New Acomplia Study Has More Good News for Obese Diabetics
The latest results of the last of four major Acomplia (rimonabant) studies added more good news to the mounting excitement about this breakthrough obesity drug.
Not only does Acomplia help obese people Acomplia (rimonabant) lose weight, raise their good cholesterol, lower their triglicerides, and reduce other cardiac risk factors, but researchers said it also helps obese diabetics reduce their all-important HbA1c level — a measure of blood sugar control.
The one-year results of Acomplia (rimonabant) the RIO-Diabetes trial, a phase III trial in which 1,045 people with type 2 diabetes either took one of two fixed-dose regimens of rimonabant or a placebo, were presented June 12th at the Scientific Sessions of the American Diabetes Association in San Diego, California Acomplia (rimonabant) .
Participants in this trial were 51 percent male, mean age 56 years, mean Body Mass Index (BMI) of 34, and mean A1c of 7.5 percent. Two-thirds of the patients were taking Glucophage (metformin) as a therapy for diabetes, and the rest were taking sulfonylurea. All participants in the trial were told to reduce their daily caloric intake by 600 calories.
This and the results of three other Acomplia (rimonabant) trials — RIO-North America, RIO--Europe and RIO Lipids — have been submitted by Acomplia developer Sanofi-Aventis to the U.S. Food and Drug Administration and European regulators as part of its effort to obtain approval to bring the drug to market by late 2005.
As in the previous studies, researchers reported that the higher 20 mg Acomplia (rimonabant) dose was far more effective in this trial than the lower 5 mg dose. [In fact, researchers said, the differences in results for those on placebo vs. the low rimonabant dose were so minor that only higher dose results were reported.]
Patients in this study treated with the higher dose of Acomplia (rimonabant) lost an average of 11.7 lbs compared to 3 lbs for patients in the placebo group. In addition, patients treated with the higher Acomplia dose saw a reduction in waist circumference of 2 inches versus 0.7 inches for those taking the placebo.
But even more exciting, among all patients who entered the RIO-Diabetes study, patients on the higher dose of rimonabant achieved an HbA1c reduction of 0.6 percent from a baseline value of 7.3 percent compared to an increase of .1 percent for those taking the placebo — a difference of .7 percent.
“ The RIO-Diabetes trial results indicated that Acomplia (rimonabant) delivered a clinically meaningful reduction in HbA1c and may offer a broad range of cardiometabolic risk factor improvements that are essential for the comprehensive management of people with type 2 diabetes,” reported Dr. Andre Scheen of the Academic Hospital of Liege, Belgium, principal researcher.
Forty three percent of patients on higher Acomplia (rimonabant) dose got their A1c level below 6.5 percent — the target treatment goal of the American Association of Clinical Endocrinologists — compared to only 21 percent on the placebo.
Among patients whose baseline A1c was higher than 7 percent, 52.7 percent of patients on the higher Acomplia dose got it below 7 per cent — the target treatment goal of the American Diabetes Association — by the end of the study compared to 26.8% of patients on a placebo.
Researchers said a statistical analysis indicated that .3 percent of the improvement in HbA1c observed with the higher rimonabant dose was attributable to wait loss and .4 percent of the improvement in HbA1c could not be explained by weight loss and thus was an independent effect attributable to Acomplia (rimonabant) .
“ What is noteworthy about the findings of the RIO-Diabetes trial is that even in a patient population with an average HbA1c level at a point where further control is difficult to achieve, rimonabant was still able to achieve a clinically significant reduction in HbA1c,” Sheen said.
HDL-cholesterol and triglycerides were also significantly improved in patients treated with the higher dose of Acomplia throughout the one year period.
Among all patients who entered the study, the good HDL-cholesterol increased by 15.4 percent in the group taking the higher Acomplia dose vs 7.1 percent in the placebo group.
Furthermore, triglycerides were reduced by 9.1 percent in patients treated with the higher Acomplia dose compared to an increase of 7.3 percent in the placebo group.
“ Again, in this and in all of the prior RIO studies, statistical analysis showed that part of the effect on lipid modification was due to the weight loss, and part due to the drug,” Sheen said.
In addition to the improvements in lipid profiles, the number of patients meeting the criteria for metabolic syndrome — a cluster of conditions linked to an increased risk of cardiovascular disease — was reduced by 18.9 percent in the group taking the higher Acomplia dose compared to 7.6 percent in the group taking a placebo.
Contributing to that was a small decline of 0.8 mmHg in systolic blood pressure in the higher dose rimonabant group compared to a 1.6 mmHg increase in the placebo group. The difference in diastolic blood pressure between the two groups was not statistically significant.
The researchers said the results of their study of the safety and tolerability of the higher dose Acomplia also was consistent with the data from the other three major Acomplia trials that have been completed.
Side effects were mainly mild and transient, the researchers said, and most frequently included nausea (experienced by 12.1 percent of patients on the higher Acomplia dose), dizziness (experienced by 9.1 percent), diarrhea (experienced by 7.4 percent), vomiting (5.9 percent), hypoglycemia (5.3 percent), fatigue (5.3 percent) and anxiety (5. 0 percent).
These side effects, which mostly occurred within the first few weeks, led to a drop-out rate of 3.3 percent among those on the higher dose of Acomplia compared to 0.9 percent in the placebo group.
Altogether, a number of researchers attending the meeting appeared to feel the report from the latest trial was promising for diabetics.
“ The weight loss reported for Acomplia (rimonabant) in patients with diabetes may be an im portant finding,” said Dr. Michael D. Jensen, a Professor of Medicine at the Mayo Clinic in Rochester, Minnesota. “Glycemic control with current therapies is often associated with weight gain. This weight gain can diminish the benefits of treatment and lessen the overall improvement in cardiometabolic risk,” he added.
Sheen noted, however, that Acomplia (rimonabant) is intended for chronic treatment.
“ If you stop the drug, the weight comes back,” he said.
And Richard Kahn, chief scientific and medical officer of the American Diabetes Association, noted that while the drug has created excitement, “the real issue is post-marketing surveillance.
“ It’s one thing to say that a drug is safe in 6,000 people tested in clinical trials, but we have to see what happens when 750,000 people are using the drug,” Kahn said Acomplia (rimonabant) .
Метки:20 mg, clinical, drug, Europe, fat, lose weight, loss, medicine, obese, obesity drug, report, results, side effects, study, weight, Zimulti, Новости
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