Gastric Bypass Lightens Load on Women's Hearts

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BOSTON — Women trim their resting heart rate and heart rate recovery as well as their waistlines when they undergo gastric bypass surgery, according to a 2-year study presented at the annual meeting of the Heart Rhythm Society.

A comparison group of similar women who did not undergo gastric bypass surgery failed to show any significant improvements during the same period.

The latest findings emerged during an analysis of gastric bypass surgery patients conducted by Stephen L. Wasmund, Ph.D., and colleagues at the University of Utah, Salt Lake City. Dr. Wasmund presented the findings during a poster session.

Heart rate recovery after exercise is a proxy for vagal tone, said Dr. Wasmund in an interview.

“Showing an improvement in heart rate recovery definitely suggests a change in autonomic variables in a good direction. Although we did not make any specific measurements of autonomic tone—we did not measure heart rate variability, for example—we think this points to improvements in vagal tone and sympathetic tone.”

Rates of gastric bypass surgery in the United States have increased more than fivefold in recent years—from 14,000 in 1998 to 108,000 in 2003, according to data collected as part of the National Hospital Discharge Survey (Obes. Res. 2005;13:2202–9). Previous studies have analyzed the impact of weight loss on blood pressure, but its effect on cardiovagal baroreflex function remains poorly understood.

To see whether gastric bypass surgery improved these markers of heart health, Dr. Wasmund and colleagues studied a random sample of 342 women from a cohort of more than 1,100 obese women enrolled in the Utah obesity study (Contemp. Clin. Trials 2005;26:534–5). Of the participants who underwent an echocardiogram or polysomnogram in that cohort, 92% had left-ventricular hypertrophy, and 85% had mild to severe sleep apnea. Another 19% had diabetes, and 35% had hypertension. Their average age was 44 years.

In the new study, one arm consisted of 154 women who underwent gastric bypass surgery. The other arm consisted of 188 severely obese women who either had not sought gastric bypass surgery or had sought but were denied surgery by their doctors.

Overall, the two groups were similar in most important clinical respects, including baseline heart rate, heart rate recovery, and treadmill scores. The controls weighed somewhat less on average than the surgery patients (268 vs. 292 pounds) and had a lower average body mass index (BMI of 43 vs. 47 kg/m

After the slimming surgery, resting heart rates of the previously obese women dropped significantly, from 73 to 60 beats per minute. Heart rate recovery also improved significantly, from a drop of 39 bpm during the 3 minutes immediately after exercise to a drop of 56 bpm. The women could also exercise nearly 50% longer on a treadmill before tiring, improving from 15.3 minutes at baseline to 22.7 minutes at follow-up.

Dr. Wasmund was not surprised by the results. “It is good to know that patients can make these improvements strictly through gastric bypass surgery,” he said.

Previous research has raised doubts about whether improvements in autonomic function after weight loss persist over time.

A 2003 study from Finland suggests the benefits of weight loss wax, then wane. In that study, 34 obese men and women with metabolic syndrome lost an average of about 32 pounds during a 9-week very-low-calorie diet, and maintained a nearly 28-pound weight loss 1 year later. (J. Hypertens. 2003;21:371–8.)

The Finnish subjects' significant short-term improvements in 24-hour ambulatory blood pressure were largely transient, however. Loss of parasympathetic tone was more gradual. Despite successful weight maintenance, their improvements in night heart rate and heart rate variability slowly disappeared within 1 year.

The new study suggests improvements among gastric bypass patients may remain substantial for up to 2 years following surgery. The authors plan to report on the full study group of 1,156 individuals at follow-up intervals of 5 and 10 years.

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BOSTON — Women trim their resting heart rate and heart rate recovery as well as their waistlines when they undergo gastric bypass surgery, according to a 2-year study presented at the annual meeting of the Heart Rhythm Society.

A comparison group of similar women who did not undergo gastric bypass surgery failed to show any significant improvements during the same period.

The latest findings emerged during an analysis of gastric bypass surgery patients conducted by Stephen L. Wasmund, Ph.D., and colleagues at the University of Utah, Salt Lake City. Dr. Wasmund presented the findings during a poster session.

Heart rate recovery after exercise is a proxy for vagal tone, said Dr. Wasmund in an interview.

“Showing an improvement in heart rate recovery definitely suggests a change in autonomic variables in a good direction. Although we did not make any specific measurements of autonomic tone—we did not measure heart rate variability, for example—we think this points to improvements in vagal tone and sympathetic tone.”

Rates of gastric bypass surgery in the United States have increased more than fivefold in recent years—from 14,000 in 1998 to 108,000 in 2003, according to data collected as part of the National Hospital Discharge Survey (Obes. Res. 2005;13:2202–9). Previous studies have analyzed the impact of weight loss on blood pressure, but its effect on cardiovagal baroreflex function remains poorly understood.

To see whether gastric bypass surgery improved these markers of heart health, Dr. Wasmund and colleagues studied a random sample of 342 women from a cohort of more than 1,100 obese women enrolled in the Utah obesity study (Contemp. Clin. Trials 2005;26:534–5). Of the participants who underwent an echocardiogram or polysomnogram in that cohort, 92% had left-ventricular hypertrophy, and 85% had mild to severe sleep apnea. Another 19% had diabetes, and 35% had hypertension. Their average age was 44 years.

In the new study, one arm consisted of 154 women who underwent gastric bypass surgery. The other arm consisted of 188 severely obese women who either had not sought gastric bypass surgery or had sought but were denied surgery by their doctors.

Overall, the two groups were similar in most important clinical respects, including baseline heart rate, heart rate recovery, and treadmill scores. The controls weighed somewhat less on average than the surgery patients (268 vs. 292 pounds) and had a lower average body mass index (BMI of 43 vs. 47 kg/m

After the slimming surgery, resting heart rates of the previously obese women dropped significantly, from 73 to 60 beats per minute. Heart rate recovery also improved significantly, from a drop of 39 bpm during the 3 minutes immediately after exercise to a drop of 56 bpm. The women could also exercise nearly 50% longer on a treadmill before tiring, improving from 15.3 minutes at baseline to 22.7 minutes at follow-up.

Dr. Wasmund was not surprised by the results. “It is good to know that patients can make these improvements strictly through gastric bypass surgery,” he said.

Previous research has raised doubts about whether improvements in autonomic function after weight loss persist over time.

A 2003 study from Finland suggests the benefits of weight loss wax, then wane. In that study, 34 obese men and women with metabolic syndrome lost an average of about 32 pounds during a 9-week very-low-calorie diet, and maintained a nearly 28-pound weight loss 1 year later. (J. Hypertens. 2003;21:371–8.)

The Finnish subjects' significant short-term improvements in 24-hour ambulatory blood pressure were largely transient, however. Loss of parasympathetic tone was more gradual. Despite successful weight maintenance, their improvements in night heart rate and heart rate variability slowly disappeared within 1 year.

The new study suggests improvements among gastric bypass patients may remain substantial for up to 2 years following surgery. The authors plan to report on the full study group of 1,156 individuals at follow-up intervals of 5 and 10 years.

BOSTON — Women trim their resting heart rate and heart rate recovery as well as their waistlines when they undergo gastric bypass surgery, according to a 2-year study presented at the annual meeting of the Heart Rhythm Society.

A comparison group of similar women who did not undergo gastric bypass surgery failed to show any significant improvements during the same period.

The latest findings emerged during an analysis of gastric bypass surgery patients conducted by Stephen L. Wasmund, Ph.D., and colleagues at the University of Utah, Salt Lake City. Dr. Wasmund presented the findings during a poster session.

Heart rate recovery after exercise is a proxy for vagal tone, said Dr. Wasmund in an interview.

“Showing an improvement in heart rate recovery definitely suggests a change in autonomic variables in a good direction. Although we did not make any specific measurements of autonomic tone—we did not measure heart rate variability, for example—we think this points to improvements in vagal tone and sympathetic tone.”

Rates of gastric bypass surgery in the United States have increased more than fivefold in recent years—from 14,000 in 1998 to 108,000 in 2003, according to data collected as part of the National Hospital Discharge Survey (Obes. Res. 2005;13:2202–9). Previous studies have analyzed the impact of weight loss on blood pressure, but its effect on cardiovagal baroreflex function remains poorly understood.

To see whether gastric bypass surgery improved these markers of heart health, Dr. Wasmund and colleagues studied a random sample of 342 women from a cohort of more than 1,100 obese women enrolled in the Utah obesity study (Contemp. Clin. Trials 2005;26:534–5). Of the participants who underwent an echocardiogram or polysomnogram in that cohort, 92% had left-ventricular hypertrophy, and 85% had mild to severe sleep apnea. Another 19% had diabetes, and 35% had hypertension. Their average age was 44 years.

In the new study, one arm consisted of 154 women who underwent gastric bypass surgery. The other arm consisted of 188 severely obese women who either had not sought gastric bypass surgery or had sought but were denied surgery by their doctors.

Overall, the two groups were similar in most important clinical respects, including baseline heart rate, heart rate recovery, and treadmill scores. The controls weighed somewhat less on average than the surgery patients (268 vs. 292 pounds) and had a lower average body mass index (BMI of 43 vs. 47 kg/m

After the slimming surgery, resting heart rates of the previously obese women dropped significantly, from 73 to 60 beats per minute. Heart rate recovery also improved significantly, from a drop of 39 bpm during the 3 minutes immediately after exercise to a drop of 56 bpm. The women could also exercise nearly 50% longer on a treadmill before tiring, improving from 15.3 minutes at baseline to 22.7 minutes at follow-up.

