Damian McNamara

ORLANDO — Although internal hernias occur infrequently, they are a potentially serious complication that can develop long after gastric bypass surgery, according to a study presented by Brennan J. Carmody, M.D., at the annual meeting of the American Society for Bariatric Surgery.

“Internal hernia can be a devastating postoperative complication that leads to intestinal obstruction,” he said. With an overall incidence of 2.5%, clinical suspicion for internal hernia needs to be high.

Consider internal hernia when a bariatric surgery patient presents with abdominal pain, even if more than a year has passed since the procedure was done, Dr. Carmody suggested. In his study, all 20 patients who required surgery to correct an internal hernia initially presented with abdominal pain. Nausea, vomiting, and bowel obstruction are other clinical clues.

Dr. Carmody and his associates reviewed 785 laparoscopic gastric bypass procedures performed between 1998 and 2003 at Virginia Commonwealth University Medical Center in Richmond. The mean preoperative body mass index was 47 kg/m

The researchers identified different types of hernias, including Peterson's, mesocolic, jejunojejunal, and adhesion-related hernias. They used contrast radiography to assess 75% of patients. All findings were suspicious for internal hernia.

Surgical technique made a difference in the complication rate. In the first 107 patients, surgeons performed a retrocolic technique without defect closure. The internal hernia rate in this group was 6.5%. An antecolic technique was used with another 136 patients, and 4.4% developed a hernia. For the remaining 542 patients, surgeons performed a retrocolic technique with closure of all defects. Three developed an internal hernia, giving this group the lowest hernia rate—0.5%.

“We recommend routine closure of all mesenteric defects,” Dr. Carmody said.

“Patients, primary care physicians, radiologists, surgeons, and physician assistants may fail to recognize signs or symptoms. Patients experiencing unexplained or intermittent abdominal pain should be considered for reexploration,” said Dr. Carmody, a laparoscopy fellow with the Minimally Invasive Surgery Center at Virginia Commonwealth University.

There might be a reluctance to reexplore patients with vague symptomatology, Dr. Carmody said. But that is not the only challenge. A mean of 303 days elapsed between bypass and development of symptoms in his study. The patient with a late complication may not see the same bariatric surgeon who performed the procedure, he said.

ORLANDO — Although internal hernias occur infrequently, they are a potentially serious complication that can develop long after gastric bypass surgery, according to a study presented by Brennan J. Carmody, M.D., at the annual meeting of the American Society for Bariatric Surgery.

“Internal hernia can be a devastating postoperative complication that leads to intestinal obstruction,” he said. With an overall incidence of 2.5%, clinical suspicion for internal hernia needs to be high.

Consider internal hernia when a bariatric surgery patient presents with abdominal pain, even if more than a year has passed since the procedure was done, Dr. Carmody suggested. In his study, all 20 patients who required surgery to correct an internal hernia initially presented with abdominal pain. Nausea, vomiting, and bowel obstruction are other clinical clues.

Dr. Carmody and his associates reviewed 785 laparoscopic gastric bypass procedures performed between 1998 and 2003 at Virginia Commonwealth University Medical Center in Richmond. The mean preoperative body mass index was 47 kg/m

The researchers identified different types of hernias, including Peterson's, mesocolic, jejunojejunal, and adhesion-related hernias. They used contrast radiography to assess 75% of patients. All findings were suspicious for internal hernia.

Surgical technique made a difference in the complication rate. In the first 107 patients, surgeons performed a retrocolic technique without defect closure. The internal hernia rate in this group was 6.5%. An antecolic technique was used with another 136 patients, and 4.4% developed a hernia. For the remaining 542 patients, surgeons performed a retrocolic technique with closure of all defects. Three developed an internal hernia, giving this group the lowest hernia rate—0.5%.

“We recommend routine closure of all mesenteric defects,” Dr. Carmody said.

“Patients, primary care physicians, radiologists, surgeons, and physician assistants may fail to recognize signs or symptoms. Patients experiencing unexplained or intermittent abdominal pain should be considered for reexploration,” said Dr. Carmody, a laparoscopy fellow with the Minimally Invasive Surgery Center at Virginia Commonwealth University.

There might be a reluctance to reexplore patients with vague symptomatology, Dr. Carmody said. But that is not the only challenge. A mean of 303 days elapsed between bypass and development of symptoms in his study. The patient with a late complication may not see the same bariatric surgeon who performed the procedure, he said.

ORLANDO — Although internal hernias occur infrequently, they are a potentially serious complication that can develop long after gastric bypass surgery, according to a study presented by Brennan J. Carmody, M.D., at the annual meeting of the American Society for Bariatric Surgery.

“Internal hernia can be a devastating postoperative complication that leads to intestinal obstruction,” he said. With an overall incidence of 2.5%, clinical suspicion for internal hernia needs to be high.

Consider internal hernia when a bariatric surgery patient presents with abdominal pain, even if more than a year has passed since the procedure was done, Dr. Carmody suggested. In his study, all 20 patients who required surgery to correct an internal hernia initially presented with abdominal pain. Nausea, vomiting, and bowel obstruction are other clinical clues.

Dr. Carmody and his associates reviewed 785 laparoscopic gastric bypass procedures performed between 1998 and 2003 at Virginia Commonwealth University Medical Center in Richmond. The mean preoperative body mass index was 47 kg/m

The researchers identified different types of hernias, including Peterson's, mesocolic, jejunojejunal, and adhesion-related hernias. They used contrast radiography to assess 75% of patients. All findings were suspicious for internal hernia.

Surgical technique made a difference in the complication rate. In the first 107 patients, surgeons performed a retrocolic technique without defect closure. The internal hernia rate in this group was 6.5%. An antecolic technique was used with another 136 patients, and 4.4% developed a hernia. For the remaining 542 patients, surgeons performed a retrocolic technique with closure of all defects. Three developed an internal hernia, giving this group the lowest hernia rate—0.5%.

“We recommend routine closure of all mesenteric defects,” Dr. Carmody said.

“Patients, primary care physicians, radiologists, surgeons, and physician assistants may fail to recognize signs or symptoms. Patients experiencing unexplained or intermittent abdominal pain should be considered for reexploration,” said Dr. Carmody, a laparoscopy fellow with the Minimally Invasive Surgery Center at Virginia Commonwealth University.

There might be a reluctance to reexplore patients with vague symptomatology, Dr. Carmody said. But that is not the only challenge. A mean of 303 days elapsed between bypass and development of symptoms in his study. The patient with a late complication may not see the same bariatric surgeon who performed the procedure, he said.

ORLANDO — Cholecystectomy or 6 months of prophylactic medication to prevent gallstones after gastric bypass surgery is unwarranted for most patients and is expensive, according to results of a study presented by Joseph A. Caruana, M.D., at the annual meeting of the American Society for Bariatric Surgery.

Dr. Caruana and his associates studied 100 women and 25 men after open Roux-en-Y gastric bypass. None of the participants received ursodeoxycholic acid, a medication often used to prevent gallstones during rapid loss of weight. All procedures were performed at the Sisters of Charity Hospital in Buffalo, N.Y., from June 2000 to July 2002. Participants did not have palpable gallstones at the time of surgery, and required at least 16 months of follow-up for inclusion in the study.

A total of 10 patients (8%) developed symptomatic gallstones that required cholecystectomy. Nine of these 10 women had laparoscopic cholecystectomy, and 1 had an open procedure. There were no serious complications from the gallstones or cholecystectomies, said Dr. Caruana, a laparoscopy fellow at the Sisters of Charity Hospital.

“Prophylactic cholecystectomy would have been unnecessary in 115 patients,” Dr. Caruana said. “The risk and cost of prophylactic cholecystectomy outweigh the benefits. Concomitant cholecystectomy is indicated only when stones are detected pre- or intraoperatively.”

The incidence of symptomatic stones in the first two postoperative years was about 6% per year, Dr. Caruana said. “Most newly formed stones after gastric bypass are asymptomatic.” He added that most patients with asymptomatic stones will remain asymptomatic during their lifetimes.

Many surgeons have proposed prevention with a cholecystectomy at the time of gastric bypass surgery (Obes. Surg. 2004;14:763–5). However, “most general surgeons would not remove the gallbladder during other procedures without the presence of stones,” Dr. Caruana said.

Rapid weight loss after gastric bypass surgery can cause gallstones to form in up to 50% of patients, Dr. Caruana noted. For this reason, some experts recommend 6 months of ursodeoxycholic acid. A 6-month course of ursodeoxycholic acid for all 125 participants in the study would have cost $56,250, he said.

A better use of ursodeoxycholic acid might be for symptomatic patients who refuse surgery, he suggested.

ORLANDO — Cholecystectomy or 6 months of prophylactic medication to prevent gallstones after gastric bypass surgery is unwarranted for most patients and is expensive, according to results of a study presented by Joseph A. Caruana, M.D., at the annual meeting of the American Society for Bariatric Surgery.

