M. Alexander Otto

SAN DIEGO – The Institute of Medicine’s report, "Epilepsy Across the Spectrum," has led to several new epilepsy initiatives at the U.S. Department of Health and Human Services, according to Assistant Secretary for Health Howard Koh.

"I want to assure you that since the day this report came out we have been meeting regularly to review what our department has done and what we can do [to] make these recommendations come alive," Dr. Koh said at the annual meeting of the American Epilepsy Society.

Several HHS agencies have already made progress. For instance, in November the Centers for Disease Control and Prevention (CDC) updated its epilepsy epidemiology statistics for the first time since 1994, a "direct result" of the Institute of Medicine’s call for further research, he said.

The new analysis estimated that about 4.1 million U.S. children and adults suffer from the condition, and that only about half of adults with active disease have seen a neurologist or epileptologist in the preceding year – an indication, perhaps, of inadequate care.

"CDC is going to take these [measurements] on a regular basis over the next decade. These data help us compare health status, comorbidities, and risk factors [with] the general public, [which] is absolutely vital," Dr. Koh said.

The CDC also partnered with the Epilepsy Foundation to launch the "Now I Know" national epilepsy media awareness campaign which, among other things, invites patients to share their experiences and advice on Facebook.

Also, "we are trying to advance the concept of self-management for people with epilepsy," which is a major IOM theme, Dr. Koh said. The CDC is working with several universities on the issue and has also helped launch a free self-management program on the Epilepsy Foundation’s website called Web-Ease.

The Food and Drug Administration is fully engaged in collaborative efforts, too, Dr. Koh said, including working with several groups to identify risk factors for Sudden Unexplained Death in Epilepsy (SUDEP), to explore if adult epilepsy drug outcomes can be extrapolated to children to speed pediatric drug development, and to establish protocols for head-to-head bioequivalency testing of generic and branded epilepsy drugs, including lamotrigine.

The IOM report – published in March 2012 – also emphasized the need to improve pediatric epilepsy care in rural and underserved settings. That task has fallen to the Health Resources and Services Administration (HRSA), which has been working on the issue since 2003, Dr. Koh said.

HRSA’s Project Access tracks epilepsy outcomes for children in underserved areas and helps ensure that they have proper insurance coverage, community services organization, referral agreements, and adult-care transfers when needed.

Telemedicine has been a major theme, especially in demonstration projects in Michigan and Nebraska. "Preliminary data" from those efforts "indicate families are spending less time traveling to reach specialty care [and that their] average wait for neurology visits has decreased from 4-6 months to 2-4 weeks," Dr. Koh said.

The National Institute of Neurological Disorders and Strokes, one of the National Institutes of Health, is on board too, issuing grants to study the effects of diet on epilepsy and whether or not it’s safe to take epilepsy drugs during pregnancy, among other research concerns, Dr. Koh said.

SAN DIEGO – The Institute of Medicine’s report, "Epilepsy Across the Spectrum," has led to several new epilepsy initiatives at the U.S. Department of Health and Human Services, according to Assistant Secretary for Health Howard Koh.

"I want to assure you that since the day this report came out we have been meeting regularly to review what our department has done and what we can do [to] make these recommendations come alive," Dr. Koh said at the annual meeting of the American Epilepsy Society.

Several HHS agencies have already made progress. For instance, in November the Centers for Disease Control and Prevention (CDC) updated its epilepsy epidemiology statistics for the first time since 1994, a "direct result" of the Institute of Medicine’s call for further research, he said.

The new analysis estimated that about 4.1 million U.S. children and adults suffer from the condition, and that only about half of adults with active disease have seen a neurologist or epileptologist in the preceding year – an indication, perhaps, of inadequate care.

"CDC is going to take these [measurements] on a regular basis over the next decade. These data help us compare health status, comorbidities, and risk factors [with] the general public, [which] is absolutely vital," Dr. Koh said.

The CDC also partnered with the Epilepsy Foundation to launch the "Now I Know" national epilepsy media awareness campaign which, among other things, invites patients to share their experiences and advice on Facebook.

Also, "we are trying to advance the concept of self-management for people with epilepsy," which is a major IOM theme, Dr. Koh said. The CDC is working with several universities on the issue and has also helped launch a free self-management program on the Epilepsy Foundation’s website called Web-Ease.

The Food and Drug Administration is fully engaged in collaborative efforts, too, Dr. Koh said, including working with several groups to identify risk factors for Sudden Unexplained Death in Epilepsy (SUDEP), to explore if adult epilepsy drug outcomes can be extrapolated to children to speed pediatric drug development, and to establish protocols for head-to-head bioequivalency testing of generic and branded epilepsy drugs, including lamotrigine.

The IOM report – published in March 2012 – also emphasized the need to improve pediatric epilepsy care in rural and underserved settings. That task has fallen to the Health Resources and Services Administration (HRSA), which has been working on the issue since 2003, Dr. Koh said.

HRSA’s Project Access tracks epilepsy outcomes for children in underserved areas and helps ensure that they have proper insurance coverage, community services organization, referral agreements, and adult-care transfers when needed.

Telemedicine has been a major theme, especially in demonstration projects in Michigan and Nebraska. "Preliminary data" from those efforts "indicate families are spending less time traveling to reach specialty care [and that their] average wait for neurology visits has decreased from 4-6 months to 2-4 weeks," Dr. Koh said.

The National Institute of Neurological Disorders and Strokes, one of the National Institutes of Health, is on board too, issuing grants to study the effects of diet on epilepsy and whether or not it’s safe to take epilepsy drugs during pregnancy, among other research concerns, Dr. Koh said.

SAN DIEGO – The Institute of Medicine’s report, "Epilepsy Across the Spectrum," has led to several new epilepsy initiatives at the U.S. Department of Health and Human Services, according to Assistant Secretary for Health Howard Koh.

"I want to assure you that since the day this report came out we have been meeting regularly to review what our department has done and what we can do [to] make these recommendations come alive," Dr. Koh said at the annual meeting of the American Epilepsy Society.

Several HHS agencies have already made progress. For instance, in November the Centers for Disease Control and Prevention (CDC) updated its epilepsy epidemiology statistics for the first time since 1994, a "direct result" of the Institute of Medicine’s call for further research, he said.

The new analysis estimated that about 4.1 million U.S. children and adults suffer from the condition, and that only about half of adults with active disease have seen a neurologist or epileptologist in the preceding year – an indication, perhaps, of inadequate care.

"CDC is going to take these [measurements] on a regular basis over the next decade. These data help us compare health status, comorbidities, and risk factors [with] the general public, [which] is absolutely vital," Dr. Koh said.

The CDC also partnered with the Epilepsy Foundation to launch the "Now I Know" national epilepsy media awareness campaign which, among other things, invites patients to share their experiences and advice on Facebook.

Also, "we are trying to advance the concept of self-management for people with epilepsy," which is a major IOM theme, Dr. Koh said. The CDC is working with several universities on the issue and has also helped launch a free self-management program on the Epilepsy Foundation’s website called Web-Ease.

The Food and Drug Administration is fully engaged in collaborative efforts, too, Dr. Koh said, including working with several groups to identify risk factors for Sudden Unexplained Death in Epilepsy (SUDEP), to explore if adult epilepsy drug outcomes can be extrapolated to children to speed pediatric drug development, and to establish protocols for head-to-head bioequivalency testing of generic and branded epilepsy drugs, including lamotrigine.

The IOM report – published in March 2012 – also emphasized the need to improve pediatric epilepsy care in rural and underserved settings. That task has fallen to the Health Resources and Services Administration (HRSA), which has been working on the issue since 2003, Dr. Koh said.

HRSA’s Project Access tracks epilepsy outcomes for children in underserved areas and helps ensure that they have proper insurance coverage, community services organization, referral agreements, and adult-care transfers when needed.

Telemedicine has been a major theme, especially in demonstration projects in Michigan and Nebraska. "Preliminary data" from those efforts "indicate families are spending less time traveling to reach specialty care [and that their] average wait for neurology visits has decreased from 4-6 months to 2-4 weeks," Dr. Koh said.

The National Institute of Neurological Disorders and Strokes, one of the National Institutes of Health, is on board too, issuing grants to study the effects of diet on epilepsy and whether or not it’s safe to take epilepsy drugs during pregnancy, among other research concerns, Dr. Koh said.

LAS VEGAS – It’s probably best to treat one area during an initial cryolipolysis session and wait "2-3 months to see what clinical benefits you have" before the next treatment, according to Dr. Mathew Avram.

"If patients are going to get another treatment, I want them to be happy with the first one," he said. Cryolipolysis is expensive, and "there are definitely patients who do not respond."

Also, "you’ll get down a little deeper to cells that weren’t reached" during the first treatment if inflammation and dead fat cells are given a chance to dissipate before the next treatment. "If you wait 2 or 3 months, I think you’ll get a better end-result," said Dr. Avram, director of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital in Boston.

Most patients can expect a small but noticeable difference with the procedure. "It’s not a home run," but it’s helpful for areas "that you can’t really get rid of with diet and exercise," he said at the SDEF Las Vegas Dermatology Seminar.

The study that earned cryolipolysis (CoolSculpting – Zeltiq Aesthetics Inc.) Food and Drug Administration clearance found that one session decreased love-handle fat layer thickness by 22.7% in 32 patients. One side was treated in each patient, with the other side used as a control. Results were assessed by high-resolution ultrasound and histology at 4 months.

"Most people come in for a little bit of protrusion in the lower abdomen. Two to three months later, they’ll see a small but noticeable decrease," said Dr. Avram, who’s also treated gynecomastia, the upper back, and other areas over the past 3 years.

But "this does not compare to liposuction. This is a much more modest amount of fat removal," he said.