Dr. Wasmund was not surprised by the results. “It is good to know that patients can make these improvements strictly through gastric bypass surgery,” he said.

Previous research has raised doubts about whether improvements in autonomic function after weight loss persist over time.

A 2003 study from Finland suggests the benefits of weight loss wax, then wane. In that study, 34 obese men and women with metabolic syndrome lost an average of about 32 pounds during a 9-week very-low-calorie diet, and maintained a nearly 28-pound weight loss 1 year later. (J. Hypertens. 2003;21:371–8.)

The Finnish subjects' significant short-term improvements in 24-hour ambulatory blood pressure were largely transient, however. Loss of parasympathetic tone was more gradual. Despite successful weight maintenance, their improvements in night heart rate and heart rate variability slowly disappeared within 1 year.

The new study suggests improvements among gastric bypass patients may remain substantial for up to 2 years following surgery. The authors plan to report on the full study group of 1,156 individuals at follow-up intervals of 5 and 10 years.

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Statins Cut Deaths in Nonischemic ICD Users

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Statins Cut Deaths in Nonischemic ICD Users

BOSTON — Statin use was associated with startling reductions in mortality and in sudden death among patients with nonischemic dilated cardiomyopathy, according to a new subanalysis from a multicenter trial of implantable cardioverter defibrillators.

In addition to a 77% decrease in overall mortality (5/110 vs. 64/348), statin use was associated with an 84% reduction in sudden death (1 vs. 18).

Statins were also associated with a 22% reduction in appropriate shocks in patients with implantable cardioverter defibrillators (ICDs).

Statins appear to have significant effects beyond lipid lowering, according to the researchers. Among patients with coronary artery disease, the lipid-lowering drugs are associated with a reduction in arrhythmic events, appropriate ICD shocks, and mortality. Statins can also improve the clinical status of patients with nonischemic heart failure.

To determine whether statins may be protective against sudden death in patients with nonischemic heart failure, Dr. Jeffrey J. Goldberger of Northwestern University, Chicago, and his colleagues compared the mortality in the 110 patients who took statins in the multicenter DEFINITE trial with the 348 patients who did not.

The patients in both groups were similar at baseline in most clinically important respects, according to Dr. Alaa Shalaby of the Pittsburgh VA Healthcare System who presented the findings during an oral presentation at the annual meeting of the Heart Rhythm Society.

The DEFINITE trial, which was published in 2004, randomized 458 patients with nonischemic dilated cardiomyopathy (DCM) and a left ventricular ejection fraction of less than 36% to receive standard medical therapy alone or medical therapy plus an ICD (N. Engl. J. Med. 2004; 350:2151–8).

The addition of an ICD provided no additional protection against death, the primary end point. But among those patients who received ICDs there was a significant (80%) reduction in sudden deaths caused by arrhythmia, the secondary end point.

In the new subanalysis, the ability of ICDs to protect against sudden death remained significant even after adjusting for statin use, Dr. Goldberger noted in an interview.

Moreover, among those patients who received ICDs, the use of statin therapy conferred an additional protection against sudden death.

But Dr. Shalaby cautioned that it is important to put these findings into perspective. “We recognize that these are post hoc analyses.”

At the time they released their 2004 findings, the DEFINITE investigators noted that the trial was not powered for subgroup analysis and that such analyses needed to be undertaken with extreme care.

Statin use was not a prespecified analysis. Of several prespecified subanalyses that they undertook in their 2004 article, none of the differences between subgroups was deemed significant.

Statin use, one among many uncontrolled variables in the DEFINITE trial, was not randomized. The patients' cholesterol levels were not uniformly available, and the duration of statin therapy and statin dose are unknown.

Dr. Goldberger acknowledged these limitations.

“Patients with hypercholesterolemia and dilated cardiomyopathy should be treated with statins. They have an indication,” Dr. Goldberger said in an interview. “For those without hypercholesterolemia, statin use needs to be tested in prospective trials.”

The DEFINITE study was funded by a grant from St. Jude Medical Inc. Several of the DEFINITE authors disclosed financial relationships with ICD makers.

None of the authors of the current subanalysis disclosed financial relationships with makers of statins.

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BOSTON — Statin use was associated with startling reductions in mortality and in sudden death among patients with nonischemic dilated cardiomyopathy, according to a new subanalysis from a multicenter trial of implantable cardioverter defibrillators.

In addition to a 77% decrease in overall mortality (5/110 vs. 64/348), statin use was associated with an 84% reduction in sudden death (1 vs. 18).

Statins were also associated with a 22% reduction in appropriate shocks in patients with implantable cardioverter defibrillators (ICDs).

Statins appear to have significant effects beyond lipid lowering, according to the researchers. Among patients with coronary artery disease, the lipid-lowering drugs are associated with a reduction in arrhythmic events, appropriate ICD shocks, and mortality. Statins can also improve the clinical status of patients with nonischemic heart failure.

To determine whether statins may be protective against sudden death in patients with nonischemic heart failure, Dr. Jeffrey J. Goldberger of Northwestern University, Chicago, and his colleagues compared the mortality in the 110 patients who took statins in the multicenter DEFINITE trial with the 348 patients who did not.

The patients in both groups were similar at baseline in most clinically important respects, according to Dr. Alaa Shalaby of the Pittsburgh VA Healthcare System who presented the findings during an oral presentation at the annual meeting of the Heart Rhythm Society.

The DEFINITE trial, which was published in 2004, randomized 458 patients with nonischemic dilated cardiomyopathy (DCM) and a left ventricular ejection fraction of less than 36% to receive standard medical therapy alone or medical therapy plus an ICD (N. Engl. J. Med. 2004; 350:2151–8).

The addition of an ICD provided no additional protection against death, the primary end point. But among those patients who received ICDs there was a significant (80%) reduction in sudden deaths caused by arrhythmia, the secondary end point.

In the new subanalysis, the ability of ICDs to protect against sudden death remained significant even after adjusting for statin use, Dr. Goldberger noted in an interview.

Moreover, among those patients who received ICDs, the use of statin therapy conferred an additional protection against sudden death.

But Dr. Shalaby cautioned that it is important to put these findings into perspective. “We recognize that these are post hoc analyses.”

At the time they released their 2004 findings, the DEFINITE investigators noted that the trial was not powered for subgroup analysis and that such analyses needed to be undertaken with extreme care.

Statin use was not a prespecified analysis. Of several prespecified subanalyses that they undertook in their 2004 article, none of the differences between subgroups was deemed significant.

Statin use, one among many uncontrolled variables in the DEFINITE trial, was not randomized. The patients' cholesterol levels were not uniformly available, and the duration of statin therapy and statin dose are unknown.

Dr. Goldberger acknowledged these limitations.

“Patients with hypercholesterolemia and dilated cardiomyopathy should be treated with statins. They have an indication,” Dr. Goldberger said in an interview. “For those without hypercholesterolemia, statin use needs to be tested in prospective trials.”

The DEFINITE study was funded by a grant from St. Jude Medical Inc. Several of the DEFINITE authors disclosed financial relationships with ICD makers.

None of the authors of the current subanalysis disclosed financial relationships with makers of statins.

BOSTON — Statin use was associated with startling reductions in mortality and in sudden death among patients with nonischemic dilated cardiomyopathy, according to a new subanalysis from a multicenter trial of implantable cardioverter defibrillators.

In addition to a 77% decrease in overall mortality (5/110 vs. 64/348), statin use was associated with an 84% reduction in sudden death (1 vs. 18).

Statins were also associated with a 22% reduction in appropriate shocks in patients with implantable cardioverter defibrillators (ICDs).

Statins appear to have significant effects beyond lipid lowering, according to the researchers. Among patients with coronary artery disease, the lipid-lowering drugs are associated with a reduction in arrhythmic events, appropriate ICD shocks, and mortality. Statins can also improve the clinical status of patients with nonischemic heart failure.

To determine whether statins may be protective against sudden death in patients with nonischemic heart failure, Dr. Jeffrey J. Goldberger of Northwestern University, Chicago, and his colleagues compared the mortality in the 110 patients who took statins in the multicenter DEFINITE trial with the 348 patients who did not.

The patients in both groups were similar at baseline in most clinically important respects, according to Dr. Alaa Shalaby of the Pittsburgh VA Healthcare System who presented the findings during an oral presentation at the annual meeting of the Heart Rhythm Society.

The DEFINITE trial, which was published in 2004, randomized 458 patients with nonischemic dilated cardiomyopathy (DCM) and a left ventricular ejection fraction of less than 36% to receive standard medical therapy alone or medical therapy plus an ICD (N. Engl. J. Med. 2004; 350:2151–8).

The addition of an ICD provided no additional protection against death, the primary end point. But among those patients who received ICDs there was a significant (80%) reduction in sudden deaths caused by arrhythmia, the secondary end point.

In the new subanalysis, the ability of ICDs to protect against sudden death remained significant even after adjusting for statin use, Dr. Goldberger noted in an interview.

Moreover, among those patients who received ICDs, the use of statin therapy conferred an additional protection against sudden death.

But Dr. Shalaby cautioned that it is important to put these findings into perspective. “We recognize that these are post hoc analyses.”

At the time they released their 2004 findings, the DEFINITE investigators noted that the trial was not powered for subgroup analysis and that such analyses needed to be undertaken with extreme care.