Dr. Caruana and his associates studied 100 women and 25 men after open Roux-en-Y gastric bypass. None of the participants received ursodeoxycholic acid, a medication often used to prevent gallstones during rapid loss of weight. All procedures were performed at the Sisters of Charity Hospital in Buffalo, N.Y., from June 2000 to July 2002. Participants did not have palpable gallstones at the time of surgery, and required at least 16 months of follow-up for inclusion in the study.

A total of 10 patients (8%) developed symptomatic gallstones that required cholecystectomy. Nine of these 10 women had laparoscopic cholecystectomy, and 1 had an open procedure. There were no serious complications from the gallstones or cholecystectomies, said Dr. Caruana, a laparoscopy fellow at the Sisters of Charity Hospital.

“Prophylactic cholecystectomy would have been unnecessary in 115 patients,” Dr. Caruana said. “The risk and cost of prophylactic cholecystectomy outweigh the benefits. Concomitant cholecystectomy is indicated only when stones are detected pre- or intraoperatively.”

The incidence of symptomatic stones in the first two postoperative years was about 6% per year, Dr. Caruana said. “Most newly formed stones after gastric bypass are asymptomatic.” He added that most patients with asymptomatic stones will remain asymptomatic during their lifetimes.

Many surgeons have proposed prevention with a cholecystectomy at the time of gastric bypass surgery (Obes. Surg. 2004;14:763–5). However, “most general surgeons would not remove the gallbladder during other procedures without the presence of stones,” Dr. Caruana said.

Rapid weight loss after gastric bypass surgery can cause gallstones to form in up to 50% of patients, Dr. Caruana noted. For this reason, some experts recommend 6 months of ursodeoxycholic acid. A 6-month course of ursodeoxycholic acid for all 125 participants in the study would have cost $56,250, he said.

A better use of ursodeoxycholic acid might be for symptomatic patients who refuse surgery, he suggested.

ORLANDO — Cholecystectomy or 6 months of prophylactic medication to prevent gallstones after gastric bypass surgery is unwarranted for most patients and is expensive, according to results of a study presented by Joseph A. Caruana, M.D., at the annual meeting of the American Society for Bariatric Surgery.

Dr. Caruana and his associates studied 100 women and 25 men after open Roux-en-Y gastric bypass. None of the participants received ursodeoxycholic acid, a medication often used to prevent gallstones during rapid loss of weight. All procedures were performed at the Sisters of Charity Hospital in Buffalo, N.Y., from June 2000 to July 2002. Participants did not have palpable gallstones at the time of surgery, and required at least 16 months of follow-up for inclusion in the study.

A total of 10 patients (8%) developed symptomatic gallstones that required cholecystectomy. Nine of these 10 women had laparoscopic cholecystectomy, and 1 had an open procedure. There were no serious complications from the gallstones or cholecystectomies, said Dr. Caruana, a laparoscopy fellow at the Sisters of Charity Hospital.

“Prophylactic cholecystectomy would have been unnecessary in 115 patients,” Dr. Caruana said. “The risk and cost of prophylactic cholecystectomy outweigh the benefits. Concomitant cholecystectomy is indicated only when stones are detected pre- or intraoperatively.”

The incidence of symptomatic stones in the first two postoperative years was about 6% per year, Dr. Caruana said. “Most newly formed stones after gastric bypass are asymptomatic.” He added that most patients with asymptomatic stones will remain asymptomatic during their lifetimes.

Many surgeons have proposed prevention with a cholecystectomy at the time of gastric bypass surgery (Obes. Surg. 2004;14:763–5). However, “most general surgeons would not remove the gallbladder during other procedures without the presence of stones,” Dr. Caruana said.

Rapid weight loss after gastric bypass surgery can cause gallstones to form in up to 50% of patients, Dr. Caruana noted. For this reason, some experts recommend 6 months of ursodeoxycholic acid. A 6-month course of ursodeoxycholic acid for all 125 participants in the study would have cost $56,250, he said.

A better use of ursodeoxycholic acid might be for symptomatic patients who refuse surgery, he suggested.

ORLANDO — Although internal hernias occur infrequently, they are a potentially serious complication that can develop long after gastric bypass surgery, according to a study presented by Brennan J. Carmody, M.D., at the annual meeting of the American Society for Bariatric Surgery.

“Internal hernia can be a devastating postoperative complication that leads to intestinal obstruction,” he said. With an overall incidence of 2.5%, clinical suspicion for internal hernia needs to be high.

Consider internal hernia when a bariatric surgery patient presents with abdominal pain, even if more than a year has passed since the procedure was done, Dr. Carmody suggested. In his study, all 20 patients who required surgery to correct an internal hernia initially presented with abdominal pain. Nausea, vomiting, and bowel obstruction are other clinical clues.

Dr. Carmody and his associates reviewed 785 laparoscopic gastric bypass procedures performed between 1998 and 2003 at Virginia Commonwealth University Medical Center in Richmond. The mean preoperative body mass index was 47 kg/m

The researchers identified different types of hernias, including Peterson's, mesocolic, jejunojejunal, and adhesion-related hernias. They used contrast radiography to assess 75% of patients. All findings were suspicious for internal hernia.

Surgical technique made a difference in the complication rate. In the first 107 patients, surgeons performed a retrocolic technique without defect closure. The internal hernia rate in this group was 6.5%. An antecolic technique was used with another 136 patients, and 4.4% developed a hernia. For the remaining 542 patients, surgeons performed a retrocolic technique with closure of all defects. Three developed an internal hernia, giving this group the lowest hernia rate—0.5%.

“We recommend routine closure of all mesenteric defects,” Dr. Carmody said.

“Patients, primary care physicians, radiologists, surgeons, and physician assistants may fail to recognize signs or symptoms.

Patients experiencing unexplained or intermittent abdominal pain should be considered for reexploration,” said Dr. Carmody, a laparoscopy Fellow with the Minimally Invasive Surgery Center at Virginia Commonwealth University.

There might be a reluctance to reexplore patients with vague symptomatology, Dr. Carmody said.

But that is not the only challenge. A mean of 303 days elapsed between bypass and development of symptoms in his study. The patient with a late complication may not see the same bariatric surgeon who performed the procedure, he said.

“Internal hernia can occur long after gastric bypass with variable presentation,” Dr. Carmody concluded.

“There is an underreporting of this complication. The true incidence is likely underestimated,” he said.

ORLANDO — Although internal hernias occur infrequently, they are a potentially serious complication that can develop long after gastric bypass surgery, according to a study presented by Brennan J. Carmody, M.D., at the annual meeting of the American Society for Bariatric Surgery.

“Internal hernia can be a devastating postoperative complication that leads to intestinal obstruction,” he said. With an overall incidence of 2.5%, clinical suspicion for internal hernia needs to be high.

Consider internal hernia when a bariatric surgery patient presents with abdominal pain, even if more than a year has passed since the procedure was done, Dr. Carmody suggested. In his study, all 20 patients who required surgery to correct an internal hernia initially presented with abdominal pain. Nausea, vomiting, and bowel obstruction are other clinical clues.

Dr. Carmody and his associates reviewed 785 laparoscopic gastric bypass procedures performed between 1998 and 2003 at Virginia Commonwealth University Medical Center in Richmond. The mean preoperative body mass index was 47 kg/m

The researchers identified different types of hernias, including Peterson's, mesocolic, jejunojejunal, and adhesion-related hernias. They used contrast radiography to assess 75% of patients. All findings were suspicious for internal hernia.

Surgical technique made a difference in the complication rate. In the first 107 patients, surgeons performed a retrocolic technique without defect closure. The internal hernia rate in this group was 6.5%. An antecolic technique was used with another 136 patients, and 4.4% developed a hernia. For the remaining 542 patients, surgeons performed a retrocolic technique with closure of all defects. Three developed an internal hernia, giving this group the lowest hernia rate—0.5%.

“We recommend routine closure of all mesenteric defects,” Dr. Carmody said.

“Patients, primary care physicians, radiologists, surgeons, and physician assistants may fail to recognize signs or symptoms.

Patients experiencing unexplained or intermittent abdominal pain should be considered for reexploration,” said Dr. Carmody, a laparoscopy Fellow with the Minimally Invasive Surgery Center at Virginia Commonwealth University.

There might be a reluctance to reexplore patients with vague symptomatology, Dr. Carmody said.

But that is not the only challenge. A mean of 303 days elapsed between bypass and development of symptoms in his study. The patient with a late complication may not see the same bariatric surgeon who performed the procedure, he said.

“Internal hernia can occur long after gastric bypass with variable presentation,” Dr. Carmody concluded.

“There is an underreporting of this complication. The true incidence is likely underestimated,” he said.

ORLANDO — Although internal hernias occur infrequently, they are a potentially serious complication that can develop long after gastric bypass surgery, according to a study presented by Brennan J. Carmody, M.D., at the annual meeting of the American Society for Bariatric Surgery.

