Lorcaserin prevents or causes remission of T2DM in overweight/obese patients with or at high risk of CVD (CAMELLIA-TIMI 61)

Reference

Bohula EA, Scirica BM, Inzucchi SE, et al, for the AMELLIA-TIMI 61 Steering Committee Investigators. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial. Lancet 2018;392(10161):2269-2279.

Synopsis

Researchers recruited overweight or obese patients (body mass index = 27 kg/m2 or higher) who had either (1) established CVD (coronary, cerebrovascular, or peripheral artery disease) and were at least 40 years of age, or (2) T2DM plus one additional CVD risk factor—such as hypertension, dyslipidemia, and so forth—and were at least 50 years of age (men) or at least 55 years of age (women) The researchers excluded patients with glycohemoglobin concentrations higher than 10%; severe pulmonary hypertension, heart failure, or hepatic dysfunction; severe valvular disease or renal dysfunction; planned bariatric surgery; or the use of pharmacological weight-loss therapy. All participants were also encouraged to participate in a multicomponent weight-management program that included dietary and exercise information and unlimited telephone access to a registered dietitian. Patients took locaserin 10 mg twice daily (n = 6000) or matched placebo (n = 6000) for a median of 3.3 years. Most of the patients (6816) had T2DM, 3991 had prediabetes, and 1193 were normoglycemic. The researchers evaluated the patients every 3 months for the first 2 years following randomization and then every 4 months thereafter. At the end of follow-up, among patients with prediabetes, 8.5% of locaserin-treated patients developed T2DM compared with 10.3% of placebo-treated patients (number needed to treat [NNT] = 56) and among all patients without overt T2DM, the rates were 6.7% and 8.4%, respectively (NNT = 58). Among patients with established T2DM, 16.3% of locaserin-treated patients experienced remission that was sustained in 12.7% compared with 13.7% and 10.0% in placebo-treated patients (NNT = 39 and 38, respectively). There was no meaningful difference in the rates of retinopathy or neuropathy between the treatment groups, but locaserin-treated patients were less likely to develop persistent microalbuminuria (7.8%) than were placebo-treated patients (10.0%). The authors combine these into a composite of all microvascular complications that makes it look like the clinically relevant outcomes are affected when they are not. The authors don't report on harms other than hypoglycemia in patients with T2DM at baseline, which occurred more frequently in locaserin-treated patients (0.4%) than in placebo-treated patients (0.1%). According to GoodRx.com, 1 month of lorcaserin costs about $300.