Robert Finn

In spite of an alarming report earlier this year by the Environmental Working Group, an analysis of human and animal studies found little support for the assertion that sunscreens containing retinyl palmitate cause skin cancer.

In a commentary published online in the Journal of the American Academy of Dermatology, Dr. Steven Q. Wang of Memorial Sloan-Kettering Cancer Center, New York, and his colleagues evaluated the compound from several points of view, and concluded that "there is no convincing evidence" that retinyl palmitate, a form of vitamin A, is carcinogenic in sunscreens (J. Amer. Acad. Dermatol. 2010 [doi:10.1016/j.jaad.2010.07.015]).

In fact, clinical observations spanning over decades suggest that retinoids are helpful in skin cancer chemoprevention, the authors wrote. "Correcting this false impression is an important and necessary step to ensure that the public continues to use sunscreen as a component of photoprotective strategy."

The suggestion by the Environmental Working Group, a nonprofit public health research and advocacy organization, that retinyl palmitate in sunscreens may cause skin cancer garnered widespread media attention, because 41% of sunscreens on the market contain this compound. Retinyl palmitate, an antioxidant, does not directly provide sun protection, but instead is added as a cosmetic ingredient.

Dr. Wang and his colleagues noted that retinyl palmitate and other closely related compounds are natural components of human skin. In 2000, the compound was referred to the National Institutes of Health's National Toxicology Program (NTP) for phototoxicity and photocarcinogenicity testing, along with many other common ingredients such as alpha- and beta-hydroxy acids, aloe vera, and nanoscale titanium dioxide and zinc oxide.

Between 2002 and 2009, the Food and Drug Administration published eight in vitro studies and three animal studies of retinyl palmitate. Several of these studies showed that the combination of retinyl palmitate and UV light induced reactive oxygen species. In addition, an NTP study involving 430 SKH-1 hairless mice examined two concentrations of retinyl palmitate and placebo at three levels of solar radiation.

This study has not been subject to peer review, but some of the data are available online, and Dr. Wang and his colleagues analyzed them. The only statistically significant results were an apparent increase in neoplasms in animals given the higher concentrations (0.5%) of retinyl palmitate at an intermediate level of simulated solar radiation (6.75 mJ/cm²). Higher levels of solar radiation resulted in no significant increase in neoplasms, so the authors concluded that the study failed to provide conclusive evidence indicating that the combination of retinyl palmitate and UV radiation is carcinogenic.

In addition, that study had several limitations, including the fact that the SKH-1 strain of hairless mice is highly susceptible to the development of skin cancer after UV exposure. In fact, at the higher level of solar radiation, 82% of the mice developed malignant skin lesions when given the placebo.

Although no similar studies in humans have been published, Dr. Wang and his colleagues noted that dermatologists have been prescribing various forms of topical retinoids to manage a variety of skin conditions for more than 40 years. While millions of patients have received these compounds, dermatologists have published no evidence suggesting that topical retinoids increase cancer risk.

The authors declared having no conflicts of interest.

In spite of an alarming report earlier this year by the Environmental Working Group, an analysis of human and animal studies found little support for the assertion that sunscreens containing retinyl palmitate cause skin cancer.

In a commentary published online in the Journal of the American Academy of Dermatology, Dr. Steven Q. Wang of Memorial Sloan-Kettering Cancer Center, New York, and his colleagues evaluated the compound from several points of view, and concluded that "there is no convincing evidence" that retinyl palmitate, a form of vitamin A, is carcinogenic in sunscreens (J. Amer. Acad. Dermatol. 2010 [doi:10.1016/j.jaad.2010.07.015]).

In fact, clinical observations spanning over decades suggest that retinoids are helpful in skin cancer chemoprevention, the authors wrote. "Correcting this false impression is an important and necessary step to ensure that the public continues to use sunscreen as a component of photoprotective strategy."

The suggestion by the Environmental Working Group, a nonprofit public health research and advocacy organization, that retinyl palmitate in sunscreens may cause skin cancer garnered widespread media attention, because 41% of sunscreens on the market contain this compound. Retinyl palmitate, an antioxidant, does not directly provide sun protection, but instead is added as a cosmetic ingredient.

Dr. Wang and his colleagues noted that retinyl palmitate and other closely related compounds are natural components of human skin. In 2000, the compound was referred to the National Institutes of Health's National Toxicology Program (NTP) for phototoxicity and photocarcinogenicity testing, along with many other common ingredients such as alpha- and beta-hydroxy acids, aloe vera, and nanoscale titanium dioxide and zinc oxide.

Between 2002 and 2009, the Food and Drug Administration published eight in vitro studies and three animal studies of retinyl palmitate. Several of these studies showed that the combination of retinyl palmitate and UV light induced reactive oxygen species. In addition, an NTP study involving 430 SKH-1 hairless mice examined two concentrations of retinyl palmitate and placebo at three levels of solar radiation.

This study has not been subject to peer review, but some of the data are available online, and Dr. Wang and his colleagues analyzed them. The only statistically significant results were an apparent increase in neoplasms in animals given the higher concentrations (0.5%) of retinyl palmitate at an intermediate level of simulated solar radiation (6.75 mJ/cm²). Higher levels of solar radiation resulted in no significant increase in neoplasms, so the authors concluded that the study failed to provide conclusive evidence indicating that the combination of retinyl palmitate and UV radiation is carcinogenic.

In addition, that study had several limitations, including the fact that the SKH-1 strain of hairless mice is highly susceptible to the development of skin cancer after UV exposure. In fact, at the higher level of solar radiation, 82% of the mice developed malignant skin lesions when given the placebo.

Although no similar studies in humans have been published, Dr. Wang and his colleagues noted that dermatologists have been prescribing various forms of topical retinoids to manage a variety of skin conditions for more than 40 years. While millions of patients have received these compounds, dermatologists have published no evidence suggesting that topical retinoids increase cancer risk.

The authors declared having no conflicts of interest.

In spite of an alarming report earlier this year by the Environmental Working Group, an analysis of human and animal studies found little support for the assertion that sunscreens containing retinyl palmitate cause skin cancer.

In a commentary published online in the Journal of the American Academy of Dermatology, Dr. Steven Q. Wang of Memorial Sloan-Kettering Cancer Center, New York, and his colleagues evaluated the compound from several points of view, and concluded that "there is no convincing evidence" that retinyl palmitate, a form of vitamin A, is carcinogenic in sunscreens (J. Amer. Acad. Dermatol. 2010 [doi:10.1016/j.jaad.2010.07.015]).

In fact, clinical observations spanning over decades suggest that retinoids are helpful in skin cancer chemoprevention, the authors wrote. "Correcting this false impression is an important and necessary step to ensure that the public continues to use sunscreen as a component of photoprotective strategy."

The suggestion by the Environmental Working Group, a nonprofit public health research and advocacy organization, that retinyl palmitate in sunscreens may cause skin cancer garnered widespread media attention, because 41% of sunscreens on the market contain this compound. Retinyl palmitate, an antioxidant, does not directly provide sun protection, but instead is added as a cosmetic ingredient.

Dr. Wang and his colleagues noted that retinyl palmitate and other closely related compounds are natural components of human skin. In 2000, the compound was referred to the National Institutes of Health's National Toxicology Program (NTP) for phototoxicity and photocarcinogenicity testing, along with many other common ingredients such as alpha- and beta-hydroxy acids, aloe vera, and nanoscale titanium dioxide and zinc oxide.

Between 2002 and 2009, the Food and Drug Administration published eight in vitro studies and three animal studies of retinyl palmitate. Several of these studies showed that the combination of retinyl palmitate and UV light induced reactive oxygen species. In addition, an NTP study involving 430 SKH-1 hairless mice examined two concentrations of retinyl palmitate and placebo at three levels of solar radiation.

This study has not been subject to peer review, but some of the data are available online, and Dr. Wang and his colleagues analyzed them. The only statistically significant results were an apparent increase in neoplasms in animals given the higher concentrations (0.5%) of retinyl palmitate at an intermediate level of simulated solar radiation (6.75 mJ/cm²). Higher levels of solar radiation resulted in no significant increase in neoplasms, so the authors concluded that the study failed to provide conclusive evidence indicating that the combination of retinyl palmitate and UV radiation is carcinogenic.

In addition, that study had several limitations, including the fact that the SKH-1 strain of hairless mice is highly susceptible to the development of skin cancer after UV exposure. In fact, at the higher level of solar radiation, 82% of the mice developed malignant skin lesions when given the placebo.

Although no similar studies in humans have been published, Dr. Wang and his colleagues noted that dermatologists have been prescribing various forms of topical retinoids to manage a variety of skin conditions for more than 40 years. While millions of patients have received these compounds, dermatologists have published no evidence suggesting that topical retinoids increase cancer risk.

The authors declared having no conflicts of interest.

Ablative fractional resurfacing appears to be safe and effective in Asians with mild to moderate atrophic acne scarring, according to a study of 13 patients.

While 12 of the 13 patients experienced some postinflammatory hyperpigmentation, this resolved in all patients in an average of 5 weeks.

The Asian patients underwent three sessions of ablative fractional resurfacing (AFR) with the Ellipse Juvia 15-W CO2 laser, wrote Dr. Woraphong Manuskiatti and colleagues of Mahidol University, Bangkok. All patients had skin phototype IV. Intervals between treatments averaged 7 weeks. All patients were followed for 6 months after the third treatment.

Independent physicians blinded to the order in which clinical photos had been taken judged the improvement in scarring to be excellent in 8% of the patients, good in 38.5% of them, fair in 38.5%, and slight in 15%. None of the patients worsened (J. Am. Acad. Dermatol. 2010;63:274-83).

By the patients’ own evaluations, 46% judged their overall improvement to be fair, 23% judged it to be good, and 31% judged it to be excellent. In both physician and patient evaluations, “slight” was defined as less than 25% improvement, “fair” as 25%-50% improvement, good as 51%-75% improvement, and excellent as 76%-100% improvement.

Postinflammatory hyperpigmentation (PIH) was the most common side effect, seen in 12 of the 13 (92%) patients and after 20 of the 39 (51%) treatment sessions. All cases of PIH were graded as mild except for one that was graded as moderate. After treatment with 4% hydroquinone cream once daily, PIH resolved in all patients within 2-16 weeks (average 5 weeks).

