol. 2007;57:54-9).

Dr. Alexis said performing laser hair removal safely in darker-skinned patients with PFB requires attention to several key principles: longer wavelengths, lower fluences, longer pulse durations, and plenty of epidermal cooling.

"The No. 1 thing is to use longer wavelengths, because the goal is deeper penetration to maximize the ratio of the temperature in the bulb of the follicle to the temperature in the epidermis," he explained.

The long-pulsed 1,064-nm Nd:YAG laser has the lowest rate of associated epidermal burns, hypopigmentation, and other adverse events in darker-skinned patients, as has been shown in a review of a wide assortment of lasers (J. Drugs Dermatol. 2007;6:40-6). It is clearly the safest laser option in patients with skin types IV-VI. The 810-nm diode laser is a reasonable alternative in skin types IV-V, Dr. Alexis said.

In treating patients for PFB with the 1,064-nm Nd:YAG laser, he said that he typically starts with a fluence of 20 J/cm² and a pulse duration of 20-30 milliseconds. After several sessions, as he makes inroads into the initially dense follicular distribution, he said that he might increase the fluence to a maximum of 50 J/cm² in the setting of skin type VI, and as high as 100 J/cm² in skin types IV or V.

Longer pulse durations allow for more efficient epidermal cooling. This minimizes heat injury to melanin-containing epidermal cells. For the 810-nm diode laser, Dr. Alexis said he uses pulse durations of 100 or 400 milliseconds.

Epidermal cooling can be accomplished in several ways. His preferred method is to utilize contact cooling via a sapphire tip or chilled copper plate attached to the laser; the cooling is done before delivering the laser pulse. Alternatively, the epidermal cooling can be done using cold gels, forced air, or spray cooling, although dyschromia can occur in darker skin types if the spray technique isn’t optimal. Another option is to apply an ice pack for 5-10 minutes post treatment.

Laser therapy is expensive, so Dr. Alexis said he likes to give his patients a range of therapeutic options. These include growing a beard, chemical depilation with barium sulfide or calcium thioglycolate every 2-4 days, modification of shaving practices, and salicylic acid chemical peels.

"It’s kind of a long conversation," he said.

Whatever form of therapy the patient decides upon, it’s important that the patient stops tweezing to remove ingrown hairs. This is a common practice that induces trauma and worsens postinflammatory hyperpigmentation.

Dr. Alexis reported that he serves as a consultant to Schick and is on the advisory board for Allergan. SDEF and this news organization are owned by Elsevier.

DENVER – More than three-quarters of the general public have no idea what palliative care is, according to a national survey. And that, as it turns out, is actually excellent for the field’s future growth prospects, according to one of the nation’s top palliative care specialists.

"This is good news for us. We can create the cognitive frame where there isn’t one already in place," said Dr. Diane E. Meier, director of the Center to Advance Palliative Care and professor of geriatrics and internal medicine at Mount Sinai School of Medicine, New York.

Bruce Jancin/IMNG Medical Media

While the public is largely a blank slate with regard to palliative care, nonpalliative care physicians and other health care professionals tend to believe that palliative care is simply end of life care. Many don’t understand that palliative care is actually about relieving the pain, symptoms, and stress of serious illness in patients of any age and at any stage of disease, and that palliative care can be delivered alongside curative or life-prolonging therapies, Dr. Meier said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

The consumer survey sponsored by the Center to Advance Palliative Care and the American Cancer Society involved 800 adults; 70% indicated they were "not at all knowledgeable" about palliative care, and another 8% had never heard of the term. Only 5% were categorized as "very knowledgeable" about palliative care.

Once they were informed about what palliative care truly is, however, survey participants of all political persuasions were very positive about it.

For example, once they were educated about palliative care, 95% of those surveyed said it’s important for patients with serious illnesses and their families to learn about palliative care. Most (92%) indicated they would likely consider it for themselves or a loved one, and an equal percentage said it’s important that palliative care services be available at all hospitals, Dr. Meier reported.

She and other leaders in the palliative care field are now seeking funding for an ambitious 5-year, multimillion-dollar social marketing campaign to increase public awareness regarding palliative care.

"We’ve recognized that we’re not going to see policy change without public support," Dr. Meier said.

Among the policy changes she and her colleagues seek is a big boost in the palliative care workforce, which at present is so small as to constitute a major barrier to access. While there is one oncologist for every 145 patients in the United States with a new cancer diagnosis, and one cardiologist for every 71 patients who have a myocardial infarction, there is just one palliative care specialist for every 1,300 people with a serious illness. And in nearly half of the states, no postgraduate training in palliative care is available.

Dr. Meier would like to see an increased number of physician and nurse practitioner fellowship programs established in palliative care. Another priority is to develop a midcareer board certification track in palliative care across all medical disciplines.

"We have a lot of people coming in from oncology, surgery, and other fields who are seeking work with meaning and purpose," she observed.

Starting in 2013, the specialty will require fellowship training for board certification in palliative care. "Grandfathering in" will no longer be possible.

Dr. Meier reported having no financial conflicts.

DENVER – More than three-quarters of the general public have no idea what palliative care is, according to a national survey. And that, as it turns out, is actually excellent for the field’s future growth prospects, according to one of the nation’s top palliative care specialists.

"This is good news for us. We can create the cognitive frame where there isn’t one already in place," said Dr. Diane E. Meier, director of the Center to Advance Palliative Care and professor of geriatrics and internal medicine at Mount Sinai School of Medicine, New York.

Bruce Jancin/IMNG Medical Media

While the public is largely a blank slate with regard to palliative care, nonpalliative care physicians and other health care professionals tend to believe that palliative care is simply end of life care. Many don’t understand that palliative care is actually about relieving the pain, symptoms, and stress of serious illness in patients of any age and at any stage of disease, and that palliative care can be delivered alongside curative or life-prolonging therapies, Dr. Meier said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

The consumer survey sponsored by the Center to Advance Palliative Care and the American Cancer Society involved 800 adults; 70% indicated they were "not at all knowledgeable" about palliative care, and another 8% had never heard of the term. Only 5% were categorized as "very knowledgeable" about palliative care.

Once they were informed about what palliative care truly is, however, survey participants of all political persuasions were very positive about it.

For example, once they were educated about palliative care, 95% of those surveyed said it’s important for patients with serious illnesses and their families to learn about palliative care. Most (92%) indicated they would likely consider it for themselves or a loved one, and an equal percentage said it’s important that palliative care services be available at all hospitals, Dr. Meier reported.

She and other leaders in the palliative care field are now seeking funding for an ambitious 5-year, multimillion-dollar social marketing campaign to increase public awareness regarding palliative care.

"We’ve recognized that we’re not going to see policy change without public support," Dr. Meier said.

Among the policy changes she and her colleagues seek is a big boost in the palliative care workforce, which at present is so small as to constitute a major barrier to access. While there is one oncologist for every 145 patients in the United States with a new cancer diagnosis, and one cardiologist for every 71 patients who have a myocardial infarction, there is just one palliative care specialist for every 1,300 people with a serious illness. And in nearly half of the states, no postgraduate training in palliative care is available.

Dr. Meier would like to see an increased number of physician and nurse practitioner fellowship programs established in palliative care. Another priority is to develop a midcareer board certification track in palliative care across all medical disciplines.

"We have a lot of people coming in from oncology, surgery, and other fields who are seeking work with meaning and purpose," she observed.

Starting in 2013, the specialty will require fellowship training for board certification in palliative care. "Grandfathering in" will no longer be possible.

Dr. Meier reported having no financial conflicts.

DENVER – More than three-quarters of the general public have no idea what palliative care is, according to a national survey. And that, as it turns out, is actually excellent for the field’s future growth prospects, according to one of the nation’s top palliative care specialists.

"This is good news for us. We can create the cognitive frame where there isn’t one already in place," said Dr. Diane E. Meier, director of the Center to Advance Palliative Care and professor of geriatrics and internal medicine at Mount Sinai School of Medicine, New York.

Bruce Jancin/IMNG Medical Media

While the public is largely a blank slate with regard to palliative care, nonpalliative care physicians and other health care professionals tend to believe that palliative care is simply end of life care. Many don’t understand that palliative care is actually about relieving the pain, symptoms, and stress of serious illness in patients of any age and at any stage of disease, and that palliative care can be delivered alongside curative or life-prolonging therapies, Dr. Meier said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

The consumer survey sponsored by the Center to Advance Palliative Care and the American Cancer Society involved 800 adults; 70% indicated they were "not at all knowledgeable" about palliative care, and another 8% had never heard of the term. Only 5% were categorized as "very knowledgeable" about palliative care.

Once they were informed about what palliative care truly is, however, survey participants of all political persuasions were very positive about it.

For example, once they were educated about palliative care, 95% of those surveyed said it’s important for patients with serious illnesses and their families to learn about palliative care. Most (92%) indicated they would likely consider it for themselves or a loved one, and an equal percentage said it’s important that palliative care services be available at all hospitals, Dr. Meier reported.

She and other leaders in the palliative care field are now seeking funding for an ambitious 5-year, multimillion-dollar social marketing campaign to increase public awareness regarding palliative care.

"We’ve recognized that we’re not going to see policy change without public support," Dr. Meier said.

Among the policy changes she and her colleagues seek is a big boost in the palliative care workforce, which at present is so small as to constitute a major barrier to access. While there is one oncologist for every 145 patients in the United States with a new cancer diagnosis, and one cardiologist for every 71 patients who have a myocardial infarction, there is just one palliative care specialist for every 1,300 people with a serious illness. And in nearly half of the states, no postgraduate training in palliative care is available.

Dr. Meier would like to see an increased number of physician and nurse practitioner fellowship programs established in palliative care. Another priority is to develop a midcareer board certification track in palliative care across all medical disciplines.

"We have a lot of people coming in from oncology, surgery, and other fields who are seeking work with meaning and purpose," she observed.

Starting in 2013, the specialty will require fellowship training for board certification in palliative care. "Grandfathering in" will no longer be possible.

Dr. Meier reported having no financial conflicts.

CHICAGO – The conventional teaching that pregnant women with congenital heart disease should undergo a passive second stage of labor assisted by forceps or vacuum delivery has been called into question.

Avoidance of active pushing during labor by such patients has long been recommended because of theoretical concerns that the reduction in preload and increased myocardial oxygen requirement that occur with the Valsalva maneuver place women with congenital heart disease at increased risk for cardiac events. But the issue has never actually been studied – until recently, noted Dr. Katherine E. Economy, a maternal-fetal medicine specialist at Brigham and Women’s Hospital, Boston.

"We’ve looked at this in our institution, and what we found is that avoiding Valsalva is associated with worse maternal outcomes: more third- and fourth-degree lacerations and more postpartum hemorrhages. So although the patient numbers were small, this has really encouraged us to move away from doing assisted second stage," she said at the annual meeting of the American College of Cardiology.

Other dogmata widely accepted by cardiologists, obstetricians, and anesthesiologists are that pregnant women with congenital heart disease should routinely be delivered a few weeks early, and by cesarean section. Dr. Economy challenged both notions.

For the Valsalva study, she and her coinvestigators carried out a retrospective cohort study including 112 pregnancies in 65 women with congenital heart disease who were delivered at the hospital during 1998-2005. The focus was on evaluating obstetric outcomes, as the great majority of previous studies of pregnancy outcomes in patients with congenital heart disease addressed maternal cardiac events.

Roughly three-quarters of the women were instructed not to push during the second stage of labor; they underwent a planned assisted delivery in accord with conventional teaching. However, during the study period a shift in practice philosophy occurred in the Boston congenital heart obstetric service, such that women were allowed a trial of pushing on an individualized basis.

Among the 62 pregnancies that reached the second stage of labor, nine (20%) postpartum hemorrhages and seven (16%) third- or fourth-degree lacerations occurred among 45 no-Valsalva patients, compared with none in 17 (0%) women who pushed during labor. The only maternal adverse cardiac event (2%) occurred in a woman who did not do the Valsalva maneuver.