Statin use was not a prespecified analysis. Of several prespecified subanalyses that they undertook in their 2004 article, none of the differences between subgroups was deemed significant.

Statin use, one among many uncontrolled variables in the DEFINITE trial, was not randomized. The patients' cholesterol levels were not uniformly available, and the duration of statin therapy and statin dose are unknown.

Dr. Goldberger acknowledged these limitations.

“Patients with hypercholesterolemia and dilated cardiomyopathy should be treated with statins. They have an indication,” Dr. Goldberger said in an interview. “For those without hypercholesterolemia, statin use needs to be tested in prospective trials.”

The DEFINITE study was funded by a grant from St. Jude Medical Inc. Several of the DEFINITE authors disclosed financial relationships with ICD makers.

None of the authors of the current subanalysis disclosed financial relationships with makers of statins.

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Is Catheter Ablation Best for Refractory Atrial Fib?

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Is Catheter Ablation Best for Refractory Atrial Fib?

BOSTON — Catheter ablation is superior to an assortment of antiarrhythmic drugs in the treatment of patients with paroxysmal atrial fibrillation who have previously failed at least one AAD, according to a new study.

At 1-year follow-up, success among patients undergoing ablation was 10-fold greater than in those taking antiarrhythmic drugs (AADs), at 75% and 7%, respectively. Duration of recurrent episodes of atrial fibrillation was also shorter in the ablation group (8 minutes vs. 150 minutes), as was freedom from anticoagulants (63% vs. 25%), said Dr. Pierre Jais of Hôpital Cardiologique Haut-Levêque in Bordeaux-Pessac, France.

Dr. Jais presented the results of the multicenter Atrial Fibrillation Ablation vs. Antiarrhythmic Drugs (A-4) trial at the annual meeting of the Heart Rhythm Society. The study was sponsored by Biosense Webster Inc., which manufactures therapeutic catheters.

The findings of the A-4 trial suggest that ablation may help people with frequent, highly symptomatic atrial fibrillation who otherwise would do poorly on AADs. High-quality trials have yet to prove whether either of these treatments for atrial fibrillation is superior to the other. Despite the glowing near-term results of this and other studies—and the meteoric rise in the number of ablation procedures in recent years—questions remain about patient selection for ablation, outcome criteria, long-term efficacy, and safety.

Dr. Jais and colleagues randomized 112 patients from two European and two North American centers to receive lasso catheter ablation (53 patients) or treatment with one or more previously untried AADs (59 patients). The patients had experienced an average of two atrial fibrillation episodes per month over the course of at least 6 months (average duration 9 ± 9 hours) and showed resistance to at least one class I or class III AAD. Their average age was 51 years; most (84%) were men. At baseline, some 80% took anticoagulants, and 21% had structural heart disease.

Clinicians were permitted to attempt as many as three interventions per patient during the first 3 months. After that, the protocol permitted failed patients to cross over to the other group. Failure was defined as atrial fibrillation lasting more than 3 minutes (self-reported or documented) at any point beyond the first 3 months.

By the 12-month follow-up mark, 84% of patients in the AAD arm had failed drug therapy, including 19 of 24 patients (79%) who had tried amiodarone for the first time. In addition, 37 patients (63%) crossed over and underwent ablation, according to Dr. Jais. Only four patients (7%) achieved complete control of arrhythmias.

The remaining 22 chose not to undergo ablation, “presumably because they were feeling much better because of the intensification of their treatments,” said Dr. Jais. The AAD group attempted 88 class I, 39 class II, 59 class III, and 6 class IV drugs.

By contrast, three patients in four who underwent ablation were free of arrhythmias. As in previous studies, repeat procedures were common; investigators required an average of 1.8 procedures per patient to achieve pulmonary vein isolation (155 procedures in 90 patients).

Secondary outcome measures, including quality of life and exercise duration, also favored the ablation procedure.

There was one case of amiodarone-induced hyperthyroidism in the AAD group. Significant complications in the ablation group included two episodes of tamponade and one case of pulmonary vein stenosis.

In patients who failed at least one AAD, “complete arrhythmia control is really unlikely using antiarrhythmics; it's a 7% success rate at 1 year,” said Dr. Jais.

“This includes amiodarone, where the success rate is just 21%. … Without any doubt, further studies are now required to compare the impact of these strategies on longer-term outcomes.”

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BOSTON — Catheter ablation is superior to an assortment of antiarrhythmic drugs in the treatment of patients with paroxysmal atrial fibrillation who have previously failed at least one AAD, according to a new study.

At 1-year follow-up, success among patients undergoing ablation was 10-fold greater than in those taking antiarrhythmic drugs (AADs), at 75% and 7%, respectively. Duration of recurrent episodes of atrial fibrillation was also shorter in the ablation group (8 minutes vs. 150 minutes), as was freedom from anticoagulants (63% vs. 25%), said Dr. Pierre Jais of Hôpital Cardiologique Haut-Levêque in Bordeaux-Pessac, France.

Dr. Jais presented the results of the multicenter Atrial Fibrillation Ablation vs. Antiarrhythmic Drugs (A-4) trial at the annual meeting of the Heart Rhythm Society. The study was sponsored by Biosense Webster Inc., which manufactures therapeutic catheters.

The findings of the A-4 trial suggest that ablation may help people with frequent, highly symptomatic atrial fibrillation who otherwise would do poorly on AADs. High-quality trials have yet to prove whether either of these treatments for atrial fibrillation is superior to the other. Despite the glowing near-term results of this and other studies—and the meteoric rise in the number of ablation procedures in recent years—questions remain about patient selection for ablation, outcome criteria, long-term efficacy, and safety.

Dr. Jais and colleagues randomized 112 patients from two European and two North American centers to receive lasso catheter ablation (53 patients) or treatment with one or more previously untried AADs (59 patients). The patients had experienced an average of two atrial fibrillation episodes per month over the course of at least 6 months (average duration 9 ± 9 hours) and showed resistance to at least one class I or class III AAD. Their average age was 51 years; most (84%) were men. At baseline, some 80% took anticoagulants, and 21% had structural heart disease.

Clinicians were permitted to attempt as many as three interventions per patient during the first 3 months. After that, the protocol permitted failed patients to cross over to the other group. Failure was defined as atrial fibrillation lasting more than 3 minutes (self-reported or documented) at any point beyond the first 3 months.

By the 12-month follow-up mark, 84% of patients in the AAD arm had failed drug therapy, including 19 of 24 patients (79%) who had tried amiodarone for the first time. In addition, 37 patients (63%) crossed over and underwent ablation, according to Dr. Jais. Only four patients (7%) achieved complete control of arrhythmias.

The remaining 22 chose not to undergo ablation, “presumably because they were feeling much better because of the intensification of their treatments,” said Dr. Jais. The AAD group attempted 88 class I, 39 class II, 59 class III, and 6 class IV drugs.

By contrast, three patients in four who underwent ablation were free of arrhythmias. As in previous studies, repeat procedures were common; investigators required an average of 1.8 procedures per patient to achieve pulmonary vein isolation (155 procedures in 90 patients).

Secondary outcome measures, including quality of life and exercise duration, also favored the ablation procedure.

There was one case of amiodarone-induced hyperthyroidism in the AAD group. Significant complications in the ablation group included two episodes of tamponade and one case of pulmonary vein stenosis.

In patients who failed at least one AAD, “complete arrhythmia control is really unlikely using antiarrhythmics; it's a 7% success rate at 1 year,” said Dr. Jais.

“This includes amiodarone, where the success rate is just 21%. … Without any doubt, further studies are now required to compare the impact of these strategies on longer-term outcomes.”

BOSTON — Catheter ablation is superior to an assortment of antiarrhythmic drugs in the treatment of patients with paroxysmal atrial fibrillation who have previously failed at least one AAD, according to a new study.

At 1-year follow-up, success among patients undergoing ablation was 10-fold greater than in those taking antiarrhythmic drugs (AADs), at 75% and 7%, respectively. Duration of recurrent episodes of atrial fibrillation was also shorter in the ablation group (8 minutes vs. 150 minutes), as was freedom from anticoagulants (63% vs. 25%), said Dr. Pierre Jais of Hôpital Cardiologique Haut-Levêque in Bordeaux-Pessac, France.

Dr. Jais presented the results of the multicenter Atrial Fibrillation Ablation vs. Antiarrhythmic Drugs (A-4) trial at the annual meeting of the Heart Rhythm Society. The study was sponsored by Biosense Webster Inc., which manufactures therapeutic catheters.

The findings of the A-4 trial suggest that ablation may help people with frequent, highly symptomatic atrial fibrillation who otherwise would do poorly on AADs. High-quality trials have yet to prove whether either of these treatments for atrial fibrillation is superior to the other. Despite the glowing near-term results of this and other studies—and the meteoric rise in the number of ablation procedures in recent years—questions remain about patient selection for ablation, outcome criteria, long-term efficacy, and safety.

Dr. Jais and colleagues randomized 112 patients from two European and two North American centers to receive lasso catheter ablation (53 patients) or treatment with one or more previously untried AADs (59 patients). The patients had experienced an average of two atrial fibrillation episodes per month over the course of at least 6 months (average duration 9 ± 9 hours) and showed resistance to at least one class I or class III AAD. Their average age was 51 years; most (84%) were men. At baseline, some 80% took anticoagulants, and 21% had structural heart disease.