Other adverse events were acneiform eruptions in four patients, allergic contact dermatitis in two patients, and herpes simplex infection in one patient.

Each treatment consisted of a full-face single-pass treatment with a 5-7 ms pulse width. Investigators adjusted the laser to deliver 49 microthermal zones (MTZs) per square centimeter, with each individual MTZ 500 mcm in diameter. The average percent coverage was 9.6%, and the investigators set the laser to deliver energies between 75-105 mJ/MTZ depending on the severity of scarring.

Although physicians prepared the patients for 1 hour before each treatment with a topical anesthetic applied to the full face with occlusion, on average patients rated their pain as 8.1 on a scale of 1-10. Pain scores tended to decrease for the second and third treatments.

The investigators described AFR as offering a treatment alternative midway between nonablative fractional resurfacing (NAFR) and fractional photothermolysis (FP). “Although NAFR has a patient-friendly advantage,” the investigators wrote, “the outcomes of most NAFR lasers still leave much to be desired in the treatment of photodamaged skin, rhytides, and atrophic scars. ... By depositing a pixelated pattern of microscopic ablative wounds surrounded by healthy tissue in a manner similar to that of [the] NAFR method, AFR combines the increased efficacy of ablative techniques with the safety and reduced downtime associated with FP.”

The investigators declared that they had no conflicts of interest. The study was supported by a research grant from Ellipse A/S, which manufactures the laser used in the study.

Ablative fractional resurfacing appears to be safe and effective in Asians with mild to moderate atrophic acne scarring, according to a study of 13 patients.

While 12 of the 13 patients experienced some postinflammatory hyperpigmentation, this resolved in all patients in an average of 5 weeks.

The Asian patients underwent three sessions of ablative fractional resurfacing (AFR) with the Ellipse Juvia 15-W CO2 laser, wrote Dr. Woraphong Manuskiatti and colleagues of Mahidol University, Bangkok. All patients had skin phototype IV. Intervals between treatments averaged 7 weeks. All patients were followed for 6 months after the third treatment.

Independent physicians blinded to the order in which clinical photos had been taken judged the improvement in scarring to be excellent in 8% of the patients, good in 38.5% of them, fair in 38.5%, and slight in 15%. None of the patients worsened (J. Am. Acad. Dermatol. 2010;63:274-83).

By the patients’ own evaluations, 46% judged their overall improvement to be fair, 23% judged it to be good, and 31% judged it to be excellent. In both physician and patient evaluations, “slight” was defined as less than 25% improvement, “fair” as 25%-50% improvement, good as 51%-75% improvement, and excellent as 76%-100% improvement.

Postinflammatory hyperpigmentation (PIH) was the most common side effect, seen in 12 of the 13 (92%) patients and after 20 of the 39 (51%) treatment sessions. All cases of PIH were graded as mild except for one that was graded as moderate. After treatment with 4% hydroquinone cream once daily, PIH resolved in all patients within 2-16 weeks (average 5 weeks).

Other adverse events were acneiform eruptions in four patients, allergic contact dermatitis in two patients, and herpes simplex infection in one patient.

Each treatment consisted of a full-face single-pass treatment with a 5-7 ms pulse width. Investigators adjusted the laser to deliver 49 microthermal zones (MTZs) per square centimeter, with each individual MTZ 500 mcm in diameter. The average percent coverage was 9.6%, and the investigators set the laser to deliver energies between 75-105 mJ/MTZ depending on the severity of scarring.

Although physicians prepared the patients for 1 hour before each treatment with a topical anesthetic applied to the full face with occlusion, on average patients rated their pain as 8.1 on a scale of 1-10. Pain scores tended to decrease for the second and third treatments.

The investigators described AFR as offering a treatment alternative midway between nonablative fractional resurfacing (NAFR) and fractional photothermolysis (FP). “Although NAFR has a patient-friendly advantage,” the investigators wrote, “the outcomes of most NAFR lasers still leave much to be desired in the treatment of photodamaged skin, rhytides, and atrophic scars. ... By depositing a pixelated pattern of microscopic ablative wounds surrounded by healthy tissue in a manner similar to that of [the] NAFR method, AFR combines the increased efficacy of ablative techniques with the safety and reduced downtime associated with FP.”

The investigators declared that they had no conflicts of interest. The study was supported by a research grant from Ellipse A/S, which manufactures the laser used in the study.

Ablative fractional resurfacing appears to be safe and effective in Asians with mild to moderate atrophic acne scarring, according to a study of 13 patients.

While 12 of the 13 patients experienced some postinflammatory hyperpigmentation, this resolved in all patients in an average of 5 weeks.

The Asian patients underwent three sessions of ablative fractional resurfacing (AFR) with the Ellipse Juvia 15-W CO2 laser, wrote Dr. Woraphong Manuskiatti and colleagues of Mahidol University, Bangkok. All patients had skin phototype IV. Intervals between treatments averaged 7 weeks. All patients were followed for 6 months after the third treatment.

Independent physicians blinded to the order in which clinical photos had been taken judged the improvement in scarring to be excellent in 8% of the patients, good in 38.5% of them, fair in 38.5%, and slight in 15%. None of the patients worsened (J. Am. Acad. Dermatol. 2010;63:274-83).

By the patients’ own evaluations, 46% judged their overall improvement to be fair, 23% judged it to be good, and 31% judged it to be excellent. In both physician and patient evaluations, “slight” was defined as less than 25% improvement, “fair” as 25%-50% improvement, good as 51%-75% improvement, and excellent as 76%-100% improvement.

Postinflammatory hyperpigmentation (PIH) was the most common side effect, seen in 12 of the 13 (92%) patients and after 20 of the 39 (51%) treatment sessions. All cases of PIH were graded as mild except for one that was graded as moderate. After treatment with 4% hydroquinone cream once daily, PIH resolved in all patients within 2-16 weeks (average 5 weeks).

Other adverse events were acneiform eruptions in four patients, allergic contact dermatitis in two patients, and herpes simplex infection in one patient.

Each treatment consisted of a full-face single-pass treatment with a 5-7 ms pulse width. Investigators adjusted the laser to deliver 49 microthermal zones (MTZs) per square centimeter, with each individual MTZ 500 mcm in diameter. The average percent coverage was 9.6%, and the investigators set the laser to deliver energies between 75-105 mJ/MTZ depending on the severity of scarring.

Although physicians prepared the patients for 1 hour before each treatment with a topical anesthetic applied to the full face with occlusion, on average patients rated their pain as 8.1 on a scale of 1-10. Pain scores tended to decrease for the second and third treatments.

The investigators described AFR as offering a treatment alternative midway between nonablative fractional resurfacing (NAFR) and fractional photothermolysis (FP). “Although NAFR has a patient-friendly advantage,” the investigators wrote, “the outcomes of most NAFR lasers still leave much to be desired in the treatment of photodamaged skin, rhytides, and atrophic scars. ... By depositing a pixelated pattern of microscopic ablative wounds surrounded by healthy tissue in a manner similar to that of [the] NAFR method, AFR combines the increased efficacy of ablative techniques with the safety and reduced downtime associated with FP.”

The investigators declared that they had no conflicts of interest. The study was supported by a research grant from Ellipse A/S, which manufactures the laser used in the study.

Rosiglitazone and pioglitazone are both associated with an increased risk of fracture in postmenopausal women with type 2 diabetes, according to a matched case-control study that used data from the Translating Research into Action for Diabetes trial.

After controlling for age, sex, race/ethnicity, body mass index, and health plan, Dori Bilik of the University of Michigan, Ann Arbor, and colleagues, found that both of the thiazolidinediones (TZDs) were associated with a 71% increase in the risk of fracture for women aged 50 and older.

TRIAD enrolled 11,927 patients with diabetes in 2000-2001. All of the patients were at least aged 18 years and in managed care for at least 18 months before the baseline patient survey.

“Our study shows that increased fracture risk is associated with higher TZD dose, but no difference between rosiglitazone and pioglitazone is apparent, suggesting a class effect of TZDs on fracture risk,” said senior author Dr. William Herman of the University of Michigan Ann Arbor, in a press release.

Higher TZD doses were associated with a statistically significant 42% increase in the odds of fractures for women age 50 and older, but not for women under 50 or for men (J. Clin. Endocrinol. Metab. 2010; doi:10.1210/jc2009-2638).

The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. The authors did not report other conflicts of interest.

Rosiglitazone and pioglitazone are both associated with an increased risk of fracture in postmenopausal women with type 2 diabetes, according to a matched case-control study that used data from the Translating Research into Action for Diabetes trial.

After controlling for age, sex, race/ethnicity, body mass index, and health plan, Dori Bilik of the University of Michigan, Ann Arbor, and colleagues, found that both of the thiazolidinediones (TZDs) were associated with a 71% increase in the risk of fracture for women aged 50 and older.

TRIAD enrolled 11,927 patients with diabetes in 2000-2001. All of the patients were at least aged 18 years and in managed care for at least 18 months before the baseline patient survey.

“Our study shows that increased fracture risk is associated with higher TZD dose, but no difference between rosiglitazone and pioglitazone is apparent, suggesting a class effect of TZDs on fracture risk,” said senior author Dr. William Herman of the University of Michigan Ann Arbor, in a press release.

Higher TZD doses were associated with a statistically significant 42% increase in the odds of fractures for women age 50 and older, but not for women under 50 or for men (J. Clin. Endocrinol. Metab. 2010; doi:10.1210/jc2009-2638).

The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. The authors did not report other conflicts of interest.

Rosiglitazone and pioglitazone are both associated with an increased risk of fracture in postmenopausal women with type 2 diabetes, according to a matched case-control study that used data from the Translating Research into Action for Diabetes trial.

After controlling for age, sex, race/ethnicity, body mass index, and health plan, Dori Bilik of the University of Michigan, Ann Arbor, and colleagues, found that both of the thiazolidinediones (TZDs) were associated with a 71% increase in the risk of fracture for women aged 50 and older.

TRIAD enrolled 11,927 patients with diabetes in 2000-2001. All of the patients were at least aged 18 years and in managed care for at least 18 months before the baseline patient survey.

“Our study shows that increased fracture risk is associated with higher TZD dose, but no difference between rosiglitazone and pioglitazone is apparent, suggesting a class effect of TZDs on fracture risk,” said senior author Dr. William Herman of the University of Michigan Ann Arbor, in a press release.