“Internal hernia can be a devastating postoperative complication that leads to intestinal obstruction,” he said. With an overall incidence of 2.5%, clinical suspicion for internal hernia needs to be high.

Consider internal hernia when a bariatric surgery patient presents with abdominal pain, even if more than a year has passed since the procedure was done, Dr. Carmody suggested. In his study, all 20 patients who required surgery to correct an internal hernia initially presented with abdominal pain. Nausea, vomiting, and bowel obstruction are other clinical clues.

Dr. Carmody and his associates reviewed 785 laparoscopic gastric bypass procedures performed between 1998 and 2003 at Virginia Commonwealth University Medical Center in Richmond. The mean preoperative body mass index was 47 kg/m

The researchers identified different types of hernias, including Peterson's, mesocolic, jejunojejunal, and adhesion-related hernias. They used contrast radiography to assess 75% of patients. All findings were suspicious for internal hernia.

Surgical technique made a difference in the complication rate. In the first 107 patients, surgeons performed a retrocolic technique without defect closure. The internal hernia rate in this group was 6.5%. An antecolic technique was used with another 136 patients, and 4.4% developed a hernia. For the remaining 542 patients, surgeons performed a retrocolic technique with closure of all defects. Three developed an internal hernia, giving this group the lowest hernia rate—0.5%.

“We recommend routine closure of all mesenteric defects,” Dr. Carmody said.

“Patients, primary care physicians, radiologists, surgeons, and physician assistants may fail to recognize signs or symptoms.

Patients experiencing unexplained or intermittent abdominal pain should be considered for reexploration,” said Dr. Carmody, a laparoscopy Fellow with the Minimally Invasive Surgery Center at Virginia Commonwealth University.

There might be a reluctance to reexplore patients with vague symptomatology, Dr. Carmody said.

But that is not the only challenge. A mean of 303 days elapsed between bypass and development of symptoms in his study. The patient with a late complication may not see the same bariatric surgeon who performed the procedure, he said.

“Internal hernia can occur long after gastric bypass with variable presentation,” Dr. Carmody concluded.

“There is an underreporting of this complication. The true incidence is likely underestimated,” he said.

BOCA RATON, FLA. — Children and adolescents with attention-deficit hyperactivity disorder did not experience withdrawal or discontinuation syndrome after abrupt cessation of modafinil film-coated tablets in a phase III, double-blind, multicenter trial.

Researchers also found efficacy as early as 1 week in this 9-week study of 6- to 17-year-olds with attention-deficit hyperactivity disorder (ADHD). The Food and Drug Administration has approved modafinil (Provigil) for treatment of narcolepsy and is currently reviewing a special pediatric formulation for ADHD.

“This is not surprising. Modafinil is a medication that improves vigilance and alertness and could improve similar symptoms in ADHD,” Joseph Biederman, M.D., said in an interview at his poster presentation during a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Dr. Biederman and his associates compared efficacy using the school and home versions of the ADHD Rating Scale-IV, the Clinical Global Impression of Improvement (CGI-I) scores, and adverse event reporting by 125 patients taking the pediatric formulation of modafinil and 64 taking a placebo.

The modafinil group had significantly improved school rating total scores, compared with those of the placebo group at 1 week, an effect that was maintained through week 7. The final 2 weeks of the study was a washout phase. Mean reduction from baseline was 17 points with modafinil versus 8 points with placebo. Significant reductions in home rating total scores also were observed with modafinil at all visits, according to Dr. Biederman, chief of the joint program in pediatric psychopharmacology, Massachusetts General Hospital, Boston.

A significantly greater percentage of modafinil patients was rated as “much” or “very much” improved on the CGI-I (49%) than were placebo patients (25%).

Modafinil was abruptly discontinued in 37 patients. Abrupt cessation was not associated with symptom rebound, and no evidence of withdrawal or discontinuation syndrome was seen.

This and other phase III study results were submitted to the FDA in December 2004. “I don't see any reason why they wouldn't approve it,” said Dr. Biederman, who reported no affiliation with Cephalon Inc., the manufacturer and sponsor of the study.

BOCA RATON, FLA. — Children and adolescents with attention-deficit hyperactivity disorder did not experience withdrawal or discontinuation syndrome after abrupt cessation of modafinil film-coated tablets in a phase III, double-blind, multicenter trial.

Researchers also found efficacy as early as 1 week in this 9-week study of 6- to 17-year-olds with attention-deficit hyperactivity disorder (ADHD). The Food and Drug Administration has approved modafinil (Provigil) for treatment of narcolepsy and is currently reviewing a special pediatric formulation for ADHD.

“This is not surprising. Modafinil is a medication that improves vigilance and alertness and could improve similar symptoms in ADHD,” Joseph Biederman, M.D., said in an interview at his poster presentation during a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Dr. Biederman and his associates compared efficacy using the school and home versions of the ADHD Rating Scale-IV, the Clinical Global Impression of Improvement (CGI-I) scores, and adverse event reporting by 125 patients taking the pediatric formulation of modafinil and 64 taking a placebo.

The modafinil group had significantly improved school rating total scores, compared with those of the placebo group at 1 week, an effect that was maintained through week 7. The final 2 weeks of the study was a washout phase. Mean reduction from baseline was 17 points with modafinil versus 8 points with placebo. Significant reductions in home rating total scores also were observed with modafinil at all visits, according to Dr. Biederman, chief of the joint program in pediatric psychopharmacology, Massachusetts General Hospital, Boston.

A significantly greater percentage of modafinil patients was rated as “much” or “very much” improved on the CGI-I (49%) than were placebo patients (25%).

Modafinil was abruptly discontinued in 37 patients. Abrupt cessation was not associated with symptom rebound, and no evidence of withdrawal or discontinuation syndrome was seen.

This and other phase III study results were submitted to the FDA in December 2004. “I don't see any reason why they wouldn't approve it,” said Dr. Biederman, who reported no affiliation with Cephalon Inc., the manufacturer and sponsor of the study.

BOCA RATON, FLA. — Children and adolescents with attention-deficit hyperactivity disorder did not experience withdrawal or discontinuation syndrome after abrupt cessation of modafinil film-coated tablets in a phase III, double-blind, multicenter trial.

Researchers also found efficacy as early as 1 week in this 9-week study of 6- to 17-year-olds with attention-deficit hyperactivity disorder (ADHD). The Food and Drug Administration has approved modafinil (Provigil) for treatment of narcolepsy and is currently reviewing a special pediatric formulation for ADHD.

“This is not surprising. Modafinil is a medication that improves vigilance and alertness and could improve similar symptoms in ADHD,” Joseph Biederman, M.D., said in an interview at his poster presentation during a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Dr. Biederman and his associates compared efficacy using the school and home versions of the ADHD Rating Scale-IV, the Clinical Global Impression of Improvement (CGI-I) scores, and adverse event reporting by 125 patients taking the pediatric formulation of modafinil and 64 taking a placebo.

The modafinil group had significantly improved school rating total scores, compared with those of the placebo group at 1 week, an effect that was maintained through week 7. The final 2 weeks of the study was a washout phase. Mean reduction from baseline was 17 points with modafinil versus 8 points with placebo. Significant reductions in home rating total scores also were observed with modafinil at all visits, according to Dr. Biederman, chief of the joint program in pediatric psychopharmacology, Massachusetts General Hospital, Boston.

A significantly greater percentage of modafinil patients was rated as “much” or “very much” improved on the CGI-I (49%) than were placebo patients (25%).

Modafinil was abruptly discontinued in 37 patients. Abrupt cessation was not associated with symptom rebound, and no evidence of withdrawal or discontinuation syndrome was seen.

This and other phase III study results were submitted to the FDA in December 2004. “I don't see any reason why they wouldn't approve it,” said Dr. Biederman, who reported no affiliation with Cephalon Inc., the manufacturer and sponsor of the study.

BOCA RATON, FLA. — A combination of escitalopram and bupropion might produce early remission in as many as one-third of patients with unipolar depression, according to a pilot study presented at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

However, the faster onset of action and increased remission rate observed with this combination compared with monotherapy come at a cost of increased adverse events. “In my mind, the adverse events were manageable in most patients,” said Jonathan W. Stewart, M.D., a researcher with the depression evaluation service at Columbia University, New York.

Delays are inherent in a sequential monotherapy approach to antidepressant treatment. Mechanistic delays include the time it takes for biochemical effects to occur. Dosing delays occur as physicians wait for a patient to get better before increasing the dose. In addition, there are programmatic delays because “we wait to see if the first one does not work before we start the second drug,” he said.

Dr. Stewart assessed 29 outpatients with major depressive disorder. The mean age was 38 years, and the patients were moderately depressed at study entry. Exclusion criteria included a history of seizures, substance abuse/dependence, bipolar disorder, or current use of other psychoactive drugs.

“We decided to mix escitalopram [Lexapro] with bupropion [Wellbutrin]. This combination may address a mechanistic delay inherent in” treatment with selective serotonin reuptake inhibitors, Dr. Stewart said. He added that the use of two effective antidepressants might overcome programmatic delays.

