DOCTOR'S VIEW ARCHIVE
Diabetes Update #9 Day 3, Sunday June 12 from the American Diabetes Association National Meeting
Diabetes Conference - Rio Diabetes Study and Rimonabant
Dr. Ruchi Mathur offers perspectives of interest on topics from the American Diabetes Association's 65th Annual Scientific Sessions (held in San Diego, California June 10-14, 2005)
This is Dr. Ruchi Mathur with a continued report on the late breaking clinical trials here at the American Diabetes Association conference. This next study called the Rio Diabetes study looked at a drug called Rimonabant- which works on a sub-type of cannaboid receptor. This study examined the effect of rimonabant in obese patients with type 2 diabetes.
This trial looked at 1045 patients with type 2 diabetes, their BMI was 27-40, their A1c was between 6.5 -10.0% and they were on either metformin or a sulfonylurea to treat their diabetes. Patients were put into one of three groups- a placebo group, 5mg of rimonabant or 20 mg of rimonabant. Patients were also advised to follow a diet with a 600 calorie deficient.
The patients studied had an average BMI of 34, were in their 50's on average, and the baseline A1c was 7.5%. In addition, 80% of patients meet the criteria for metabolic syndrome.
Basically the results are as follows: Body weight decreased by 1.4 kg in the placebo group, 2.3 kg in the 5 mg group an 5.3 kg (that's about 12 pounds) in the 20 mg group. A1c decreased by 0.7 % more in the 20 mg group compared to placebo. A goal A1c of <6.5 % was achieved in 20% of patients on placebo and 43% of those who received 20mg of rimonabant.
The data was also encouraging in other areas. In the 20mg of rimonabant group, triglycerides, systolic and diastolic blood pressure also decreased, though whether clinically significantly or not is unclear. Those meeting criteria for metabolic syndrome decreased by 18% as well.
Side effects were nausea, dizziness, hypoglycemia and anxiety, and up to 15% of patients in the rimonabant group dropped out of study compared to 5% of those receiving placebo.
So what does all this mean for you? Well- this new class of drugs for treating obesity in the general population as well as in those with diabetes certainly does seems promising. However, the side effects need to be assessed fully. In addition, more long-term data particularly on safety and tolerability is needed.
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