Adverse obstetric events occurred in one-third of women. However, a multivariate analysis didn’t identify any reliable independent predictors for sustaining an adverse obstetric event. Thus, women with congenital heart disease who move forward with pregnancy are at an overall increased risk for adverse obstetric outcomes, but baseline maternal cardiac factors aren’t helpful in picking out a higher-risk subgroup.

The most common adverse obstetric outcome was preterm delivery; the 21% incidence was nearly twice that seen in the general population. Also noteworthy were the 14% incidence of postpartum hemorrhage and the 10% rate of preterm premature rupture of membranes (Int. J. Cardiol. 2010;144:195-9).

Dr. Economy observed that with growing numbers of women with congenital heart disease who survive well into their childbearing years, congenital heart disease now accounts for more than 50% of heart disease in pregnancy. And although maternal deaths due to hemorrhage or venous thromboembolism have fallen sharply over the last 20 years, maternal deaths from cardiovascular disease have risen. Indeed, cardiac disease in pregnancy is now the leading cause of indirect maternal mortality.

"So we think of this in maternal-fetal medicine as a major public health issue," the ob.gyn. said.

She noted that in discussing the possibility of termination in the event of unplanned pregnancy in a patient with congenital heart disease, it’s important to understand that by the second trimester, many of the cardiovascular changes in pregnancy – including a 30%-50% increase in cardiac output, a drop in systemic vascular resistance, and an increase in heart rate – will already have occurred. At that point, the maternal risk may not be altered all that much by terminating.

Managing maternal cardiac risk in patients with congenital aortic root dilatation in accord with joint multispecialty society-backed guidelines (J. Am. Coll. Cardiol. 2010;55:1509-44) entails strict blood pressure control with a beta-blocker, the discontinuation of angiotensin receptor blocker therapy, a monthly or bimonthly echocardiography, an MRI without gadolinium, and delivery in a center with cardiac surgery backup.

In the management of obstetric risk in patients with aortic disease, Dr. Economy recommends a first trimester ultrasound for dating, sequential cervical length measurements beginning at 16 weeks, serious consideration of cerclage placement if the cervix shortens, and ultrasound for fetal growth surveillance.

Interestingly, patients with Marfan syndrome or other connective tissue disorders associated with aortic disease have a high rate of cervical incompetence (Placenta 2009;30:207-15). That’s probably because the cervix is 90% collagen; thus, the cervix may be affected by the same genetic defects that lead to other, more familiar manifestations of disordered connective tissue synthesis and metabolism, she explained.

Timing of delivery is individualized based upon cardiac status, gestational age, Bishop score, and other factors.

"Many of you probably start to lose your nerve a bit at the end and say, ‘Pregnancy is bad for heart disease; we should just deliver.’ But generally speaking, if your patients are doing well in the third trimester, there’s really no reason to induce prematurity," Dr. Economy asserted.

She cited a large multicenter study that has turned heads in the world of maternal-fetal medicine. The study showed significantly increased rates of NICU admission, newborn sepsis, and respiratory complications requiring prolonged intubation with delivery at 37-38 weeks’ gestation, compared with 39 weeks’, in a broad population of pregnant women (N. Engl. J. Med. 2009;360:111-20).

"If your patients are doing well, let them stay pregnant," the ob.gyn. urged.

Cesarean section is really popular in patients with congenital heart disease. The joint guidelines state, "Fetal delivery via cesarean section is reasonable for patients with significant aortic enlargement, dissection, or severe aortic valve regurgitation" (Circulation 2010;121:1544-79). But Dr. Economy pointed out that this recommendation is rated class II, level of evidence C, meaning that it is based solely on expert opinion. And these joint guidelines were drawn up and approved by numerous cardiovascular and imaging societies without the endorsement of any obstetric organizations.

"I would put to you that every time you think about a cesarean section, you stop and remember that cesarean section is worse for women. For all women. C-section is worse for them, okay? It increases the risk of significant blood loss, increases infection risk, and increases the risk of venous thromboembolism," she said.

"My personal opinion is cesarean section should be reserved for obstetric indications – things like failure to progress, breech presentation, or nonreassuring fetal status in labor. The vast majority of patients will be better served by vaginal delivery. Plan on an interdisciplinary effort between obstetrics, cardiology, anesthesiology, and nursing," Dr. Economy advised.

Dr. Economy and her associates reported that they had no relevant financial disclosures.

CHICAGO – The conventional teaching that pregnant women with congenital heart disease should undergo a passive second stage of labor assisted by forceps or vacuum delivery has been called into question.

Avoidance of active pushing during labor by such patients has long been recommended because of theoretical concerns that the reduction in preload and increased myocardial oxygen requirement that occur with the Valsalva maneuver place women with congenital heart disease at increased risk for cardiac events. But the issue has never actually been studied – until recently, noted Dr. Katherine E. Economy, a maternal-fetal medicine specialist at Brigham and Women’s Hospital, Boston.

"We’ve looked at this in our institution, and what we found is that avoiding Valsalva is associated with worse maternal outcomes: more third- and fourth-degree lacerations and more postpartum hemorrhages. So although the patient numbers were small, this has really encouraged us to move away from doing assisted second stage," she said at the annual meeting of the American College of Cardiology.

Other dogmata widely accepted by cardiologists, obstetricians, and anesthesiologists are that pregnant women with congenital heart disease should routinely be delivered a few weeks early, and by cesarean section. Dr. Economy challenged both notions.

For the Valsalva study, she and her coinvestigators carried out a retrospective cohort study including 112 pregnancies in 65 women with congenital heart disease who were delivered at the hospital during 1998-2005. The focus was on evaluating obstetric outcomes, as the great majority of previous studies of pregnancy outcomes in patients with congenital heart disease addressed maternal cardiac events.

Roughly three-quarters of the women were instructed not to push during the second stage of labor; they underwent a planned assisted delivery in accord with conventional teaching. However, during the study period a shift in practice philosophy occurred in the Boston congenital heart obstetric service, such that women were allowed a trial of pushing on an individualized basis.

Among the 62 pregnancies that reached the second stage of labor, nine (20%) postpartum hemorrhages and seven (16%) third- or fourth-degree lacerations occurred among 45 no-Valsalva patients, compared with none in 17 (0%) women who pushed during labor. The only maternal adverse cardiac event (2%) occurred in a woman who did not do the Valsalva maneuver.

Adverse obstetric events occurred in one-third of women. However, a multivariate analysis didn’t identify any reliable independent predictors for sustaining an adverse obstetric event. Thus, women with congenital heart disease who move forward with pregnancy are at an overall increased risk for adverse obstetric outcomes, but baseline maternal cardiac factors aren’t helpful in picking out a higher-risk subgroup.

The most common adverse obstetric outcome was preterm delivery; the 21% incidence was nearly twice that seen in the general population. Also noteworthy were the 14% incidence of postpartum hemorrhage and the 10% rate of preterm premature rupture of membranes (Int. J. Cardiol. 2010;144:195-9).

Dr. Economy observed that with growing numbers of women with congenital heart disease who survive well into their childbearing years, congenital heart disease now accounts for more than 50% of heart disease in pregnancy. And although maternal deaths due to hemorrhage or venous thromboembolism have fallen sharply over the last 20 years, maternal deaths from cardiovascular disease have risen. Indeed, cardiac disease in pregnancy is now the leading cause of indirect maternal mortality.

"So we think of this in maternal-fetal medicine as a major public health issue," the ob.gyn. said.

She noted that in discussing the possibility of termination in the event of unplanned pregnancy in a patient with congenital heart disease, it’s important to understand that by the second trimester, many of the cardiovascular changes in pregnancy – including a 30%-50% increase in cardiac output, a drop in systemic vascular resistance, and an increase in heart rate – will already have occurred. At that point, the maternal risk may not be altered all that much by terminating.

Managing maternal cardiac risk in patients with congenital aortic root dilatation in accord with joint multispecialty society-backed guidelines (J. Am. Coll. Cardiol. 2010;55:1509-44) entails strict blood pressure control with a beta-blocker, the discontinuation of angiotensin receptor blocker therapy, a monthly or bimonthly echocardiography, an MRI without gadolinium, and delivery in a center with cardiac surgery backup.

In the management of obstetric risk in patients with aortic disease, Dr. Economy recommends a first trimester ultrasound for dating, sequential cervical length measurements beginning at 16 weeks, serious consideration of cerclage placement if the cervix shortens, and ultrasound for fetal growth surveillance.

Interestingly, patients with Marfan syndrome or other connective tissue disorders associated with aortic disease have a high rate of cervical incompetence (Placenta 2009;30:207-15). That’s probably because the cervix is 90% collagen; thus, the cervix may be affected by the same genetic defects that lead to other, more familiar manifestations of disordered connective tissue synthesis and metabolism, she explained.

Timing of delivery is individualized based upon cardiac status, gestational age, Bishop score, and other factors.

"Many of you probably start to lose your nerve a bit at the end and say, ‘Pregnancy is bad for heart disease; we should just deliver.’ But generally speaking, if your patients are doing well in the third trimester, there’s really no reason to induce prematurity," Dr. Economy asserted.

She cited a large multicenter study that has turned heads in the world of maternal-fetal medicine. The study showed significantly increased rates of NICU admission, newborn sepsis, and respiratory complications requiring prolonged intubation with delivery at 37-38 weeks’ gestation, compared with 39 weeks’, in a broad population of pregnant women (N. Engl. J. Med. 2009;360:111-20).

"If your patients are doing well, let them stay pregnant," the ob.gyn. urged.

Cesarean section is really popular in patients with congenital heart disease. The joint guidelines state, "Fetal delivery via cesarean section is reasonable for patients with significant aortic enlargement, dissection, or severe aortic valve regurgitation" (Circulation 2010;121:1544-79). But Dr. Economy pointed out that this recommendation is rated class II, level of evidence C, meaning that it is based solely on expert opinion. And these joint guidelines were drawn up and approved by numerous cardiovascular and imaging societies without the endorsement of any obstetric organizations.

"I would put to you that every time you think about a cesarean section, you stop and remember that cesarean section is worse for women. For all women. C-section is worse for them, okay? It increases the risk of significant blood loss, increases infection risk, and increases the risk of venous thromboembolism," she said.

"My personal opinion is cesarean section should be reserved for obstetric indications – things like failure to progress, breech presentation, or nonreassuring fetal status in labor. The vast majority of patients will be better served by vaginal delivery. Plan on an interdisciplinary effort between obstetrics, cardiology, anesthesiology, and nursing," Dr. Economy advised.

Dr. Economy and her associates reported that they had no relevant financial disclosures.

CHICAGO – The conventional teaching that pregnant women with congenital heart disease should undergo a passive second stage of labor assisted by forceps or vacuum delivery has been called into question.

Avoidance of active pushing during labor by such patients has long been recommended because of theoretical concerns that the reduction in preload and increased myocardial oxygen requirement that occur with the Valsalva maneuver place women with congenital heart disease at increased risk for cardiac events. But the issue has never actually been studied – until recently, noted Dr. Katherine E. Economy, a maternal-fetal medicine specialist at Brigham and Women’s Hospital, Boston.

"We’ve looked at this in our institution, and what we found is that avoiding Valsalva is associated with worse maternal outcomes: more third- and fourth-degree lacerations and more postpartum hemorrhages. So although the patient numbers were small, this has really encouraged us to move away from doing assisted second stage," she said at the annual meeting of the American College of Cardiology.

Other dogmata widely accepted by cardiologists, obstetricians, and anesthesiologists are that pregnant women with congenital heart disease should routinely be delivered a few weeks early, and by cesarean section. Dr. Economy challenged both notions.

For the Valsalva study, she and her coinvestigators carried out a retrospective cohort study including 112 pregnancies in 65 women with congenital heart disease who were delivered at the hospital during 1998-2005. The focus was on evaluating obstetric outcomes, as the great majority of previous studies of pregnancy outcomes in patients with congenital heart disease addressed maternal cardiac events.

Roughly three-quarters of the women were instructed not to push during the second stage of labor; they underwent a planned assisted delivery in accord with conventional teaching. However, during the study period a shift in practice philosophy occurred in the Boston congenital heart obstetric service, such that women were allowed a trial of pushing on an individualized basis.

