Sharon Worcester

BOSTON – The glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide does not increase the risk for cardiovascular problems in diabetic patients, according to findings from the first cardiovascular disease outcomes trial for this widely prescribed class of glucose-lowering drugs.

The findings of the randomized, placebo-controlled Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial, presented at the annual scientific sessions of the American Diabetes Association, dissipate the “cloud of suspicion” that has cast a shadow over GLP-1 agonists with regard to their possible effects on cardiovascular risk, the investigators said.

“We have shown that patients and their health care providers should have no cause for concern, even if they are at high risk of heart-related problems,” said principal investigator Dr. Marc Pfeffer, professor of medicine at Harvard University and senior physician in the division of cardiology at Brigham and Women’s Hospital, Boston.

Dr. Pfeffer and his colleagues studied 6,068 patients who were randomized to receive placebo or lixisenatide (Lyxumia), which is investigational in the United States but approved in more than 50 countries worldwide. The study subjects were followed for a mean of 2.1 years.

The composite primary outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina occurred in 399 of 3,304 placebo-group patients (13.2%) and in 406 of 3,034 treatment-group patients (13.4%; hazard ratio, 1.02), Dr. Pfeffer said.

No difference was seen between the groups for any of the individual components of the composite outcome (HR: 0.98 for cardiovascular death, 1.03 for MI, 1.12 for stroke, and 1.11 for unstable angina), and no differences were seen based on sex, age, race, or region.

“No sign of interactions, and no patterns emerged in older patients or sicker patients,” Dr. Pfeffer added.

Heart failure, which is “a very important outcome,” did occur more often in those with heart failure prior to randomization, but again, the outcomes did not differ between the placebo and treatment group (HR, 0.97 for cardiovascular death plus heart failure hospitalization), he noted.

All-cause death also occurred at a similar rate in both groups: 7.4% and 7% for the placebo vs. treatment groups (HR, 0.94).

Treatment can confidently be said to be safe, as well as neutral, with respect to the various outcome measures, he said.

Dr. Matthew Riddle of Oregon Health and Science University, Portland, further reported that patients in the lixisenatide group were more likely than those who received placebo to experience a modest benefit in terms of weight. Those in the treatment group did not gain weight, while those in the placebo group did (–0.7 kg between-group difference from baseline), he said, noting that this is a finding that “has some possibility of clinical relevance.”

A similar pattern was seen with systolic blood pressure, with treatment-group patients experiencing a modest but statistically significant improvement (–0.8 mm Hg between-group difference from baseline).

The treatment-group patients were not more likely than those who received placebo to experience hypoglycemia, despite better glucose control, nor were they more likely to experience pancreatitis or pancreatic cancer, he said.

A modest significant difference was seen with respect to HbA_1c levels and fasting plasma glucose with treatment vs. placebo (–0.27% mean postbaseline difference for each).

Patients included in the ELIXA trial were adults over age 30 years who had experienced a recent acute coronary syndrome event. They were enrolled from 782 sites in 49 countries within 180 days (mean, 72 days) of the event, which was MI in most cases.

Patients received a single injection each day of either lixisenatide or volume-matched placebo before breakfast. The dosage could be titrated up from 10 mcg to 20 mcg, or down for those not able to tolerate the full dose. Other than adjustments to prevent hypoglycemia, local standards of care for lifestyle, glycemic targets, and risk factor management were followed.

At least one adverse event was reported by 77% and 81% of placebo and treatment-group patients, with nausea and vomiting – common side effects for GLP-1 agonists – accounting for most of the difference. No difference was seen between the groups with respect to serious adverse events (22% in each arm reported serious events).

Adverse events, however, led to treatment discontinuation in 7.2% of placebo-group patients, compared with 11.4% of lixisenatide-group patients.

The findings confirm that lixisenatide does not increase the risk of major adverse cardiac events, and no signal was seen for pancreatic cancer, pancreatitis, other cancers, or heart failure, said discussant Dr. Silvio Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn., who was invited by the ADA to comment on the findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important endpoint, “the answer is a resounding yes,” he said.

Lixisenatide was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medical products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

According to Sanofi, a New Drug Application for lixisenatide is on track to be resubmitted to the Food and Drug Administration in the third quarter of 2015. An initial application was accepted for review in 2013, but Sanofi delayed the approval process based on concerns regarding cardiovascular risk. The application to be resubmitted later this year will include findings from the GetGoal Duo-2 clinical trial, which were reported in a poster at the ADA meeting; all coprimary endpoints in the 26-week, randomized, open-label trial were met, reported Dr. Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center.

In GetGoal Duo-2, lixisenatide was compared as a once-daily 20 mcg add-on to optimally titrated insulin glargine with or without metformin vs. the addition of rapid-acting insulin glulisine with or without metformin injected once daily at the time of the patient’s main meal (basal-plus), or three times daily at meal time (basal-bolus). Subjects were adults with poorly controlled diabetes on basal insulin with or without oral antidiabetic drugs for at least 6 months.

In 890 patients included in an intention-to-treat analysis, lixisenatide was noninferior to both comparator insulin regimens for reducing HbA_1c levels (mean difference, –0.05% vs. basal plus and 0.21% vs. basal bolus), and was shown to be statistically superior to basal-bolus for body weight change (mean difference, –2 kg), Dr. Rosenstock said.

Postprandial glucose also was significantly reduced with lixisenatide vs. both insulin glulisine regimens (mean difference, –37 mg/dL vs. basal plus and –40 mg/dL vs. basal bolus), as was hypoglycemia (estimated rate ratios, 0.8 and 0.5, respectively).

Nausea occurred in 25% of the lixisenatide patients vs. 1% and 2% of the basal plus and basal bolus patients, respectively, and vomiting and diarrhea occurred in 9% and 7%, respectively, of the lixisenatide patients.

Both lixisenatide studies were sponsored by Sanofi. Dr. Pfeffer reported receiving honoraria and/or research grants from, or serving as a consultant for, Aastrom, Amgen, Bristol-Myers Squibb, Celladon, Concert, Hamilton Health Sciences, Keryx, Medtronic, Merck, Novartis, Roche, Sanofi-Aventis, Servier, Teva, University of Oxford, and Xoma. The Brigham and Women’s Hospital has patents for the use of inhibitors of the renin-angiotensin system in survivors of MI with Novartis.

BOSTON – The glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide does not increase the risk for cardiovascular problems in diabetic patients, according to findings from the first cardiovascular disease outcomes trial for this widely prescribed class of glucose-lowering drugs.

The findings of the randomized, placebo-controlled Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial, presented at the annual scientific sessions of the American Diabetes Association, dissipate the “cloud of suspicion” that has cast a shadow over GLP-1 agonists with regard to their possible effects on cardiovascular risk, the investigators said.

“We have shown that patients and their health care providers should have no cause for concern, even if they are at high risk of heart-related problems,” said principal investigator Dr. Marc Pfeffer, professor of medicine at Harvard University and senior physician in the division of cardiology at Brigham and Women’s Hospital, Boston.

Dr. Pfeffer and his colleagues studied 6,068 patients who were randomized to receive placebo or lixisenatide (Lyxumia), which is investigational in the United States but approved in more than 50 countries worldwide. The study subjects were followed for a mean of 2.1 years.

The composite primary outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina occurred in 399 of 3,304 placebo-group patients (13.2%) and in 406 of 3,034 treatment-group patients (13.4%; hazard ratio, 1.02), Dr. Pfeffer said.

No difference was seen between the groups for any of the individual components of the composite outcome (HR: 0.98 for cardiovascular death, 1.03 for MI, 1.12 for stroke, and 1.11 for unstable angina), and no differences were seen based on sex, age, race, or region.

“No sign of interactions, and no patterns emerged in older patients or sicker patients,” Dr. Pfeffer added.

Heart failure, which is “a very important outcome,” did occur more often in those with heart failure prior to randomization, but again, the outcomes did not differ between the placebo and treatment group (HR, 0.97 for cardiovascular death plus heart failure hospitalization), he noted.

All-cause death also occurred at a similar rate in both groups: 7.4% and 7% for the placebo vs. treatment groups (HR, 0.94).

Treatment can confidently be said to be safe, as well as neutral, with respect to the various outcome measures, he said.

Dr. Matthew Riddle of Oregon Health and Science University, Portland, further reported that patients in the lixisenatide group were more likely than those who received placebo to experience a modest benefit in terms of weight. Those in the treatment group did not gain weight, while those in the placebo group did (–0.7 kg between-group difference from baseline), he said, noting that this is a finding that “has some possibility of clinical relevance.”

A similar pattern was seen with systolic blood pressure, with treatment-group patients experiencing a modest but statistically significant improvement (–0.8 mm Hg between-group difference from baseline).

The treatment-group patients were not more likely than those who received placebo to experience hypoglycemia, despite better glucose control, nor were they more likely to experience pancreatitis or pancreatic cancer, he said.

A modest significant difference was seen with respect to HbA_1c levels and fasting plasma glucose with treatment vs. placebo (–0.27% mean postbaseline difference for each).

Patients included in the ELIXA trial were adults over age 30 years who had experienced a recent acute coronary syndrome event. They were enrolled from 782 sites in 49 countries within 180 days (mean, 72 days) of the event, which was MI in most cases.

Patients received a single injection each day of either lixisenatide or volume-matched placebo before breakfast. The dosage could be titrated up from 10 mcg to 20 mcg, or down for those not able to tolerate the full dose. Other than adjustments to prevent hypoglycemia, local standards of care for lifestyle, glycemic targets, and risk factor management were followed.

At least one adverse event was reported by 77% and 81% of placebo and treatment-group patients, with nausea and vomiting – common side effects for GLP-1 agonists – accounting for most of the difference. No difference was seen between the groups with respect to serious adverse events (22% in each arm reported serious events).

Adverse events, however, led to treatment discontinuation in 7.2% of placebo-group patients, compared with 11.4% of lixisenatide-group patients.

The findings confirm that lixisenatide does not increase the risk of major adverse cardiac events, and no signal was seen for pancreatic cancer, pancreatitis, other cancers, or heart failure, said discussant Dr. Silvio Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn., who was invited by the ADA to comment on the findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important endpoint, “the answer is a resounding yes,” he said.

Lixisenatide was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medical products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

According to Sanofi, a New Drug Application for lixisenatide is on track to be resubmitted to the Food and Drug Administration in the third quarter of 2015. An initial application was accepted for review in 2013, but Sanofi delayed the approval process based on concerns regarding cardiovascular risk. The application to be resubmitted later this year will include findings from the GetGoal Duo-2 clinical trial, which were reported in a poster at the ADA meeting; all coprimary endpoints in the 26-week, randomized, open-label trial were met, reported Dr. Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center.

In GetGoal Duo-2, lixisenatide was compared as a once-daily 20 mcg add-on to optimally titrated insulin glargine with or without metformin vs. the addition of rapid-acting insulin glulisine with or without metformin injected once daily at the time of the patient’s main meal (basal-plus), or three times daily at meal time (basal-bolus). Subjects were adults with poorly controlled diabetes on basal insulin with or without oral antidiabetic drugs for at least 6 months.

In 890 patients included in an intention-to-treat analysis, lixisenatide was noninferior to both comparator insulin regimens for reducing HbA_1c levels (mean difference, –0.05% vs. basal plus and 0.21% vs. basal bolus), and was shown to be statistically superior to basal-bolus for body weight change (mean difference, –2 kg), Dr. Rosenstock said.

Postprandial glucose also was significantly reduced with lixisenatide vs. both insulin glulisine regimens (mean difference, –37 mg/dL vs. basal plus and –40 mg/dL vs. basal bolus), as was hypoglycemia (estimated rate ratios, 0.8 and 0.5, respectively).