CoolSculpting takes about 1-3 hours and does not require close supervision once the cooling device is placed. The procedure is thought to crystalize lipids in subcutaneous fat cells at near-freezing temperatures, causing their death without damaging the skin. Fat "feels like slush underneath the skin" after treatment, and patients can expect some redness, numbness, and bruising where the device was applied.

Overall, it’s "typically very mild – not a very painful treatment." Postprocedure massage may improve clinical results [although] "there are no hard data to show that," Dr. Avram said.

The areas that respond best are "grabbable areas of fat" because the cooling applicator is not contoured to curved areas like the buttocks, though Zeltiq is working to address the problem, he said.

"The posterior upper arms don’t do as well either. Typically both laxity and fat are involved, and sometimes you can get a little problem with the nerve root there," he said.

The procedure does not change skin pigmentation, but rarely patients can experience significant pain 3-7 days following treatment that resolves with no sequelae. Even more rarely, there can be a paradoxical fat increase in the treated area 3-5 months later, Dr. Avram said.

Cold-air urticaria, cryoglobulinemia, and hernia are all contraindications.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Avram is on the scientific advisory board of Zeltiq and is a paid consultant to the company.

LAS VEGAS – It’s probably best to treat one area during an initial cryolipolysis session and wait "2-3 months to see what clinical benefits you have" before the next treatment, according to Dr. Mathew Avram.

"If patients are going to get another treatment, I want them to be happy with the first one," he said. Cryolipolysis is expensive, and "there are definitely patients who do not respond."

Also, "you’ll get down a little deeper to cells that weren’t reached" during the first treatment if inflammation and dead fat cells are given a chance to dissipate before the next treatment. "If you wait 2 or 3 months, I think you’ll get a better end-result," said Dr. Avram, director of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital in Boston.

Most patients can expect a small but noticeable difference with the procedure. "It’s not a home run," but it’s helpful for areas "that you can’t really get rid of with diet and exercise," he said at the SDEF Las Vegas Dermatology Seminar.

The study that earned cryolipolysis (CoolSculpting – Zeltiq Aesthetics Inc.) Food and Drug Administration clearance found that one session decreased love-handle fat layer thickness by 22.7% in 32 patients. One side was treated in each patient, with the other side used as a control. Results were assessed by high-resolution ultrasound and histology at 4 months.

"Most people come in for a little bit of protrusion in the lower abdomen. Two to three months later, they’ll see a small but noticeable decrease," said Dr. Avram, who’s also treated gynecomastia, the upper back, and other areas over the past 3 years.

But "this does not compare to liposuction. This is a much more modest amount of fat removal," he said.

CoolSculpting takes about 1-3 hours and does not require close supervision once the cooling device is placed. The procedure is thought to crystalize lipids in subcutaneous fat cells at near-freezing temperatures, causing their death without damaging the skin. Fat "feels like slush underneath the skin" after treatment, and patients can expect some redness, numbness, and bruising where the device was applied.

Overall, it’s "typically very mild – not a very painful treatment." Postprocedure massage may improve clinical results [although] "there are no hard data to show that," Dr. Avram said.

The areas that respond best are "grabbable areas of fat" because the cooling applicator is not contoured to curved areas like the buttocks, though Zeltiq is working to address the problem, he said.

"The posterior upper arms don’t do as well either. Typically both laxity and fat are involved, and sometimes you can get a little problem with the nerve root there," he said.

The procedure does not change skin pigmentation, but rarely patients can experience significant pain 3-7 days following treatment that resolves with no sequelae. Even more rarely, there can be a paradoxical fat increase in the treated area 3-5 months later, Dr. Avram said.

Cold-air urticaria, cryoglobulinemia, and hernia are all contraindications.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Avram is on the scientific advisory board of Zeltiq and is a paid consultant to the company.

LAS VEGAS – It’s probably best to treat one area during an initial cryolipolysis session and wait "2-3 months to see what clinical benefits you have" before the next treatment, according to Dr. Mathew Avram.

"If patients are going to get another treatment, I want them to be happy with the first one," he said. Cryolipolysis is expensive, and "there are definitely patients who do not respond."

Also, "you’ll get down a little deeper to cells that weren’t reached" during the first treatment if inflammation and dead fat cells are given a chance to dissipate before the next treatment. "If you wait 2 or 3 months, I think you’ll get a better end-result," said Dr. Avram, director of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital in Boston.

Most patients can expect a small but noticeable difference with the procedure. "It’s not a home run," but it’s helpful for areas "that you can’t really get rid of with diet and exercise," he said at the SDEF Las Vegas Dermatology Seminar.

The study that earned cryolipolysis (CoolSculpting – Zeltiq Aesthetics Inc.) Food and Drug Administration clearance found that one session decreased love-handle fat layer thickness by 22.7% in 32 patients. One side was treated in each patient, with the other side used as a control. Results were assessed by high-resolution ultrasound and histology at 4 months.

"Most people come in for a little bit of protrusion in the lower abdomen. Two to three months later, they’ll see a small but noticeable decrease," said Dr. Avram, who’s also treated gynecomastia, the upper back, and other areas over the past 3 years.

But "this does not compare to liposuction. This is a much more modest amount of fat removal," he said.

CoolSculpting takes about 1-3 hours and does not require close supervision once the cooling device is placed. The procedure is thought to crystalize lipids in subcutaneous fat cells at near-freezing temperatures, causing their death without damaging the skin. Fat "feels like slush underneath the skin" after treatment, and patients can expect some redness, numbness, and bruising where the device was applied.

Overall, it’s "typically very mild – not a very painful treatment." Postprocedure massage may improve clinical results [although] "there are no hard data to show that," Dr. Avram said.

The areas that respond best are "grabbable areas of fat" because the cooling applicator is not contoured to curved areas like the buttocks, though Zeltiq is working to address the problem, he said.

"The posterior upper arms don’t do as well either. Typically both laxity and fat are involved, and sometimes you can get a little problem with the nerve root there," he said.

The procedure does not change skin pigmentation, but rarely patients can experience significant pain 3-7 days following treatment that resolves with no sequelae. Even more rarely, there can be a paradoxical fat increase in the treated area 3-5 months later, Dr. Avram said.

Cold-air urticaria, cryoglobulinemia, and hernia are all contraindications.

SDEF and this news organization are owned by Frontline Medical Communications. Dr. Avram is on the scientific advisory board of Zeltiq and is a paid consultant to the company.

SAN DIEGO – High-dose prednisolone appears to be an effective alternative to adrenocorticotropic hormone for infantile spasms, according to a small prospective study from the University of California, Los Angeles.

Sixty percent of infants (18 of 30) with the potentially devastating childhood epilepsy for a median of 4.5 months were cured following 2 weeks of high-dose oral prednisolone, 8 mg/kg per day. Five of the 12 (42%) who failed prednisolone were cured with a subsequent 2 weeks of intramuscular adrenocorticotropic hormone (ACTH), 150 IU/m² per day.

Lead investigator and neurologist Dr. Shaun Hussain, a UCLA clinical assistant professor of pediatrics, said he did the study because "there’s no agreement about which agent is best and which dosage is best." Previous studies have shown superiority for ACTH, but only against doses of prednisolone lower than 2 mg/kg per day; more recent work suggests high-dose prednisolone works as well as ACTH (Epilepsy Behav. 2009;14:674-6).

ACTH is also far more expensive than prednisolone, about $125,000 per treatment course instead of $200.

A large multicenter randomized comparison trial is needed to settle the debate; Dr. Hussain said he hopes to organize one. In the meantime, institutions like UCLA are leaning toward high-dose prednisolone, others lean toward ACTH, and some have abandoned ACTH altogether, he said.

For now, "I don’t think ACTH should be abandoned. I say that because five patients ended up responding to ACTH after they failed prednisolone. I believe instead of abandoning ACTH, it should simply be reserved for those patients who fail high-dose prednisolone," Dr. Hussain said at the annual meeting of the American Epilepsy Society.

Spasm onset in the 30 infants came at a median of 6.5 months, and study entry at a median of 11 months. Most of the children were boys, most were symptomatic, and most had an identifiable cause of the problem, including prenatal stroke and focal cortical dysplasia.

The children had failed prior treatments, contributing to the delay in trial entry. "We think in general [the delay] contributed to intractability," and that the cumulative response rate of "77% [23 of 30] is pretty good given our refractory population." Had the protocol been applied to a less-refractory group, it’s possible the results would have rivaled the 90% or so ACTH cure rates reported with more tractable patients, Dr. Hussain said.

That some patients who failed high-dose prednisolone responded to ACTH may mean that ACTH is better, or that prednisolone should have been continued a week or two longer, he noted.

Twenty patients (67%) had hypsarrhythmia at baseline, confirmed by overnight video EEGs. A second overnight video EEG assessed cure rates – a complete absence of spasms and hypsarrhythmia – following 2 weeks of prednisolone. The 12 infants who did not respond were immediately switched to ACTH.

Two of the 18 prednisolone responders (11%) relapsed within 5 months; one responded to additional high-dose prednisolone. Two of the five ACTH responders (40%) relapsed.

Dr. Hussain is an adviser to Questcor, the maker of ACTH (Acthar Gel), and has a research grant from Lundbeck.

SAN DIEGO – High-dose prednisolone appears to be an effective alternative to adrenocorticotropic hormone for infantile spasms, according to a small prospective study from the University of California, Los Angeles.

Sixty percent of infants (18 of 30) with the potentially devastating childhood epilepsy for a median of 4.5 months were cured following 2 weeks of high-dose oral prednisolone, 8 mg/kg per day. Five of the 12 (42%) who failed prednisolone were cured with a subsequent 2 weeks of intramuscular adrenocorticotropic hormone (ACTH), 150 IU/m² per day.