Higher TZD doses were associated with a statistically significant 42% increase in the odds of fractures for women age 50 and older, but not for women under 50 or for men (J. Clin. Endocrinol. Metab. 2010; doi:10.1210/jc2009-2638).

The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. The authors did not report other conflicts of interest.

Major Finding: Five-year survival of patients whose atrial fibrillation is repaired during heart valve surgery was 89%, compared with 85% in patients without atrial fibrillation.

Data Source: Retrospective analysis of 3,337 patients undergoing valve surgery.

Disclosures: Dr. Lee disclosed that he has served as a consultant to, and has received research funding from, Medtronic Inc.

OJAI, CALIF. — The presence of atrial fibrillation tends to decrease survival time following valve surgery, and some studies have shown that medical treatment of AF does not improve survival.

But a new retrospective analysis by Dr. Richard Lee of Northwestern University, Evanston, Ill., suggests that when AF is treated with the maze procedure during valve repair, patients survive just as long as do those without AF.

“We think the effect, if reproducible, may be due to the higher rate of sinus restoration from the surgical treatment as opposed to medical treatment,” Dr. Lee said at the annual meeting of the Western Thoracic Surgical Association. “Concomitant AF treatment should be strongly considered in all patients with a history of AF undergoing cardiac surgery.”

The study involved 3,337 patients who underwent valve surgery at a single institution between April 2004 and April 2009. Of those, 17% had the maze procedure for AF at the same time as their valve repair.

Dr. Lee followed the patients for up to 6 years using the Social Security death index and registry. As expected, initial Kaplan-Meier analysis confirmed that survival after valve repair was shorter for patients with AF than for those without it.

Patients with AF on average were significantly older, more likely to be female, and more likely to have heart failure or severe pulmonary hypertension compared with their non-AF counterparts.

Dr. Lee next compared two groups of patients with AF. The group that underwent the maze procedure at the time of valve surgery had significantly longer survival than did those who did not undergo the procedure.

Once again, however, the two groups differed significantly in several demographic characteristics. For example, the AF patients who underwent the maze procedure were significantly more likely to be female, and less likely to have heart failure or diabetes than were those who did not have the procedure. These differences made it difficult to conclude that the maze procedure had led to the longer survival.

To overcome that obstacle, Dr. Lee conducted a propensity-matched analysis comparing 378 patients with AF who underwent the maze procedure with 378 patients who did not have AF. There were no significant demographic differences between those two groups. Importantly, there also were no differences in survival time according to Kaplan-Meier analysis. The 5-year survival rate for patients with AF who underwent the maze procedure was 89%, compared with 85% among patients without AF.

There also were no significant differences between groups in a number of other characteristics, including length of hospital stay, 30-day mortality, overall mortality, and cardiac death.

The lack of significant differences between the two groups persisted when Dr. Lee looked at subgroups of patients who had mitral valve repair, aortic valve repair, or coronary artery bypass grafting in addition to valve repair.

Dr. Lee acknowledged several limitations of the study. It involved a relatively small sample at a single institution, and selection bias might have eliminated the highest-risk AF patients. In addition, he was unable to compare successful AF treatment with unsuccessful treatment.

Nevertheless, Dr. Lee strongly suggests surgical repair of AF, especially since it adds just 10-20 minutes to valve repair surgery.

Major Finding: Five-year survival of patients whose atrial fibrillation is repaired during heart valve surgery was 89%, compared with 85% in patients without atrial fibrillation.

Data Source: Retrospective analysis of 3,337 patients undergoing valve surgery.

Disclosures: Dr. Lee disclosed that he has served as a consultant to, and has received research funding from, Medtronic Inc.

OJAI, CALIF. — The presence of atrial fibrillation tends to decrease survival time following valve surgery, and some studies have shown that medical treatment of AF does not improve survival.

But a new retrospective analysis by Dr. Richard Lee of Northwestern University, Evanston, Ill., suggests that when AF is treated with the maze procedure during valve repair, patients survive just as long as do those without AF.

“We think the effect, if reproducible, may be due to the higher rate of sinus restoration from the surgical treatment as opposed to medical treatment,” Dr. Lee said at the annual meeting of the Western Thoracic Surgical Association. “Concomitant AF treatment should be strongly considered in all patients with a history of AF undergoing cardiac surgery.”

The study involved 3,337 patients who underwent valve surgery at a single institution between April 2004 and April 2009. Of those, 17% had the maze procedure for AF at the same time as their valve repair.

Dr. Lee followed the patients for up to 6 years using the Social Security death index and registry. As expected, initial Kaplan-Meier analysis confirmed that survival after valve repair was shorter for patients with AF than for those without it.

Patients with AF on average were significantly older, more likely to be female, and more likely to have heart failure or severe pulmonary hypertension compared with their non-AF counterparts.

Dr. Lee next compared two groups of patients with AF. The group that underwent the maze procedure at the time of valve surgery had significantly longer survival than did those who did not undergo the procedure.

Once again, however, the two groups differed significantly in several demographic characteristics. For example, the AF patients who underwent the maze procedure were significantly more likely to be female, and less likely to have heart failure or diabetes than were those who did not have the procedure. These differences made it difficult to conclude that the maze procedure had led to the longer survival.

To overcome that obstacle, Dr. Lee conducted a propensity-matched analysis comparing 378 patients with AF who underwent the maze procedure with 378 patients who did not have AF. There were no significant demographic differences between those two groups. Importantly, there also were no differences in survival time according to Kaplan-Meier analysis. The 5-year survival rate for patients with AF who underwent the maze procedure was 89%, compared with 85% among patients without AF.

There also were no significant differences between groups in a number of other characteristics, including length of hospital stay, 30-day mortality, overall mortality, and cardiac death.

The lack of significant differences between the two groups persisted when Dr. Lee looked at subgroups of patients who had mitral valve repair, aortic valve repair, or coronary artery bypass grafting in addition to valve repair.

Dr. Lee acknowledged several limitations of the study. It involved a relatively small sample at a single institution, and selection bias might have eliminated the highest-risk AF patients. In addition, he was unable to compare successful AF treatment with unsuccessful treatment.

Nevertheless, Dr. Lee strongly suggests surgical repair of AF, especially since it adds just 10-20 minutes to valve repair surgery.

Major Finding: Five-year survival of patients whose atrial fibrillation is repaired during heart valve surgery was 89%, compared with 85% in patients without atrial fibrillation.

Data Source: Retrospective analysis of 3,337 patients undergoing valve surgery.

Disclosures: Dr. Lee disclosed that he has served as a consultant to, and has received research funding from, Medtronic Inc.

OJAI, CALIF. — The presence of atrial fibrillation tends to decrease survival time following valve surgery, and some studies have shown that medical treatment of AF does not improve survival.

But a new retrospective analysis by Dr. Richard Lee of Northwestern University, Evanston, Ill., suggests that when AF is treated with the maze procedure during valve repair, patients survive just as long as do those without AF.

“We think the effect, if reproducible, may be due to the higher rate of sinus restoration from the surgical treatment as opposed to medical treatment,” Dr. Lee said at the annual meeting of the Western Thoracic Surgical Association. “Concomitant AF treatment should be strongly considered in all patients with a history of AF undergoing cardiac surgery.”

The study involved 3,337 patients who underwent valve surgery at a single institution between April 2004 and April 2009. Of those, 17% had the maze procedure for AF at the same time as their valve repair.

Dr. Lee followed the patients for up to 6 years using the Social Security death index and registry. As expected, initial Kaplan-Meier analysis confirmed that survival after valve repair was shorter for patients with AF than for those without it.

Patients with AF on average were significantly older, more likely to be female, and more likely to have heart failure or severe pulmonary hypertension compared with their non-AF counterparts.

Dr. Lee next compared two groups of patients with AF. The group that underwent the maze procedure at the time of valve surgery had significantly longer survival than did those who did not undergo the procedure.

Once again, however, the two groups differed significantly in several demographic characteristics. For example, the AF patients who underwent the maze procedure were significantly more likely to be female, and less likely to have heart failure or diabetes than were those who did not have the procedure. These differences made it difficult to conclude that the maze procedure had led to the longer survival.

To overcome that obstacle, Dr. Lee conducted a propensity-matched analysis comparing 378 patients with AF who underwent the maze procedure with 378 patients who did not have AF. There were no significant demographic differences between those two groups. Importantly, there also were no differences in survival time according to Kaplan-Meier analysis. The 5-year survival rate for patients with AF who underwent the maze procedure was 89%, compared with 85% among patients without AF.

There also were no significant differences between groups in a number of other characteristics, including length of hospital stay, 30-day mortality, overall mortality, and cardiac death.

The lack of significant differences between the two groups persisted when Dr. Lee looked at subgroups of patients who had mitral valve repair, aortic valve repair, or coronary artery bypass grafting in addition to valve repair.

Dr. Lee acknowledged several limitations of the study. It involved a relatively small sample at a single institution, and selection bias might have eliminated the highest-risk AF patients. In addition, he was unable to compare successful AF treatment with unsuccessful treatment.

Nevertheless, Dr. Lee strongly suggests surgical repair of AF, especially since it adds just 10-20 minutes to valve repair surgery.

OJAI, CALIF. — Surgical treatment for infective endocarditis is notoriously risky, with mortality up to 20% in some studies and morbidity much higher. But a new scoring system designed to identify the 13 most significant risk factors for morbidity and mortality might help guide clinical decision making.

Using data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, a research team led by Dr. Jeffrey G. Gaca of Duke University Medical Center, Durham, N.C., conducted a multivariate analysis to identify the risk factors and from that, they developed a simple bedside scoring system, Dr. Gaca said at the meeting.

The investigators identified every patient in the STS database who underwent surgery on the aortic, mitral, or tricuspid valve during 2002-2008. Of those 416,277 patients, 19,730 had the surgery for infective endocarditis.

The investigators randomly selected 70% of those cases to develop the scoring system, reserving the remaining 30% to test it. They then developed two separate scoring systems, one intended to predict mortality alone and the other intended to predict a composite of deep external wound infection, mortality and serious morbidity, prolonged ventilation, postoperative stroke, pneumonia, renal failure, dialysis, multisystem organ failure, and readmission within 30 days of surgery.