Nausea occurred in 25% of the lixisenatide patients vs. 1% and 2% of the basal plus and basal bolus patients, respectively, and vomiting and diarrhea occurred in 9% and 7%, respectively, of the lixisenatide patients.

Both lixisenatide studies were sponsored by Sanofi. Dr. Pfeffer reported receiving honoraria and/or research grants from, or serving as a consultant for, Aastrom, Amgen, Bristol-Myers Squibb, Celladon, Concert, Hamilton Health Sciences, Keryx, Medtronic, Merck, Novartis, Roche, Sanofi-Aventis, Servier, Teva, University of Oxford, and Xoma. The Brigham and Women’s Hospital has patents for the use of inhibitors of the renin-angiotensin system in survivors of MI with Novartis.

BOSTON – The glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide does not increase the risk for cardiovascular problems in diabetic patients, according to findings from the first cardiovascular disease outcomes trial for this widely prescribed class of glucose-lowering drugs.

The findings of the randomized, placebo-controlled Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial, presented at the annual scientific sessions of the American Diabetes Association, dissipate the “cloud of suspicion” that has cast a shadow over GLP-1 agonists with regard to their possible effects on cardiovascular risk, the investigators said.

“We have shown that patients and their health care providers should have no cause for concern, even if they are at high risk of heart-related problems,” said principal investigator Dr. Marc Pfeffer, professor of medicine at Harvard University and senior physician in the division of cardiology at Brigham and Women’s Hospital, Boston.

Dr. Pfeffer and his colleagues studied 6,068 patients who were randomized to receive placebo or lixisenatide (Lyxumia), which is investigational in the United States but approved in more than 50 countries worldwide. The study subjects were followed for a mean of 2.1 years.

The composite primary outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina occurred in 399 of 3,304 placebo-group patients (13.2%) and in 406 of 3,034 treatment-group patients (13.4%; hazard ratio, 1.02), Dr. Pfeffer said.

No difference was seen between the groups for any of the individual components of the composite outcome (HR: 0.98 for cardiovascular death, 1.03 for MI, 1.12 for stroke, and 1.11 for unstable angina), and no differences were seen based on sex, age, race, or region.

“No sign of interactions, and no patterns emerged in older patients or sicker patients,” Dr. Pfeffer added.

Heart failure, which is “a very important outcome,” did occur more often in those with heart failure prior to randomization, but again, the outcomes did not differ between the placebo and treatment group (HR, 0.97 for cardiovascular death plus heart failure hospitalization), he noted.

All-cause death also occurred at a similar rate in both groups: 7.4% and 7% for the placebo vs. treatment groups (HR, 0.94).

Treatment can confidently be said to be safe, as well as neutral, with respect to the various outcome measures, he said.

Dr. Matthew Riddle of Oregon Health and Science University, Portland, further reported that patients in the lixisenatide group were more likely than those who received placebo to experience a modest benefit in terms of weight. Those in the treatment group did not gain weight, while those in the placebo group did (–0.7 kg between-group difference from baseline), he said, noting that this is a finding that “has some possibility of clinical relevance.”

A similar pattern was seen with systolic blood pressure, with treatment-group patients experiencing a modest but statistically significant improvement (–0.8 mm Hg between-group difference from baseline).

The treatment-group patients were not more likely than those who received placebo to experience hypoglycemia, despite better glucose control, nor were they more likely to experience pancreatitis or pancreatic cancer, he said.

A modest significant difference was seen with respect to HbA_1c levels and fasting plasma glucose with treatment vs. placebo (–0.27% mean postbaseline difference for each).

Patients included in the ELIXA trial were adults over age 30 years who had experienced a recent acute coronary syndrome event. They were enrolled from 782 sites in 49 countries within 180 days (mean, 72 days) of the event, which was MI in most cases.

Patients received a single injection each day of either lixisenatide or volume-matched placebo before breakfast. The dosage could be titrated up from 10 mcg to 20 mcg, or down for those not able to tolerate the full dose. Other than adjustments to prevent hypoglycemia, local standards of care for lifestyle, glycemic targets, and risk factor management were followed.

At least one adverse event was reported by 77% and 81% of placebo and treatment-group patients, with nausea and vomiting – common side effects for GLP-1 agonists – accounting for most of the difference. No difference was seen between the groups with respect to serious adverse events (22% in each arm reported serious events).

Adverse events, however, led to treatment discontinuation in 7.2% of placebo-group patients, compared with 11.4% of lixisenatide-group patients.

The findings confirm that lixisenatide does not increase the risk of major adverse cardiac events, and no signal was seen for pancreatic cancer, pancreatitis, other cancers, or heart failure, said discussant Dr. Silvio Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn., who was invited by the ADA to comment on the findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important endpoint, “the answer is a resounding yes,” he said.

Lixisenatide was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medical products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

According to Sanofi, a New Drug Application for lixisenatide is on track to be resubmitted to the Food and Drug Administration in the third quarter of 2015. An initial application was accepted for review in 2013, but Sanofi delayed the approval process based on concerns regarding cardiovascular risk. The application to be resubmitted later this year will include findings from the GetGoal Duo-2 clinical trial, which were reported in a poster at the ADA meeting; all coprimary endpoints in the 26-week, randomized, open-label trial were met, reported Dr. Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center.

In GetGoal Duo-2, lixisenatide was compared as a once-daily 20 mcg add-on to optimally titrated insulin glargine with or without metformin vs. the addition of rapid-acting insulin glulisine with or without metformin injected once daily at the time of the patient’s main meal (basal-plus), or three times daily at meal time (basal-bolus). Subjects were adults with poorly controlled diabetes on basal insulin with or without oral antidiabetic drugs for at least 6 months.

In 890 patients included in an intention-to-treat analysis, lixisenatide was noninferior to both comparator insulin regimens for reducing HbA_1c levels (mean difference, –0.05% vs. basal plus and 0.21% vs. basal bolus), and was shown to be statistically superior to basal-bolus for body weight change (mean difference, –2 kg), Dr. Rosenstock said.

Postprandial glucose also was significantly reduced with lixisenatide vs. both insulin glulisine regimens (mean difference, –37 mg/dL vs. basal plus and –40 mg/dL vs. basal bolus), as was hypoglycemia (estimated rate ratios, 0.8 and 0.5, respectively).

Nausea occurred in 25% of the lixisenatide patients vs. 1% and 2% of the basal plus and basal bolus patients, respectively, and vomiting and diarrhea occurred in 9% and 7%, respectively, of the lixisenatide patients.

Both lixisenatide studies were sponsored by Sanofi. Dr. Pfeffer reported receiving honoraria and/or research grants from, or serving as a consultant for, Aastrom, Amgen, Bristol-Myers Squibb, Celladon, Concert, Hamilton Health Sciences, Keryx, Medtronic, Merck, Novartis, Roche, Sanofi-Aventis, Servier, Teva, University of Oxford, and Xoma. The Brigham and Women’s Hospital has patents for the use of inhibitors of the renin-angiotensin system in survivors of MI with Novartis.

BOSTON – The glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide does not increase the risk for cardiovascular problems in diabetic patients, according to findings from the first cardiovascular disease outcomes trial for this widely prescribed class of glucose-lowering drugs.

The findings of the randomized, placebo-controlled Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial, presented at the annual scientific sessions of the American Diabetes Association, dissipate the “cloud of suspicion” that has cast a shadow over GLP-1 agonists with regard to their possible effects on cardiovascular risk, the investigators said.

“We have shown that patients and their health care providers should have no cause for concern, even if they are at high risk of heart-related problems,” said principal investigator Dr. Marc Pfeffer, professor of medicine at Harvard University and senior physician in the division of cardiology at Brigham and Women’s Hospital, Boston.

Dr. Pfeffer and his colleagues studied 6,068 patients who were randomized to receive placebo or lixisenatide (Lyxumia), which is investigational in the United States but approved in more than 50 countries worldwide. The study subjects were followed for a mean of 2.1 years.

The composite primary outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina occurred in 399 of 3,304 placebo-group patients (13.2%) and in 406 of 3,034 treatment-group patients (13.4%; hazard ratio, 1.02), Dr. Pfeffer said.

No difference was seen between the groups for any of the individual components of the composite outcome (HR: 0.98 for cardiovascular death, 1.03 for MI, 1.12 for stroke, and 1.11 for unstable angina), and no differences were seen based on sex, age, race, or region.

“No sign of interactions, and no patterns emerged in older patients or sicker patients,” Dr. Pfeffer added.

Heart failure, which is “a very important outcome,” did occur more often in those with heart failure prior to randomization, but again, the outcomes did not differ between the placebo and treatment group (HR, 0.97 for cardiovascular death plus heart failure hospitalization), he noted.

All-cause death also occurred at a similar rate in both groups: 7.4% and 7% for the placebo vs. treatment groups (HR, 0.94).

Treatment can confidently be said to be safe, as well as neutral, with respect to the various outcome measures, he said.

Dr. Matthew Riddle of Oregon Health and Science University, Portland, further reported that patients in the lixisenatide group were more likely than those who received placebo to experience a modest benefit in terms of weight. Those in the treatment group did not gain weight, while those in the placebo group did (–0.7 kg between-group difference from baseline), he said, noting that this is a finding that “has some possibility of clinical relevance.”

A similar pattern was seen with systolic blood pressure, with treatment-group patients experiencing a modest but statistically significant improvement (–0.8 mm Hg between-group difference from baseline).

The treatment-group patients were not more likely than those who received placebo to experience hypoglycemia, despite better glucose control, nor were they more likely to experience pancreatitis or pancreatic cancer, he said.

A modest significant difference was seen with respect to HbA_1c levels and fasting plasma glucose with treatment vs. placebo (–0.27% mean postbaseline difference for each).

Patients included in the ELIXA trial were adults over age 30 years who had experienced a recent acute coronary syndrome event. They were enrolled from 782 sites in 49 countries within 180 days (mean, 72 days) of the event, which was MI in most cases.

Patients received a single injection each day of either lixisenatide or volume-matched placebo before breakfast. The dosage could be titrated up from 10 mcg to 20 mcg, or down for those not able to tolerate the full dose. Other than adjustments to prevent hypoglycemia, local standards of care for lifestyle, glycemic targets, and risk factor management were followed.

At least one adverse event was reported by 77% and 81% of placebo and treatment-group patients, with nausea and vomiting – common side effects for GLP-1 agonists – accounting for most of the difference. No difference was seen between the groups with respect to serious adverse events (22% in each arm reported serious events).

Adverse events, however, led to treatment discontinuation in 7.2% of placebo-group patients, compared with 11.4% of lixisenatide-group patients.

The findings confirm that lixisenatide does not increase the risk of major adverse cardiac events, and no signal was seen for pancreatic cancer, pancreatitis, other cancers, or heart failure, said discussant Dr. Silvio Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn., who was invited by the ADA to comment on the findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important endpoint, “the answer is a resounding yes,” he said.

Lixisenatide was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medical products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

According to Sanofi, a New Drug Application for lixisenatide is on track to be resubmitted to the Food and Drug Administration in the third quarter of 2015. An initial application was accepted for review in 2013, but Sanofi delayed the approval process based on concerns regarding cardiovascular risk. The application to be resubmitted later this year will include findings from the GetGoal Duo-2 clinical trial, which were reported in a poster at the ADA meeting; all coprimary endpoints in the 26-week, randomized, open-label trial were met, reported Dr. Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center.

In GetGoal Duo-2, lixisenatide was compared as a once-daily 20 mcg add-on to optimally titrated insulin glargine with or without metformin vs. the addition of rapid-acting insulin glulisine with or without metformin injected once daily at the time of the patient’s main meal (basal-plus), or three times daily at meal time (basal-bolus). Subjects were adults with poorly controlled diabetes on basal insulin with or without oral antidiabetic drugs for at least 6 months.