Among the 62 pregnancies that reached the second stage of labor, nine (20%) postpartum hemorrhages and seven (16%) third- or fourth-degree lacerations occurred among 45 no-Valsalva patients, compared with none in 17 (0%) women who pushed during labor. The only maternal adverse cardiac event (2%) occurred in a woman who did not do the Valsalva maneuver.

Adverse obstetric events occurred in one-third of women. However, a multivariate analysis didn’t identify any reliable independent predictors for sustaining an adverse obstetric event. Thus, women with congenital heart disease who move forward with pregnancy are at an overall increased risk for adverse obstetric outcomes, but baseline maternal cardiac factors aren’t helpful in picking out a higher-risk subgroup.

The most common adverse obstetric outcome was preterm delivery; the 21% incidence was nearly twice that seen in the general population. Also noteworthy were the 14% incidence of postpartum hemorrhage and the 10% rate of preterm premature rupture of membranes (Int. J. Cardiol. 2010;144:195-9).

Dr. Economy observed that with growing numbers of women with congenital heart disease who survive well into their childbearing years, congenital heart disease now accounts for more than 50% of heart disease in pregnancy. And although maternal deaths due to hemorrhage or venous thromboembolism have fallen sharply over the last 20 years, maternal deaths from cardiovascular disease have risen. Indeed, cardiac disease in pregnancy is now the leading cause of indirect maternal mortality.

"So we think of this in maternal-fetal medicine as a major public health issue," the ob.gyn. said.

She noted that in discussing the possibility of termination in the event of unplanned pregnancy in a patient with congenital heart disease, it’s important to understand that by the second trimester, many of the cardiovascular changes in pregnancy – including a 30%-50% increase in cardiac output, a drop in systemic vascular resistance, and an increase in heart rate – will already have occurred. At that point, the maternal risk may not be altered all that much by terminating.

Managing maternal cardiac risk in patients with congenital aortic root dilatation in accord with joint multispecialty society-backed guidelines (J. Am. Coll. Cardiol. 2010;55:1509-44) entails strict blood pressure control with a beta-blocker, the discontinuation of angiotensin receptor blocker therapy, a monthly or bimonthly echocardiography, an MRI without gadolinium, and delivery in a center with cardiac surgery backup.

In the management of obstetric risk in patients with aortic disease, Dr. Economy recommends a first trimester ultrasound for dating, sequential cervical length measurements beginning at 16 weeks, serious consideration of cerclage placement if the cervix shortens, and ultrasound for fetal growth surveillance.

Interestingly, patients with Marfan syndrome or other connective tissue disorders associated with aortic disease have a high rate of cervical incompetence (Placenta 2009;30:207-15). That’s probably because the cervix is 90% collagen; thus, the cervix may be affected by the same genetic defects that lead to other, more familiar manifestations of disordered connective tissue synthesis and metabolism, she explained.

Timing of delivery is individualized based upon cardiac status, gestational age, Bishop score, and other factors.

"Many of you probably start to lose your nerve a bit at the end and say, ‘Pregnancy is bad for heart disease; we should just deliver.’ But generally speaking, if your patients are doing well in the third trimester, there’s really no reason to induce prematurity," Dr. Economy asserted.

She cited a large multicenter study that has turned heads in the world of maternal-fetal medicine. The study showed significantly increased rates of NICU admission, newborn sepsis, and respiratory complications requiring prolonged intubation with delivery at 37-38 weeks’ gestation, compared with 39 weeks’, in a broad population of pregnant women (N. Engl. J. Med. 2009;360:111-20).

"If your patients are doing well, let them stay pregnant," the ob.gyn. urged.

Cesarean section is really popular in patients with congenital heart disease. The joint guidelines state, "Fetal delivery via cesarean section is reasonable for patients with significant aortic enlargement, dissection, or severe aortic valve regurgitation" (Circulation 2010;121:1544-79). But Dr. Economy pointed out that this recommendation is rated class II, level of evidence C, meaning that it is based solely on expert opinion. And these joint guidelines were drawn up and approved by numerous cardiovascular and imaging societies without the endorsement of any obstetric organizations.

"I would put to you that every time you think about a cesarean section, you stop and remember that cesarean section is worse for women. For all women. C-section is worse for them, okay? It increases the risk of significant blood loss, increases infection risk, and increases the risk of venous thromboembolism," she said.

"My personal opinion is cesarean section should be reserved for obstetric indications – things like failure to progress, breech presentation, or nonreassuring fetal status in labor. The vast majority of patients will be better served by vaginal delivery. Plan on an interdisciplinary effort between obstetrics, cardiology, anesthesiology, and nursing," Dr. Economy advised.

Dr. Economy and her associates reported that they had no relevant financial disclosures.

CHICAGO – The obesity paradox has emerged among coronary artery bypass graft surgery patients in New Jersey. That is, a fat patient undergoing CABG in the state is significantly more likely to be alive several years later than is a normal-weight person.

Analysis of 60,635 patients in the state’s vaunted, ground-breaking Myocardial Infarction Data Acquisition System (MIDAS) database who underwent an isolated CABG procedure during 1998-2007 showed a significantly greater mortality in normal-weight patients as compared with those who were overweight or obese, through 2 years of postsurgical follow-up, according to Dr. Yingzi Deng of Robert Wood Johnson Medical School, New Brunswick, N.J.

For example, from 90 days through 2 years post CABG, all-cause mortality in 13,306 normal-weight patients was 6.3%, compared with 4.1% in 25,648 overweight patients and 3.8% in 21,681 obese patients, she reported at the conference.

This translated to a 29% reduction in the relative risk of death in overweight and a 30% decrease in mortality risk in obese patients in a multivariate analysis adjusted for numerous potential confounders including age, gender, year of surgery, smoking status, diabetes, hypertension, chronic renal or pulmonary disease, left main disease, and ejection fraction.

Earlier studies had shown that better short-term outcomes in CABG patients who were overweight or obese patients (J. Am. Coll. Cardiol. 2003;42:668-76). The MIDAS registry study reflecting the statewide New Jersey experience provided a unique opportunity to see how body mass index affects long-term survival following CABG.

The obesity paradox has also been shown to pertain to patients undergoing percutaneous coronary intervention, as well as to patients hospitalized for acute deterioration of heart failure. The explanation for this intriguingly counterintuitive phenomenon remains unclear.

Dr. Deng reported having no financial conflicts.

CHICAGO – The obesity paradox has emerged among coronary artery bypass graft surgery patients in New Jersey. That is, a fat patient undergoing CABG in the state is significantly more likely to be alive several years later than is a normal-weight person.

Analysis of 60,635 patients in the state’s vaunted, ground-breaking Myocardial Infarction Data Acquisition System (MIDAS) database who underwent an isolated CABG procedure during 1998-2007 showed a significantly greater mortality in normal-weight patients as compared with those who were overweight or obese, through 2 years of postsurgical follow-up, according to Dr. Yingzi Deng of Robert Wood Johnson Medical School, New Brunswick, N.J.

For example, from 90 days through 2 years post CABG, all-cause mortality in 13,306 normal-weight patients was 6.3%, compared with 4.1% in 25,648 overweight patients and 3.8% in 21,681 obese patients, she reported at the conference.

This translated to a 29% reduction in the relative risk of death in overweight and a 30% decrease in mortality risk in obese patients in a multivariate analysis adjusted for numerous potential confounders including age, gender, year of surgery, smoking status, diabetes, hypertension, chronic renal or pulmonary disease, left main disease, and ejection fraction.

Earlier studies had shown that better short-term outcomes in CABG patients who were overweight or obese patients (J. Am. Coll. Cardiol. 2003;42:668-76). The MIDAS registry study reflecting the statewide New Jersey experience provided a unique opportunity to see how body mass index affects long-term survival following CABG.

The obesity paradox has also been shown to pertain to patients undergoing percutaneous coronary intervention, as well as to patients hospitalized for acute deterioration of heart failure. The explanation for this intriguingly counterintuitive phenomenon remains unclear.

Dr. Deng reported having no financial conflicts.

CHICAGO – The obesity paradox has emerged among coronary artery bypass graft surgery patients in New Jersey. That is, a fat patient undergoing CABG in the state is significantly more likely to be alive several years later than is a normal-weight person.

Analysis of 60,635 patients in the state’s vaunted, ground-breaking Myocardial Infarction Data Acquisition System (MIDAS) database who underwent an isolated CABG procedure during 1998-2007 showed a significantly greater mortality in normal-weight patients as compared with those who were overweight or obese, through 2 years of postsurgical follow-up, according to Dr. Yingzi Deng of Robert Wood Johnson Medical School, New Brunswick, N.J.

For example, from 90 days through 2 years post CABG, all-cause mortality in 13,306 normal-weight patients was 6.3%, compared with 4.1% in 25,648 overweight patients and 3.8% in 21,681 obese patients, she reported at the conference.

This translated to a 29% reduction in the relative risk of death in overweight and a 30% decrease in mortality risk in obese patients in a multivariate analysis adjusted for numerous potential confounders including age, gender, year of surgery, smoking status, diabetes, hypertension, chronic renal or pulmonary disease, left main disease, and ejection fraction.

Earlier studies had shown that better short-term outcomes in CABG patients who were overweight or obese patients (J. Am. Coll. Cardiol. 2003;42:668-76). The MIDAS registry study reflecting the statewide New Jersey experience provided a unique opportunity to see how body mass index affects long-term survival following CABG.

The obesity paradox has also been shown to pertain to patients undergoing percutaneous coronary intervention, as well as to patients hospitalized for acute deterioration of heart failure. The explanation for this intriguingly counterintuitive phenomenon remains unclear.

Dr. Deng reported having no financial conflicts.

NEW ORLEANS – Most clinical laboratories utilize an overly broad, out-of-date normal reference range for thyroid-stimulating hormone values in patients with hypothyroidism who are on thyroid hormone replacement therapy.

Today, most labs still define a normal TSH reference range as running from 0.5 at the bottom to a maximum of 4.5 or even 5.5 mIU/L on the basis of early cross-sectional studies that didn’t exclude patients with underlying thyroid disease.

Several recent studies, including the National Health and Nutrition Examination Survey III, suggest a much lower upper limit of normal once individuals with positive antithyroid antibodies or a family history of thyroid disease have been excluded. As recently as 2002, the American Association of Clinical Endocrinologists recommended a normal reference range of 0.3-3.0 mIU/L. The National Academy of Clinical Biochemistry has suggested that "normal" is 0.4-2.5 mIU/L. But most labs have yet to adopt either of these tighter standards, explained Dr. Thomas L. O’Connell, an endocrinologist at Duke University in Durham, N.C.

The implications for clinical practice have been laid out in a joint statement by the American Association of Clinical Endocrinologists, the Endocrine Society, and the American Thyroid Association (J. Clin. Endocrinol. Metab. 2005;90:581-5). The organizations recommended that if a patient being treated for hypothyroidism feels well and has a TSH level within the laboratory’s upper limit of normal, then fine, leave the dosing of thyroid hormone replacement therapy as is. But if the patient continues to have symptoms, then it’s appropriate to boost treatment to drop the TSH level to the lower half of the lab’s "normal" range.

"I do this all the time. It’s a perfectly reasonable thing to try. I’ll have patients come to me with a TSH of 5.0 and their physician says their thyroid function has been normalized because the lab has a normal range of 0.5-5.5 mIU/L or something like that, yet they still have fatigue and are gaining weight and have the other classic symptoms of hypothyroidism. So what I do is tweak their dose a bit and get their TSH below 2.5, and if need be close to 1.0. It’s often a matter of taking one extra half-pill 1 day per week or several days a week," the endocrinologist said at the annual meeting of the American College of Physicians.

He reported that he serves as a consultant to Sanofi Aventis and Amylin.

NEW ORLEANS – Most clinical laboratories utilize an overly broad, out-of-date normal reference range for thyroid-stimulating hormone values in patients with hypothyroidism who are on thyroid hormone replacement therapy.

Today, most labs still define a normal TSH reference range as running from 0.5 at the bottom to a maximum of 4.5 or even 5.5 mIU/L on the basis of early cross-sectional studies that didn’t exclude patients with underlying thyroid disease.

