Jennie Smith

Major Finding: In the group who gave birth prior to surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to preeclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the postsurgery group were.

Data Source: A study of claims data from seven private insurance plans to find 585 U.S. women who were aged16-45, had undergone bariatric surgery for weight loss, and had at least one prior pregnancy and delivery.

Disclosures: None was reported.

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including preeclampsia and eclampsia, than women who have yet to undergo the surgery, study results showed.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and her colleagues at the Johns Hopkins University, Baltimore, evaluated claims data from seven private insurance plans to find 585 U.S. women aged 16-45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 April 13;340:c1662 [doi: 10.1136/bmj.c1662

A total of 269 of the women gave birth before gastric bypass surgery or another weight-loss surgery, and 316 were delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. Gastric bypass surgery accounted for 81.5% of procedures overall, with other surgeries, such as adjustable gastric banding, making up the rest. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group who gave birth before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to preeclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the postsurgery group were, even after adjustment for such factors as age at delivery, multiple pregnancy, the type of surgery, and preexisting diabetes.

Preeclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks post partum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said in an interview. “Women can get postpartum preeclampsia.”

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and her colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and preeclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and preeclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett noted that her team reviewed relatively new and geographically diverse data (the claims were dated from 2002 to 2006 and were from more than one region of the United States), compared with other recent studies on bariatric surgery and pregnancy. This afforded the authors an up-to-date picture reflecting outcomes from surgeries currently performed, she said.

The team's data set lacked height and weight information for the subjects before and after surgeries, though all had been diagnosed as obese (having a body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. For example, they wrote, “an obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

Major Finding: In the group who gave birth prior to surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to preeclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the postsurgery group were.

Data Source: A study of claims data from seven private insurance plans to find 585 U.S. women who were aged16-45, had undergone bariatric surgery for weight loss, and had at least one prior pregnancy and delivery.

Disclosures: None was reported.

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including preeclampsia and eclampsia, than women who have yet to undergo the surgery, study results showed.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and her colleagues at the Johns Hopkins University, Baltimore, evaluated claims data from seven private insurance plans to find 585 U.S. women aged 16-45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 April 13;340:c1662 [doi: 10.1136/bmj.c1662

A total of 269 of the women gave birth before gastric bypass surgery or another weight-loss surgery, and 316 were delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. Gastric bypass surgery accounted for 81.5% of procedures overall, with other surgeries, such as adjustable gastric banding, making up the rest. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group who gave birth before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to preeclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the postsurgery group were, even after adjustment for such factors as age at delivery, multiple pregnancy, the type of surgery, and preexisting diabetes.

Preeclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks post partum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said in an interview. “Women can get postpartum preeclampsia.”

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and her colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and preeclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and preeclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett noted that her team reviewed relatively new and geographically diverse data (the claims were dated from 2002 to 2006 and were from more than one region of the United States), compared with other recent studies on bariatric surgery and pregnancy. This afforded the authors an up-to-date picture reflecting outcomes from surgeries currently performed, she said.

The team's data set lacked height and weight information for the subjects before and after surgeries, though all had been diagnosed as obese (having a body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. For example, they wrote, “an obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

Major Finding: In the group who gave birth prior to surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to preeclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the postsurgery group were.

Data Source: A study of claims data from seven private insurance plans to find 585 U.S. women who were aged16-45, had undergone bariatric surgery for weight loss, and had at least one prior pregnancy and delivery.

Disclosures: None was reported.

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including preeclampsia and eclampsia, than women who have yet to undergo the surgery, study results showed.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and her colleagues at the Johns Hopkins University, Baltimore, evaluated claims data from seven private insurance plans to find 585 U.S. women aged 16-45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 April 13;340:c1662 [doi: 10.1136/bmj.c1662

A total of 269 of the women gave birth before gastric bypass surgery or another weight-loss surgery, and 316 were delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. Gastric bypass surgery accounted for 81.5% of procedures overall, with other surgeries, such as adjustable gastric banding, making up the rest. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group who gave birth before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to preeclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the postsurgery group were, even after adjustment for such factors as age at delivery, multiple pregnancy, the type of surgery, and preexisting diabetes.

Preeclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks post partum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said in an interview. “Women can get postpartum preeclampsia.”

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and her colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and preeclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and preeclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett noted that her team reviewed relatively new and geographically diverse data (the claims were dated from 2002 to 2006 and were from more than one region of the United States), compared with other recent studies on bariatric surgery and pregnancy. This afforded the authors an up-to-date picture reflecting outcomes from surgeries currently performed, she said.

The team's data set lacked height and weight information for the subjects before and after surgeries, though all had been diagnosed as obese (having a body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. For example, they wrote, “an obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including pre-eclampsia and eclampsia, than women who have yet to undergo the surgery, according to new research.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and colleagues at the Johns Hopkins University School of Medicine, Baltimore, evaluated claims data from 7 private insurance plans to find 585 U.S. women between the ages of 16 and 45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 Apr. 13;340:c1662 [doi: 10.1136/bmj.c1662]).

A total of 269 of the women delivered their babies before gastric bypass surgery or another weight-loss surgery, and 316 delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. Gastric bypass surgery accounted for 81.5% of procedures overall, with other surgeries, such as adjustable gastric banding, making up the rest. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group that delivered before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to pre-eclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and two weeks after birth, while only 9.8% of the post-surgery group did, even after adjusting for factors such as age at delivery, multiple pregnancy, the type of surgery, and pre-existing diabetes.

Pre-eclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks postpartum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said in an interview. “Women can get postpartum pre-eclampsia.”

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and pre-eclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and pre-eclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett noted that her team reviewed relatively new and geographically diverse data (the claims were dated from 2002 to 2006, from more than one region of the United States), compared with other recent studies on bariatric surgery and pregnancy. This afforded the authors an up-to-date picture reflecting outcomes from surgeries currently performed, she said.

The team's dataset lacked height and weight information for subjects before and after surgeries, though all had been diagnosed as obese (body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. For example, they wrote, “an obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

None of the authors declared any conflicts of interest.

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including pre-eclampsia and eclampsia, than women who have yet to undergo the surgery, according to new research.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and colleagues at the Johns Hopkins University School of Medicine, Baltimore, evaluated claims data from 7 private insurance plans to find 585 U.S. women between the ages of 16 and 45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 Apr. 13;340:c1662 [doi: 10.1136/bmj.c1662]).

A total of 269 of the women delivered their babies before gastric bypass surgery or another weight-loss surgery, and 316 delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. Gastric bypass surgery accounted for 81.5% of procedures overall, with other surgeries, such as adjustable gastric banding, making up the rest. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group that delivered before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to pre-eclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and two weeks after birth, while only 9.8% of the post-surgery group did, even after adjusting for factors such as age at delivery, multiple pregnancy, the type of surgery, and pre-existing diabetes.

Pre-eclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks postpartum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said in an interview. “Women can get postpartum pre-eclampsia.”

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and pre-eclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and pre-eclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett noted that her team reviewed relatively new and geographically diverse data (the claims were dated from 2002 to 2006, from more than one region of the United States), compared with other recent studies on bariatric surgery and pregnancy. This afforded the authors an up-to-date picture reflecting outcomes from surgeries currently performed, she said.

The team's dataset lacked height and weight information for subjects before and after surgeries, though all had been diagnosed as obese (body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. For example, they wrote, “an obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

None of the authors declared any conflicts of interest.

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including pre-eclampsia and eclampsia, than women who have yet to undergo the surgery, according to new research.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and colleagues at the Johns Hopkins University School of Medicine, Baltimore, evaluated claims data from 7 private insurance plans to find 585 U.S. women between the ages of 16 and 45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 Apr. 13;340:c1662 [doi: 10.1136/bmj.c1662]).

A total of 269 of the women delivered their babies before gastric bypass surgery or another weight-loss surgery, and 316 delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. Gastric bypass surgery accounted for 81.5% of procedures overall, with other surgeries, such as adjustable gastric banding, making up the rest. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group that delivered before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to pre-eclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and two weeks after birth, while only 9.8% of the post-surgery group did, even after adjusting for factors such as age at delivery, multiple pregnancy, the type of surgery, and pre-existing diabetes.

Pre-eclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks postpartum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said in an interview. “Women can get postpartum pre-eclampsia.”

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and pre-eclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and pre-eclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett noted that her team reviewed relatively new and geographically diverse data (the claims were dated from 2002 to 2006, from more than one region of the United States), compared with other recent studies on bariatric surgery and pregnancy. This afforded the authors an up-to-date picture reflecting outcomes from surgeries currently performed, she said.

The team's dataset lacked height and weight information for subjects before and after surgeries, though all had been diagnosed as obese (body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. For example, they wrote, “an obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

None of the authors declared any conflicts of interest.

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including pre-eclampsia and eclampsia, than women who have yet to undergo the surgery, according to new research.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and colleagues at the Johns Hopkins University in Baltimore evaluated claims data from 7 private insurance plans to find 585 U.S. women between the ages of 16 and 45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 Apr. 13;340:c1662 [doi: 10.1136/bmj.c1662]).