In 890 patients included in an intention-to-treat analysis, lixisenatide was noninferior to both comparator insulin regimens for reducing HbA_1c levels (mean difference, –0.05% vs. basal plus and 0.21% vs. basal bolus), and was shown to be statistically superior to basal-bolus for body weight change (mean difference, –2 kg), Dr. Rosenstock said.

Postprandial glucose also was significantly reduced with lixisenatide vs. both insulin glulisine regimens (mean difference, –37 mg/dL vs. basal plus and –40 mg/dL vs. basal bolus), as was hypoglycemia (estimated rate ratios, 0.8 and 0.5, respectively).

Nausea occurred in 25% of the lixisenatide patients vs. 1% and 2% of the basal plus and basal bolus patients, respectively, and vomiting and diarrhea occurred in 9% and 7%, respectively, of the lixisenatide patients.

Both lixisenatide studies were sponsored by Sanofi. Dr. Pfeffer reported receiving honoraria and/or research grants from, or serving as a consultant for, Aastrom, Amgen, Bristol-Myers Squibb, Celladon, Concert, Hamilton Health Sciences, Keryx, Medtronic, Merck, Novartis, Roche, Sanofi-Aventis, Servier, Teva, University of Oxford, and Xoma. The Brigham and Women’s Hospital has patents for the use of inhibitors of the renin-angiotensin system in survivors of MI with Novartis.

sworcester@frontlinemedcom.com

BOSTON – The glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide does not increase the risk for cardiovascular problems in diabetic patients, according to findings from the first cardiovascular disease outcomes trial for this widely prescribed class of glucose-lowering drugs.

The findings of the randomized, placebo-controlled Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial, presented at the annual scientific sessions of the American Diabetes Association, dissipate the “cloud of suspicion” that has cast a shadow over GLP-1 agonists with regard to their possible effects on cardiovascular risk, the investigators said.

“We have shown that patients and their health care providers should have no cause for concern, even if they are at high risk of heart-related problems,” said principal investigator Dr. Marc Pfeffer, professor of medicine at Harvard University and senior physician in the division of cardiology at Brigham and Women’s Hospital, Boston.

Dr. Pfeffer and his colleagues studied 6,068 patients who were randomized to receive placebo or lixisenatide (Lyxumia), which is investigational in the United States but approved in more than 50 countries worldwide. The study subjects were followed for a mean of 2.1 years.

The composite primary outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina occurred in 399 of 3,304 placebo-group patients (13.2%) and in 406 of 3,034 treatment-group patients (13.4%; hazard ratio, 1.02), Dr. Pfeffer said.

No difference was seen between the groups for any of the individual components of the composite outcome (HR: 0.98 for cardiovascular death, 1.03 for MI, 1.12 for stroke, and 1.11 for unstable angina), and no differences were seen based on sex, age, race, or region.

“No sign of interactions, and no patterns emerged in older patients or sicker patients,” Dr. Pfeffer added.

Heart failure, which is “a very important outcome,” did occur more often in those with heart failure prior to randomization, but again, the outcomes did not differ between the placebo and treatment group (HR, 0.97 for cardiovascular death plus heart failure hospitalization), he noted.

All-cause death also occurred at a similar rate in both groups: 7.4% and 7% for the placebo vs. treatment groups (HR, 0.94).

Treatment can confidently be said to be safe, as well as neutral, with respect to the various outcome measures, he said.

Dr. Matthew Riddle of Oregon Health and Science University, Portland, further reported that patients in the lixisenatide group were more likely than those who received placebo to experience a modest benefit in terms of weight. Those in the treatment group did not gain weight, while those in the placebo group did (–0.7 kg between-group difference from baseline), he said, noting that this is a finding that “has some possibility of clinical relevance.”

A similar pattern was seen with systolic blood pressure, with treatment-group patients experiencing a modest but statistically significant improvement (–0.8 mm Hg between-group difference from baseline).

The treatment-group patients were not more likely than those who received placebo to experience hypoglycemia, despite better glucose control, nor were they more likely to experience pancreatitis or pancreatic cancer, he said.

A modest significant difference was seen with respect to HbA_1c levels and fasting plasma glucose with treatment vs. placebo (–0.27% mean postbaseline difference for each).

Patients included in the ELIXA trial were adults over age 30 years who had experienced a recent acute coronary syndrome event. They were enrolled from 782 sites in 49 countries within 180 days (mean, 72 days) of the event, which was MI in most cases.

Patients received a single injection each day of either lixisenatide or volume-matched placebo before breakfast. The dosage could be titrated up from 10 mcg to 20 mcg, or down for those not able to tolerate the full dose. Other than adjustments to prevent hypoglycemia, local standards of care for lifestyle, glycemic targets, and risk factor management were followed.

At least one adverse event was reported by 77% and 81% of placebo and treatment-group patients, with nausea and vomiting – common side effects for GLP-1 agonists – accounting for most of the difference. No difference was seen between the groups with respect to serious adverse events (22% in each arm reported serious events).

Adverse events, however, led to treatment discontinuation in 7.2% of placebo-group patients, compared with 11.4% of lixisenatide-group patients.

The findings confirm that lixisenatide does not increase the risk of major adverse cardiac events, and no signal was seen for pancreatic cancer, pancreatitis, other cancers, or heart failure, said discussant Dr. Silvio Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn., who was invited by the ADA to comment on the findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important endpoint, “the answer is a resounding yes,” he said.

Lixisenatide was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medical products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

According to Sanofi, a New Drug Application for lixisenatide is on track to be resubmitted to the Food and Drug Administration in the third quarter of 2015. An initial application was accepted for review in 2013, but Sanofi delayed the approval process based on concerns regarding cardiovascular risk. The application to be resubmitted later this year will include findings from the GetGoal Duo-2 clinical trial, which were reported in a poster at the ADA meeting; all coprimary endpoints in the 26-week, randomized, open-label trial were met, reported Dr. Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center.

In GetGoal Duo-2, lixisenatide was compared as a once-daily 20 mcg add-on to optimally titrated insulin glargine with or without metformin vs. the addition of rapid-acting insulin glulisine with or without metformin injected once daily at the time of the patient’s main meal (basal-plus), or three times daily at meal time (basal-bolus). Subjects were adults with poorly controlled diabetes on basal insulin with or without oral antidiabetic drugs for at least 6 months.

In 890 patients included in an intention-to-treat analysis, lixisenatide was noninferior to both comparator insulin regimens for reducing HbA_1c levels (mean difference, –0.05% vs. basal plus and 0.21% vs. basal bolus), and was shown to be statistically superior to basal-bolus for body weight change (mean difference, –2 kg), Dr. Rosenstock said.

Postprandial glucose also was significantly reduced with lixisenatide vs. both insulin glulisine regimens (mean difference, –37 mg/dL vs. basal plus and –40 mg/dL vs. basal bolus), as was hypoglycemia (estimated rate ratios, 0.8 and 0.5, respectively).

Nausea occurred in 25% of the lixisenatide patients vs. 1% and 2% of the basal plus and basal bolus patients, respectively, and vomiting and diarrhea occurred in 9% and 7%, respectively, of the lixisenatide patients.

Both lixisenatide studies were sponsored by Sanofi. Dr. Pfeffer reported receiving honoraria and/or research grants from, or serving as a consultant for, Aastrom, Amgen, Bristol-Myers Squibb, Celladon, Concert, Hamilton Health Sciences, Keryx, Medtronic, Merck, Novartis, Roche, Sanofi-Aventis, Servier, Teva, University of Oxford, and Xoma. The Brigham and Women’s Hospital has patents for the use of inhibitors of the renin-angiotensin system in survivors of MI with Novartis.

sworcester@frontlinemedcom.com

BOSTON – The glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide does not increase the risk for cardiovascular problems in diabetic patients, according to findings from the first cardiovascular disease outcomes trial for this widely prescribed class of glucose-lowering drugs.

The findings of the randomized, placebo-controlled Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial, presented at the annual scientific sessions of the American Diabetes Association, dissipate the “cloud of suspicion” that has cast a shadow over GLP-1 agonists with regard to their possible effects on cardiovascular risk, the investigators said.

“We have shown that patients and their health care providers should have no cause for concern, even if they are at high risk of heart-related problems,” said principal investigator Dr. Marc Pfeffer, professor of medicine at Harvard University and senior physician in the division of cardiology at Brigham and Women’s Hospital, Boston.

Dr. Pfeffer and his colleagues studied 6,068 patients who were randomized to receive placebo or lixisenatide (Lyxumia), which is investigational in the United States but approved in more than 50 countries worldwide. The study subjects were followed for a mean of 2.1 years.

The composite primary outcome of cardiovascular death, myocardial infarction, stroke, or unstable angina occurred in 399 of 3,304 placebo-group patients (13.2%) and in 406 of 3,034 treatment-group patients (13.4%; hazard ratio, 1.02), Dr. Pfeffer said.

No difference was seen between the groups for any of the individual components of the composite outcome (HR: 0.98 for cardiovascular death, 1.03 for MI, 1.12 for stroke, and 1.11 for unstable angina), and no differences were seen based on sex, age, race, or region.

“No sign of interactions, and no patterns emerged in older patients or sicker patients,” Dr. Pfeffer added.

Heart failure, which is “a very important outcome,” did occur more often in those with heart failure prior to randomization, but again, the outcomes did not differ between the placebo and treatment group (HR, 0.97 for cardiovascular death plus heart failure hospitalization), he noted.

All-cause death also occurred at a similar rate in both groups: 7.4% and 7% for the placebo vs. treatment groups (HR, 0.94).

Treatment can confidently be said to be safe, as well as neutral, with respect to the various outcome measures, he said.

Dr. Matthew Riddle of Oregon Health and Science University, Portland, further reported that patients in the lixisenatide group were more likely than those who received placebo to experience a modest benefit in terms of weight. Those in the treatment group did not gain weight, while those in the placebo group did (–0.7 kg between-group difference from baseline), he said, noting that this is a finding that “has some possibility of clinical relevance.”

A similar pattern was seen with systolic blood pressure, with treatment-group patients experiencing a modest but statistically significant improvement (–0.8 mm Hg between-group difference from baseline).

The treatment-group patients were not more likely than those who received placebo to experience hypoglycemia, despite better glucose control, nor were they more likely to experience pancreatitis or pancreatic cancer, he said.

A modest significant difference was seen with respect to HbA_1c levels and fasting plasma glucose with treatment vs. placebo (–0.27% mean postbaseline difference for each).

Patients included in the ELIXA trial were adults over age 30 years who had experienced a recent acute coronary syndrome event. They were enrolled from 782 sites in 49 countries within 180 days (mean, 72 days) of the event, which was MI in most cases.

Patients received a single injection each day of either lixisenatide or volume-matched placebo before breakfast. The dosage could be titrated up from 10 mcg to 20 mcg, or down for those not able to tolerate the full dose. Other than adjustments to prevent hypoglycemia, local standards of care for lifestyle, glycemic targets, and risk factor management were followed.

At least one adverse event was reported by 77% and 81% of placebo and treatment-group patients, with nausea and vomiting – common side effects for GLP-1 agonists – accounting for most of the difference. No difference was seen between the groups with respect to serious adverse events (22% in each arm reported serious events).

Adverse events, however, led to treatment discontinuation in 7.2% of placebo-group patients, compared with 11.4% of lixisenatide-group patients.

The findings confirm that lixisenatide does not increase the risk of major adverse cardiac events, and no signal was seen for pancreatic cancer, pancreatitis, other cancers, or heart failure, said discussant Dr. Silvio Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn., who was invited by the ADA to comment on the findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important endpoint, “the answer is a resounding yes,” he said.

Lixisenatide was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medical products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control.