Several recent studies, including the National Health and Nutrition Examination Survey III, suggest a much lower upper limit of normal once individuals with positive antithyroid antibodies or a family history of thyroid disease have been excluded. As recently as 2002, the American Association of Clinical Endocrinologists recommended a normal reference range of 0.3-3.0 mIU/L. The National Academy of Clinical Biochemistry has suggested that "normal" is 0.4-2.5 mIU/L. But most labs have yet to adopt either of these tighter standards, explained Dr. Thomas L. O’Connell, an endocrinologist at Duke University in Durham, N.C.

The implications for clinical practice have been laid out in a joint statement by the American Association of Clinical Endocrinologists, the Endocrine Society, and the American Thyroid Association (J. Clin. Endocrinol. Metab. 2005;90:581-5). The organizations recommended that if a patient being treated for hypothyroidism feels well and has a TSH level within the laboratory’s upper limit of normal, then fine, leave the dosing of thyroid hormone replacement therapy as is. But if the patient continues to have symptoms, then it’s appropriate to boost treatment to drop the TSH level to the lower half of the lab’s "normal" range.

"I do this all the time. It’s a perfectly reasonable thing to try. I’ll have patients come to me with a TSH of 5.0 and their physician says their thyroid function has been normalized because the lab has a normal range of 0.5-5.5 mIU/L or something like that, yet they still have fatigue and are gaining weight and have the other classic symptoms of hypothyroidism. So what I do is tweak their dose a bit and get their TSH below 2.5, and if need be close to 1.0. It’s often a matter of taking one extra half-pill 1 day per week or several days a week," the endocrinologist said at the annual meeting of the American College of Physicians.

He reported that he serves as a consultant to Sanofi Aventis and Amylin.

NEW ORLEANS – Most clinical laboratories utilize an overly broad, out-of-date normal reference range for thyroid-stimulating hormone values in patients with hypothyroidism who are on thyroid hormone replacement therapy.

Today, most labs still define a normal TSH reference range as running from 0.5 at the bottom to a maximum of 4.5 or even 5.5 mIU/L on the basis of early cross-sectional studies that didn’t exclude patients with underlying thyroid disease.

Several recent studies, including the National Health and Nutrition Examination Survey III, suggest a much lower upper limit of normal once individuals with positive antithyroid antibodies or a family history of thyroid disease have been excluded. As recently as 2002, the American Association of Clinical Endocrinologists recommended a normal reference range of 0.3-3.0 mIU/L. The National Academy of Clinical Biochemistry has suggested that "normal" is 0.4-2.5 mIU/L. But most labs have yet to adopt either of these tighter standards, explained Dr. Thomas L. O’Connell, an endocrinologist at Duke University in Durham, N.C.

The implications for clinical practice have been laid out in a joint statement by the American Association of Clinical Endocrinologists, the Endocrine Society, and the American Thyroid Association (J. Clin. Endocrinol. Metab. 2005;90:581-5). The organizations recommended that if a patient being treated for hypothyroidism feels well and has a TSH level within the laboratory’s upper limit of normal, then fine, leave the dosing of thyroid hormone replacement therapy as is. But if the patient continues to have symptoms, then it’s appropriate to boost treatment to drop the TSH level to the lower half of the lab’s "normal" range.

"I do this all the time. It’s a perfectly reasonable thing to try. I’ll have patients come to me with a TSH of 5.0 and their physician says their thyroid function has been normalized because the lab has a normal range of 0.5-5.5 mIU/L or something like that, yet they still have fatigue and are gaining weight and have the other classic symptoms of hypothyroidism. So what I do is tweak their dose a bit and get their TSH below 2.5, and if need be close to 1.0. It’s often a matter of taking one extra half-pill 1 day per week or several days a week," the endocrinologist said at the annual meeting of the American College of Physicians.

He reported that he serves as a consultant to Sanofi Aventis and Amylin.

WAIKOLOA, HAWAII – The calcineurin inhibitors are effective for long-term maintenance therapy in chronic hand dermatitis, despite their black box warning, and can help reduce the use of topical steroids, according to dermatologist Joseph F. Fowler Jr.

Pimecrolimus 1% cream is nongreasy and thus preferred by many patients over tacrolimus 0.1% ointment, he said at the seminar sponsored by the Skin Disease Education Foundation (SDEF).

Bruce Jancin/IMNG Medical Media

"Please understand that I love topical steroids. We all need to use them. But I don’t want to use them continuously because of the variety of adverse effects, especially local atrophy. And if we’re worried about skin barrier function, we don’t want to thin the skin out and reduce the barrier even more with overuse of topical steroids," he said.

"So after we’ve got somebody under control with aggressive use of higher-potency topical steroids, I like to think about the calcineurin inhibitors. I also like to think about what I call the therapeutic moisturizers – those device and [over-the-counter] products that contain ceramides and natural moisturizing factors – and I’ll maybe use a low- to midpotency topical steroid two or three times a week as needed," added Dr. Fowler of the University of Louisville (Ky.).

There are several skin barrier protection products approved as prescription devices rather than medications, such as Atopiclair, Eletone, EpiCeram, Hylatopic, Neosalus, and Tetrix. Many aren’t promoted much anymore by their manufacturers, yet all have supporting evidence that they enhance the skin barrier, he said.

The two skin barrier products Dr. Fowler is most familiar with because of his involvement in clinical trials are Tetrix and Neosalus.

The investigator-blinded, nonrandomized Tetrix cream study involved patients with known allergies to three common, structurally dissimilar test antigens: nickel, neomycin, and fragrance mix. Following exposure to the test antigens, delayed-type hypersensitivity reactions on patch testing were significantly less at sites pretreated with Tetrix cream than at untreated test sites (Cutis 2008;82[suppl. 4]:21-8).

In the multicenter prospective Neosalus foam study, 31 patients with chronic allergic or irritant hand dermatitis of at least 12 months’ duration were randomized to treatment with Neosalus foam plus triamcinolone cream 0.1% or to an over-the-counter (OTC) moisturizer plus the topical steroid. During 8 weeks, patients in the Neosalus group averaged 51.4 doses of the topical steroid, compared with 72.5 doses in controls. Eczema severity scores were also significantly better in the Neosalus group (Am. J. Contact Dermat. 2000;11:165-9).

OTC moisturizers containing ceramide, a lipid that boosts stratum corneum function, include Aveeno eczema therapy moisturizing cream, CeraVe lotion and cleanser, Cetaphil Restoraderm moisturizer, and Curel Sensitive Skin Remedy, Dr. Fowler continued.

He said that he likes to choose from a short list of topical steroids for maintenance therapy. Fluticasone cream or lotion has fewer local adverse effects than many other steroids and has demonstrated long-term efficacy and safety in the setting of atopic dermatitis. Hydrocortisone butyrate lipid cream or lotion has excellent tolerability and a good moisturizing effect.

When there is concern that a patient’s dermatitis may be compounded by topical steroid allergy, clocortolone cream or desonide ointment are excellent choices; there is virtually no allergenicity to either product, according to Dr. Fowler.

"If I’m worried about topical steroid allergy, the sprays, I think, are very nice. Clobetasol spray has almost nothing in it that’s likely to be an allergen, although it’s a little oily and that can be an issue. But if you’re worried about allergy either to the steroid or to other factors in the product, that’s a good one. Also, triamcinolone ... has virtually nothing in it that’s allergenic other than occasionally the triamcinolone itself, and it’s not oily," he said.

The topical corticosteroid foams are a well-received option for maintenance therapy on hairy areas or for large surfaces.

When a higher-potency topical steroid is desired during a breakthrough episode, halcinonide cream has low allergenicity, a desirable biphasic quick and then delayed release, and good moisturizing and emollient properties, Dr. Fowler said.

He reported that he serves as a consultant to Allerderm, Coria, Galderma, Graceway, Hyland, Johnson & Johnson, Quinnova, Ranbaxy, Shire, Stiefel, Triax, and UCB.

SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – The calcineurin inhibitors are effective for long-term maintenance therapy in chronic hand dermatitis, despite their black box warning, and can help reduce the use of topical steroids, according to dermatologist Joseph F. Fowler Jr.

Pimecrolimus 1% cream is nongreasy and thus preferred by many patients over tacrolimus 0.1% ointment, he said at the seminar sponsored by the Skin Disease Education Foundation (SDEF).

Bruce Jancin/IMNG Medical Media

"Please understand that I love topical steroids. We all need to use them. But I don’t want to use them continuously because of the variety of adverse effects, especially local atrophy. And if we’re worried about skin barrier function, we don’t want to thin the skin out and reduce the barrier even more with overuse of topical steroids," he said.

"So after we’ve got somebody under control with aggressive use of higher-potency topical steroids, I like to think about the calcineurin inhibitors. I also like to think about what I call the therapeutic moisturizers – those device and [over-the-counter] products that contain ceramides and natural moisturizing factors – and I’ll maybe use a low- to midpotency topical steroid two or three times a week as needed," added Dr. Fowler of the University of Louisville (Ky.).

There are several skin barrier protection products approved as prescription devices rather than medications, such as Atopiclair, Eletone, EpiCeram, Hylatopic, Neosalus, and Tetrix. Many aren’t promoted much anymore by their manufacturers, yet all have supporting evidence that they enhance the skin barrier, he said.

The two skin barrier products Dr. Fowler is most familiar with because of his involvement in clinical trials are Tetrix and Neosalus.

The investigator-blinded, nonrandomized Tetrix cream study involved patients with known allergies to three common, structurally dissimilar test antigens: nickel, neomycin, and fragrance mix. Following exposure to the test antigens, delayed-type hypersensitivity reactions on patch testing were significantly less at sites pretreated with Tetrix cream than at untreated test sites (Cutis 2008;82[suppl. 4]:21-8).

In the multicenter prospective Neosalus foam study, 31 patients with chronic allergic or irritant hand dermatitis of at least 12 months’ duration were randomized to treatment with Neosalus foam plus triamcinolone cream 0.1% or to an over-the-counter (OTC) moisturizer plus the topical steroid. During 8 weeks, patients in the Neosalus group averaged 51.4 doses of the topical steroid, compared with 72.5 doses in controls. Eczema severity scores were also significantly better in the Neosalus group (Am. J. Contact Dermat. 2000;11:165-9).

OTC moisturizers containing ceramide, a lipid that boosts stratum corneum function, include Aveeno eczema therapy moisturizing cream, CeraVe lotion and cleanser, Cetaphil Restoraderm moisturizer, and Curel Sensitive Skin Remedy, Dr. Fowler continued.

He said that he likes to choose from a short list of topical steroids for maintenance therapy. Fluticasone cream or lotion has fewer local adverse effects than many other steroids and has demonstrated long-term efficacy and safety in the setting of atopic dermatitis. Hydrocortisone butyrate lipid cream or lotion has excellent tolerability and a good moisturizing effect.

When there is concern that a patient’s dermatitis may be compounded by topical steroid allergy, clocortolone cream or desonide ointment are excellent choices; there is virtually no allergenicity to either product, according to Dr. Fowler.

"If I’m worried about topical steroid allergy, the sprays, I think, are very nice. Clobetasol spray has almost nothing in it that’s likely to be an allergen, although it’s a little oily and that can be an issue. But if you’re worried about allergy either to the steroid or to other factors in the product, that’s a good one. Also, triamcinolone ... has virtually nothing in it that’s allergenic other than occasionally the triamcinolone itself, and it’s not oily," he said.

The topical corticosteroid foams are a well-received option for maintenance therapy on hairy areas or for large surfaces.

When a higher-potency topical steroid is desired during a breakthrough episode, halcinonide cream has low allergenicity, a desirable biphasic quick and then delayed release, and good moisturizing and emollient properties, Dr. Fowler said.

He reported that he serves as a consultant to Allerderm, Coria, Galderma, Graceway, Hyland, Johnson & Johnson, Quinnova, Ranbaxy, Shire, Stiefel, Triax, and UCB.

SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – The calcineurin inhibitors are effective for long-term maintenance therapy in chronic hand dermatitis, despite their black box warning, and can help reduce the use of topical steroids, according to dermatologist Joseph F. Fowler Jr.