There was a rapid dose escalation during the first 15 days, after which dosages were stabilized to day 56. Almost half of the patients, 49%, followed the protocol dosing, and 54% were on the maximum dosages at study completion at 8 weeks.

At 2 weeks, 10 of 29 patients (34%) met remission criteria—defined as a Hamilton Rating Scale for Depression (HAMD-17) score of less than 8. “So we're getting a third of the patients better at 2 weeks,” he noted. The mean score at 2 weeks was 11.

By comparison, there is a 6% remission rate with monotherapy at 2 weeks, according to Dr. Stewart's own unpublished data for more than 500 patients.

At 8 weeks, 18 patients (62%) met remission criteria, and the mean HAMD-17 score was 6. Dr. Stewart said that the remission rate with monotherapy in his own unpublished data is 38%.

A total of six patients withdrew from the study, four because of adverse events. The most common adverse events were sleep related (reported by 55% of participants), including daytime sedation and insomnia. A total of 38% reported gastrointestinal effects, including abdominal pain and constipation, and 24% reported sexual effects, including decreased libido and anorgasmia. Patients also reported word-finding difficulty, headaches, dizziness, hives, sweating, increased blood pressure, and dizziness.

Despite the early onset of action of an escitalopram (Lexapro) and bupropion combination, efficacy beyond 2 weeks looks similar to other combinations, Dr. Stewart said.

BOCA RATON, FLA. — A combination of escitalopram and bupropion might produce early remission in as many as one-third of patients with unipolar depression, according to a pilot study presented at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

However, the faster onset of action and increased remission rate observed with this combination compared with monotherapy come at a cost of increased adverse events. “In my mind, the adverse events were manageable in most patients,” said Jonathan W. Stewart, M.D., a researcher with the depression evaluation service at Columbia University, New York.

Delays are inherent in a sequential monotherapy approach to antidepressant treatment. Mechanistic delays include the time it takes for biochemical effects to occur. Dosing delays occur as physicians wait for a patient to get better before increasing the dose. In addition, there are programmatic delays because “we wait to see if the first one does not work before we start the second drug,” he said.

Dr. Stewart assessed 29 outpatients with major depressive disorder. The mean age was 38 years, and the patients were moderately depressed at study entry. Exclusion criteria included a history of seizures, substance abuse/dependence, bipolar disorder, or current use of other psychoactive drugs.

“We decided to mix escitalopram [Lexapro] with bupropion [Wellbutrin]. This combination may address a mechanistic delay inherent in” treatment with selective serotonin reuptake inhibitors, Dr. Stewart said. He added that the use of two effective antidepressants might overcome programmatic delays.

There was a rapid dose escalation during the first 15 days, after which dosages were stabilized to day 56. Almost half of the patients, 49%, followed the protocol dosing, and 54% were on the maximum dosages at study completion at 8 weeks.

At 2 weeks, 10 of 29 patients (34%) met remission criteria—defined as a Hamilton Rating Scale for Depression (HAMD-17) score of less than 8. “So we're getting a third of the patients better at 2 weeks,” he noted. The mean score at 2 weeks was 11.

By comparison, there is a 6% remission rate with monotherapy at 2 weeks, according to Dr. Stewart's own unpublished data for more than 500 patients.

At 8 weeks, 18 patients (62%) met remission criteria, and the mean HAMD-17 score was 6. Dr. Stewart said that the remission rate with monotherapy in his own unpublished data is 38%.

A total of six patients withdrew from the study, four because of adverse events. The most common adverse events were sleep related (reported by 55% of participants), including daytime sedation and insomnia. A total of 38% reported gastrointestinal effects, including abdominal pain and constipation, and 24% reported sexual effects, including decreased libido and anorgasmia. Patients also reported word-finding difficulty, headaches, dizziness, hives, sweating, increased blood pressure, and dizziness.

Despite the early onset of action of an escitalopram (Lexapro) and bupropion combination, efficacy beyond 2 weeks looks similar to other combinations, Dr. Stewart said.

BOCA RATON, FLA. — A combination of escitalopram and bupropion might produce early remission in as many as one-third of patients with unipolar depression, according to a pilot study presented at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

However, the faster onset of action and increased remission rate observed with this combination compared with monotherapy come at a cost of increased adverse events. “In my mind, the adverse events were manageable in most patients,” said Jonathan W. Stewart, M.D., a researcher with the depression evaluation service at Columbia University, New York.

Delays are inherent in a sequential monotherapy approach to antidepressant treatment. Mechanistic delays include the time it takes for biochemical effects to occur. Dosing delays occur as physicians wait for a patient to get better before increasing the dose. In addition, there are programmatic delays because “we wait to see if the first one does not work before we start the second drug,” he said.

Dr. Stewart assessed 29 outpatients with major depressive disorder. The mean age was 38 years, and the patients were moderately depressed at study entry. Exclusion criteria included a history of seizures, substance abuse/dependence, bipolar disorder, or current use of other psychoactive drugs.

“We decided to mix escitalopram [Lexapro] with bupropion [Wellbutrin]. This combination may address a mechanistic delay inherent in” treatment with selective serotonin reuptake inhibitors, Dr. Stewart said. He added that the use of two effective antidepressants might overcome programmatic delays.

There was a rapid dose escalation during the first 15 days, after which dosages were stabilized to day 56. Almost half of the patients, 49%, followed the protocol dosing, and 54% were on the maximum dosages at study completion at 8 weeks.

At 2 weeks, 10 of 29 patients (34%) met remission criteria—defined as a Hamilton Rating Scale for Depression (HAMD-17) score of less than 8. “So we're getting a third of the patients better at 2 weeks,” he noted. The mean score at 2 weeks was 11.

By comparison, there is a 6% remission rate with monotherapy at 2 weeks, according to Dr. Stewart's own unpublished data for more than 500 patients.

At 8 weeks, 18 patients (62%) met remission criteria, and the mean HAMD-17 score was 6. Dr. Stewart said that the remission rate with monotherapy in his own unpublished data is 38%.

A total of six patients withdrew from the study, four because of adverse events. The most common adverse events were sleep related (reported by 55% of participants), including daytime sedation and insomnia. A total of 38% reported gastrointestinal effects, including abdominal pain and constipation, and 24% reported sexual effects, including decreased libido and anorgasmia. Patients also reported word-finding difficulty, headaches, dizziness, hives, sweating, increased blood pressure, and dizziness.

Despite the early onset of action of an escitalopram (Lexapro) and bupropion combination, efficacy beyond 2 weeks looks similar to other combinations, Dr. Stewart said.

BAL HARBOUR, FLA. – Cognition declines in the years after a single stroke for a substantial minority of patients, according to a study presented at the annual meeting of the American Neuropsychiatric Association.

After the initial poststroke period, most experts would expect cognition to improve or remain static, according to the literature. However, some studies with a longer follow-up now suggest cognitive decline is possible after a single stroke, even in younger patients. The current research supports that finding and shows the utility of screening patients with the Mini Mental State Examination (MMSE).

The cognitive impairment due to stroke is not static. “Our findings suggest there is a subpopulation that continues to decline as they age,” Gregory Kellermeyer, M.D., said in an interview.

The investigators assessed 16 men and 10 women at least 1 year following a single known stroke. The mean follow-up was almost 6 years. Participants were relatively young with a mean age of 58 years. Pretreatment data for the stroke survivors came from a study of constraint-induced movement therapy for upper extremity motor impairment. Cognitive deficits can occur independent of motor decline. The implication is that “even a single stroke may in some persons incite a progressive neurodegenerative process that preferentially affects cognition,” the investigators wrote.

There was possible cognitive impairment in 6 of 27 participants (22%) and definite cognitive impairment in 2 of 27 (7%). Possible cognitive impairment was defined as a greater than 1 standard deviation on the adjusted MMSE; definite cognitive impairment was defined as greater than 2 standard deviations. “The Mini Mental State Examination is a possible way to identify this subpopulation,” said Dr. Kellermeyer, a fourth-year resident in psychiatry at the University of Colorado, Denver.

Patient age alone, gender, handedness, stroke laterality, and severity of motor impairments were not significantly associated with raw or adjusted MMSE results. These MMSE scores were inversely related to time since the stroke.

BAL HARBOUR, FLA. – Cognition declines in the years after a single stroke for a substantial minority of patients, according to a study presented at the annual meeting of the American Neuropsychiatric Association.

After the initial poststroke period, most experts would expect cognition to improve or remain static, according to the literature. However, some studies with a longer follow-up now suggest cognitive decline is possible after a single stroke, even in younger patients. The current research supports that finding and shows the utility of screening patients with the Mini Mental State Examination (MMSE).

The cognitive impairment due to stroke is not static. “Our findings suggest there is a subpopulation that continues to decline as they age,” Gregory Kellermeyer, M.D., said in an interview.

