Hypoglycemia was a pre-specified safety outcome.

Other secondary outcomes included diabetic microvascular complications. The pre-specified secondary efficacy outcomes included incident diabetes in patients without diabetes, achievement of normoglycemia in individuals with prediabetes and change in glycated hemoglobin (HbA 1C) in those with diabetes. The primary efficacy outcome was incident diabetes among patients with prediabetes at baseline. The CAMELLIA-TIMI 61 study involved 12,000 overweight or obese patients (body mass index ≥27 kg/m 2) with atherosclerotic cardiovascular disease or multiple cardiovascular risk factors and compared lorcaserin (10 mg twice daily) with placebo. 8 Lorcaserin is a serotonergic agonist that primarily acts on 5-hydroxytryptamine 2C receptors and inhibits appetite in part via activation of the anorexigenic pro-opiomelanocortin pathway. 8 This study aimed at evaluating long-term cardiovascular and metabolic safety and efficacy of lorcaserin as part of a post-marketing requirement by the FDA.

Concerns for the safety of an FDA-approved drug lorcaserin as an adjunct to lifestyle changes for chronic weight management led to the establishment of the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial. 7 Hitherto, the use of weight loss medications in addition to lifestyle modification for diabetes prevention or management is not recommended, as these medications have not been formally tested in large-scale clinical trials for such an indication, and because of a lack of data on their efficacy and safety profile. While a number of medications have been evaluated for diabetes prevention in clinical trials, only metformin is recommended by the American Diabetes Association (ADA) for diabetes prevention in specific patient subgroups. 5,6 Consequently, weight loss medications are a consideration as adjunctive therapy for diabetes prevention. 3,4 However, implementing lifestyle modification that results in sustainable weight loss is challenging. 2 Studies show that lifestyle modification can lead to prevention or remission of diabetes, mainly through weight loss. 1 This high disease prevalence parallels that of obesity. Prediabetes and type 2 diabetes mellitus are highly prevalent in the United States, each affecting approximately 38% and 12% of adults, respectively.

Camellia timi 61