Clinicians were permitted to attempt as many as three interventions per patient during the first 3 months. After that, the protocol permitted failed patients to cross over to the other group. Failure was defined as atrial fibrillation lasting more than 3 minutes (self-reported or documented) at any point beyond the first 3 months.

By the 12-month follow-up mark, 84% of patients in the AAD arm had failed drug therapy, including 19 of 24 patients (79%) who had tried amiodarone for the first time. In addition, 37 patients (63%) crossed over and underwent ablation, according to Dr. Jais. Only four patients (7%) achieved complete control of arrhythmias.

The remaining 22 chose not to undergo ablation, “presumably because they were feeling much better because of the intensification of their treatments,” said Dr. Jais. The AAD group attempted 88 class I, 39 class II, 59 class III, and 6 class IV drugs.

By contrast, three patients in four who underwent ablation were free of arrhythmias. As in previous studies, repeat procedures were common; investigators required an average of 1.8 procedures per patient to achieve pulmonary vein isolation (155 procedures in 90 patients).

Secondary outcome measures, including quality of life and exercise duration, also favored the ablation procedure.

There was one case of amiodarone-induced hyperthyroidism in the AAD group. Significant complications in the ablation group included two episodes of tamponade and one case of pulmonary vein stenosis.

In patients who failed at least one AAD, “complete arrhythmia control is really unlikely using antiarrhythmics; it's a 7% success rate at 1 year,” said Dr. Jais.

“This includes amiodarone, where the success rate is just 21%. … Without any doubt, further studies are now required to compare the impact of these strategies on longer-term outcomes.”

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One-Third of Girls Sexually Active by Age 15 But Only 44% Say Partners Use Condoms

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BOSTON — By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior is important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections, as well as the psychological and emotional health of young women.

Media reports increasingly suggest that, as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%.

The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey—more than doubling from 26% at age 15 to 70% by age 18 (see box). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age, 39% gave oral sex and 52% received.

Amid all this activity, the use of condoms is less than full fledged. Only 44% of female teens said their partners used condoms. The prevalence of self-reported STIs was relatively low: Among all females aged 15–19 years in the survey, about 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

ELSEVIER GLOBAL MEDICAL NEWS

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BOSTON — By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior is important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections, as well as the psychological and emotional health of young women.

Media reports increasingly suggest that, as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%.

The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey—more than doubling from 26% at age 15 to 70% by age 18 (see box). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age, 39% gave oral sex and 52% received.

Amid all this activity, the use of condoms is less than full fledged. Only 44% of female teens said their partners used condoms. The prevalence of self-reported STIs was relatively low: Among all females aged 15–19 years in the survey, about 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

ELSEVIER GLOBAL MEDICAL NEWS

BOSTON — By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior is important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections, as well as the psychological and emotional health of young women.

Media reports increasingly suggest that, as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%.

The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey—more than doubling from 26% at age 15 to 70% by age 18 (see box). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age, 39% gave oral sex and 52% received.

Amid all this activity, the use of condoms is less than full fledged. Only 44% of female teens said their partners used condoms. The prevalence of self-reported STIs was relatively low: Among all females aged 15–19 years in the survey, about 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

ELSEVIER GLOBAL MEDICAL NEWS

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Statins Slash Mortality 77% in Nonischemic Cardiomyopathy

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Statins Slash Mortality 77% in Nonischemic Cardiomyopathy

BOSTON — Statin use was associated with startling reductions in mortality and sudden death among patients with nonischemic dilated cardiomyopathy, according to a new subanalysis from a multicenter trial of implantable cardiac defibrillators.

In addition to a 77% decrease in overall mortality (5/110 vs. 64/348), statin use was associated with an 84% reduction in sudden death (1 vs. 18). Statins were also associated with a 22% reduction in appropriate shocks in patients with implantable cardioverter defibrillators (ICDs).

Statins appear to have significant effects beyond lipid lowering. Among patients with coronary artery disease, the lipid-lowering drugs are associated with a reduction in arrhythmic events, appropriate ICD shocks, and mortality. Statins can also improve the clinical status of patients with nonischemic heart failure.

To determine whether statins may be protective against sudden death in patients with nonischemic heart failure, Dr. Jeffrey J. Goldberger of Northwestern University, Chicago, and colleagues compared mortality in the 110 patients who took statins in the multicenter DEFINITE trial with the 348 patients who did not. The patients in both groups were similar at baseline in most clinically important respects.

Dr. Alaa Shalaby of the Pittsburgh VA Healthcare System presented the findings during an oral presentation at the annual meeting of the Heart Rhythm Society.

The DEFINITE trial, published in 2004, randomized 458 patients with nonischemic dilated cardiomyopathy (DCM) and a left ventricular ejection fraction of less than 36% to receive standard medical therapy alone or medical therapy plus an ICD (N. Engl. J. Med. 2004;350:2151–8). The addition of an ICD provided no additional protection against death, the primary end point. But among patients who received ICDs there was a significant (80%) reduction in sudden deaths caused by arrhythmia, the secondary end point.

In the new subanalysis, the ability of ICDs to protect against sudden death remained significant after adjusting for statin use, Dr. Goldberger noted in an interview. Moreover, among patients with ICDs, the use of statin therapy conferred additional protection against sudden death. But Dr. Shalaby cautioned that it is important to put these findings into perspective. “We recognize that these are post hoc analyses.”

At the time they released their 2004 findings, the DEFINITE investigators noted that the trial was not powered for subgroup analysis and that such analyses need to be undertaken with extreme care. Statin use was not a prespecified analysis. Of several prespecified subanalyses that they undertook in their 2004 article, none of the differences between subgroups were deemed significant.

The DEFINITE study was funded by a grant from St. Jude Medical. Several of the DEFINITE authors disclosed financial relationships with ICD makers. None of the authors of the current subanalysis disclosed financial relationships with makers of statins.

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BOSTON — Statin use was associated with startling reductions in mortality and sudden death among patients with nonischemic dilated cardiomyopathy, according to a new subanalysis from a multicenter trial of implantable cardiac defibrillators.

In addition to a 77% decrease in overall mortality (5/110 vs. 64/348), statin use was associated with an 84% reduction in sudden death (1 vs. 18). Statins were also associated with a 22% reduction in appropriate shocks in patients with implantable cardioverter defibrillators (ICDs).

Statins appear to have significant effects beyond lipid lowering. Among patients with coronary artery disease, the lipid-lowering drugs are associated with a reduction in arrhythmic events, appropriate ICD shocks, and mortality. Statins can also improve the clinical status of patients with nonischemic heart failure.

To determine whether statins may be protective against sudden death in patients with nonischemic heart failure, Dr. Jeffrey J. Goldberger of Northwestern University, Chicago, and colleagues compared mortality in the 110 patients who took statins in the multicenter DEFINITE trial with the 348 patients who did not. The patients in both groups were similar at baseline in most clinically important respects.

Dr. Alaa Shalaby of the Pittsburgh VA Healthcare System presented the findings during an oral presentation at the annual meeting of the Heart Rhythm Society.

The DEFINITE trial, published in 2004, randomized 458 patients with nonischemic dilated cardiomyopathy (DCM) and a left ventricular ejection fraction of less than 36% to receive standard medical therapy alone or medical therapy plus an ICD (N. Engl. J. Med. 2004;350:2151–8). The addition of an ICD provided no additional protection against death, the primary end point. But among patients who received ICDs there was a significant (80%) reduction in sudden deaths caused by arrhythmia, the secondary end point.

In the new subanalysis, the ability of ICDs to protect against sudden death remained significant after adjusting for statin use, Dr. Goldberger noted in an interview. Moreover, among patients with ICDs, the use of statin therapy conferred additional protection against sudden death. But Dr. Shalaby cautioned that it is important to put these findings into perspective. “We recognize that these are post hoc analyses.”

At the time they released their 2004 findings, the DEFINITE investigators noted that the trial was not powered for subgroup analysis and that such analyses need to be undertaken with extreme care. Statin use was not a prespecified analysis. Of several prespecified subanalyses that they undertook in their 2004 article, none of the differences between subgroups were deemed significant.

The DEFINITE study was funded by a grant from St. Jude Medical. Several of the DEFINITE authors disclosed financial relationships with ICD makers. None of the authors of the current subanalysis disclosed financial relationships with makers of statins.

BOSTON — Statin use was associated with startling reductions in mortality and sudden death among patients with nonischemic dilated cardiomyopathy, according to a new subanalysis from a multicenter trial of implantable cardiac defibrillators.

In addition to a 77% decrease in overall mortality (5/110 vs. 64/348), statin use was associated with an 84% reduction in sudden death (1 vs. 18). Statins were also associated with a 22% reduction in appropriate shocks in patients with implantable cardioverter defibrillators (ICDs).

Statins appear to have significant effects beyond lipid lowering. Among patients with coronary artery disease, the lipid-lowering drugs are associated with a reduction in arrhythmic events, appropriate ICD shocks, and mortality. Statins can also improve the clinical status of patients with nonischemic heart failure.

To determine whether statins may be protective against sudden death in patients with nonischemic heart failure, Dr. Jeffrey J. Goldberger of Northwestern University, Chicago, and colleagues compared mortality in the 110 patients who took statins in the multicenter DEFINITE trial with the 348 patients who did not. The patients in both groups were similar at baseline in most clinically important respects.

Dr. Alaa Shalaby of the Pittsburgh VA Healthcare System presented the findings during an oral presentation at the annual meeting of the Heart Rhythm Society.

