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A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register

https://doi.org/10.20996/1819-6446-2016-12-1-16-20

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Abstract

Aim. To study the efficacy and safety of generic orlistat in comparison with the original drug in obese patients.

Material and methods. Patients with obesity degree 1-3 (n=60; 11.7% men and 88.3% women) were included into the open comparative randomized controlled study in parallel groups. After randomization 40 patients received of generic orlistat and 20 – the original orlistat. The duration of follow-up was 12 weeks. Changes in body weight, body mass index, and waist circumference were assessed, as well as the proportion of patients with a weight loss of 5-10% or more from baseline.

Results. Weight loss >5% was observed in 28 and 25% of patients in the groups of generic and original orlistat, respectively, and weight loss >10% - in 7.7% of patients only in the group of generic drug. No significant changes in blood pressure and heart rate were found. A significant reduction in total cholesterol and low density lipoprotein cholesterol was revealed. 11 (27.5%) adverse events were observed in the group of generic orlistat and 5 (25%) – in the group of original orlistat.

Conclusion. Generic orlistat 120 mg in capsules showed clinical equivalence to the original drug. Safety and tolerability of treatment with both drugs were comparable.

About the Authors

A. V. Zakharova
State Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 Russia
Russian Federation


S. N. Tolpygina
State Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 Russia
Russian Federation


V. P. Voronina
State Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 Russia
Russian Federation


S. Yu. Martsevich
State Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 Russia
Russian Federation


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Review

For citation:


Zakharova A.V., Tolpygina S.N., Voronina V.P., Martsevich S.Yu. A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register. Rational Pharmacotherapy in Cardiology. 2016;12(1):16-20. (In Russ.) https://doi.org/10.20996/1819-6446-2016-12-1-16-20

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ISSN 1819-6446 (Print)
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