According to Sanofi, a New Drug Application for lixisenatide is on track to be resubmitted to the Food and Drug Administration in the third quarter of 2015. An initial application was accepted for review in 2013, but Sanofi delayed the approval process based on concerns regarding cardiovascular risk. The application to be resubmitted later this year will include findings from the GetGoal Duo-2 clinical trial, which were reported in a poster at the ADA meeting; all coprimary endpoints in the 26-week, randomized, open-label trial were met, reported Dr. Julio Rosenstock, director of the Dallas Diabetes and Endocrine Center.

In GetGoal Duo-2, lixisenatide was compared as a once-daily 20 mcg add-on to optimally titrated insulin glargine with or without metformin vs. the addition of rapid-acting insulin glulisine with or without metformin injected once daily at the time of the patient’s main meal (basal-plus), or three times daily at meal time (basal-bolus). Subjects were adults with poorly controlled diabetes on basal insulin with or without oral antidiabetic drugs for at least 6 months.

In 890 patients included in an intention-to-treat analysis, lixisenatide was noninferior to both comparator insulin regimens for reducing HbA_1c levels (mean difference, –0.05% vs. basal plus and 0.21% vs. basal bolus), and was shown to be statistically superior to basal-bolus for body weight change (mean difference, –2 kg), Dr. Rosenstock said.

Postprandial glucose also was significantly reduced with lixisenatide vs. both insulin glulisine regimens (mean difference, –37 mg/dL vs. basal plus and –40 mg/dL vs. basal bolus), as was hypoglycemia (estimated rate ratios, 0.8 and 0.5, respectively).

Nausea occurred in 25% of the lixisenatide patients vs. 1% and 2% of the basal plus and basal bolus patients, respectively, and vomiting and diarrhea occurred in 9% and 7%, respectively, of the lixisenatide patients.

Both lixisenatide studies were sponsored by Sanofi. Dr. Pfeffer reported receiving honoraria and/or research grants from, or serving as a consultant for, Aastrom, Amgen, Bristol-Myers Squibb, Celladon, Concert, Hamilton Health Sciences, Keryx, Medtronic, Merck, Novartis, Roche, Sanofi-Aventis, Servier, Teva, University of Oxford, and Xoma. The Brigham and Women’s Hospital has patents for the use of inhibitors of the renin-angiotensin system in survivors of MI with Novartis.

sworcester@frontlinemedcom.com

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

sworcester@frontlinemedcom.com

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

sworcester@frontlinemedcom.com

BOSTON – Weight loss was greater with laparoscopic adjustable gastric banding than with an intensive lifestyle intervention among obese patients with type 2 diabetes in a randomized clinical trial, but the effects on diabetes control, cardiometabolic risk, and quality of life were comparable.

Weight loss in 18 patients randomized to undergo the bariatric surgery was an average of 13.5 lb at 12 months’ follow-up, compared with 8.5 lb in those randomized to the active component of the study: a 12-week lifestyle intervention (Weight Achievement and Intensive Treatment–the Why WAIT program), Dr. Osama Hamdy reported in a poster at the annual scientific sessions of the American Diabetes Association.

However, hemogobin A_1c reduction was similar in the two groups at –1.2% vs. –1%, respectively. Further, improvements in blood pressure, triglycerides, and low-density lipoprotein levels did not differ between the groups, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Clinic, Harvard Medical School, Boston.

The risk of fatal coronary heart disease events also decreased in both groups, from 6.5% to 5.9% in the bariatric surgery group, and from 5.8% to 5.5% in the Why WAIT group; the difference between the groups was not statistically significant, he said.

Quality of life as assessed by the 36-item Short Form Survey’s physical and mental health summary measures changed only slightly from baseline in both groups, with no between-group differences. Similarly, scores on the Impact of Weight on Quality of Life and on Problem Areas in Diabetes improved significantly in both groups, but no between-group differences were seen.

“These findings suggest that the Why WAIT program and laparoscopic adjustable gastric banding have similar benefits for diabetes control, cardiometabolic risk, and quality of life parameters,” according to Dr. Hamdy, who noted that the findings may be useful for guiding obese patients with type 2 diabetes as they explore weight management options.

Dr. Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck, and that he has received research support and is an author for Neurometrix.

sworcester@frontlinemedcom.com

BOSTON – Significant weight reduction in obese patients with diabetes can be maintained for 5 years in a “real world” clinical practice setting, but such long-term maintenance is most likely in those who maintain at least 7% weight loss at 1 year, according to findings from the Weight Achievement and Intensive Treatment (Why WAIT) program.

Sustained weight loss in 129 program participants who were included in the longitudinal study was associated with lower hemoglobin A_1c for 5 years, and with lower blood pressure for the first 18 months; HbA_1c and triglycerides, however, were the first risk factors to deteriorate with weight regain, Dr. Osama Hamdy reported at the annual scientific sessions of the American Diabetes Association.

The study subjects had completed the Why WAIT program – a 12-week intensive lifestyle intervention model designed for clinical practice – and were grouped according to their percentage weight loss: Group A included 61 patients who failed to maintain at least 7% weight loss, and group B included 68 patients who maintained at least 7% weight loss.

Overall, the total cohort lost an average of 23.8 pounds (–9.7%) and maintained an average of 16.2 pounds lost (–6.4%). Group A maintained an average of 8.4 pounds lost (–3.5%) and group B maintained an average of 23.1 pounds lost (–9.0%) at 5 years.

HbA_1c decreased from 7.5% to 6.7% at 12 weeks in the group A patients, but increased to 7.7% at 1 year, and to 8.0% at 5 years. HbA_1c decreased from 7.4% to 6.4% at 12 weeks in the group B patients, but increased to 6.8% at 1 year, and to 7.3% at 5 years, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Center, Harvard Medical School, Boston.

Despite the weight regain, group A subjects maintained significant improvement in both low- and high-density lipoprotein cholesterol levels. They had no change in blood pressure, but had worsening of serum triglycerides, noted Dr. Hamdy, whose abstract received the 2015 ADA Michaela Modan Memorial Award for top abstracts in the areas of human studies on the epidemiology, complications, and prevention of diabetes.

Group B subjects experienced similar improvement in lipid profile, but had lower blood pressure for the first 18 months.

Weight loss through intensive lifestyle interventions are typically followed by either weight regain or sustained weight loss after the first year, but the impact of sustained weight loss vs. weight regain on cardiovascular risk factors was unknown, Dr. Hamdy said.

Thus, he and his colleagues evaluated the impact in Why WAIT participants. Why WAIT is a multidisciplinary approach to weight loss that involves structured dietary interventions and modified macronutrient composition, gradual balanced and individualized physical activity (including flexibility, aerobic, and strength training), adjustment of medications that affect body weight (including diabetes medications and antidepressants), cognitive behavioral modification, and group diabetes education.

“Our study demonstrated that sustained weight loss is associated with improved diabetes control for 5 years, and improved blood pressure for the first 18 months,” he said, noting that the ability to maintain at least 7% weight loss at 1 year predicts long-term wight loss.

The study “provides further understanding that regaining the weight does eliminate some of the benefits associated with the initial weight loss,” he added.

The findings change the misconception that people who lose weight with nonsurgical interventions will fail to maintain their weight loss beyond 6 months, he said.

“Our patients maintained 6.4% weight loss after 5 years, and approximately 53% of them achieved an average of 9% weight loss.”

The Why WAIT study is supported by Joslin Diabetes Center. Dr Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck & Co., and that he has received research support and is an author for Neurometrix.

 * This article was updated on 6/8/2015

BOSTON – Significant weight reduction in obese patients with diabetes can be maintained for 5 years in a “real world” clinical practice setting, but such long-term maintenance is most likely in those who maintain at least 7% weight loss at 1 year, according to findings from the Weight Achievement and Intensive Treatment (Why WAIT) program.

Sustained weight loss in 129 program participants who were included in the longitudinal study was associated with lower hemoglobin A_1c for 5 years, and with lower blood pressure for the first 18 months; HbA_1c and triglycerides, however, were the first risk factors to deteriorate with weight regain, Dr. Osama Hamdy reported at the annual scientific sessions of the American Diabetes Association.

The study subjects had completed the Why WAIT program – a 12-week intensive lifestyle intervention model designed for clinical practice – and were grouped according to their percentage weight loss: Group A included 61 patients who failed to maintain at least 7% weight loss, and group B included 68 patients who maintained at least 7% weight loss.

Overall, the total cohort lost an average of 23.8 pounds (–9.7%) and maintained an average of 16.2 pounds lost (–6.4%). Group A maintained an average of 8.4 pounds lost (–3.5%) and group B maintained an average of 23.1 pounds lost (–9.0%) at 5 years.

HbA_1c decreased from 7.5% to 6.7% at 12 weeks in the group A patients, but increased to 7.7% at 1 year, and to 8.0% at 5 years. HbA_1c decreased from 7.4% to 6.4% at 12 weeks in the group B patients, but increased to 6.8% at 1 year, and to 7.3% at 5 years, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Center, Harvard Medical School, Boston.

Despite the weight regain, group A subjects maintained significant improvement in both low- and high-density lipoprotein cholesterol levels. They had no change in blood pressure, but had worsening of serum triglycerides, noted Dr. Hamdy, whose abstract received the 2015 ADA Michaela Modan Memorial Award for top abstracts in the areas of human studies on the epidemiology, complications, and prevention of diabetes.

Group B subjects experienced similar improvement in lipid profile, but had lower blood pressure for the first 18 months.

Weight loss through intensive lifestyle interventions are typically followed by either weight regain or sustained weight loss after the first year, but the impact of sustained weight loss vs. weight regain on cardiovascular risk factors was unknown, Dr. Hamdy said.

Thus, he and his colleagues evaluated the impact in Why WAIT participants. Why WAIT is a multidisciplinary approach to weight loss that involves structured dietary interventions and modified macronutrient composition, gradual balanced and individualized physical activity (including flexibility, aerobic, and strength training), adjustment of medications that affect body weight (including diabetes medications and antidepressants), cognitive behavioral modification, and group diabetes education.

“Our study demonstrated that sustained weight loss is associated with improved diabetes control for 5 years, and improved blood pressure for the first 18 months,” he said, noting that the ability to maintain at least 7% weight loss at 1 year predicts long-term wight loss.

The study “provides further understanding that regaining the weight does eliminate some of the benefits associated with the initial weight loss,” he added.

The findings change the misconception that people who lose weight with nonsurgical interventions will fail to maintain their weight loss beyond 6 months, he said.

“Our patients maintained 6.4% weight loss after 5 years, and approximately 53% of them achieved an average of 9% weight loss.”

The Why WAIT study is supported by Joslin Diabetes Center. Dr Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck & Co., and that he has received research support and is an author for Neurometrix.

 * This article was updated on 6/8/2015

BOSTON – Significant weight reduction in obese patients with diabetes can be maintained for 5 years in a “real world” clinical practice setting, but such long-term maintenance is most likely in those who maintain at least 7% weight loss at 1 year, according to findings from the Weight Achievement and Intensive Treatment (Why WAIT) program.

Sustained weight loss in 129 program participants who were included in the longitudinal study was associated with lower hemoglobin A_1c for 5 years, and with lower blood pressure for the first 18 months; HbA_1c and triglycerides, however, were the first risk factors to deteriorate with weight regain, Dr. Osama Hamdy reported at the annual scientific sessions of the American Diabetes Association.

The study subjects had completed the Why WAIT program – a 12-week intensive lifestyle intervention model designed for clinical practice – and were grouped according to their percentage weight loss: Group A included 61 patients who failed to maintain at least 7% weight loss, and group B included 68 patients who maintained at least 7% weight loss.

Overall, the total cohort lost an average of 23.8 pounds (–9.7%) and maintained an average of 16.2 pounds lost (–6.4%). Group A maintained an average of 8.4 pounds lost (–3.5%) and group B maintained an average of 23.1 pounds lost (–9.0%) at 5 years.