A total of 269 of the women delivered their babies before gastric bypass surgery or another weight-loss surgery, and 316 delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group that delivered before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to pre-eclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the post-surgery group did, even after adjusting for factors such as age at delivery, multiple pregnancy, the type of surgery, and pre-existing diabetes.

Pre-eclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks post partum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said.

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and pre-eclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and pre-eclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett's study reviewed relatively new and geographically diverse data, reflecting outcomes from surgeries currently performed, she said.

The team's dataset lacked height and weight information for the subjects before and after surgeries, though all had been diagnosed as obese (having a body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. “An obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

Disclosures: None of the authors declared any conflicts of interest.

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including pre-eclampsia and eclampsia, than women who have yet to undergo the surgery, according to new research.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and colleagues at the Johns Hopkins University in Baltimore evaluated claims data from 7 private insurance plans to find 585 U.S. women between the ages of 16 and 45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 Apr. 13;340:c1662 [doi: 10.1136/bmj.c1662]).

A total of 269 of the women delivered their babies before gastric bypass surgery or another weight-loss surgery, and 316 delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group that delivered before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to pre-eclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the post-surgery group did, even after adjusting for factors such as age at delivery, multiple pregnancy, the type of surgery, and pre-existing diabetes.

Pre-eclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks post partum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said.

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and pre-eclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and pre-eclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett's study reviewed relatively new and geographically diverse data, reflecting outcomes from surgeries currently performed, she said.

The team's dataset lacked height and weight information for the subjects before and after surgeries, though all had been diagnosed as obese (having a body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. “An obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

Disclosures: None of the authors declared any conflicts of interest.

Women who have had bariatric surgery are far less likely to experience serious hypertensive disorders during pregnancy, including pre-eclampsia and eclampsia, than women who have yet to undergo the surgery, according to new research.

Investigators found a 75% reduction in the odds of being diagnosed with a hypertensive disorder in pregnancy in those who had undergone the surgery, compared with their counterparts.

For their study, Dr. Wendy L. Bennett and colleagues at the Johns Hopkins University in Baltimore evaluated claims data from 7 private insurance plans to find 585 U.S. women between the ages of 16 and 45 who had undergone bariatric surgery for weight loss and had at least one prior pregnancy and delivery (BMJ 2010 Apr. 13;340:c1662 [doi: 10.1136/bmj.c1662]).

A total of 269 of the women delivered their babies before gastric bypass surgery or another weight-loss surgery, and 316 delivered afterward. For the first group, the mean time from delivery to surgery was 17.9 months, and for the second, the mean time from surgery to delivery was 23.6 months. The mean age of the women was 31.9 years at delivery and 31.5 years at surgery.

In the group that delivered before having surgery, 31.2% of the women were diagnosed with a hypertensive disorder—from chronic and gestational hypertension to pre-eclampsia and eclampsia alone or superimposed on hypertension—between the start of pregnancy and 2 weeks after birth, while only 9.8% of the post-surgery group did, even after adjusting for factors such as age at delivery, multiple pregnancy, the type of surgery, and pre-existing diabetes.

Pre-eclampsia or eclampsia was diagnosed in 14.5% of women in the presurgery group and 2.5% in the postsurgery group. “We went 2 weeks post partum, because we wanted to make sure we got all the diagnoses,” Dr. Bennett said.

The Hopkins findings confirm those from an earlier Israeli study of similar design (Int. J. Gynecol. Obstet. 2008;103:246-51), which found the rate of a composite of hypertensive disorders during pregnancy to be more than halved after bariatric surgery.

The Hopkins team saw an even more dramatic reduction—about 75%—in the odds of all hypertensive disorders in pregnancy, and was able to isolate all severities of hypertensive disorders by analyzing outpatient and inpatient codes for each. Further, Dr. Bennett and colleagues wrote that they were “able to describe outcomes of chronic hypertension complicating a pregnancy and pre-eclampsia superimposed on chronic hypertension among women who have had bariatric surgery.” Chronic hypertension in pregnancy and pre-eclampsia, the authors noted, can increase the long-term risk of chronic disease in the mother, including cardiovascular and renal disease.

Dr. Bennett's study reviewed relatively new and geographically diverse data, reflecting outcomes from surgeries currently performed, she said.

The team's dataset lacked height and weight information for the subjects before and after surgeries, though all had been diagnosed as obese (having a body mass index of 35 kg/m

The authors noted a further limitation to their study, which was the possibility of selection bias and confounding by indication. “An obese woman with gestational hypertension might have been more likely to subsequently undergo bariatric surgery if she developed chronic hypertension after her pregnancy or had other comorbidities associated with obesity making her eligible for bariatric surgery. If this occurred, the number of diagnoses of hypertensive disorder in pregnancy in the women who delivered before surgery could be increased and bias our results.”

Disclosures: None of the authors declared any conflicts of interest.

The experimental drug LCZ696, which inhibits both the angiotensin II receptor and neprilysin, has been shown to reduce blood pressure more effectively than the established angiotensin receptor blocker valsartan—and without apparent risk of angioedema, in a phase II trial.

LCZ696 is a single molecule, developed by Novartis, that contains properties of both valsartan (Novartis, Diovan) and AHU377, an experimental neprilysin inhibitor also developed by Novartis. In a randomized, double-blind, phase II trial sponsored the manufacturer, all three agents were compared for efficacy, and the dual-acting molecule did better than either comparator (Lancet 2010 March 16 [DOI:10.1016/S0140-6736(09)61966-8]).

“There is synergistic effect when the two are put together,” Dr. Luis Miguel Ruilope of the Hospital 12 de Octubre in Madrid, the lead investigator of the study, said in an interview.

Dr. Ruilope and colleagues enrolled 1,328 patients, with a mean age 53, all with mild to moderate essential hypertension (mean sitting diastolic blood pressure of 90-109 mm Hg after antihypertensive washout, or 95-109 mm Hg for untreated patients).

Enrollees were divided into eight paired groups of between 156 and 173 patients each. Six of the groups were randomized to receive oral LCZ696 100 mg, 200 mg, 200 mg daily switched after 5 weeks to 400 mg daily, or a comparable-strength regimen of valsartan (80 mg, 160 mg, or 320 mg daily). A seventh group received 200 mg of AHU377 daily, the neprilysin inhibitor, and was paired with an eighth group that received placebo. A total of 91% of patients completed the 8-week treatment period.

The primary outcome was the lowering of mean sitting diastolic BP during the 8-week treatment period The investigators found greater reductions in mean sitting diastolic BP from baselines in all groups taking LCZ696 over those taking valsartan—of the three paired dose groups, the LCZ696 arm saw a mean drop −2.17/–4.20 mm Hg.

The difference in reduction was not significant at the lowest dose but became marked at the higher doses, and the contrast widened with the dose increases.

The neprilysin inhibitor AHU377, tested only at the 200-mg dose, performed better than placebo but not as well as LCZ696 at any dose, with a change from baseline in mean sitting blood pressure of −4.20/–2.99 mm Hg

Adverse effects across all study groups were minimal, even at the highest doses. Though patients with previous angioedema were not allowed to enroll, there were no reports of angioedema in any of the study categories.

Dr. Bernard Waeber and Dr. Fran ois Feihl of the Universit de Lausanne in Switzerland, noted the “great potential” of LCZ696 in an accompanying editorial (DOI:10. 1016/S0140-6736[10]60363-7).

The absence of angioedema during the trial is especially encouraging, they wrote, since a previous hypertension drug candidate with somewhat similar dual activity, omapatrilat (Bristol-Myers Squibb), had shown great promise in reducing BP, but could not be marketed because of a high association with angioedema.

Dr. Ruilope and two of his co-authors have financial relationships with Novartis; two more authors are employees of Novartis, and one declared no conflicts of interest.

Dr. Waeber and Dr. Feihl declared no conflicts of interest.

The experimental drug LCZ696, which inhibits both the angiotensin II receptor and neprilysin, has been shown to reduce blood pressure more effectively than the established angiotensin receptor blocker valsartan—and without apparent risk of angioedema, in a phase II trial.

LCZ696 is a single molecule, developed by Novartis, that contains properties of both valsartan (Novartis, Diovan) and AHU377, an experimental neprilysin inhibitor also developed by Novartis. In a randomized, double-blind, phase II trial sponsored the manufacturer, all three agents were compared for efficacy, and the dual-acting molecule did better than either comparator (Lancet 2010 March 16 [DOI:10.1016/S0140-6736(09)61966-8]).

“There is synergistic effect when the two are put together,” Dr. Luis Miguel Ruilope of the Hospital 12 de Octubre in Madrid, the lead investigator of the study, said in an interview.

Dr. Ruilope and colleagues enrolled 1,328 patients, with a mean age 53, all with mild to moderate essential hypertension (mean sitting diastolic blood pressure of 90-109 mm Hg after antihypertensive washout, or 95-109 mm Hg for untreated patients).

Enrollees were divided into eight paired groups of between 156 and 173 patients each. Six of the groups were randomized to receive oral LCZ696 100 mg, 200 mg, 200 mg daily switched after 5 weeks to 400 mg daily, or a comparable-strength regimen of valsartan (80 mg, 160 mg, or 320 mg daily). A seventh group received 200 mg of AHU377 daily, the neprilysin inhibitor, and was paired with an eighth group that received placebo. A total of 91% of patients completed the 8-week treatment period.