The patients' average age was 55 years, and 67% were male. Preoperatively, 52% had active endocarditis, 23% were in renal failure, 21% had prior valve surgery, 19% had arrhythmia, and 19% had prior cerebrovascular disease.

The surgery was urgent for 50% of the patients, elective for 43%, and emergent for just under 7%. Fewer than 1% of the patients had salvage surgery.

Overall, 8.2% of the patients died, a lower percentage than that seen in other studies. But 53% had postoperative complication such as prolonged ventilation (28%), strokes within 72 hours (3%), and transient neurological deficits (1%).

After conducting a multiple logistic regression controlling for relevant demographic and clinical characteristics, the investigators used the top 13 significant risk factors to develop their scoring systems (see box). The top two risk factors were the same in the mortality and mortality/morbidity scoring systems: Patients who were emergent, salvage, or in cardiogenic shock were three times more likely to die or to have major morbidity than was the average patient. And patients in renal failure were twice as likely to experience adverse outcomes.

Dr. Gaca explained using the example of a 65-year-old man with active mitral valve endocarditis, NYHA class IV heart failure, type 1 diabetes, serum creatinine of 2.2 mg/dL, and chronic obstructive pulmonary disease. His risk score for major morbidity and mortality would be 36, and his score for mortality alone would be 35.

When those values are plotted on risk graphs, a score of 35 translates to an 11% chance of mortality, and a score of 36 translates to about a 65% chance of mortality or major morbidity.

In commenting on the study, Dr. James M. Douglas of St. Joseph's Hospital in Bellingham, Wash., noted that most of the identified risk factors were functional or physiologic, whereas in his experience anatomical peculiarities such as aneurysms and fistulae present the most vexing challenges in these patients.

Dr. Gaca acknowledged that anatomic issues do affect a patient's risk, and those factors are not included in the STS database. Another limitation of that database is the lack of microbiological data.

Disclosures: The investigators had no relevant disclosures.

Source Elsevier Global Medical News

OJAI, CALIF. — Surgical treatment for infective endocarditis is notoriously risky, with mortality up to 20% in some studies and morbidity much higher. But a new scoring system designed to identify the 13 most significant risk factors for morbidity and mortality might help guide clinical decision making.

Using data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, a research team led by Dr. Jeffrey G. Gaca of Duke University Medical Center, Durham, N.C., conducted a multivariate analysis to identify the risk factors and from that, they developed a simple bedside scoring system, Dr. Gaca said at the meeting.

The investigators identified every patient in the STS database who underwent surgery on the aortic, mitral, or tricuspid valve during 2002-2008. Of those 416,277 patients, 19,730 had the surgery for infective endocarditis.

The investigators randomly selected 70% of those cases to develop the scoring system, reserving the remaining 30% to test it. They then developed two separate scoring systems, one intended to predict mortality alone and the other intended to predict a composite of deep external wound infection, mortality and serious morbidity, prolonged ventilation, postoperative stroke, pneumonia, renal failure, dialysis, multisystem organ failure, and readmission within 30 days of surgery.

The patients' average age was 55 years, and 67% were male. Preoperatively, 52% had active endocarditis, 23% were in renal failure, 21% had prior valve surgery, 19% had arrhythmia, and 19% had prior cerebrovascular disease.

The surgery was urgent for 50% of the patients, elective for 43%, and emergent for just under 7%. Fewer than 1% of the patients had salvage surgery.

Overall, 8.2% of the patients died, a lower percentage than that seen in other studies. But 53% had postoperative complication such as prolonged ventilation (28%), strokes within 72 hours (3%), and transient neurological deficits (1%).

After conducting a multiple logistic regression controlling for relevant demographic and clinical characteristics, the investigators used the top 13 significant risk factors to develop their scoring systems (see box). The top two risk factors were the same in the mortality and mortality/morbidity scoring systems: Patients who were emergent, salvage, or in cardiogenic shock were three times more likely to die or to have major morbidity than was the average patient. And patients in renal failure were twice as likely to experience adverse outcomes.

Dr. Gaca explained using the example of a 65-year-old man with active mitral valve endocarditis, NYHA class IV heart failure, type 1 diabetes, serum creatinine of 2.2 mg/dL, and chronic obstructive pulmonary disease. His risk score for major morbidity and mortality would be 36, and his score for mortality alone would be 35.

When those values are plotted on risk graphs, a score of 35 translates to an 11% chance of mortality, and a score of 36 translates to about a 65% chance of mortality or major morbidity.

In commenting on the study, Dr. James M. Douglas of St. Joseph's Hospital in Bellingham, Wash., noted that most of the identified risk factors were functional or physiologic, whereas in his experience anatomical peculiarities such as aneurysms and fistulae present the most vexing challenges in these patients.

Dr. Gaca acknowledged that anatomic issues do affect a patient's risk, and those factors are not included in the STS database. Another limitation of that database is the lack of microbiological data.

Disclosures: The investigators had no relevant disclosures.

Source Elsevier Global Medical News

OJAI, CALIF. — Surgical treatment for infective endocarditis is notoriously risky, with mortality up to 20% in some studies and morbidity much higher. But a new scoring system designed to identify the 13 most significant risk factors for morbidity and mortality might help guide clinical decision making.

Using data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, a research team led by Dr. Jeffrey G. Gaca of Duke University Medical Center, Durham, N.C., conducted a multivariate analysis to identify the risk factors and from that, they developed a simple bedside scoring system, Dr. Gaca said at the meeting.

The investigators identified every patient in the STS database who underwent surgery on the aortic, mitral, or tricuspid valve during 2002-2008. Of those 416,277 patients, 19,730 had the surgery for infective endocarditis.

The investigators randomly selected 70% of those cases to develop the scoring system, reserving the remaining 30% to test it. They then developed two separate scoring systems, one intended to predict mortality alone and the other intended to predict a composite of deep external wound infection, mortality and serious morbidity, prolonged ventilation, postoperative stroke, pneumonia, renal failure, dialysis, multisystem organ failure, and readmission within 30 days of surgery.

The patients' average age was 55 years, and 67% were male. Preoperatively, 52% had active endocarditis, 23% were in renal failure, 21% had prior valve surgery, 19% had arrhythmia, and 19% had prior cerebrovascular disease.

The surgery was urgent for 50% of the patients, elective for 43%, and emergent for just under 7%. Fewer than 1% of the patients had salvage surgery.

Overall, 8.2% of the patients died, a lower percentage than that seen in other studies. But 53% had postoperative complication such as prolonged ventilation (28%), strokes within 72 hours (3%), and transient neurological deficits (1%).

After conducting a multiple logistic regression controlling for relevant demographic and clinical characteristics, the investigators used the top 13 significant risk factors to develop their scoring systems (see box). The top two risk factors were the same in the mortality and mortality/morbidity scoring systems: Patients who were emergent, salvage, or in cardiogenic shock were three times more likely to die or to have major morbidity than was the average patient. And patients in renal failure were twice as likely to experience adverse outcomes.

Dr. Gaca explained using the example of a 65-year-old man with active mitral valve endocarditis, NYHA class IV heart failure, type 1 diabetes, serum creatinine of 2.2 mg/dL, and chronic obstructive pulmonary disease. His risk score for major morbidity and mortality would be 36, and his score for mortality alone would be 35.

When those values are plotted on risk graphs, a score of 35 translates to an 11% chance of mortality, and a score of 36 translates to about a 65% chance of mortality or major morbidity.

In commenting on the study, Dr. James M. Douglas of St. Joseph's Hospital in Bellingham, Wash., noted that most of the identified risk factors were functional or physiologic, whereas in his experience anatomical peculiarities such as aneurysms and fistulae present the most vexing challenges in these patients.

Dr. Gaca acknowledged that anatomic issues do affect a patient's risk, and those factors are not included in the STS database. Another limitation of that database is the lack of microbiological data.

Disclosures: The investigators had no relevant disclosures.

Source Elsevier Global Medical News

Major Finding: Adolescents undergoing surgery for congenital heart disease have a mortality rate of 0.15% when the procedure is done in a children's hospital, compared with 0.7% when the surgery is done in an adult hospital, and 2.1% when the surgery is done in an adult hospital with a children's unit.

Data Source: A national sample representing 22 million hospital discharges of patients aged 20 years and below during 2000, 2003, and 2006.

Disclosures: The investigators stated that they had no financial disclosures related to this work.

OJAI, CALIF. — Congenital heart surgery, once confined to infants and very young children, is increasingly being performed on older children and adults, the result of more effective medical and surgical treatments. A new study of a nationally representative database of pediatric hospital admissions has now shown that older children have a significantly lower mortality rate when their surgery is performed at a children's hospital instead of an adult hospital.

In 2006, for example, the mortality rate from congenital heart surgery for children and adolescents aged 14-20 years was 0.15% when the surgery was performed in a children's hospital. This is significantly lower than the mortality rate of 0.7% when the surgery was performed in an adult hospital or 2.1% when the surgery was performed in an adult hospital with a children's unit, Dr. Jeffrey S. Heinle reported at the annual meeting of the Western Thoracic Surgical Association.

“The vast majority of adolescent patients continue to be cared for in adult hospitals without a congenital unit,” said Dr. Heinle of the Baylor College of Medicine, Houston. “If you do a large volume of congenital cases, your outcomes in adult patients are better. … Even lesions we would consider simple, such as a ventricular septal defect in an adult, are better cared for with better outcomes by congenital heart surgeons rather than adult surgeons.”

The investigators used data from the Healthcare Cost and Utilization Project Kids' Inpatient Database, which provides nationally representative estimates of pediatric hospital discharges. Data for the 3 years studied—2000, 2003, and 2006—represent 22 million discharges, of which about 190,000 (0.8%) were for congenital heart surgery.

The number of congenital heart surgeries increased from about 57,000 in 2000 to about 70,000 in 2006. During that time the median age of children receiving congenital heart surgery rose significantly, from 6 years in 2000 to 8 years in 2003 and to 9 years in 2006.

The proportion of infant surgeries remained at about 33% during all 3 years studied. The proportion of surgeries in children aged 1-13 years decreased significantly from 29% to 23%. And the proportion of surgeries in adolescents aged 14-20 years increased significantly from 38% to 44%.

The in-hospital mortality rate declined significantly in infants, from 8.5% to 7.1%; and in adolescents, from 1.7% to 1.1%. Mortality remained between 1.5% and 1.7% for children aged 1-13 years.