Lead investigator and neurologist Dr. Shaun Hussain, a UCLA clinical assistant professor of pediatrics, said he did the study because "there’s no agreement about which agent is best and which dosage is best." Previous studies have shown superiority for ACTH, but only against doses of prednisolone lower than 2 mg/kg per day; more recent work suggests high-dose prednisolone works as well as ACTH (Epilepsy Behav. 2009;14:674-6).

ACTH is also far more expensive than prednisolone, about $125,000 per treatment course instead of $200.

A large multicenter randomized comparison trial is needed to settle the debate; Dr. Hussain said he hopes to organize one. In the meantime, institutions like UCLA are leaning toward high-dose prednisolone, others lean toward ACTH, and some have abandoned ACTH altogether, he said.

For now, "I don’t think ACTH should be abandoned. I say that because five patients ended up responding to ACTH after they failed prednisolone. I believe instead of abandoning ACTH, it should simply be reserved for those patients who fail high-dose prednisolone," Dr. Hussain said at the annual meeting of the American Epilepsy Society.

Spasm onset in the 30 infants came at a median of 6.5 months, and study entry at a median of 11 months. Most of the children were boys, most were symptomatic, and most had an identifiable cause of the problem, including prenatal stroke and focal cortical dysplasia.

The children had failed prior treatments, contributing to the delay in trial entry. "We think in general [the delay] contributed to intractability," and that the cumulative response rate of "77% [23 of 30] is pretty good given our refractory population." Had the protocol been applied to a less-refractory group, it’s possible the results would have rivaled the 90% or so ACTH cure rates reported with more tractable patients, Dr. Hussain said.

That some patients who failed high-dose prednisolone responded to ACTH may mean that ACTH is better, or that prednisolone should have been continued a week or two longer, he noted.

Twenty patients (67%) had hypsarrhythmia at baseline, confirmed by overnight video EEGs. A second overnight video EEG assessed cure rates – a complete absence of spasms and hypsarrhythmia – following 2 weeks of prednisolone. The 12 infants who did not respond were immediately switched to ACTH.

Two of the 18 prednisolone responders (11%) relapsed within 5 months; one responded to additional high-dose prednisolone. Two of the five ACTH responders (40%) relapsed.

Dr. Hussain is an adviser to Questcor, the maker of ACTH (Acthar Gel), and has a research grant from Lundbeck.

SAN DIEGO – High-dose prednisolone appears to be an effective alternative to adrenocorticotropic hormone for infantile spasms, according to a small prospective study from the University of California, Los Angeles.

Sixty percent of infants (18 of 30) with the potentially devastating childhood epilepsy for a median of 4.5 months were cured following 2 weeks of high-dose oral prednisolone, 8 mg/kg per day. Five of the 12 (42%) who failed prednisolone were cured with a subsequent 2 weeks of intramuscular adrenocorticotropic hormone (ACTH), 150 IU/m² per day.

Lead investigator and neurologist Dr. Shaun Hussain, a UCLA clinical assistant professor of pediatrics, said he did the study because "there’s no agreement about which agent is best and which dosage is best." Previous studies have shown superiority for ACTH, but only against doses of prednisolone lower than 2 mg/kg per day; more recent work suggests high-dose prednisolone works as well as ACTH (Epilepsy Behav. 2009;14:674-6).

ACTH is also far more expensive than prednisolone, about $125,000 per treatment course instead of $200.

A large multicenter randomized comparison trial is needed to settle the debate; Dr. Hussain said he hopes to organize one. In the meantime, institutions like UCLA are leaning toward high-dose prednisolone, others lean toward ACTH, and some have abandoned ACTH altogether, he said.

For now, "I don’t think ACTH should be abandoned. I say that because five patients ended up responding to ACTH after they failed prednisolone. I believe instead of abandoning ACTH, it should simply be reserved for those patients who fail high-dose prednisolone," Dr. Hussain said at the annual meeting of the American Epilepsy Society.

Spasm onset in the 30 infants came at a median of 6.5 months, and study entry at a median of 11 months. Most of the children were boys, most were symptomatic, and most had an identifiable cause of the problem, including prenatal stroke and focal cortical dysplasia.

The children had failed prior treatments, contributing to the delay in trial entry. "We think in general [the delay] contributed to intractability," and that the cumulative response rate of "77% [23 of 30] is pretty good given our refractory population." Had the protocol been applied to a less-refractory group, it’s possible the results would have rivaled the 90% or so ACTH cure rates reported with more tractable patients, Dr. Hussain said.

That some patients who failed high-dose prednisolone responded to ACTH may mean that ACTH is better, or that prednisolone should have been continued a week or two longer, he noted.

Twenty patients (67%) had hypsarrhythmia at baseline, confirmed by overnight video EEGs. A second overnight video EEG assessed cure rates – a complete absence of spasms and hypsarrhythmia – following 2 weeks of prednisolone. The 12 infants who did not respond were immediately switched to ACTH.

Two of the 18 prednisolone responders (11%) relapsed within 5 months; one responded to additional high-dose prednisolone. Two of the five ACTH responders (40%) relapsed.

Dr. Hussain is an adviser to Questcor, the maker of ACTH (Acthar Gel), and has a research grant from Lundbeck.

SAN FRANCISCO – Blood and urine culture results need to be followed up in emergency department patients discharged on empiric antibiotic therapy.

During a 4-month prospective study, pharmacists at the Henry Ford Hospital in Detroit found antibiotic-bacteria mismatches in 26% of 196 ED patients based on cross-checking of culture results and antibiotics prescribed.

When alerted to the problems, physicians called the patients to change their antibiotic regimens based on the pharmacists’ recommendations.

Alex Otto/IMNG Medical Media

Compared to 124 well-matched historical controls who did not get the extra oversight, the 196 patients had a 7% combined decrease in 72-hour ED revisits and 30-day admissions (17% vs. 10%, P = .08). Among uninsured patients, ED revisits dropped more than 10% (15% vs. 2%, P = .04).

The situation isn’t unique to Henry Ford. Empiric treatment is common pending culture results, and sometimes even the best guesses are wrong, said lead investigator Lisa Dumkow, Pharm.D., a pharmacy resident at Henry Ford, at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy . ED physicians had been struggling with culture follow-up and the hospital pharmacists "were really excited to have us there to help them. It was nice for patient satisfaction, too. Some of the patients were appreciative."

Most of the patients in the study were women with urinary tract infections caused by Escherichia coli.

The majority of pharmacist interventions were for pathogen nonsusceptibility, followed by inappropriate dose, or duration of antibiotic therapy.

The conference was sponsored by the American Society for Microbiology. The researchers said they have no disclosures.

SAN FRANCISCO – Blood and urine culture results need to be followed up in emergency department patients discharged on empiric antibiotic therapy.

During a 4-month prospective study, pharmacists at the Henry Ford Hospital in Detroit found antibiotic-bacteria mismatches in 26% of 196 ED patients based on cross-checking of culture results and antibiotics prescribed.

When alerted to the problems, physicians called the patients to change their antibiotic regimens based on the pharmacists’ recommendations.

Alex Otto/IMNG Medical Media

Compared to 124 well-matched historical controls who did not get the extra oversight, the 196 patients had a 7% combined decrease in 72-hour ED revisits and 30-day admissions (17% vs. 10%, P = .08). Among uninsured patients, ED revisits dropped more than 10% (15% vs. 2%, P = .04).

The situation isn’t unique to Henry Ford. Empiric treatment is common pending culture results, and sometimes even the best guesses are wrong, said lead investigator Lisa Dumkow, Pharm.D., a pharmacy resident at Henry Ford, at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy . ED physicians had been struggling with culture follow-up and the hospital pharmacists "were really excited to have us there to help them. It was nice for patient satisfaction, too. Some of the patients were appreciative."

Most of the patients in the study were women with urinary tract infections caused by Escherichia coli.

The majority of pharmacist interventions were for pathogen nonsusceptibility, followed by inappropriate dose, or duration of antibiotic therapy.

The conference was sponsored by the American Society for Microbiology. The researchers said they have no disclosures.

SAN FRANCISCO – Blood and urine culture results need to be followed up in emergency department patients discharged on empiric antibiotic therapy.

During a 4-month prospective study, pharmacists at the Henry Ford Hospital in Detroit found antibiotic-bacteria mismatches in 26% of 196 ED patients based on cross-checking of culture results and antibiotics prescribed.

When alerted to the problems, physicians called the patients to change their antibiotic regimens based on the pharmacists’ recommendations.

Alex Otto/IMNG Medical Media

Compared to 124 well-matched historical controls who did not get the extra oversight, the 196 patients had a 7% combined decrease in 72-hour ED revisits and 30-day admissions (17% vs. 10%, P = .08). Among uninsured patients, ED revisits dropped more than 10% (15% vs. 2%, P = .04).

The situation isn’t unique to Henry Ford. Empiric treatment is common pending culture results, and sometimes even the best guesses are wrong, said lead investigator Lisa Dumkow, Pharm.D., a pharmacy resident at Henry Ford, at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy . ED physicians had been struggling with culture follow-up and the hospital pharmacists "were really excited to have us there to help them. It was nice for patient satisfaction, too. Some of the patients were appreciative."

Most of the patients in the study were women with urinary tract infections caused by Escherichia coli.

The majority of pharmacist interventions were for pathogen nonsusceptibility, followed by inappropriate dose, or duration of antibiotic therapy.

The conference was sponsored by the American Society for Microbiology. The researchers said they have no disclosures.

SAN DIEGO – Selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants did not increase seizure frequency in a retrospective series of epilepsy patients seen at Rush University Medical Center in Chicago.

The researchers investigated how 84 adult epilepsy patients fared after being put on the drugs for 6 months. None had an increase – and some actually had a decrease – in seizure frequency, and almost all had improvements in their baseline depression and anxiety.