The primary outcome was the lowering of mean sitting diastolic BP during the 8-week treatment period The investigators found greater reductions in mean sitting diastolic BP from baselines in all groups taking LCZ696 over those taking valsartan—of the three paired dose groups, the LCZ696 arm saw a mean drop −2.17/–4.20 mm Hg.

The difference in reduction was not significant at the lowest dose but became marked at the higher doses, and the contrast widened with the dose increases.

The neprilysin inhibitor AHU377, tested only at the 200-mg dose, performed better than placebo but not as well as LCZ696 at any dose, with a change from baseline in mean sitting blood pressure of −4.20/–2.99 mm Hg

Adverse effects across all study groups were minimal, even at the highest doses. Though patients with previous angioedema were not allowed to enroll, there were no reports of angioedema in any of the study categories.

Dr. Bernard Waeber and Dr. Fran ois Feihl of the Universit de Lausanne in Switzerland, noted the “great potential” of LCZ696 in an accompanying editorial (DOI:10. 1016/S0140-6736[10]60363-7).

The absence of angioedema during the trial is especially encouraging, they wrote, since a previous hypertension drug candidate with somewhat similar dual activity, omapatrilat (Bristol-Myers Squibb), had shown great promise in reducing BP, but could not be marketed because of a high association with angioedema.

Dr. Ruilope and two of his co-authors have financial relationships with Novartis; two more authors are employees of Novartis, and one declared no conflicts of interest.

Dr. Waeber and Dr. Feihl declared no conflicts of interest.

The experimental drug LCZ696, which inhibits both the angiotensin II receptor and neprilysin, has been shown to reduce blood pressure more effectively than the established angiotensin receptor blocker valsartan—and without apparent risk of angioedema, in a phase II trial.

LCZ696 is a single molecule, developed by Novartis, that contains properties of both valsartan (Novartis, Diovan) and AHU377, an experimental neprilysin inhibitor also developed by Novartis. In a randomized, double-blind, phase II trial sponsored the manufacturer, all three agents were compared for efficacy, and the dual-acting molecule did better than either comparator (Lancet 2010 March 16 [DOI:10.1016/S0140-6736(09)61966-8]).

“There is synergistic effect when the two are put together,” Dr. Luis Miguel Ruilope of the Hospital 12 de Octubre in Madrid, the lead investigator of the study, said in an interview.

Dr. Ruilope and colleagues enrolled 1,328 patients, with a mean age 53, all with mild to moderate essential hypertension (mean sitting diastolic blood pressure of 90-109 mm Hg after antihypertensive washout, or 95-109 mm Hg for untreated patients).

Enrollees were divided into eight paired groups of between 156 and 173 patients each. Six of the groups were randomized to receive oral LCZ696 100 mg, 200 mg, 200 mg daily switched after 5 weeks to 400 mg daily, or a comparable-strength regimen of valsartan (80 mg, 160 mg, or 320 mg daily). A seventh group received 200 mg of AHU377 daily, the neprilysin inhibitor, and was paired with an eighth group that received placebo. A total of 91% of patients completed the 8-week treatment period.

The primary outcome was the lowering of mean sitting diastolic BP during the 8-week treatment period The investigators found greater reductions in mean sitting diastolic BP from baselines in all groups taking LCZ696 over those taking valsartan—of the three paired dose groups, the LCZ696 arm saw a mean drop −2.17/–4.20 mm Hg.

The difference in reduction was not significant at the lowest dose but became marked at the higher doses, and the contrast widened with the dose increases.

The neprilysin inhibitor AHU377, tested only at the 200-mg dose, performed better than placebo but not as well as LCZ696 at any dose, with a change from baseline in mean sitting blood pressure of −4.20/–2.99 mm Hg

Adverse effects across all study groups were minimal, even at the highest doses. Though patients with previous angioedema were not allowed to enroll, there were no reports of angioedema in any of the study categories.

Dr. Bernard Waeber and Dr. Fran ois Feihl of the Universit de Lausanne in Switzerland, noted the “great potential” of LCZ696 in an accompanying editorial (DOI:10. 1016/S0140-6736[10]60363-7).

The absence of angioedema during the trial is especially encouraging, they wrote, since a previous hypertension drug candidate with somewhat similar dual activity, omapatrilat (Bristol-Myers Squibb), had shown great promise in reducing BP, but could not be marketed because of a high association with angioedema.

Dr. Ruilope and two of his co-authors have financial relationships with Novartis; two more authors are employees of Novartis, and one declared no conflicts of interest.

Dr. Waeber and Dr. Feihl declared no conflicts of interest.

Obese women who consume moderate amounts of alcohol have a risk of developing cirrhosis nearly twice that of normal-weight women who drink the same amount, and obesity and heavy alcohol consumption act in concert to increase deaths from liver disease in men, according to two studies.

“In combination with moderate alcohol consumption, obesity substantially increases the likelihood of liver cirrhosis,” Bette Liu, Ph.D., lead author of the first study, said in a prepared statement.

Dr. Liu and her colleagues at the University of Oxford's Cancer Epidemiology Unit—with funding from Cancer Research UK, the National Health Service, and the Medical Research Council—analyzed data from a cohort of 1,230,662 U.K. women, recruited between 1996 and 2001, with a mean age of 56. All had been screened for prior liver disease or cancer, though a fifth were current smokers and 2.4% had been treated for diabetes. A total of 46% of women in the study were considered to be of healthy weight or underweight (with a body mass index of less than 25 kg/m10.1136/bmj.c912

Over a mean follow-up of 6.2 years, 1,811 women had a first cirrhosis-related hospital admission or death, and 421 of these women had cirrhosis recorded for the first time at death.

Of middle-aged women of normal weight (a BMI of between 22.5 and 25) who drank less than 70 g of alcohol per week (a mean of less than half a drink per day), 0.8 in 1,000 risked being hospitalized with or dying from cirrhosis over 5 years, compared with 1 in 1,000 for obese women with light drinking habits. When the drinks increased, however, the risk profile was magnified across all weight categories, and the risk contrast between normal-weight and obese women became starker.

Normal-weight women who consumed at least 150 g of alcohol per week (a mean of about two and a half alcoholic drinks a day) carried a risk of 2.7 in 1,000 of being hospitalized for or dying from cirrhosis within 5 years, the researchers found, with a 28% increase for each 5-unit increase in BMI above 22.5. For obese women, the risk increased to 5 in 1,000.

In the second study, funded by the Scottish government, Carole L. Hart, Ph.D., of the University of Glasgow and colleagues analyzed links among obesity, liver disease, and alcohol in 9,559 Scottish men, many of whom did report heavy drinking and just under half of whom were overweight or obese (42% and 6%, respectively). The men in the analysis had been recruited at varying ages (mean 47 years) in the 1960s and 1970s for two long-term cohort studies, which tracked their health data for an average of 29 years (BMJ 2010;340:c1240 doi:10.1136/bmj.c1240

Eighty men died with liver disease as the main cause of death, and 146 died with liver disease mentioned in any of the causes of death.

Obese men who reported drinking at least 15 units of alcohol per week had a relative rate of developing liver disease nearly double that of obese men who drank between 14 or fewer units per week (9.73 vs 4.50, after adjustment).

Neither Dr. Liu's nor Dr. Hart's teams declared any conflicts of interest.

Obese women who consume moderate amounts of alcohol have a risk of developing cirrhosis nearly twice that of normal-weight women who drink the same amount, and obesity and heavy alcohol consumption act in concert to increase deaths from liver disease in men, according to two studies.

“In combination with moderate alcohol consumption, obesity substantially increases the likelihood of liver cirrhosis,” Bette Liu, Ph.D., lead author of the first study, said in a prepared statement.

Dr. Liu and her colleagues at the University of Oxford's Cancer Epidemiology Unit—with funding from Cancer Research UK, the National Health Service, and the Medical Research Council—analyzed data from a cohort of 1,230,662 U.K. women, recruited between 1996 and 2001, with a mean age of 56. All had been screened for prior liver disease or cancer, though a fifth were current smokers and 2.4% had been treated for diabetes. A total of 46% of women in the study were considered to be of healthy weight or underweight (with a body mass index of less than 25 kg/m10.1136/bmj.c912

Over a mean follow-up of 6.2 years, 1,811 women had a first cirrhosis-related hospital admission or death, and 421 of these women had cirrhosis recorded for the first time at death.

Of middle-aged women of normal weight (a BMI of between 22.5 and 25) who drank less than 70 g of alcohol per week (a mean of less than half a drink per day), 0.8 in 1,000 risked being hospitalized with or dying from cirrhosis over 5 years, compared with 1 in 1,000 for obese women with light drinking habits. When the drinks increased, however, the risk profile was magnified across all weight categories, and the risk contrast between normal-weight and obese women became starker.

Normal-weight women who consumed at least 150 g of alcohol per week (a mean of about two and a half alcoholic drinks a day) carried a risk of 2.7 in 1,000 of being hospitalized for or dying from cirrhosis within 5 years, the researchers found, with a 28% increase for each 5-unit increase in BMI above 22.5. For obese women, the risk increased to 5 in 1,000.