HbA_1c decreased from 7.5% to 6.7% at 12 weeks in the group A patients, but increased to 7.7% at 1 year, and to 8.0% at 5 years. HbA_1c decreased from 7.4% to 6.4% at 12 weeks in the group B patients, but increased to 6.8% at 1 year, and to 7.3% at 5 years, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Center, Harvard Medical School, Boston.

Despite the weight regain, group A subjects maintained significant improvement in both low- and high-density lipoprotein cholesterol levels. They had no change in blood pressure, but had worsening of serum triglycerides, noted Dr. Hamdy, whose abstract received the 2015 ADA Michaela Modan Memorial Award for top abstracts in the areas of human studies on the epidemiology, complications, and prevention of diabetes.

Group B subjects experienced similar improvement in lipid profile, but had lower blood pressure for the first 18 months.

Weight loss through intensive lifestyle interventions are typically followed by either weight regain or sustained weight loss after the first year, but the impact of sustained weight loss vs. weight regain on cardiovascular risk factors was unknown, Dr. Hamdy said.

Thus, he and his colleagues evaluated the impact in Why WAIT participants. Why WAIT is a multidisciplinary approach to weight loss that involves structured dietary interventions and modified macronutrient composition, gradual balanced and individualized physical activity (including flexibility, aerobic, and strength training), adjustment of medications that affect body weight (including diabetes medications and antidepressants), cognitive behavioral modification, and group diabetes education.

“Our study demonstrated that sustained weight loss is associated with improved diabetes control for 5 years, and improved blood pressure for the first 18 months,” he said, noting that the ability to maintain at least 7% weight loss at 1 year predicts long-term wight loss.

The study “provides further understanding that regaining the weight does eliminate some of the benefits associated with the initial weight loss,” he added.

The findings change the misconception that people who lose weight with nonsurgical interventions will fail to maintain their weight loss beyond 6 months, he said.

“Our patients maintained 6.4% weight loss after 5 years, and approximately 53% of them achieved an average of 9% weight loss.”

The Why WAIT study is supported by Joslin Diabetes Center. Dr Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck & Co., and that he has received research support and is an author for Neurometrix.

 * This article was updated on 6/8/2015

BOSTON – Significant weight reduction in obese patients with diabetes can be maintained for 5 years in a “real world” clinical practice setting, but such long-term maintenance is most likely in those who maintain at least 7% weight loss at 1 year, according to findings from the Weight Achievement and Intensive Treatment (Why WAIT) program.

Sustained weight loss in 129 program participants who were included in the longitudinal study was associated with lower hemoglobin A_1c for 5 years, and with lower blood pressure for the first 18 months; HbA_1c and triglycerides, however, were the first risk factors to deteriorate with weight regain, Dr. Osama Hamdy reported at the annual scientific sessions of the American Diabetes Association.

The study subjects had completed the Why WAIT program – a 12-week intensive lifestyle intervention model designed for clinical practice – and were grouped according to their percentage weight loss: Group A included 61 patients who failed to maintain at least 7% weight loss, and group B included 68 patients who maintained at least 7% weight loss.

Overall, the total cohort lost an average of 23.8 pounds (–9.7%) and maintained an average of 16.2 pounds lost (–6.4%). Group A maintained an average of 8.4 pounds lost (–3.5%) and group B maintained an average of 23.1 pounds lost (–9.0%) at 5 years.

HbA_1c decreased from 7.5% to 6.7% at 12 weeks in the group A patients, but increased to 7.7% at 1 year, and to 8.0% at 5 years. HbA_1c decreased from 7.4% to 6.4% at 12 weeks in the group B patients, but increased to 6.8% at 1 year, and to 7.3% at 5 years, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Center, Harvard Medical School, Boston.

Despite the weight regain, group A subjects maintained significant improvement in both low- and high-density lipoprotein cholesterol levels. They had no change in blood pressure, but had worsening of serum triglycerides, noted Dr. Hamdy, whose abstract received the 2015 ADA Michaela Modan Memorial Award for top abstracts in the areas of human studies on the epidemiology, complications, and prevention of diabetes.

Group B subjects experienced similar improvement in lipid profile, but had lower blood pressure for the first 18 months.

Weight loss through intensive lifestyle interventions are typically followed by either weight regain or sustained weight loss after the first year, but the impact of sustained weight loss vs. weight regain on cardiovascular risk factors was unknown, Dr. Hamdy said.

Thus, he and his colleagues evaluated the impact in Why WAIT participants. Why WAIT is a multidisciplinary approach to weight loss that involves structured dietary interventions and modified macronutrient composition, gradual balanced and individualized physical activity (including flexibility, aerobic, and strength training), adjustment of medications that affect body weight (including diabetes medications and antidepressants), cognitive behavioral modification, and group diabetes education.

“Our study demonstrated that sustained weight loss is associated with improved diabetes control for 5 years, and improved blood pressure for the first 18 months,” he said, noting that the ability to maintain at least 7% weight loss at 1 year predicts long-term wight loss.

The study “provides further understanding that regaining the weight does eliminate some of the benefits associated with the initial weight loss,” he added.

The findings change the misconception that people who lose weight with nonsurgical interventions will fail to maintain their weight loss beyond 6 months, he said.

“Our patients maintained 6.4% weight loss after 5 years, and approximately 53% of them achieved an average of 9% weight loss.”

The Why WAIT study is supported by Joslin Diabetes Center. Dr Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck & Co., and that he has received research support and is an author for Neurometrix.

sworcester@frontlinemedcom.com

 * This article was updated on 6/8/2015

BOSTON – Significant weight reduction in obese patients with diabetes can be maintained for 5 years in a “real world” clinical practice setting, but such long-term maintenance is most likely in those who maintain at least 7% weight loss at 1 year, according to findings from the Weight Achievement and Intensive Treatment (Why WAIT) program.

Sustained weight loss in 129 program participants who were included in the longitudinal study was associated with lower hemoglobin A_1c for 5 years, and with lower blood pressure for the first 18 months; HbA_1c and triglycerides, however, were the first risk factors to deteriorate with weight regain, Dr. Osama Hamdy reported at the annual scientific sessions of the American Diabetes Association.

The study subjects had completed the Why WAIT program – a 12-week intensive lifestyle intervention model designed for clinical practice – and were grouped according to their percentage weight loss: Group A included 61 patients who failed to maintain at least 7% weight loss, and group B included 68 patients who maintained at least 7% weight loss.

Overall, the total cohort lost an average of 23.8 pounds (–9.7%) and maintained an average of 16.2 pounds lost (–6.4%). Group A maintained an average of 8.4 pounds lost (–3.5%) and group B maintained an average of 23.1 pounds lost (–9.0%) at 5 years.

HbA_1c decreased from 7.5% to 6.7% at 12 weeks in the group A patients, but increased to 7.7% at 1 year, and to 8.0% at 5 years. HbA_1c decreased from 7.4% to 6.4% at 12 weeks in the group B patients, but increased to 6.8% at 1 year, and to 7.3% at 5 years, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Center, Harvard Medical School, Boston.

Despite the weight regain, group A subjects maintained significant improvement in both low- and high-density lipoprotein cholesterol levels. They had no change in blood pressure, but had worsening of serum triglycerides, noted Dr. Hamdy, whose abstract received the 2015 ADA Michaela Modan Memorial Award for top abstracts in the areas of human studies on the epidemiology, complications, and prevention of diabetes.

Group B subjects experienced similar improvement in lipid profile, but had lower blood pressure for the first 18 months.

Weight loss through intensive lifestyle interventions are typically followed by either weight regain or sustained weight loss after the first year, but the impact of sustained weight loss vs. weight regain on cardiovascular risk factors was unknown, Dr. Hamdy said.

Thus, he and his colleagues evaluated the impact in Why WAIT participants. Why WAIT is a multidisciplinary approach to weight loss that involves structured dietary interventions and modified macronutrient composition, gradual balanced and individualized physical activity (including flexibility, aerobic, and strength training), adjustment of medications that affect body weight (including diabetes medications and antidepressants), cognitive behavioral modification, and group diabetes education.

“Our study demonstrated that sustained weight loss is associated with improved diabetes control for 5 years, and improved blood pressure for the first 18 months,” he said, noting that the ability to maintain at least 7% weight loss at 1 year predicts long-term wight loss.

The study “provides further understanding that regaining the weight does eliminate some of the benefits associated with the initial weight loss,” he added.

The findings change the misconception that people who lose weight with nonsurgical interventions will fail to maintain their weight loss beyond 6 months, he said.

“Our patients maintained 6.4% weight loss after 5 years, and approximately 53% of them achieved an average of 9% weight loss.”

The Why WAIT study is supported by Joslin Diabetes Center. Dr Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck & Co., and that he has received research support and is an author for Neurometrix.

sworcester@frontlinemedcom.com

 * This article was updated on 6/8/2015

BOSTON – Significant weight reduction in obese patients with diabetes can be maintained for 5 years in a “real world” clinical practice setting, but such long-term maintenance is most likely in those who maintain at least 7% weight loss at 1 year, according to findings from the Weight Achievement and Intensive Treatment (Why WAIT) program.

Sustained weight loss in 129 program participants who were included in the longitudinal study was associated with lower hemoglobin A_1c for 5 years, and with lower blood pressure for the first 18 months; HbA_1c and triglycerides, however, were the first risk factors to deteriorate with weight regain, Dr. Osama Hamdy reported at the annual scientific sessions of the American Diabetes Association.

The study subjects had completed the Why WAIT program – a 12-week intensive lifestyle intervention model designed for clinical practice – and were grouped according to their percentage weight loss: Group A included 61 patients who failed to maintain at least 7% weight loss, and group B included 68 patients who maintained at least 7% weight loss.

Overall, the total cohort lost an average of 23.8 pounds (–9.7%) and maintained an average of 16.2 pounds lost (–6.4%). Group A maintained an average of 8.4 pounds lost (–3.5%) and group B maintained an average of 23.1 pounds lost (–9.0%) at 5 years.

HbA_1c decreased from 7.5% to 6.7% at 12 weeks in the group A patients, but increased to 7.7% at 1 year, and to 8.0% at 5 years. HbA_1c decreased from 7.4% to 6.4% at 12 weeks in the group B patients, but increased to 6.8% at 1 year, and to 7.3% at 5 years, said Dr. Hamdy, medical director of the obesity clinical program, and director of the inpatient program at Joslin Diabetes Center, Harvard Medical School, Boston.

Despite the weight regain, group A subjects maintained significant improvement in both low- and high-density lipoprotein cholesterol levels. They had no change in blood pressure, but had worsening of serum triglycerides, noted Dr. Hamdy, whose abstract received the 2015 ADA Michaela Modan Memorial Award for top abstracts in the areas of human studies on the epidemiology, complications, and prevention of diabetes.

Group B subjects experienced similar improvement in lipid profile, but had lower blood pressure for the first 18 months.

Weight loss through intensive lifestyle interventions are typically followed by either weight regain or sustained weight loss after the first year, but the impact of sustained weight loss vs. weight regain on cardiovascular risk factors was unknown, Dr. Hamdy said.

Thus, he and his colleagues evaluated the impact in Why WAIT participants. Why WAIT is a multidisciplinary approach to weight loss that involves structured dietary interventions and modified macronutrient composition, gradual balanced and individualized physical activity (including flexibility, aerobic, and strength training), adjustment of medications that affect body weight (including diabetes medications and antidepressants), cognitive behavioral modification, and group diabetes education.

“Our study demonstrated that sustained weight loss is associated with improved diabetes control for 5 years, and improved blood pressure for the first 18 months,” he said, noting that the ability to maintain at least 7% weight loss at 1 year predicts long-term wight loss.