The mean length of hospital stay rose significantly, from 13.7 days in 2000 to 16.3 days in 2006. This increase was driven largely by the increase in infants' average length of stay, from 29 to 38 days.

Infants and children 1-13 years of age were much more likely to be treated in a children's hospital or an adult hospital with a children's unit than in an adult hospital without a children's unit. On the other hand, about 75% of adolescents were treated in an adult hospital without a children's unit.

It wasn't only adolescents who had lower mortality when treated in a children's hospital. Infants too had significantly lower mortality: 6.1%, compared with 7.4% in adult hospitals and 7.7% in adult hospitals with a children's unit.

Major Finding: Adolescents undergoing surgery for congenital heart disease have a mortality rate of 0.15% when the procedure is done in a children's hospital, compared with 0.7% when the surgery is done in an adult hospital, and 2.1% when the surgery is done in an adult hospital with a children's unit.

Data Source: A national sample representing 22 million hospital discharges of patients aged 20 years and below during 2000, 2003, and 2006.

Disclosures: The investigators stated that they had no financial disclosures related to this work.

OJAI, CALIF. — Congenital heart surgery, once confined to infants and very young children, is increasingly being performed on older children and adults, the result of more effective medical and surgical treatments. A new study of a nationally representative database of pediatric hospital admissions has now shown that older children have a significantly lower mortality rate when their surgery is performed at a children's hospital instead of an adult hospital.

In 2006, for example, the mortality rate from congenital heart surgery for children and adolescents aged 14-20 years was 0.15% when the surgery was performed in a children's hospital. This is significantly lower than the mortality rate of 0.7% when the surgery was performed in an adult hospital or 2.1% when the surgery was performed in an adult hospital with a children's unit, Dr. Jeffrey S. Heinle reported at the annual meeting of the Western Thoracic Surgical Association.

“The vast majority of adolescent patients continue to be cared for in adult hospitals without a congenital unit,” said Dr. Heinle of the Baylor College of Medicine, Houston. “If you do a large volume of congenital cases, your outcomes in adult patients are better. … Even lesions we would consider simple, such as a ventricular septal defect in an adult, are better cared for with better outcomes by congenital heart surgeons rather than adult surgeons.”

The investigators used data from the Healthcare Cost and Utilization Project Kids' Inpatient Database, which provides nationally representative estimates of pediatric hospital discharges. Data for the 3 years studied—2000, 2003, and 2006—represent 22 million discharges, of which about 190,000 (0.8%) were for congenital heart surgery.

The number of congenital heart surgeries increased from about 57,000 in 2000 to about 70,000 in 2006. During that time the median age of children receiving congenital heart surgery rose significantly, from 6 years in 2000 to 8 years in 2003 and to 9 years in 2006.

The proportion of infant surgeries remained at about 33% during all 3 years studied. The proportion of surgeries in children aged 1-13 years decreased significantly from 29% to 23%. And the proportion of surgeries in adolescents aged 14-20 years increased significantly from 38% to 44%.

The in-hospital mortality rate declined significantly in infants, from 8.5% to 7.1%; and in adolescents, from 1.7% to 1.1%. Mortality remained between 1.5% and 1.7% for children aged 1-13 years.

The mean length of hospital stay rose significantly, from 13.7 days in 2000 to 16.3 days in 2006. This increase was driven largely by the increase in infants' average length of stay, from 29 to 38 days.

Infants and children 1-13 years of age were much more likely to be treated in a children's hospital or an adult hospital with a children's unit than in an adult hospital without a children's unit. On the other hand, about 75% of adolescents were treated in an adult hospital without a children's unit.

It wasn't only adolescents who had lower mortality when treated in a children's hospital. Infants too had significantly lower mortality: 6.1%, compared with 7.4% in adult hospitals and 7.7% in adult hospitals with a children's unit.

Major Finding: Adolescents undergoing surgery for congenital heart disease have a mortality rate of 0.15% when the procedure is done in a children's hospital, compared with 0.7% when the surgery is done in an adult hospital, and 2.1% when the surgery is done in an adult hospital with a children's unit.

Data Source: A national sample representing 22 million hospital discharges of patients aged 20 years and below during 2000, 2003, and 2006.

Disclosures: The investigators stated that they had no financial disclosures related to this work.

OJAI, CALIF. — Congenital heart surgery, once confined to infants and very young children, is increasingly being performed on older children and adults, the result of more effective medical and surgical treatments. A new study of a nationally representative database of pediatric hospital admissions has now shown that older children have a significantly lower mortality rate when their surgery is performed at a children's hospital instead of an adult hospital.

In 2006, for example, the mortality rate from congenital heart surgery for children and adolescents aged 14-20 years was 0.15% when the surgery was performed in a children's hospital. This is significantly lower than the mortality rate of 0.7% when the surgery was performed in an adult hospital or 2.1% when the surgery was performed in an adult hospital with a children's unit, Dr. Jeffrey S. Heinle reported at the annual meeting of the Western Thoracic Surgical Association.

“The vast majority of adolescent patients continue to be cared for in adult hospitals without a congenital unit,” said Dr. Heinle of the Baylor College of Medicine, Houston. “If you do a large volume of congenital cases, your outcomes in adult patients are better. … Even lesions we would consider simple, such as a ventricular septal defect in an adult, are better cared for with better outcomes by congenital heart surgeons rather than adult surgeons.”

The investigators used data from the Healthcare Cost and Utilization Project Kids' Inpatient Database, which provides nationally representative estimates of pediatric hospital discharges. Data for the 3 years studied—2000, 2003, and 2006—represent 22 million discharges, of which about 190,000 (0.8%) were for congenital heart surgery.

The number of congenital heart surgeries increased from about 57,000 in 2000 to about 70,000 in 2006. During that time the median age of children receiving congenital heart surgery rose significantly, from 6 years in 2000 to 8 years in 2003 and to 9 years in 2006.

The proportion of infant surgeries remained at about 33% during all 3 years studied. The proportion of surgeries in children aged 1-13 years decreased significantly from 29% to 23%. And the proportion of surgeries in adolescents aged 14-20 years increased significantly from 38% to 44%.

The in-hospital mortality rate declined significantly in infants, from 8.5% to 7.1%; and in adolescents, from 1.7% to 1.1%. Mortality remained between 1.5% and 1.7% for children aged 1-13 years.

The mean length of hospital stay rose significantly, from 13.7 days in 2000 to 16.3 days in 2006. This increase was driven largely by the increase in infants' average length of stay, from 29 to 38 days.

Infants and children 1-13 years of age were much more likely to be treated in a children's hospital or an adult hospital with a children's unit than in an adult hospital without a children's unit. On the other hand, about 75% of adolescents were treated in an adult hospital without a children's unit.

It wasn't only adolescents who had lower mortality when treated in a children's hospital. Infants too had significantly lower mortality: 6.1%, compared with 7.4% in adult hospitals and 7.7% in adult hospitals with a children's unit.

The Advisory Committee on Immunization Practices recommended that a seasonal influenza vaccine manufactured by CSL Biotherapies for the U.S. market not be used in children between the ages of 6 months and 8 years.

The company's trivalent influenza vaccine (TIV) sold under the trade name Afluria in the United States was associated with a large increase in the risk of fevers and febrile seizures in children in Australia and New Zealand. In April 2010, authorities in those two countries recommended that physicians suspend use of CSL's influenza vaccines in children aged 5 years and under. In response, the company voluntarily withdrew its vaccine from markets in the southern hemisphere.

In the northern hemisphere, CSL's influenza vaccines have been approved for use in Germany, the United Kingdom, and the United States. In June 2010, authorities in the United Kingdom recommended that physicians avoid using CSL's influenza vaccine in children aged 5 years and under.

In making their recommendation, members of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) noted that there should be adequate supplies of seasonal influenza vaccine even in the absence of Afluria. Other manufacturers are expected to supply 145-150 million doses of the vaccine in the United States; the largest number of doses ever used in one flu season was 114 million.

During the course of the teleconference, representatives of Sanofi-Aventis, GlaxoSmithKline, Novartis, and MedImmune all said that they had adequate supplies of vaccine, and they were willing to increase production if necessary to compensate for the 6-12 million doses that CSL had been expected to provide.

According to the CDC's Dr. Tim Uyeki, CSL's vaccine was associated with a ninefold increase in the risk of febrile seizures, compared with other manufacturers' vaccines in children aged 6 months through 4 years in Australia.

The rate was nine per 1,000 doses in these children, compared with an expected rate of one per 1,000 doses. The rate of febrile seizures was especially high in children aged 3-4 years old given Fluvax Junior, one of CSL's two versions of this year's TIV. The rate in those children was 15 per 1,000 doses.

Febrile seizures occurred an average of 7.2 hours after the child received a dose of vaccine, with a range of 5.9-8.4 hours. Dr. Uyeki said that no explanation for the increased risk of fever and febrile seizures has been identified.

Although there was no apparent increase in febrile seizures in children aged 5-8 years, children in that age group did experience an increase in the incidence of fever. Sixteen percent of children in that age group experienced a fever following a dose of a CSL flu vaccine, compared with 9% of children receiving another manufacturer's vaccine.

ACIP members voted to include children aged 5-8 years in their recommendation in order to increase the simplicity and consistency of the public health message. Other ACIP recommendations regarding flu vaccination in children, both for the seasonal TIV and for pandemic influenza A(H1N1), involve children age 6 months to 8 years, and most members believed it would be confusing to have this new recommendation cover children age 6 months to 5 years.

They did agree, however, that children aged 5-8 years could receive the CSL vaccine if they were at especially high risk from influenza and if no other vaccine was available.

Several committee members voiced concern about providers who may already have placed orders for the CSL vaccine. Since most vaccine from other manufacturers has already been allocated, they worried that it would be too late for some clinicians to change their orders. In response, a representative from the American Medical Association recommended that providers visit the AMA's Influenza Vaccine Availability Tracking System (IVATS) at http://www.preventinfluenza.org/ivats

In related news, the CDC reported Aug. 4 that they've observed outbreaks of seasonal influenza A(H3N2) in two nonbordering counties in Iowa, along with sporadic cases of influenza 2009 H1N1 A and B in 11 other states.