"There’s a long-held misconception that antidepressants have proconvulsive properties," probably because a few older tricyclic antidepressants and bupropion do, said lead investigator Dr. Ramses Ribot, a neurophysiology fellow at Rush.

That concern has carried over to SSRIs and SNRIs, for which there is no evidence of a proseizure effect. As a result, neurologists "are very hesitant to" prescribe the newer agents to epilepsy patients, and depression and anxiety – both common in epilepsy – remain "definitely undertreated," Dr. Ribot said at the annual meeting of the American Epilepsy Society.

Seventy-nine patients in the study were on SSRIs, most commonly escitalopram (Lexapro); the remaining five were taking SNRIs.

Among the 44 who entered the study with fewer than one seizure per month, seizure frequency did not change during antidepressant therapy.

Among the 40 patients who entered with 1-12 seizures per month, seizure frequency was reduced to fewer than one per month in 11 (27.5%) and did not change in 27 (68%). Seizures increased from one per month to two or three in two patients. Overall, 16 (40%) of the 40 patients had a greater than 50% reduction in seizure frequency.

The findings suggest that "these medications could have an anticonvulsant effect" – something that’s been suggested in previous research as well, Dr. Ribot said (Neurology 1995;45:1926-7).

Sixty-one of the 71 patients (86%) for whom psychiatric evaluations were available had improvements or remissions of depression and anxiety symptoms while on antidepressants, a finding that appeared to be independent of seizure frequency.

There were no procedural interventions or changes to antiepileptic drug regimens during the study and the 3 months leading up to it. The patients were over 18 years old, about evenly split between men and women, and clinically diagnosed with depression or anxiety disorders at baseline.

The researchers said that they have no disclosures.

SAN DIEGO – Selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants did not increase seizure frequency in a retrospective series of epilepsy patients seen at Rush University Medical Center in Chicago.

The researchers investigated how 84 adult epilepsy patients fared after being put on the drugs for 6 months. None had an increase – and some actually had a decrease – in seizure frequency, and almost all had improvements in their baseline depression and anxiety.

"There’s a long-held misconception that antidepressants have proconvulsive properties," probably because a few older tricyclic antidepressants and bupropion do, said lead investigator Dr. Ramses Ribot, a neurophysiology fellow at Rush.

That concern has carried over to SSRIs and SNRIs, for which there is no evidence of a proseizure effect. As a result, neurologists "are very hesitant to" prescribe the newer agents to epilepsy patients, and depression and anxiety – both common in epilepsy – remain "definitely undertreated," Dr. Ribot said at the annual meeting of the American Epilepsy Society.

Seventy-nine patients in the study were on SSRIs, most commonly escitalopram (Lexapro); the remaining five were taking SNRIs.

Among the 44 who entered the study with fewer than one seizure per month, seizure frequency did not change during antidepressant therapy.

Among the 40 patients who entered with 1-12 seizures per month, seizure frequency was reduced to fewer than one per month in 11 (27.5%) and did not change in 27 (68%). Seizures increased from one per month to two or three in two patients. Overall, 16 (40%) of the 40 patients had a greater than 50% reduction in seizure frequency.

The findings suggest that "these medications could have an anticonvulsant effect" – something that’s been suggested in previous research as well, Dr. Ribot said (Neurology 1995;45:1926-7).

Sixty-one of the 71 patients (86%) for whom psychiatric evaluations were available had improvements or remissions of depression and anxiety symptoms while on antidepressants, a finding that appeared to be independent of seizure frequency.

There were no procedural interventions or changes to antiepileptic drug regimens during the study and the 3 months leading up to it. The patients were over 18 years old, about evenly split between men and women, and clinically diagnosed with depression or anxiety disorders at baseline.

The researchers said that they have no disclosures.

SAN DIEGO – Selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants did not increase seizure frequency in a retrospective series of epilepsy patients seen at Rush University Medical Center in Chicago.

The researchers investigated how 84 adult epilepsy patients fared after being put on the drugs for 6 months. None had an increase – and some actually had a decrease – in seizure frequency, and almost all had improvements in their baseline depression and anxiety.

"There’s a long-held misconception that antidepressants have proconvulsive properties," probably because a few older tricyclic antidepressants and bupropion do, said lead investigator Dr. Ramses Ribot, a neurophysiology fellow at Rush.

That concern has carried over to SSRIs and SNRIs, for which there is no evidence of a proseizure effect. As a result, neurologists "are very hesitant to" prescribe the newer agents to epilepsy patients, and depression and anxiety – both common in epilepsy – remain "definitely undertreated," Dr. Ribot said at the annual meeting of the American Epilepsy Society.

Seventy-nine patients in the study were on SSRIs, most commonly escitalopram (Lexapro); the remaining five were taking SNRIs.

Among the 44 who entered the study with fewer than one seizure per month, seizure frequency did not change during antidepressant therapy.

Among the 40 patients who entered with 1-12 seizures per month, seizure frequency was reduced to fewer than one per month in 11 (27.5%) and did not change in 27 (68%). Seizures increased from one per month to two or three in two patients. Overall, 16 (40%) of the 40 patients had a greater than 50% reduction in seizure frequency.

The findings suggest that "these medications could have an anticonvulsant effect" – something that’s been suggested in previous research as well, Dr. Ribot said (Neurology 1995;45:1926-7).

Sixty-one of the 71 patients (86%) for whom psychiatric evaluations were available had improvements or remissions of depression and anxiety symptoms while on antidepressants, a finding that appeared to be independent of seizure frequency.

There were no procedural interventions or changes to antiepileptic drug regimens during the study and the 3 months leading up to it. The patients were over 18 years old, about evenly split between men and women, and clinically diagnosed with depression or anxiety disorders at baseline.

The researchers said that they have no disclosures.

SAN DIEGO – Patients who have been newly diagnosed with psychogenic nonepileptic seizures probably benefit from counseling and group therapy sessions before being referred to psychiatrists for treatment of their underlying mental health problem.

That’s what researchers from the Baylor College of Medicine in Houston found when they compared outcomes for 16 patients immediately referred to mental health services following diagnosis – the standard practice – with 19 others who had three educational group sessions beforehand where they learned about their condition and shared coping strategies.

Following their sessions, support group patients were more likely than were control group patients to agree that "my attacks do not really bother me or affect my life that much anymore" (P less than .001) and that "I have some control over my attacks" (P = .003). Perhaps most tellingly, patients in the treatment group were significantly less likely to return to the emergency department 3 months later (7% vs. 22%, P = .018).

"Clearly what we are seeing is that these patients need significant follow-up, perhaps with a neurologist rather than simply a mental health professional. Psychiatrists don’t feel comfortable addressing this issue; having a team approach with both a neurologist and a psychiatrist probably gives the best outcomes," lead investigator Dr. Atul Maheshwari of the department of neurology at Baylor said at the annual meeting of the American Epilepsy Society.

The patients in the randomized study were adults, mostly male, and had at least one seizure per week. They were diagnosed with psychogenic nonepileptic events (PNEE) in the epilepsy monitoring unit of Houston Veterans Affairs Medical Center, where the study was conducted. Psychiatric problems included depression, posttraumatic stress disorder, and childhood abuse.

The diagnosis of PNEE is often a hard blow to patients convinced that they have epilepsy or a brain tumor and feel like doctors aren’t taking them seriously; accepting that their seizures are caused by underlying psychiatric stress is difficult, Dr. Maheshwari said.

A nurse practitioner led the group sessions with talking points and instructions from a neurologist. "The first session helped [patients] understand [that] PNEE are nonpathologic, don’t cause the brain to be fried or cause long-term brain damage, but still require treatment. They were also shown videos of what PNEE look like and what epileptic seizures look like so they could better understand what’s going on. [Ultimately,] the goal was to take away the negative associations people have with the diagnosis," Dr. Maheshwari said.

"Subsequent sessions focused on finding constructive channels for stress release, focusing on the idea that [PNEE] are manifestations of inner-stress. Patients were allowed to discuss what strategies they found helpful. Peer-to-peer acceptance and evaluation helps," Dr. Maheshwari said.

Identification of triggers, including those for PTSD, was key, Dr. Maheshwari said. "For some people, [that means] identifying the aura so they can use stress-release strategies to avoid the seizure. It’s helpful to share those things with other people who have the same symptoms so they can appreciate they are not alone."

He cautioned that research is ongoing and the trial’s results are preliminary. Also, more people in the treatment group were married. Dr. Maheshwari noted that "we didn’t help out with the frequency and intensity of events, but there were significant improvements in patients’ perceptions of the problem" and quality of life.

Dr. Maheshwari said that he had no relevant disclosures.

SAN DIEGO – Patients who have been newly diagnosed with psychogenic nonepileptic seizures probably benefit from counseling and group therapy sessions before being referred to psychiatrists for treatment of their underlying mental health problem.

That’s what researchers from the Baylor College of Medicine in Houston found when they compared outcomes for 16 patients immediately referred to mental health services following diagnosis – the standard practice – with 19 others who had three educational group sessions beforehand where they learned about their condition and shared coping strategies.

Following their sessions, support group patients were more likely than were control group patients to agree that "my attacks do not really bother me or affect my life that much anymore" (P less than .001) and that "I have some control over my attacks" (P = .003). Perhaps most tellingly, patients in the treatment group were significantly less likely to return to the emergency department 3 months later (7% vs. 22%, P = .018).

"Clearly what we are seeing is that these patients need significant follow-up, perhaps with a neurologist rather than simply a mental health professional. Psychiatrists don’t feel comfortable addressing this issue; having a team approach with both a neurologist and a psychiatrist probably gives the best outcomes," lead investigator Dr. Atul Maheshwari of the department of neurology at Baylor said at the annual meeting of the American Epilepsy Society.

