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ACOMPLIA (RIMONABANT): CLINICAL STUDIES

Weight Management

In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies. The patients included in the phase 3 trials followed a restrictive diet during the trial prescribed by a dietician and they were advised to increase their physical activity. Patients had a BMI >= 30 kg/m2 or BMI > 27 kg/m2 with hypertension and/or dyslipidemia at inclusion. Approximately 80% of the population were women, 87% Caucasian and 9% Black. Experience in patients over 75 years and Orientals/Asians was limited.

Significant mean weight reductions from baseline to one year for Rimonabant (Acomplia) tablets 20 mg versus placebo were demonstrated in three studies conducted in non-di abetic patients. A mean weight loss of 6.5 kg from baseline to one year was shown for Acomplia 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI 95% -5.3;-4.4, p< 0.001).

Most of the observed weight reduction was obtained within the first nine months of treatment. Acomplia (Rimonabant) 20 mg was effective in maintaining weight loss up to two years. Weight loss at two years was 5.1 kg for patients who received Rimonabant (Acomplia) 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p< 0.001).

Acomplia (Rimonabant) tablets 20 mg reduced the risk of weight regain. Patients who received Rimonabant 20 mg for one year were re-randomized to Acomplia 20 mg or placebo. At two years, patients continuing on rimonabant had a mean total weight loss of 7.5 kg over 2 years whereas patients re-randomized to placebo group during the second year had a mean total weight loss of 3.1 kg over 2 years. At two years, the difference in total weight loss between this drug and placebo was -4.2 kg (CI95% -5.0;-3.4, p< 0.001).

Treatment with rimonabant was associated with significant reductions in waist circumference, a known marker of intra-abdominal fat.

The effects on body weight appeared to be consistent among men and women. In the limited number of Black patients weight loss was less pronounced (mean difference to placebo -2.9 kg). No conclusions can be drawn with regard to effects in patients over 75 years or in Asian/Oriental patients due to the low number of patients.

Weight management and additional risk factors

In the non-diabetic studies including a mixed population of subjects with/without (treated) dyslipidemia, an increase in HDL-C and decrease in triglycerides (at one year) was observed. For HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 1.24 mmol/l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/l). The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p< 0.001). For the triglycerides an average decrease of 6.9% was seen under Rimonabant (Acomplia) 20 mg (baseline TG 1.62 mmol/l) compared to an increase of 5.8% for placebo (baseline TG 1.65 mmol/l). The difference was statistically significant (Difference -13.3% CI 95% -16.5; -10.2% p< 0.001). It is estimated that approximately half of the observed improvement in HDL-C and triglycerides in patients who received Rimonabant 20 mg was beyond that expected from weight loss alone. Generally Acomplia 20 mg had no significant effect on Total-C or LDL-C levels.

In the trial in type 2 diabetic patients (RIO-Diabetes) who were overweight or obese treated with metformin or sulfonylurea improvements in HbA1c and body weight were observed. The absolute change in HbA1c at one year was -0.6 for Acomplia (Rimonabant) tablets 20 mg (baseline 7.3%) and +0.1 on placebo (baseline 7.2%). Differences were statistically significant (Difference -0.7%, CI95% -0.80;-0.5, p < 0.001).

At one year a mean weight loss of 5.3 kg was shown for Rimonabant (Acomplia) tablets 20 mg versus a loss on placebo of 1.4 kg (Difference 3.9 kg CI95% -4.6;-3.3 p < 0.001). In a second trial in treatment naive type 2 diabetic obese patients (Serenade), the absolute change in HbA1c (with a baseline of 7.9% for both groups) at six months was -0.8 for rimonabant 20 mg and -0.3 under placebo (Difference -0.51 CI95% -0.78, -0.24 p < 0.001). The percentage of patients reaching HbA1c < 7% was 51% in the rimonabant group and 35% in the placebo group. The difference in mean body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p< 0.001).

Changes in HDL-C and TG in this population were similar to that of the non-diabetic population. It is estimated that approximately half of the mean improvement in HbA1c in patients receiving Acomplia (Rimonabant) 20 mg was beyond that expected from weight loss alone.

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