In the second study, funded by the Scottish government, Carole L. Hart, Ph.D., of the University of Glasgow and colleagues analyzed links among obesity, liver disease, and alcohol in 9,559 Scottish men, many of whom did report heavy drinking and just under half of whom were overweight or obese (42% and 6%, respectively). The men in the analysis had been recruited at varying ages (mean 47 years) in the 1960s and 1970s for two long-term cohort studies, which tracked their health data for an average of 29 years (BMJ 2010;340:c1240 doi:10.1136/bmj.c1240

Eighty men died with liver disease as the main cause of death, and 146 died with liver disease mentioned in any of the causes of death.

Obese men who reported drinking at least 15 units of alcohol per week had a relative rate of developing liver disease nearly double that of obese men who drank between 14 or fewer units per week (9.73 vs 4.50, after adjustment).

Neither Dr. Liu's nor Dr. Hart's teams declared any conflicts of interest.

Obese women who consume moderate amounts of alcohol have a risk of developing cirrhosis nearly twice that of normal-weight women who drink the same amount, and obesity and heavy alcohol consumption act in concert to increase deaths from liver disease in men, according to two studies.

“In combination with moderate alcohol consumption, obesity substantially increases the likelihood of liver cirrhosis,” Bette Liu, Ph.D., lead author of the first study, said in a prepared statement.

Dr. Liu and her colleagues at the University of Oxford's Cancer Epidemiology Unit—with funding from Cancer Research UK, the National Health Service, and the Medical Research Council—analyzed data from a cohort of 1,230,662 U.K. women, recruited between 1996 and 2001, with a mean age of 56. All had been screened for prior liver disease or cancer, though a fifth were current smokers and 2.4% had been treated for diabetes. A total of 46% of women in the study were considered to be of healthy weight or underweight (with a body mass index of less than 25 kg/m10.1136/bmj.c912

Over a mean follow-up of 6.2 years, 1,811 women had a first cirrhosis-related hospital admission or death, and 421 of these women had cirrhosis recorded for the first time at death.

Of middle-aged women of normal weight (a BMI of between 22.5 and 25) who drank less than 70 g of alcohol per week (a mean of less than half a drink per day), 0.8 in 1,000 risked being hospitalized with or dying from cirrhosis over 5 years, compared with 1 in 1,000 for obese women with light drinking habits. When the drinks increased, however, the risk profile was magnified across all weight categories, and the risk contrast between normal-weight and obese women became starker.

Normal-weight women who consumed at least 150 g of alcohol per week (a mean of about two and a half alcoholic drinks a day) carried a risk of 2.7 in 1,000 of being hospitalized for or dying from cirrhosis within 5 years, the researchers found, with a 28% increase for each 5-unit increase in BMI above 22.5. For obese women, the risk increased to 5 in 1,000.

In the second study, funded by the Scottish government, Carole L. Hart, Ph.D., of the University of Glasgow and colleagues analyzed links among obesity, liver disease, and alcohol in 9,559 Scottish men, many of whom did report heavy drinking and just under half of whom were overweight or obese (42% and 6%, respectively). The men in the analysis had been recruited at varying ages (mean 47 years) in the 1960s and 1970s for two long-term cohort studies, which tracked their health data for an average of 29 years (BMJ 2010;340:c1240 doi:10.1136/bmj.c1240

Eighty men died with liver disease as the main cause of death, and 146 died with liver disease mentioned in any of the causes of death.

Obese men who reported drinking at least 15 units of alcohol per week had a relative rate of developing liver disease nearly double that of obese men who drank between 14 or fewer units per week (9.73 vs 4.50, after adjustment).

Neither Dr. Liu's nor Dr. Hart's teams declared any conflicts of interest.

A sweeping review of influenza vaccine studies has concluded that data on vaccination are too flawed, dated, or limited to show any effectiveness in preventing influenza or pneumonia in people over 65—a group consistently targeted by public health agencies.

In a smaller, separate review, researchers also found insufficient evidence to support the theory—also translated widely into public health practice—that vaccinating health care workers against influenza prevents older patients from contracting influenza or pneumonia in health facilities. Both reviews were published by the Cochrane Library.

The large review looked at dozens of studies over a 40-year period. “We have a massive data set—75 studies over 100 flu seasons,” said epidemiologist Tom Jefferson, the Rome-based lead author of both papers. “Can we draw a conclusion? No, we can't. Yet all this money is being spent. It's a very costly form of hopefulness.”

Moreover, Dr. Jefferson said in an interview, “the vast majority of these studies are of poor quality, associated with optimistic conclusions not supported in the actual data.”

The optimism, Dr. Jefferson has argued in earlier papers, likely stems from the sponsors of the vaccine studies themselves. In one article (BMJ 2009;338: b354), he and his colleagues analyzed 274 published studies on influenza vaccines—some of which were also included in the new reviews—and found “evidence of widespread manipulation of conclusions,” he said. Studies sponsored by vaccine manufacturers, they found, were more likely to present positive findings than were those sponsored by public health agencies.

Dr. Jefferson's team also found in that same analysis that industry-sponsored vaccine studies received more and better placement in prestigious medical journals, compared with publicly funded studies of similar size and methodology.

Although it is not news that influenza vaccines may be less effective in the elderly, that concern has contributed to an emphasis on vaccinating health care workers in the hope of preventing flu transmission to elderly patients.

Dr. Jefferson and his colleagues analyzed the results of four randomized, controlled trials showing that vaccination of health care workers “reduced influenza-like illness and resident all-cause mortality” and reduced primary care visits for influenza-like illness. “There was no effect on the outcomes of direct interest, namely laboratory-proven influenza, lower respiratory tract infections, admissions to hospital and deaths from pneumonia” (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD005187

In their larger review of studies concerning vaccinations and older patients, the researchers also identified an emphasis on reductions in illness and death that were not directly attributable to influenza. “Empirical work done by other researchers 5 years ago shows that influenza is at the most responsible for 5% of deaths annually,” Dr. Jefferson said, “and here we have studies that claim 50% effectiveness against death from all causes.”

However, only 1 of the 75 studies cited in the larger Cochrane review was a randomized, controlled trial, and only 1 tested vaccines that are comparable to those in use today. Large, multiseason, publicly funded, randomized, controlled trials are essential, the authors concluded, to determine the real value of flu vaccines for the elderly. And better trials, if not necessarily blinded ones, are needed to determine the benefit of vaccinating health care providers, Dr. Jefferson said, because vaccine uptake among them was low in some of the studies (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD004876

“The two reviews are different in content but not on their conclusions,” Dr. Jefferson said. “They highlight serious problems with the current evidence base.”

Disclosures: Dr. Jefferson reported owning shares in GlaxoSmithKline and receiving consultancy fees from Sanofi Synthelabo and Roche. The other authors of the two reviews reported no relevant conflicts of interest.

A sweeping review of influenza vaccine studies has concluded that data on vaccination are too flawed, dated, or limited to show any effectiveness in preventing influenza or pneumonia in people over 65—a group consistently targeted by public health agencies.

In a smaller, separate review, researchers also found insufficient evidence to support the theory—also translated widely into public health practice—that vaccinating health care workers against influenza prevents older patients from contracting influenza or pneumonia in health facilities. Both reviews were published by the Cochrane Library.

The large review looked at dozens of studies over a 40-year period. “We have a massive data set—75 studies over 100 flu seasons,” said epidemiologist Tom Jefferson, the Rome-based lead author of both papers. “Can we draw a conclusion? No, we can't. Yet all this money is being spent. It's a very costly form of hopefulness.”

Moreover, Dr. Jefferson said in an interview, “the vast majority of these studies are of poor quality, associated with optimistic conclusions not supported in the actual data.”

The optimism, Dr. Jefferson has argued in earlier papers, likely stems from the sponsors of the vaccine studies themselves. In one article (BMJ 2009;338: b354), he and his colleagues analyzed 274 published studies on influenza vaccines—some of which were also included in the new reviews—and found “evidence of widespread manipulation of conclusions,” he said. Studies sponsored by vaccine manufacturers, they found, were more likely to present positive findings than were those sponsored by public health agencies.

Dr. Jefferson's team also found in that same analysis that industry-sponsored vaccine studies received more and better placement in prestigious medical journals, compared with publicly funded studies of similar size and methodology.

Although it is not news that influenza vaccines may be less effective in the elderly, that concern has contributed to an emphasis on vaccinating health care workers in the hope of preventing flu transmission to elderly patients.

Dr. Jefferson and his colleagues analyzed the results of four randomized, controlled trials showing that vaccination of health care workers “reduced influenza-like illness and resident all-cause mortality” and reduced primary care visits for influenza-like illness. “There was no effect on the outcomes of direct interest, namely laboratory-proven influenza, lower respiratory tract infections, admissions to hospital and deaths from pneumonia” (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD005187

In their larger review of studies concerning vaccinations and older patients, the researchers also identified an emphasis on reductions in illness and death that were not directly attributable to influenza. “Empirical work done by other researchers 5 years ago shows that influenza is at the most responsible for 5% of deaths annually,” Dr. Jefferson said, “and here we have studies that claim 50% effectiveness against death from all causes.”