The agency reminded physicians to consider influenza as a possible diagnosis in individuals with respiratory illnesses even though influenza is not often seen in the summer. Clinicians also were advised not to rely on the rapid influenza diagnostic test because of its moderate sensitivity and an increased chance of false positives during times when overall influenza prevalence is low.

Disclosures: While several members of ACIP disclosed that they had relationships with vaccine manufacturers, only members with no such conflicts of interest were permitted to vote.

The Advisory Committee on Immunization Practices recommended that a seasonal influenza vaccine manufactured by CSL Biotherapies for the U.S. market not be used in children between the ages of 6 months and 8 years.

The company's trivalent influenza vaccine (TIV) sold under the trade name Afluria in the United States was associated with a large increase in the risk of fevers and febrile seizures in children in Australia and New Zealand. In April 2010, authorities in those two countries recommended that physicians suspend use of CSL's influenza vaccines in children aged 5 years and under. In response, the company voluntarily withdrew its vaccine from markets in the southern hemisphere.

In the northern hemisphere, CSL's influenza vaccines have been approved for use in Germany, the United Kingdom, and the United States. In June 2010, authorities in the United Kingdom recommended that physicians avoid using CSL's influenza vaccine in children aged 5 years and under.

In making their recommendation, members of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) noted that there should be adequate supplies of seasonal influenza vaccine even in the absence of Afluria. Other manufacturers are expected to supply 145-150 million doses of the vaccine in the United States; the largest number of doses ever used in one flu season was 114 million.

During the course of the teleconference, representatives of Sanofi-Aventis, GlaxoSmithKline, Novartis, and MedImmune all said that they had adequate supplies of vaccine, and they were willing to increase production if necessary to compensate for the 6-12 million doses that CSL had been expected to provide.

According to the CDC's Dr. Tim Uyeki, CSL's vaccine was associated with a ninefold increase in the risk of febrile seizures, compared with other manufacturers' vaccines in children aged 6 months through 4 years in Australia.

The rate was nine per 1,000 doses in these children, compared with an expected rate of one per 1,000 doses. The rate of febrile seizures was especially high in children aged 3-4 years old given Fluvax Junior, one of CSL's two versions of this year's TIV. The rate in those children was 15 per 1,000 doses.

Febrile seizures occurred an average of 7.2 hours after the child received a dose of vaccine, with a range of 5.9-8.4 hours. Dr. Uyeki said that no explanation for the increased risk of fever and febrile seizures has been identified.

Although there was no apparent increase in febrile seizures in children aged 5-8 years, children in that age group did experience an increase in the incidence of fever. Sixteen percent of children in that age group experienced a fever following a dose of a CSL flu vaccine, compared with 9% of children receiving another manufacturer's vaccine.

ACIP members voted to include children aged 5-8 years in their recommendation in order to increase the simplicity and consistency of the public health message. Other ACIP recommendations regarding flu vaccination in children, both for the seasonal TIV and for pandemic influenza A(H1N1), involve children age 6 months to 8 years, and most members believed it would be confusing to have this new recommendation cover children age 6 months to 5 years.

They did agree, however, that children aged 5-8 years could receive the CSL vaccine if they were at especially high risk from influenza and if no other vaccine was available.

Several committee members voiced concern about providers who may already have placed orders for the CSL vaccine. Since most vaccine from other manufacturers has already been allocated, they worried that it would be too late for some clinicians to change their orders. In response, a representative from the American Medical Association recommended that providers visit the AMA's Influenza Vaccine Availability Tracking System (IVATS) at http://www.preventinfluenza.org/ivats

In related news, the CDC reported Aug. 4 that they've observed outbreaks of seasonal influenza A(H3N2) in two nonbordering counties in Iowa, along with sporadic cases of influenza 2009 H1N1 A and B in 11 other states.

The agency reminded physicians to consider influenza as a possible diagnosis in individuals with respiratory illnesses even though influenza is not often seen in the summer. Clinicians also were advised not to rely on the rapid influenza diagnostic test because of its moderate sensitivity and an increased chance of false positives during times when overall influenza prevalence is low.

Disclosures: While several members of ACIP disclosed that they had relationships with vaccine manufacturers, only members with no such conflicts of interest were permitted to vote.

The Advisory Committee on Immunization Practices recommended that a seasonal influenza vaccine manufactured by CSL Biotherapies for the U.S. market not be used in children between the ages of 6 months and 8 years.

The company's trivalent influenza vaccine (TIV) sold under the trade name Afluria in the United States was associated with a large increase in the risk of fevers and febrile seizures in children in Australia and New Zealand. In April 2010, authorities in those two countries recommended that physicians suspend use of CSL's influenza vaccines in children aged 5 years and under. In response, the company voluntarily withdrew its vaccine from markets in the southern hemisphere.

In the northern hemisphere, CSL's influenza vaccines have been approved for use in Germany, the United Kingdom, and the United States. In June 2010, authorities in the United Kingdom recommended that physicians avoid using CSL's influenza vaccine in children aged 5 years and under.

In making their recommendation, members of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) noted that there should be adequate supplies of seasonal influenza vaccine even in the absence of Afluria. Other manufacturers are expected to supply 145-150 million doses of the vaccine in the United States; the largest number of doses ever used in one flu season was 114 million.

During the course of the teleconference, representatives of Sanofi-Aventis, GlaxoSmithKline, Novartis, and MedImmune all said that they had adequate supplies of vaccine, and they were willing to increase production if necessary to compensate for the 6-12 million doses that CSL had been expected to provide.

According to the CDC's Dr. Tim Uyeki, CSL's vaccine was associated with a ninefold increase in the risk of febrile seizures, compared with other manufacturers' vaccines in children aged 6 months through 4 years in Australia.

The rate was nine per 1,000 doses in these children, compared with an expected rate of one per 1,000 doses. The rate of febrile seizures was especially high in children aged 3-4 years old given Fluvax Junior, one of CSL's two versions of this year's TIV. The rate in those children was 15 per 1,000 doses.

Febrile seizures occurred an average of 7.2 hours after the child received a dose of vaccine, with a range of 5.9-8.4 hours. Dr. Uyeki said that no explanation for the increased risk of fever and febrile seizures has been identified.

Although there was no apparent increase in febrile seizures in children aged 5-8 years, children in that age group did experience an increase in the incidence of fever. Sixteen percent of children in that age group experienced a fever following a dose of a CSL flu vaccine, compared with 9% of children receiving another manufacturer's vaccine.

ACIP members voted to include children aged 5-8 years in their recommendation in order to increase the simplicity and consistency of the public health message. Other ACIP recommendations regarding flu vaccination in children, both for the seasonal TIV and for pandemic influenza A(H1N1), involve children age 6 months to 8 years, and most members believed it would be confusing to have this new recommendation cover children age 6 months to 5 years.

They did agree, however, that children aged 5-8 years could receive the CSL vaccine if they were at especially high risk from influenza and if no other vaccine was available.

Several committee members voiced concern about providers who may already have placed orders for the CSL vaccine. Since most vaccine from other manufacturers has already been allocated, they worried that it would be too late for some clinicians to change their orders. In response, a representative from the American Medical Association recommended that providers visit the AMA's Influenza Vaccine Availability Tracking System (IVATS) at http://www.preventinfluenza.org/ivats

In related news, the CDC reported Aug. 4 that they've observed outbreaks of seasonal influenza A(H3N2) in two nonbordering counties in Iowa, along with sporadic cases of influenza 2009 H1N1 A and B in 11 other states.

The agency reminded physicians to consider influenza as a possible diagnosis in individuals with respiratory illnesses even though influenza is not often seen in the summer. Clinicians also were advised not to rely on the rapid influenza diagnostic test because of its moderate sensitivity and an increased chance of false positives during times when overall influenza prevalence is low.

Disclosures: While several members of ACIP disclosed that they had relationships with vaccine manufacturers, only members with no such conflicts of interest were permitted to vote.

Major Finding: Both rosiglitazone and pioglitazone are associated with a 71% increase in the risk of fracture in diabetic women 50 years of age and older. In men with diabetes, there is a 3.5-fold increase in the risk of fracture when TZDs are used together with loop diuretics, but not when TZDs are used alone.

Data Source: Case-control study involving 786 cases of fractures and 2,657 matched controls in patients with type 2 diabetes.

Disclosures: The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. The authors did not report other conflicts of interest.

Rosiglitazone and pioglitazone are both associated with an increased risk of fracture in postmenopausal women with type 2 diabetes, according to a matched case-control study that used data from the Translating Research into Action for Diabetes (TRIAD) trial.

After controlling for age, sex, race/ethnicity, body mass index, and health plan, Dori Bilik of the University of Michigan, Ann Arbor, and colleagues, found that both of the thiazolidinediones (TZDs) were associated with a 71% increase in the risk of fracture for women aged 50 and older, according to the study, published July 14 online.

The investigators detected no such increase in risk for younger women. In men, TZDs alone showed no association with an increase in fracture risk. But men who took both TZDs and loop diuretics experienced a 3.5-fold increase in the risk of fractures.

TRIAD enrolled 11,927 patients with diabetes in 2000–2001. All were at least age 18 years and in managed care for at least 18 months before the baseline patient survey. The investigators analyzed data from patients with type 2 diabetes, excluding those who were diagnosed before age 30 and treated only with insulin. Among these patients were 786 with a diagnosis of fracture, which the investigators matched with 2,657 controls, up to 4 controls per case and followed for a mean of 1.9 years.

“Our study shows that increased fracture risk is associated with higher TZD dose, but no difference between rosiglitazone and pioglitazone is apparent, suggesting a class effect of TZDs on fracture risk,” said senior author Dr. William Herman of the University of Michigan Ann Arbor, in a prepared statement. “Physicians should be aware of this risk and weigh the benefits and risks of therapy when they initially prescribe or renew prescriptions for TZDs.”

Researchers found a dose-response relationship between TZDs and fracture risk. Higher TZD doses were associated with a significant 42% increase in the odds of fractures for women aged 50 years and older, but not for women under 50 years or for men (J. Clin. Endocrinol. Metab. 2010 July 14 [doi:10.1210/jc2009-2638]).

Major Finding: Both rosiglitazone and pioglitazone are associated with a 71% increase in the risk of fracture in diabetic women 50 years of age and older. In men with diabetes, there is a 3.5-fold increase in the risk of fracture when TZDs are used together with loop diuretics, but not when TZDs are used alone.