The investigators assessed 16 men and 10 women at least 1 year following a single known stroke. The mean follow-up was almost 6 years. Participants were relatively young with a mean age of 58 years. Pretreatment data for the stroke survivors came from a study of constraint-induced movement therapy for upper extremity motor impairment. Cognitive deficits can occur independent of motor decline. The implication is that “even a single stroke may in some persons incite a progressive neurodegenerative process that preferentially affects cognition,” the investigators wrote.

There was possible cognitive impairment in 6 of 27 participants (22%) and definite cognitive impairment in 2 of 27 (7%). Possible cognitive impairment was defined as a greater than 1 standard deviation on the adjusted MMSE; definite cognitive impairment was defined as greater than 2 standard deviations. “The Mini Mental State Examination is a possible way to identify this subpopulation,” said Dr. Kellermeyer, a fourth-year resident in psychiatry at the University of Colorado, Denver.

Patient age alone, gender, handedness, stroke laterality, and severity of motor impairments were not significantly associated with raw or adjusted MMSE results. These MMSE scores were inversely related to time since the stroke.

BAL HARBOUR, FLA. – Cognition declines in the years after a single stroke for a substantial minority of patients, according to a study presented at the annual meeting of the American Neuropsychiatric Association.

After the initial poststroke period, most experts would expect cognition to improve or remain static, according to the literature. However, some studies with a longer follow-up now suggest cognitive decline is possible after a single stroke, even in younger patients. The current research supports that finding and shows the utility of screening patients with the Mini Mental State Examination (MMSE).

The cognitive impairment due to stroke is not static. “Our findings suggest there is a subpopulation that continues to decline as they age,” Gregory Kellermeyer, M.D., said in an interview.

The investigators assessed 16 men and 10 women at least 1 year following a single known stroke. The mean follow-up was almost 6 years. Participants were relatively young with a mean age of 58 years. Pretreatment data for the stroke survivors came from a study of constraint-induced movement therapy for upper extremity motor impairment. Cognitive deficits can occur independent of motor decline. The implication is that “even a single stroke may in some persons incite a progressive neurodegenerative process that preferentially affects cognition,” the investigators wrote.

There was possible cognitive impairment in 6 of 27 participants (22%) and definite cognitive impairment in 2 of 27 (7%). Possible cognitive impairment was defined as a greater than 1 standard deviation on the adjusted MMSE; definite cognitive impairment was defined as greater than 2 standard deviations. “The Mini Mental State Examination is a possible way to identify this subpopulation,” said Dr. Kellermeyer, a fourth-year resident in psychiatry at the University of Colorado, Denver.

Patient age alone, gender, handedness, stroke laterality, and severity of motor impairments were not significantly associated with raw or adjusted MMSE results. These MMSE scores were inversely related to time since the stroke.

The Food and Drug Administration approved a new pediatric indication for an antiepileptic drug as adjunctive treatment of partial-onset seizures in patients 4 years of age and older.

Levetiracetam (Keppra, UCB Pharma Inc.) effectively reduced seizure frequency in this population, judging from findings from a double-blind, multicenter study. The FDA considered data from the study during its priority review for the new indication.

Investigators randomized 101 patients to levetiracetam and 97 to placebo. Children taking levetiracetam for 14 weeks experienced a 27% reduction in weekly partial seizure frequency, compared with no reduction in children taking placebo. All participants were 4–16 years old, with refractory partial-onset seizures.

The initial daily dose for pediatric patients 4–15 years old is 20 mg/kg, given as twice-daily dosing (10 mg/kg b.i.d.). Increase the daily dose every 2 weeks by 20-mg/kg increments to the recommended daily dose of 60 mg/kg (30 mg/kg b.i.d.). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced, according to the package insert.

Although other agents are approved for pediatric seizure control, the levetiracetam study is the first to include only treatment-resistant seizures, according to Tracy A. Glauser, M.D., lead author of the study (in press). He added that about 30% of children do not achieve adequate seizure control with existing drugs, which include oxcarbazepine (Trileptal), lamotrigine (Lamictal), gabapentin (Neurontin), and topiramate (Topamax).

Partial-onset seizures account for approximately two-thirds of epilepsy among 4- to 16-year-old children.

FDA approval “allows neurologists and pediatricians who treat children with partial seizures to know it is efficacious and well tolerated. It validates its use in children,” said Dr. Glauser, of Cincinnati Children's Hospital Medical Center.

Somnolence, fatigue, and behavioral abnormalities (including agitation, anxiety, and apathy) were associated with levetiracetam use in the study.

Keppra has been approved for use in U.S. adults since 1999. Dr. Glauser is a consultant for UCB Pharma.

The Food and Drug Administration approved a new pediatric indication for an antiepileptic drug as adjunctive treatment of partial-onset seizures in patients 4 years of age and older.

Levetiracetam (Keppra, UCB Pharma Inc.) effectively reduced seizure frequency in this population, judging from findings from a double-blind, multicenter study. The FDA considered data from the study during its priority review for the new indication.

Investigators randomized 101 patients to levetiracetam and 97 to placebo. Children taking levetiracetam for 14 weeks experienced a 27% reduction in weekly partial seizure frequency, compared with no reduction in children taking placebo. All participants were 4–16 years old, with refractory partial-onset seizures.

The initial daily dose for pediatric patients 4–15 years old is 20 mg/kg, given as twice-daily dosing (10 mg/kg b.i.d.). Increase the daily dose every 2 weeks by 20-mg/kg increments to the recommended daily dose of 60 mg/kg (30 mg/kg b.i.d.). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced, according to the package insert.

Although other agents are approved for pediatric seizure control, the levetiracetam study is the first to include only treatment-resistant seizures, according to Tracy A. Glauser, M.D., lead author of the study (in press). He added that about 30% of children do not achieve adequate seizure control with existing drugs, which include oxcarbazepine (Trileptal), lamotrigine (Lamictal), gabapentin (Neurontin), and topiramate (Topamax).

Partial-onset seizures account for approximately two-thirds of epilepsy among 4- to 16-year-old children.

FDA approval “allows neurologists and pediatricians who treat children with partial seizures to know it is efficacious and well tolerated. It validates its use in children,” said Dr. Glauser, of Cincinnati Children's Hospital Medical Center.

Somnolence, fatigue, and behavioral abnormalities (including agitation, anxiety, and apathy) were associated with levetiracetam use in the study.

Keppra has been approved for use in U.S. adults since 1999. Dr. Glauser is a consultant for UCB Pharma.

The Food and Drug Administration approved a new pediatric indication for an antiepileptic drug as adjunctive treatment of partial-onset seizures in patients 4 years of age and older.

Levetiracetam (Keppra, UCB Pharma Inc.) effectively reduced seizure frequency in this population, judging from findings from a double-blind, multicenter study. The FDA considered data from the study during its priority review for the new indication.

Investigators randomized 101 patients to levetiracetam and 97 to placebo. Children taking levetiracetam for 14 weeks experienced a 27% reduction in weekly partial seizure frequency, compared with no reduction in children taking placebo. All participants were 4–16 years old, with refractory partial-onset seizures.

The initial daily dose for pediatric patients 4–15 years old is 20 mg/kg, given as twice-daily dosing (10 mg/kg b.i.d.). Increase the daily dose every 2 weeks by 20-mg/kg increments to the recommended daily dose of 60 mg/kg (30 mg/kg b.i.d.). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced, according to the package insert.

Although other agents are approved for pediatric seizure control, the levetiracetam study is the first to include only treatment-resistant seizures, according to Tracy A. Glauser, M.D., lead author of the study (in press). He added that about 30% of children do not achieve adequate seizure control with existing drugs, which include oxcarbazepine (Trileptal), lamotrigine (Lamictal), gabapentin (Neurontin), and topiramate (Topamax).

Partial-onset seizures account for approximately two-thirds of epilepsy among 4- to 16-year-old children.

FDA approval “allows neurologists and pediatricians who treat children with partial seizures to know it is efficacious and well tolerated. It validates its use in children,” said Dr. Glauser, of Cincinnati Children's Hospital Medical Center.

Somnolence, fatigue, and behavioral abnormalities (including agitation, anxiety, and apathy) were associated with levetiracetam use in the study.

Keppra has been approved for use in U.S. adults since 1999. Dr. Glauser is a consultant for UCB Pharma.

ORLANDO — Body mass index alone is not a good indicator of cardiovascular risk in the morbidly obese and should be supplemented with body habitus measures for screening bariatric surgery candidates, Edward H. Livingston, M.D., said at the annual meeting of the American Society for Bariatric Surgery.

“We rely on BMI as the basis of all bariatric surgery criteria. BMI is thought to correlate to morbidity, but the relationship is not perfect,” said Dr. Livingston, professor of surgery at the University of Texas, Dallas.

In an effort to go beyond BMI, he and his associates looked at several body habitus measures in 7,634 healthy volunteers who participated in the third National Health and Nutrition Examination Survey (NHANES III).

