Lorcaserin resulted in a non-significant increase in the rate of achievement of normoglycaemia in patients with prediabetes (185 vs 151 1♲0, 0♹7–1♴9 p=0♰93). At 1 year, patients treated with lorcaserin had a net weight loss beyond placebo of 2♶ kg (95% CI 2♳–2♹) for those with diabetes, 2♸ kg (2♵–3♲) for those with prediabetes, and 3♳ kg (2♶–4♰) for those with normoglycaemia (p vs 204 of 1976 hazard ratio 0♸1, 95% CI 0♶6–0♹9 p=0♰38) and by 23% in patients without diabetes (174 of 2615 vs 215 of 2569 0♷7, 0♶3–0♹4 p=0♰12). Findings Between Feb 7, 2014, and Nov 20, 2015, 12 000 patients were randomly assigned to lorcaserin or placebo (6000 patients in each group) and followed up for a median of 3♳ years (IQR 3♰–3♵). This trial is registered with, number NCT02019264. Analysis was by intention to treat, using Cox proportional hazard models for time-to-event analyses. Hypoglycaemia was a prespecified safety outcome. The prespecified secondary outcomes for efficacy were incident diabetes in all patients without diabetes, achievement of normoglycaemia in patients with prediabetes, and change in glycated haemoglobin (HbA 1c ) in patients with diabetes. The prespecified primary metabolic efficacy endpoint of time to incident diabetes was assessed in patients with prediabetes at baseline. Additionally, all patients had access to a standardised weight management programme based on lifestyle modification. Patients were randomly assigned to receive either lorcaserin (10 mg twice daily) or matching placebo. Eligible patients were aged 40 years or older patients at high risk for atherosclerotic vascular disease had to be aged 50 years or older with diabetes and at least one other risk factor. Methods In this randomised, double-blind, placebo-controlled trial done in eight countries, we recruited overweight or obese patients (body-mass index ≥27 kg/m 2 ) with or at high risk for atherosclerotic vascular disease. We aimed to evaluate the long-term effects of lorcaserin on diabetes prevention and remission. Lorcaserin, a selective serotonin 2C receptor agonist that suppresses appetite, has been shown to facilitate sustained weight loss in obese or overweight patients. Abstract: Summary Background There is a direct relationship between bodyweight and risk of diabetes.
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