Data Source: Case-control study involving 786 cases of fractures and 2,657 matched controls in patients with type 2 diabetes.

Disclosures: The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. The authors did not report other conflicts of interest.

Rosiglitazone and pioglitazone are both associated with an increased risk of fracture in postmenopausal women with type 2 diabetes, according to a matched case-control study that used data from the Translating Research into Action for Diabetes (TRIAD) trial.

After controlling for age, sex, race/ethnicity, body mass index, and health plan, Dori Bilik of the University of Michigan, Ann Arbor, and colleagues, found that both of the thiazolidinediones (TZDs) were associated with a 71% increase in the risk of fracture for women aged 50 and older, according to the study, published July 14 online.

The investigators detected no such increase in risk for younger women. In men, TZDs alone showed no association with an increase in fracture risk. But men who took both TZDs and loop diuretics experienced a 3.5-fold increase in the risk of fractures.

TRIAD enrolled 11,927 patients with diabetes in 2000–2001. All were at least age 18 years and in managed care for at least 18 months before the baseline patient survey. The investigators analyzed data from patients with type 2 diabetes, excluding those who were diagnosed before age 30 and treated only with insulin. Among these patients were 786 with a diagnosis of fracture, which the investigators matched with 2,657 controls, up to 4 controls per case and followed for a mean of 1.9 years.

“Our study shows that increased fracture risk is associated with higher TZD dose, but no difference between rosiglitazone and pioglitazone is apparent, suggesting a class effect of TZDs on fracture risk,” said senior author Dr. William Herman of the University of Michigan Ann Arbor, in a prepared statement. “Physicians should be aware of this risk and weigh the benefits and risks of therapy when they initially prescribe or renew prescriptions for TZDs.”

Researchers found a dose-response relationship between TZDs and fracture risk. Higher TZD doses were associated with a significant 42% increase in the odds of fractures for women aged 50 years and older, but not for women under 50 years or for men (J. Clin. Endocrinol. Metab. 2010 July 14 [doi:10.1210/jc2009-2638]).

Major Finding: Both rosiglitazone and pioglitazone are associated with a 71% increase in the risk of fracture in diabetic women 50 years of age and older. In men with diabetes, there is a 3.5-fold increase in the risk of fracture when TZDs are used together with loop diuretics, but not when TZDs are used alone.

Data Source: Case-control study involving 786 cases of fractures and 2,657 matched controls in patients with type 2 diabetes.

Disclosures: The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases funded the study. The authors did not report other conflicts of interest.

Rosiglitazone and pioglitazone are both associated with an increased risk of fracture in postmenopausal women with type 2 diabetes, according to a matched case-control study that used data from the Translating Research into Action for Diabetes (TRIAD) trial.

After controlling for age, sex, race/ethnicity, body mass index, and health plan, Dori Bilik of the University of Michigan, Ann Arbor, and colleagues, found that both of the thiazolidinediones (TZDs) were associated with a 71% increase in the risk of fracture for women aged 50 and older, according to the study, published July 14 online.

The investigators detected no such increase in risk for younger women. In men, TZDs alone showed no association with an increase in fracture risk. But men who took both TZDs and loop diuretics experienced a 3.5-fold increase in the risk of fractures.

TRIAD enrolled 11,927 patients with diabetes in 2000–2001. All were at least age 18 years and in managed care for at least 18 months before the baseline patient survey. The investigators analyzed data from patients with type 2 diabetes, excluding those who were diagnosed before age 30 and treated only with insulin. Among these patients were 786 with a diagnosis of fracture, which the investigators matched with 2,657 controls, up to 4 controls per case and followed for a mean of 1.9 years.

“Our study shows that increased fracture risk is associated with higher TZD dose, but no difference between rosiglitazone and pioglitazone is apparent, suggesting a class effect of TZDs on fracture risk,” said senior author Dr. William Herman of the University of Michigan Ann Arbor, in a prepared statement. “Physicians should be aware of this risk and weigh the benefits and risks of therapy when they initially prescribe or renew prescriptions for TZDs.”

Researchers found a dose-response relationship between TZDs and fracture risk. Higher TZD doses were associated with a significant 42% increase in the odds of fractures for women aged 50 years and older, but not for women under 50 years or for men (J. Clin. Endocrinol. Metab. 2010 July 14 [doi:10.1210/jc2009-2638]).

More men than women report nonmedical prescription opioid use, according to the results of a nationally representative survey of 55,279 individuals published online in Addictive Behaviors.

Men were significantly more likely to endorse lifetime nonmedical use of prescription opioids (15.9% vs. 11.2%) and past-year use (5.9% vs. 4.2%), according to Sudie E. Back, Ph.D., and colleagues at the Medical University of South Carolina, Charleston (Addict. Behav. 2010 June 22 [doi:10.1016/j.addbeh.2010.06.018

The investigators looked at data from the Substance Abuse and Mental Health Services Administration's 2006 National Survey on Drug Use and Health. Most of the participants were over age 35, white, employed, and married.

The investigators found no significant difference between men and women on the rates of opioid abuse or dependence. Among individuals who had used prescription opioids nonmedically during the past year, 13.2% met the criteria for current abuse or dependence.

In a multivariate analysis that controlled for numerous demographic factors, the investigators isolated several independent predictors of past-year nonmedical prescription opioid use. Among both men and women, nonmedical tranquilizer or sedative use was the strongest predictor, with adjusted odds ratios of 16.4 for men and 16.5 for women. Among men, but not women, use of heroin, cocaine, or hallucinogens, and illicit drug or alcohol use or dependence were significant independent predictors of past-year nonmedical prescription opioid use. Among women, but not men, serious psychological distress and cigarette use were significant independent predictors.

For both men and women, younger age was an independent predictor of prescription opioid use and abuse, with the age group 18-25 at the highest risk. “Given that young age is a consistent correlate of the initiation of nonmedical prescription opioid use as well as abuse/dependence, urgent attention focused on adolescents and young adults is warranted,” the authors wrote.

More men than women report nonmedical prescription opioid use, according to the results of a nationally representative survey of 55,279 individuals published online in Addictive Behaviors.

Men were significantly more likely to endorse lifetime nonmedical use of prescription opioids (15.9% vs. 11.2%) and past-year use (5.9% vs. 4.2%), according to Sudie E. Back, Ph.D., and colleagues at the Medical University of South Carolina, Charleston (Addict. Behav. 2010 June 22 [doi:10.1016/j.addbeh.2010.06.018

The investigators looked at data from the Substance Abuse and Mental Health Services Administration's 2006 National Survey on Drug Use and Health. Most of the participants were over age 35, white, employed, and married.

The investigators found no significant difference between men and women on the rates of opioid abuse or dependence. Among individuals who had used prescription opioids nonmedically during the past year, 13.2% met the criteria for current abuse or dependence.

In a multivariate analysis that controlled for numerous demographic factors, the investigators isolated several independent predictors of past-year nonmedical prescription opioid use. Among both men and women, nonmedical tranquilizer or sedative use was the strongest predictor, with adjusted odds ratios of 16.4 for men and 16.5 for women. Among men, but not women, use of heroin, cocaine, or hallucinogens, and illicit drug or alcohol use or dependence were significant independent predictors of past-year nonmedical prescription opioid use. Among women, but not men, serious psychological distress and cigarette use were significant independent predictors.

For both men and women, younger age was an independent predictor of prescription opioid use and abuse, with the age group 18-25 at the highest risk. “Given that young age is a consistent correlate of the initiation of nonmedical prescription opioid use as well as abuse/dependence, urgent attention focused on adolescents and young adults is warranted,” the authors wrote.

More men than women report nonmedical prescription opioid use, according to the results of a nationally representative survey of 55,279 individuals published online in Addictive Behaviors.

Men were significantly more likely to endorse lifetime nonmedical use of prescription opioids (15.9% vs. 11.2%) and past-year use (5.9% vs. 4.2%), according to Sudie E. Back, Ph.D., and colleagues at the Medical University of South Carolina, Charleston (Addict. Behav. 2010 June 22 [doi:10.1016/j.addbeh.2010.06.018

The investigators looked at data from the Substance Abuse and Mental Health Services Administration's 2006 National Survey on Drug Use and Health. Most of the participants were over age 35, white, employed, and married.

The investigators found no significant difference between men and women on the rates of opioid abuse or dependence. Among individuals who had used prescription opioids nonmedically during the past year, 13.2% met the criteria for current abuse or dependence.

In a multivariate analysis that controlled for numerous demographic factors, the investigators isolated several independent predictors of past-year nonmedical prescription opioid use. Among both men and women, nonmedical tranquilizer or sedative use was the strongest predictor, with adjusted odds ratios of 16.4 for men and 16.5 for women. Among men, but not women, use of heroin, cocaine, or hallucinogens, and illicit drug or alcohol use or dependence were significant independent predictors of past-year nonmedical prescription opioid use. Among women, but not men, serious psychological distress and cigarette use were significant independent predictors.

For both men and women, younger age was an independent predictor of prescription opioid use and abuse, with the age group 18-25 at the highest risk. “Given that young age is a consistent correlate of the initiation of nonmedical prescription opioid use as well as abuse/dependence, urgent attention focused on adolescents and young adults is warranted,” the authors wrote.

Major Finding: Child psychiatrists report that insomnia is a major problem for 28% of the patients they see in a typical month. In a typical month, 96% of respondents recommended a prescription medication, and 88% recommended an over-the-counter medication.

Data Source: Surveys completed by 1,273 child psychiatrists during a 6-month period beginning in the fall of 2003.

Disclosures: The study was supported by an unrestricted grant from Sanofi-Aventis. The investigators disclosed that none of them received a salary or other compensation for this work.

Child psychiatrists report that nearly a third of the children they see in a typical month have insomnia as a major problem, according to a survey completed by 1,273 members of the American Academy of Child and Adolescent Psychiatry.

Virtually all (96.4%) of the respondents said that they prescribed at least one type of prescription drug for insomnia during a typical month, and 88.3% reported recommending at least one over-the-counter medication, wrote Dr. Judith A. Owens of Brown University in Providence, R.I., and her colleagues.

