Jane Salodof MacNeil

SAN FRANCISCO — Children younger than 2 years with acute otitis media in both ears constitute the pediatric population most likely to benefit from antibiotic treatment of this common childhood infection, according to the findings of a metaanalysis presented at the annual meeting of the Pediatric Academic Societies.

“For most other children—older children and children with unilateral acute otitis media—an observational policy seems justified,” said Maroeska M. Rovers, Ph.D., the lead author of the study.

Dr. Rovers, an epidemiologist in the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht (the Netherlands), based this conclusion on the experience of 824 untreated children in the control groups of six randomized trials in the metaanalysis.

Untreated children younger than 2 years with bilateral acute otitis media (AOM) were twice as likely to suffer pain and/or fever at 3–7 days, according to Dr. Rovers and her coinvestigators. She reported that the independent predictors of having pain at 3–7 days were an age younger than 2 years (odds ratio 2.07) and bilateral AOM (odds ratio 1.70).

More than half (55%) of 134 children younger than 2 years with bilateral AOM still had pain and/or fever in the target time period, she said. Only 30% of similar children suffered from these symptoms 3–7 days after receiving antibiotic treatment in the six trials.

Dr. Rovers said a need-to-treat analysis found that giving antibiotics to just four children younger than 2 years with bilateral AOM would be enough to prevent pain and/or fever in one child.

For children who were younger than 2 years but had AOM in only one ear, the benefit was much more modest. Of 132 untreated children, 40% continued to have symptoms vs. 35% of their counterparts who were given antibiotics in the trials. Dr. Rovers said that physicians would need to give antibiotics to 20 children with unilateral AOM in this age group to prevent prolonged pain and fever in one child.

Among untreated children 2 years of age and older, 86 had bilateral AOM. More than a third (35%) continued to have fever and/or pain in the 3- to 7-day window.

As symptoms persisted in 23% of comparable children who were treated with antibiotics, Dr. Rovers said that physicians would have to give antibiotics to nine children with bilateral AOM in this age group to prevent extended pain and fever in one child.

Most older children with unilateral AOM had neither pain nor fever at 3–7 days; only 26% of 308 children in the control groups and 19% of those treated with antibiotics continued to suffer these symptoms. Physicians would have to treat 25 children with antibiotics to prevent late pain and fever in one older child with unilateral AOM, according to the need-to-treat analysis.

The randomized controlled trials, conducted in the United Kingdom, the United States, Canada, and the Netherlands, were selected from 19 randomized trials found by the multinational group of investigators. Data were not available for four trials and nine were excluded for such reasons as inadequate randomization, special population, or lack of information on the outcome studied in the metaanalysis.

Demographic data on the 824 untreated children available for the analysis showed that 35% were younger than 2 years old, half were boys, and 27% had bilateral AOM. At the outset of the trials, 35% had fever and 88% had ear pain.

In an interview at the meeting—which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics—Dr. Rovers said she felt confident that the results are “quite stable.” She hoped they would be helpful to physicians trying to discriminate between children with mild, self-limiting episodes of AOM and those who are at risk of prolonged illness and possibly complications if not treated with antibiotics.

SAN FRANCISCO — Children younger than 2 years with acute otitis media in both ears constitute the pediatric population most likely to benefit from antibiotic treatment of this common childhood infection, according to the findings of a metaanalysis presented at the annual meeting of the Pediatric Academic Societies.

“For most other children—older children and children with unilateral acute otitis media—an observational policy seems justified,” said Maroeska M. Rovers, Ph.D., the lead author of the study.

Dr. Rovers, an epidemiologist in the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht (the Netherlands), based this conclusion on the experience of 824 untreated children in the control groups of six randomized trials in the metaanalysis.

Untreated children younger than 2 years with bilateral acute otitis media (AOM) were twice as likely to suffer pain and/or fever at 3–7 days, according to Dr. Rovers and her coinvestigators. She reported that the independent predictors of having pain at 3–7 days were an age younger than 2 years (odds ratio 2.07) and bilateral AOM (odds ratio 1.70).

More than half (55%) of 134 children younger than 2 years with bilateral AOM still had pain and/or fever in the target time period, she said. Only 30% of similar children suffered from these symptoms 3–7 days after receiving antibiotic treatment in the six trials.

Dr. Rovers said a need-to-treat analysis found that giving antibiotics to just four children younger than 2 years with bilateral AOM would be enough to prevent pain and/or fever in one child.

For children who were younger than 2 years but had AOM in only one ear, the benefit was much more modest. Of 132 untreated children, 40% continued to have symptoms vs. 35% of their counterparts who were given antibiotics in the trials. Dr. Rovers said that physicians would need to give antibiotics to 20 children with unilateral AOM in this age group to prevent prolonged pain and fever in one child.

Among untreated children 2 years of age and older, 86 had bilateral AOM. More than a third (35%) continued to have fever and/or pain in the 3- to 7-day window.

As symptoms persisted in 23% of comparable children who were treated with antibiotics, Dr. Rovers said that physicians would have to give antibiotics to nine children with bilateral AOM in this age group to prevent extended pain and fever in one child.

Most older children with unilateral AOM had neither pain nor fever at 3–7 days; only 26% of 308 children in the control groups and 19% of those treated with antibiotics continued to suffer these symptoms. Physicians would have to treat 25 children with antibiotics to prevent late pain and fever in one older child with unilateral AOM, according to the need-to-treat analysis.

The randomized controlled trials, conducted in the United Kingdom, the United States, Canada, and the Netherlands, were selected from 19 randomized trials found by the multinational group of investigators. Data were not available for four trials and nine were excluded for such reasons as inadequate randomization, special population, or lack of information on the outcome studied in the metaanalysis.

Demographic data on the 824 untreated children available for the analysis showed that 35% were younger than 2 years old, half were boys, and 27% had bilateral AOM. At the outset of the trials, 35% had fever and 88% had ear pain.

In an interview at the meeting—which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics—Dr. Rovers said she felt confident that the results are “quite stable.” She hoped they would be helpful to physicians trying to discriminate between children with mild, self-limiting episodes of AOM and those who are at risk of prolonged illness and possibly complications if not treated with antibiotics.

SAN FRANCISCO — Children younger than 2 years with acute otitis media in both ears constitute the pediatric population most likely to benefit from antibiotic treatment of this common childhood infection, according to the findings of a metaanalysis presented at the annual meeting of the Pediatric Academic Societies.

“For most other children—older children and children with unilateral acute otitis media—an observational policy seems justified,” said Maroeska M. Rovers, Ph.D., the lead author of the study.

Dr. Rovers, an epidemiologist in the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht (the Netherlands), based this conclusion on the experience of 824 untreated children in the control groups of six randomized trials in the metaanalysis.

Untreated children younger than 2 years with bilateral acute otitis media (AOM) were twice as likely to suffer pain and/or fever at 3–7 days, according to Dr. Rovers and her coinvestigators. She reported that the independent predictors of having pain at 3–7 days were an age younger than 2 years (odds ratio 2.07) and bilateral AOM (odds ratio 1.70).

More than half (55%) of 134 children younger than 2 years with bilateral AOM still had pain and/or fever in the target time period, she said. Only 30% of similar children suffered from these symptoms 3–7 days after receiving antibiotic treatment in the six trials.

Dr. Rovers said a need-to-treat analysis found that giving antibiotics to just four children younger than 2 years with bilateral AOM would be enough to prevent pain and/or fever in one child.

For children who were younger than 2 years but had AOM in only one ear, the benefit was much more modest. Of 132 untreated children, 40% continued to have symptoms vs. 35% of their counterparts who were given antibiotics in the trials. Dr. Rovers said that physicians would need to give antibiotics to 20 children with unilateral AOM in this age group to prevent prolonged pain and fever in one child.

Among untreated children 2 years of age and older, 86 had bilateral AOM. More than a third (35%) continued to have fever and/or pain in the 3- to 7-day window.

As symptoms persisted in 23% of comparable children who were treated with antibiotics, Dr. Rovers said that physicians would have to give antibiotics to nine children with bilateral AOM in this age group to prevent extended pain and fever in one child.

Most older children with unilateral AOM had neither pain nor fever at 3–7 days; only 26% of 308 children in the control groups and 19% of those treated with antibiotics continued to suffer these symptoms. Physicians would have to treat 25 children with antibiotics to prevent late pain and fever in one older child with unilateral AOM, according to the need-to-treat analysis.

The randomized controlled trials, conducted in the United Kingdom, the United States, Canada, and the Netherlands, were selected from 19 randomized trials found by the multinational group of investigators. Data were not available for four trials and nine were excluded for such reasons as inadequate randomization, special population, or lack of information on the outcome studied in the metaanalysis.

Demographic data on the 824 untreated children available for the analysis showed that 35% were younger than 2 years old, half were boys, and 27% had bilateral AOM. At the outset of the trials, 35% had fever and 88% had ear pain.

In an interview at the meeting—which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics—Dr. Rovers said she felt confident that the results are “quite stable.” She hoped they would be helpful to physicians trying to discriminate between children with mild, self-limiting episodes of AOM and those who are at risk of prolonged illness and possibly complications if not treated with antibiotics.

PARIS — Investigators have reported that an experimental on-demand drug for premature ejaculation was well tolerated in a 9-month open-label extension of two 12-week randomized controlled trials supporting its effectiveness.

A total of 962 (54.2%) of 1,774 participants stayed on dapoxetine hydrochloride for a full year, according to a poster presented by Dr. Wayne Hellstrom at the annual congress of the European Association of Urology.

The 812 dropouts (45.8%) included 227 men (12.8%) who withdrew because of lack of efficacy and 119 (6.7%) who quit because of adverse events. Another 175 men (9.9%) were lost to follow-up.

“People move. People have different reasons to drop out. For a 12-month study to maintain 54% of the patients on a drug is pretty good,” Dr. Hellstrom, a professor of urology and chief of andrology at Tulane University in New Orleans, told a physician in the audience who questioned the study's dropout rate during a discussion of the poster.

Dapoxetine's developer, Alza Corporation, announced in October 2005 that the Food and Drug Administration had sent a “not approvable” letter in response to Alza's new drug application for dapoxetine. Dr. Hellstrom said that he did not know the reason for the rejection but that he had been told the company plans to reapply.

No medications are currently approved for premature ejaculation in the United States or in Europe, according to Dr. Hellstrom. He said selective serotonin reuptake inhibitors are sometimes prescribed.

“The problem is there are side effects,” he said. “Patients have to take [SSRIs] for 2 weeks to get inhibition.”

Phosphodiesterase-5 inhibitors also are used occasionally, he said, with the qualification that there is little evidence to support use of erectile dysfunction drugs for premature ejaculation.

Dapoxetine is a serotonin transporter inhibitor designed to increase intravaginal ejaculatory latency time (IELT) with a single dose taken 1–3 hours before intercourse.

The initial 12-week double-blind multicenter studies enrolled men 18 years of age and older who were in a stable, monogamous relationship for at least 6 months and met diagnostic criteria for premature ejaculation. All had an IELT of 2 minutes or less as measured with a stopwatch by their female partners in at least 75% of intercourse episodes during a 2-week period. In self-reports, the men characterized their premature ejaculation as moderate or severe.

The men were randomized to 30-mg or 60-mg doses of dapoxetine or placebo in the initial trials, which reported that dapoxetine was effective.

The 9-month open-label extension study enrolled men from September 2003 to April 2005. All participants started on a 60-mg dose 1–3 hours before intercourse, regardless of the treatment to which they were assigned in the first set of trials.

