A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register
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 rand...
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| Format: | Article |
| Language: | English |
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Столичная издательская компания
2016-03-01
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| Series: | Рациональная фармакотерапия в кардиологии |
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| Online Access: | https://www.rpcardio.online/jour/article/view/1187 |
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| _version_ | 1849227717897093120 |
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| author | A. V. Zakharova S. N. Tolpygina V. P. Voronina S. Yu. Martsevich |
| author_facet | A. V. Zakharova S. N. Tolpygina V. P. Voronina S. Yu. Martsevich |
| author_sort | A. V. Zakharova |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-452b37fbd415412ca1122a7cfb0b4435 |
| institution | Kabale University |
| issn | 1819-6446 2225-3653 |
| language | English |
| publishDate | 2016-03-01 |
| publisher | Столичная издательская компания |
| record_format | Article |
| series | Рациональная фармакотерапия в кардиологии |
| spelling | doaj-art-452b37fbd415412ca1122a7cfb0b44352025-08-23T10:00:26ZengСтоличная издательская компанияРациональная фармакотерапия в кардиологии1819-64462225-36532016-03-01121162010.20996/1819-6446-2016-12-1-16-201176A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL registerA. V. Zakharova0S. N. Tolpygina1V. P. Voronina2S. Yu. Martsevich3State Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 RussiaState Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 RussiaState Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 RussiaState Research Centre for Preventive Medicine. Petroverigsky per. 10, Moscow, 101990 RussiaAim. 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.https://www.rpcardio.online/jour/article/view/1187obesityorlistatgeneric drug |
| spellingShingle | A. V. Zakharova S. N. Tolpygina V. P. Voronina S. Yu. Martsevich A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register Рациональная фармакотерапия в кардиологии obesity orlistat generic drug |
| title | A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register |
| title_full | A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register |
| title_fullStr | A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register |
| title_full_unstemmed | A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register |
| title_short | A comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the PROFIL register |
| title_sort | comparative study of the efficacy and safety of the original and generic orlistat in obese patients in the profil register |
| topic | obesity orlistat generic drug |
| url | https://www.rpcardio.online/jour/article/view/1187 |
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