Pimecrolimus 1% cream is nongreasy and thus preferred by many patients over tacrolimus 0.1% ointment, he said at the seminar sponsored by the Skin Disease Education Foundation (SDEF).

Bruce Jancin/IMNG Medical Media

"Please understand that I love topical steroids. We all need to use them. But I don’t want to use them continuously because of the variety of adverse effects, especially local atrophy. And if we’re worried about skin barrier function, we don’t want to thin the skin out and reduce the barrier even more with overuse of topical steroids," he said.

"So after we’ve got somebody under control with aggressive use of higher-potency topical steroids, I like to think about the calcineurin inhibitors. I also like to think about what I call the therapeutic moisturizers – those device and [over-the-counter] products that contain ceramides and natural moisturizing factors – and I’ll maybe use a low- to midpotency topical steroid two or three times a week as needed," added Dr. Fowler of the University of Louisville (Ky.).

There are several skin barrier protection products approved as prescription devices rather than medications, such as Atopiclair, Eletone, EpiCeram, Hylatopic, Neosalus, and Tetrix. Many aren’t promoted much anymore by their manufacturers, yet all have supporting evidence that they enhance the skin barrier, he said.

The two skin barrier products Dr. Fowler is most familiar with because of his involvement in clinical trials are Tetrix and Neosalus.

The investigator-blinded, nonrandomized Tetrix cream study involved patients with known allergies to three common, structurally dissimilar test antigens: nickel, neomycin, and fragrance mix. Following exposure to the test antigens, delayed-type hypersensitivity reactions on patch testing were significantly less at sites pretreated with Tetrix cream than at untreated test sites (Cutis 2008;82[suppl. 4]:21-8).

In the multicenter prospective Neosalus foam study, 31 patients with chronic allergic or irritant hand dermatitis of at least 12 months’ duration were randomized to treatment with Neosalus foam plus triamcinolone cream 0.1% or to an over-the-counter (OTC) moisturizer plus the topical steroid. During 8 weeks, patients in the Neosalus group averaged 51.4 doses of the topical steroid, compared with 72.5 doses in controls. Eczema severity scores were also significantly better in the Neosalus group (Am. J. Contact Dermat. 2000;11:165-9).

OTC moisturizers containing ceramide, a lipid that boosts stratum corneum function, include Aveeno eczema therapy moisturizing cream, CeraVe lotion and cleanser, Cetaphil Restoraderm moisturizer, and Curel Sensitive Skin Remedy, Dr. Fowler continued.

He said that he likes to choose from a short list of topical steroids for maintenance therapy. Fluticasone cream or lotion has fewer local adverse effects than many other steroids and has demonstrated long-term efficacy and safety in the setting of atopic dermatitis. Hydrocortisone butyrate lipid cream or lotion has excellent tolerability and a good moisturizing effect.

When there is concern that a patient’s dermatitis may be compounded by topical steroid allergy, clocortolone cream or desonide ointment are excellent choices; there is virtually no allergenicity to either product, according to Dr. Fowler.

"If I’m worried about topical steroid allergy, the sprays, I think, are very nice. Clobetasol spray has almost nothing in it that’s likely to be an allergen, although it’s a little oily and that can be an issue. But if you’re worried about allergy either to the steroid or to other factors in the product, that’s a good one. Also, triamcinolone ... has virtually nothing in it that’s allergenic other than occasionally the triamcinolone itself, and it’s not oily," he said.

The topical corticosteroid foams are a well-received option for maintenance therapy on hairy areas or for large surfaces.

When a higher-potency topical steroid is desired during a breakthrough episode, halcinonide cream has low allergenicity, a desirable biphasic quick and then delayed release, and good moisturizing and emollient properties, Dr. Fowler said.

He reported that he serves as a consultant to Allerderm, Coria, Galderma, Graceway, Hyland, Johnson & Johnson, Quinnova, Ranbaxy, Shire, Stiefel, Triax, and UCB.

SDEF and this news organization are owned by Elsevier.

NEW ORLEANS – Alternative dosing regimens solve the common problem of statin-induced muscle pain in most cases.

Lowering the daily dose of the statin, dropping down to alternate-day or even once-weekly therapy, or switching to another statin having a better track record with regard to myalgia all have been shown to improve tolerability while maintaining reasonably effective lipid-lowering, according to Dr. Karol E. Watson, codirector of the University of California, Los Angeles, Program in Preventive Cardiology.

It must be emphasized, however, that none of the alternative dosing regimens have proved to reduce cardiovascular events. The issue hasn’t been studied. That being said, alternative dosing strategies do provide an option for patients who would otherwise go without the proven benefits of statin therapy, she noted at the annual meeting of the American College of Physicians.

Statin-induced muscle pain, cramping, or weakness is far more common than rates from major clinical trials would suggest. Statin-induced myalgia occurs in 10%-20% of treated patients in everyday practice. In contrast, in the landmark clinical trials, where patients were carefully preselected and there was often an active run-in phase, myalgia rates were far lower and similar to placebo.

Factors that increase the likelihood of statin-induced myopathy include advanced age, diabetes, hypothyroidism, renal insufficiency, alcohol abuse, liver disease, and smaller muscle mass, as is common in patients of smaller body size, including women. But people who experience more muscle side effects also tend to get the biggest lipid responses to statin therapy, Dr. Watson noted.

Of all the statins, rosuvastatin (Crestor) has been shown to have the most favorable ratio of LDL lowering to creatine kinase elevation (Cleve. Clin. J. Med. 2011;78:393-403). It’s a good option in patients experiencing problematic myalgia on another statin.

Also, fluvastatin XL performed exceptionally well in the large French observational Prediction of Muscular Risk in Observational Conditions (PRIMO) study, the cardiologist continued. Among nearly 8,000 French patients on high-dose statins for at least 3 months, 10.5% reported muscle-related symptoms. The lowest rate, at 5.1%, was in patients on fluvastatin XL at 80 mg/day. The highest rate, 18.2%, was in patients on simvastatin at 40-80 mg/day. PRIMO participants on atorvastatin at 40-80 mg/day had a 14.9% incidence of muscle symptoms, while those on 40 mg/day of pravastatin had a 10.9% rate (Cardiovasc. Drugs Ther. 2005:19:403-14).

Alternate-day dosing as an answer for statin-intolerant patients only can be carried out effectively with rosuvastatin or atorvastatin, drugs with half-lives markedly longer than the other statins. Alternate-day dosing with 5 or 10 mg of rosuvastatin was studied in a retrospective analysis involving 51 patients, 37 (73%) of whom were able to tolerate the regimen. Among those who tolerated every-other-day dosing, the mean reduction in LDL was 34.5%, enabling half of them to achieve their LDL target (Ann. Pharmacother. 2008;42:341-6).

In another retrospective study, once-weekly dosing of rosuvastatin at 2.5-20 mg was introduced to 50 previously statin-intolerant patients. Thirty-seven patients (74%) were able to tolerate the once-weekly therapy at a mean dose of 10 mg. They responded with a 23% reduction in LDL from a baseline of 167 mg/dL (Am. J. Cardiol. 2009;103:393-4).

In a prospective pilot study, 61 consecutive patients intolerant to other statins were placed on rosuvastatin at 5 mg/day if they were moderately high risk and 10 mg/day if they were at very high risk. Only 1 of the 61 patients discontinued rosuvastatin because of muscle pain. From a baseline mean LDL of 177 mg/dL, patients in the 5-mg/day group dropped their LDL by a mean of 75 mg/dL and those on 10 mg/day lowered their LDL by 79 mg/dL (Clin. Ther. 2006;28:933-42).

The National Lipid Association advises that it’s not routinely necessary to get a baseline creatine kinase level before starting statin therapy, nor is it necessary to obtain one during treatment in asymptomatic patients, Dr. Watson noted. But patients on statin therapy need to be counseled about the associated increased risk of muscle complaints and the importance of contacting their physicians should they arise (Am. J. Cardiol. 2006;97:89C-94C).

Those who develop tolerable muscle symptoms may continue with therapy, according to the National Lipid Association Statin Safety Task Force. But patients who experience intolerable symptoms with or without a creatine kinase elevation should stop treatment. Once they’re asymptomatic, the same drug can be restarted at the same dose, or one of the alternative strategies Dr. Watson described can be employed.

She reported serving as a consultant to Pfizer and on the Merck clinical trials adjudication committee.

NEW ORLEANS – Alternative dosing regimens solve the common problem of statin-induced muscle pain in most cases.

Lowering the daily dose of the statin, dropping down to alternate-day or even once-weekly therapy, or switching to another statin having a better track record with regard to myalgia all have been shown to improve tolerability while maintaining reasonably effective lipid-lowering, according to Dr. Karol E. Watson, codirector of the University of California, Los Angeles, Program in Preventive Cardiology.

It must be emphasized, however, that none of the alternative dosing regimens have proved to reduce cardiovascular events. The issue hasn’t been studied. That being said, alternative dosing strategies do provide an option for patients who would otherwise go without the proven benefits of statin therapy, she noted at the annual meeting of the American College of Physicians.

Statin-induced muscle pain, cramping, or weakness is far more common than rates from major clinical trials would suggest. Statin-induced myalgia occurs in 10%-20% of treated patients in everyday practice. In contrast, in the landmark clinical trials, where patients were carefully preselected and there was often an active run-in phase, myalgia rates were far lower and similar to placebo.

Factors that increase the likelihood of statin-induced myopathy include advanced age, diabetes, hypothyroidism, renal insufficiency, alcohol abuse, liver disease, and smaller muscle mass, as is common in patients of smaller body size, including women. But people who experience more muscle side effects also tend to get the biggest lipid responses to statin therapy, Dr. Watson noted.

Of all the statins, rosuvastatin (Crestor) has been shown to have the most favorable ratio of LDL lowering to creatine kinase elevation (Cleve. Clin. J. Med. 2011;78:393-403). It’s a good option in patients experiencing problematic myalgia on another statin.

Also, fluvastatin XL performed exceptionally well in the large French observational Prediction of Muscular Risk in Observational Conditions (PRIMO) study, the cardiologist continued. Among nearly 8,000 French patients on high-dose statins for at least 3 months, 10.5% reported muscle-related symptoms. The lowest rate, at 5.1%, was in patients on fluvastatin XL at 80 mg/day. The highest rate, 18.2%, was in patients on simvastatin at 40-80 mg/day. PRIMO participants on atorvastatin at 40-80 mg/day had a 14.9% incidence of muscle symptoms, while those on 40 mg/day of pravastatin had a 10.9% rate (Cardiovasc. Drugs Ther. 2005:19:403-14).

Alternate-day dosing as an answer for statin-intolerant patients only can be carried out effectively with rosuvastatin or atorvastatin, drugs with half-lives markedly longer than the other statins. Alternate-day dosing with 5 or 10 mg of rosuvastatin was studied in a retrospective analysis involving 51 patients, 37 (73%) of whom were able to tolerate the regimen. Among those who tolerated every-other-day dosing, the mean reduction in LDL was 34.5%, enabling half of them to achieve their LDL target (Ann. Pharmacother. 2008;42:341-6).

In another retrospective study, once-weekly dosing of rosuvastatin at 2.5-20 mg was introduced to 50 previously statin-intolerant patients. Thirty-seven patients (74%) were able to tolerate the once-weekly therapy at a mean dose of 10 mg. They responded with a 23% reduction in LDL from a baseline of 167 mg/dL (Am. J. Cardiol. 2009;103:393-4).

In a prospective pilot study, 61 consecutive patients intolerant to other statins were placed on rosuvastatin at 5 mg/day if they were moderately high risk and 10 mg/day if they were at very high risk. Only 1 of the 61 patients discontinued rosuvastatin because of muscle pain. From a baseline mean LDL of 177 mg/dL, patients in the 5-mg/day group dropped their LDL by a mean of 75 mg/dL and those on 10 mg/day lowered their LDL by 79 mg/dL (Clin. Ther. 2006;28:933-42).

The National Lipid Association advises that it’s not routinely necessary to get a baseline creatine kinase level before starting statin therapy, nor is it necessary to obtain one during treatment in asymptomatic patients, Dr. Watson noted. But patients on statin therapy need to be counseled about the associated increased risk of muscle complaints and the importance of contacting their physicians should they arise (Am. J. Cardiol. 2006;97:89C-94C).

