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Three New Weight-Loss Drugs Show Benefits for Diabetics
Posted: Wednesday, June 17, 2009
Three investigational diet drugs hold promise for preventing and treating diabetes. The findings show that the drugs can help "halt the progression towards Type 2 diabetes.
All three showed improvements in risk factors besides obesity, including blood glucose, blood pressure, and triglycerides, according to three presentations at the American Diabetes Association meeting.
Louis Aronne, M.D., of Weill-Cornell and New York Presbyterian, who presented data as a lead investigator on a trial for Qnexa, a combination of phentermine and topiramate stated that, "Instead of sulfonylureas and thiazolidinediones, the next generation of diabetes medications will likely be weight-loss drugs."
Dr. Aronne said there is "no real winner" among the three, with lorcaserin (combining benzazepine and hydrochloride) and Contrave (combining bupropion and naltrexone) also showing similar improvements in overall health.
But each reported somewhat different cardiometabolic benefits at oral and poster sessions at ADA.
Patients taking lorcaserin had significantly lower levels of fasting plasma glucose and a greater decrease in fasting insulin and insulin resistance as measured by HOMA-IR than those on placebo (P<0.0001). They also had significant reductions in blood pressure, total cholesterol, and triglycerides compared with controls, according to Christen M. Anderson, M.D., Ph.D., vice president of clinical development for drugmaker Arena Pharmaceuticals.
Dr. Anderson presented the findings from year two of the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) trial as one of its investigators at a late-breaking poster session.
"We had dramatic improvements in insulin resistance and in biomarkers of cardiovascular disease," Dr. Anderson said. In terms of weight loss, 47.5% of patients on the drug lost at least 5% of their body weight, compared with 20.3% of those on placebo, and 22.6% lost at least 10% of their body weight compared with 7.7% of placebo patients (P<0.0001).
After two years, patients on the drug maintained a significantly greater amount of weight loss compared with those who had switched to placebo after one year, Dr. Anderson said.
"We are looking at long-term treatment," she said. "That's the implication here."
Dr. Anderson stressed that there was no excess valvular insufficiency during two years of use. That was a problem with the combination diet drug phentermine and fenfluramine (Phen-Fen), which was pulled from the market because of cardiovascular complications.
Qnexa showed significant reductions in hemoglobin A1c levels in both diabetic and prediabetic populations, according to two studies. Among diabetic patients, those on the drug had a 1.6% reduction in HbA1c from baseline, compared with 1.1% for patients on placebo (P=0.038), according to W. Timothy Garvey, M.D., of the University of Alabama at Birmingham.
Dr. Garvey presented the findings from a 56-week trial of 130 diabetic patients at an oral session at the ADA sessions.
The patients also experienced significant reductions in blood pressure and triglycerides, as well as better reductions in fasting plasma glucose -- from 176 mg/dL to 133 mg/dL in treatment patients compared with 171 mg/dL to 145 mg/dL for the placebo group (P=0.02). Dr. Garvey said patients on the drug had a significant reduction in antidiabetic medication use compared with controls, as well as significant improvements in fasting glucose, systolic blood pressure, and waist circumference.
"These results suggest that [the drug] has the potential to play an important role in diabetes management with respect to blood sugar control and sustained weight loss," he said. He noted 65% of those on the drug lost at least 5% of their body weight, compared with 24% in the placebo group (P<0.001). A total of 37% lost at least 10%, compared with 9% of placebo patients (P<0.001).
Among 756 nondiabetic obese patients, those who received the drug dropped their HbA1c levels by 0.01% and 0.02%, respectively, with regard to dose (P<0.0001). In comparison, HbA1c rose by 0.09% over the six-month study period among placebo patients, said Dr. Aronne, who presented the findings of the EQUATE study at an oral session here.
The findings show that the drug can help "halt the progression towards Type 2 diabetes," he said. Taken together, both trials show that the drug "lowers HbA1c in diabetic patients, and for patients that haven't been diagnosed with diabetes, [it] can prevent increases in HbA1c levels," Dr. Aronne said.
Contrave also showed benefits for cardiometabolic parameters, but results of a late-stage phase III trial primarily focused on the drug's safety and efficacy with regard to weight loss. Overall, 66.4% of patients on the drug lost at least 5% of their body weight, compared with 42.5% of placebo patients, and 41.5% lost at least 10% of their weight compared with 20.2% of placebo patients (P<0.001), according to Thomas Wadden, Ph.D., of the University of Pennsylvania, who presented the findings at an oral session here.
Dr. Wadden did not provide many details with regard to effects on diabetic and prediabetic patients, but he said those on the drug saw "greater improvements in cardiometabolic risk factors such as waist circumference, triglycerides, and LDL cholesterol."
Nearly all of the researchers agreed that all three drugs, once approved, will play a role in both obesity and diabetes treatment. "There will definitely be a place for all three," Dr. Anderson said.
Dr. Aronne said that since one medication "may work better for one person than for another," physicians "need many different options."
"We need this whole group of treatments," he said, "in order to better manage both obesity and diabetes."
Explain that the three investigational weight-loss drugs -- lorcaserin, Qnexa, and Contrave -- improve blood glucose and other parameters of cardiometabolic risk factors.
Note that none of the agents are FDA approved.
Source: Diabetes In Control: Smith S, et al "Lorcaserin reduces body weight in obese and overweight subjects: Behavioral modification and lorcaserin for overweight and obesity management, the BLOOM trial" ADA2009; Abstract 96-LB.
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