The DEFINITE trial, published in 2004, randomized 458 patients with nonischemic dilated cardiomyopathy (DCM) and a left ventricular ejection fraction of less than 36% to receive standard medical therapy alone or medical therapy plus an ICD (N. Engl. J. Med. 2004;350:2151–8). The addition of an ICD provided no additional protection against death, the primary end point. But among patients who received ICDs there was a significant (80%) reduction in sudden deaths caused by arrhythmia, the secondary end point.

In the new subanalysis, the ability of ICDs to protect against sudden death remained significant after adjusting for statin use, Dr. Goldberger noted in an interview. Moreover, among patients with ICDs, the use of statin therapy conferred additional protection against sudden death. But Dr. Shalaby cautioned that it is important to put these findings into perspective. “We recognize that these are post hoc analyses.”

At the time they released their 2004 findings, the DEFINITE investigators noted that the trial was not powered for subgroup analysis and that such analyses need to be undertaken with extreme care. Statin use was not a prespecified analysis. Of several prespecified subanalyses that they undertook in their 2004 article, none of the differences between subgroups were deemed significant.

The DEFINITE study was funded by a grant from St. Jude Medical. Several of the DEFINITE authors disclosed financial relationships with ICD makers. None of the authors of the current subanalysis disclosed financial relationships with makers of statins.

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Combo OC Use in Factor V Leiden Not Advised

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Combo OC Use in Factor V Leiden Not Advised

BOSTON — Estrogen-containing oral contraceptives appear to greatly increase the relative risk of venous thromboembolism among women with the factor V Leiden genetic mutation, according to a recent review by the World Health Organization.

Asked if they would prescribe estrogen-containing oral contraceptives for these women, members of a recent expert panel agreed they would not. The risks of a blood clot are too great, they said.

“I'd be very cautious about using estrogen. I would use methods that had progestin in them if the patient wanted a hormonal method at all,” said panelist Sharon Schnare of the South Kitsap Family Care Clinic in Port Orchard, Wash.

“They really should not use a contraceptive method that has estrogen in it,” agreed Dr. Michael Policar, medical director of the California state office of family planning.

The clinicians spoke during a conference on contraceptive technology sponsored by Contemporary Forums.

Clots: Relative and Absolute Risks

The evidence on the risks of VTE among women who carry factor V Leiden and who also take combined oral contraceptives (COCs) is murky. The research suffers from a variety of biases and sometimes offers conflicting assessments.

Given the evidence, who should receive screening? And what contraceptive methods should those with the clotting gene use?

The WHO undertook its systematic review to answer some of these questions (Contraception 2006;73:166–78). In its analysis of 16 studies, the WHO authors found the following:

▸ Factor V Leiden alone increased the risk of VTE among women of child-bearing age by a range of 30% to 30-fold (OR 1.3 to 30.0).

▸ Women with the factor V Leiden mutation who took COCs increased their risk of VTE compared with women with neither risk factor by 6.4- to 99-fold.

▸ Compared to nonusers with the mutation, women with the mutation who took COCs increased their risk of VTE by a range of 30% to 25-fold (OR 1.3 to 25.1).

▸ The absolute risk of VTE remains rare; 99.9% of women who carry the mutation would not have thrombosis if they received oral contraceptive pills.

▸ In one analysis of women carrying the clotting gene, first- and second-generation COCs were more than twice as likely to be associated with a VTE (OR 64.7) as were third-generation pills (OR 29.6).

Despite numerous limitations inherent in the studies they analyzed—and the tremendous variability in the studies' results—the WHO authors say it is possible to tease out at least one definitive conclusion. “The data overwhelmingly suggest that there is a multiplicative effect at work—the combination of factors produces greater risk than thrombogenic mutation alone,” they write.

Screening, Contraceptive Advice

The WHO does not recommend routine screening for thrombogenic mutations. The yield would be tiny, the number of lives saved minuscule, and the cost astronomical. According to one cost-effectiveness analysis, clinicians would have to screen 92,000 factor V Leiden carriers at a cost of nearly $300 million to prevent one death from VTE attributed to COCs (Fertil. Steril. 1999;72:646–51).

Unfortunately, no one has looked at risks associated with other forms of contraception among women with thrombogenic mutations, according to the WHO authors. On the basis of two reports—a postmarketing surveillance study of Norplant (Contraception 2001;63:187–209) and an international, multicenter, case-control study conducted by the WHO (Contraception 1998;57:315–24)—they conclude that there is “limited evidence” that progestin-only methods and combined injectable contraceptives do not increase the risk of VTE.

Doing nothing is perilous in a woman of childbearing age carrying the factor V Leiden mutation because pregnancy is also a risk factor for VTE in these women, Dr. Policar told the audience. “While an estrogen-containing contraceptive is dangerous, pregnancy is also really dangerous,” he noted. “If a patient reveals to you that she has factor V Leiden and she is not actively trying to get pregnant right now, it's extremely important that you help her obtain effective contraception,” he said.

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BOSTON — Estrogen-containing oral contraceptives appear to greatly increase the relative risk of venous thromboembolism among women with the factor V Leiden genetic mutation, according to a recent review by the World Health Organization.

Asked if they would prescribe estrogen-containing oral contraceptives for these women, members of a recent expert panel agreed they would not. The risks of a blood clot are too great, they said.

“I'd be very cautious about using estrogen. I would use methods that had progestin in them if the patient wanted a hormonal method at all,” said panelist Sharon Schnare of the South Kitsap Family Care Clinic in Port Orchard, Wash.

“They really should not use a contraceptive method that has estrogen in it,” agreed Dr. Michael Policar, medical director of the California state office of family planning.

The clinicians spoke during a conference on contraceptive technology sponsored by Contemporary Forums.

Clots: Relative and Absolute Risks

The evidence on the risks of VTE among women who carry factor V Leiden and who also take combined oral contraceptives (COCs) is murky. The research suffers from a variety of biases and sometimes offers conflicting assessments.

Given the evidence, who should receive screening? And what contraceptive methods should those with the clotting gene use?

The WHO undertook its systematic review to answer some of these questions (Contraception 2006;73:166–78). In its analysis of 16 studies, the WHO authors found the following:

▸ Factor V Leiden alone increased the risk of VTE among women of child-bearing age by a range of 30% to 30-fold (OR 1.3 to 30.0).

▸ Women with the factor V Leiden mutation who took COCs increased their risk of VTE compared with women with neither risk factor by 6.4- to 99-fold.

▸ Compared to nonusers with the mutation, women with the mutation who took COCs increased their risk of VTE by a range of 30% to 25-fold (OR 1.3 to 25.1).

▸ The absolute risk of VTE remains rare; 99.9% of women who carry the mutation would not have thrombosis if they received oral contraceptive pills.

▸ In one analysis of women carrying the clotting gene, first- and second-generation COCs were more than twice as likely to be associated with a VTE (OR 64.7) as were third-generation pills (OR 29.6).

Despite numerous limitations inherent in the studies they analyzed—and the tremendous variability in the studies' results—the WHO authors say it is possible to tease out at least one definitive conclusion. “The data overwhelmingly suggest that there is a multiplicative effect at work—the combination of factors produces greater risk than thrombogenic mutation alone,” they write.

Screening, Contraceptive Advice

The WHO does not recommend routine screening for thrombogenic mutations. The yield would be tiny, the number of lives saved minuscule, and the cost astronomical. According to one cost-effectiveness analysis, clinicians would have to screen 92,000 factor V Leiden carriers at a cost of nearly $300 million to prevent one death from VTE attributed to COCs (Fertil. Steril. 1999;72:646–51).

Unfortunately, no one has looked at risks associated with other forms of contraception among women with thrombogenic mutations, according to the WHO authors. On the basis of two reports—a postmarketing surveillance study of Norplant (Contraception 2001;63:187–209) and an international, multicenter, case-control study conducted by the WHO (Contraception 1998;57:315–24)—they conclude that there is “limited evidence” that progestin-only methods and combined injectable contraceptives do not increase the risk of VTE.

Doing nothing is perilous in a woman of childbearing age carrying the factor V Leiden mutation because pregnancy is also a risk factor for VTE in these women, Dr. Policar told the audience. “While an estrogen-containing contraceptive is dangerous, pregnancy is also really dangerous,” he noted. “If a patient reveals to you that she has factor V Leiden and she is not actively trying to get pregnant right now, it's extremely important that you help her obtain effective contraception,” he said.

BOSTON — Estrogen-containing oral contraceptives appear to greatly increase the relative risk of venous thromboembolism among women with the factor V Leiden genetic mutation, according to a recent review by the World Health Organization.

Asked if they would prescribe estrogen-containing oral contraceptives for these women, members of a recent expert panel agreed they would not. The risks of a blood clot are too great, they said.

“I'd be very cautious about using estrogen. I would use methods that had progestin in them if the patient wanted a hormonal method at all,” said panelist Sharon Schnare of the South Kitsap Family Care Clinic in Port Orchard, Wash.

“They really should not use a contraceptive method that has estrogen in it,” agreed Dr. Michael Policar, medical director of the California state office of family planning.

The clinicians spoke during a conference on contraceptive technology sponsored by Contemporary Forums.

Clots: Relative and Absolute Risks

The evidence on the risks of VTE among women who carry factor V Leiden and who also take combined oral contraceptives (COCs) is murky. The research suffers from a variety of biases and sometimes offers conflicting assessments.

