Editor's ChoiceMain Category: Diabetes
Also Included In: Obesity / Weight Loss / Fitness;??Regulatory Affairs / Drug Approvals;??Medical Devices / Diagnostics
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Obesity drug, lorcaserin, was found to help patients with type 2 diabetes achieve significant weight loss during a 1-year trial, Arena Pharmaceuticals and Eisei Inc. announced. In the BLOOM-DM trial, lorcaserin met all three co-primary endpoints for effectiveness. There were also significant improvements in HbA1c when lorcaserin patients were compared to those on a placebo. The HbA1c test measures the amount of glycated hemoglobin in the patient's blood; it can give a good estimate of how well the individual has managed his/her diabetes over a period of 2 to 3 months.
The BLOOM-DM study involved 604 patients with diabetes type 2; they were all overweight/obese. They were randomly selected to receive: Lorcaserin 10 mg twice daily - 256 patientsLorcaserin 10 mg once daily - 95 patientsA placebo (dummy drug) - 253 patientsThe Trial was specifically looking and aiming for three main targets (primary endpoints): What percentage of participants managed to lose at least 5% of their baseline body weightWhat was the change from baseline in body weightWhat percentage of participants lost at least 10% of their baseline body weightArena Pharmaceuticals today announced that lorcaserin 10 mg twice daily met all three primary efficacy endpoints - there was a statistically significant difference in weight loss when compared to those on the placebo.
Some of the trial results, at week 52, include: 37.5% of the lorcaserin 10mg twice daily participants lost 5% or more of their body weight, compared to 16.1% for the placebo groupThe mean weight loss of all the lorcaserin 10mg twice daily participants was 4.7kg (4.5%), compared to 1.6kg (1.5%) in the placebo group16.3% of the lorcaserin 10mg twice daily participants lost at least 10% of their body weight, compared to 4.4%% for the placebo groupJack Lief, Arena's President and Chief Executive Officer, said:
We look forward to reviewing the BLOOM-DM data with the FDA as the efficacy results are aligned with the agency's categorical benchmark for weight management.
Experts say they are not sure whether the trial results are strong enough for FDA (Food and Drug Administration) approval. Last month the FDA turned down an application for lorcaserin's. The Agency asked for more information on cancer rates in animal studies, as well as more data on the medication's efficacy; describing it as "marginal".
Source: Arena Pharmaceuticals
Written by Christian Nordqvist
Copyright: Medical News Today
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