All of the subjects were at least 18 years of age. Overall, the study population was 53% female, and the ethnic breakdown was 41% white, 28% black, 27% Hispanic, and 4% other.

The body habitus measures examined were subcutaneous skinfold thickness, waist circumference, waist-to-hip ratio, and waist-to-thigh ratio.

The research team analyzed the contribution of these measures to insulin resistance and diabetes mellitus, two important factors underlying cardiovascular disease. The measures were analyzed according to gender.

The investigators found significant correlations between all the body measures and both insulin resistance and diabetes mellitus, except for suprailiac skinfold thickness and development of diabetes in men, Dr. Livingston said.

Interestingly, thigh skinfold thickness was a strong negative predictor for the development of obesity and diabetes mellitus (0.31 odds ratio for diabetes among women and 0.38 among men), Dr. Livingston reported. This suggests that accumulation of fat in the lower body protects against insulin resistance and diabetes mellitus, he noted.

Surprisingly, the study indicated that cardiovascular risk profiles actually improved for some people with a BMI over 35 kg/m

“If we are operating on the basis of BMI, we are operating on the wrong people,” he commented.

“I operate on a large number of patients, and I'm surprised at the small number of cardiovascular complications I see. You would expect to see more cardiovascular disease in the population we treat,” Dr. Livingston noted. “One reason people get really huge is an unlimited ability to store subcutaneous fat from the food they take in. It may not mean they have an elevated cardiovascular risk.”

In response to a meeting attendee's question, Dr. Livingston further explained that “the relationship of central obesity to cardiovascular risk factors has been overstated. A number of studies show cardiovascular disease is a function of total upper body fat and not visceral fat.”

The heterogenicity of body fat distribution among obese patients may explain the discrepancy in findings among different studies that have linked BMI to mortality, Dr. Livingston said.

Since 1991, the National Institutes of Health has recommended bariatric surgery for appropriate candidates with a body mass index of 40 or greater. The NIH consensus statement addressed concerns about increased mortality in this patient population.

Although cardiovascular disease is the leading cause of death in the morbidly obese, the relationship to BMI is not direct, Dr. Livingston said.

The results of the study suggest that body habitus measurements should be incorporated into routine screening of candidates for bariatric surgery, Dr. Livingston explained.

ORLANDO — Body mass index alone is not a good indicator of cardiovascular risk in the morbidly obese and should be supplemented with body habitus measures for screening bariatric surgery candidates, Edward H. Livingston, M.D., said at the annual meeting of the American Society for Bariatric Surgery.

“We rely on BMI as the basis of all bariatric surgery criteria. BMI is thought to correlate to morbidity, but the relationship is not perfect,” said Dr. Livingston, professor of surgery at the University of Texas, Dallas.

In an effort to go beyond BMI, he and his associates looked at several body habitus measures in 7,634 healthy volunteers who participated in the third National Health and Nutrition Examination Survey (NHANES III).

All of the subjects were at least 18 years of age. Overall, the study population was 53% female, and the ethnic breakdown was 41% white, 28% black, 27% Hispanic, and 4% other.

The body habitus measures examined were subcutaneous skinfold thickness, waist circumference, waist-to-hip ratio, and waist-to-thigh ratio.

The research team analyzed the contribution of these measures to insulin resistance and diabetes mellitus, two important factors underlying cardiovascular disease. The measures were analyzed according to gender.

The investigators found significant correlations between all the body measures and both insulin resistance and diabetes mellitus, except for suprailiac skinfold thickness and development of diabetes in men, Dr. Livingston said.

Interestingly, thigh skinfold thickness was a strong negative predictor for the development of obesity and diabetes mellitus (0.31 odds ratio for diabetes among women and 0.38 among men), Dr. Livingston reported. This suggests that accumulation of fat in the lower body protects against insulin resistance and diabetes mellitus, he noted.

Surprisingly, the study indicated that cardiovascular risk profiles actually improved for some people with a BMI over 35 kg/m

“If we are operating on the basis of BMI, we are operating on the wrong people,” he commented.

“I operate on a large number of patients, and I'm surprised at the small number of cardiovascular complications I see. You would expect to see more cardiovascular disease in the population we treat,” Dr. Livingston noted. “One reason people get really huge is an unlimited ability to store subcutaneous fat from the food they take in. It may not mean they have an elevated cardiovascular risk.”

In response to a meeting attendee's question, Dr. Livingston further explained that “the relationship of central obesity to cardiovascular risk factors has been overstated. A number of studies show cardiovascular disease is a function of total upper body fat and not visceral fat.”

The heterogenicity of body fat distribution among obese patients may explain the discrepancy in findings among different studies that have linked BMI to mortality, Dr. Livingston said.

Since 1991, the National Institutes of Health has recommended bariatric surgery for appropriate candidates with a body mass index of 40 or greater. The NIH consensus statement addressed concerns about increased mortality in this patient population.

Although cardiovascular disease is the leading cause of death in the morbidly obese, the relationship to BMI is not direct, Dr. Livingston said.

The results of the study suggest that body habitus measurements should be incorporated into routine screening of candidates for bariatric surgery, Dr. Livingston explained.

ORLANDO — Body mass index alone is not a good indicator of cardiovascular risk in the morbidly obese and should be supplemented with body habitus measures for screening bariatric surgery candidates, Edward H. Livingston, M.D., said at the annual meeting of the American Society for Bariatric Surgery.

“We rely on BMI as the basis of all bariatric surgery criteria. BMI is thought to correlate to morbidity, but the relationship is not perfect,” said Dr. Livingston, professor of surgery at the University of Texas, Dallas.

In an effort to go beyond BMI, he and his associates looked at several body habitus measures in 7,634 healthy volunteers who participated in the third National Health and Nutrition Examination Survey (NHANES III).

All of the subjects were at least 18 years of age. Overall, the study population was 53% female, and the ethnic breakdown was 41% white, 28% black, 27% Hispanic, and 4% other.

The body habitus measures examined were subcutaneous skinfold thickness, waist circumference, waist-to-hip ratio, and waist-to-thigh ratio.

The research team analyzed the contribution of these measures to insulin resistance and diabetes mellitus, two important factors underlying cardiovascular disease. The measures were analyzed according to gender.

The investigators found significant correlations between all the body measures and both insulin resistance and diabetes mellitus, except for suprailiac skinfold thickness and development of diabetes in men, Dr. Livingston said.

Interestingly, thigh skinfold thickness was a strong negative predictor for the development of obesity and diabetes mellitus (0.31 odds ratio for diabetes among women and 0.38 among men), Dr. Livingston reported. This suggests that accumulation of fat in the lower body protects against insulin resistance and diabetes mellitus, he noted.

Surprisingly, the study indicated that cardiovascular risk profiles actually improved for some people with a BMI over 35 kg/m

“If we are operating on the basis of BMI, we are operating on the wrong people,” he commented.

“I operate on a large number of patients, and I'm surprised at the small number of cardiovascular complications I see. You would expect to see more cardiovascular disease in the population we treat,” Dr. Livingston noted. “One reason people get really huge is an unlimited ability to store subcutaneous fat from the food they take in. It may not mean they have an elevated cardiovascular risk.”

In response to a meeting attendee's question, Dr. Livingston further explained that “the relationship of central obesity to cardiovascular risk factors has been overstated. A number of studies show cardiovascular disease is a function of total upper body fat and not visceral fat.”

The heterogenicity of body fat distribution among obese patients may explain the discrepancy in findings among different studies that have linked BMI to mortality, Dr. Livingston said.

Since 1991, the National Institutes of Health has recommended bariatric surgery for appropriate candidates with a body mass index of 40 or greater. The NIH consensus statement addressed concerns about increased mortality in this patient population.

Although cardiovascular disease is the leading cause of death in the morbidly obese, the relationship to BMI is not direct, Dr. Livingston said.

The results of the study suggest that body habitus measurements should be incorporated into routine screening of candidates for bariatric surgery, Dr. Livingston explained.

ORLANDO — The clinical benefits of gastric bypass surgery go beyond weight loss and include lowering the risk of coronary artery disease, according to the results of a study presented by D. Brandon Williams, M.D., at the annual meeting of the American Society for Bariatric Surgery.

Obesity is among the major risk factors for coronary heart disease and stroke, and that risk may be particularly high among the morbidly obese, Dr. Williams said.

In a prospective study, Dr. Williams and coinvestigators monitored 8 markers of cardiovascular risk in 222 morbidly obese patients before and after gastric bypass surgery.

The markers—which included both traditional and emerging biochemical measurements—improved up to 1 year after surgery, compared with preoperative values, said Dr. Williams, a surgery resident at Stanford University Medical Center in Palo Alto, Calif. Gastric bypass is the most common form of weight loss surgery at Stanford.

All participants had Roux-en-Y gastric bypass surgery; 99% of the procedures were laparoscopic. The mean age of the patients was 43 years, and 84% were female.

At baseline, 31% of the subjects were diabetic, 50% were hypertensive, and 18% were taking lipid-lowering medication.