The patients in the randomized study were adults, mostly male, and had at least one seizure per week. They were diagnosed with psychogenic nonepileptic events (PNEE) in the epilepsy monitoring unit of Houston Veterans Affairs Medical Center, where the study was conducted. Psychiatric problems included depression, posttraumatic stress disorder, and childhood abuse.

The diagnosis of PNEE is often a hard blow to patients convinced that they have epilepsy or a brain tumor and feel like doctors aren’t taking them seriously; accepting that their seizures are caused by underlying psychiatric stress is difficult, Dr. Maheshwari said.

A nurse practitioner led the group sessions with talking points and instructions from a neurologist. "The first session helped [patients] understand [that] PNEE are nonpathologic, don’t cause the brain to be fried or cause long-term brain damage, but still require treatment. They were also shown videos of what PNEE look like and what epileptic seizures look like so they could better understand what’s going on. [Ultimately,] the goal was to take away the negative associations people have with the diagnosis," Dr. Maheshwari said.

"Subsequent sessions focused on finding constructive channels for stress release, focusing on the idea that [PNEE] are manifestations of inner-stress. Patients were allowed to discuss what strategies they found helpful. Peer-to-peer acceptance and evaluation helps," Dr. Maheshwari said.

Identification of triggers, including those for PTSD, was key, Dr. Maheshwari said. "For some people, [that means] identifying the aura so they can use stress-release strategies to avoid the seizure. It’s helpful to share those things with other people who have the same symptoms so they can appreciate they are not alone."

He cautioned that research is ongoing and the trial’s results are preliminary. Also, more people in the treatment group were married. Dr. Maheshwari noted that "we didn’t help out with the frequency and intensity of events, but there were significant improvements in patients’ perceptions of the problem" and quality of life.

Dr. Maheshwari said that he had no relevant disclosures.

SAN DIEGO – Patients who have been newly diagnosed with psychogenic nonepileptic seizures probably benefit from counseling and group therapy sessions before being referred to psychiatrists for treatment of their underlying mental health problem.

That’s what researchers from the Baylor College of Medicine in Houston found when they compared outcomes for 16 patients immediately referred to mental health services following diagnosis – the standard practice – with 19 others who had three educational group sessions beforehand where they learned about their condition and shared coping strategies.

Following their sessions, support group patients were more likely than were control group patients to agree that "my attacks do not really bother me or affect my life that much anymore" (P less than .001) and that "I have some control over my attacks" (P = .003). Perhaps most tellingly, patients in the treatment group were significantly less likely to return to the emergency department 3 months later (7% vs. 22%, P = .018).

"Clearly what we are seeing is that these patients need significant follow-up, perhaps with a neurologist rather than simply a mental health professional. Psychiatrists don’t feel comfortable addressing this issue; having a team approach with both a neurologist and a psychiatrist probably gives the best outcomes," lead investigator Dr. Atul Maheshwari of the department of neurology at Baylor said at the annual meeting of the American Epilepsy Society.

The patients in the randomized study were adults, mostly male, and had at least one seizure per week. They were diagnosed with psychogenic nonepileptic events (PNEE) in the epilepsy monitoring unit of Houston Veterans Affairs Medical Center, where the study was conducted. Psychiatric problems included depression, posttraumatic stress disorder, and childhood abuse.

The diagnosis of PNEE is often a hard blow to patients convinced that they have epilepsy or a brain tumor and feel like doctors aren’t taking them seriously; accepting that their seizures are caused by underlying psychiatric stress is difficult, Dr. Maheshwari said.

A nurse practitioner led the group sessions with talking points and instructions from a neurologist. "The first session helped [patients] understand [that] PNEE are nonpathologic, don’t cause the brain to be fried or cause long-term brain damage, but still require treatment. They were also shown videos of what PNEE look like and what epileptic seizures look like so they could better understand what’s going on. [Ultimately,] the goal was to take away the negative associations people have with the diagnosis," Dr. Maheshwari said.

"Subsequent sessions focused on finding constructive channels for stress release, focusing on the idea that [PNEE] are manifestations of inner-stress. Patients were allowed to discuss what strategies they found helpful. Peer-to-peer acceptance and evaluation helps," Dr. Maheshwari said.

Identification of triggers, including those for PTSD, was key, Dr. Maheshwari said. "For some people, [that means] identifying the aura so they can use stress-release strategies to avoid the seizure. It’s helpful to share those things with other people who have the same symptoms so they can appreciate they are not alone."

He cautioned that research is ongoing and the trial’s results are preliminary. Also, more people in the treatment group were married. Dr. Maheshwari noted that "we didn’t help out with the frequency and intensity of events, but there were significant improvements in patients’ perceptions of the problem" and quality of life.

Dr. Maheshwari said that he had no relevant disclosures.

SAN DIEGO – The women who were most likely to be on older antiepileptic drugs were the least likely to be counseled about the dangers those drugs pose to bone health in a retrospective study of 756 women with epilepsy.

Being uninsured or having Medicaid coverage was associated with about 50% lower odds for receiving counseling for bone health among women on phenytoin, carbamazepine, or phenobarbital – older antiepileptic drugs that are known to increase bone turnover and cause other bone issues that are especially problematic for women – investigator and second-year medical student Katie Paniszyn reported at the annual meeting of the American Epilepsy Society.

"This is a big problem. You have this huge discrepancy between who’s being prescribed these medications and who’s being counseled. Privately insured patients were less likely to be on these drugs, but more likely to get proper counseling when they were," said Ms. Paniszyn of Brown University, Providence, R.I.

She and her colleagues identified 756 female patients with epilepsy aged 11-60 years who were seen in 2010 at the outpatient academic neurology clinics affiliated with Hasbro Children’s Hospital and Rhode Island Hospital. They analyzed the patients’ clinical notes from 2005 to 2010.

The older antiepileptic drugs were more commonly used in uninsured patients (39 of 59, 66%) and those on Medicaid (52 of 103, 50%) and Medicare (42 of 85, 49%), compared with privately insured women (147 of 509, 29%). That’s not surprising because, as generics, they are more affordable to people with limited income.

What was surprising, however, was that uninsured and Medicaid patients were about half as likely to be encouraged to do weight-bearing exercises, have regular bone density scans, and take vitamin D and calcium supplements while taking the drugs. Bone health counseling was noted in the charts of 64% of Medicare (27 of 42) and 62% of privately insured patients (91 of 147), but in only 31% of Medicaid (16 of 52) and 36% of uninsured patients (14 of 39) (P less than .001). Epilepsy specialists were more likely to provide bone-health counseling than were general neurologists.

The reason for the discrepancy isn’t clear, but could have something to do with the fact that uninsured and Medicaid patients made fewer visits to the neurology clinic so that there were fewer opportunities to counsel them. Advice about compliance and more immediate side effects may have taken precedence, she said.

Whatever the reason is for the discrepancy, the investigators plan to add a flag to their electronic medical record system to remind clinicians about bone health counseling when they prescribe phenytoin, carbamazepine, or phenobarbital. Even "if someone only comes in once or twice, hopefully that will trigger counseling," she said.

While more than half of the women in the study spoke English, many spoke other languages. Because of that, the investigators also plan to print bone health brochures for epilepsy patients in several languages.

Ms. Paniszyn said she had no relevant financial disclosures.

SAN DIEGO – The women who were most likely to be on older antiepileptic drugs were the least likely to be counseled about the dangers those drugs pose to bone health in a retrospective study of 756 women with epilepsy.

Being uninsured or having Medicaid coverage was associated with about 50% lower odds for receiving counseling for bone health among women on phenytoin, carbamazepine, or phenobarbital – older antiepileptic drugs that are known to increase bone turnover and cause other bone issues that are especially problematic for women – investigator and second-year medical student Katie Paniszyn reported at the annual meeting of the American Epilepsy Society.

"This is a big problem. You have this huge discrepancy between who’s being prescribed these medications and who’s being counseled. Privately insured patients were less likely to be on these drugs, but more likely to get proper counseling when they were," said Ms. Paniszyn of Brown University, Providence, R.I.

She and her colleagues identified 756 female patients with epilepsy aged 11-60 years who were seen in 2010 at the outpatient academic neurology clinics affiliated with Hasbro Children’s Hospital and Rhode Island Hospital. They analyzed the patients’ clinical notes from 2005 to 2010.

The older antiepileptic drugs were more commonly used in uninsured patients (39 of 59, 66%) and those on Medicaid (52 of 103, 50%) and Medicare (42 of 85, 49%), compared with privately insured women (147 of 509, 29%). That’s not surprising because, as generics, they are more affordable to people with limited income.

What was surprising, however, was that uninsured and Medicaid patients were about half as likely to be encouraged to do weight-bearing exercises, have regular bone density scans, and take vitamin D and calcium supplements while taking the drugs. Bone health counseling was noted in the charts of 64% of Medicare (27 of 42) and 62% of privately insured patients (91 of 147), but in only 31% of Medicaid (16 of 52) and 36% of uninsured patients (14 of 39) (P less than .001). Epilepsy specialists were more likely to provide bone-health counseling than were general neurologists.

The reason for the discrepancy isn’t clear, but could have something to do with the fact that uninsured and Medicaid patients made fewer visits to the neurology clinic so that there were fewer opportunities to counsel them. Advice about compliance and more immediate side effects may have taken precedence, she said.

Whatever the reason is for the discrepancy, the investigators plan to add a flag to their electronic medical record system to remind clinicians about bone health counseling when they prescribe phenytoin, carbamazepine, or phenobarbital. Even "if someone only comes in once or twice, hopefully that will trigger counseling," she said.

While more than half of the women in the study spoke English, many spoke other languages. Because of that, the investigators also plan to print bone health brochures for epilepsy patients in several languages.

Ms. Paniszyn said she had no relevant financial disclosures.