However, only 1 of the 75 studies cited in the larger Cochrane review was a randomized, controlled trial, and only 1 tested vaccines that are comparable to those in use today. Large, multiseason, publicly funded, randomized, controlled trials are essential, the authors concluded, to determine the real value of flu vaccines for the elderly. And better trials, if not necessarily blinded ones, are needed to determine the benefit of vaccinating health care providers, Dr. Jefferson said, because vaccine uptake among them was low in some of the studies (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD004876

“The two reviews are different in content but not on their conclusions,” Dr. Jefferson said. “They highlight serious problems with the current evidence base.”

Disclosures: Dr. Jefferson reported owning shares in GlaxoSmithKline and receiving consultancy fees from Sanofi Synthelabo and Roche. The other authors of the two reviews reported no relevant conflicts of interest.

A sweeping review of influenza vaccine studies has concluded that data on vaccination are too flawed, dated, or limited to show any effectiveness in preventing influenza or pneumonia in people over 65—a group consistently targeted by public health agencies.

In a smaller, separate review, researchers also found insufficient evidence to support the theory—also translated widely into public health practice—that vaccinating health care workers against influenza prevents older patients from contracting influenza or pneumonia in health facilities. Both reviews were published by the Cochrane Library.

The large review looked at dozens of studies over a 40-year period. “We have a massive data set—75 studies over 100 flu seasons,” said epidemiologist Tom Jefferson, the Rome-based lead author of both papers. “Can we draw a conclusion? No, we can't. Yet all this money is being spent. It's a very costly form of hopefulness.”

Moreover, Dr. Jefferson said in an interview, “the vast majority of these studies are of poor quality, associated with optimistic conclusions not supported in the actual data.”

The optimism, Dr. Jefferson has argued in earlier papers, likely stems from the sponsors of the vaccine studies themselves. In one article (BMJ 2009;338: b354), he and his colleagues analyzed 274 published studies on influenza vaccines—some of which were also included in the new reviews—and found “evidence of widespread manipulation of conclusions,” he said. Studies sponsored by vaccine manufacturers, they found, were more likely to present positive findings than were those sponsored by public health agencies.

Dr. Jefferson's team also found in that same analysis that industry-sponsored vaccine studies received more and better placement in prestigious medical journals, compared with publicly funded studies of similar size and methodology.

Although it is not news that influenza vaccines may be less effective in the elderly, that concern has contributed to an emphasis on vaccinating health care workers in the hope of preventing flu transmission to elderly patients.

Dr. Jefferson and his colleagues analyzed the results of four randomized, controlled trials showing that vaccination of health care workers “reduced influenza-like illness and resident all-cause mortality” and reduced primary care visits for influenza-like illness. “There was no effect on the outcomes of direct interest, namely laboratory-proven influenza, lower respiratory tract infections, admissions to hospital and deaths from pneumonia” (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD005187

In their larger review of studies concerning vaccinations and older patients, the researchers also identified an emphasis on reductions in illness and death that were not directly attributable to influenza. “Empirical work done by other researchers 5 years ago shows that influenza is at the most responsible for 5% of deaths annually,” Dr. Jefferson said, “and here we have studies that claim 50% effectiveness against death from all causes.”

However, only 1 of the 75 studies cited in the larger Cochrane review was a randomized, controlled trial, and only 1 tested vaccines that are comparable to those in use today. Large, multiseason, publicly funded, randomized, controlled trials are essential, the authors concluded, to determine the real value of flu vaccines for the elderly. And better trials, if not necessarily blinded ones, are needed to determine the benefit of vaccinating health care providers, Dr. Jefferson said, because vaccine uptake among them was low in some of the studies (Cochrane Database Syst. Rev. 2010 [doi:10.1002/14651858.CD004876

“The two reviews are different in content but not on their conclusions,” Dr. Jefferson said. “They highlight serious problems with the current evidence base.”

Disclosures: Dr. Jefferson reported owning shares in GlaxoSmithKline and receiving consultancy fees from Sanofi Synthelabo and Roche. The other authors of the two reviews reported no relevant conflicts of interest.

Estrogen-only hormone therapy has been shown to increase the risk of developing asthma after menopause by 54% among postmenopausal women compared with those who have never been treated with HT, according to data from a health survey of French women.

Researchers at the National Instituto of Public Health, Cuernavaca, Mexico, and INSERM and the Université Paris-Sud, France, used data from the E3N cohort, a health survey of nearly 100,000 French women who were born between 1925 and 1950.

The women, mostly teachers, responded to biannual questionnaires between 1990 and 2002 (Thorax 2010 Feb. 8 [doi:10.1136/thx.2009.116079]).

Of the 57,664 women who were free of asthma at menopause, just under two-thirds used some sort of HT, and 569 were later diagnosed with asthma.

The study, which was led by Dr. Isabelle Romieu of the Mexican institute, found that “the increased risk of asthma onset among women using [HT] was present only in users of estrogen alone [hazard ratio 1.54]. The effect was observed only in recent users including current users and women for whom time since last use was less than 1.5 years.”

Moreover, the authors wrote, “Fifty-eight percent of women reporting the use of estrogen alone at the time of asthma onset or as last treatment before asthma onset had previously used another [HT]. This supports our finding that the increased risk of asthma onset is linked to estrogen use.”

The authors found that the risk of developing asthma increased to 80% and 86% (hazard ratios of 1.80 and 1.86), respectively, among postmenopausal women who were treated with estrogen-only HT who never smoked or had a history of allergies before menopause, compared with women who were untreated.

The authors cautioned, however, that the allergy histories were self-reported and that potential misclassifications of allergic disease could have occurred.

The apparently lower susceptibility of HT-treated women who smoke or have smoked to postmenopausal asthma had been noted in earlier studies, Dr. Romieu and her couthors wrote.

“This might be due to the antioestrogenic effect of smoking or to the difficulty of isolating the additional effect of [HT] among smokers,” they noted.

Female hormones have long been suspected of playing a role in the development of asthma, and the connection between HT and postmenopausal asthma had been investigated in a large-scale U.S. study published several years ago (Arch. Int. Med. 2004;164:379-86).

That study determined that recent HT treatment was linked to an increased risk of postmenopausal patients developing asthma. But the study found the risk to be similar whether patients were treated with estrogen only or with a combination of estrogen and progestin.

As a possible explanation for the disparity, Dr. Romieu and her colleagues offered the fact that French and American physicians generally use different ratios of estrogen and progestin, as well as different types of progestin, in HT treatment regimens.

Also in contrast to the earlier U.S. study, Dr. Romieu's team of investigators did not observe interactions between body mass index and risk of asthma among HT and non-HT patients following menopause, but they indicated that this may have been because the French cohort presented leaner body mass as a whole.

The study investigators reported no financial conflicts of interest.

Estrogen-only hormone therapy has been shown to increase the risk of developing asthma after menopause by 54% among postmenopausal women compared with those who have never been treated with HT, according to data from a health survey of French women.

Researchers at the National Instituto of Public Health, Cuernavaca, Mexico, and INSERM and the Université Paris-Sud, France, used data from the E3N cohort, a health survey of nearly 100,000 French women who were born between 1925 and 1950.

The women, mostly teachers, responded to biannual questionnaires between 1990 and 2002 (Thorax 2010 Feb. 8 [doi:10.1136/thx.2009.116079]).

Of the 57,664 women who were free of asthma at menopause, just under two-thirds used some sort of HT, and 569 were later diagnosed with asthma.

The study, which was led by Dr. Isabelle Romieu of the Mexican institute, found that “the increased risk of asthma onset among women using [HT] was present only in users of estrogen alone [hazard ratio 1.54]. The effect was observed only in recent users including current users and women for whom time since last use was less than 1.5 years.”

Moreover, the authors wrote, “Fifty-eight percent of women reporting the use of estrogen alone at the time of asthma onset or as last treatment before asthma onset had previously used another [HT]. This supports our finding that the increased risk of asthma onset is linked to estrogen use.”

The authors found that the risk of developing asthma increased to 80% and 86% (hazard ratios of 1.80 and 1.86), respectively, among postmenopausal women who were treated with estrogen-only HT who never smoked or had a history of allergies before menopause, compared with women who were untreated.

The authors cautioned, however, that the allergy histories were self-reported and that potential misclassifications of allergic disease could have occurred.

The apparently lower susceptibility of HT-treated women who smoke or have smoked to postmenopausal asthma had been noted in earlier studies, Dr. Romieu and her couthors wrote.

“This might be due to the antioestrogenic effect of smoking or to the difficulty of isolating the additional effect of [HT] among smokers,” they noted.

Female hormones have long been suspected of playing a role in the development of asthma, and the connection between HT and postmenopausal asthma had been investigated in a large-scale U.S. study published several years ago (Arch. Int. Med. 2004;164:379-86).

That study determined that recent HT treatment was linked to an increased risk of postmenopausal patients developing asthma. But the study found the risk to be similar whether patients were treated with estrogen only or with a combination of estrogen and progestin.

As a possible explanation for the disparity, Dr. Romieu and her colleagues offered the fact that French and American physicians generally use different ratios of estrogen and progestin, as well as different types of progestin, in HT treatment regimens.

