Reduction of dietary fat absorption by the novel gastrointestinal lipase inhibitor cetilistat in healthy volunteers.

British journal of clinical pharmacology. 2009;67(3):309-15

Plain language summary

Obesity is epidemic and many obese patients seek drug treatment. Orlistat (a lipase inhibitor) is effective, but associated with gastrointestinal side effects. This study aimed to demonstrate that Cetilistat inhibits gastrointestinal lipase and is well tolerated in comparison to Orlistat. Results from three Phase I clinical studies (all double-blind, randomized, placebo-controlled, parallel-group studies in healthy male volunteers (age 18-45y, BMI ≤30 kg m−2, minimum weight of 60 kg) (total n=99) resident in a clinical unit) are reported. Subjects receives placebo (n=24), one of a range of Cetilistat doses (n=66) or 120mg Orlistat x3/daily (n=9) for 5 days, whilst maintained on a strict diet. 30% of calories were derived from fat. Each dose of Cetilistat in the 3 studies increased mean faecal fat excretion relative to both baseline and placebo. Increased faecal fat excretion was significant compared with placebo at 150 mg t.i.d. (study 1). Faecal fat excretion was significantly higher in both the Cetilistat 120 and 240 mg t.i.d. groups (study 3). Overall, fecal fat excretion for Orlistat 120 mg t.i.d. was similar to Cetilistat. Gastroinetstinal side effects were most common (51%) for Cetilistat. Steatorrhoea (oily stool) was more frequent in the Orlistat group (4.11 events per subject) than in any Cetilistat dose group. Most side-effects (98%) were mild or moderate. 3 subjects taking Cetilistat were withdrawn from the study after developing maculopapular rash, but no reaction was observed (pin-prick). The chemical structure of Orlistat and Cetistat are different which may affect how they interact with fat micelles in the intestines. The author speculates that Cetilistat may act more like a detergent, whereas Orlistat may promote the coalescence of micelles, leading to oils and increased gastrointestinal adverse events. Cetilistat is an effective inhibitor of gastrointestinal lipases, increasing faecal fat excretion in at all doses studied. Cetilistat is well tolerated across a range of doses, and comparison with Orlistat suggests improved tolerability.

Abstract

AIMS: To assess the efficacy, pharmacodynamics, safety and tolerability of a range of doses of cetilistat, a novel inhibitor of gastrointestinal lipases, in healthy volunteers. METHODS Three Phase I, randomized, placebo-controlled, parallel-group studies were conducted. Enrolled subjects in the three studies (n = 99) received a controlled calorie diet (total intake 2160 calories daily, 30% from fat). Twenty-four subjects were randomized to placebo and 66 were randomized to the following cetilistat doses: 50 mg three times daily [t.i.d. (n = 7)], 60 mg t.i.d. (n = 9), 100 mg t.i.d. (n = 7), 120 mg t.i.d. (n = 9), 150 mg t.i.d. (n = 16), 240 mg t.i.d. (n = 9) and 300 mg t.i.d. (n = 9). Nine subjects received the approved orlistat dose (120 mg t.i.d.). Treatment was for 5 days, with a 2-day run-in period and 1-day post-treatment follow-up. The primary outcome measure was daily faecal fat excretion. Secondary outcomes included plasma lipid levels, tolerability [gastrointestinal adverse events (AEs)] and safety. RESULTS Cetilistat increased faecal fat excretion relative to baseline at all doses. Cetilistat was well tolerated, with gastrointestinal AEs the most common (51%). Steatorrhoea (oily stool) was more frequent in the orlistat group (4.11 events per subject) than in any cetilistat dose group (0.14-1.81 events per subject). Most AEs (98%) were mild or moderate in intensity. CONCLUSIONS Cetilistat increased dietary fat excretion in healthy volunteers receiving a controlled calorie diet. Cetilistat was well tolerated at all doses examined and tolerability appeared to be improved relative to orlistat. Faecal fat excretion in the cetilistat groups was at least comparable to the orlistat 120 mg t.i.d. group.

Lifestyle medicine

Fundamental Clinical Imbalances : Digestive, absorptive and microbiological
Patient Centred Factors : Mediators/Weight loss
Environmental Inputs : Diet ; Nutrients
Personal Lifestyle Factors : Nutrition
Functional Laboratory Testing : Stool

Methodological quality

Allocation concealment : No

Metadata

Nutrition Evidence keywords : Weight loss ; Faecal fat excretion ; Weight loss drug