SAN DIEGO – The women who were most likely to be on older antiepileptic drugs were the least likely to be counseled about the dangers those drugs pose to bone health in a retrospective study of 756 women with epilepsy.

Being uninsured or having Medicaid coverage was associated with about 50% lower odds for receiving counseling for bone health among women on phenytoin, carbamazepine, or phenobarbital – older antiepileptic drugs that are known to increase bone turnover and cause other bone issues that are especially problematic for women – investigator and second-year medical student Katie Paniszyn reported at the annual meeting of the American Epilepsy Society.

"This is a big problem. You have this huge discrepancy between who’s being prescribed these medications and who’s being counseled. Privately insured patients were less likely to be on these drugs, but more likely to get proper counseling when they were," said Ms. Paniszyn of Brown University, Providence, R.I.

She and her colleagues identified 756 female patients with epilepsy aged 11-60 years who were seen in 2010 at the outpatient academic neurology clinics affiliated with Hasbro Children’s Hospital and Rhode Island Hospital. They analyzed the patients’ clinical notes from 2005 to 2010.

The older antiepileptic drugs were more commonly used in uninsured patients (39 of 59, 66%) and those on Medicaid (52 of 103, 50%) and Medicare (42 of 85, 49%), compared with privately insured women (147 of 509, 29%). That’s not surprising because, as generics, they are more affordable to people with limited income.

What was surprising, however, was that uninsured and Medicaid patients were about half as likely to be encouraged to do weight-bearing exercises, have regular bone density scans, and take vitamin D and calcium supplements while taking the drugs. Bone health counseling was noted in the charts of 64% of Medicare (27 of 42) and 62% of privately insured patients (91 of 147), but in only 31% of Medicaid (16 of 52) and 36% of uninsured patients (14 of 39) (P less than .001). Epilepsy specialists were more likely to provide bone-health counseling than were general neurologists.

The reason for the discrepancy isn’t clear, but could have something to do with the fact that uninsured and Medicaid patients made fewer visits to the neurology clinic so that there were fewer opportunities to counsel them. Advice about compliance and more immediate side effects may have taken precedence, she said.

Whatever the reason is for the discrepancy, the investigators plan to add a flag to their electronic medical record system to remind clinicians about bone health counseling when they prescribe phenytoin, carbamazepine, or phenobarbital. Even "if someone only comes in once or twice, hopefully that will trigger counseling," she said.

While more than half of the women in the study spoke English, many spoke other languages. Because of that, the investigators also plan to print bone health brochures for epilepsy patients in several languages.

Ms. Paniszyn said she had no relevant financial disclosures.

LAS VEGAS – Acne patients need to know it’s a bad idea to spot-treat comedones with topical retinoids, according to Dr. Linda F. Stein Gold.

"We have to educate our patients that if they spot treat, they’re going to have acne indefinitely until their body decides it’s done having acne," she said. "You have to educate them that they have to treat the entire acne-prone area and [keep treating it] to maintain remission. Their skin may look clear, but they are not cured."

Topical retinoids remain the gold standard for acne treatment. They clear and prevent comedones, help clindamycin and other antibiotics penetrate the skin, and calm inflammation, which is probably the initial step in acne’s development, noted Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit.

Microsphere and micronized tretinoin gel formulations are less irritating than generic topical tretinoin, and they’re less apt to be deactivated by benzoyl peroxide and ultraviolet light, she said at SDEF Las Vegas Dermatology Seminar.

One of the newer topicals combines benzoyl peroxide and a retinoid stable in its presence, adapalene. One study found about a 70% reduction in lesions after 4 months of use (J. Drugs Dermatol. 2007;6:899-905). With that topical combination and other acne treatments, patients should be told that it may take a while to see maximal improvements, she said.

With any retinoid treatment, patients should also expect flare-ups of redness, irritation, and dryness in the first 2 weeks. "If I’m concerned about irritation, I’ll ask them to go every other night for the first 2 weeks until they adjust to the medication, and then titrate up to every night," Dr. Stein Gold noted. "I also have them use a moisturizer and general cleanser." But she tells them not to use facial scrubs, because scrubbing does "more harm than good."

Benzoil peroxide also remains important, either alone or in combination, because Propionibacterium acnes bacteria do not develop resistance to it, and it helps prevent resistance when used with antibiotics.

"You get a nice reduction both in inflammatory and noninflammatory lesions with benzoil peroxide," she said, but patients should be warned about possible skin bleaching.

The concentration of benzoyl peroxide isn’t that important, Dr. Stein Gold explained. "We know that 2.5% and 10% gels have fairly similar efficacy," she added (Int. J. Dermatol. 1986;25:664-7).

Benzoil peroxide gels are known to work well, although foams and cleansers are available for patients who find them too irritating. Cleansers appear most effective at reducing P. acnes on the face, as long as patients wait 20 seconds before rinsing. One study found foams effective on the back when massaged into dry skin for 20 seconds and patients waited 2 minutes before showering (J. Drugs Dermatol. 2012;11:830-3).

Whatever the treatment, Dr. Stein Gold noted, "stress compliance. My first question is, ‘Did you get a chance to fill your medicine?’ and then, ‘How many times do you think you got a chance to use it?’ "

She cautioned physicians to "have no expectations" – that way, patients won’t be afraid to admit that they only used it once or twice. Whatever their usage, "you say, ‘Great. Good for you. Keep on going.’ "

In addition, "the simpler you make the regimen, the more likely it is your patients are going to" stick with it, Dr. Stein Gold explained.

Dr. Stein Gold is a consultant or researcher for Galderma, Leo, Medicis, Novartis, and Stiefel. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients need to know it’s a bad idea to spot-treat comedones with topical retinoids, according to Dr. Linda F. Stein Gold.

"We have to educate our patients that if they spot treat, they’re going to have acne indefinitely until their body decides it’s done having acne," she said. "You have to educate them that they have to treat the entire acne-prone area and [keep treating it] to maintain remission. Their skin may look clear, but they are not cured."

Topical retinoids remain the gold standard for acne treatment. They clear and prevent comedones, help clindamycin and other antibiotics penetrate the skin, and calm inflammation, which is probably the initial step in acne’s development, noted Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit.

Microsphere and micronized tretinoin gel formulations are less irritating than generic topical tretinoin, and they’re less apt to be deactivated by benzoyl peroxide and ultraviolet light, she said at SDEF Las Vegas Dermatology Seminar.

One of the newer topicals combines benzoyl peroxide and a retinoid stable in its presence, adapalene. One study found about a 70% reduction in lesions after 4 months of use (J. Drugs Dermatol. 2007;6:899-905). With that topical combination and other acne treatments, patients should be told that it may take a while to see maximal improvements, she said.

With any retinoid treatment, patients should also expect flare-ups of redness, irritation, and dryness in the first 2 weeks. "If I’m concerned about irritation, I’ll ask them to go every other night for the first 2 weeks until they adjust to the medication, and then titrate up to every night," Dr. Stein Gold noted. "I also have them use a moisturizer and general cleanser." But she tells them not to use facial scrubs, because scrubbing does "more harm than good."

Benzoil peroxide also remains important, either alone or in combination, because Propionibacterium acnes bacteria do not develop resistance to it, and it helps prevent resistance when used with antibiotics.

"You get a nice reduction both in inflammatory and noninflammatory lesions with benzoil peroxide," she said, but patients should be warned about possible skin bleaching.

The concentration of benzoyl peroxide isn’t that important, Dr. Stein Gold explained. "We know that 2.5% and 10% gels have fairly similar efficacy," she added (Int. J. Dermatol. 1986;25:664-7).

Benzoil peroxide gels are known to work well, although foams and cleansers are available for patients who find them too irritating. Cleansers appear most effective at reducing P. acnes on the face, as long as patients wait 20 seconds before rinsing. One study found foams effective on the back when massaged into dry skin for 20 seconds and patients waited 2 minutes before showering (J. Drugs Dermatol. 2012;11:830-3).

Whatever the treatment, Dr. Stein Gold noted, "stress compliance. My first question is, ‘Did you get a chance to fill your medicine?’ and then, ‘How many times do you think you got a chance to use it?’ "

She cautioned physicians to "have no expectations" – that way, patients won’t be afraid to admit that they only used it once or twice. Whatever their usage, "you say, ‘Great. Good for you. Keep on going.’ "

In addition, "the simpler you make the regimen, the more likely it is your patients are going to" stick with it, Dr. Stein Gold explained.

Dr. Stein Gold is a consultant or researcher for Galderma, Leo, Medicis, Novartis, and Stiefel. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients need to know it’s a bad idea to spot-treat comedones with topical retinoids, according to Dr. Linda F. Stein Gold.

"We have to educate our patients that if they spot treat, they’re going to have acne indefinitely until their body decides it’s done having acne," she said. "You have to educate them that they have to treat the entire acne-prone area and [keep treating it] to maintain remission. Their skin may look clear, but they are not cured."

Topical retinoids remain the gold standard for acne treatment. They clear and prevent comedones, help clindamycin and other antibiotics penetrate the skin, and calm inflammation, which is probably the initial step in acne’s development, noted Dr. Stein Gold, director of dermatology research at Henry Ford Hospital, Detroit.

Microsphere and micronized tretinoin gel formulations are less irritating than generic topical tretinoin, and they’re less apt to be deactivated by benzoyl peroxide and ultraviolet light, she said at SDEF Las Vegas Dermatology Seminar.

One of the newer topicals combines benzoyl peroxide and a retinoid stable in its presence, adapalene. One study found about a 70% reduction in lesions after 4 months of use (J. Drugs Dermatol. 2007;6:899-905). With that topical combination and other acne treatments, patients should be told that it may take a while to see maximal improvements, she said.