The study “provides further understanding that regaining the weight does eliminate some of the benefits associated with the initial weight loss,” he added.

The findings change the misconception that people who lose weight with nonsurgical interventions will fail to maintain their weight loss beyond 6 months, he said.

“Our patients maintained 6.4% weight loss after 5 years, and approximately 53% of them achieved an average of 9% weight loss.”

The Why WAIT study is supported by Joslin Diabetes Center. Dr Hamdy reported that he has received research support and is an advisory panel member and author for Metagenics, that he is a consultant and author for Abbott Nutrition and Merck & Co., and that he has received research support and is an author for Neurometrix.

sworcester@frontlinemedcom.com

 * This article was updated on 6/8/2015

BOSTON – Efforts to address obesity with a goal of reducing the risk of adult diabetes should involve overweight children, and should begin as early as age 2 years, particularly in those from racial or ethnic minorities and from low income families, findings from the Early Childhood Longitudinal Study–Birth Cohort of 2001 suggest.

Of 3,400 children from the nationally representative cohort, 15.9% were obese at age 2 years, and the risk of obesity during the preschool years, from age 2 years to 5 years, was 12.1%, Shivani A. Patel, Ph.D., reported in a poster at the annual scientific sessions of the American Diabetes Association.

Those who were overweight vs. normal weight at age 2 years were more likely to be obese at age 5 years (odds ratio, 2.7), said Dr Patel of Emory University, Atlanta.

Incident obesity at age 5 years was higher among Hispanic children (OR, 2.3) and black children (OR, 2.1), compared with white children, and among those from low vs. high income families (OR, 2.1).

Those with birth weight greater than 2,500 g vs. those with low birth weight also were more likely to be obese at age 5 years (OR, 6.6,) as were those whose mothers were obese vs. non-obese before their pregnancy (OR, 2.0), according to Dr. Patel.

“Of overweight 2-years-olds, more than 1 in 4 who were Hispanic, non-Hispanic black, low-income, or who were born to obese mothers became obese by age 5,” she noted.

The Early Childhood Longitudinal Study involves three nationally representative cohorts, including the birth cohort addressed in the current study (children born in 2001 and followed through kindergarten entry), a cohort of children in kindergarten during 1998-1999 who were followed through the eighth grade, and a cohort of children in kindergarten in 2010-2011, who will be followed through the fifth grade. The study is examining child development, school readiness, and early childhood experiences. Normal weight, overweight, and obesity were defined using age-appropriate Centers for Disease Control and Prevention body mass index cut points.

The findings provide important information about incident obesity – a potential risk factor for adult diabetes – in preschool age children; few prior studies have addressed incident obesity in this age group, Dr. Patel said.

She reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com

BOSTON – Efforts to address obesity with a goal of reducing the risk of adult diabetes should involve overweight children, and should begin as early as age 2 years, particularly in those from racial or ethnic minorities and from low income families, findings from the Early Childhood Longitudinal Study–Birth Cohort of 2001 suggest.

Of 3,400 children from the nationally representative cohort, 15.9% were obese at age 2 years, and the risk of obesity during the preschool years, from age 2 years to 5 years, was 12.1%, Shivani A. Patel, Ph.D., reported in a poster at the annual scientific sessions of the American Diabetes Association.

Those who were overweight vs. normal weight at age 2 years were more likely to be obese at age 5 years (odds ratio, 2.7), said Dr Patel of Emory University, Atlanta.

Incident obesity at age 5 years was higher among Hispanic children (OR, 2.3) and black children (OR, 2.1), compared with white children, and among those from low vs. high income families (OR, 2.1).

Those with birth weight greater than 2,500 g vs. those with low birth weight also were more likely to be obese at age 5 years (OR, 6.6,) as were those whose mothers were obese vs. non-obese before their pregnancy (OR, 2.0), according to Dr. Patel.

“Of overweight 2-years-olds, more than 1 in 4 who were Hispanic, non-Hispanic black, low-income, or who were born to obese mothers became obese by age 5,” she noted.

The Early Childhood Longitudinal Study involves three nationally representative cohorts, including the birth cohort addressed in the current study (children born in 2001 and followed through kindergarten entry), a cohort of children in kindergarten during 1998-1999 who were followed through the eighth grade, and a cohort of children in kindergarten in 2010-2011, who will be followed through the fifth grade. The study is examining child development, school readiness, and early childhood experiences. Normal weight, overweight, and obesity were defined using age-appropriate Centers for Disease Control and Prevention body mass index cut points.

The findings provide important information about incident obesity – a potential risk factor for adult diabetes – in preschool age children; few prior studies have addressed incident obesity in this age group, Dr. Patel said.

She reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com

BOSTON – Efforts to address obesity with a goal of reducing the risk of adult diabetes should involve overweight children, and should begin as early as age 2 years, particularly in those from racial or ethnic minorities and from low income families, findings from the Early Childhood Longitudinal Study–Birth Cohort of 2001 suggest.

Of 3,400 children from the nationally representative cohort, 15.9% were obese at age 2 years, and the risk of obesity during the preschool years, from age 2 years to 5 years, was 12.1%, Shivani A. Patel, Ph.D., reported in a poster at the annual scientific sessions of the American Diabetes Association.

Those who were overweight vs. normal weight at age 2 years were more likely to be obese at age 5 years (odds ratio, 2.7), said Dr Patel of Emory University, Atlanta.

Incident obesity at age 5 years was higher among Hispanic children (OR, 2.3) and black children (OR, 2.1), compared with white children, and among those from low vs. high income families (OR, 2.1).

Those with birth weight greater than 2,500 g vs. those with low birth weight also were more likely to be obese at age 5 years (OR, 6.6,) as were those whose mothers were obese vs. non-obese before their pregnancy (OR, 2.0), according to Dr. Patel.

“Of overweight 2-years-olds, more than 1 in 4 who were Hispanic, non-Hispanic black, low-income, or who were born to obese mothers became obese by age 5,” she noted.

The Early Childhood Longitudinal Study involves three nationally representative cohorts, including the birth cohort addressed in the current study (children born in 2001 and followed through kindergarten entry), a cohort of children in kindergarten during 1998-1999 who were followed through the eighth grade, and a cohort of children in kindergarten in 2010-2011, who will be followed through the fifth grade. The study is examining child development, school readiness, and early childhood experiences. Normal weight, overweight, and obesity were defined using age-appropriate Centers for Disease Control and Prevention body mass index cut points.

The findings provide important information about incident obesity – a potential risk factor for adult diabetes – in preschool age children; few prior studies have addressed incident obesity in this age group, Dr. Patel said.

She reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com

DENVER – Obstructive sleep apnea was common among patients in the multinational Sleep and Stent Study who underwent successful percutaneous coronary intervention, but most of those affected had no daytime sleepiness, and only about half had positive findings on the Berlin Questionnaire.

Further, findings at up to 4 years of follow-up show that coronary artery disease patients with vs. without obstructive sleep apnea (OSA) had nearly twice the risk of adverse events.

The findings suggest that OSA has important clinical implications for coronary artery disease (CAD), and that validated tools for identifying OSA risk in the general population may not be useful in those with cardiovascular disease, Sofia Furlan, Ph.D. said in a press briefing at an international conference of the American Thoracic Society.

Of 1,305 patients included in the ongoing observational study, 45% had OSA, including 21.8% who had severe OSA defined by an apnea-hypopnea index of 30 or more events/hour. Excessive daytime sleepiness, defined as an Epworth Sleepiness Scale score of greater than 10, was identified in 24.5% of the OSA patients, and a Berlin Questionnaire score indicative of high risk for OSA was found in 54.3% of patients with OSA, said Dr. Furlan of the University of Sao Paulo, Brazil.

The adverse event rate was 11% in CAD patients with OSA, compared with 6.5% in those without OSA – a significant difference thus far in the study, Dr. Furlan noted.

Patients in the Sleep and Stent Study, which was designed to look at the relationships between OSA and cardiovascular outcomes in adults treated with percutaneous coronary intervention, were aged 18-80 years and were enrolled from eight centers in five countries: Singapore, China and Hong Kong, India, Myanmar, and Brazil.

Indications for percutaneous coronary intervention included ST segment elevation myocardial infarction in 33% of subjects, non-ST segment elevation myocardial infarction in 20% of subjects, unstable angina in 16% of subjects, and stable angina in 31% of subjects. All patients underwent an overnight sleep study using a level-3 portable diagnostic device prior to hospital discharge, and the tracings were analyzed by a blinded sleep physician.

The prevalence of OSA was comparable across study sites, Dr. Furlan said.

The findings reinforce the known association between OSA and cardiovascular disease, lead researcher Dr. Luciano Drager, also of the University of Sao Paulo, said in a press statement.

“Earlier studies have shown strong relationships between sleep apnea and a number of cardiovascular conditions, including high blood pressure, arrhythmia, stroke, and heart failure. Our study supports this strong association between OSA and heart disease and also suggests that the methods used to screen for OSA in patients with cardiovascular disease need to be improved,” Dr. Drager said.

Given the apparent association between sleep apnea and adverse outcomes in patients with CAD, and the fact that sleep apnea is underdiagnosed, it may be time to consider monitoring for sleep apnea in CAD patients, Dr. Furlan added.

Non–sleep related predictors of OSA in patients with cardiovascular disease also should be explored, she said.

Press briefing moderator Dr. Mihaela Teodorescu of the University of Wisconsin, Madison, noted that other studies also have suggested that coexistent OSA manifests differently in different disease states.

“This is a very good example. Whereas in the general population sleepiness is one of the major presenting symptoms, in this particularly vulnerable population with heart attacks and severe coronary artery disease, these people are not sleepy, ” she said, adding that “current screening questionnaires, which are relatively widely used in clinical populations, may not do the job.”

In fact, if traditional criteria for diagnosis are used, a large proportion of patients with OSA will be missed, she said.

“To me as a clinician, this is the major take-home message: Don’t rely on symptoms, because we will miss a large proportion of patients simply based on that.”

The investigators reported having no disclosures. The Sleep and Stent Study is sponsored by Boston Scientific Corporation.

DENVER – Obstructive sleep apnea was common among patients in the multinational Sleep and Stent Study who underwent successful percutaneous coronary intervention, but most of those affected had no daytime sleepiness, and only about half had positive findings on the Berlin Questionnaire.

Further, findings at up to 4 years of follow-up show that coronary artery disease patients with vs. without obstructive sleep apnea (OSA) had nearly twice the risk of adverse events.

The findings suggest that OSA has important clinical implications for coronary artery disease (CAD), and that validated tools for identifying OSA risk in the general population may not be useful in those with cardiovascular disease, Sofia Furlan, Ph.D. said in a press briefing at an international conference of the American Thoracic Society.

Of 1,305 patients included in the ongoing observational study, 45% had OSA, including 21.8% who had severe OSA defined by an apnea-hypopnea index of 30 or more events/hour. Excessive daytime sleepiness, defined as an Epworth Sleepiness Scale score of greater than 10, was identified in 24.5% of the OSA patients, and a Berlin Questionnaire score indicative of high risk for OSA was found in 54.3% of patients with OSA, said Dr. Furlan of the University of Sao Paulo, Brazil.

The adverse event rate was 11% in CAD patients with OSA, compared with 6.5% in those without OSA – a significant difference thus far in the study, Dr. Furlan noted.

Patients in the Sleep and Stent Study, which was designed to look at the relationships between OSA and cardiovascular outcomes in adults treated with percutaneous coronary intervention, were aged 18-80 years and were enrolled from eight centers in five countries: Singapore, China and Hong Kong, India, Myanmar, and Brazil.