Investigators were allowed to reduce the dapoxetine dose to 30 mg in patients who did not tolerate 60 mg or requested a lower dose. Adverse events led to reduction of the dose for 192 men. In two other men, the dose was lowered by request.

The most common adverse events during the extension study were nausea in 265 men (14.9%), dizziness in 90 men (5.1%), and diarrhea in 82 men (4.6%). Other side effects occurring in 2% or more of the population were headache, somnolence, insomnia, dyspepsia, and asthenia.

Three men had serious treatment-related adverse events: one case each of syncope, seizure, and a syncopal episode.

“With the 9-month extension, there wasn't any difference from the first 3 months,” Dr. Hellstrom said, reporting that no new safety concerns emerged with longer use of dapoxetine.

He said he serves on the speakers' bureau and is a consultant to Alza Corporation, which supported the study.

PARIS — Investigators have reported that an experimental on-demand drug for premature ejaculation was well tolerated in a 9-month open-label extension of two 12-week randomized controlled trials supporting its effectiveness.

A total of 962 (54.2%) of 1,774 participants stayed on dapoxetine hydrochloride for a full year, according to a poster presented by Dr. Wayne Hellstrom at the annual congress of the European Association of Urology.

The 812 dropouts (45.8%) included 227 men (12.8%) who withdrew because of lack of efficacy and 119 (6.7%) who quit because of adverse events. Another 175 men (9.9%) were lost to follow-up.

“People move. People have different reasons to drop out. For a 12-month study to maintain 54% of the patients on a drug is pretty good,” Dr. Hellstrom, a professor of urology and chief of andrology at Tulane University in New Orleans, told a physician in the audience who questioned the study's dropout rate during a discussion of the poster.

Dapoxetine's developer, Alza Corporation, announced in October 2005 that the Food and Drug Administration had sent a “not approvable” letter in response to Alza's new drug application for dapoxetine. Dr. Hellstrom said that he did not know the reason for the rejection but that he had been told the company plans to reapply.

No medications are currently approved for premature ejaculation in the United States or in Europe, according to Dr. Hellstrom. He said selective serotonin reuptake inhibitors are sometimes prescribed.

“The problem is there are side effects,” he said. “Patients have to take [SSRIs] for 2 weeks to get inhibition.”

Phosphodiesterase-5 inhibitors also are used occasionally, he said, with the qualification that there is little evidence to support use of erectile dysfunction drugs for premature ejaculation.

Dapoxetine is a serotonin transporter inhibitor designed to increase intravaginal ejaculatory latency time (IELT) with a single dose taken 1–3 hours before intercourse.

The initial 12-week double-blind multicenter studies enrolled men 18 years of age and older who were in a stable, monogamous relationship for at least 6 months and met diagnostic criteria for premature ejaculation. All had an IELT of 2 minutes or less as measured with a stopwatch by their female partners in at least 75% of intercourse episodes during a 2-week period. In self-reports, the men characterized their premature ejaculation as moderate or severe.

The men were randomized to 30-mg or 60-mg doses of dapoxetine or placebo in the initial trials, which reported that dapoxetine was effective.

The 9-month open-label extension study enrolled men from September 2003 to April 2005. All participants started on a 60-mg dose 1–3 hours before intercourse, regardless of the treatment to which they were assigned in the first set of trials.

Investigators were allowed to reduce the dapoxetine dose to 30 mg in patients who did not tolerate 60 mg or requested a lower dose. Adverse events led to reduction of the dose for 192 men. In two other men, the dose was lowered by request.

The most common adverse events during the extension study were nausea in 265 men (14.9%), dizziness in 90 men (5.1%), and diarrhea in 82 men (4.6%). Other side effects occurring in 2% or more of the population were headache, somnolence, insomnia, dyspepsia, and asthenia.

Three men had serious treatment-related adverse events: one case each of syncope, seizure, and a syncopal episode.

“With the 9-month extension, there wasn't any difference from the first 3 months,” Dr. Hellstrom said, reporting that no new safety concerns emerged with longer use of dapoxetine.

He said he serves on the speakers' bureau and is a consultant to Alza Corporation, which supported the study.

PARIS — Investigators have reported that an experimental on-demand drug for premature ejaculation was well tolerated in a 9-month open-label extension of two 12-week randomized controlled trials supporting its effectiveness.

A total of 962 (54.2%) of 1,774 participants stayed on dapoxetine hydrochloride for a full year, according to a poster presented by Dr. Wayne Hellstrom at the annual congress of the European Association of Urology.

The 812 dropouts (45.8%) included 227 men (12.8%) who withdrew because of lack of efficacy and 119 (6.7%) who quit because of adverse events. Another 175 men (9.9%) were lost to follow-up.

“People move. People have different reasons to drop out. For a 12-month study to maintain 54% of the patients on a drug is pretty good,” Dr. Hellstrom, a professor of urology and chief of andrology at Tulane University in New Orleans, told a physician in the audience who questioned the study's dropout rate during a discussion of the poster.

Dapoxetine's developer, Alza Corporation, announced in October 2005 that the Food and Drug Administration had sent a “not approvable” letter in response to Alza's new drug application for dapoxetine. Dr. Hellstrom said that he did not know the reason for the rejection but that he had been told the company plans to reapply.

No medications are currently approved for premature ejaculation in the United States or in Europe, according to Dr. Hellstrom. He said selective serotonin reuptake inhibitors are sometimes prescribed.

“The problem is there are side effects,” he said. “Patients have to take [SSRIs] for 2 weeks to get inhibition.”

Phosphodiesterase-5 inhibitors also are used occasionally, he said, with the qualification that there is little evidence to support use of erectile dysfunction drugs for premature ejaculation.

Dapoxetine is a serotonin transporter inhibitor designed to increase intravaginal ejaculatory latency time (IELT) with a single dose taken 1–3 hours before intercourse.

The initial 12-week double-blind multicenter studies enrolled men 18 years of age and older who were in a stable, monogamous relationship for at least 6 months and met diagnostic criteria for premature ejaculation. All had an IELT of 2 minutes or less as measured with a stopwatch by their female partners in at least 75% of intercourse episodes during a 2-week period. In self-reports, the men characterized their premature ejaculation as moderate or severe.

The men were randomized to 30-mg or 60-mg doses of dapoxetine or placebo in the initial trials, which reported that dapoxetine was effective.

The 9-month open-label extension study enrolled men from September 2003 to April 2005. All participants started on a 60-mg dose 1–3 hours before intercourse, regardless of the treatment to which they were assigned in the first set of trials.

Investigators were allowed to reduce the dapoxetine dose to 30 mg in patients who did not tolerate 60 mg or requested a lower dose. Adverse events led to reduction of the dose for 192 men. In two other men, the dose was lowered by request.

The most common adverse events during the extension study were nausea in 265 men (14.9%), dizziness in 90 men (5.1%), and diarrhea in 82 men (4.6%). Other side effects occurring in 2% or more of the population were headache, somnolence, insomnia, dyspepsia, and asthenia.

Three men had serious treatment-related adverse events: one case each of syncope, seizure, and a syncopal episode.

“With the 9-month extension, there wasn't any difference from the first 3 months,” Dr. Hellstrom said, reporting that no new safety concerns emerged with longer use of dapoxetine.

He said he serves on the speakers' bureau and is a consultant to Alza Corporation, which supported the study.

SAN FRANCISCO — Children younger than 2 years with acute otitis media in both ears constitute the pediatric population most likely to benefit from antibiotic treatment of this common childhood infection, according to the findings of a metaanalysis presented at the annual meeting of the Pediatric Academic Societies.

“For most other children—older children and children with unilateral acute otitis media—an observational policy seems justified,” said Maroeska M. Rovers, Ph.D., the lead author of the study.

Dr. Rovers, an epidemiologist in the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht (the Netherlands), based this conclusion on the experience of 824 untreated children in the control groups of six randomized trials in the metaanalysis.

Untreated children younger than 2 years with bilateral acute otitis media (AOM) were twice as likely to suffer pain and/or fever at 3–7 days, according to Dr. Rovers and her coinvestigators. She reported that the independent predictors of having pain at 3–7 days were an age younger than 2 years (odds ratio 2.07) and bilateral AOM (odds ratio 1.70).

More than half (55%) of 134 children younger than 2 years with bilateral AOM still had pain and/or fever in the target time period, she said. Only 30% of similar children suffered from these symptoms 3–7 days after receiving antibiotic treatment in the six trials.

Dr. Rovers said a need-to-treat analysis found that giving antibiotics to just four children younger than 2 years with bilateral AOM would be enough to prevent pain and/or fever in one child.

For children who were younger than 2 years but had AOM in only one ear, the benefit was much more modest. Of 132 untreated children, 40% continued to have symptoms vs. 35% of their counterparts who were given antibiotics in the trials. Dr. Rovers said that physicians would need to give antibiotics to 20 children with unilateral AOM in this age group to prevent prolonged pain and fever in one child.

Among untreated children 2 years of age and older, 86 had bilateral AOM. More than a third (35%) continued to have fever and/or pain in the 3–7 day window.

As symptoms persisted in 23% of comparable children who were treated with antibiotics, Dr. Rovers said that physicians would have to give antibiotics to nine children with bilateral AOM in this age group to prevent extended pain and fever in one child.

Most older children with unilateral AOM had neither pain nor fever at 3–7 days; only 26% of 308 children in the control groups and 19% of those treated with antibiotics continued to suffer these symptoms. Physicians would have to treat 25 children with antibiotics to prevent late pain and fever in one older child with unilateral AOM, according to the need-to-treat analysis.

Dr. Rovers said the randomized controlled trials were conducted in the United Kingdom, the United States, Canada, and the Netherlands. They were selected from 19 randomized trials found by the multinational group of investigators. Data were not available for four trials, she said, and nine were excluded for such reasons as inadequate randomization, special population, or lack of information on the outcome studied in the metaanalysis.

Demographic data on the 824 untreated children available for the analysis showed that 35% were younger than 2 years old, half were boys, and 27% had bilateral AOM. At the outset of the trials, 35% had fever and 88% had ear pain.

In an interview at the meeting—which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics—Dr. Rovers said she felt confident that the results are “quite stable.”

Dr. Rovers added that she hoped the findings would be helpful to physicians trying to discriminate between children with mild, self-limiting episodes of AOM and those who are at risk of prolonged illness and possibly complications if not treated with antibiotics.

SAN FRANCISCO — Children younger than 2 years with acute otitis media in both ears constitute the pediatric population most likely to benefit from antibiotic treatment of this common childhood infection, according to the findings of a metaanalysis presented at the annual meeting of the Pediatric Academic Societies.

“For most other children—older children and children with unilateral acute otitis media—an observational policy seems justified,” said Maroeska M. Rovers, Ph.D., the lead author of the study.

Dr. Rovers, an epidemiologist in the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht (the Netherlands), based this conclusion on the experience of 824 untreated children in the control groups of six randomized trials in the metaanalysis.

Untreated children younger than 2 years with bilateral acute otitis media (AOM) were twice as likely to suffer pain and/or fever at 3–7 days, according to Dr. Rovers and her coinvestigators. She reported that the independent predictors of having pain at 3–7 days were an age younger than 2 years (odds ratio 2.07) and bilateral AOM (odds ratio 1.70).

More than half (55%) of 134 children younger than 2 years with bilateral AOM still had pain and/or fever in the target time period, she said. Only 30% of similar children suffered from these symptoms 3–7 days after receiving antibiotic treatment in the six trials.

Dr. Rovers said a need-to-treat analysis found that giving antibiotics to just four children younger than 2 years with bilateral AOM would be enough to prevent pain and/or fever in one child.