Those who develop tolerable muscle symptoms may continue with therapy, according to the National Lipid Association Statin Safety Task Force. But patients who experience intolerable symptoms with or without a creatine kinase elevation should stop treatment. Once they’re asymptomatic, the same drug can be restarted at the same dose, or one of the alternative strategies Dr. Watson described can be employed.

She reported serving as a consultant to Pfizer and on the Merck clinical trials adjudication committee.

NEW ORLEANS – Alternative dosing regimens solve the common problem of statin-induced muscle pain in most cases.

Lowering the daily dose of the statin, dropping down to alternate-day or even once-weekly therapy, or switching to another statin having a better track record with regard to myalgia all have been shown to improve tolerability while maintaining reasonably effective lipid-lowering, according to Dr. Karol E. Watson, codirector of the University of California, Los Angeles, Program in Preventive Cardiology.

It must be emphasized, however, that none of the alternative dosing regimens have proved to reduce cardiovascular events. The issue hasn’t been studied. That being said, alternative dosing strategies do provide an option for patients who would otherwise go without the proven benefits of statin therapy, she noted at the annual meeting of the American College of Physicians.

Statin-induced muscle pain, cramping, or weakness is far more common than rates from major clinical trials would suggest. Statin-induced myalgia occurs in 10%-20% of treated patients in everyday practice. In contrast, in the landmark clinical trials, where patients were carefully preselected and there was often an active run-in phase, myalgia rates were far lower and similar to placebo.

Factors that increase the likelihood of statin-induced myopathy include advanced age, diabetes, hypothyroidism, renal insufficiency, alcohol abuse, liver disease, and smaller muscle mass, as is common in patients of smaller body size, including women. But people who experience more muscle side effects also tend to get the biggest lipid responses to statin therapy, Dr. Watson noted.

Of all the statins, rosuvastatin (Crestor) has been shown to have the most favorable ratio of LDL lowering to creatine kinase elevation (Cleve. Clin. J. Med. 2011;78:393-403). It’s a good option in patients experiencing problematic myalgia on another statin.

Also, fluvastatin XL performed exceptionally well in the large French observational Prediction of Muscular Risk in Observational Conditions (PRIMO) study, the cardiologist continued. Among nearly 8,000 French patients on high-dose statins for at least 3 months, 10.5% reported muscle-related symptoms. The lowest rate, at 5.1%, was in patients on fluvastatin XL at 80 mg/day. The highest rate, 18.2%, was in patients on simvastatin at 40-80 mg/day. PRIMO participants on atorvastatin at 40-80 mg/day had a 14.9% incidence of muscle symptoms, while those on 40 mg/day of pravastatin had a 10.9% rate (Cardiovasc. Drugs Ther. 2005:19:403-14).

Alternate-day dosing as an answer for statin-intolerant patients only can be carried out effectively with rosuvastatin or atorvastatin, drugs with half-lives markedly longer than the other statins. Alternate-day dosing with 5 or 10 mg of rosuvastatin was studied in a retrospective analysis involving 51 patients, 37 (73%) of whom were able to tolerate the regimen. Among those who tolerated every-other-day dosing, the mean reduction in LDL was 34.5%, enabling half of them to achieve their LDL target (Ann. Pharmacother. 2008;42:341-6).

In another retrospective study, once-weekly dosing of rosuvastatin at 2.5-20 mg was introduced to 50 previously statin-intolerant patients. Thirty-seven patients (74%) were able to tolerate the once-weekly therapy at a mean dose of 10 mg. They responded with a 23% reduction in LDL from a baseline of 167 mg/dL (Am. J. Cardiol. 2009;103:393-4).

In a prospective pilot study, 61 consecutive patients intolerant to other statins were placed on rosuvastatin at 5 mg/day if they were moderately high risk and 10 mg/day if they were at very high risk. Only 1 of the 61 patients discontinued rosuvastatin because of muscle pain. From a baseline mean LDL of 177 mg/dL, patients in the 5-mg/day group dropped their LDL by a mean of 75 mg/dL and those on 10 mg/day lowered their LDL by 79 mg/dL (Clin. Ther. 2006;28:933-42).

The National Lipid Association advises that it’s not routinely necessary to get a baseline creatine kinase level before starting statin therapy, nor is it necessary to obtain one during treatment in asymptomatic patients, Dr. Watson noted. But patients on statin therapy need to be counseled about the associated increased risk of muscle complaints and the importance of contacting their physicians should they arise (Am. J. Cardiol. 2006;97:89C-94C).

Those who develop tolerable muscle symptoms may continue with therapy, according to the National Lipid Association Statin Safety Task Force. But patients who experience intolerable symptoms with or without a creatine kinase elevation should stop treatment. Once they’re asymptomatic, the same drug can be restarted at the same dose, or one of the alternative strategies Dr. Watson described can be employed.

She reported serving as a consultant to Pfizer and on the Merck clinical trials adjudication committee.

WAIKOLOA, HAWAII – The dermoscopic features that reliably distinguish malignant mucosal lesions are a combination of structureless areas within the lesion along with blue, gray, or white color, a multicenter study conducted by the International Dermoscopy Society has shown.

This combination of dermoscopic findings yielded 100% sensitivity for histopathologically confirmed melanoma and 93% sensitivity for any malignancy, lead investigator Dr. Andreas Blum reported at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

He noted that while the key points in dermoscopic differentiation between malignant and benign and pigmented and nonpigmented lesions of the skin, nail apparatus, and scalp are well established, the important features to look for in dermoscopic evaluation of lesions of the oral mucosa and genitalia haven’t been well characterized. That was the impetus for the international observational study.

Consensus regarding dermoscopy of mucosal lesions has lagged for a couple of reasons, explained Dr. Blum, professor of dermatology at the University of Tübingen (Germany). One is that pigmented mucosal lesions are uncommon. And another is that manipulating the dermoscope in mucosal areas can be a challenge.

The study took place at 14 specialized skin cancer clinics in 10 countries. It included 140 patients with pigmented mucosal lesions, of which 126 ultimately proved benign, while 11 were melanomas, 2 were squamous cell carcinoma in situ lesions, and 1 was a metastasis (Arch. Dermatol. 2011;147:1181-7).

The investigators scored the dermoscopic patterns they saw as dots, globules, or clods, circles, lines, or structureless using a pattern analysis method developed by Dr. Harald Kittler.

The key study finding was that in a univariate analysis, lesions that were blue, white, or gray in color under the dermoscope and that contained structureless zones had a 100% sensitivity for melanoma, a 93% sensitivity for any malignancy, and an 83% specificity for being benign.

"When you see structureless areas – and only part of the lesion needs to be structureless – with blue, gray, or white zones, then you know something has gone wrong and it’s time to do a biopsy or excision," he said.

Recognizing structureless areas might be at times a difficult call for less-experienced physicians to make, the investigators also analyzed the data based solely upon a lesion’s color. Blue, gray, or white still had a sensitivity of 100% for melanoma and 93% for any malignancy, but the specificity dropped to 64%.

"So if you’re unsure about whether you’re seeing a structureless area, based upon color only, you’ll reliably detect melanomas and other malignancies, but you’ll end up doing unnecessary biopsies for benign lesions," Dr. Blum explained.

He credited Dr. Alfred W. Kopf of New York University with a suggestion that has made dermoscopic evaluation of mucosal lesions much more practical. To avoid contaminating the lens of the dermoscope, simply wrap the head of the device in plastic food wrap that has been coated on both sides with mineral oil.

Session chair Dr. Ashfaq A. Marghoob, a coinvestigator in the international study, offered a cautionary tale. He said that he has had two teenage patients with vulvar pigmented lesions that looked clinically like a clear-cut melanoma, and dermoscopically like melanoma, and the pathology report on the biopsy specimen came back as melanoma. Yet an alert gynecologic surgical oncologist contacted him and said he thought the white area surrounding the pigmented lesion looked like lichen sclerosus et atrophicus. It turned out the surgeon was right.

"I saw the patients again, and lo and behold it was as obvious as could be. I had missed the LS & A [lichen sclerosus et atrophicus], because I was so focused on the pigmented lesion that I just hadn’t realized it was there. It turns out that if you have LS & A, you can develop pigmented lesions within it that look like melanoma clinically, that look like melanoma under dermoscopy, and look like melanoma histologically," said Dr. Marghoob, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.

The surgery planned for one of these young patients entailed removal of the clitoral area, so timely recognition that she actually had LS & A and not melanoma spared her from a life-changing mistake.

"We’ve now been following her for 5 years, and she’s absolutely fine with no change in the pigmented lesion," he noted.

The lesson he said he’d like to share: "A vulvar melanoma in somebody under the age of 50 is almost unheard of, and I’d strongly consider LS & A instead, checking with a Wood’s light."

Neither Dr. Blum nor Dr. Marghoob reported having any relevant financial disclosures. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – The dermoscopic features that reliably distinguish malignant mucosal lesions are a combination of structureless areas within the lesion along with blue, gray, or white color, a multicenter study conducted by the International Dermoscopy Society has shown.

This combination of dermoscopic findings yielded 100% sensitivity for histopathologically confirmed melanoma and 93% sensitivity for any malignancy, lead investigator Dr. Andreas Blum reported at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

He noted that while the key points in dermoscopic differentiation between malignant and benign and pigmented and nonpigmented lesions of the skin, nail apparatus, and scalp are well established, the important features to look for in dermoscopic evaluation of lesions of the oral mucosa and genitalia haven’t been well characterized. That was the impetus for the international observational study.

Consensus regarding dermoscopy of mucosal lesions has lagged for a couple of reasons, explained Dr. Blum, professor of dermatology at the University of Tübingen (Germany). One is that pigmented mucosal lesions are uncommon. And another is that manipulating the dermoscope in mucosal areas can be a challenge.

The study took place at 14 specialized skin cancer clinics in 10 countries. It included 140 patients with pigmented mucosal lesions, of which 126 ultimately proved benign, while 11 were melanomas, 2 were squamous cell carcinoma in situ lesions, and 1 was a metastasis (Arch. Dermatol. 2011;147:1181-7).

The investigators scored the dermoscopic patterns they saw as dots, globules, or clods, circles, lines, or structureless using a pattern analysis method developed by Dr. Harald Kittler.

The key study finding was that in a univariate analysis, lesions that were blue, white, or gray in color under the dermoscope and that contained structureless zones had a 100% sensitivity for melanoma, a 93% sensitivity for any malignancy, and an 83% specificity for being benign.

"When you see structureless areas – and only part of the lesion needs to be structureless – with blue, gray, or white zones, then you know something has gone wrong and it’s time to do a biopsy or excision," he said.

Recognizing structureless areas might be at times a difficult call for less-experienced physicians to make, the investigators also analyzed the data based solely upon a lesion’s color. Blue, gray, or white still had a sensitivity of 100% for melanoma and 93% for any malignancy, but the specificity dropped to 64%.

"So if you’re unsure about whether you’re seeing a structureless area, based upon color only, you’ll reliably detect melanomas and other malignancies, but you’ll end up doing unnecessary biopsies for benign lesions," Dr. Blum explained.

He credited Dr. Alfred W. Kopf of New York University with a suggestion that has made dermoscopic evaluation of mucosal lesions much more practical. To avoid contaminating the lens of the dermoscope, simply wrap the head of the device in plastic food wrap that has been coated on both sides with mineral oil.

Session chair Dr. Ashfaq A. Marghoob, a coinvestigator in the international study, offered a cautionary tale. He said that he has had two teenage patients with vulvar pigmented lesions that looked clinically like a clear-cut melanoma, and dermoscopically like melanoma, and the pathology report on the biopsy specimen came back as melanoma. Yet an alert gynecologic surgical oncologist contacted him and said he thought the white area surrounding the pigmented lesion looked like lichen sclerosus et atrophicus. It turned out the surgeon was right.

"I saw the patients again, and lo and behold it was as obvious as could be. I had missed the LS & A [lichen sclerosus et atrophicus], because I was so focused on the pigmented lesion that I just hadn’t realized it was there. It turns out that if you have LS & A, you can develop pigmented lesions within it that look like melanoma clinically, that look like melanoma under dermoscopy, and look like melanoma histologically," said Dr. Marghoob, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.