Indications for percutaneous coronary intervention included ST segment elevation myocardial infarction in 33% of subjects, non-ST segment elevation myocardial infarction in 20% of subjects, unstable angina in 16% of subjects, and stable angina in 31% of subjects. All patients underwent an overnight sleep study using a level-3 portable diagnostic device prior to hospital discharge, and the tracings were analyzed by a blinded sleep physician.

The prevalence of OSA was comparable across study sites, Dr. Furlan said.

The findings reinforce the known association between OSA and cardiovascular disease, lead researcher Dr. Luciano Drager, also of the University of Sao Paulo, said in a press statement.

“Earlier studies have shown strong relationships between sleep apnea and a number of cardiovascular conditions, including high blood pressure, arrhythmia, stroke, and heart failure. Our study supports this strong association between OSA and heart disease and also suggests that the methods used to screen for OSA in patients with cardiovascular disease need to be improved,” Dr. Drager said.

Given the apparent association between sleep apnea and adverse outcomes in patients with CAD, and the fact that sleep apnea is underdiagnosed, it may be time to consider monitoring for sleep apnea in CAD patients, Dr. Furlan added.

Non–sleep related predictors of OSA in patients with cardiovascular disease also should be explored, she said.

Press briefing moderator Dr. Mihaela Teodorescu of the University of Wisconsin, Madison, noted that other studies also have suggested that coexistent OSA manifests differently in different disease states.

“This is a very good example. Whereas in the general population sleepiness is one of the major presenting symptoms, in this particularly vulnerable population with heart attacks and severe coronary artery disease, these people are not sleepy, ” she said, adding that “current screening questionnaires, which are relatively widely used in clinical populations, may not do the job.”

In fact, if traditional criteria for diagnosis are used, a large proportion of patients with OSA will be missed, she said.

“To me as a clinician, this is the major take-home message: Don’t rely on symptoms, because we will miss a large proportion of patients simply based on that.”

The investigators reported having no disclosures. The Sleep and Stent Study is sponsored by Boston Scientific Corporation.

DENVER – Obstructive sleep apnea was common among patients in the multinational Sleep and Stent Study who underwent successful percutaneous coronary intervention, but most of those affected had no daytime sleepiness, and only about half had positive findings on the Berlin Questionnaire.

Further, findings at up to 4 years of follow-up show that coronary artery disease patients with vs. without obstructive sleep apnea (OSA) had nearly twice the risk of adverse events.

The findings suggest that OSA has important clinical implications for coronary artery disease (CAD), and that validated tools for identifying OSA risk in the general population may not be useful in those with cardiovascular disease, Sofia Furlan, Ph.D. said in a press briefing at an international conference of the American Thoracic Society.

Of 1,305 patients included in the ongoing observational study, 45% had OSA, including 21.8% who had severe OSA defined by an apnea-hypopnea index of 30 or more events/hour. Excessive daytime sleepiness, defined as an Epworth Sleepiness Scale score of greater than 10, was identified in 24.5% of the OSA patients, and a Berlin Questionnaire score indicative of high risk for OSA was found in 54.3% of patients with OSA, said Dr. Furlan of the University of Sao Paulo, Brazil.

The adverse event rate was 11% in CAD patients with OSA, compared with 6.5% in those without OSA – a significant difference thus far in the study, Dr. Furlan noted.

Patients in the Sleep and Stent Study, which was designed to look at the relationships between OSA and cardiovascular outcomes in adults treated with percutaneous coronary intervention, were aged 18-80 years and were enrolled from eight centers in five countries: Singapore, China and Hong Kong, India, Myanmar, and Brazil.

Indications for percutaneous coronary intervention included ST segment elevation myocardial infarction in 33% of subjects, non-ST segment elevation myocardial infarction in 20% of subjects, unstable angina in 16% of subjects, and stable angina in 31% of subjects. All patients underwent an overnight sleep study using a level-3 portable diagnostic device prior to hospital discharge, and the tracings were analyzed by a blinded sleep physician.

The prevalence of OSA was comparable across study sites, Dr. Furlan said.

The findings reinforce the known association between OSA and cardiovascular disease, lead researcher Dr. Luciano Drager, also of the University of Sao Paulo, said in a press statement.

“Earlier studies have shown strong relationships between sleep apnea and a number of cardiovascular conditions, including high blood pressure, arrhythmia, stroke, and heart failure. Our study supports this strong association between OSA and heart disease and also suggests that the methods used to screen for OSA in patients with cardiovascular disease need to be improved,” Dr. Drager said.

Given the apparent association between sleep apnea and adverse outcomes in patients with CAD, and the fact that sleep apnea is underdiagnosed, it may be time to consider monitoring for sleep apnea in CAD patients, Dr. Furlan added.

Non–sleep related predictors of OSA in patients with cardiovascular disease also should be explored, she said.

Press briefing moderator Dr. Mihaela Teodorescu of the University of Wisconsin, Madison, noted that other studies also have suggested that coexistent OSA manifests differently in different disease states.

“This is a very good example. Whereas in the general population sleepiness is one of the major presenting symptoms, in this particularly vulnerable population with heart attacks and severe coronary artery disease, these people are not sleepy, ” she said, adding that “current screening questionnaires, which are relatively widely used in clinical populations, may not do the job.”

In fact, if traditional criteria for diagnosis are used, a large proportion of patients with OSA will be missed, she said.

“To me as a clinician, this is the major take-home message: Don’t rely on symptoms, because we will miss a large proportion of patients simply based on that.”

The investigators reported having no disclosures. The Sleep and Stent Study is sponsored by Boston Scientific Corporation.

DENVER – Obstructive sleep apnea was common among patients in the multinational Sleep and Stent Study who underwent successful percutaneous coronary intervention, but most of those affected had no daytime sleepiness, and only about half had positive findings on the Berlin Questionnaire.

Further, findings at up to 4 years of follow-up show that coronary artery disease patients with vs. without obstructive sleep apnea (OSA) had nearly twice the risk of adverse events.

The findings suggest that OSA has important clinical implications for coronary artery disease (CAD), and that validated tools for identifying OSA risk in the general population may not be useful in those with cardiovascular disease, Sofia Furlan, Ph.D. said in a press briefing at an international conference of the American Thoracic Society.

Of 1,305 patients included in the ongoing observational study, 45% had OSA, including 21.8% who had severe OSA defined by an apnea-hypopnea index of 30 or more events/hour. Excessive daytime sleepiness, defined as an Epworth Sleepiness Scale score of greater than 10, was identified in 24.5% of the OSA patients, and a Berlin Questionnaire score indicative of high risk for OSA was found in 54.3% of patients with OSA, said Dr. Furlan of the University of Sao Paulo, Brazil.

The adverse event rate was 11% in CAD patients with OSA, compared with 6.5% in those without OSA – a significant difference thus far in the study, Dr. Furlan noted.

Patients in the Sleep and Stent Study, which was designed to look at the relationships between OSA and cardiovascular outcomes in adults treated with percutaneous coronary intervention, were aged 18-80 years and were enrolled from eight centers in five countries: Singapore, China and Hong Kong, India, Myanmar, and Brazil.

Indications for percutaneous coronary intervention included ST segment elevation myocardial infarction in 33% of subjects, non-ST segment elevation myocardial infarction in 20% of subjects, unstable angina in 16% of subjects, and stable angina in 31% of subjects. All patients underwent an overnight sleep study using a level-3 portable diagnostic device prior to hospital discharge, and the tracings were analyzed by a blinded sleep physician.

The prevalence of OSA was comparable across study sites, Dr. Furlan said.

The findings reinforce the known association between OSA and cardiovascular disease, lead researcher Dr. Luciano Drager, also of the University of Sao Paulo, said in a press statement.

“Earlier studies have shown strong relationships between sleep apnea and a number of cardiovascular conditions, including high blood pressure, arrhythmia, stroke, and heart failure. Our study supports this strong association between OSA and heart disease and also suggests that the methods used to screen for OSA in patients with cardiovascular disease need to be improved,” Dr. Drager said.

Given the apparent association between sleep apnea and adverse outcomes in patients with CAD, and the fact that sleep apnea is underdiagnosed, it may be time to consider monitoring for sleep apnea in CAD patients, Dr. Furlan added.

Non–sleep related predictors of OSA in patients with cardiovascular disease also should be explored, she said.

Press briefing moderator Dr. Mihaela Teodorescu of the University of Wisconsin, Madison, noted that other studies also have suggested that coexistent OSA manifests differently in different disease states.

“This is a very good example. Whereas in the general population sleepiness is one of the major presenting symptoms, in this particularly vulnerable population with heart attacks and severe coronary artery disease, these people are not sleepy, ” she said, adding that “current screening questionnaires, which are relatively widely used in clinical populations, may not do the job.”

In fact, if traditional criteria for diagnosis are used, a large proportion of patients with OSA will be missed, she said.

“To me as a clinician, this is the major take-home message: Don’t rely on symptoms, because we will miss a large proportion of patients simply based on that.”

The investigators reported having no disclosures. The Sleep and Stent Study is sponsored by Boston Scientific Corporation.

sworcester@frontlinemedcom.com

DENVER – Obstructive sleep apnea was common among patients in the multinational Sleep and Stent Study who underwent successful percutaneous coronary intervention, but most of those affected had no daytime sleepiness, and only about half had positive findings on the Berlin Questionnaire.

Further, findings at up to 4 years of follow-up show that coronary artery disease patients with vs. without obstructive sleep apnea (OSA) had nearly twice the risk of adverse events.

The findings suggest that OSA has important clinical implications for coronary artery disease (CAD), and that validated tools for identifying OSA risk in the general population may not be useful in those with cardiovascular disease, Sofia Furlan, Ph.D. said in a press briefing at an international conference of the American Thoracic Society.

Of 1,305 patients included in the ongoing observational study, 45% had OSA, including 21.8% who had severe OSA defined by an apnea-hypopnea index of 30 or more events/hour. Excessive daytime sleepiness, defined as an Epworth Sleepiness Scale score of greater than 10, was identified in 24.5% of the OSA patients, and a Berlin Questionnaire score indicative of high risk for OSA was found in 54.3% of patients with OSA, said Dr. Furlan of the University of Sao Paulo, Brazil.

The adverse event rate was 11% in CAD patients with OSA, compared with 6.5% in those without OSA – a significant difference thus far in the study, Dr. Furlan noted.

Patients in the Sleep and Stent Study, which was designed to look at the relationships between OSA and cardiovascular outcomes in adults treated with percutaneous coronary intervention, were aged 18-80 years and were enrolled from eight centers in five countries: Singapore, China and Hong Kong, India, Myanmar, and Brazil.

Indications for percutaneous coronary intervention included ST segment elevation myocardial infarction in 33% of subjects, non-ST segment elevation myocardial infarction in 20% of subjects, unstable angina in 16% of subjects, and stable angina in 31% of subjects. All patients underwent an overnight sleep study using a level-3 portable diagnostic device prior to hospital discharge, and the tracings were analyzed by a blinded sleep physician.

The prevalence of OSA was comparable across study sites, Dr. Furlan said.

The findings reinforce the known association between OSA and cardiovascular disease, lead researcher Dr. Luciano Drager, also of the University of Sao Paulo, said in a press statement.

“Earlier studies have shown strong relationships between sleep apnea and a number of cardiovascular conditions, including high blood pressure, arrhythmia, stroke, and heart failure. Our study supports this strong association between OSA and heart disease and also suggests that the methods used to screen for OSA in patients with cardiovascular disease need to be improved,” Dr. Drager said.

Given the apparent association between sleep apnea and adverse outcomes in patients with CAD, and the fact that sleep apnea is underdiagnosed, it may be time to consider monitoring for sleep apnea in CAD patients, Dr. Furlan added.

Non–sleep related predictors of OSA in patients with cardiovascular disease also should be explored, she said.

