Effect of Acomplia as a CB1 receptor blocker on body weight and cardiovascular risk factors in overweight or obese patients (this was the RIO (Rimonabant In Obesity) Europe trial).
STUDY OBJECTIVE
To assess the effect of Acomplia as a CB1 receptor blocker on body weight and cardiovascular risk factors in overweight or obese patients (this was the RIO (Rimonabant In Obesity) Europe trial).
DESIGN
This was a double-blind randomised study with a placebo control.
PATIENTS
1507 patients aged 18 years or older with a BMI 30 kg/m2 or greater, or a BMI greater than 27 kg/m2 who were suffering from dyslipidemia, hypertension or both, were recruited from sixty sites (only 276 patients were recruited in the USA). All the patients had the same weight within 5kg. 920 patients completed the one-year study.
INTERVENTIONS
5mg or 20mg Acomplia was given orally once daily as a supplement to a low-calorie diet designed to produce a net deficit of 600 kcal/day, monitoring weight, body measurements, blood pressure and blood chemistry from a baseline to values at the end of one year.
RESULTS
As against the placebo, the results for both dosages were significantly better for Acomplia than for the placebo. The higher dose produced statistically significant reductions in waist measurement and the lipid concentrations were improved. The results from the lower dose were less clinically significant. In general Acomplia was well tolerated and produced only weak and transient side-effects, with more reporting side-effects at the higher dosage. More reported headaches, fatigue and upper respiratory infection in the placebo group. There was some evidence of mild mood disorders in both groups with the primary cause for withdrawal from the study being frustration at the lack of effect.
CONCLUSIONS
Acomplia was effective in producing weight loss and an improvement in cardiovascular profile.
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| Giving up smoking |
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| Weight loss |
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