Orlistat vs Placebo in the Inhibition of Dietary Fat in Obese Adult Nigerian Volunteers

Abstract

Objective: To compare the efficacy and safety of orlistat (120mg tid) versus placebo in the inhibition of dietary fat absorption in healthy adult Nigerian volunteers.

Method: This was a double blind randomised cross-over study, with each arm of the cross-over lasting 4 weeks with a one week placebo run-in period before and in-between treatment. Four males and 16 females, with a mean BMI of 35.1 and a mean age of 40.08 years, participated in the study. Prior to allocation to treatment, subjects were given placebo for a 7-day period, while receiving a moderate hypocaloric supporting diet as prescribed for each individual by the dietician. During this period, a 72-hour faeces was collected from each subject for estimation of baseline faecal fat excretion. Additionally blood and urine samples were collected for evaluation of plasma lipid profile, haemogram, blood chemistry and urinalysis. Subjects were assigned to treatment according to their enrolment number i. e. subject no. 1 received treatment labelled DBN 1. Each subject was given a weekly pack of medication as specified in the label. The subjects took one capsule three times a day with the prescribed diet. At the end of each week of treatment, subjects were required to submit 24-hr faeces for faecal fat estimation. Blood samples were collected at week 5 and week 10 for haematological profile, lipid profile, blood chemistry and liver function tests. At each weekly clinical visit, subjects were questioned closely on the incidence of any adverse event, they also discussed their diet with the dietician. At the end of the study the emergency code envelopes were opened and the subjects were assigned into groups according to the treatment sequence, the sequence Placebo/ Orlistat were assigned group 1 and Orlistat/ Placebo group 2.

Results: The difference in faecal fat excretion with orlistat compared to placebo was significant (p<0.05). The Plasma lipid profile was not significantly affected by short term treatment with orlistat. Adverse events (AE) occurred in 81% and the drop out rate was 31.8%. The commonest AEs were changes in defaecation pattern accompanied by soft oily stool and oily flatulence, this led to drop-out in 13.6% of the cases. The laboratory safety parameters were also not significantly affected by treatment.

Conclusion: We were able to demonstrate that orlistat is significantly more effective than placebo in enhancing faecal fat excretion through inhibition of gastric lipase, in Nigerian subjects on wholly Nigerian diet. Patients and/ or subjects on orlistat therapy may require the use of adequate protection to avoid the embarrassment that may be caused by stains resulting from the oily flatulence.


NQJHM Vol. 15 (1) 2005: pp. 13-18