Also in contrast to the earlier U.S. study, Dr. Romieu's team of investigators did not observe interactions between body mass index and risk of asthma among HT and non-HT patients following menopause, but they indicated that this may have been because the French cohort presented leaner body mass as a whole.

The study investigators reported no financial conflicts of interest.

Estrogen-only hormone therapy has been shown to increase the risk of developing asthma after menopause by 54% among postmenopausal women compared with those who have never been treated with HT, according to data from a health survey of French women.

Researchers at the National Instituto of Public Health, Cuernavaca, Mexico, and INSERM and the Université Paris-Sud, France, used data from the E3N cohort, a health survey of nearly 100,000 French women who were born between 1925 and 1950.

The women, mostly teachers, responded to biannual questionnaires between 1990 and 2002 (Thorax 2010 Feb. 8 [doi:10.1136/thx.2009.116079]).

Of the 57,664 women who were free of asthma at menopause, just under two-thirds used some sort of HT, and 569 were later diagnosed with asthma.

The study, which was led by Dr. Isabelle Romieu of the Mexican institute, found that “the increased risk of asthma onset among women using [HT] was present only in users of estrogen alone [hazard ratio 1.54]. The effect was observed only in recent users including current users and women for whom time since last use was less than 1.5 years.”

Moreover, the authors wrote, “Fifty-eight percent of women reporting the use of estrogen alone at the time of asthma onset or as last treatment before asthma onset had previously used another [HT]. This supports our finding that the increased risk of asthma onset is linked to estrogen use.”

The authors found that the risk of developing asthma increased to 80% and 86% (hazard ratios of 1.80 and 1.86), respectively, among postmenopausal women who were treated with estrogen-only HT who never smoked or had a history of allergies before menopause, compared with women who were untreated.

The authors cautioned, however, that the allergy histories were self-reported and that potential misclassifications of allergic disease could have occurred.

The apparently lower susceptibility of HT-treated women who smoke or have smoked to postmenopausal asthma had been noted in earlier studies, Dr. Romieu and her couthors wrote.

“This might be due to the antioestrogenic effect of smoking or to the difficulty of isolating the additional effect of [HT] among smokers,” they noted.

Female hormones have long been suspected of playing a role in the development of asthma, and the connection between HT and postmenopausal asthma had been investigated in a large-scale U.S. study published several years ago (Arch. Int. Med. 2004;164:379-86).

That study determined that recent HT treatment was linked to an increased risk of postmenopausal patients developing asthma. But the study found the risk to be similar whether patients were treated with estrogen only or with a combination of estrogen and progestin.

As a possible explanation for the disparity, Dr. Romieu and her colleagues offered the fact that French and American physicians generally use different ratios of estrogen and progestin, as well as different types of progestin, in HT treatment regimens.

Also in contrast to the earlier U.S. study, Dr. Romieu's team of investigators did not observe interactions between body mass index and risk of asthma among HT and non-HT patients following menopause, but they indicated that this may have been because the French cohort presented leaner body mass as a whole.

The study investigators reported no financial conflicts of interest.

Estrogen-only hormone therapy has been shown to increase the risk of developing asthma after menopause by 54% among postmenopausal women compared with those never treated with HT, according to a new analysis.

Researchers at the National Instituto of Public Health, Cuernavaca, Mexico, and INSERM and the Université Paris-Sud, France, used data from the E3N cohort, a health survey of nearly 100,000 French women born between 1925 and 1950. The women, mostly teachers, responded to biannual questionnaires between 1990 and 2002 (Thorax 2010 Feb. 8 [doi:10.1136/thx.2009.116079]).

Of the 57,664 women free of asthma at menopause, just under two-thirds used some sort of HT, and 569 were later diagnosed with asthma. The study, led by Dr. Isabelle Romieu of the Mexican institute, found that “the increased risk of asthma onset among women using [HT] was present only in users of estrogen alone [hazard ratio 1.54]. The effect was observed only in recent users including current users and women for whom time since last use was <1.5 years.”

Moreover, the authors wrote, “Fifty-eight percent of women reporting the use of estrogen alone at the time of asthma onset or as last treatment before asthma onset had previously used another [HT]. This supports our finding that the increased risk of asthma onset is linked to estrogen use.”

The authors found the risk of developing asthma increased to 80% and 86% (hazard ratios of 1.80 and 1.86), respectively, among postmenopausal women treated with estrogen-only HT who never smoked or had a history of allergies before menopause, compared with untreated women. The authors cautioned, however, that the allergy histories were self-reported and that potential misclassifications of allergic disease could have occurred.

The apparently lower susceptibility of HT-treated women who smoke or have smoked to postmenopausal asthma, the authors said, had been noted in earlier studies. “This might be due to the antioestrogenic effect of smoking or to the difficulty of isolating the additional effect of [HT] among smokers,” they wrote.

Female hormones have long been suspected to play a role in the development of asthma, and the connection between HT and postmenopausal asthma had been investigated in a large-scale U.S. study published in 2004 (Arch. Int. Med. 2004;164:379-86). That study determined that recent HT treatment was linked to an increased risk of postmenopausal patients developing asthma. But it found the risk to be similar whether patients were treated with estrogen only, or a combination therapy.

Dr. Romieu and colleagues offered as a possible explanation for the disparity the fact that French and American physicians generally use different ratios of estrogen and progestin, as well as different types of progestin, in HT treatment regimens.

Also in contrast to the earlier U.S. study, Dr. Romieu's team did not observe interactions between body mass index and risk of asthma among HT and non-HT patients following menopause, but stated that this may have been because the French cohort presented leaner body mass as a whole.

Disclosures: The study investigators reported no financial conflicts of interest.

Estrogen-only hormone therapy has been shown to increase the risk of developing asthma after menopause by 54% among postmenopausal women compared with those never treated with HT, according to a new analysis.

Researchers at the National Instituto of Public Health, Cuernavaca, Mexico, and INSERM and the Université Paris-Sud, France, used data from the E3N cohort, a health survey of nearly 100,000 French women born between 1925 and 1950. The women, mostly teachers, responded to biannual questionnaires between 1990 and 2002 (Thorax 2010 Feb. 8 [doi:10.1136/thx.2009.116079]).

Of the 57,664 women free of asthma at menopause, just under two-thirds used some sort of HT, and 569 were later diagnosed with asthma. The study, led by Dr. Isabelle Romieu of the Mexican institute, found that “the increased risk of asthma onset among women using [HT] was present only in users of estrogen alone [hazard ratio 1.54]. The effect was observed only in recent users including current users and women for whom time since last use was <1.5 years.”

Moreover, the authors wrote, “Fifty-eight percent of women reporting the use of estrogen alone at the time of asthma onset or as last treatment before asthma onset had previously used another [HT]. This supports our finding that the increased risk of asthma onset is linked to estrogen use.”

The authors found the risk of developing asthma increased to 80% and 86% (hazard ratios of 1.80 and 1.86), respectively, among postmenopausal women treated with estrogen-only HT who never smoked or had a history of allergies before menopause, compared with untreated women. The authors cautioned, however, that the allergy histories were self-reported and that potential misclassifications of allergic disease could have occurred.

The apparently lower susceptibility of HT-treated women who smoke or have smoked to postmenopausal asthma, the authors said, had been noted in earlier studies. “This might be due to the antioestrogenic effect of smoking or to the difficulty of isolating the additional effect of [HT] among smokers,” they wrote.

Female hormones have long been suspected to play a role in the development of asthma, and the connection between HT and postmenopausal asthma had been investigated in a large-scale U.S. study published in 2004 (Arch. Int. Med. 2004;164:379-86). That study determined that recent HT treatment was linked to an increased risk of postmenopausal patients developing asthma. But it found the risk to be similar whether patients were treated with estrogen only, or a combination therapy.

Dr. Romieu and colleagues offered as a possible explanation for the disparity the fact that French and American physicians generally use different ratios of estrogen and progestin, as well as different types of progestin, in HT treatment regimens.

Also in contrast to the earlier U.S. study, Dr. Romieu's team did not observe interactions between body mass index and risk of asthma among HT and non-HT patients following menopause, but stated that this may have been because the French cohort presented leaner body mass as a whole.

Disclosures: The study investigators reported no financial conflicts of interest.

Estrogen-only hormone therapy has been shown to increase the risk of developing asthma after menopause by 54% among postmenopausal women compared with those never treated with HT, according to a new analysis.

Researchers at the National Instituto of Public Health, Cuernavaca, Mexico, and INSERM and the Université Paris-Sud, France, used data from the E3N cohort, a health survey of nearly 100,000 French women born between 1925 and 1950. The women, mostly teachers, responded to biannual questionnaires between 1990 and 2002 (Thorax 2010 Feb. 8 [doi:10.1136/thx.2009.116079]).

Of the 57,664 women free of asthma at menopause, just under two-thirds used some sort of HT, and 569 were later diagnosed with asthma. The study, led by Dr. Isabelle Romieu of the Mexican institute, found that “the increased risk of asthma onset among women using [HT] was present only in users of estrogen alone [hazard ratio 1.54]. The effect was observed only in recent users including current users and women for whom time since last use was <1.5 years.”