The study was published online (Sleep Med. 2010 [doi:10.1016/j.sleep.2009.11.015

Psychiatrists estimated that they treated insomnia with medications for 29% of the 13- to 18-year-old patients, 25% of the 6- to 12-year-olds, 17% of the 3- to 5-year-olds, and 3.5% of those aged 2 years and younger.

The relationship between medication use for insomnia and the child's age was statistically significant.

Among nonprescription medications, antihistamines were the most commonly recommended, followed by melatonin, herbals such as chamomile tea, and pain-reliever combinations such as Tylenol PM.

This order of preference was the same regardless of the patient's diagnosis.

Among prescription medications, on the other hand, significant differences were found in medication preferences depending on the patient's diagnosis. For children with attention-deficit/hyperactivity disorder (ADHD), 81% of psychiatrists prescribed an alpha-agonist such as clonidine, compared with 67% who prescribed an alpha-agonist for mental retardation/developmental delay (MR/DD) and autism spectrum disorders, 40% who prescribed a drug in this class for anxiety disorders, and 31% who prescribed it for mood disorders. The differences were statistically significant.

Child psychiatrists frequently used antidepressants–particularly sedating antidepressants–for insomnia, especially in patients with anxiety and mood disorders. Among the respondents, 85% said they used sedating antidepressants for insomnia in children with mood disorders, 82% used them in anxiety disorders, 76% in MR/DD and autism, and 71% in ADHD.

Slightly more than half of child psychiatrists (51%-52%) used atypical antipsychotics for insomnia in children with mood disorders or with MR/DD and autism. In contrast, only 33%-34% used atypical antipsychotics in children with ADHD or anxiety disorders.

Short-acting hypnotics were the choice of 42% of child psychiatrists treating children with mood disorders and 41% of those treating children with anxiety disorders. Child psychiatrists were significantly less likely to use short-acting hypnotics for children with MR/DD and autism (21%) or ADHD (18%).

Investigators sent the eight-page survey to 6,091 listed members of the American Academy of Child and Adolescent Psychiatry in the fall of 2003, with a reminder 1 month later to nonrespondents. In all, 1,601 surveys (26.3%) were returned, but only 1,273 (20.9%) were usable.

Psychiatrists with a greater number of years in practice were significantly less likely than their less experienced colleagues to prescribe medication for insomnia for patients in most categories.

Similarly, psychiatrists with an academic appointment at a medical school were significantly less likely to recommend medication than were psychiatrists in community settings.

The investigators noted that few well-designed, controlled studies have been published on the use of medications for insomnia in children.

This lack of information on efficacy, tolerability, dosing, and safety in children, “significantly hampers the rational clinical use of these medications in child psychiatry clinical practice,” they wrote.

“Clinical trials of these drugs are needed to establish effective dosing ranges, to address safety and tolerability issues, to assess withdrawal and discontinuation effects, and to determine the relative efficacy in terms of sleep induction and maintenance.”

Major Finding: Child psychiatrists report that insomnia is a major problem for 28% of the patients they see in a typical month. In a typical month, 96% of respondents recommended a prescription medication, and 88% recommended an over-the-counter medication.

Data Source: Surveys completed by 1,273 child psychiatrists during a 6-month period beginning in the fall of 2003.

Disclosures: The study was supported by an unrestricted grant from Sanofi-Aventis. The investigators disclosed that none of them received a salary or other compensation for this work.

Child psychiatrists report that nearly a third of the children they see in a typical month have insomnia as a major problem, according to a survey completed by 1,273 members of the American Academy of Child and Adolescent Psychiatry.

Virtually all (96.4%) of the respondents said that they prescribed at least one type of prescription drug for insomnia during a typical month, and 88.3% reported recommending at least one over-the-counter medication, wrote Dr. Judith A. Owens of Brown University in Providence, R.I., and her colleagues.

The study was published online (Sleep Med. 2010 [doi:10.1016/j.sleep.2009.11.015

Psychiatrists estimated that they treated insomnia with medications for 29% of the 13- to 18-year-old patients, 25% of the 6- to 12-year-olds, 17% of the 3- to 5-year-olds, and 3.5% of those aged 2 years and younger.

The relationship between medication use for insomnia and the child's age was statistically significant.

Among nonprescription medications, antihistamines were the most commonly recommended, followed by melatonin, herbals such as chamomile tea, and pain-reliever combinations such as Tylenol PM.

This order of preference was the same regardless of the patient's diagnosis.

Among prescription medications, on the other hand, significant differences were found in medication preferences depending on the patient's diagnosis. For children with attention-deficit/hyperactivity disorder (ADHD), 81% of psychiatrists prescribed an alpha-agonist such as clonidine, compared with 67% who prescribed an alpha-agonist for mental retardation/developmental delay (MR/DD) and autism spectrum disorders, 40% who prescribed a drug in this class for anxiety disorders, and 31% who prescribed it for mood disorders. The differences were statistically significant.

Child psychiatrists frequently used antidepressants–particularly sedating antidepressants–for insomnia, especially in patients with anxiety and mood disorders. Among the respondents, 85% said they used sedating antidepressants for insomnia in children with mood disorders, 82% used them in anxiety disorders, 76% in MR/DD and autism, and 71% in ADHD.

Slightly more than half of child psychiatrists (51%-52%) used atypical antipsychotics for insomnia in children with mood disorders or with MR/DD and autism. In contrast, only 33%-34% used atypical antipsychotics in children with ADHD or anxiety disorders.

Short-acting hypnotics were the choice of 42% of child psychiatrists treating children with mood disorders and 41% of those treating children with anxiety disorders. Child psychiatrists were significantly less likely to use short-acting hypnotics for children with MR/DD and autism (21%) or ADHD (18%).

Investigators sent the eight-page survey to 6,091 listed members of the American Academy of Child and Adolescent Psychiatry in the fall of 2003, with a reminder 1 month later to nonrespondents. In all, 1,601 surveys (26.3%) were returned, but only 1,273 (20.9%) were usable.

Psychiatrists with a greater number of years in practice were significantly less likely than their less experienced colleagues to prescribe medication for insomnia for patients in most categories.

Similarly, psychiatrists with an academic appointment at a medical school were significantly less likely to recommend medication than were psychiatrists in community settings.

The investigators noted that few well-designed, controlled studies have been published on the use of medications for insomnia in children.

This lack of information on efficacy, tolerability, dosing, and safety in children, “significantly hampers the rational clinical use of these medications in child psychiatry clinical practice,” they wrote.

“Clinical trials of these drugs are needed to establish effective dosing ranges, to address safety and tolerability issues, to assess withdrawal and discontinuation effects, and to determine the relative efficacy in terms of sleep induction and maintenance.”

Major Finding: Child psychiatrists report that insomnia is a major problem for 28% of the patients they see in a typical month. In a typical month, 96% of respondents recommended a prescription medication, and 88% recommended an over-the-counter medication.

Data Source: Surveys completed by 1,273 child psychiatrists during a 6-month period beginning in the fall of 2003.

Disclosures: The study was supported by an unrestricted grant from Sanofi-Aventis. The investigators disclosed that none of them received a salary or other compensation for this work.

Child psychiatrists report that nearly a third of the children they see in a typical month have insomnia as a major problem, according to a survey completed by 1,273 members of the American Academy of Child and Adolescent Psychiatry.

Virtually all (96.4%) of the respondents said that they prescribed at least one type of prescription drug for insomnia during a typical month, and 88.3% reported recommending at least one over-the-counter medication, wrote Dr. Judith A. Owens of Brown University in Providence, R.I., and her colleagues.

The study was published online (Sleep Med. 2010 [doi:10.1016/j.sleep.2009.11.015

Psychiatrists estimated that they treated insomnia with medications for 29% of the 13- to 18-year-old patients, 25% of the 6- to 12-year-olds, 17% of the 3- to 5-year-olds, and 3.5% of those aged 2 years and younger.

The relationship between medication use for insomnia and the child's age was statistically significant.

Among nonprescription medications, antihistamines were the most commonly recommended, followed by melatonin, herbals such as chamomile tea, and pain-reliever combinations such as Tylenol PM.

This order of preference was the same regardless of the patient's diagnosis.

Among prescription medications, on the other hand, significant differences were found in medication preferences depending on the patient's diagnosis. For children with attention-deficit/hyperactivity disorder (ADHD), 81% of psychiatrists prescribed an alpha-agonist such as clonidine, compared with 67% who prescribed an alpha-agonist for mental retardation/developmental delay (MR/DD) and autism spectrum disorders, 40% who prescribed a drug in this class for anxiety disorders, and 31% who prescribed it for mood disorders. The differences were statistically significant.

Child psychiatrists frequently used antidepressants–particularly sedating antidepressants–for insomnia, especially in patients with anxiety and mood disorders. Among the respondents, 85% said they used sedating antidepressants for insomnia in children with mood disorders, 82% used them in anxiety disorders, 76% in MR/DD and autism, and 71% in ADHD.

Slightly more than half of child psychiatrists (51%-52%) used atypical antipsychotics for insomnia in children with mood disorders or with MR/DD and autism. In contrast, only 33%-34% used atypical antipsychotics in children with ADHD or anxiety disorders.

Short-acting hypnotics were the choice of 42% of child psychiatrists treating children with mood disorders and 41% of those treating children with anxiety disorders. Child psychiatrists were significantly less likely to use short-acting hypnotics for children with MR/DD and autism (21%) or ADHD (18%).

Investigators sent the eight-page survey to 6,091 listed members of the American Academy of Child and Adolescent Psychiatry in the fall of 2003, with a reminder 1 month later to nonrespondents. In all, 1,601 surveys (26.3%) were returned, but only 1,273 (20.9%) were usable.

Psychiatrists with a greater number of years in practice were significantly less likely than their less experienced colleagues to prescribe medication for insomnia for patients in most categories.

Similarly, psychiatrists with an academic appointment at a medical school were significantly less likely to recommend medication than were psychiatrists in community settings.

The investigators noted that few well-designed, controlled studies have been published on the use of medications for insomnia in children.

This lack of information on efficacy, tolerability, dosing, and safety in children, “significantly hampers the rational clinical use of these medications in child psychiatry clinical practice,” they wrote.

“Clinical trials of these drugs are needed to establish effective dosing ranges, to address safety and tolerability issues, to assess withdrawal and discontinuation effects, and to determine the relative efficacy in terms of sleep induction and maintenance.”