The active ingredient in alli® (orlistat) has been used in the United States as a prescription-only medication at double the dose found in alli. Xenical® (orlistat 120 mg/TID) was introduced in the United States in 1999 following rigorous clinical studies and FDA approval. Orlistat has an extensive clinical history. It has had 30 million patient treatments and has been studied in more than 100 controlled clinical trials.1
When comparing alli to Xenical® it is important to consider the manageability and tolerability of GI side effects. In clinical studies, the 60 mg capsule of alli demonstrated comparable efficacy and safety profiles to the 120 mg prescription capsule, but had a lower incidence of treatment effects, compared with the 120 mg dosage. Only a small percentage of trial subjects withdrew due to GI side effects (5.4% on 120 mg compared to only 3.2% on 60 mg), further reinforcing the tolerability of the 60 mg dose. After 90 days of using alli, 81% of study participants reported being satisfied or very satisfied with orlistat and 91% reported losing weight.
Reference
- Chanoine JP 2008. Data presented at the European Congress on Obesity, Geneva, May 2008 during the symposium “Obesity – A Short History in Time” (Roche).