For children who were younger than 2 years but had AOM in only one ear, the benefit was much more modest. Of 132 untreated children, 40% continued to have symptoms vs. 35% of their counterparts who were given antibiotics in the trials. Dr. Rovers said that physicians would need to give antibiotics to 20 children with unilateral AOM in this age group to prevent prolonged pain and fever in one child.

Among untreated children 2 years of age and older, 86 had bilateral AOM. More than a third (35%) continued to have fever and/or pain in the 3–7 day window.

As symptoms persisted in 23% of comparable children who were treated with antibiotics, Dr. Rovers said that physicians would have to give antibiotics to nine children with bilateral AOM in this age group to prevent extended pain and fever in one child.

Most older children with unilateral AOM had neither pain nor fever at 3–7 days; only 26% of 308 children in the control groups and 19% of those treated with antibiotics continued to suffer these symptoms. Physicians would have to treat 25 children with antibiotics to prevent late pain and fever in one older child with unilateral AOM, according to the need-to-treat analysis.

Dr. Rovers said the randomized controlled trials were conducted in the United Kingdom, the United States, Canada, and the Netherlands. They were selected from 19 randomized trials found by the multinational group of investigators. Data were not available for four trials, she said, and nine were excluded for such reasons as inadequate randomization, special population, or lack of information on the outcome studied in the metaanalysis.

Demographic data on the 824 untreated children available for the analysis showed that 35% were younger than 2 years old, half were boys, and 27% had bilateral AOM. At the outset of the trials, 35% had fever and 88% had ear pain.

In an interview at the meeting—which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics—Dr. Rovers said she felt confident that the results are “quite stable.”

Dr. Rovers added that she hoped the findings would be helpful to physicians trying to discriminate between children with mild, self-limiting episodes of AOM and those who are at risk of prolonged illness and possibly complications if not treated with antibiotics.

SAN FRANCISCO — Children younger than 2 years with acute otitis media in both ears constitute the pediatric population most likely to benefit from antibiotic treatment of this common childhood infection, according to the findings of a metaanalysis presented at the annual meeting of the Pediatric Academic Societies.

“For most other children—older children and children with unilateral acute otitis media—an observational policy seems justified,” said Maroeska M. Rovers, Ph.D., the lead author of the study.

Dr. Rovers, an epidemiologist in the Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht (the Netherlands), based this conclusion on the experience of 824 untreated children in the control groups of six randomized trials in the metaanalysis.

Untreated children younger than 2 years with bilateral acute otitis media (AOM) were twice as likely to suffer pain and/or fever at 3–7 days, according to Dr. Rovers and her coinvestigators. She reported that the independent predictors of having pain at 3–7 days were an age younger than 2 years (odds ratio 2.07) and bilateral AOM (odds ratio 1.70).

More than half (55%) of 134 children younger than 2 years with bilateral AOM still had pain and/or fever in the target time period, she said. Only 30% of similar children suffered from these symptoms 3–7 days after receiving antibiotic treatment in the six trials.

Dr. Rovers said a need-to-treat analysis found that giving antibiotics to just four children younger than 2 years with bilateral AOM would be enough to prevent pain and/or fever in one child.

For children who were younger than 2 years but had AOM in only one ear, the benefit was much more modest. Of 132 untreated children, 40% continued to have symptoms vs. 35% of their counterparts who were given antibiotics in the trials. Dr. Rovers said that physicians would need to give antibiotics to 20 children with unilateral AOM in this age group to prevent prolonged pain and fever in one child.

Among untreated children 2 years of age and older, 86 had bilateral AOM. More than a third (35%) continued to have fever and/or pain in the 3–7 day window.

As symptoms persisted in 23% of comparable children who were treated with antibiotics, Dr. Rovers said that physicians would have to give antibiotics to nine children with bilateral AOM in this age group to prevent extended pain and fever in one child.

Most older children with unilateral AOM had neither pain nor fever at 3–7 days; only 26% of 308 children in the control groups and 19% of those treated with antibiotics continued to suffer these symptoms. Physicians would have to treat 25 children with antibiotics to prevent late pain and fever in one older child with unilateral AOM, according to the need-to-treat analysis.

Dr. Rovers said the randomized controlled trials were conducted in the United Kingdom, the United States, Canada, and the Netherlands. They were selected from 19 randomized trials found by the multinational group of investigators. Data were not available for four trials, she said, and nine were excluded for such reasons as inadequate randomization, special population, or lack of information on the outcome studied in the metaanalysis.

Demographic data on the 824 untreated children available for the analysis showed that 35% were younger than 2 years old, half were boys, and 27% had bilateral AOM. At the outset of the trials, 35% had fever and 88% had ear pain.

In an interview at the meeting—which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics—Dr. Rovers said she felt confident that the results are “quite stable.”

Dr. Rovers added that she hoped the findings would be helpful to physicians trying to discriminate between children with mild, self-limiting episodes of AOM and those who are at risk of prolonged illness and possibly complications if not treated with antibiotics.

PARIS — The α-1 blocker alfuzosin prevented overall clinical progression of benign prostatic hyperplasia but had no impact on acute urinary retention in a 2-year, double-blind, placebo-controlled, multinational study that enrolled 1,522 men at high risk of serious outcomes.

Alfuzosin (Uroxatral) reduced the relative risk for any worsening of lower urinary tract symptoms by 26%, according to data reported by Dr. Claus Roehrborn at the annual congress of the European Association of Urology.

A total of 289 patients in both arms of the study had at least one event signalling progression. Symptom deterioration was the most common, occurring in 215 men, followed by surgery related to benign prostatic hyperplasia (BPH) in 87 men and acute urinary retention in 30 men. The overall incidence of events was 16.3% of 754 men on alfuzosin vs. 22.1% of 761 men on placebo.

Dr. Roehrborn of the University of Texas Southwestern Medical Center at Dallas presented the results on behalf of the Alfuzosin Long-Term Efficacy and Safety Study (ALTESS) study group.

He reported that alfuzosin was associated with a 30% reduction in the relative risk of the International Prostate Symptom Score (IPSS) worsening by at least four points. The cumulative incidence of this measure was 11.7% in the alfuzosin arm vs. 16.8% of placebo patients. Patients on alfuzosin also were 22% less likely to have BPH-related surgery: 5.1% required operative interventions vs. 6.5% of the placebo group.

Only the cumulative incidence of acute urinary retention was similar in the two groups: 2.1% of the alfuzosin group vs. 1.8% of placebo. “This may be attributable to selection of patients with higher risk of retention,” Dr. Roehrborn said.

He noted that the study was designed to enroll high-risk patients aged 55 or older. The criteria included an IPSS at or above 13, a Qmax of 5–12 mL/sec for a voided volume of 150 mL or more, postvoid residual urine of 350 mL or more, prostate size of 30 g or more as estimated by a digital rectal exam, and a prostate-specific antigen concentration of 1.4–10 ng/mL.

Patients were enrolled from May 2001 to March 2005 at 148 urology centers in North America, Europe, Australia, the Middle East, and South Africa, according to Dr. Roehrborn's poster. Subjects randomized to alfuzosin took 10 mg daily for 2 years.

About one-third of the patients—513 men-—dropped out of the study. Lack of efficacy or disease progression prompted 9.9% of the alfuzosin patients and 14.5% of the placebo group to withdraw from the trial. Adverse events led to 9.4% and 8.1% of withdrawals, respectively.

Alfuzosin had a similar side effect profile to placebo and was well tolerated, according to Dr. Roehrborn. The most common adverse event was dizziness in both arms of the study (alfuzosin, 6.0% and placebo, 4.6%). Only 1.2% of patients in the alfuzosin arm had hypotension or postural hypotension. Ejaculatory disorders were rare as well (0.4%).

Dr. Roehrborn also reported significant improvements in IPSS scores over 2 years and peak flow rate at 12 months for alfuzosin vs. placebo. Over 2 years, prostate-specific antigen levels decreased 0.6% with alfuzosin, but increased 3.6% with placebo.

The results are similar to those for doxazosin in the Medical Therapy of Prostatic Symptoms study, Dr. Roehrborn said. “We have learned the limits and the utilities of α-blockers in the long term for patients with lower urinary tract symptoms and benign prostatic hyperplasia.”

Postvoid Residual Found Predictive

ALTESS trial investigators were surprised to find that postvoid residual urine could predict progression of benign prostatic hyperplasia symptoms over time, according to Dr. Roehrborn.

He reported that increasing postvoid residual (PVR) scores were associated with a worsening of symptoms in the alfuzosin and the placebo arms of the study.

The predictive power of PVR has been underestimated when patients are observed longitudinally. Guidelines for long-term monitoring of benign prostatic hyperplasia should be recognized, he said.

“We have brushed it [PVR] off as an unreliable and not reproducible value,” when in fact the opposite is true.

Dr. Roehrborn reported that age was not a risk factor for any of the study's outcomes, but higher baseline prostate-specific antigen concentration was predictive of surgery and of acute urinary retention. This was true whether patients were taking alfuzosin or placebo.

Analysis of ALTESS data suggests that the severity of baseline symptoms as measured by the International Prostate Symptom Score is unlikely to predict thresholds of symptoms worsening, Dr. Roehrborn added. He reported that patients with lower scores were more likely to have their symptoms worsen, whereas patients with higher IPSSs were more likely to have surgery.

He called the finding paradoxical and attributed it to a ceiling effect. “In other words, it is more difficult for symptoms to worsen by 4 points or more in the highest symptom group score,” he explained.

PARIS — The α-1 blocker alfuzosin prevented overall clinical progression of benign prostatic hyperplasia but had no impact on acute urinary retention in a 2-year, double-blind, placebo-controlled, multinational study that enrolled 1,522 men at high risk of serious outcomes.

Alfuzosin (Uroxatral) reduced the relative risk for any worsening of lower urinary tract symptoms by 26%, according to data reported by Dr. Claus Roehrborn at the annual congress of the European Association of Urology.

A total of 289 patients in both arms of the study had at least one event signalling progression. Symptom deterioration was the most common, occurring in 215 men, followed by surgery related to benign prostatic hyperplasia (BPH) in 87 men and acute urinary retention in 30 men. The overall incidence of events was 16.3% of 754 men on alfuzosin vs. 22.1% of 761 men on placebo.

Dr. Roehrborn of the University of Texas Southwestern Medical Center at Dallas presented the results on behalf of the Alfuzosin Long-Term Efficacy and Safety Study (ALTESS) study group.

He reported that alfuzosin was associated with a 30% reduction in the relative risk of the International Prostate Symptom Score (IPSS) worsening by at least four points. The cumulative incidence of this measure was 11.7% in the alfuzosin arm vs. 16.8% of placebo patients. Patients on alfuzosin also were 22% less likely to have BPH-related surgery: 5.1% required operative interventions vs. 6.5% of the placebo group.

Only the cumulative incidence of acute urinary retention was similar in the two groups: 2.1% of the alfuzosin group vs. 1.8% of placebo. “This may be attributable to selection of patients with higher risk of retention,” Dr. Roehrborn said.

He noted that the study was designed to enroll high-risk patients aged 55 or older. The criteria included an IPSS at or above 13, a Qmax of 5–12 mL/sec for a voided volume of 150 mL or more, postvoid residual urine of 350 mL or more, prostate size of 30 g or more as estimated by a digital rectal exam, and a prostate-specific antigen concentration of 1.4–10 ng/mL.

Patients were enrolled from May 2001 to March 2005 at 148 urology centers in North America, Europe, Australia, the Middle East, and South Africa, according to Dr. Roehrborn's poster. Subjects randomized to alfuzosin took 10 mg daily for 2 years.