Given the evidence, who should receive screening? And what contraceptive methods should those with the clotting gene use?

The WHO undertook its systematic review to answer some of these questions (Contraception 2006;73:166–78). In its analysis of 16 studies, the WHO authors found the following:

▸ Factor V Leiden alone increased the risk of VTE among women of child-bearing age by a range of 30% to 30-fold (OR 1.3 to 30.0).

▸ Women with the factor V Leiden mutation who took COCs increased their risk of VTE compared with women with neither risk factor by 6.4- to 99-fold.

▸ Compared to nonusers with the mutation, women with the mutation who took COCs increased their risk of VTE by a range of 30% to 25-fold (OR 1.3 to 25.1).

▸ The absolute risk of VTE remains rare; 99.9% of women who carry the mutation would not have thrombosis if they received oral contraceptive pills.

▸ In one analysis of women carrying the clotting gene, first- and second-generation COCs were more than twice as likely to be associated with a VTE (OR 64.7) as were third-generation pills (OR 29.6).

Despite numerous limitations inherent in the studies they analyzed—and the tremendous variability in the studies' results—the WHO authors say it is possible to tease out at least one definitive conclusion. “The data overwhelmingly suggest that there is a multiplicative effect at work—the combination of factors produces greater risk than thrombogenic mutation alone,” they write.

Screening, Contraceptive Advice

The WHO does not recommend routine screening for thrombogenic mutations. The yield would be tiny, the number of lives saved minuscule, and the cost astronomical. According to one cost-effectiveness analysis, clinicians would have to screen 92,000 factor V Leiden carriers at a cost of nearly $300 million to prevent one death from VTE attributed to COCs (Fertil. Steril. 1999;72:646–51).

Unfortunately, no one has looked at risks associated with other forms of contraception among women with thrombogenic mutations, according to the WHO authors. On the basis of two reports—a postmarketing surveillance study of Norplant (Contraception 2001;63:187–209) and an international, multicenter, case-control study conducted by the WHO (Contraception 1998;57:315–24)—they conclude that there is “limited evidence” that progestin-only methods and combined injectable contraceptives do not increase the risk of VTE.

Doing nothing is perilous in a woman of childbearing age carrying the factor V Leiden mutation because pregnancy is also a risk factor for VTE in these women, Dr. Policar told the audience. “While an estrogen-containing contraceptive is dangerous, pregnancy is also really dangerous,” he noted. “If a patient reveals to you that she has factor V Leiden and she is not actively trying to get pregnant right now, it's extremely important that you help her obtain effective contraception,” he said.

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Updated STD Guidelines From CDC Coming Soon

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BOSTON — The soon-to-be-released 2006 STD treatment guidelines from the Centers for Disease Control and Prevention are likely to include new recommendations for the diagnosis or treatment of gonorrhea, bacterial vaginosis, trichomoniasis, herpes simplex virus, and human papillomavirus, according to a former CDC official.

Some of the recommendations could change before publication of the final report, but probably not in these treatment areas, Dr. Willard Cates explained. He outlined his predictions for the new guidelines during a conference on contraceptive technology sponsored by Contemporary Forums.

The CDC plans to release the 2006 STD guidelines later this summer. They represent the first update since 2002. When making its recommendations, the CDC weighs scientific evidence, costs, availability, and ease of adherence.

According to Dr. Cates, the updated guidelines will recommend new regimens for treating homosexual men with gonorrhea, pregnant women with bacterial vaginosis, and all individuals with trichomoniasis.

The CDC guidelines also will recommend “what you might think of as suppressive therapy” to reduce the transmission of herpes simplex virus in heterosexual couples. “Treatment is preventative,” observed Dr. Cates, president of the Family Health Institute in Research Triangle Park, N.C.

To improve medication adherence among individuals with recurrent disease, some of the new guidelines will recommend higher antiviral dosing for shorter periods of time, he added.

In addition to offering diagnostic and treatment recommendations, the new CDC guidelines also will emphasize counseling for sex partners and other strategies aimed at interrupting chains of transmission.

The CDC guidelines are intended to serve as “tools, not rules,” Dr. Cates emphasized. “More choices allow you more flexibility and adherence, with an emphasis on client-centered counseling.”

Here are some of the likely new recommendations in the 2006 guidelines, according to Dr. Cates:

Gonorrhea

▸ Quinolones will continue to be appropriate therapy in women and in heterosexual men and women.

▸ Cefpodoxime 400 mg or cefuroxime 1 g will be acceptable alternative therapies in men who have sex with men and in geographical areas where quinolone-resistant gonorrhea has become increasingly prevalent.

▸ Azithromycin will not be recommended because of concerns about potential emergence of antimicrobial resistance.

Bacterial Vaginosis

▸ In a woman with a previous high-risk pregnancy, oral metronidazole 500 mg twice daily will be recommended.

Trichomoniasis

▸ Expanded diagnostic options will include the OSOM Trichomonas rapid test (an immunochromatographic capillary flow/dipstick assay) and the Affirm VP III nucleic acid probe test.

▸ Single-dose tinidazole 2 g will be recommended for initial treatment or treatment failure.

Herpes Simplex Virus

▸ For recurrent episodes, treatment recommendations will include acyclovir 800 mg three times daily for 2 days or famciclovir 1 g twice daily for 1 day.

▸ Valacyclovir 500 mg daily will be recommended to reduce transmission in herpes-discordant heterosexual couples.

Human Papillomavirus

▸ The guidelines will recommend that HPV tests be reserved for cervical cancer screening only.

▸ The guidelines will recommend against HPV screening for sexually transmitted disease in the general population.

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BOSTON — The soon-to-be-released 2006 STD treatment guidelines from the Centers for Disease Control and Prevention are likely to include new recommendations for the diagnosis or treatment of gonorrhea, bacterial vaginosis, trichomoniasis, herpes simplex virus, and human papillomavirus, according to a former CDC official.

Some of the recommendations could change before publication of the final report, but probably not in these treatment areas, Dr. Willard Cates explained. He outlined his predictions for the new guidelines during a conference on contraceptive technology sponsored by Contemporary Forums.

The CDC plans to release the 2006 STD guidelines later this summer. They represent the first update since 2002. When making its recommendations, the CDC weighs scientific evidence, costs, availability, and ease of adherence.

According to Dr. Cates, the updated guidelines will recommend new regimens for treating homosexual men with gonorrhea, pregnant women with bacterial vaginosis, and all individuals with trichomoniasis.

The CDC guidelines also will recommend “what you might think of as suppressive therapy” to reduce the transmission of herpes simplex virus in heterosexual couples. “Treatment is preventative,” observed Dr. Cates, president of the Family Health Institute in Research Triangle Park, N.C.

To improve medication adherence among individuals with recurrent disease, some of the new guidelines will recommend higher antiviral dosing for shorter periods of time, he added.

In addition to offering diagnostic and treatment recommendations, the new CDC guidelines also will emphasize counseling for sex partners and other strategies aimed at interrupting chains of transmission.

The CDC guidelines are intended to serve as “tools, not rules,” Dr. Cates emphasized. “More choices allow you more flexibility and adherence, with an emphasis on client-centered counseling.”

Here are some of the likely new recommendations in the 2006 guidelines, according to Dr. Cates:

Gonorrhea

▸ Quinolones will continue to be appropriate therapy in women and in heterosexual men and women.

▸ Cefpodoxime 400 mg or cefuroxime 1 g will be acceptable alternative therapies in men who have sex with men and in geographical areas where quinolone-resistant gonorrhea has become increasingly prevalent.

▸ Azithromycin will not be recommended because of concerns about potential emergence of antimicrobial resistance.

Bacterial Vaginosis

▸ In a woman with a previous high-risk pregnancy, oral metronidazole 500 mg twice daily will be recommended.

Trichomoniasis

▸ Expanded diagnostic options will include the OSOM Trichomonas rapid test (an immunochromatographic capillary flow/dipstick assay) and the Affirm VP III nucleic acid probe test.

▸ Single-dose tinidazole 2 g will be recommended for initial treatment or treatment failure.

Herpes Simplex Virus

▸ For recurrent episodes, treatment recommendations will include acyclovir 800 mg three times daily for 2 days or famciclovir 1 g twice daily for 1 day.

▸ Valacyclovir 500 mg daily will be recommended to reduce transmission in herpes-discordant heterosexual couples.

Human Papillomavirus

▸ The guidelines will recommend that HPV tests be reserved for cervical cancer screening only.

▸ The guidelines will recommend against HPV screening for sexually transmitted disease in the general population.

BOSTON — The soon-to-be-released 2006 STD treatment guidelines from the Centers for Disease Control and Prevention are likely to include new recommendations for the diagnosis or treatment of gonorrhea, bacterial vaginosis, trichomoniasis, herpes simplex virus, and human papillomavirus, according to a former CDC official.

Some of the recommendations could change before publication of the final report, but probably not in these treatment areas, Dr. Willard Cates explained. He outlined his predictions for the new guidelines during a conference on contraceptive technology sponsored by Contemporary Forums.

The CDC plans to release the 2006 STD guidelines later this summer. They represent the first update since 2002. When making its recommendations, the CDC weighs scientific evidence, costs, availability, and ease of adherence.

According to Dr. Cates, the updated guidelines will recommend new regimens for treating homosexual men with gonorrhea, pregnant women with bacterial vaginosis, and all individuals with trichomoniasis.