The surgery planned for one of these young patients entailed removal of the clitoral area, so timely recognition that she actually had LS & A and not melanoma spared her from a life-changing mistake.

"We’ve now been following her for 5 years, and she’s absolutely fine with no change in the pigmented lesion," he noted.

The lesson he said he’d like to share: "A vulvar melanoma in somebody under the age of 50 is almost unheard of, and I’d strongly consider LS & A instead, checking with a Wood’s light."

Neither Dr. Blum nor Dr. Marghoob reported having any relevant financial disclosures. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – The dermoscopic features that reliably distinguish malignant mucosal lesions are a combination of structureless areas within the lesion along with blue, gray, or white color, a multicenter study conducted by the International Dermoscopy Society has shown.

This combination of dermoscopic findings yielded 100% sensitivity for histopathologically confirmed melanoma and 93% sensitivity for any malignancy, lead investigator Dr. Andreas Blum reported at the Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation (SDEF).

He noted that while the key points in dermoscopic differentiation between malignant and benign and pigmented and nonpigmented lesions of the skin, nail apparatus, and scalp are well established, the important features to look for in dermoscopic evaluation of lesions of the oral mucosa and genitalia haven’t been well characterized. That was the impetus for the international observational study.

Consensus regarding dermoscopy of mucosal lesions has lagged for a couple of reasons, explained Dr. Blum, professor of dermatology at the University of Tübingen (Germany). One is that pigmented mucosal lesions are uncommon. And another is that manipulating the dermoscope in mucosal areas can be a challenge.

The study took place at 14 specialized skin cancer clinics in 10 countries. It included 140 patients with pigmented mucosal lesions, of which 126 ultimately proved benign, while 11 were melanomas, 2 were squamous cell carcinoma in situ lesions, and 1 was a metastasis (Arch. Dermatol. 2011;147:1181-7).

The investigators scored the dermoscopic patterns they saw as dots, globules, or clods, circles, lines, or structureless using a pattern analysis method developed by Dr. Harald Kittler.

The key study finding was that in a univariate analysis, lesions that were blue, white, or gray in color under the dermoscope and that contained structureless zones had a 100% sensitivity for melanoma, a 93% sensitivity for any malignancy, and an 83% specificity for being benign.

"When you see structureless areas – and only part of the lesion needs to be structureless – with blue, gray, or white zones, then you know something has gone wrong and it’s time to do a biopsy or excision," he said.

Recognizing structureless areas might be at times a difficult call for less-experienced physicians to make, the investigators also analyzed the data based solely upon a lesion’s color. Blue, gray, or white still had a sensitivity of 100% for melanoma and 93% for any malignancy, but the specificity dropped to 64%.

"So if you’re unsure about whether you’re seeing a structureless area, based upon color only, you’ll reliably detect melanomas and other malignancies, but you’ll end up doing unnecessary biopsies for benign lesions," Dr. Blum explained.

He credited Dr. Alfred W. Kopf of New York University with a suggestion that has made dermoscopic evaluation of mucosal lesions much more practical. To avoid contaminating the lens of the dermoscope, simply wrap the head of the device in plastic food wrap that has been coated on both sides with mineral oil.

Session chair Dr. Ashfaq A. Marghoob, a coinvestigator in the international study, offered a cautionary tale. He said that he has had two teenage patients with vulvar pigmented lesions that looked clinically like a clear-cut melanoma, and dermoscopically like melanoma, and the pathology report on the biopsy specimen came back as melanoma. Yet an alert gynecologic surgical oncologist contacted him and said he thought the white area surrounding the pigmented lesion looked like lichen sclerosus et atrophicus. It turned out the surgeon was right.

"I saw the patients again, and lo and behold it was as obvious as could be. I had missed the LS & A [lichen sclerosus et atrophicus], because I was so focused on the pigmented lesion that I just hadn’t realized it was there. It turns out that if you have LS & A, you can develop pigmented lesions within it that look like melanoma clinically, that look like melanoma under dermoscopy, and look like melanoma histologically," said Dr. Marghoob, a dermatologist at Memorial Sloan-Kettering Cancer Center in New York.

The surgery planned for one of these young patients entailed removal of the clitoral area, so timely recognition that she actually had LS & A and not melanoma spared her from a life-changing mistake.

"We’ve now been following her for 5 years, and she’s absolutely fine with no change in the pigmented lesion," he noted.

The lesson he said he’d like to share: "A vulvar melanoma in somebody under the age of 50 is almost unheard of, and I’d strongly consider LS & A instead, checking with a Wood’s light."

Neither Dr. Blum nor Dr. Marghoob reported having any relevant financial disclosures. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, HAWAII – Topically applied botulinum toxin type A may no longer be a pipe dream, as it is now likely full speed ahead for proposed phase III trials of the agent.

The completed phase II program consisted of 11 clinical studies in which 553 patients had their lateral canthal lines treated with the investigational topical product known for now as RT001, under development by Revance Therapeutics. The results were highly impressive, according to Dr. Alastair Carruthers, a dermatologist at the University of British Columbia, Vancouver.

"Watch out for topical botulinum toxin. I think Revance is going to turn the neurotoxin market upside down," he predicted at the Hawaii Dermatology Seminar, sponsored by Skin Disease Education Foundation (SDEF).

Revance has developed a proprietary platform that enables transcutaneous flux of large medicinal payloads. The company has reported successful proof-of-concept studies for topically delivered insulin, growth factors, and numerous other macromolecules with applications in fields ranging from cardiovascular disease to cancer. But it’s the topical botulinum toxin project that has captured Dr. Carruthers’ attention.

"Their technology enables you to get the neurotoxin across intact skin, which is something I never thought that we would see. But it really works," he said.

No significant adverse events occurred in the phase II studies. There was no evidence of diffusion of neurotoxin away from the target muscle, and no effect upon the cranial nerves, he said. Laboratory monitoring and ECGs did not yield any evidence of systemic exposure.

The median duration of therapeutic effect was 113 days. The response rate was up to 89% based upon a stringent composite end point requiring a 2-point improvement as assessed independently by investigator and patient, he said.

The key to this technology is a synthetic peptide carrier which contains protein transduction domains and a backbone core that attaches to the neurotoxin molecule. This peptide carrier can be set to achieve different depths of penetration.

The proposed commercial product that will undergo phase III testing entails mixing the viscous topical gel in a one-step applicator, which is then used in treating the lateral canthal lines. The mixing and application takes only a couple of minutes. The gel is left on for perhaps 30 minutes – the optimal time is yet to be determined – and then removed with a proprietary cleanser.

Dr. Carruthers said that as many know, increasing competition has arrived among the manufacturers of the three Food and Drug Administration–approved injectable botulinum toxin type A products.

"I doubt that the battle, such as it is, will be fought on intellectual, scientific issues. I think it will be fought based upon cost, marketing, and other intangibles," he predicted.

Brand loyalty, company sponsorship of medical education, appeals to nationalism – one manufacturer is U.S.-based, the others German and French – these are the sorts of issues he expects to see brought forth.

That’s because the things that really matter to clinicians, such as onset of therapeutic effect, its spread, duration, and side effects, are all a function of dose – and there is no agreement as to what the comparable dose is between the various commercial preparations. Despite manufacturers’ claims, it’s not possible to detect small differences in effectiveness, immunogenicity, or other end points without doing studies that would require enormous numbers of patients, according to Dr. Carruthers.

He advised that given the uncertainty regarding dosing comparability, the best practice is to have only one botulinum toxin type A product in the office. This avoids the thorny issue of trying to use comparably effective dilutions.

In a separate presentation at the annual meeting of the American Society for Dermatologic Surgery, Dr. Gary D. Monheit, a dermatologist in private practice in Birmingham, Ala., agreed that the topical botulinum toxin could be practice changing.

He said that RT001 is best for superficial musculature such as crows’ feet, and possibly in the future for perioral and forehead wrinkles.

The investigational product affects pore size and helps smooth the skin, he said. And since the product is mostly absorbed in the superficial musculature, it could eventually be used on the eyelids and lips for superficial wrinkles and to brighten up dull skin.

Dr. Carruthers reported that he has no financial relationship with Revance. He is a consultant to, and paid investigator for, Allergan and Merz, which market Botox (onabotulinumtoxinA) and Xeomin (incobotulinumtoxinA), respectively.

Dr. Monheit is a consultant and clinical investigator for Revance.

SDEF and this news organization are owned by Elsevier.

Naseem Miller was a contributing writer.

WAIKOLOA, HAWAII – Topically applied botulinum toxin type A may no longer be a pipe dream, as it is now likely full speed ahead for proposed phase III trials of the agent.

The completed phase II program consisted of 11 clinical studies in which 553 patients had their lateral canthal lines treated with the investigational topical product known for now as RT001, under development by Revance Therapeutics. The results were highly impressive, according to Dr. Alastair Carruthers, a dermatologist at the University of British Columbia, Vancouver.

"Watch out for topical botulinum toxin. I think Revance is going to turn the neurotoxin market upside down," he predicted at the Hawaii Dermatology Seminar, sponsored by Skin Disease Education Foundation (SDEF).

Revance has developed a proprietary platform that enables transcutaneous flux of large medicinal payloads. The company has reported successful proof-of-concept studies for topically delivered insulin, growth factors, and numerous other macromolecules with applications in fields ranging from cardiovascular disease to cancer. But it’s the topical botulinum toxin project that has captured Dr. Carruthers’ attention.

"Their technology enables you to get the neurotoxin across intact skin, which is something I never thought that we would see. But it really works," he said.

No significant adverse events occurred in the phase II studies. There was no evidence of diffusion of neurotoxin away from the target muscle, and no effect upon the cranial nerves, he said. Laboratory monitoring and ECGs did not yield any evidence of systemic exposure.

The median duration of therapeutic effect was 113 days. The response rate was up to 89% based upon a stringent composite end point requiring a 2-point improvement as assessed independently by investigator and patient, he said.

The key to this technology is a synthetic peptide carrier which contains protein transduction domains and a backbone core that attaches to the neurotoxin molecule. This peptide carrier can be set to achieve different depths of penetration.

The proposed commercial product that will undergo phase III testing entails mixing the viscous topical gel in a one-step applicator, which is then used in treating the lateral canthal lines. The mixing and application takes only a couple of minutes. The gel is left on for perhaps 30 minutes – the optimal time is yet to be determined – and then removed with a proprietary cleanser.

Dr. Carruthers said that as many know, increasing competition has arrived among the manufacturers of the three Food and Drug Administration–approved injectable botulinum toxin type A products.

"I doubt that the battle, such as it is, will be fought on intellectual, scientific issues. I think it will be fought based upon cost, marketing, and other intangibles," he predicted.

Brand loyalty, company sponsorship of medical education, appeals to nationalism – one manufacturer is U.S.-based, the others German and French – these are the sorts of issues he expects to see brought forth.

That’s because the things that really matter to clinicians, such as onset of therapeutic effect, its spread, duration, and side effects, are all a function of dose – and there is no agreement as to what the comparable dose is between the various commercial preparations. Despite manufacturers’ claims, it’s not possible to detect small differences in effectiveness, immunogenicity, or other end points without doing studies that would require enormous numbers of patients, according to Dr. Carruthers.

He advised that given the uncertainty regarding dosing comparability, the best practice is to have only one botulinum toxin type A product in the office. This avoids the thorny issue of trying to use comparably effective dilutions.

In a separate presentation at the annual meeting of the American Society for Dermatologic Surgery, Dr. Gary D. Monheit, a dermatologist in private practice in Birmingham, Ala., agreed that the topical botulinum toxin could be practice changing.

He said that RT001 is best for superficial musculature such as crows’ feet, and possibly in the future for perioral and forehead wrinkles.

The investigational product affects pore size and helps smooth the skin, he said. And since the product is mostly absorbed in the superficial musculature, it could eventually be used on the eyelids and lips for superficial wrinkles and to brighten up dull skin.

Dr. Carruthers reported that he has no financial relationship with Revance. He is a consultant to, and paid investigator for, Allergan and Merz, which market Botox (onabotulinumtoxinA) and Xeomin (incobotulinumtoxinA), respectively.