About one-third of the patients—513 men-—dropped out of the study. Lack of efficacy or disease progression prompted 9.9% of the alfuzosin patients and 14.5% of the placebo group to withdraw from the trial. Adverse events led to 9.4% and 8.1% of withdrawals, respectively.

Alfuzosin had a similar side effect profile to placebo and was well tolerated, according to Dr. Roehrborn. The most common adverse event was dizziness in both arms of the study (alfuzosin, 6.0% and placebo, 4.6%). Only 1.2% of patients in the alfuzosin arm had hypotension or postural hypotension. Ejaculatory disorders were rare as well (0.4%).

Dr. Roehrborn also reported significant improvements in IPSS scores over 2 years and peak flow rate at 12 months for alfuzosin vs. placebo. Over 2 years, prostate-specific antigen levels decreased 0.6% with alfuzosin, but increased 3.6% with placebo.

The results are similar to those for doxazosin in the Medical Therapy of Prostatic Symptoms study, Dr. Roehrborn said. “We have learned the limits and the utilities of α-blockers in the long term for patients with lower urinary tract symptoms and benign prostatic hyperplasia.”

Postvoid Residual Found Predictive

ALTESS trial investigators were surprised to find that postvoid residual urine could predict progression of benign prostatic hyperplasia symptoms over time, according to Dr. Roehrborn.

He reported that increasing postvoid residual (PVR) scores were associated with a worsening of symptoms in the alfuzosin and the placebo arms of the study.

The predictive power of PVR has been underestimated when patients are observed longitudinally. Guidelines for long-term monitoring of benign prostatic hyperplasia should be recognized, he said.

“We have brushed it [PVR] off as an unreliable and not reproducible value,” when in fact the opposite is true.

Dr. Roehrborn reported that age was not a risk factor for any of the study's outcomes, but higher baseline prostate-specific antigen concentration was predictive of surgery and of acute urinary retention. This was true whether patients were taking alfuzosin or placebo.

Analysis of ALTESS data suggests that the severity of baseline symptoms as measured by the International Prostate Symptom Score is unlikely to predict thresholds of symptoms worsening, Dr. Roehrborn added. He reported that patients with lower scores were more likely to have their symptoms worsen, whereas patients with higher IPSSs were more likely to have surgery.

He called the finding paradoxical and attributed it to a ceiling effect. “In other words, it is more difficult for symptoms to worsen by 4 points or more in the highest symptom group score,” he explained.

PARIS — The α-1 blocker alfuzosin prevented overall clinical progression of benign prostatic hyperplasia but had no impact on acute urinary retention in a 2-year, double-blind, placebo-controlled, multinational study that enrolled 1,522 men at high risk of serious outcomes.

Alfuzosin (Uroxatral) reduced the relative risk for any worsening of lower urinary tract symptoms by 26%, according to data reported by Dr. Claus Roehrborn at the annual congress of the European Association of Urology.

A total of 289 patients in both arms of the study had at least one event signalling progression. Symptom deterioration was the most common, occurring in 215 men, followed by surgery related to benign prostatic hyperplasia (BPH) in 87 men and acute urinary retention in 30 men. The overall incidence of events was 16.3% of 754 men on alfuzosin vs. 22.1% of 761 men on placebo.

Dr. Roehrborn of the University of Texas Southwestern Medical Center at Dallas presented the results on behalf of the Alfuzosin Long-Term Efficacy and Safety Study (ALTESS) study group.

He reported that alfuzosin was associated with a 30% reduction in the relative risk of the International Prostate Symptom Score (IPSS) worsening by at least four points. The cumulative incidence of this measure was 11.7% in the alfuzosin arm vs. 16.8% of placebo patients. Patients on alfuzosin also were 22% less likely to have BPH-related surgery: 5.1% required operative interventions vs. 6.5% of the placebo group.

Only the cumulative incidence of acute urinary retention was similar in the two groups: 2.1% of the alfuzosin group vs. 1.8% of placebo. “This may be attributable to selection of patients with higher risk of retention,” Dr. Roehrborn said.

He noted that the study was designed to enroll high-risk patients aged 55 or older. The criteria included an IPSS at or above 13, a Qmax of 5–12 mL/sec for a voided volume of 150 mL or more, postvoid residual urine of 350 mL or more, prostate size of 30 g or more as estimated by a digital rectal exam, and a prostate-specific antigen concentration of 1.4–10 ng/mL.

Patients were enrolled from May 2001 to March 2005 at 148 urology centers in North America, Europe, Australia, the Middle East, and South Africa, according to Dr. Roehrborn's poster. Subjects randomized to alfuzosin took 10 mg daily for 2 years.

About one-third of the patients—513 men-—dropped out of the study. Lack of efficacy or disease progression prompted 9.9% of the alfuzosin patients and 14.5% of the placebo group to withdraw from the trial. Adverse events led to 9.4% and 8.1% of withdrawals, respectively.

Alfuzosin had a similar side effect profile to placebo and was well tolerated, according to Dr. Roehrborn. The most common adverse event was dizziness in both arms of the study (alfuzosin, 6.0% and placebo, 4.6%). Only 1.2% of patients in the alfuzosin arm had hypotension or postural hypotension. Ejaculatory disorders were rare as well (0.4%).

Dr. Roehrborn also reported significant improvements in IPSS scores over 2 years and peak flow rate at 12 months for alfuzosin vs. placebo. Over 2 years, prostate-specific antigen levels decreased 0.6% with alfuzosin, but increased 3.6% with placebo.

The results are similar to those for doxazosin in the Medical Therapy of Prostatic Symptoms study, Dr. Roehrborn said. “We have learned the limits and the utilities of α-blockers in the long term for patients with lower urinary tract symptoms and benign prostatic hyperplasia.”

Postvoid Residual Found Predictive

ALTESS trial investigators were surprised to find that postvoid residual urine could predict progression of benign prostatic hyperplasia symptoms over time, according to Dr. Roehrborn.

He reported that increasing postvoid residual (PVR) scores were associated with a worsening of symptoms in the alfuzosin and the placebo arms of the study.

The predictive power of PVR has been underestimated when patients are observed longitudinally. Guidelines for long-term monitoring of benign prostatic hyperplasia should be recognized, he said.

“We have brushed it [PVR] off as an unreliable and not reproducible value,” when in fact the opposite is true.

Dr. Roehrborn reported that age was not a risk factor for any of the study's outcomes, but higher baseline prostate-specific antigen concentration was predictive of surgery and of acute urinary retention. This was true whether patients were taking alfuzosin or placebo.

Analysis of ALTESS data suggests that the severity of baseline symptoms as measured by the International Prostate Symptom Score is unlikely to predict thresholds of symptoms worsening, Dr. Roehrborn added. He reported that patients with lower scores were more likely to have their symptoms worsen, whereas patients with higher IPSSs were more likely to have surgery.

He called the finding paradoxical and attributed it to a ceiling effect. “In other words, it is more difficult for symptoms to worsen by 4 points or more in the highest symptom group score,” he explained.

SAN FRANCISCO — A small intervention had a sizable impact on documentation of asthma severity and appropriate treatment of children at an inner-city health center, according to results of a randomized controlled trial reported in a poster at the annual meeting of the Pediatric Academic Societies.

Every other week for 6 weeks, Dr. Sandra F. Braganza and her colleagues affixed 2-by-3-inch stickers to the charts of children scheduled for health center visits who had previously been diagnosed with asthma.

The stickers listed the National Asthma Education and Prevention Program (NAEPP) criteria for asthma severity classification. Highlighted in red were the criteria for prescribing inhaled steroids.

“It prompts the physicians to classify asthma severity, and by physicians classifying asthma severity we hope they are properly treating the child's asthma,” said Dr. Braganza of Albert Einstein College of Medicine and Montefiore Medical Center, New York.

The children's appointments were not necessarily for asthma, she noted in an interview at the meeting, which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

After each visit—during weeks when the stickers were used and the alternate weeks when they were not—a research assistant interviewed the children's parents about the severity of each child's asthma and each child's use of medications. The assistant was blinded to what the physicians had written and prescribed.

Analysis of charts and parent interviews showed significant differences in asthma care between the intervention group and the control group of children who visited the clinic when stickers were not used.

The clinicians documented asthma severity for 135 (98%) of 138 children who had stickers on their charts but only 128 (73%) of 175 children in the control group who did not.

Moreover, review of 263 charts with notations for asthma severity revealed that physicians were significantly more likely to classify severity correctly when they had information on the classification criteria in front of them. They did so on 46% of charts with stickers but only 28% of charts for children in the control group.

The charts with the stickers affixed also were more likely to contain records of appropriate therapy, as defined by use of inhaled corticosteroids in children whose symptoms were consistent with persistent asthma. Appropriate therapy was recorded on 64% of charts with stickers but only 50% of charts for the control group.

Dr. Braganza and her colleagues calculated that the little sticker more than doubled the odds of a child having a correct asthma severity classification (adjusted odds ratio, 2.58) and significantly increased the odds of a child receiving appropriate therapy according to NAEPP criteria (adjusted odds ratio, 1.77).

SAN FRANCISCO — A small intervention had a sizable impact on documentation of asthma severity and appropriate treatment of children at an inner-city health center, according to results of a randomized controlled trial reported in a poster at the annual meeting of the Pediatric Academic Societies.

Every other week for 6 weeks, Dr. Sandra F. Braganza and her colleagues affixed 2-by-3-inch stickers to the charts of children scheduled for health center visits who had previously been diagnosed with asthma.

The stickers listed the National Asthma Education and Prevention Program (NAEPP) criteria for asthma severity classification. Highlighted in red were the criteria for prescribing inhaled steroids.

“It prompts the physicians to classify asthma severity, and by physicians classifying asthma severity we hope they are properly treating the child's asthma,” said Dr. Braganza of Albert Einstein College of Medicine and Montefiore Medical Center, New York.

The children's appointments were not necessarily for asthma, she noted in an interview at the meeting, which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

After each visit—during weeks when the stickers were used and the alternate weeks when they were not—a research assistant interviewed the children's parents about the severity of each child's asthma and each child's use of medications. The assistant was blinded to what the physicians had written and prescribed.

Analysis of charts and parent interviews showed significant differences in asthma care between the intervention group and the control group of children who visited the clinic when stickers were not used.

The clinicians documented asthma severity for 135 (98%) of 138 children who had stickers on their charts but only 128 (73%) of 175 children in the control group who did not.

Moreover, review of 263 charts with notations for asthma severity revealed that physicians were significantly more likely to classify severity correctly when they had information on the classification criteria in front of them. They did so on 46% of charts with stickers but only 28% of charts for children in the control group.

The charts with the stickers affixed also were more likely to contain records of appropriate therapy, as defined by use of inhaled corticosteroids in children whose symptoms were consistent with persistent asthma. Appropriate therapy was recorded on 64% of charts with stickers but only 50% of charts for the control group.

Dr. Braganza and her colleagues calculated that the little sticker more than doubled the odds of a child having a correct asthma severity classification (adjusted odds ratio, 2.58) and significantly increased the odds of a child receiving appropriate therapy according to NAEPP criteria (adjusted odds ratio, 1.77).

SAN FRANCISCO — A small intervention had a sizable impact on documentation of asthma severity and appropriate treatment of children at an inner-city health center, according to results of a randomized controlled trial reported in a poster at the annual meeting of the Pediatric Academic Societies.

Every other week for 6 weeks, Dr. Sandra F. Braganza and her colleagues affixed 2-by-3-inch stickers to the charts of children scheduled for health center visits who had previously been diagnosed with asthma.

The stickers listed the National Asthma Education and Prevention Program (NAEPP) criteria for asthma severity classification. Highlighted in red were the criteria for prescribing inhaled steroids.