Moreover, the authors wrote, “Fifty-eight percent of women reporting the use of estrogen alone at the time of asthma onset or as last treatment before asthma onset had previously used another [HT]. This supports our finding that the increased risk of asthma onset is linked to estrogen use.”

The authors found the risk of developing asthma increased to 80% and 86% (hazard ratios of 1.80 and 1.86), respectively, among postmenopausal women treated with estrogen-only HT who never smoked or had a history of allergies before menopause, compared with untreated women. The authors cautioned, however, that the allergy histories were self-reported and that potential misclassifications of allergic disease could have occurred.

The apparently lower susceptibility of HT-treated women who smoke or have smoked to postmenopausal asthma, the authors said, had been noted in earlier studies. “This might be due to the antioestrogenic effect of smoking or to the difficulty of isolating the additional effect of [HT] among smokers,” they wrote.

Female hormones have long been suspected to play a role in the development of asthma, and the connection between HT and postmenopausal asthma had been investigated in a large-scale U.S. study published in 2004 (Arch. Int. Med. 2004;164:379-86). That study determined that recent HT treatment was linked to an increased risk of postmenopausal patients developing asthma. But it found the risk to be similar whether patients were treated with estrogen only, or a combination therapy.

Dr. Romieu and colleagues offered as a possible explanation for the disparity the fact that French and American physicians generally use different ratios of estrogen and progestin, as well as different types of progestin, in HT treatment regimens.

Also in contrast to the earlier U.S. study, Dr. Romieu's team did not observe interactions between body mass index and risk of asthma among HT and non-HT patients following menopause, but stated that this may have been because the French cohort presented leaner body mass as a whole.

Disclosures: The study investigators reported no financial conflicts of interest.

Major Finding: The risk of pregnancy was 0.9% with ulipristal vs. 2.5% with levonorgestrel when women presented within 24 hours after unprotected intercourse.

Data Source: A multisite study of 1,899 women who presented at family planning clinics requesting emergency contraception.

Disclosures: Funded by HRA Pharma, the manufacturer of ulipristal. Three investigators report having received lecture honoraria from HRA Pharma. Three are current employees of HRA Pharma, one is a former employee and a stockholder, another reports having received consulting fees from HRA, and five report no conflicts of interest.

The investigational drug ulipristal acetate is more effective than the widely used levonorgestrel in preventing pregnancy at any point within 5 days of unprotected intercourse.

Researchers led by Dr. Anna F. Glasier of the National Health Service in Edinburgh performed their own study of nearly 2,000 women in Europe and the United States and also analyzed findings from a previous study.

Though neither study was of sufficient size to demonstrate the superiority of ulipristal over levonorgestrel, Dr. Glasier and her colleagues wrote, combining the data from both studies showed that ulipristal “almost halved the risk of becoming pregnant compared to levonorgestrel in women who received emergency contraception within 120 hours” (1.3% vs. 2.2%). The risk was reduced by nearly two-thirds when women presented within 24 hours (0.9% vs. 2.5%), the investigators wrote.

“Only when we put the two studies together were we able to demonstrate superiority,” said Dr. Glasier in an interview.

In the multisite study, 1,899 women who presented requesting emergency contraception at family planning clinics in the United Kingdom, Ireland, and the United States were assigned to a single dose of either ulipristal 30 mg (n= 941) or levonorgestrel 1.5 mg (n= 958) (Lancet 2010 [doi:10.1016/S0140-6736(10)60101-8

Ulipristal is manufactured by HRA Pharma, which funded the study. Levonorgestrel is made by Shering.

Of the 1,696 women who had presented within 72 hours of intercourse, there were 15 pregnancies in the ulipristal group (1.8% of 844 women) and 22 in the levonorgestrel group (2.6 % of 852).

Among the 203 women who received emergency contraception after 72 hours, there were three pregnancies, all in the levonorgestrel group.

Patients ranged in age from 16 years to over 35; they were not told which drug they had received. Follow-up with pregnancy testing began within a week after the expected onset of next menses.

The 1,899 women in the analyzed group were those remaining from a total 2,221 who had presented to the family planning clinics.

Excluded from study were those who were older than 35, who were lost to follow-up, who were pregnant when presenting, who re-enrolled in the study, or whose pregnancy status was unknown following treatment.

The authors also analyzed findings from a 2006 randomized controlled trial comparing ulipristal to levonorgestrel in 1,546 efficacy-evaluable women, all of whom had presented within 72 hours of intercourse (Obstet Gynecol 2006;108:1089-97). There, too, the pregnancy rate was lower for ulipristal—7 pregnancies out of 773 patients (0.9%) and 13 out of 773 (1.7%) for levonorgestrel.

The European Medicines Agency approved ulipristal in May 2009 for preventing pregnancy up to 120 hours after intercourse. It is not currently approved in the United States.

Levonorgestrel is approved in both the United States and in the European Union for use up to 72 hours after intercourse.

Major Finding: The risk of pregnancy was 0.9% with ulipristal vs. 2.5% with levonorgestrel when women presented within 24 hours after unprotected intercourse.

Data Source: A multisite study of 1,899 women who presented at family planning clinics requesting emergency contraception.

Disclosures: Funded by HRA Pharma, the manufacturer of ulipristal. Three investigators report having received lecture honoraria from HRA Pharma. Three are current employees of HRA Pharma, one is a former employee and a stockholder, another reports having received consulting fees from HRA, and five report no conflicts of interest.

The investigational drug ulipristal acetate is more effective than the widely used levonorgestrel in preventing pregnancy at any point within 5 days of unprotected intercourse.

Researchers led by Dr. Anna F. Glasier of the National Health Service in Edinburgh performed their own study of nearly 2,000 women in Europe and the United States and also analyzed findings from a previous study.

Though neither study was of sufficient size to demonstrate the superiority of ulipristal over levonorgestrel, Dr. Glasier and her colleagues wrote, combining the data from both studies showed that ulipristal “almost halved the risk of becoming pregnant compared to levonorgestrel in women who received emergency contraception within 120 hours” (1.3% vs. 2.2%). The risk was reduced by nearly two-thirds when women presented within 24 hours (0.9% vs. 2.5%), the investigators wrote.

“Only when we put the two studies together were we able to demonstrate superiority,” said Dr. Glasier in an interview.

In the multisite study, 1,899 women who presented requesting emergency contraception at family planning clinics in the United Kingdom, Ireland, and the United States were assigned to a single dose of either ulipristal 30 mg (n= 941) or levonorgestrel 1.5 mg (n= 958) (Lancet 2010 [doi:10.1016/S0140-6736(10)60101-8

Ulipristal is manufactured by HRA Pharma, which funded the study. Levonorgestrel is made by Shering.

Of the 1,696 women who had presented within 72 hours of intercourse, there were 15 pregnancies in the ulipristal group (1.8% of 844 women) and 22 in the levonorgestrel group (2.6 % of 852).

Among the 203 women who received emergency contraception after 72 hours, there were three pregnancies, all in the levonorgestrel group.

Patients ranged in age from 16 years to over 35; they were not told which drug they had received. Follow-up with pregnancy testing began within a week after the expected onset of next menses.

The 1,899 women in the analyzed group were those remaining from a total 2,221 who had presented to the family planning clinics.

Excluded from study were those who were older than 35, who were lost to follow-up, who were pregnant when presenting, who re-enrolled in the study, or whose pregnancy status was unknown following treatment.

The authors also analyzed findings from a 2006 randomized controlled trial comparing ulipristal to levonorgestrel in 1,546 efficacy-evaluable women, all of whom had presented within 72 hours of intercourse (Obstet Gynecol 2006;108:1089-97). There, too, the pregnancy rate was lower for ulipristal—7 pregnancies out of 773 patients (0.9%) and 13 out of 773 (1.7%) for levonorgestrel.

The European Medicines Agency approved ulipristal in May 2009 for preventing pregnancy up to 120 hours after intercourse. It is not currently approved in the United States.

Levonorgestrel is approved in both the United States and in the European Union for use up to 72 hours after intercourse.

Major Finding: The risk of pregnancy was 0.9% with ulipristal vs. 2.5% with levonorgestrel when women presented within 24 hours after unprotected intercourse.

Data Source: A multisite study of 1,899 women who presented at family planning clinics requesting emergency contraception.

Disclosures: Funded by HRA Pharma, the manufacturer of ulipristal. Three investigators report having received lecture honoraria from HRA Pharma. Three are current employees of HRA Pharma, one is a former employee and a stockholder, another reports having received consulting fees from HRA, and five report no conflicts of interest.

The investigational drug ulipristal acetate is more effective than the widely used levonorgestrel in preventing pregnancy at any point within 5 days of unprotected intercourse.

Researchers led by Dr. Anna F. Glasier of the National Health Service in Edinburgh performed their own study of nearly 2,000 women in Europe and the United States and also analyzed findings from a previous study.

Though neither study was of sufficient size to demonstrate the superiority of ulipristal over levonorgestrel, Dr. Glasier and her colleagues wrote, combining the data from both studies showed that ulipristal “almost halved the risk of becoming pregnant compared to levonorgestrel in women who received emergency contraception within 120 hours” (1.3% vs. 2.2%). The risk was reduced by nearly two-thirds when women presented within 24 hours (0.9% vs. 2.5%), the investigators wrote.

