Rimonabant Appears to Reduce Risk for Diabetes Complications

Jacqueline H. Kostick, PharmD

Disclosures

Medscape Pharmacists. 2006;8(2) 

This viewpoint offers commentary on important clinical research in the area of pharmacy.

Efficacy and Tolerability of Rimonabant in Overweight or Obese Patients With Type 2 Diabetes: A Randomised, Controlled Study

Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF; RIO-Diabetes Study Group
Lancet. 2006;368:1660-1672

Study Summary

The RIO-Diabetes study, which was performed in 159 centers in 11 countries, showed that rimonabant 20 mg once daily can reduce body weight and improve cardiovascular and metabolic risk factors in obese patients with type 2 diabetes.

Rimonabant, a selective cannabinoid type 1 receptor blocker, significantly improved cardiometabolic risk factors, including weight, HbA1C levels, fasting glucose levels, high-density-lipoprotein (HDL) cholesterol levels, triglyceride levels, systolic blood pressure, and waist circumference in obese type 2 diabetic patients whose condition was uncontrolled with metformin or sulfonylureas. Subjects in this double-blinded trial were randomized to receive rimonabant 20 mg/day, rimonabant 5 mg/day, or placebo for 1 year. All patients were also treated with an oral hypoglycemic drug, as prescribed by their physician.

At the end of 1 year, patients receiving rimonabant 20 mg had an average weight loss of 5.3 kg, compared with 1.4 kg in the placebo group. Average levels of HbA1C decreased by 0.7 percent in the rimonabant 20-mg group from a baseline level of 7.3%, but increased in the placebo group by 0.1%. In fact, 43% of all subjects treated with rimonabant 20 mg/day achieved an HbA1C level of less than 6.5%, compared with just 21% in the placebo group. The effects of the rimonabant 5 mg/day were not as significant.

Viewpoint

Type 2 diabetes frequently occurs with other cardiovascular and metabolic risk factors, including abdominal obesity, low HDL-cholesterol concentrations, high triglyceride levels, and raised blood pressure. For obese patients with type 2 diabetes who have failed therapy with metformin or sulfonylureas, rimonabant may be a plausible treatment option to improve several of these risk factors. Pharmacists need to counsel patients that rimonabant should be taken in conjunction with diet and exercise. All of the patients in the trial were given a mild hypocaloric diet and increased their physical activity throughout the trial, which likely contributed to their success. One of the limitations of the study is that it did not mention the details of the diet and exercise plan.

The most important conclusion from the study was that rimonabant 20 mg/day helped lower HbA1C levels. Previous studies have shown that every 1% reduction in HbA1C is associated with a 21% reduction in risk for any endpoint related to diabetes.[1]

Many patients receiving rimonabant 20-mg/day had to have their other diabetic medications reduced during the trial. Therefore, it is important that patients taking rimonabant are closely monitored for potential medication adjustments. In the 20-mg/day rimonabant group, hypoglycemia was more frequently reported in diabetic patients treated with sulfonylureas than in those given metformin, but only 1 case led to treatment discontinuation.

The RIO-Diabetes was only a 1-year trial, and future studies will need to assess the long-term safety and effectiveness of rimonabant on weight and diabetes-related complications. In fact, only two thirds of study participants completed the 1 year of treatment. One of the most common adverse events that led to premature study discontinuation in the 20 mg/day rimonabant group was depression. Thus, long-term studies of rimonabant should also examine whether patients are at an increased risk for depression.

Abstract: www.medscape.com/medline/abstract/17098084

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