“It prompts the physicians to classify asthma severity, and by physicians classifying asthma severity we hope they are properly treating the child's asthma,” said Dr. Braganza of Albert Einstein College of Medicine and Montefiore Medical Center, New York.

The children's appointments were not necessarily for asthma, she noted in an interview at the meeting, which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

After each visit—during weeks when the stickers were used and the alternate weeks when they were not—a research assistant interviewed the children's parents about the severity of each child's asthma and each child's use of medications. The assistant was blinded to what the physicians had written and prescribed.

Analysis of charts and parent interviews showed significant differences in asthma care between the intervention group and the control group of children who visited the clinic when stickers were not used.

The clinicians documented asthma severity for 135 (98%) of 138 children who had stickers on their charts but only 128 (73%) of 175 children in the control group who did not.

Moreover, review of 263 charts with notations for asthma severity revealed that physicians were significantly more likely to classify severity correctly when they had information on the classification criteria in front of them. They did so on 46% of charts with stickers but only 28% of charts for children in the control group.

The charts with the stickers affixed also were more likely to contain records of appropriate therapy, as defined by use of inhaled corticosteroids in children whose symptoms were consistent with persistent asthma. Appropriate therapy was recorded on 64% of charts with stickers but only 50% of charts for the control group.

Dr. Braganza and her colleagues calculated that the little sticker more than doubled the odds of a child having a correct asthma severity classification (adjusted odds ratio, 2.58) and significantly increased the odds of a child receiving appropriate therapy according to NAEPP criteria (adjusted odds ratio, 1.77).

SAN FRANCISCO — A study of 975 asthmatic children in four states found only one child in five achieved optimal symptom control through use of preventive medication.

While 37% of the symptomatic children did not use any preventive medications, 43% had persistent symptoms despite parent reports that these children used their prescribed therapies, according to data Dr. Jill S. Halterman presented at the annual meeting of the Pediatric Academic Societies.

“We still have a lot of work to do to identify children with persistent asthma, and to ensure that they use effective preventive therapy,” said Dr. Halterman of the University of Rochester (N.Y.) and its Golisano Children's Hospital at Strong, also in Rochester.

She called the substantial number of children with poor asthma symptom control despite reported use of preventive medications “a newly highlighted concern.”

Dr. Halterman and her coinvestigators based their findings on parent responses to the Asthma Survey Form included in the 2003 State and Local Area Integrated Telephone Survey (SLAITS), a random-digit-dial survey. The sample covered Alabama, California, Illinois, and Texas.

For the analysis, the researchers selected parents of children aged 17 years and younger who had persistent symptoms according to national asthma guidelines and/or used preventive asthma medications (defined as inhaled corticosteroids, mast cell stabilizers, theophylline derivatives, leukotriene modifiers, and combined corticosteroids and long-acting β₂-agonists).

Poor children were at the highest risk of receiving inadequate therapy, according to Dr. Halterman's poster and a talk she gave at the meeting, which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

More than half (53%) of children from families with incomes less than $15,000 a year did not use any medication and had persistent symptoms during the month before their parents were surveyed. Another 35% of poor children had suboptimal control, which the researchers defined as persistent symptoms or more than one acute episode within the past 3 months despite reported use of medication.

Higher income did not guarantee optimal control. Most children from families with incomes in the $15,000–$44,999 range had inadequate therapy (42%) or suboptimal control (40%). Nearly a quarter of the children from families earning upward of $45,000 received inadequate therapy. About half had suboptimal control.

Listing factors that might lead to poor asthma control in the study population as a whole, Dr. Halterman reported 72% of the children lived with household triggers, 58% did not have an asthma management plan, and 16% had someone smoke in their homes during the week before a parent answered the survey.

In addition, 35% of all children with suboptimal control had poor medication adherence.

Discontinuous insurance coverage was the leading demographic factor associated with inadequate therapy for asthma (odds ratio 2.4), according to Dr. Halterman. Of the total study population, only 15% had discontinuous insurance coverage, but 56% of the poorest children did.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — A study of 975 asthmatic children in four states found only one child in five achieved optimal symptom control through use of preventive medication.

While 37% of the symptomatic children did not use any preventive medications, 43% had persistent symptoms despite parent reports that these children used their prescribed therapies, according to data Dr. Jill S. Halterman presented at the annual meeting of the Pediatric Academic Societies.

“We still have a lot of work to do to identify children with persistent asthma, and to ensure that they use effective preventive therapy,” said Dr. Halterman of the University of Rochester (N.Y.) and its Golisano Children's Hospital at Strong, also in Rochester.

She called the substantial number of children with poor asthma symptom control despite reported use of preventive medications “a newly highlighted concern.”

Dr. Halterman and her coinvestigators based their findings on parent responses to the Asthma Survey Form included in the 2003 State and Local Area Integrated Telephone Survey (SLAITS), a random-digit-dial survey. The sample covered Alabama, California, Illinois, and Texas.

For the analysis, the researchers selected parents of children aged 17 years and younger who had persistent symptoms according to national asthma guidelines and/or used preventive asthma medications (defined as inhaled corticosteroids, mast cell stabilizers, theophylline derivatives, leukotriene modifiers, and combined corticosteroids and long-acting β₂-agonists).

Poor children were at the highest risk of receiving inadequate therapy, according to Dr. Halterman's poster and a talk she gave at the meeting, which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

More than half (53%) of children from families with incomes less than $15,000 a year did not use any medication and had persistent symptoms during the month before their parents were surveyed. Another 35% of poor children had suboptimal control, which the researchers defined as persistent symptoms or more than one acute episode within the past 3 months despite reported use of medication.

Higher income did not guarantee optimal control. Most children from families with incomes in the $15,000–$44,999 range had inadequate therapy (42%) or suboptimal control (40%). Nearly a quarter of the children from families earning upward of $45,000 received inadequate therapy. About half had suboptimal control.

Listing factors that might lead to poor asthma control in the study population as a whole, Dr. Halterman reported 72% of the children lived with household triggers, 58% did not have an asthma management plan, and 16% had someone smoke in their homes during the week before a parent answered the survey.

In addition, 35% of all children with suboptimal control had poor medication adherence.

Discontinuous insurance coverage was the leading demographic factor associated with inadequate therapy for asthma (odds ratio 2.4), according to Dr. Halterman. Of the total study population, only 15% had discontinuous insurance coverage, but 56% of the poorest children did.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — A study of 975 asthmatic children in four states found only one child in five achieved optimal symptom control through use of preventive medication.

While 37% of the symptomatic children did not use any preventive medications, 43% had persistent symptoms despite parent reports that these children used their prescribed therapies, according to data Dr. Jill S. Halterman presented at the annual meeting of the Pediatric Academic Societies.

“We still have a lot of work to do to identify children with persistent asthma, and to ensure that they use effective preventive therapy,” said Dr. Halterman of the University of Rochester (N.Y.) and its Golisano Children's Hospital at Strong, also in Rochester.

She called the substantial number of children with poor asthma symptom control despite reported use of preventive medications “a newly highlighted concern.”

Dr. Halterman and her coinvestigators based their findings on parent responses to the Asthma Survey Form included in the 2003 State and Local Area Integrated Telephone Survey (SLAITS), a random-digit-dial survey. The sample covered Alabama, California, Illinois, and Texas.

For the analysis, the researchers selected parents of children aged 17 years and younger who had persistent symptoms according to national asthma guidelines and/or used preventive asthma medications (defined as inhaled corticosteroids, mast cell stabilizers, theophylline derivatives, leukotriene modifiers, and combined corticosteroids and long-acting β₂-agonists).

Poor children were at the highest risk of receiving inadequate therapy, according to Dr. Halterman's poster and a talk she gave at the meeting, which was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

More than half (53%) of children from families with incomes less than $15,000 a year did not use any medication and had persistent symptoms during the month before their parents were surveyed. Another 35% of poor children had suboptimal control, which the researchers defined as persistent symptoms or more than one acute episode within the past 3 months despite reported use of medication.

Higher income did not guarantee optimal control. Most children from families with incomes in the $15,000–$44,999 range had inadequate therapy (42%) or suboptimal control (40%). Nearly a quarter of the children from families earning upward of $45,000 received inadequate therapy. About half had suboptimal control.

Listing factors that might lead to poor asthma control in the study population as a whole, Dr. Halterman reported 72% of the children lived with household triggers, 58% did not have an asthma management plan, and 16% had someone smoke in their homes during the week before a parent answered the survey.

In addition, 35% of all children with suboptimal control had poor medication adherence.

Discontinuous insurance coverage was the leading demographic factor associated with inadequate therapy for asthma (odds ratio 2.4), according to Dr. Halterman. Of the total study population, only 15% had discontinuous insurance coverage, but 56% of the poorest children did.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — Physicians can administer the live attenuated influenza vaccine marketed as FluMist during the same healthy infant visit in which they administer the measles-mumps-rubella and varicella vaccines, without diminishing the safety or effectiveness of any of the vaccines, according to the results of a phase III trial reported at the annual meeting of the Pediatric Academic Societies.

The study randomized healthy infants at 44 sites in the United States during the months from May to October in 2001 and 2002. Infants also were randomized from November to May in 2001 and 2002 at three additional sites in Australia, where Dr. Nolan is the head of the school of population health at the University of Melbourne.

Investigators used the formulation of FluMist that is currently approved for healthy children and adults aged 5–49 years in the United States. MedImmune Vaccines Inc. of Gaithersburg, Md., manufacturer of FluMist, has announced that it will seek approval of a newer formulation in children as young as 6 months.

The principal change in the new product is that it can be refrigerated—the current formulation must be stored in a freezer—and delivered in a lower dose. MedImmune sponsored Dr. Nolan's trial.

Both FluMist formulations are delivered as an intranasal spray. This gives FluMist an advantage over the trivalent inactivated influenza vaccine (TIV) that is already approved for inoculation of healthy infants, according to Dr. Nolan.

“The vaccine [FluMist] is easier to give to babies because it is not an injection. They don't cry. They love it,” he said. “And it appears to be as effective, if not more effective, than the injected vaccine. So it's a very promising vaccine for the future.”

Dr. Nolan's study randomized infants into three groups:

▸ In Group 1, 411 infants received the measles-mumps-rubella (MMR II) and varicella (Varivax) vaccines and a placebo on the first visit. They were given FluMist on the second and third visits.

▸ In Group 2, 422 infants received MMR-II, Varivax, and FluMist on their first visit. They were given FluMist on the second visit, and a placebo on the third visit.

▸ In Group 3, the remaining 412 infants received FluMist alone during the first and second visits. They were given MMR II and Varivax on the third visit.

Investigators collected serum samples during office visits on days 0, 42, and 72 of the study. They reported that concurrent administration of FluMist with the other vaccines did not alter seroresponse rates or geometric mean titers to MMR II and Varivax vaccines. Similarly, there was no change in the strain-specific seroconversion rates or geometric mean titers for each of the three vaccine strains in the FluMist vaccine.

A comparison of the first and second groups showed that children in Group 2 who were given concurrent vaccinations had significantly more rhinorrhea and nasal congestion during the following 42 days than did those in Group 1 (84% vs. 78%, respectively). Differences in other reactogenicity events were not statistically significant at 42 days.

During the 10 days after the first dose of FluMist, however, children in Group 2 who were given concomitant vaccinations had significantly more irritability (60% vs. 52%), fever over 101° F (29% vs. 14%), and vomiting (14% vs. 9%) than did children in Group 3 who received FluMist alone.

