Phentermine/Topiramate Reduces Type 2 Diabetes
Treatment with a weight-loss drug appeared to help pre-diabetic and diabetic patients shed pounds and improve dysglycemia, researchers said here.
After 56 weeks of treatment with extended-release phentermine/topiramate (Qsymia), obese/overweight individuals, with and without diagnosed type 2 diabetes, experienced a mean percent weight loss ranging from 6.8% to 8.9% with a low-dose regimen, and 8.8% to 11% with a high-dose regimen, reported Tim Garvey, MD, from the University of Alabama at Birmingham, and colleagues.
In comparison, placebo patients had a mean percent weight loss of 1.9% to 2.7% at 56 weeks. All the weight loss with the study drug compared with placebo was statistically significant (P<0.001), they reported in a poster at the annual World Congress on Insulin Resistance.
Also, among type 2 diabetes patients, there was an average 1.6% decrease in glycated hemoglobin (HbA1c) from baseline to week 56 of treatment compared with a 1.2% reduction for patients
on placebo (P<0.05), according to the authors.
Both the American Association of Clinical Endocrinologists and the American Diabetes Association recommend weight loss to improve dysglycemia in obese individuals, Gary’s group pointed out.
They analyzed results from the phase III CONQUER trial. The patients in the studies were about 5o-years-old and about two-thirds were women. The mean weight of the subjects was around 220 pounds.
In the trial arm that included obese/overweight (body mass index ≥27 kg/m2 and ≤45 kg/m2) prediabetic patients, those treated with low-dose phentermine/topiramate (7.5 mg/46 mg) achieved 0.03% decline in HbA1c (P
In trial arm that enrolled obese/overweight patients with type 2 diabetes, there was an average decline of 0.04% in those on the low-dose and high-dose regimens compared with 0.1% for the placebo patients (P Garvey said that treating the prediabetes patients showed a modest change in HbA1c, but more effect was seen in mild diabetes and “we got more pronounced decreases in more severe diabetes, which are significant. This reduction puts many of these patients with diabetes at the target of an HbA1c of 7%.”
Zachary Bloomgarden, MD, of Mount Sinai School of Medicine in New York City pointed out that the study results in the
diabetic patients were important.
“The baseline HbA1c was 6.8%, and there was a very modest reduction of 0.4%, but that is OK because to go down 0.4% from 6.8% is quite good,” he told MedPage Today. “In the other study, they started at 8.7% and they went down by 1.6% which is appreciable. So this shows that this product can reduce weight by about 10% which is fantastic and it looks like it has glycemic benefit.”
The study was funded by VIVUS, the maker of Qysmia.
Garvey reported commercial relationships with Daiichi-Sankyo, Janssen, Boehringer Ingelheim, VIVUS, Eisai, Novo Nordisk, and Liposcience.
Bloomgarden reported that he has “worked with everybody” including the Diabetes Medical Advisory Board, Merck-Medco Managed Care, the Amaryl Advisory Panel, Hoechst Marion Roussel, the Novartis Lipid and Diabetes Advisory Boards, the National Diabetes Education Initiative faculty, the Vascular Biology Working Group, the Novo Nordisk Diabetes Management Pharmacological Therapy faculty, and the Bristol Meyers Squibb Diabetes Education Faculty.