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Year : 2011  |  Volume : 15  |  Issue : 2  |  Page : 99-104

Evaluation of efficacy and safety of orlistat in obese patients

1 Department of Pharmacology, Government Medical College, Miraj, India
2 Department of Pharmacology, R.C.S.M. Government Medical College, Kolhapur, India
3 Director, Patwardhan Endocrinology Hospital and Research Centre, Miraj, Maharashtra, India

Correspondence Address:
Suyog S Jain
Department of Pharmacology, Government Medical College, Miraj, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2230-8210.81938

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Context: Rapidly rising prevalence of obesity is alarming. Obesity predisposes to co-morbidities like hypertension, type 2 diabetes mellitus, dyslipidemias, thus substantially rising healthcare expenditure. Lifestyle modifications alone have very limited success, necessitating the addition of pharmacotherapy to it. Objective: Present study was carried out to evaluate the efficacy and safety of orlistat in obese patients. Materials and Methods: Eighty obese (BMI>30) patients according to inclusion and exclusion criteria were randomized into either of the two groups. Group 1 received orlistat 120 mg three times a day and group 2 received placebo three times a day. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL, LDL were measured at baseline and then at 8 th , 16 th and 24 th week. ADR reported by patients were recorded. For safety evaluation various hematological and biochemical parameters were assessed. Z test was used for analysis of data. Results: Compared to placebo, orlistat caused significant reduction (P<0.05) in weight (4.65 kg vs 2.5 kg; orlistat vs placebo, respectively), BMI (1.91 kg/m 2 vs 0.64 kg/m 2 ) and waist circumference (4.84 cm vs 2 cm), cholesterol (10.68 mg vs 6.18 mg) and LDL level (5.87 mg vs 2.33 mg). In the orlistat group, the GI side effects like loose stools, oily stools/spotting, abdominal pain and fecal urgency were observed. Conclusion: Orlistat is an effective and well-tolerated antiobesity drug, which can be employed as an adjunct to therapeutic lifestyle changes to achieve and maintain optimal weight.

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