The most frequently reported adverse events after concurrent vaccination (Group 2) were diarrhea (17%) and otitis media (8%). Nine serious adverse events (including pneumonia, bronchiolitis, croup, viral chest infection and/or bronchospasm) may have been related to the study vaccine. The investigators concluded that concurrent administration was safe and well tolerated.

The meeting was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

SAN FRANCISCO — Physicians can administer the live attenuated influenza vaccine marketed as FluMist during the same healthy infant visit in which they administer the measles-mumps-rubella and varicella vaccines, without diminishing the safety or effectiveness of any of the vaccines, according to the results of a phase III trial reported at the annual meeting of the Pediatric Academic Societies.

The study randomized healthy infants at 44 sites in the United States during the months from May to October in 2001 and 2002. Infants also were randomized from November to May in 2001 and 2002 at three additional sites in Australia, where Dr. Nolan is the head of the school of population health at the University of Melbourne.

Investigators used the formulation of FluMist that is currently approved for healthy children and adults aged 5–49 years in the United States. MedImmune Vaccines Inc. of Gaithersburg, Md., manufacturer of FluMist, has announced that it will seek approval of a newer formulation in children as young as 6 months.

The principal change in the new product is that it can be refrigerated—the current formulation must be stored in a freezer—and delivered in a lower dose. MedImmune sponsored Dr. Nolan's trial.

Both FluMist formulations are delivered as an intranasal spray. This gives FluMist an advantage over the trivalent inactivated influenza vaccine (TIV) that is already approved for inoculation of healthy infants, according to Dr. Nolan.

“The vaccine [FluMist] is easier to give to babies because it is not an injection. They don't cry. They love it,” he said. “And it appears to be as effective, if not more effective, than the injected vaccine. So it's a very promising vaccine for the future.”

Dr. Nolan's study randomized infants into three groups:

▸ In Group 1, 411 infants received the measles-mumps-rubella (MMR II) and varicella (Varivax) vaccines and a placebo on the first visit. They were given FluMist on the second and third visits.

▸ In Group 2, 422 infants received MMR-II, Varivax, and FluMist on their first visit. They were given FluMist on the second visit, and a placebo on the third visit.

▸ In Group 3, the remaining 412 infants received FluMist alone during the first and second visits. They were given MMR II and Varivax on the third visit.

Investigators collected serum samples during office visits on days 0, 42, and 72 of the study. They reported that concurrent administration of FluMist with the other vaccines did not alter seroresponse rates or geometric mean titers to MMR II and Varivax vaccines. Similarly, there was no change in the strain-specific seroconversion rates or geometric mean titers for each of the three vaccine strains in the FluMist vaccine.

A comparison of the first and second groups showed that children in Group 2 who were given concurrent vaccinations had significantly more rhinorrhea and nasal congestion during the following 42 days than did those in Group 1 (84% vs. 78%, respectively). Differences in other reactogenicity events were not statistically significant at 42 days.

During the 10 days after the first dose of FluMist, however, children in Group 2 who were given concomitant vaccinations had significantly more irritability (60% vs. 52%), fever over 101° F (29% vs. 14%), and vomiting (14% vs. 9%) than did children in Group 3 who received FluMist alone.

The most frequently reported adverse events after concurrent vaccination (Group 2) were diarrhea (17%) and otitis media (8%). Nine serious adverse events (including pneumonia, bronchiolitis, croup, viral chest infection and/or bronchospasm) may have been related to the study vaccine. The investigators concluded that concurrent administration was safe and well tolerated.

The meeting was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

SAN FRANCISCO — Physicians can administer the live attenuated influenza vaccine marketed as FluMist during the same healthy infant visit in which they administer the measles-mumps-rubella and varicella vaccines, without diminishing the safety or effectiveness of any of the vaccines, according to the results of a phase III trial reported at the annual meeting of the Pediatric Academic Societies.

The study randomized healthy infants at 44 sites in the United States during the months from May to October in 2001 and 2002. Infants also were randomized from November to May in 2001 and 2002 at three additional sites in Australia, where Dr. Nolan is the head of the school of population health at the University of Melbourne.

Investigators used the formulation of FluMist that is currently approved for healthy children and adults aged 5–49 years in the United States. MedImmune Vaccines Inc. of Gaithersburg, Md., manufacturer of FluMist, has announced that it will seek approval of a newer formulation in children as young as 6 months.

The principal change in the new product is that it can be refrigerated—the current formulation must be stored in a freezer—and delivered in a lower dose. MedImmune sponsored Dr. Nolan's trial.

Both FluMist formulations are delivered as an intranasal spray. This gives FluMist an advantage over the trivalent inactivated influenza vaccine (TIV) that is already approved for inoculation of healthy infants, according to Dr. Nolan.

“The vaccine [FluMist] is easier to give to babies because it is not an injection. They don't cry. They love it,” he said. “And it appears to be as effective, if not more effective, than the injected vaccine. So it's a very promising vaccine for the future.”

Dr. Nolan's study randomized infants into three groups:

▸ In Group 1, 411 infants received the measles-mumps-rubella (MMR II) and varicella (Varivax) vaccines and a placebo on the first visit. They were given FluMist on the second and third visits.

▸ In Group 2, 422 infants received MMR-II, Varivax, and FluMist on their first visit. They were given FluMist on the second visit, and a placebo on the third visit.

▸ In Group 3, the remaining 412 infants received FluMist alone during the first and second visits. They were given MMR II and Varivax on the third visit.

Investigators collected serum samples during office visits on days 0, 42, and 72 of the study. They reported that concurrent administration of FluMist with the other vaccines did not alter seroresponse rates or geometric mean titers to MMR II and Varivax vaccines. Similarly, there was no change in the strain-specific seroconversion rates or geometric mean titers for each of the three vaccine strains in the FluMist vaccine.

A comparison of the first and second groups showed that children in Group 2 who were given concurrent vaccinations had significantly more rhinorrhea and nasal congestion during the following 42 days than did those in Group 1 (84% vs. 78%, respectively). Differences in other reactogenicity events were not statistically significant at 42 days.

During the 10 days after the first dose of FluMist, however, children in Group 2 who were given concomitant vaccinations had significantly more irritability (60% vs. 52%), fever over 101° F (29% vs. 14%), and vomiting (14% vs. 9%) than did children in Group 3 who received FluMist alone.

The most frequently reported adverse events after concurrent vaccination (Group 2) were diarrhea (17%) and otitis media (8%). Nine serious adverse events (including pneumonia, bronchiolitis, croup, viral chest infection and/or bronchospasm) may have been related to the study vaccine. The investigators concluded that concurrent administration was safe and well tolerated.

The meeting was sponsored by the American Pediatric Society, Society for Pediatric Research, Ambulatory Pediatric Association, and American Academy of Pediatrics.

SAN FRANCISCO — An experimental refrigerator-stable formulation of the live attenuated influenza vaccine marketed as FluMist was comparable to the approved frozen formulation in a phase III trial presented in a poster at the annual meeting of the Pediatric Academic Societies.

Dr. Stan L. Block reported that the two intranasal FluMist formulations had equivalent immunogenicity against three influenza strains (two type A and one type B). Seroresponse rates and reactogenicity events were comparable in the randomized, double-blind study.

Diarrhea, upper abdominal pain, and nausea were the most frequently reported adverse events. All occurred in less than 5% of patients, regardless of formulation. No serious side effects were attributed to either version of the live attenuated influenza vaccine.

The new formulation has two advantages over the approved FluMist, according to Dr. Block, who is in private practice in Bardstown, Ky. It is administered in a smaller volume, and physicians can store it in a refrigerator.

The immunogenicity trial was conducted at 26 U.S. sites from July 2004 to May 2005. Investigators randomized 981 subjects, of whom 942 could be evaluated for safety and 878 for immunogenicity. The latter analysis included 332 children aged 5–8 years and 546 subjects aged 9–49 years.

None of the younger children had been vaccinated before. They received two doses of FluMist, 46–60 days apart. Participants 9 years of age and older received one dose. The dose used with the new formulation was 0.2 mL (0.1 mL in each nostril) vs. 0.5 mL (0.25 mL in each nostril) with the approved formulation.

FluMist manufacturer MedImmune Inc. of Gaithersburg, Md., sponsored the study. MedImmune is seeking approval of the new formulation for use in healthy children aged 6–59 months as well as in healthy children and adults aged 5–49 years, for whom the original formulation was approved in 2003.

The two intranasal FluMist formulations had equivalent immunogenicity against three influenza strains. DR. BLOCK

SAN FRANCISCO — An experimental refrigerator-stable formulation of the live attenuated influenza vaccine marketed as FluMist was comparable to the approved frozen formulation in a phase III trial presented in a poster at the annual meeting of the Pediatric Academic Societies.

Dr. Stan L. Block reported that the two intranasal FluMist formulations had equivalent immunogenicity against three influenza strains (two type A and one type B). Seroresponse rates and reactogenicity events were comparable in the randomized, double-blind study.

Diarrhea, upper abdominal pain, and nausea were the most frequently reported adverse events. All occurred in less than 5% of patients, regardless of formulation. No serious side effects were attributed to either version of the live attenuated influenza vaccine.

The new formulation has two advantages over the approved FluMist, according to Dr. Block, who is in private practice in Bardstown, Ky. It is administered in a smaller volume, and physicians can store it in a refrigerator.

The immunogenicity trial was conducted at 26 U.S. sites from July 2004 to May 2005. Investigators randomized 981 subjects, of whom 942 could be evaluated for safety and 878 for immunogenicity. The latter analysis included 332 children aged 5–8 years and 546 subjects aged 9–49 years.

None of the younger children had been vaccinated before. They received two doses of FluMist, 46–60 days apart. Participants 9 years of age and older received one dose. The dose used with the new formulation was 0.2 mL (0.1 mL in each nostril) vs. 0.5 mL (0.25 mL in each nostril) with the approved formulation.

FluMist manufacturer MedImmune Inc. of Gaithersburg, Md., sponsored the study. MedImmune is seeking approval of the new formulation for use in healthy children aged 6–59 months as well as in healthy children and adults aged 5–49 years, for whom the original formulation was approved in 2003.

The two intranasal FluMist formulations had equivalent immunogenicity against three influenza strains. DR. BLOCK

SAN FRANCISCO — An experimental refrigerator-stable formulation of the live attenuated influenza vaccine marketed as FluMist was comparable to the approved frozen formulation in a phase III trial presented in a poster at the annual meeting of the Pediatric Academic Societies.

Dr. Stan L. Block reported that the two intranasal FluMist formulations had equivalent immunogenicity against three influenza strains (two type A and one type B). Seroresponse rates and reactogenicity events were comparable in the randomized, double-blind study.

Diarrhea, upper abdominal pain, and nausea were the most frequently reported adverse events. All occurred in less than 5% of patients, regardless of formulation. No serious side effects were attributed to either version of the live attenuated influenza vaccine.

The new formulation has two advantages over the approved FluMist, according to Dr. Block, who is in private practice in Bardstown, Ky. It is administered in a smaller volume, and physicians can store it in a refrigerator.

The immunogenicity trial was conducted at 26 U.S. sites from July 2004 to May 2005. Investigators randomized 981 subjects, of whom 942 could be evaluated for safety and 878 for immunogenicity. The latter analysis included 332 children aged 5–8 years and 546 subjects aged 9–49 years.

None of the younger children had been vaccinated before. They received two doses of FluMist, 46–60 days apart. Participants 9 years of age and older received one dose. The dose used with the new formulation was 0.2 mL (0.1 mL in each nostril) vs. 0.5 mL (0.25 mL in each nostril) with the approved formulation.

