The drug is against obesity. Experience with the application of the generic

October 11, 2016

Active substances:
ICD-10:
IV.E65-E68    Obesity and other types of redundancy
IV.E65-E68.E66.9    Obesity, unspecified
IV.E65-E68.E66    Obesity
Obesity, treatment of obesity, orlistat, endocrinology, dietology, the choice of a generic
Today obesity is a global epidemiological problem. In ICD-10, it is separated into a separate category as an independent disease. All major giants of the pharmaceutical industry are developing drugs to treat obesity.One of the first medicines in this direction was orlistat (approved by the FDA in 1999). The original drug (Xenical) is manufactured by Hoffmann-La Roche, but at the moment some generics are also on the market. The first of these was the drug Orsoten company KRKA. This material presents the results of a study of the clinical efficacy of this drug in comparison with the original drug. The work was carried out at the FGU "Endocrinology Research Center" (Moscow).
The mechanism of action of orlistat consists in the inhibition of intestinal and pancreatic lipases in the lumen of the small intestine, which leads to a violation of the absorption of lipids. This in turn entails a decrease in the total actual calorie content of food and stimulates peripheral lipolysis, against which the patient loses weight.
Scientists from the Endocrinology Research Center decided to compare the clinical efficacy of two drugs orlistat: the original (Xenical) and generic (Orsotene).
In terms of design, it was an open, multicenter, randomized, comparative, controlled study of clinical equivalence, efficacy and safety.It was attended by 169 patients with obesity.
The work was carried out on bases five research centers:
  • FGU Endocrinology Research Center (Moscow);
  • GU GKB No. 67 (Moscow);
  • GU GKB No. 63 (Moscow);
  • FGU GKB No. 68 (Moscow);
  • Federal Center of Heart, Blood and Endocrinology. V.A. Almazova (St. Petersburg).
The dynamics of changes in body weight against the background of the application of both drugs is presented on the graph:
Other relevant research results are presented in the table:
Conclusion:
Thus, the authors state that Xenical and Orsoten preparations have comparable clinical efficacy and safety.
Note:A source:

Melnichenko GA, Komshilova KA, Berkovskaya MA Experience of using the drug Orsoten (orlistat) in obese patients // Obesity and Metabolism. 2010. № 1.

Authors:G.A. Melnichenko, K.A. Komshilova, M.A. Berkovskaya