“Patients had a high percentage of elevated risk factors,” Dr. Williams said. Only 1% had known coronary artery disease at enrollment.

Researchers measured traditional laboratory values, including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol, at 3 months and 6 months after surgery.

But “our markers are not perfect,” Dr. Williams said. Therefore, they also assessed three emerging markers: lipoprotein (a), homocysteine, and C-reactive protein.

Total cholesterol lipids initially decreased from a mean 201 mg/dL preoperatively to 168 at 3 months and then slightly increased to 169 at 6 months after surgery.

Triglycerides decreased from a mean 188 mg/dL to 129 at 3 months and 119 at 6 months.

LDL cholesterol was a mean 181 mg/dL preoperatively and decreased to 112 at 3 months and 102 at 6 months.

HDL cholesterol initially dropped after surgery but then improved, Dr. Williams reported. From a baseline mean of 47 mg/dL, HDL decreased to 42 at 3 months but increased to 49 at 6 months.

Researchers observed similar improvements in the other risk factors.

For example, from a preoperative value of 36 mg/L, lipoprotein (a) changed to 25 at 3 months and 30 at 6 months. From a baseline mean of 10.8 mmol/L, homocysteine decreased to 9.9 at 3 months and 9.5 at 6 months.

The eighth indicator of risk was body mass index.

The mean body mass index was 47 kg/m

Although all the markers improved postoperatively, there was “a dramatic improvement” in C-reactive protein (CRP) over time, Dr. Williams said. From a preoperative mean value of 10.7 mg/L, CRP decreased to 8.1 at 3 months and 4.2 at 6 months. A growing number of studies indicate that abnormally high levels of CRP and some other blood proteins indicate elevated cardiovascular disease risk. “Even with low total cholesterol, CRP remains a strong cardiovascular risk factor,” Dr. Williams said.

CRP is the strongest of the biochemical risk factors, he added, followed by the total cholesterol/HDL ratio. “Combined, these two are even stronger.”

A total of 80% of participants had abnormal CRP values preoperatively, indicating that the morbidly obese are extremely vulnerable to cardiac disease, according to John Morton, M.D., senior author of the study and director of bariatric surgery at Stanford. “The new risk factors, in particular C-reactive protein, have been shown to add substantially to risk assessment,” Dr. Williams added. “About half of strokes and myocardial infarctions occur in people with normal LDL, so C-reactive protein adds to the risk assessment.”

Lipoprotein (a) is helpful because it does not simply mirror the lipid profile, he explained. Similar in structure to LDL cholesterol, lipoprotein (a) is involved in atherothrombosis, a risk factor for premature coronary artery disease.

Homocysteine measurements are useful because homocysteine is prothrombotic and an independent predictor of coronary artery disease.

A meeting attendee asked Dr. Williams if he found a correlation between the magnitude of individual weight loss and improvement in risk factors. “There was a correlation, but it was somewhat low, implying there are other factors involved,” he replied. “For example, diet and exercise can improve C-reactive protein.”

Although other weight loss strategies could lower cardiovascular risk, “the only effective and enduring long-term therapy for obesity is bariatric surgery,” Dr. Williams said. Obesity and smoking are the primary modifiable coronary artery disease risk factors, he added. “Smoking has decreased, but obesity is on the rise.”

The study was completed in March 2005 to include a total of 371 participants and up to 12 months of follow-up data. Updated findings still demonstrated improvements in all eight risk factors after gastric bypass surgery, Dr. Williams commented.

ORLANDO — The clinical benefits of gastric bypass surgery go beyond weight loss and include lowering the risk of coronary artery disease, according to the results of a study presented by D. Brandon Williams, M.D., at the annual meeting of the American Society for Bariatric Surgery.

Obesity is among the major risk factors for coronary heart disease and stroke, and that risk may be particularly high among the morbidly obese, Dr. Williams said.

In a prospective study, Dr. Williams and coinvestigators monitored 8 markers of cardiovascular risk in 222 morbidly obese patients before and after gastric bypass surgery.

The markers—which included both traditional and emerging biochemical measurements—improved up to 1 year after surgery, compared with preoperative values, said Dr. Williams, a surgery resident at Stanford University Medical Center in Palo Alto, Calif. Gastric bypass is the most common form of weight loss surgery at Stanford.

All participants had Roux-en-Y gastric bypass surgery; 99% of the procedures were laparoscopic. The mean age of the patients was 43 years, and 84% were female.

At baseline, 31% of the subjects were diabetic, 50% were hypertensive, and 18% were taking lipid-lowering medication.

“Patients had a high percentage of elevated risk factors,” Dr. Williams said. Only 1% had known coronary artery disease at enrollment.

Researchers measured traditional laboratory values, including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol, at 3 months and 6 months after surgery.

But “our markers are not perfect,” Dr. Williams said. Therefore, they also assessed three emerging markers: lipoprotein (a), homocysteine, and C-reactive protein.

Total cholesterol lipids initially decreased from a mean 201 mg/dL preoperatively to 168 at 3 months and then slightly increased to 169 at 6 months after surgery.

Triglycerides decreased from a mean 188 mg/dL to 129 at 3 months and 119 at 6 months.

LDL cholesterol was a mean 181 mg/dL preoperatively and decreased to 112 at 3 months and 102 at 6 months.

HDL cholesterol initially dropped after surgery but then improved, Dr. Williams reported. From a baseline mean of 47 mg/dL, HDL decreased to 42 at 3 months but increased to 49 at 6 months.

Researchers observed similar improvements in the other risk factors.

For example, from a preoperative value of 36 mg/L, lipoprotein (a) changed to 25 at 3 months and 30 at 6 months. From a baseline mean of 10.8 mmol/L, homocysteine decreased to 9.9 at 3 months and 9.5 at 6 months.

The eighth indicator of risk was body mass index.

The mean body mass index was 47 kg/m

Although all the markers improved postoperatively, there was “a dramatic improvement” in C-reactive protein (CRP) over time, Dr. Williams said. From a preoperative mean value of 10.7 mg/L, CRP decreased to 8.1 at 3 months and 4.2 at 6 months. A growing number of studies indicate that abnormally high levels of CRP and some other blood proteins indicate elevated cardiovascular disease risk. “Even with low total cholesterol, CRP remains a strong cardiovascular risk factor,” Dr. Williams said.

CRP is the strongest of the biochemical risk factors, he added, followed by the total cholesterol/HDL ratio. “Combined, these two are even stronger.”

A total of 80% of participants had abnormal CRP values preoperatively, indicating that the morbidly obese are extremely vulnerable to cardiac disease, according to John Morton, M.D., senior author of the study and director of bariatric surgery at Stanford. “The new risk factors, in particular C-reactive protein, have been shown to add substantially to risk assessment,” Dr. Williams added. “About half of strokes and myocardial infarctions occur in people with normal LDL, so C-reactive protein adds to the risk assessment.”

Lipoprotein (a) is helpful because it does not simply mirror the lipid profile, he explained. Similar in structure to LDL cholesterol, lipoprotein (a) is involved in atherothrombosis, a risk factor for premature coronary artery disease.

Homocysteine measurements are useful because homocysteine is prothrombotic and an independent predictor of coronary artery disease.

A meeting attendee asked Dr. Williams if he found a correlation between the magnitude of individual weight loss and improvement in risk factors. “There was a correlation, but it was somewhat low, implying there are other factors involved,” he replied. “For example, diet and exercise can improve C-reactive protein.”

Although other weight loss strategies could lower cardiovascular risk, “the only effective and enduring long-term therapy for obesity is bariatric surgery,” Dr. Williams said. Obesity and smoking are the primary modifiable coronary artery disease risk factors, he added. “Smoking has decreased, but obesity is on the rise.”

The study was completed in March 2005 to include a total of 371 participants and up to 12 months of follow-up data. Updated findings still demonstrated improvements in all eight risk factors after gastric bypass surgery, Dr. Williams commented.

ORLANDO — The clinical benefits of gastric bypass surgery go beyond weight loss and include lowering the risk of coronary artery disease, according to the results of a study presented by D. Brandon Williams, M.D., at the annual meeting of the American Society for Bariatric Surgery.

Obesity is among the major risk factors for coronary heart disease and stroke, and that risk may be particularly high among the morbidly obese, Dr. Williams said.

In a prospective study, Dr. Williams and coinvestigators monitored 8 markers of cardiovascular risk in 222 morbidly obese patients before and after gastric bypass surgery.

The markers—which included both traditional and emerging biochemical measurements—improved up to 1 year after surgery, compared with preoperative values, said Dr. Williams, a surgery resident at Stanford University Medical Center in Palo Alto, Calif. Gastric bypass is the most common form of weight loss surgery at Stanford.

All participants had Roux-en-Y gastric bypass surgery; 99% of the procedures were laparoscopic. The mean age of the patients was 43 years, and 84% were female.