With any retinoid treatment, patients should also expect flare-ups of redness, irritation, and dryness in the first 2 weeks. "If I’m concerned about irritation, I’ll ask them to go every other night for the first 2 weeks until they adjust to the medication, and then titrate up to every night," Dr. Stein Gold noted. "I also have them use a moisturizer and general cleanser." But she tells them not to use facial scrubs, because scrubbing does "more harm than good."

Benzoil peroxide also remains important, either alone or in combination, because Propionibacterium acnes bacteria do not develop resistance to it, and it helps prevent resistance when used with antibiotics.

"You get a nice reduction both in inflammatory and noninflammatory lesions with benzoil peroxide," she said, but patients should be warned about possible skin bleaching.

The concentration of benzoyl peroxide isn’t that important, Dr. Stein Gold explained. "We know that 2.5% and 10% gels have fairly similar efficacy," she added (Int. J. Dermatol. 1986;25:664-7).

Benzoil peroxide gels are known to work well, although foams and cleansers are available for patients who find them too irritating. Cleansers appear most effective at reducing P. acnes on the face, as long as patients wait 20 seconds before rinsing. One study found foams effective on the back when massaged into dry skin for 20 seconds and patients waited 2 minutes before showering (J. Drugs Dermatol. 2012;11:830-3).

Whatever the treatment, Dr. Stein Gold noted, "stress compliance. My first question is, ‘Did you get a chance to fill your medicine?’ and then, ‘How many times do you think you got a chance to use it?’ "

She cautioned physicians to "have no expectations" – that way, patients won’t be afraid to admit that they only used it once or twice. Whatever their usage, "you say, ‘Great. Good for you. Keep on going.’ "

In addition, "the simpler you make the regimen, the more likely it is your patients are going to" stick with it, Dr. Stein Gold explained.

Dr. Stein Gold is a consultant or researcher for Galderma, Leo, Medicis, Novartis, and Stiefel. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients treated with oral antibiotics don’t necessarily need to stay on them for more than 3 months, according to Dr. Joshua Zeichner.

"Even if you are initially treating them with an oral antibiotic for severe acne, you can maintain them after about 12 weeks just on a topical therapy like tazarotene, explained Dr. Zeichner, director of cosmetic and clinical research in the dermatology department at Mt. Sinai Medical Center in New York. "You don’t necessarily need to keep your patients on oral antibiotics for long periods of time."

To prevent resistance and other problems, "try to limit use to about 3 months, and think about maintenance using just a topical therapy," he said at the Las Vegas Dermatology seminar, sponsored by the Skin Disease Education Foundation.

Several studies prove the point. In one, 189 patients with severe acne received 0.1% tazarotene gel each evening and 100 mg minocycline twice daily for 12 weeks. The 110 (58%) with at least a 75% global improvement were then assigned to 12 weeks of maintenance with tazarotene gel, minocycline, or tazarotene plus minocycline.

Keeping the antibiotic onboard past 12 weeks made no difference. All three groups – including the tazarotene-only group – did equally well. At week 24, more than 80% of the patients had at least a 50% global improvement from baseline, and 50% had at least a 75% improvement (Arch. Dermatol. 2006;142:605-12).

In his own practice, Dr. Zeichner said he often puts patients on oral antibiotics with topical therapies while they wait a month for their oral isotretinoin prescriptions to come through. "There are a lot of cases where patients don’t even end up going on isotretinoin because they are doing well," he said.

The approach also offers an alternative for severe acne patients who, for whatever reason, can’t take isotretinoin.

Another combination that’s been shown to work is minocycline extended release (Solodyn) about 1 mg/kg daily, daily clindamycin phosphate 1.2%/tretinoin 0.025% gel, and benzoil peroxide 6% foaming cloths. There’s an excellent chance isotretinoin candidates will no longer be candidates after 12 weeks of treatment, Dr. Zeichner said.

Some patients will need to stay on oral antibiotics a bit longer than 3 months. Even so, "try to get them off the antibiotic as early as possible. If they flare up again, [you can always] give them another course," he said.

Although the antibiotic may be stopped, Dr. Zeichner cautioned, it’s important to continue topical treatment to keep acne from coming back.

"I’d much rather see women on hormonal-type therapies than on oral antibiotics. I feel it gets a little more to the root of the issue," he noted.

Dr. Zeichner is a consultant, an investigator, or an advisory board member for several pharmaceutical companies, including Allergan, Beiersdorf, Galderma, Medicis, and Valeant. The SDEF and this publication are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients treated with oral antibiotics don’t necessarily need to stay on them for more than 3 months, according to Dr. Joshua Zeichner.

"Even if you are initially treating them with an oral antibiotic for severe acne, you can maintain them after about 12 weeks just on a topical therapy like tazarotene, explained Dr. Zeichner, director of cosmetic and clinical research in the dermatology department at Mt. Sinai Medical Center in New York. "You don’t necessarily need to keep your patients on oral antibiotics for long periods of time."

To prevent resistance and other problems, "try to limit use to about 3 months, and think about maintenance using just a topical therapy," he said at the Las Vegas Dermatology seminar, sponsored by the Skin Disease Education Foundation.

Several studies prove the point. In one, 189 patients with severe acne received 0.1% tazarotene gel each evening and 100 mg minocycline twice daily for 12 weeks. The 110 (58%) with at least a 75% global improvement were then assigned to 12 weeks of maintenance with tazarotene gel, minocycline, or tazarotene plus minocycline.

Keeping the antibiotic onboard past 12 weeks made no difference. All three groups – including the tazarotene-only group – did equally well. At week 24, more than 80% of the patients had at least a 50% global improvement from baseline, and 50% had at least a 75% improvement (Arch. Dermatol. 2006;142:605-12).

In his own practice, Dr. Zeichner said he often puts patients on oral antibiotics with topical therapies while they wait a month for their oral isotretinoin prescriptions to come through. "There are a lot of cases where patients don’t even end up going on isotretinoin because they are doing well," he said.

The approach also offers an alternative for severe acne patients who, for whatever reason, can’t take isotretinoin.

Another combination that’s been shown to work is minocycline extended release (Solodyn) about 1 mg/kg daily, daily clindamycin phosphate 1.2%/tretinoin 0.025% gel, and benzoil peroxide 6% foaming cloths. There’s an excellent chance isotretinoin candidates will no longer be candidates after 12 weeks of treatment, Dr. Zeichner said.

Some patients will need to stay on oral antibiotics a bit longer than 3 months. Even so, "try to get them off the antibiotic as early as possible. If they flare up again, [you can always] give them another course," he said.

Although the antibiotic may be stopped, Dr. Zeichner cautioned, it’s important to continue topical treatment to keep acne from coming back.

"I’d much rather see women on hormonal-type therapies than on oral antibiotics. I feel it gets a little more to the root of the issue," he noted.

Dr. Zeichner is a consultant, an investigator, or an advisory board member for several pharmaceutical companies, including Allergan, Beiersdorf, Galderma, Medicis, and Valeant. The SDEF and this publication are owned by Frontline Medical Communications.

LAS VEGAS – Acne patients treated with oral antibiotics don’t necessarily need to stay on them for more than 3 months, according to Dr. Joshua Zeichner.

"Even if you are initially treating them with an oral antibiotic for severe acne, you can maintain them after about 12 weeks just on a topical therapy like tazarotene, explained Dr. Zeichner, director of cosmetic and clinical research in the dermatology department at Mt. Sinai Medical Center in New York. "You don’t necessarily need to keep your patients on oral antibiotics for long periods of time."

To prevent resistance and other problems, "try to limit use to about 3 months, and think about maintenance using just a topical therapy," he said at the Las Vegas Dermatology seminar, sponsored by the Skin Disease Education Foundation.

Several studies prove the point. In one, 189 patients with severe acne received 0.1% tazarotene gel each evening and 100 mg minocycline twice daily for 12 weeks. The 110 (58%) with at least a 75% global improvement were then assigned to 12 weeks of maintenance with tazarotene gel, minocycline, or tazarotene plus minocycline.

Keeping the antibiotic onboard past 12 weeks made no difference. All three groups – including the tazarotene-only group – did equally well. At week 24, more than 80% of the patients had at least a 50% global improvement from baseline, and 50% had at least a 75% improvement (Arch. Dermatol. 2006;142:605-12).

In his own practice, Dr. Zeichner said he often puts patients on oral antibiotics with topical therapies while they wait a month for their oral isotretinoin prescriptions to come through. "There are a lot of cases where patients don’t even end up going on isotretinoin because they are doing well," he said.

The approach also offers an alternative for severe acne patients who, for whatever reason, can’t take isotretinoin.

Another combination that’s been shown to work is minocycline extended release (Solodyn) about 1 mg/kg daily, daily clindamycin phosphate 1.2%/tretinoin 0.025% gel, and benzoil peroxide 6% foaming cloths. There’s an excellent chance isotretinoin candidates will no longer be candidates after 12 weeks of treatment, Dr. Zeichner said.

Some patients will need to stay on oral antibiotics a bit longer than 3 months. Even so, "try to get them off the antibiotic as early as possible. If they flare up again, [you can always] give them another course," he said.

Although the antibiotic may be stopped, Dr. Zeichner cautioned, it’s important to continue topical treatment to keep acne from coming back.

"I’d much rather see women on hormonal-type therapies than on oral antibiotics. I feel it gets a little more to the root of the issue," he noted.

Dr. Zeichner is a consultant, an investigator, or an advisory board member for several pharmaceutical companies, including Allergan, Beiersdorf, Galderma, Medicis, and Valeant. The SDEF and this publication are owned by Frontline Medical Communications.

LAS VEGAS – Cardiovascular event rates in patients treated with ustekinumab have been found to remain stable over time, according to 5-year follow-up data from the manufacturer.

"The overall safety profile of ustekinumab [Stelara] remained stable in adults with moderate to severe plaque psoriasis receiving up to 5 years of ustekinumab treatment," noted the manufacturer of Stelara, Janssen Pharmaceuticals, in a statement. "There was no dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of overall and targeted adverse events after up to 5 years of treatment."

