According to new data from the CAMELLIA-TIMI 61 study, treatment with lorcaserin (Belviq; Eisai) was associated with a reduced risk of incident diabetes in patients with prediabetes. Findings from the study were presented at the European Association for the Study of Diabetes annual meeting and published in The Lancet.
Lorcaserin, a serotonin 2C receptor agonist, is currently approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least 1 weight-related comorbidity (eg, hypertension, dyslipidemia, type 2 diabetes). In CAMELLIA-TIMI 61, researchers recruited overweight or obese patients with or at high risk for atherosclerotic vascular disease (N=12,000) and randomized them to receive either lorcaserin or placebo. In this new analysis, researchers looked at the long-term effects of the drug on diabetes prevention and remission in these patients. At baseline, 56.8% of patients had diabetes, 33.3% had prediabetes, and 9.9% were normoglycemic; patients were followed for a median of 3.3 years.
Results showed that compared with placebo, treatment with lorcaserin reduced the risk of incident diabetes by 19% (8.5% vs. 10.3%; HR 0.81; 95% CI: 0.66-0.99; P=.038) in patients with prediabetes and by 23% in patients without diabetes (6.7% vs 8.4% HR 0.77; 95% CI: 0.63-0.94; P=.012). Moreover, lorcaserin was associated with a non-significant increase in the rate of normoglycemia achievement in patients with prediabetes (9.2% vs. 7.6%; HR 1.20, 0.97-1.49; P=.093) and increased the rate of hyperglycemia remission in patients with diabetes (7.1% vs. 6.0%; HR 1.21, 1.00-1.45; P=.049).
In patients with diabetes, lorcarserin reduced HbA1c by 0.33% (95% CI: 0.29-0.38; P<.0001) from a mean baseline of 7.0%, compared with placebo at 1 year. In patients with baseline HbA1c >8.0%, lorcaserin was associated with a mean reduction in HbA1c at 1 year of 0.87% (95% CI: 0.76−0.97) compared with 0.35% (95% CI: 0.23−0.46) for placebo. In addition, treatment with lorcaserin reduced the risk for microvascular events (composite of incident microalbuminuria, diabetic retinopathy or neuropathy) by 21%.
“The prevalence of diabetes is growing, which is likely related in part to the increasing prevalence of obesity,” said Erin Bohula, MD, DPHIL cardiologist and staff investigator, TIMI Study Group, Brigham and Women’s Hospital. “These data provide valuable information to doctors treating patients that are overweight and obese with T2DM or who are at risk of developing T2DM.”
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