FluMist manufacturer MedImmune Inc. of Gaithersburg, Md., sponsored the study. MedImmune is seeking approval of the new formulation for use in healthy children aged 6–59 months as well as in healthy children and adults aged 5–49 years, for whom the original formulation was approved in 2003.

The two intranasal FluMist formulations had equivalent immunogenicity against three influenza strains. DR. BLOCK

PARIS — Phosphodieterase-5 inhibitors may have a role in the relief of lower urinary tract symptoms, according to two studies presented at the annual congress of the European Association of Urology.

Daily tadalafil (Cialis) therapy significantly improved symptom scores in men with benign prostatic hyperplasia in a placebo-controlled, phase II trial reported by Dr. Kevin T. McVary.

The 12-week, double-blind study enrolled 281 participants. Not unexpectedly, a sexually active subset with erectile dysfunction also experienced significantly improved erectile function with tadalafil.

In the second study, investigators combined sildenafil (Viagra) with alfuzosin (Uroxatral), an alpha₁-blocker, for previously untreated lower urinary tract symptoms (LUTS) and erectile dysfunction. Dr. Steven A. Kaplan reported that the combination was more effective than either agent alone in the three-armed study of 62 men who had the two conditions.

Dr. McVary, a professor of surgery at Northwestern University, Chicago, described his results as “somewhat provocative” and the benefits as comparable to others reported on the use of alpha-blockers for LUTS. Patients on tadalafil improved in all end points except for the Qmax measure of urinary peak flow.

“If you give combinations of medications, you might be able to enhance both sexual function and voiding function,” said Dr. Kaplan, a professor of urology at Cornell University, New York.

Daily Tadalafil

Dr. McVary and his colleagues randomly assigned men with benign prostatic hyperplasia to tadalafil (n = 138) or placebo (n = 143). Both groups had an average age in the early 60s (range, 45–82 years).

At baseline, nearly two-thirds of the men had moderate LUTS, defined as International Prostate Symptom Score (IPSS) results below 20. The remainder had severe LUTS, with IPSS results of 20–35. A greater proportion of the tadalafil group had erectile dysfunction (72%), compared with the placebo group (59%).

After wash-out and placebo run-in periods, patients began taking either 5 mg of tadalafil or placebo at week 3. They continued at this daily dose for another 3 weeks, then moved to a 20-mg dose.

Average IPSS results declined by 2.8 points, compared with baseline, for the men on the 5-mg tadalafil dose.

Increasing the dose to 20 mg brought the decline to 3.8 points by the end of the 12-week trial. The placebo group's scores fell by 1.2 points at week 6 and 1.7 points at week 12.

Tadalafil also improved LUTS and International Index of Erectile Function (IIEF) scores for the subset (56%) who were sexually active and had erectile dysfunction, but the correlation was weak.

“There was a disconnect,” Dr. McVary said. “There were patients who had improvement in symptom scores for IPSS that did not directly correlate or correspond to changes in sexual function.”

He described tadalafil as well tolerated with no serious adverse events. The most frequent treatment-related side effects were increased erection, dyspepsia, back pain, and headache.

Lilly ICOS LLC funded the study.

Sildenafil Plus Alfuzosin

Dr. Kaplan and his colleagues randomized 62 consecutive men, with an average age of 63 years (range 50–76 years). For 12 weeks, 20 men took 10 mg daily of alfuzosin, an alpha₁-blocker that has been shown to relieve LUTS with “minimal sexual and cardiovascular side effects.” Another 21 men took 25 mg of sildenafil each day. The other 21 men took both.

All three groups had significant improvements on the IPSS at 12 weeks. Scores fell from 17.8 to 14.6 with alfuzosin alone, from 16.9 to 14.9 with sildenafil alone, and from 17.3 to 13.5 with both.

Alfuzosin significantly improved frequency, nocturia, peak flow rate (Qmax), and postvoid residual urine equally well when used alone or in combination. Sildenafil alone did not have a significant effect.

All arms of the study showed improvement in erectile function, frequency of penetration, and frequency of maintained erections after penetration. Notably, IIEF scores went from 17.4 to 20.3 with alfuzosin alone, from 14.3 to 21.4 with sildenafil alone, and from 16.2 to 25.7 with both agents. These changes reached significance only in the sildenafil arms.

Seven patients dropped out because of dizziness, flushing, or dyspepsia.

PARIS — Phosphodieterase-5 inhibitors may have a role in the relief of lower urinary tract symptoms, according to two studies presented at the annual congress of the European Association of Urology.

Daily tadalafil (Cialis) therapy significantly improved symptom scores in men with benign prostatic hyperplasia in a placebo-controlled, phase II trial reported by Dr. Kevin T. McVary.

The 12-week, double-blind study enrolled 281 participants. Not unexpectedly, a sexually active subset with erectile dysfunction also experienced significantly improved erectile function with tadalafil.

In the second study, investigators combined sildenafil (Viagra) with alfuzosin (Uroxatral), an alpha₁-blocker, for previously untreated lower urinary tract symptoms (LUTS) and erectile dysfunction. Dr. Steven A. Kaplan reported that the combination was more effective than either agent alone in the three-armed study of 62 men who had the two conditions.

Dr. McVary, a professor of surgery at Northwestern University, Chicago, described his results as “somewhat provocative” and the benefits as comparable to others reported on the use of alpha-blockers for LUTS. Patients on tadalafil improved in all end points except for the Qmax measure of urinary peak flow.

“If you give combinations of medications, you might be able to enhance both sexual function and voiding function,” said Dr. Kaplan, a professor of urology at Cornell University, New York.

Daily Tadalafil

Dr. McVary and his colleagues randomly assigned men with benign prostatic hyperplasia to tadalafil (n = 138) or placebo (n = 143). Both groups had an average age in the early 60s (range, 45–82 years).

At baseline, nearly two-thirds of the men had moderate LUTS, defined as International Prostate Symptom Score (IPSS) results below 20. The remainder had severe LUTS, with IPSS results of 20–35. A greater proportion of the tadalafil group had erectile dysfunction (72%), compared with the placebo group (59%).

After wash-out and placebo run-in periods, patients began taking either 5 mg of tadalafil or placebo at week 3. They continued at this daily dose for another 3 weeks, then moved to a 20-mg dose.

Average IPSS results declined by 2.8 points, compared with baseline, for the men on the 5-mg tadalafil dose.

Increasing the dose to 20 mg brought the decline to 3.8 points by the end of the 12-week trial. The placebo group's scores fell by 1.2 points at week 6 and 1.7 points at week 12.

Tadalafil also improved LUTS and International Index of Erectile Function (IIEF) scores for the subset (56%) who were sexually active and had erectile dysfunction, but the correlation was weak.

“There was a disconnect,” Dr. McVary said. “There were patients who had improvement in symptom scores for IPSS that did not directly correlate or correspond to changes in sexual function.”

He described tadalafil as well tolerated with no serious adverse events. The most frequent treatment-related side effects were increased erection, dyspepsia, back pain, and headache.

Lilly ICOS LLC funded the study.

Sildenafil Plus Alfuzosin

Dr. Kaplan and his colleagues randomized 62 consecutive men, with an average age of 63 years (range 50–76 years). For 12 weeks, 20 men took 10 mg daily of alfuzosin, an alpha₁-blocker that has been shown to relieve LUTS with “minimal sexual and cardiovascular side effects.” Another 21 men took 25 mg of sildenafil each day. The other 21 men took both.

All three groups had significant improvements on the IPSS at 12 weeks. Scores fell from 17.8 to 14.6 with alfuzosin alone, from 16.9 to 14.9 with sildenafil alone, and from 17.3 to 13.5 with both.

Alfuzosin significantly improved frequency, nocturia, peak flow rate (Qmax), and postvoid residual urine equally well when used alone or in combination. Sildenafil alone did not have a significant effect.

All arms of the study showed improvement in erectile function, frequency of penetration, and frequency of maintained erections after penetration. Notably, IIEF scores went from 17.4 to 20.3 with alfuzosin alone, from 14.3 to 21.4 with sildenafil alone, and from 16.2 to 25.7 with both agents. These changes reached significance only in the sildenafil arms.

Seven patients dropped out because of dizziness, flushing, or dyspepsia.

PARIS — Phosphodieterase-5 inhibitors may have a role in the relief of lower urinary tract symptoms, according to two studies presented at the annual congress of the European Association of Urology.

Daily tadalafil (Cialis) therapy significantly improved symptom scores in men with benign prostatic hyperplasia in a placebo-controlled, phase II trial reported by Dr. Kevin T. McVary.

The 12-week, double-blind study enrolled 281 participants. Not unexpectedly, a sexually active subset with erectile dysfunction also experienced significantly improved erectile function with tadalafil.

In the second study, investigators combined sildenafil (Viagra) with alfuzosin (Uroxatral), an alpha₁-blocker, for previously untreated lower urinary tract symptoms (LUTS) and erectile dysfunction. Dr. Steven A. Kaplan reported that the combination was more effective than either agent alone in the three-armed study of 62 men who had the two conditions.

Dr. McVary, a professor of surgery at Northwestern University, Chicago, described his results as “somewhat provocative” and the benefits as comparable to others reported on the use of alpha-blockers for LUTS. Patients on tadalafil improved in all end points except for the Qmax measure of urinary peak flow.

“If you give combinations of medications, you might be able to enhance both sexual function and voiding function,” said Dr. Kaplan, a professor of urology at Cornell University, New York.

Daily Tadalafil

Dr. McVary and his colleagues randomly assigned men with benign prostatic hyperplasia to tadalafil (n = 138) or placebo (n = 143). Both groups had an average age in the early 60s (range, 45–82 years).

At baseline, nearly two-thirds of the men had moderate LUTS, defined as International Prostate Symptom Score (IPSS) results below 20. The remainder had severe LUTS, with IPSS results of 20–35. A greater proportion of the tadalafil group had erectile dysfunction (72%), compared with the placebo group (59%).

After wash-out and placebo run-in periods, patients began taking either 5 mg of tadalafil or placebo at week 3. They continued at this daily dose for another 3 weeks, then moved to a 20-mg dose.

Average IPSS results declined by 2.8 points, compared with baseline, for the men on the 5-mg tadalafil dose.

Increasing the dose to 20 mg brought the decline to 3.8 points by the end of the 12-week trial. The placebo group's scores fell by 1.2 points at week 6 and 1.7 points at week 12.

Tadalafil also improved LUTS and International Index of Erectile Function (IIEF) scores for the subset (56%) who were sexually active and had erectile dysfunction, but the correlation was weak.

“There was a disconnect,” Dr. McVary said. “There were patients who had improvement in symptom scores for IPSS that did not directly correlate or correspond to changes in sexual function.”

He described tadalafil as well tolerated with no serious adverse events. The most frequent treatment-related side effects were increased erection, dyspepsia, back pain, and headache.

Lilly ICOS LLC funded the study.

Sildenafil Plus Alfuzosin

Dr. Kaplan and his colleagues randomized 62 consecutive men, with an average age of 63 years (range 50–76 years). For 12 weeks, 20 men took 10 mg daily of alfuzosin, an alpha₁-blocker that has been shown to relieve LUTS with “minimal sexual and cardiovascular side effects.” Another 21 men took 25 mg of sildenafil each day. The other 21 men took both.

All three groups had significant improvements on the IPSS at 12 weeks. Scores fell from 17.8 to 14.6 with alfuzosin alone, from 16.9 to 14.9 with sildenafil alone, and from 17.3 to 13.5 with both.

Alfuzosin significantly improved frequency, nocturia, peak flow rate (Qmax), and postvoid residual urine equally well when used alone or in combination. Sildenafil alone did not have a significant effect.