The cardiovascular safety of the plaque psoriasis treatment has been a concern because early testing detected a slightly higher incidence of events in patients treated with ustekinumab, compared with placebo.

But among 3,117 patients – 838 of whom were on the biologic for 5 years – and after a cumulative total of 8,998 patient-years, the rate of major adverse cardiovascular events (MACEs) held largely steady at 0.47 per 100 patient-years at year 1, 0.44 at year 5, and comparable numbers in between. The data were pooled from one phase II and three phase III trials, with MACE defined as stroke, myocardial infarction, or cardiovascular death.

The MACE rate at 5-year follow-up was 0.56 per 100 patient-years (95% confidence interval, 0.35-0.85) among patients receiving the 45-mg dose of the injectable and 0.36 per 100 patient-years (95% CI, 0.22-0.57) in patients receiving 90 mg.

In comparable 4-year follow-up data, researchers found that MACE and other serious adverse event rates among ustekinumab users "were consistent with those in the general and psoriasis populations" (J. Drugs Dermatol. 2012;11:300-12).

"The cardiovascular events over time seem to be stable," said Dr. Craig Leonardi, of the dermatology department at St. Louis University, who summarized the 5-year findings during a talk about the drug.

Even so, Dr. Leonardi, who presented the study results at a seminar sponsored by Skin Disease Education Foundation (SDEF), said that he remains concerned, noting that follow-up studies select for patients who do well on a drug and have minimal adverse events.

It’s possible that patients susceptible to MACEs – those with preexisting cardiac risk factors or, perhaps, an as-yet unrecognized genetic predisposition – dropped out early due to angina or other problems.

Dr. Leonardi also noted a recent meta-analysis that found a higher risk of MACEs in patients treated with ustekinumab or briakinumab – another interleukin-12/23 antibody no longer under development – compared with those on placebo (J. Eur. Acad. Dermatol. Venereol. 2012 March 8 [doi: 10.1111/j.1468-3083.2012.04500]).

It followed an earlier meta-analysis, conducted by Dr. Leonardi and his colleagues, of 22 trials that found 10 MACEs among 3,179 patients on ustekinumab or briakinumab but none among 1,474 placebo patients (JAMA 2011;306:864-71). Even though the results were not statistically significant, "there was a trend, and we are concerned about it. It seems to correspond to peak levels of the drug. We are awaiting further analysis," Dr. Leonardi said.

There’s "no question [ustekinumab] is a high-performance drug with a durable response," but in the meantime, "I am putting all my ustekinumab patients on aspirin, 81 mg/day," he said.

Patients with multiple cardiovascular risk factors should start with a tumor necrosis factor antagonist instead, according to Dr. Leonardi. "These are drugs with proven cardiovascular friendliness," he added. It is also probably wise to start out with the lower 45-mg dose of ustekinumab when initiating treatment.

Dr. Leonardi is a consultant, investigator, and speaker for Abbott, Amgen, and other companies. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Cardiovascular event rates in patients treated with ustekinumab have been found to remain stable over time, according to 5-year follow-up data from the manufacturer.

"The overall safety profile of ustekinumab [Stelara] remained stable in adults with moderate to severe plaque psoriasis receiving up to 5 years of ustekinumab treatment," noted the manufacturer of Stelara, Janssen Pharmaceuticals, in a statement. "There was no dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of overall and targeted adverse events after up to 5 years of treatment."

The cardiovascular safety of the plaque psoriasis treatment has been a concern because early testing detected a slightly higher incidence of events in patients treated with ustekinumab, compared with placebo.

But among 3,117 patients – 838 of whom were on the biologic for 5 years – and after a cumulative total of 8,998 patient-years, the rate of major adverse cardiovascular events (MACEs) held largely steady at 0.47 per 100 patient-years at year 1, 0.44 at year 5, and comparable numbers in between. The data were pooled from one phase II and three phase III trials, with MACE defined as stroke, myocardial infarction, or cardiovascular death.

The MACE rate at 5-year follow-up was 0.56 per 100 patient-years (95% confidence interval, 0.35-0.85) among patients receiving the 45-mg dose of the injectable and 0.36 per 100 patient-years (95% CI, 0.22-0.57) in patients receiving 90 mg.

In comparable 4-year follow-up data, researchers found that MACE and other serious adverse event rates among ustekinumab users "were consistent with those in the general and psoriasis populations" (J. Drugs Dermatol. 2012;11:300-12).

"The cardiovascular events over time seem to be stable," said Dr. Craig Leonardi, of the dermatology department at St. Louis University, who summarized the 5-year findings during a talk about the drug.

Even so, Dr. Leonardi, who presented the study results at a seminar sponsored by Skin Disease Education Foundation (SDEF), said that he remains concerned, noting that follow-up studies select for patients who do well on a drug and have minimal adverse events.

It’s possible that patients susceptible to MACEs – those with preexisting cardiac risk factors or, perhaps, an as-yet unrecognized genetic predisposition – dropped out early due to angina or other problems.

Dr. Leonardi also noted a recent meta-analysis that found a higher risk of MACEs in patients treated with ustekinumab or briakinumab – another interleukin-12/23 antibody no longer under development – compared with those on placebo (J. Eur. Acad. Dermatol. Venereol. 2012 March 8 [doi: 10.1111/j.1468-3083.2012.04500]).

It followed an earlier meta-analysis, conducted by Dr. Leonardi and his colleagues, of 22 trials that found 10 MACEs among 3,179 patients on ustekinumab or briakinumab but none among 1,474 placebo patients (JAMA 2011;306:864-71). Even though the results were not statistically significant, "there was a trend, and we are concerned about it. It seems to correspond to peak levels of the drug. We are awaiting further analysis," Dr. Leonardi said.

There’s "no question [ustekinumab] is a high-performance drug with a durable response," but in the meantime, "I am putting all my ustekinumab patients on aspirin, 81 mg/day," he said.

Patients with multiple cardiovascular risk factors should start with a tumor necrosis factor antagonist instead, according to Dr. Leonardi. "These are drugs with proven cardiovascular friendliness," he added. It is also probably wise to start out with the lower 45-mg dose of ustekinumab when initiating treatment.

Dr. Leonardi is a consultant, investigator, and speaker for Abbott, Amgen, and other companies. SDEF and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Cardiovascular event rates in patients treated with ustekinumab have been found to remain stable over time, according to 5-year follow-up data from the manufacturer.

"The overall safety profile of ustekinumab [Stelara] remained stable in adults with moderate to severe plaque psoriasis receiving up to 5 years of ustekinumab treatment," noted the manufacturer of Stelara, Janssen Pharmaceuticals, in a statement. "There was no dose-response or cumulative effect of increasing duration of exposure to ustekinumab on the rates of overall and targeted adverse events after up to 5 years of treatment."

The cardiovascular safety of the plaque psoriasis treatment has been a concern because early testing detected a slightly higher incidence of events in patients treated with ustekinumab, compared with placebo.

But among 3,117 patients – 838 of whom were on the biologic for 5 years – and after a cumulative total of 8,998 patient-years, the rate of major adverse cardiovascular events (MACEs) held largely steady at 0.47 per 100 patient-years at year 1, 0.44 at year 5, and comparable numbers in between. The data were pooled from one phase II and three phase III trials, with MACE defined as stroke, myocardial infarction, or cardiovascular death.

The MACE rate at 5-year follow-up was 0.56 per 100 patient-years (95% confidence interval, 0.35-0.85) among patients receiving the 45-mg dose of the injectable and 0.36 per 100 patient-years (95% CI, 0.22-0.57) in patients receiving 90 mg.

In comparable 4-year follow-up data, researchers found that MACE and other serious adverse event rates among ustekinumab users "were consistent with those in the general and psoriasis populations" (J. Drugs Dermatol. 2012;11:300-12).

"The cardiovascular events over time seem to be stable," said Dr. Craig Leonardi, of the dermatology department at St. Louis University, who summarized the 5-year findings during a talk about the drug.

Even so, Dr. Leonardi, who presented the study results at a seminar sponsored by Skin Disease Education Foundation (SDEF), said that he remains concerned, noting that follow-up studies select for patients who do well on a drug and have minimal adverse events.

It’s possible that patients susceptible to MACEs – those with preexisting cardiac risk factors or, perhaps, an as-yet unrecognized genetic predisposition – dropped out early due to angina or other problems.

Dr. Leonardi also noted a recent meta-analysis that found a higher risk of MACEs in patients treated with ustekinumab or briakinumab – another interleukin-12/23 antibody no longer under development – compared with those on placebo (J. Eur. Acad. Dermatol. Venereol. 2012 March 8 [doi: 10.1111/j.1468-3083.2012.04500]).

It followed an earlier meta-analysis, conducted by Dr. Leonardi and his colleagues, of 22 trials that found 10 MACEs among 3,179 patients on ustekinumab or briakinumab but none among 1,474 placebo patients (JAMA 2011;306:864-71). Even though the results were not statistically significant, "there was a trend, and we are concerned about it. It seems to correspond to peak levels of the drug. We are awaiting further analysis," Dr. Leonardi said.

There’s "no question [ustekinumab] is a high-performance drug with a durable response," but in the meantime, "I am putting all my ustekinumab patients on aspirin, 81 mg/day," he said.

Patients with multiple cardiovascular risk factors should start with a tumor necrosis factor antagonist instead, according to Dr. Leonardi. "These are drugs with proven cardiovascular friendliness," he added. It is also probably wise to start out with the lower 45-mg dose of ustekinumab when initiating treatment.

Dr. Leonardi is a consultant, investigator, and speaker for Abbott, Amgen, and other companies. SDEF and this news organization are owned by Frontline Medical Communications.