Press briefing moderator Dr. Mihaela Teodorescu of the University of Wisconsin, Madison, noted that other studies also have suggested that coexistent OSA manifests differently in different disease states.

“This is a very good example. Whereas in the general population sleepiness is one of the major presenting symptoms, in this particularly vulnerable population with heart attacks and severe coronary artery disease, these people are not sleepy, ” she said, adding that “current screening questionnaires, which are relatively widely used in clinical populations, may not do the job.”

In fact, if traditional criteria for diagnosis are used, a large proportion of patients with OSA will be missed, she said.

“To me as a clinician, this is the major take-home message: Don’t rely on symptoms, because we will miss a large proportion of patients simply based on that.”

The investigators reported having no disclosures. The Sleep and Stent Study is sponsored by Boston Scientific Corporation.

sworcester@frontlinemedcom.com

DENVER – Obstructive sleep apnea was common among patients in the multinational Sleep and Stent Study who underwent successful percutaneous coronary intervention, but most of those affected had no daytime sleepiness, and only about half had positive findings on the Berlin Questionnaire.

Further, findings at up to 4 years of follow-up show that coronary artery disease patients with vs. without obstructive sleep apnea (OSA) had nearly twice the risk of adverse events.

The findings suggest that OSA has important clinical implications for coronary artery disease (CAD), and that validated tools for identifying OSA risk in the general population may not be useful in those with cardiovascular disease, Sofia Furlan, Ph.D. said in a press briefing at an international conference of the American Thoracic Society.

Of 1,305 patients included in the ongoing observational study, 45% had OSA, including 21.8% who had severe OSA defined by an apnea-hypopnea index of 30 or more events/hour. Excessive daytime sleepiness, defined as an Epworth Sleepiness Scale score of greater than 10, was identified in 24.5% of the OSA patients, and a Berlin Questionnaire score indicative of high risk for OSA was found in 54.3% of patients with OSA, said Dr. Furlan of the University of Sao Paulo, Brazil.

The adverse event rate was 11% in CAD patients with OSA, compared with 6.5% in those without OSA – a significant difference thus far in the study, Dr. Furlan noted.

Patients in the Sleep and Stent Study, which was designed to look at the relationships between OSA and cardiovascular outcomes in adults treated with percutaneous coronary intervention, were aged 18-80 years and were enrolled from eight centers in five countries: Singapore, China and Hong Kong, India, Myanmar, and Brazil.

Indications for percutaneous coronary intervention included ST segment elevation myocardial infarction in 33% of subjects, non-ST segment elevation myocardial infarction in 20% of subjects, unstable angina in 16% of subjects, and stable angina in 31% of subjects. All patients underwent an overnight sleep study using a level-3 portable diagnostic device prior to hospital discharge, and the tracings were analyzed by a blinded sleep physician.

The prevalence of OSA was comparable across study sites, Dr. Furlan said.

The findings reinforce the known association between OSA and cardiovascular disease, lead researcher Dr. Luciano Drager, also of the University of Sao Paulo, said in a press statement.

“Earlier studies have shown strong relationships between sleep apnea and a number of cardiovascular conditions, including high blood pressure, arrhythmia, stroke, and heart failure. Our study supports this strong association between OSA and heart disease and also suggests that the methods used to screen for OSA in patients with cardiovascular disease need to be improved,” Dr. Drager said.

Given the apparent association between sleep apnea and adverse outcomes in patients with CAD, and the fact that sleep apnea is underdiagnosed, it may be time to consider monitoring for sleep apnea in CAD patients, Dr. Furlan added.

Non–sleep related predictors of OSA in patients with cardiovascular disease also should be explored, she said.

Press briefing moderator Dr. Mihaela Teodorescu of the University of Wisconsin, Madison, noted that other studies also have suggested that coexistent OSA manifests differently in different disease states.

“This is a very good example. Whereas in the general population sleepiness is one of the major presenting symptoms, in this particularly vulnerable population with heart attacks and severe coronary artery disease, these people are not sleepy, ” she said, adding that “current screening questionnaires, which are relatively widely used in clinical populations, may not do the job.”

In fact, if traditional criteria for diagnosis are used, a large proportion of patients with OSA will be missed, she said.

“To me as a clinician, this is the major take-home message: Don’t rely on symptoms, because we will miss a large proportion of patients simply based on that.”

The investigators reported having no disclosures. The Sleep and Stent Study is sponsored by Boston Scientific Corporation.

sworcester@frontlinemedcom.com

DENVER – Obesity and weight gain of more than 5 kg during the first trimester in women with asthma are significant predictors of asthma exacerbation during pregnancy, according to findings from the Management of Asthma during Pregnancy (MAP) study.

Of 1,018 women in the prospective study, 370 experienced a total of 407 asthma exacerbations. The risk of exacerbation was greatest in those with body mass index over 30 kg/m² (odds ratio, 2.2) and in those with gestational weight gain of more than 5 kg in the first trimester (OR, 8.2), Zarqa Ali of Hvidovre Hospital, Copenhagen, and colleagues reported in a poster at an international conference of the American Thoracic Society.

©JGI/Thinkstock.com

Other risk factors for exacerbation included previous asthma exacerbations (OR, 1.3), uncontrolled asthma (OR, 2), inhaled corticosteroid treatment (OR, 5.8), and current and former smoking (OR, 1.9), the investigators said.

Risk factors for severe exacerbation of asthma, which occurred in 157 women, included gestational weight gain of greater than 5 kg (OR, 4.1), and age (OR, 1.1).

After excluding women with a prepregnancy body mass index above the mean of 24.1, risk factors for exacerbation included first-trimester weight gain greater than 5 kg (OR, 13.1) and lower prepregnancy body weight (OR, 0.9), they noted.

Women included in the study had a diagnosis of asthma, had been prescribed rescue bronchodilator therapy, had their first outpatient clinic visit within the first 18 weeks of pregnancy, and were seen for scheduled visits about every 4 weeks during pregnancy and for 3 months post partum. The women had a mean age of 31 years, 73% had never smoked, and their mean forced expiratory volume in 1 second (FEV₁) % predicted was 92, and mean exhaled nitric oxide was 20 ppb.

FEV₁% predicted was significantly greater at baseline in those without exacerbations vs. with exacerbations (93 vs. 90), and exhaled nitric oxide was significantly lower in the groups, respectively (18 vs. 23 ppb).

The findings are important, as acute exacerbations of asthma during pregnancy may be the most significant risk factor for unfavorable pregnancy outcomes in women with asthma, the investigators said, noting that exacerbations occur in about 30% of pregnant women with asthma and are associated with complications such as preterm delivery, low birth weight, excessive antepartum hemorrhage, and cesarean delivery.

Risk factors for exacerbation identified in prior studies include severe asthma, viral infections, nonadherence to controller medication, tobacco exposure, and possibly fetal gender and maternal body mass index, the investigators said.

The investigators reported having no disclosures.

sworcester@frontlinemedcom.com

DENVER – Obesity and weight gain of more than 5 kg during the first trimester in women with asthma are significant predictors of asthma exacerbation during pregnancy, according to findings from the Management of Asthma during Pregnancy (MAP) study.

Of 1,018 women in the prospective study, 370 experienced a total of 407 asthma exacerbations. The risk of exacerbation was greatest in those with body mass index over 30 kg/m² (odds ratio, 2.2) and in those with gestational weight gain of more than 5 kg in the first trimester (OR, 8.2), Zarqa Ali of Hvidovre Hospital, Copenhagen, and colleagues reported in a poster at an international conference of the American Thoracic Society.

©JGI/Thinkstock.com

Other risk factors for exacerbation included previous asthma exacerbations (OR, 1.3), uncontrolled asthma (OR, 2), inhaled corticosteroid treatment (OR, 5.8), and current and former smoking (OR, 1.9), the investigators said.

Risk factors for severe exacerbation of asthma, which occurred in 157 women, included gestational weight gain of greater than 5 kg (OR, 4.1), and age (OR, 1.1).

After excluding women with a prepregnancy body mass index above the mean of 24.1, risk factors for exacerbation included first-trimester weight gain greater than 5 kg (OR, 13.1) and lower prepregnancy body weight (OR, 0.9), they noted.

Women included in the study had a diagnosis of asthma, had been prescribed rescue bronchodilator therapy, had their first outpatient clinic visit within the first 18 weeks of pregnancy, and were seen for scheduled visits about every 4 weeks during pregnancy and for 3 months post partum. The women had a mean age of 31 years, 73% had never smoked, and their mean forced expiratory volume in 1 second (FEV₁) % predicted was 92, and mean exhaled nitric oxide was 20 ppb.

FEV₁% predicted was significantly greater at baseline in those without exacerbations vs. with exacerbations (93 vs. 90), and exhaled nitric oxide was significantly lower in the groups, respectively (18 vs. 23 ppb).

The findings are important, as acute exacerbations of asthma during pregnancy may be the most significant risk factor for unfavorable pregnancy outcomes in women with asthma, the investigators said, noting that exacerbations occur in about 30% of pregnant women with asthma and are associated with complications such as preterm delivery, low birth weight, excessive antepartum hemorrhage, and cesarean delivery.

Risk factors for exacerbation identified in prior studies include severe asthma, viral infections, nonadherence to controller medication, tobacco exposure, and possibly fetal gender and maternal body mass index, the investigators said.

The investigators reported having no disclosures.

sworcester@frontlinemedcom.com

DENVER – Obesity and weight gain of more than 5 kg during the first trimester in women with asthma are significant predictors of asthma exacerbation during pregnancy, according to findings from the Management of Asthma during Pregnancy (MAP) study.

Of 1,018 women in the prospective study, 370 experienced a total of 407 asthma exacerbations. The risk of exacerbation was greatest in those with body mass index over 30 kg/m² (odds ratio, 2.2) and in those with gestational weight gain of more than 5 kg in the first trimester (OR, 8.2), Zarqa Ali of Hvidovre Hospital, Copenhagen, and colleagues reported in a poster at an international conference of the American Thoracic Society.

©JGI/Thinkstock.com

Other risk factors for exacerbation included previous asthma exacerbations (OR, 1.3), uncontrolled asthma (OR, 2), inhaled corticosteroid treatment (OR, 5.8), and current and former smoking (OR, 1.9), the investigators said.

Risk factors for severe exacerbation of asthma, which occurred in 157 women, included gestational weight gain of greater than 5 kg (OR, 4.1), and age (OR, 1.1).

After excluding women with a prepregnancy body mass index above the mean of 24.1, risk factors for exacerbation included first-trimester weight gain greater than 5 kg (OR, 13.1) and lower prepregnancy body weight (OR, 0.9), they noted.

Women included in the study had a diagnosis of asthma, had been prescribed rescue bronchodilator therapy, had their first outpatient clinic visit within the first 18 weeks of pregnancy, and were seen for scheduled visits about every 4 weeks during pregnancy and for 3 months post partum. The women had a mean age of 31 years, 73% had never smoked, and their mean forced expiratory volume in 1 second (FEV₁) % predicted was 92, and mean exhaled nitric oxide was 20 ppb.

FEV₁% predicted was significantly greater at baseline in those without exacerbations vs. with exacerbations (93 vs. 90), and exhaled nitric oxide was significantly lower in the groups, respectively (18 vs. 23 ppb).

The findings are important, as acute exacerbations of asthma during pregnancy may be the most significant risk factor for unfavorable pregnancy outcomes in women with asthma, the investigators said, noting that exacerbations occur in about 30% of pregnant women with asthma and are associated with complications such as preterm delivery, low birth weight, excessive antepartum hemorrhage, and cesarean delivery.

Risk factors for exacerbation identified in prior studies include severe asthma, viral infections, nonadherence to controller medication, tobacco exposure, and possibly fetal gender and maternal body mass index, the investigators said.

The investigators reported having no disclosures.

sworcester@frontlinemedcom.com