Dr. Monheit is a consultant and clinical investigator for Revance.

SDEF and this news organization are owned by Elsevier.

Naseem Miller was a contributing writer.

WAIKOLOA, HAWAII – Topically applied botulinum toxin type A may no longer be a pipe dream, as it is now likely full speed ahead for proposed phase III trials of the agent.

The completed phase II program consisted of 11 clinical studies in which 553 patients had their lateral canthal lines treated with the investigational topical product known for now as RT001, under development by Revance Therapeutics. The results were highly impressive, according to Dr. Alastair Carruthers, a dermatologist at the University of British Columbia, Vancouver.

"Watch out for topical botulinum toxin. I think Revance is going to turn the neurotoxin market upside down," he predicted at the Hawaii Dermatology Seminar, sponsored by Skin Disease Education Foundation (SDEF).

Revance has developed a proprietary platform that enables transcutaneous flux of large medicinal payloads. The company has reported successful proof-of-concept studies for topically delivered insulin, growth factors, and numerous other macromolecules with applications in fields ranging from cardiovascular disease to cancer. But it’s the topical botulinum toxin project that has captured Dr. Carruthers’ attention.

"Their technology enables you to get the neurotoxin across intact skin, which is something I never thought that we would see. But it really works," he said.

No significant adverse events occurred in the phase II studies. There was no evidence of diffusion of neurotoxin away from the target muscle, and no effect upon the cranial nerves, he said. Laboratory monitoring and ECGs did not yield any evidence of systemic exposure.

The median duration of therapeutic effect was 113 days. The response rate was up to 89% based upon a stringent composite end point requiring a 2-point improvement as assessed independently by investigator and patient, he said.

The key to this technology is a synthetic peptide carrier which contains protein transduction domains and a backbone core that attaches to the neurotoxin molecule. This peptide carrier can be set to achieve different depths of penetration.

The proposed commercial product that will undergo phase III testing entails mixing the viscous topical gel in a one-step applicator, which is then used in treating the lateral canthal lines. The mixing and application takes only a couple of minutes. The gel is left on for perhaps 30 minutes – the optimal time is yet to be determined – and then removed with a proprietary cleanser.

Dr. Carruthers said that as many know, increasing competition has arrived among the manufacturers of the three Food and Drug Administration–approved injectable botulinum toxin type A products.

"I doubt that the battle, such as it is, will be fought on intellectual, scientific issues. I think it will be fought based upon cost, marketing, and other intangibles," he predicted.

Brand loyalty, company sponsorship of medical education, appeals to nationalism – one manufacturer is U.S.-based, the others German and French – these are the sorts of issues he expects to see brought forth.

That’s because the things that really matter to clinicians, such as onset of therapeutic effect, its spread, duration, and side effects, are all a function of dose – and there is no agreement as to what the comparable dose is between the various commercial preparations. Despite manufacturers’ claims, it’s not possible to detect small differences in effectiveness, immunogenicity, or other end points without doing studies that would require enormous numbers of patients, according to Dr. Carruthers.

He advised that given the uncertainty regarding dosing comparability, the best practice is to have only one botulinum toxin type A product in the office. This avoids the thorny issue of trying to use comparably effective dilutions.

In a separate presentation at the annual meeting of the American Society for Dermatologic Surgery, Dr. Gary D. Monheit, a dermatologist in private practice in Birmingham, Ala., agreed that the topical botulinum toxin could be practice changing.

He said that RT001 is best for superficial musculature such as crows’ feet, and possibly in the future for perioral and forehead wrinkles.

The investigational product affects pore size and helps smooth the skin, he said. And since the product is mostly absorbed in the superficial musculature, it could eventually be used on the eyelids and lips for superficial wrinkles and to brighten up dull skin.

Dr. Carruthers reported that he has no financial relationship with Revance. He is a consultant to, and paid investigator for, Allergan and Merz, which market Botox (onabotulinumtoxinA) and Xeomin (incobotulinumtoxinA), respectively.

Dr. Monheit is a consultant and clinical investigator for Revance.

SDEF and this news organization are owned by Elsevier.

Naseem Miller was a contributing writer.

NEW ORLEANS – Physicians are feeling the heat over the highly publicized national public health crisis stemming from overprescribing oxycodone for non-cancer chronic pain. One result has been a huge shift to using methadone for that indication. But is that the answer?

Methadone is widely perceived as an attractive alternative to oxycodone because it’s less euphoria-inducing and thus somewhat less prone to abuse, as well as less expensive. But the reality is it’s a very tricky drug to use safely for pain management, according to Dr. Barak Gaster, a general internist at the University of Washington, Seattle.

Methadone is a highly unusual opiate. The dose-response relationship is far more variable and idiosyncratic than for oxycodone or other opiates. Methadone has numerous active metabolites. And as those active metabolites accumulate during the first 2 weeks on any given dose of the drug, patients will gradually experience greater analgesia and, disturbingly, more respiratory depression as well.

"This is one of the most dangerous situations for unintentional overdose. Patients have to understand that this is kind of a dangerous medication, and it’s going to take a couple weeks to kick in during which it’s absolutely essential that they don’t increase the dose on their own," Dr. Gaster explained at the annual meeting of the American College of Physicians.

The other major shortcoming of methadone as a treatment for chronic pain is that the drug comes in big-dose tablets designed for once-daily treatment of heroin addiction. The smallest available dose – a 5-mg tablet – is 3-4 times more potent than a 5-mg pill of oxycodone. So patients placed on 5 mg per day of methadone are really being started at 3 times the usual starting dose of oxycodone, hydrocodone, or morphine. And 60 mg of methadone is really more like 200 mg of oxycodone.

An opiate-naive individual should be started on half a 5-mg tablet of methadone twice daily for 2 weeks. Titration should then proceed very slowly, since it takes about 2 weeks for each new dose to reach steady state.

"There’s a weird Catch-22 situation with methadone where on the one hand it’s a short-acting drug in terms of its analgesic effect and needs to be dosed at least 3 times a day, but on the other hand it has this very long-acting risk potential," the internist observed.

The burgeoning shift from away from prescribing oxycodone in favor of methadone for chronic pain is fueled by a general recognition that something has gone very much awry nationally with regard to opiate prescribing. Prescriptions for opiates have tripled in the last 10 years. Surveys indicate 1 in 20 American adults has taken prescription opiates to get high. Most disturbingly, the annual number of unintentional fatal overdoses attributed to prescription opiates now exceeds those from heroin and cocaine combined.

Of note, Dr. Gaster observed, these unintentional fatal opiate overdoses very rarely occur in individuals who are on a single somnolence-inducing medication. The classic setup is the patient who is on an opioid for chronic pain, but who is also drinking alcohol, taking a benzodiazepine, and has sleep apnea.

He reported having no financial conflicts.

NEW ORLEANS – Physicians are feeling the heat over the highly publicized national public health crisis stemming from overprescribing oxycodone for non-cancer chronic pain. One result has been a huge shift to using methadone for that indication. But is that the answer?

Methadone is widely perceived as an attractive alternative to oxycodone because it’s less euphoria-inducing and thus somewhat less prone to abuse, as well as less expensive. But the reality is it’s a very tricky drug to use safely for pain management, according to Dr. Barak Gaster, a general internist at the University of Washington, Seattle.

Methadone is a highly unusual opiate. The dose-response relationship is far more variable and idiosyncratic than for oxycodone or other opiates. Methadone has numerous active metabolites. And as those active metabolites accumulate during the first 2 weeks on any given dose of the drug, patients will gradually experience greater analgesia and, disturbingly, more respiratory depression as well.

"This is one of the most dangerous situations for unintentional overdose. Patients have to understand that this is kind of a dangerous medication, and it’s going to take a couple weeks to kick in during which it’s absolutely essential that they don’t increase the dose on their own," Dr. Gaster explained at the annual meeting of the American College of Physicians.

The other major shortcoming of methadone as a treatment for chronic pain is that the drug comes in big-dose tablets designed for once-daily treatment of heroin addiction. The smallest available dose – a 5-mg tablet – is 3-4 times more potent than a 5-mg pill of oxycodone. So patients placed on 5 mg per day of methadone are really being started at 3 times the usual starting dose of oxycodone, hydrocodone, or morphine. And 60 mg of methadone is really more like 200 mg of oxycodone.

An opiate-naive individual should be started on half a 5-mg tablet of methadone twice daily for 2 weeks. Titration should then proceed very slowly, since it takes about 2 weeks for each new dose to reach steady state.

"There’s a weird Catch-22 situation with methadone where on the one hand it’s a short-acting drug in terms of its analgesic effect and needs to be dosed at least 3 times a day, but on the other hand it has this very long-acting risk potential," the internist observed.

The burgeoning shift from away from prescribing oxycodone in favor of methadone for chronic pain is fueled by a general recognition that something has gone very much awry nationally with regard to opiate prescribing. Prescriptions for opiates have tripled in the last 10 years. Surveys indicate 1 in 20 American adults has taken prescription opiates to get high. Most disturbingly, the annual number of unintentional fatal overdoses attributed to prescription opiates now exceeds those from heroin and cocaine combined.

Of note, Dr. Gaster observed, these unintentional fatal opiate overdoses very rarely occur in individuals who are on a single somnolence-inducing medication. The classic setup is the patient who is on an opioid for chronic pain, but who is also drinking alcohol, taking a benzodiazepine, and has sleep apnea.

He reported having no financial conflicts.

NEW ORLEANS – Physicians are feeling the heat over the highly publicized national public health crisis stemming from overprescribing oxycodone for non-cancer chronic pain. One result has been a huge shift to using methadone for that indication. But is that the answer?

Methadone is widely perceived as an attractive alternative to oxycodone because it’s less euphoria-inducing and thus somewhat less prone to abuse, as well as less expensive. But the reality is it’s a very tricky drug to use safely for pain management, according to Dr. Barak Gaster, a general internist at the University of Washington, Seattle.

Methadone is a highly unusual opiate. The dose-response relationship is far more variable and idiosyncratic than for oxycodone or other opiates. Methadone has numerous active metabolites. And as those active metabolites accumulate during the first 2 weeks on any given dose of the drug, patients will gradually experience greater analgesia and, disturbingly, more respiratory depression as well.

"This is one of the most dangerous situations for unintentional overdose. Patients have to understand that this is kind of a dangerous medication, and it’s going to take a couple weeks to kick in during which it’s absolutely essential that they don’t increase the dose on their own," Dr. Gaster explained at the annual meeting of the American College of Physicians.

The other major shortcoming of methadone as a treatment for chronic pain is that the drug comes in big-dose tablets designed for once-daily treatment of heroin addiction. The smallest available dose – a 5-mg tablet – is 3-4 times more potent than a 5-mg pill of oxycodone. So patients placed on 5 mg per day of methadone are really being started at 3 times the usual starting dose of oxycodone, hydrocodone, or morphine. And 60 mg of methadone is really more like 200 mg of oxycodone.

An opiate-naive individual should be started on half a 5-mg tablet of methadone twice daily for 2 weeks. Titration should then proceed very slowly, since it takes about 2 weeks for each new dose to reach steady state.

"There’s a weird Catch-22 situation with methadone where on the one hand it’s a short-acting drug in terms of its analgesic effect and needs to be dosed at least 3 times a day, but on the other hand it has this very long-acting risk potential," the internist observed.

The burgeoning shift from away from prescribing oxycodone in favor of methadone for chronic pain is fueled by a general recognition that something has gone very much awry nationally with regard to opiate prescribing. Prescriptions for opiates have tripled in the last 10 years. Surveys indicate 1 in 20 American adults has taken prescription opiates to get high. Most disturbingly, the annual number of unintentional fatal overdoses attributed to prescription opiates now exceeds those from heroin and cocaine combined.

Of note, Dr. Gaster observed, these unintentional fatal opiate overdoses very rarely occur in individuals who are on a single somnolence-inducing medication. The classic setup is the patient who is on an opioid for chronic pain, but who is also drinking alcohol, taking a benzodiazepine, and has sleep apnea.

He reported having no financial conflicts.