“Only when we put the two studies together were we able to demonstrate superiority,” said Dr. Glasier in an interview.

In the multisite study, 1,899 women who presented requesting emergency contraception at family planning clinics in the United Kingdom, Ireland, and the United States were assigned to a single dose of either ulipristal 30 mg (n= 941) or levonorgestrel 1.5 mg (n= 958) (Lancet 2010 [doi:10.1016/S0140-6736(10)60101-8

Ulipristal is manufactured by HRA Pharma, which funded the study. Levonorgestrel is made by Shering.

Of the 1,696 women who had presented within 72 hours of intercourse, there were 15 pregnancies in the ulipristal group (1.8% of 844 women) and 22 in the levonorgestrel group (2.6 % of 852).

Among the 203 women who received emergency contraception after 72 hours, there were three pregnancies, all in the levonorgestrel group.

Patients ranged in age from 16 years to over 35; they were not told which drug they had received. Follow-up with pregnancy testing began within a week after the expected onset of next menses.

The 1,899 women in the analyzed group were those remaining from a total 2,221 who had presented to the family planning clinics.

Excluded from study were those who were older than 35, who were lost to follow-up, who were pregnant when presenting, who re-enrolled in the study, or whose pregnancy status was unknown following treatment.

The authors also analyzed findings from a 2006 randomized controlled trial comparing ulipristal to levonorgestrel in 1,546 efficacy-evaluable women, all of whom had presented within 72 hours of intercourse (Obstet Gynecol 2006;108:1089-97). There, too, the pregnancy rate was lower for ulipristal—7 pregnancies out of 773 patients (0.9%) and 13 out of 773 (1.7%) for levonorgestrel.

The European Medicines Agency approved ulipristal in May 2009 for preventing pregnancy up to 120 hours after intercourse. It is not currently approved in the United States.

Levonorgestrel is approved in both the United States and in the European Union for use up to 72 hours after intercourse.

A computer device used to treat anorexic patients has been shown to be effective against adolescent obesity, reducing patients' body mass index and rate of food consumption even 6 months after the completion of treatment and monitoring.

The Mandometer, as the device is called, was developed at the Karolinska Institutet in Stockholm. It consists of a scale placed beneath the plate of food, and a small monitor that helps patients compare and align their perceptions of satiety, in real time, with those of a normal eater.

Anorexic patients at Mandometer clinics in Sweden, the United States, and Australia have used the device to retrain themselves to eat more food than would typically cause them feel full.

“With obesity, it teaches patients to eat slower,” Per Södersten, Ph.D., one of the report's authors and the inventor of the device, said in an interview. “Otherwise the principles are identical.”

The report presents results from a randomized controlled trial of 106 obese patients between the ages of 9 and 17 at the Bristol (England) Royal Hospital for Children. Dr. Julian P.H. Shield led the study along with Anna L. Ford, a research nurse trained a Mandometer clinic in Sweden.

Of the participants, 54 were trained to use the device during evening meals at home, while the other 52 were given standard care consisting mostly of advice on exercise and nutrition. The same advice was provided to the group using the Mandometer (BMJ 2010;340:b5388).

After a year, the Mandometer group showed significant improvements in body mass index. Of the 91 patients who were assessed at 12 months, the mean adjusted standard deviation score difference between the two groups was 0.27, the report said. Importantly, that difference was maintained at 18 months, 6 months after treatment and monitoring had ceased. (Nine patients were lost to follow-up in the Madometer group; six were lost in the standard-care group.) Though their Mandometers had been taken away, the subjects still tended to eat significantly smaller portions than they had before beginning treatment.

The discovery of maintained weight loss and consumption of smaller portions 6 months on “was probably the best bit,” Dr. Shield said in an interview. “We specifically chose adolescents because they're a difficult group to persuade to eat better and exercise. But by doing this extra thing to help them eat more slowly it allows them to curtail their portion sizes.”

Using a computer to track eating habits is not entirely novel, said Dr. Södersten, who cited research dating back to the 1960s in the United States, and the 1970s in Germany. “We followed that tradition and realized the device could be used for clinical intervention,” he said.

The adolescent subjects of the Bristol study adapted well to using the device, he added. “Young people like computers and they're used to them. They comply better because it's fun for them.”

Dr. Södersten and another coauthor own shares in the company that manufactures Mandometer.

A computer device used to treat anorexic patients has been shown to be effective against adolescent obesity, reducing patients' body mass index and rate of food consumption even 6 months after the completion of treatment and monitoring.

The Mandometer, as the device is called, was developed at the Karolinska Institutet in Stockholm. It consists of a scale placed beneath the plate of food, and a small monitor that helps patients compare and align their perceptions of satiety, in real time, with those of a normal eater.

Anorexic patients at Mandometer clinics in Sweden, the United States, and Australia have used the device to retrain themselves to eat more food than would typically cause them feel full.

“With obesity, it teaches patients to eat slower,” Per Södersten, Ph.D., one of the report's authors and the inventor of the device, said in an interview. “Otherwise the principles are identical.”

The report presents results from a randomized controlled trial of 106 obese patients between the ages of 9 and 17 at the Bristol (England) Royal Hospital for Children. Dr. Julian P.H. Shield led the study along with Anna L. Ford, a research nurse trained a Mandometer clinic in Sweden.

Of the participants, 54 were trained to use the device during evening meals at home, while the other 52 were given standard care consisting mostly of advice on exercise and nutrition. The same advice was provided to the group using the Mandometer (BMJ 2010;340:b5388).

After a year, the Mandometer group showed significant improvements in body mass index. Of the 91 patients who were assessed at 12 months, the mean adjusted standard deviation score difference between the two groups was 0.27, the report said. Importantly, that difference was maintained at 18 months, 6 months after treatment and monitoring had ceased. (Nine patients were lost to follow-up in the Madometer group; six were lost in the standard-care group.) Though their Mandometers had been taken away, the subjects still tended to eat significantly smaller portions than they had before beginning treatment.

The discovery of maintained weight loss and consumption of smaller portions 6 months on “was probably the best bit,” Dr. Shield said in an interview. “We specifically chose adolescents because they're a difficult group to persuade to eat better and exercise. But by doing this extra thing to help them eat more slowly it allows them to curtail their portion sizes.”

Using a computer to track eating habits is not entirely novel, said Dr. Södersten, who cited research dating back to the 1960s in the United States, and the 1970s in Germany. “We followed that tradition and realized the device could be used for clinical intervention,” he said.

The adolescent subjects of the Bristol study adapted well to using the device, he added. “Young people like computers and they're used to them. They comply better because it's fun for them.”

Dr. Södersten and another coauthor own shares in the company that manufactures Mandometer.

A computer device used to treat anorexic patients has been shown to be effective against adolescent obesity, reducing patients' body mass index and rate of food consumption even 6 months after the completion of treatment and monitoring.

The Mandometer, as the device is called, was developed at the Karolinska Institutet in Stockholm. It consists of a scale placed beneath the plate of food, and a small monitor that helps patients compare and align their perceptions of satiety, in real time, with those of a normal eater.

Anorexic patients at Mandometer clinics in Sweden, the United States, and Australia have used the device to retrain themselves to eat more food than would typically cause them feel full.

“With obesity, it teaches patients to eat slower,” Per Södersten, Ph.D., one of the report's authors and the inventor of the device, said in an interview. “Otherwise the principles are identical.”

The report presents results from a randomized controlled trial of 106 obese patients between the ages of 9 and 17 at the Bristol (England) Royal Hospital for Children. Dr. Julian P.H. Shield led the study along with Anna L. Ford, a research nurse trained a Mandometer clinic in Sweden.

Of the participants, 54 were trained to use the device during evening meals at home, while the other 52 were given standard care consisting mostly of advice on exercise and nutrition. The same advice was provided to the group using the Mandometer (BMJ 2010;340:b5388).

After a year, the Mandometer group showed significant improvements in body mass index. Of the 91 patients who were assessed at 12 months, the mean adjusted standard deviation score difference between the two groups was 0.27, the report said. Importantly, that difference was maintained at 18 months, 6 months after treatment and monitoring had ceased. (Nine patients were lost to follow-up in the Madometer group; six were lost in the standard-care group.) Though their Mandometers had been taken away, the subjects still tended to eat significantly smaller portions than they had before beginning treatment.

The discovery of maintained weight loss and consumption of smaller portions 6 months on “was probably the best bit,” Dr. Shield said in an interview. “We specifically chose adolescents because they're a difficult group to persuade to eat better and exercise. But by doing this extra thing to help them eat more slowly it allows them to curtail their portion sizes.”

Using a computer to track eating habits is not entirely novel, said Dr. Södersten, who cited research dating back to the 1960s in the United States, and the 1970s in Germany. “We followed that tradition and realized the device could be used for clinical intervention,” he said.

The adolescent subjects of the Bristol study adapted well to using the device, he added. “Young people like computers and they're used to them. They comply better because it's fun for them.”

Dr. Södersten and another coauthor own shares in the company that manufactures Mandometer.