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At the meeting of the European Association for the Study of Diabetes of 2018, the TIMI study group (Brigham and Women's Hospital) group of study on thrombolysis and myocardial infarction (TIMI) presented the diabetes-related findings of CAMELLIA-TIMI 61, a clinical trial designed for obese or obese patients. to test lorcaserine, a weight loss drug manufactured by the sponsor of the trial, Eisai Inc. In addition to reporting sustained weight loss without increased risk of major cardiovascular events, the group of TIMI study also presented data showing that lorcaserine had reduced the risk of diabetes by 19 percent in pre-diabetic patients, induced a remission of hyperglycemia in diabetic patients and reduced the risk of microvascular complications diabetics such as microalbuminuria. The findings of the team are detailed in an article published simultaneously in The lancet.
"We recently presented results showing that lorcaserine use resulted in modest but sustained weight loss in obese and overweight patients with no increased risk of heart attack or stroke," he said. co-lead author Erin Bohula, MD, MD, PhD in Cardiovascular Medicine BWH. Investigator for the TIMI study group at BWH. "Now, we report that, when added to lifestyle-based interventions, Loracerin significantly reduced the incidence of diabetes, increased the rates of diabetes remission, and reduced the risk of microvascular complications." diabetics. "
"Taken together, these findings reinforce the notion that modest and sustainable weight loss can improve cardiometabolic health and reinforce the role of lorcaserine as adjunctive therapy in chronic weight management," he said. said co-author Benjamin Scirica, MD, cardiovascular medicine specialist at BWH and senior investigator of the TIMI study group. "It offers another tool in the arsenal of therapeutics, beyond diet and exercise, for patients who wish to achieve and maintain weight loss." And luckily even a weight loss relatively modest can improve diabetes control in diabetics and reduce the development of diabetes in people at risk. "
In the study Cardiovascular and Metabolic Effects of Lorcaserine in Obese or Obese Patients – Thrombolysis of Myocardial Infarction 61 (CAMELLIA-TIMI 61), 12,000 obese or overweight patients with cardiovascular risk were randomized to receive either a lorcaser, a placebo. Patients were followed for a median period of more than three years. At the start of the trial, more than half of the participants had diabetes and another third was prediabetes.
Among patients with prediabetes, lorcaserine reduced the risk of diabetes by 19% compared to placebo (172 out of 2,015 patients taking lorcaserine developed diabetes, compared to 204 out of 1,976 taking placebo). In addition, 9.2% of prediabetes patients taking lorcaserine were able to achieve normal blood glucose levels, compared with 7.6% of patients taking placebo (185 of 2,015 vs. 151 of 1,976). Lorcaserin also significantly increased the rate of remission of hyperglycemia in diabetic patients, with 7.1% of patients on medication achieving remission compared to 6% of patients in the placebo group (242 out of 3,385 versus 206 out of 3 431).
Lorcaserin also reduced the risk of diabetic microvascular complications by 21%, including persistent microalbuminuria, diabetic retinopathy, or diabetic neuropathy in diabetic patients.
Patients included in the study had well-controlled diabetes at the beginning of the trial, but lorcaserine always resulted in a net decrease in hemoglobin A1c (a measure of glycemic control).
Hypoglycaemia – dangerously low blood sugar levels – was reported in 223 (6.6%) of patients with diabetes receiving lorcaserine, compared to 199 (5.8%) who received placebo. In patients under insulin or sulfonylurea, drugs known to cause hypoglycemia, there were numerically more events of severe hypoglycemia requiring hospitalization or considered life-threatening with lorcaserine (12 events with lorcaserine compared to 4 events with placebo, p-value not-important). The authors note that this discovery underscores the importance of carefully-known titrants to increase the risk of hypoglycaemia, particularly in patients seeking to lose weight.
As noted earlier, in addition to lifestyle counseling, Lorcaserine helped patients reduce weight by an average of 4.2 kg (9.3 pounds), compared with 1.4 kg for placebo at one year. Many more patients taking lorcaserine lost at least 5% of their body weight (39% of the lorcaserine group versus 17% of the placebo group) or at least 10% of their body weight (15% versus 5%). %) an. The differences remained statistically significant throughout the trial.
"Given the global prevalence of obesity and its association with type 2 diabetes and complications that can lead to death or significantly reduce quality of life, we need therapeutic strategies that can be added to the modification. of lifestyle to prevent and control diabetes, "said Scirica. "This rigorous and large-scale randomized study demonstrates the potential for improving glycemic control when adding a weight loss agent to a treatment plan."
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More information:
The lancet (2018). www.thelancet.com/journals/lan… (18) 32328-6 / full text
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