The CDC guidelines also will recommend “what you might think of as suppressive therapy” to reduce the transmission of herpes simplex virus in heterosexual couples. “Treatment is preventative,” observed Dr. Cates, president of the Family Health Institute in Research Triangle Park, N.C.

To improve medication adherence among individuals with recurrent disease, some of the new guidelines will recommend higher antiviral dosing for shorter periods of time, he added.

In addition to offering diagnostic and treatment recommendations, the new CDC guidelines also will emphasize counseling for sex partners and other strategies aimed at interrupting chains of transmission.

The CDC guidelines are intended to serve as “tools, not rules,” Dr. Cates emphasized. “More choices allow you more flexibility and adherence, with an emphasis on client-centered counseling.”

Here are some of the likely new recommendations in the 2006 guidelines, according to Dr. Cates:

Gonorrhea

▸ Quinolones will continue to be appropriate therapy in women and in heterosexual men and women.

▸ Cefpodoxime 400 mg or cefuroxime 1 g will be acceptable alternative therapies in men who have sex with men and in geographical areas where quinolone-resistant gonorrhea has become increasingly prevalent.

▸ Azithromycin will not be recommended because of concerns about potential emergence of antimicrobial resistance.

Bacterial Vaginosis

▸ In a woman with a previous high-risk pregnancy, oral metronidazole 500 mg twice daily will be recommended.

Trichomoniasis

▸ Expanded diagnostic options will include the OSOM Trichomonas rapid test (an immunochromatographic capillary flow/dipstick assay) and the Affirm VP III nucleic acid probe test.

▸ Single-dose tinidazole 2 g will be recommended for initial treatment or treatment failure.

Herpes Simplex Virus

▸ For recurrent episodes, treatment recommendations will include acyclovir 800 mg three times daily for 2 days or famciclovir 1 g twice daily for 1 day.

▸ Valacyclovir 500 mg daily will be recommended to reduce transmission in herpes-discordant heterosexual couples.

Human Papillomavirus

▸ The guidelines will recommend that HPV tests be reserved for cervical cancer screening only.

▸ The guidelines will recommend against HPV screening for sexually transmitted disease in the general population.

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One-Third of U.S. Girls Sexually Active by Age 15, CDC Says

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One-Third of U.S. Girls Sexually Active by Age 15, CDC Says

BOSTON – By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior is important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections (as well as the psychological and emotional health of young women). If, as expected, the Food and Drug Administration approves a human papillomavirus vaccine in mid-2006, public health officials will need to accurately predict the age when girls become sexually active in order to recommend an age for vaccination.

Media reports increasingly suggest that as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in, “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%. The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey–more than doubling from 26% at age 15 to 70% by age 18 (see table). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age 39% gave oral sex and 52% received.

Amid all this activity, the use of condoms is less than full-fledged. Only 44% of female teens said their partners used condoms. The prevalence of STIs remains relatively low. Among all females aged 15–19 years in the survey, some 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

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BOSTON – By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior is important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections (as well as the psychological and emotional health of young women). If, as expected, the Food and Drug Administration approves a human papillomavirus vaccine in mid-2006, public health officials will need to accurately predict the age when girls become sexually active in order to recommend an age for vaccination.

Media reports increasingly suggest that as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in, “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%. The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey–more than doubling from 26% at age 15 to 70% by age 18 (see table). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age 39% gave oral sex and 52% received.

Amid all this activity, the use of condoms is less than full-fledged. Only 44% of female teens said their partners used condoms. The prevalence of STIs remains relatively low. Among all females aged 15–19 years in the survey, some 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

ELSEVIER GLOBAL MEDICAL NEWS

BOSTON – By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior is important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections (as well as the psychological and emotional health of young women). If, as expected, the Food and Drug Administration approves a human papillomavirus vaccine in mid-2006, public health officials will need to accurately predict the age when girls become sexually active in order to recommend an age for vaccination.

Media reports increasingly suggest that as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in, “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%. The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey–more than doubling from 26% at age 15 to 70% by age 18 (see table). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age 39% gave oral sex and 52% received.

Amid all this activity, the use of condoms is less than full-fledged. Only 44% of female teens said their partners used condoms. The prevalence of STIs remains relatively low. Among all females aged 15–19 years in the survey, some 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

ELSEVIER GLOBAL MEDICAL NEWS

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One-Third of U.S. Girls Sexually Active by Age 15

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One-Third of U.S. Girls Sexually Active by Age 15

BOSTON — By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior are important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections (as well as the psychological and emotional health of young women). If, as expected, the Food and Drug Administration approves a human papillomavirus vaccine in mid-2006, public health officials will need to accurately predict the age when girls become sexually active in order to recommend an age for vaccination.

Media reports increasingly suggest that as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in, “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%.

The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey—more than doubling from 26% at age 15 to 70% by age 18 (see box). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age 39% gave oral sex and 52% received.

Amid all this activity the use of condoms is less than full fledged. Only 44% of female teens said their partners used condoms.

Fortunately, the prevalence of STIs remains relatively low. Among all females aged 15–19 years in the survey, some 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

About half of all STIs occur in people aged 15–25—at a cost estimated in 2000 to be $6.5 billion annually. Some 34% of HIV cases are transmitted during heterosexual vaginal intercourse.

ELSEVIER GLOBAL MEDICAL NEWS

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BOSTON — By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior are important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections (as well as the psychological and emotional health of young women). If, as expected, the Food and Drug Administration approves a human papillomavirus vaccine in mid-2006, public health officials will need to accurately predict the age when girls become sexually active in order to recommend an age for vaccination.

Media reports increasingly suggest that as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in, “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%.

The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey—more than doubling from 26% at age 15 to 70% by age 18 (see box). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age 39% gave oral sex and 52% received.

Amid all this activity the use of condoms is less than full fledged. Only 44% of female teens said their partners used condoms.

Fortunately, the prevalence of STIs remains relatively low. Among all females aged 15–19 years in the survey, some 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

About half of all STIs occur in people aged 15–25—at a cost estimated in 2000 to be $6.5 billion annually. Some 34% of HIV cases are transmitted during heterosexual vaginal intercourse.

ELSEVIER GLOBAL MEDICAL NEWS

BOSTON — By age 15, more than a third of American girls say they are sexually active, according to a Centers for Disease Control and Prevention survey. About 26% have had oral sex, 26% have had vaginal intercourse, and another 8% have had oral sex without intercourse. The proportion that is sexually active grows substantially every year thereafter, according to a presentation at a conference on contraceptive technology sponsored by Contemporary Forums.

Accurate data on teenagers' sexual behavior are important for any clinician concerned about unintended pregnancy and the spread of sexually transmitted infections (as well as the psychological and emotional health of young women). If, as expected, the Food and Drug Administration approves a human papillomavirus vaccine in mid-2006, public health officials will need to accurately predict the age when girls become sexually active in order to recommend an age for vaccination.

Media reports increasingly suggest that as conventional teen dating and romance plunge, oral sex and casual sexual “hookups” among so-called “friends with benefits” have become commonplace. Anecdotal reports of teen promiscuity have seemed to proliferate, after a reporter described teenagers he met through an Internet site where high school and college students post their profiles, chat, and arrange meetings for sex in, “Friends, Friends With Benefits, and the Benefits of the Local Mall” (New York Times, May 30, 2004).

According to the CDC data, the typical teen who is sexually active has one or two partners, though a substantial minority have many more. Among the 15- to 19-year-olds surveyed, girls had a median of 1.4 sexual partners and boys a median of 1.6. Among all 15- to 19-year-olds, 45% had no sexual partner in the last 12 months, 30% had one opposite-sex partner, and 22% had two or more opposite-sex partners. The percentage with same-sex partners was less than 1%.

The results were released in late 2005 and are based on 2002 data (CDC Advance Data from Vital and Health Statistics, Sept. 2005;362:1–56).

The proportion of all young women having oral sex is relatively high, according to the survey—more than doubling from 26% at age 15 to 70% by age 18 (see box). The gender gap on giving and receiving oral sex was small: Among 15- to 19-year-old females, 44% gave oral sex and 50% received. Among males of the same age 39% gave oral sex and 52% received.

Amid all this activity the use of condoms is less than full fledged. Only 44% of female teens said their partners used condoms.

Fortunately, the prevalence of STIs remains relatively low. Among all females aged 15–19 years in the survey, some 3% reported genital herpes, genital warts, syphilis, or pelvic inflammatory disease.

About half of all STIs occur in people aged 15–25—at a cost estimated in 2000 to be $6.5 billion annually. Some 34% of HIV cases are transmitted during heterosexual vaginal intercourse.

ELSEVIER GLOBAL MEDICAL NEWS

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Plan B Has Limited Effect on Bleeding Patterns

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Plan B Has Limited Effect on Bleeding Patterns

BOSTON — A single dose of Plan B (levonorgestrel) alters the timing and duration of the menstrual period that immediately follows emergency contraception, according to a new study. Taken early in the cycle, it causes the menstrual period to commence earlier than usual. Taken late in the cycle, it prolongs the next menstrual period.

But intermenstrual bleeding is uncommon, and menstrual timing resumes its normal pattern with the second cycle said coauthor James Trussell, Ph.D., professor and director of the Office of Population Research at Princeton University. Dr. Trussell presented the research at a conference on contraceptive technology sponsored by Contemporary Forums. The paper was simultaneously published in the journal Contraception (2006;73:376–81).

