Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Abstract BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)

The Predictive Syndemic Effect of Multiple Psychosocial Problems on Health Care Costs and Utilization among Sexual Minority Women

Previous studies documenting sexual minority women’s disproportionate risk for a range of medical, mental health, and substance use disorders have not provided a predictive framework for understanding their interrelations and outcomes. The present study aimed to address this gap by testing the syndemic effect of co-occurring psychosocial problems on 7-year health care costs and utilization among sexual minority women. The sample was comprised of sexual minority women (N = 341) who were seen at an urban LGBT-affirmative community health center. Medical and mental health care utilization and cost data were extracted from electronic medical records. Demographically adjusted regression models revealed that co-occurring psychosocial problems (i.e., childhood sexual abuse, partner violence, substance use, and mental health distress [history of suicide attempt]) were all strongly interrelated. The presence of these indicators had a syndemic (additive) effect on medical costs and utilization and mental health utilization over 7-year follow-up, but no effect on 7-year mental health costs. These results suggest that the presence and additive effect of these syndemic conditions may, in part, explain increased medical costs and utilization (and higher medical morbidity) among sexual minority women