At baseline, 31% of the subjects were diabetic, 50% were hypertensive, and 18% were taking lipid-lowering medication.

“Patients had a high percentage of elevated risk factors,” Dr. Williams said. Only 1% had known coronary artery disease at enrollment.

Researchers measured traditional laboratory values, including total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol, at 3 months and 6 months after surgery.

But “our markers are not perfect,” Dr. Williams said. Therefore, they also assessed three emerging markers: lipoprotein (a), homocysteine, and C-reactive protein.

Total cholesterol lipids initially decreased from a mean 201 mg/dL preoperatively to 168 at 3 months and then slightly increased to 169 at 6 months after surgery.

Triglycerides decreased from a mean 188 mg/dL to 129 at 3 months and 119 at 6 months.

LDL cholesterol was a mean 181 mg/dL preoperatively and decreased to 112 at 3 months and 102 at 6 months.

HDL cholesterol initially dropped after surgery but then improved, Dr. Williams reported. From a baseline mean of 47 mg/dL, HDL decreased to 42 at 3 months but increased to 49 at 6 months.

Researchers observed similar improvements in the other risk factors.

For example, from a preoperative value of 36 mg/L, lipoprotein (a) changed to 25 at 3 months and 30 at 6 months. From a baseline mean of 10.8 mmol/L, homocysteine decreased to 9.9 at 3 months and 9.5 at 6 months.

The eighth indicator of risk was body mass index.

The mean body mass index was 47 kg/m

Although all the markers improved postoperatively, there was “a dramatic improvement” in C-reactive protein (CRP) over time, Dr. Williams said. From a preoperative mean value of 10.7 mg/L, CRP decreased to 8.1 at 3 months and 4.2 at 6 months. A growing number of studies indicate that abnormally high levels of CRP and some other blood proteins indicate elevated cardiovascular disease risk. “Even with low total cholesterol, CRP remains a strong cardiovascular risk factor,” Dr. Williams said.

CRP is the strongest of the biochemical risk factors, he added, followed by the total cholesterol/HDL ratio. “Combined, these two are even stronger.”

A total of 80% of participants had abnormal CRP values preoperatively, indicating that the morbidly obese are extremely vulnerable to cardiac disease, according to John Morton, M.D., senior author of the study and director of bariatric surgery at Stanford. “The new risk factors, in particular C-reactive protein, have been shown to add substantially to risk assessment,” Dr. Williams added. “About half of strokes and myocardial infarctions occur in people with normal LDL, so C-reactive protein adds to the risk assessment.”

Lipoprotein (a) is helpful because it does not simply mirror the lipid profile, he explained. Similar in structure to LDL cholesterol, lipoprotein (a) is involved in atherothrombosis, a risk factor for premature coronary artery disease.

Homocysteine measurements are useful because homocysteine is prothrombotic and an independent predictor of coronary artery disease.

A meeting attendee asked Dr. Williams if he found a correlation between the magnitude of individual weight loss and improvement in risk factors. “There was a correlation, but it was somewhat low, implying there are other factors involved,” he replied. “For example, diet and exercise can improve C-reactive protein.”

Although other weight loss strategies could lower cardiovascular risk, “the only effective and enduring long-term therapy for obesity is bariatric surgery,” Dr. Williams said. Obesity and smoking are the primary modifiable coronary artery disease risk factors, he added. “Smoking has decreased, but obesity is on the rise.”

The study was completed in March 2005 to include a total of 371 participants and up to 12 months of follow-up data. Updated findings still demonstrated improvements in all eight risk factors after gastric bypass surgery, Dr. Williams commented.

NEW ORLEANS — Older parents and those with private insurance were more likely to miss well child visits, according to a study in a family practice clinic that treats both parents and children, Dwenda Gjerdingen, M.D., said at the annual conference of the Society of Teachers of Family Medicine.

Children younger than 18 years comprise one-fifth of all visits to primary care physicians. Well child visits are the sixth most common reason for seeing a family physician, and the No. 1 reason for seeing a pediatrician.

“Despite their importance, many well child visits are missed,” said Dr. Gjerdingen, professor in the department of family medicine and community health at the University of Minnesota, Minneapolis.

Dr. Gjerdingen and her associates conducted a telephone survey of parents at the university's Bethesda Clinic in St. Paul who missed an appointment between January and December 2002. Respondents were 90% female, 61% married, and 50% employed. Fifty-seven percent were insured through public assistance. Mean age of parents was 26 years and mean age of children was 5.4 months. Parents were 65% Southeast Asian, 15% African American, 14% white, and 6% other. Almost half (48%) had less than a 12th-grade education; 86% kept well child visits. Among the 14% who were noncompliant, “I forgot” was the No. 1 reason cited. Most parents, 77%, said they like telephone reminders.

All respondents said they believed well child visits are important, citing vaccinations as the No. 1 reason. Therefore, Dr. Gjerdingen said, “We can use that for encouraging parents to come to visits.”

A minority of parents, 20%, said they were “often” or “always” stressed. Financial or employment concerns were most often cited.

Contrary to other compliance studies, younger parents were more likely to keep visits, Dr. Gjerdingen found. “I was surprised by age, that the older they were the more likely they were to miss the appointment,” she said.

Another unexpected finding was parents with private insurance were more likely to miss appointments compared with those who had public insurance. “I was wondering if it was a copay differential,” she said.

Small sample size and single center setting were limitations of the study.

NEW ORLEANS — Older parents and those with private insurance were more likely to miss well child visits, according to a study in a family practice clinic that treats both parents and children, Dwenda Gjerdingen, M.D., said at the annual conference of the Society of Teachers of Family Medicine.

Children younger than 18 years comprise one-fifth of all visits to primary care physicians. Well child visits are the sixth most common reason for seeing a family physician, and the No. 1 reason for seeing a pediatrician.

“Despite their importance, many well child visits are missed,” said Dr. Gjerdingen, professor in the department of family medicine and community health at the University of Minnesota, Minneapolis.

Dr. Gjerdingen and her associates conducted a telephone survey of parents at the university's Bethesda Clinic in St. Paul who missed an appointment between January and December 2002. Respondents were 90% female, 61% married, and 50% employed. Fifty-seven percent were insured through public assistance. Mean age of parents was 26 years and mean age of children was 5.4 months. Parents were 65% Southeast Asian, 15% African American, 14% white, and 6% other. Almost half (48%) had less than a 12th-grade education; 86% kept well child visits. Among the 14% who were noncompliant, “I forgot” was the No. 1 reason cited. Most parents, 77%, said they like telephone reminders.

All respondents said they believed well child visits are important, citing vaccinations as the No. 1 reason. Therefore, Dr. Gjerdingen said, “We can use that for encouraging parents to come to visits.”

A minority of parents, 20%, said they were “often” or “always” stressed. Financial or employment concerns were most often cited.

Contrary to other compliance studies, younger parents were more likely to keep visits, Dr. Gjerdingen found. “I was surprised by age, that the older they were the more likely they were to miss the appointment,” she said.

Another unexpected finding was parents with private insurance were more likely to miss appointments compared with those who had public insurance. “I was wondering if it was a copay differential,” she said.

Small sample size and single center setting were limitations of the study.

NEW ORLEANS — Older parents and those with private insurance were more likely to miss well child visits, according to a study in a family practice clinic that treats both parents and children, Dwenda Gjerdingen, M.D., said at the annual conference of the Society of Teachers of Family Medicine.

Children younger than 18 years comprise one-fifth of all visits to primary care physicians. Well child visits are the sixth most common reason for seeing a family physician, and the No. 1 reason for seeing a pediatrician.

“Despite their importance, many well child visits are missed,” said Dr. Gjerdingen, professor in the department of family medicine and community health at the University of Minnesota, Minneapolis.

Dr. Gjerdingen and her associates conducted a telephone survey of parents at the university's Bethesda Clinic in St. Paul who missed an appointment between January and December 2002. Respondents were 90% female, 61% married, and 50% employed. Fifty-seven percent were insured through public assistance. Mean age of parents was 26 years and mean age of children was 5.4 months. Parents were 65% Southeast Asian, 15% African American, 14% white, and 6% other. Almost half (48%) had less than a 12th-grade education; 86% kept well child visits. Among the 14% who were noncompliant, “I forgot” was the No. 1 reason cited. Most parents, 77%, said they like telephone reminders.

All respondents said they believed well child visits are important, citing vaccinations as the No. 1 reason. Therefore, Dr. Gjerdingen said, “We can use that for encouraging parents to come to visits.”

A minority of parents, 20%, said they were “often” or “always” stressed. Financial or employment concerns were most often cited.

Contrary to other compliance studies, younger parents were more likely to keep visits, Dr. Gjerdingen found. “I was surprised by age, that the older they were the more likely they were to miss the appointment,” she said.

Another unexpected finding was parents with private insurance were more likely to miss appointments compared with those who had public insurance. “I was wondering if it was a copay differential,” she said.

Small sample size and single center setting were limitations of the study.