All arms of the study showed improvement in erectile function, frequency of penetration, and frequency of maintained erections after penetration. Notably, IIEF scores went from 17.4 to 20.3 with alfuzosin alone, from 14.3 to 21.4 with sildenafil alone, and from 16.2 to 25.7 with both agents. These changes reached significance only in the sildenafil arms.

Seven patients dropped out because of dizziness, flushing, or dyspepsia.

PARIS — A randomized, multicenter trial and two retrospective studies presented at the annual congress of the European Association of Urology found outcomes were similar whether patients had the transvaginal or transobturator sling procedure for urinary stress incontinence.

The investigators agreed that their results favored the newer transobturator tape (TOT) procedure, as it is simpler than constructing midurethral synthetic slings with transvaginal tape (TVT). “Both are the same in my experience. The TOT is easier, and it is inherently safe,” Dr. Graeme H. Urwin of the United Kingdom said in a conclusion echoed by investigators from France and Canada.

“My sense is transobturator is a little easier to carry out, so it gave me a little confidence to recommend this,” said Dr. Sender Herschorn, professor of urology at the University of Toronto.

Less clear was whether some patients might present with conditions that would be better treated by TVT or TOT. Dr. Herschorn said he did “not know of any specific indications for one over the other.”

The French group is continuing to investigate this question. “There might be some specific indications for the retropubic route, but we don't have enough data to support this yet. We are going to do more work,” Dr. Emmanuel David-Montefiore of Hôpital Tenon, Paris, said in an interview.

Dr. David-Montefiore reported 3-month data from a multicenter trial in which 88 women with similar demographics and clinical histories were randomized: 42 to a retropubic route (TVT) and 46 to TOT. He said the same tape was used in both groups.

At 3 months, 89.3% of the retropubic cohort and 88.6% of the transobturator group were dry. Satisfaction rates were 90% and 92%. He also reported de novo pollakiuria in 10.7% of the retropubic patients vs. 5.7% of transobturator patients. De novo urgency occurred in 17.9% and 17.1%.

Average hospital stays and overall morbidity were similar between the two groups. Bladder injuries occurred only in retropubic patients, however: 9.5% vs. 0% of the transobturator patients. The retropubic cohort reportedly had more pain and longer operating times.

Dr. Herschorn reviewed outcomes of 40 women who underwent TVT and 35 in whom TOT was used. A majority of both groups had mixed incontinence, and half had prior surgeries for urinary stress incontinence.

The only statistically significant difference in outcomes was that 8 (20%) of the TVT group vs. 3 (9%) of the TOT cohort had urinary retention after the procedure. Dr. Herschorn reported that all voided within a month.

He also reported three perforations (two bladder and one urethral) with the TVT procedure. Although there were slightly more complications with TVT, he said the difference was not statistically significant.

Most patients who responded to a subjective questionnaire described their condition as cured or improved, regardless of the procedure used.

Dr. Urwin reviewed available case notes for 73 of 83 TVT patients and 126 of 131 TOT patients at York (England) District General Hospital. He reported that most had preoperative urodynamics and about two-thirds had pure urinary stress incontinence.

Operating times were similar, while use of regional anesthesia was significantly more common with TVT and general anesthesia was more common with TOT. A learning curve was observed, but it did not significantly affect the complication rate, which was described as low and similar between both groups.

Monarc Sling Keeps Providing Symptom Relief for 24 Months

Two years after being implanted with the Monarc transobturator sling, most evaluable patients in an international study had symptom relief and were satisfied with the results, according to a poster presentation at the meeting.

Dr. Dirk Deridder reported that the proportion of patients who had a negative cough test dropped from 94.5% before surgery to 12.4% of 105 patients available for testing at 24 months. Pad use also declined from 3.4 to 0.6 per day, and the average weight gain per pad fell from 68.7 g/hour to 9.4 g/hour.

“One pad a day is more a security pad than anything else,” said Dr. Deridder of the University Hospital KU Leuven (Belgium). The single-arm study enrolled 148 patients at 15 sites in Europe, Canada, and Australia between January 2003 and February 2004.

Dr. Deridder disclosed that the sling's maker, American Medical Systems (AMS) of Minnetonka, Minn., sponsored the study and that he is an AMS advisory board member.

PARIS — A randomized, multicenter trial and two retrospective studies presented at the annual congress of the European Association of Urology found outcomes were similar whether patients had the transvaginal or transobturator sling procedure for urinary stress incontinence.

The investigators agreed that their results favored the newer transobturator tape (TOT) procedure, as it is simpler than constructing midurethral synthetic slings with transvaginal tape (TVT). “Both are the same in my experience. The TOT is easier, and it is inherently safe,” Dr. Graeme H. Urwin of the United Kingdom said in a conclusion echoed by investigators from France and Canada.

“My sense is transobturator is a little easier to carry out, so it gave me a little confidence to recommend this,” said Dr. Sender Herschorn, professor of urology at the University of Toronto.

Less clear was whether some patients might present with conditions that would be better treated by TVT or TOT. Dr. Herschorn said he did “not know of any specific indications for one over the other.”

The French group is continuing to investigate this question. “There might be some specific indications for the retropubic route, but we don't have enough data to support this yet. We are going to do more work,” Dr. Emmanuel David-Montefiore of Hôpital Tenon, Paris, said in an interview.

Dr. David-Montefiore reported 3-month data from a multicenter trial in which 88 women with similar demographics and clinical histories were randomized: 42 to a retropubic route (TVT) and 46 to TOT. He said the same tape was used in both groups.

At 3 months, 89.3% of the retropubic cohort and 88.6% of the transobturator group were dry. Satisfaction rates were 90% and 92%. He also reported de novo pollakiuria in 10.7% of the retropubic patients vs. 5.7% of transobturator patients. De novo urgency occurred in 17.9% and 17.1%.

Average hospital stays and overall morbidity were similar between the two groups. Bladder injuries occurred only in retropubic patients, however: 9.5% vs. 0% of the transobturator patients. The retropubic cohort reportedly had more pain and longer operating times.

Dr. Herschorn reviewed outcomes of 40 women who underwent TVT and 35 in whom TOT was used. A majority of both groups had mixed incontinence, and half had prior surgeries for urinary stress incontinence.

The only statistically significant difference in outcomes was that 8 (20%) of the TVT group vs. 3 (9%) of the TOT cohort had urinary retention after the procedure. Dr. Herschorn reported that all voided within a month.

He also reported three perforations (two bladder and one urethral) with the TVT procedure. Although there were slightly more complications with TVT, he said the difference was not statistically significant.

Most patients who responded to a subjective questionnaire described their condition as cured or improved, regardless of the procedure used.

Dr. Urwin reviewed available case notes for 73 of 83 TVT patients and 126 of 131 TOT patients at York (England) District General Hospital. He reported that most had preoperative urodynamics and about two-thirds had pure urinary stress incontinence.

Operating times were similar, while use of regional anesthesia was significantly more common with TVT and general anesthesia was more common with TOT. A learning curve was observed, but it did not significantly affect the complication rate, which was described as low and similar between both groups.

Monarc Sling Keeps Providing Symptom Relief for 24 Months

Two years after being implanted with the Monarc transobturator sling, most evaluable patients in an international study had symptom relief and were satisfied with the results, according to a poster presentation at the meeting.

Dr. Dirk Deridder reported that the proportion of patients who had a negative cough test dropped from 94.5% before surgery to 12.4% of 105 patients available for testing at 24 months. Pad use also declined from 3.4 to 0.6 per day, and the average weight gain per pad fell from 68.7 g/hour to 9.4 g/hour.

“One pad a day is more a security pad than anything else,” said Dr. Deridder of the University Hospital KU Leuven (Belgium). The single-arm study enrolled 148 patients at 15 sites in Europe, Canada, and Australia between January 2003 and February 2004.

Dr. Deridder disclosed that the sling's maker, American Medical Systems (AMS) of Minnetonka, Minn., sponsored the study and that he is an AMS advisory board member.

PARIS — A randomized, multicenter trial and two retrospective studies presented at the annual congress of the European Association of Urology found outcomes were similar whether patients had the transvaginal or transobturator sling procedure for urinary stress incontinence.

The investigators agreed that their results favored the newer transobturator tape (TOT) procedure, as it is simpler than constructing midurethral synthetic slings with transvaginal tape (TVT). “Both are the same in my experience. The TOT is easier, and it is inherently safe,” Dr. Graeme H. Urwin of the United Kingdom said in a conclusion echoed by investigators from France and Canada.

“My sense is transobturator is a little easier to carry out, so it gave me a little confidence to recommend this,” said Dr. Sender Herschorn, professor of urology at the University of Toronto.

Less clear was whether some patients might present with conditions that would be better treated by TVT or TOT. Dr. Herschorn said he did “not know of any specific indications for one over the other.”

The French group is continuing to investigate this question. “There might be some specific indications for the retropubic route, but we don't have enough data to support this yet. We are going to do more work,” Dr. Emmanuel David-Montefiore of Hôpital Tenon, Paris, said in an interview.

Dr. David-Montefiore reported 3-month data from a multicenter trial in which 88 women with similar demographics and clinical histories were randomized: 42 to a retropubic route (TVT) and 46 to TOT. He said the same tape was used in both groups.

At 3 months, 89.3% of the retropubic cohort and 88.6% of the transobturator group were dry. Satisfaction rates were 90% and 92%. He also reported de novo pollakiuria in 10.7% of the retropubic patients vs. 5.7% of transobturator patients. De novo urgency occurred in 17.9% and 17.1%.

Average hospital stays and overall morbidity were similar between the two groups. Bladder injuries occurred only in retropubic patients, however: 9.5% vs. 0% of the transobturator patients. The retropubic cohort reportedly had more pain and longer operating times.

Dr. Herschorn reviewed outcomes of 40 women who underwent TVT and 35 in whom TOT was used. A majority of both groups had mixed incontinence, and half had prior surgeries for urinary stress incontinence.

The only statistically significant difference in outcomes was that 8 (20%) of the TVT group vs. 3 (9%) of the TOT cohort had urinary retention after the procedure. Dr. Herschorn reported that all voided within a month.

He also reported three perforations (two bladder and one urethral) with the TVT procedure. Although there were slightly more complications with TVT, he said the difference was not statistically significant.

Most patients who responded to a subjective questionnaire described their condition as cured or improved, regardless of the procedure used.

Dr. Urwin reviewed available case notes for 73 of 83 TVT patients and 126 of 131 TOT patients at York (England) District General Hospital. He reported that most had preoperative urodynamics and about two-thirds had pure urinary stress incontinence.

Operating times were similar, while use of regional anesthesia was significantly more common with TVT and general anesthesia was more common with TOT. A learning curve was observed, but it did not significantly affect the complication rate, which was described as low and similar between both groups.

Monarc Sling Keeps Providing Symptom Relief for 24 Months

Two years after being implanted with the Monarc transobturator sling, most evaluable patients in an international study had symptom relief and were satisfied with the results, according to a poster presentation at the meeting.

Dr. Dirk Deridder reported that the proportion of patients who had a negative cough test dropped from 94.5% before surgery to 12.4% of 105 patients available for testing at 24 months. Pad use also declined from 3.4 to 0.6 per day, and the average weight gain per pad fell from 68.7 g/hour to 9.4 g/hour.

“One pad a day is more a security pad than anything else,” said Dr. Deridder of the University Hospital KU Leuven (Belgium). The single-arm study enrolled 148 patients at 15 sites in Europe, Canada, and Australia between January 2003 and February 2004.

Dr. Deridder disclosed that the sling's maker, American Medical Systems (AMS) of Minnetonka, Minn., sponsored the study and that he is an AMS advisory board member.