The study may help to settle an ongoing debate about the clinical significance of bleeding after the use of emergency contraceptive pills (ECPs). Several previous studies have suggested that ECPs provoke intermenstrual bleeding. The new study's message—that Plan B merely hastens the end of a cycle and that this effect is short-lived—will be reassuring to many women.

For women with late menses, however, the study suggests a pregnancy test may be in order.

Researcher Dr. Elizabeth G. Raymond, of Family Health International in Research Triangle Park, N.C., with Dr. Trussell and colleagues asked 113 women to maintain daily bleeding diaries for 10 weeks after receiving a single dose of 1.5 mg of levonorgestrel.

The women, who were patients at a Planned Parenthood clinic in Boston, had no known risk factors for bleeding abnormalities.

Though Plan B dosing approved by the Food and Drug Administration consists of two 0.75-mg pills taken 12 hours apart, the International Consortium for Emergency Contraception currently recommends the 1.5-mg single-dose regimen. Research since Plan B's 1999 approval suggests that the single-dose regimen is safe and effective (Lancet 2002;360:1803–10; Contraception 2002;66:269–73).

To control for menstrual irregularities that frequently arise in untreated women, researchers compared bleeding patterns in the women taking Plan B with an external comparison group of 843 women who, as subjects in an unrelated trial, kept daily bleeding diaries.

In addition, the researchers compared each Plan B users' bleeding pattern with her usual bleeding pattern reported at study entry. A menstrual period was defined as bleeding of at least 3 days' duration preceded by at least 2 days without bleeding.

Plan B taken in the first 3 weeks of a menstrual cycle significantly shortened the cycle, compared with the women's own usual cycle and the cycles in the external control group. The earlier in the cycle Plan B was taken, the sooner menstrual bleeding commenced.

Plan B taken in week 3 or later in the cycle significantly increased the number of bleeding days in the next cycle but did not affect the timing of the cycle.

The length of the second cycle after taking levonorgestrel returned to normal.

Though uncommon, bleeding between menstrual periods in either cycle one or cycle two occurred in significantly more among women taking Plan B (13%) than among controls (7%).

The new study is the first specifically designed to evaluate bleeding patterns after Plan B emergency contraception, said Dr. Trussell. It is also the first to study bleeding patterns in the second menstrual cycle after Plan B use, he added.

Potentially, factors other than Plan B could account for some of the study's results. For example, body weight—which can affect hormone secretion and uterine bleeding—was not measured in the external comparison group.

And since the subjects did not undergo routine pregnancy testing, it is possible that undetected, lost pregnancies could account for some bleeding irregularities.

Despite these limitations, the authors say in their published report, “An early menstrual period … will likely be welcome to many women using ECPs, who are eager for evidence that they are not pregnant.”

The study was supported in part by Barr Laboratories.

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BOSTON — A single dose of Plan B (levonorgestrel) alters the timing and duration of the menstrual period that immediately follows emergency contraception, according to a new study. Taken early in the cycle, it causes the menstrual period to commence earlier than usual. Taken late in the cycle, it prolongs the next menstrual period.

But intermenstrual bleeding is uncommon, and menstrual timing resumes its normal pattern with the second cycle said coauthor James Trussell, Ph.D., professor and director of the Office of Population Research at Princeton University. Dr. Trussell presented the research at a conference on contraceptive technology sponsored by Contemporary Forums. The paper was simultaneously published in the journal Contraception (2006;73:376–81).

The study may help to settle an ongoing debate about the clinical significance of bleeding after the use of emergency contraceptive pills (ECPs). Several previous studies have suggested that ECPs provoke intermenstrual bleeding. The new study's message—that Plan B merely hastens the end of a cycle and that this effect is short-lived—will be reassuring to many women.

For women with late menses, however, the study suggests a pregnancy test may be in order.

Researcher Dr. Elizabeth G. Raymond, of Family Health International in Research Triangle Park, N.C., with Dr. Trussell and colleagues asked 113 women to maintain daily bleeding diaries for 10 weeks after receiving a single dose of 1.5 mg of levonorgestrel.

The women, who were patients at a Planned Parenthood clinic in Boston, had no known risk factors for bleeding abnormalities.

Though Plan B dosing approved by the Food and Drug Administration consists of two 0.75-mg pills taken 12 hours apart, the International Consortium for Emergency Contraception currently recommends the 1.5-mg single-dose regimen. Research since Plan B's 1999 approval suggests that the single-dose regimen is safe and effective (Lancet 2002;360:1803–10; Contraception 2002;66:269–73).

To control for menstrual irregularities that frequently arise in untreated women, researchers compared bleeding patterns in the women taking Plan B with an external comparison group of 843 women who, as subjects in an unrelated trial, kept daily bleeding diaries.

In addition, the researchers compared each Plan B users' bleeding pattern with her usual bleeding pattern reported at study entry. A menstrual period was defined as bleeding of at least 3 days' duration preceded by at least 2 days without bleeding.

Plan B taken in the first 3 weeks of a menstrual cycle significantly shortened the cycle, compared with the women's own usual cycle and the cycles in the external control group. The earlier in the cycle Plan B was taken, the sooner menstrual bleeding commenced.

Plan B taken in week 3 or later in the cycle significantly increased the number of bleeding days in the next cycle but did not affect the timing of the cycle.

The length of the second cycle after taking levonorgestrel returned to normal.

Though uncommon, bleeding between menstrual periods in either cycle one or cycle two occurred in significantly more among women taking Plan B (13%) than among controls (7%).

The new study is the first specifically designed to evaluate bleeding patterns after Plan B emergency contraception, said Dr. Trussell. It is also the first to study bleeding patterns in the second menstrual cycle after Plan B use, he added.

Potentially, factors other than Plan B could account for some of the study's results. For example, body weight—which can affect hormone secretion and uterine bleeding—was not measured in the external comparison group.

And since the subjects did not undergo routine pregnancy testing, it is possible that undetected, lost pregnancies could account for some bleeding irregularities.

Despite these limitations, the authors say in their published report, “An early menstrual period … will likely be welcome to many women using ECPs, who are eager for evidence that they are not pregnant.”

The study was supported in part by Barr Laboratories.

BOSTON — A single dose of Plan B (levonorgestrel) alters the timing and duration of the menstrual period that immediately follows emergency contraception, according to a new study. Taken early in the cycle, it causes the menstrual period to commence earlier than usual. Taken late in the cycle, it prolongs the next menstrual period.

But intermenstrual bleeding is uncommon, and menstrual timing resumes its normal pattern with the second cycle said coauthor James Trussell, Ph.D., professor and director of the Office of Population Research at Princeton University. Dr. Trussell presented the research at a conference on contraceptive technology sponsored by Contemporary Forums. The paper was simultaneously published in the journal Contraception (2006;73:376–81).

The study may help to settle an ongoing debate about the clinical significance of bleeding after the use of emergency contraceptive pills (ECPs). Several previous studies have suggested that ECPs provoke intermenstrual bleeding. The new study's message—that Plan B merely hastens the end of a cycle and that this effect is short-lived—will be reassuring to many women.

For women with late menses, however, the study suggests a pregnancy test may be in order.

Researcher Dr. Elizabeth G. Raymond, of Family Health International in Research Triangle Park, N.C., with Dr. Trussell and colleagues asked 113 women to maintain daily bleeding diaries for 10 weeks after receiving a single dose of 1.5 mg of levonorgestrel.

The women, who were patients at a Planned Parenthood clinic in Boston, had no known risk factors for bleeding abnormalities.

Though Plan B dosing approved by the Food and Drug Administration consists of two 0.75-mg pills taken 12 hours apart, the International Consortium for Emergency Contraception currently recommends the 1.5-mg single-dose regimen. Research since Plan B's 1999 approval suggests that the single-dose regimen is safe and effective (Lancet 2002;360:1803–10; Contraception 2002;66:269–73).

To control for menstrual irregularities that frequently arise in untreated women, researchers compared bleeding patterns in the women taking Plan B with an external comparison group of 843 women who, as subjects in an unrelated trial, kept daily bleeding diaries.

In addition, the researchers compared each Plan B users' bleeding pattern with her usual bleeding pattern reported at study entry. A menstrual period was defined as bleeding of at least 3 days' duration preceded by at least 2 days without bleeding.

Plan B taken in the first 3 weeks of a menstrual cycle significantly shortened the cycle, compared with the women's own usual cycle and the cycles in the external control group. The earlier in the cycle Plan B was taken, the sooner menstrual bleeding commenced.

Plan B taken in week 3 or later in the cycle significantly increased the number of bleeding days in the next cycle but did not affect the timing of the cycle.

The length of the second cycle after taking levonorgestrel returned to normal.

Though uncommon, bleeding between menstrual periods in either cycle one or cycle two occurred in significantly more among women taking Plan B (13%) than among controls (7%).

The new study is the first specifically designed to evaluate bleeding patterns after Plan B emergency contraception, said Dr. Trussell. It is also the first to study bleeding patterns in the second menstrual cycle after Plan B use, he added.

Potentially, factors other than Plan B could account for some of the study's results. For example, body weight—which can affect hormone secretion and uterine bleeding—was not measured in the external comparison group.

And since the subjects did not undergo routine pregnancy testing, it is possible that undetected, lost pregnancies could account for some bleeding irregularities.

Despite these limitations, the authors say in their published report, “An early menstrual period … will likely be welcome to many women using ECPs, who are eager for evidence that they are not pregnant.”

The study was supported in part by Barr Laboratories.

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