EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA
Aim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlip...
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| Format: | Article |
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Столичная издательская компания
2015-12-01
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| Series: | Рациональная фармакотерапия в кардиологии |
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| Online Access: | https://www.rpcardio.online/jour/article/view/365 |
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| author | J. E. Semyonova S. Y. Martsevich N. V. Perova A. M. Olferiev N. P. Kutishenko N. Y. Ivanenkova N. A. Dmitrieva A. A. Serazhim |
| author_facet | J. E. Semyonova S. Y. Martsevich N. V. Perova A. M. Olferiev N. P. Kutishenko N. Y. Ivanenkova N. A. Dmitrieva A. A. Serazhim |
| author_sort | J. E. Semyonova |
| collection | DOAJ |
| description | Aim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlipidemia, who didn’t receive hypolipidemic drugs within 6 weeks, or followed hypolipidemic diet for 4 weeks. Each patient received therapy with one of the studied drugs within 6 weeks. Then after 4-week wash-out period the second therapy with the other drug was held. Consequence of courses with each drug was set by randomization. Initial dose of both drugs was 10 mg daily. Dose was adjusted after 3 weeks. The dose was increased to 20 mg daily if cholesterol of low density lipoproteid (CLDL) hadn’t reached target level (< 115 mg/dl). of Treatment safety was assessed on the basis of clinical data, hepatic enzymes activity and creatine phosphokinase levels.Results. It is shown, that to reach target figures of plasma lipid spectrum, Vasilip dose was increased significantly more often, than Tulip dose. Average Tulip dose after titration was 14,8 mg daily, Vasilip dose – 15,6 mg daily. Patients with initially higher level of triglycerides (TG > 170 mg/dl) after 6 weeks with Tulip treatment showed TG reduction by 38% and with Vasilip treatment – by 20%. Both drugs showed good tolerance, no significant differences in number of side-effects were observed.Conclusion. 6-week treatment with atorvastatine generic Tulip shows significant hypolipidemic effect, which appears in significant reduction of CLDL, total cholesterol, TG compared to the initial levels. Degree of total cholesterol reduction is significantly higher with Tulip treatment compared to Vasilip treatment. Analyses shown that target levels of the assessed figures were reached in more patients, treated with Tulip. Side-effects in Tulip treatment were not severe. |
| format | Article |
| id | doaj-art-a7237908eff34bad9f62fa2cbf836d68 |
| institution | Kabale University |
| issn | 1819-6446 2225-3653 |
| language | English |
| publishDate | 2015-12-01 |
| publisher | Столичная издательская компания |
| record_format | Article |
| series | Рациональная фармакотерапия в кардиологии |
| spelling | doaj-art-a7237908eff34bad9f62fa2cbf836d682025-08-23T10:00:19ZengСтоличная издательская компанияРациональная фармакотерапия в кардиологии1819-64462225-36532015-12-0113242810.20996/1819-6446-2005-1-3-24-28365EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIAJ. E. Semyonova0S. Y. Martsevich1N. V. Perova2A. M. Olferiev3N. P. Kutishenko4N. Y. Ivanenkova5N. A. Dmitrieva6A. A. Serazhim7State Research Center for Preventive Medicine of Roszdrav, MoscowState Research Center for Preventive Medicine of Roszdrav, MoscowState Research Center for Preventive Medicine of Roszdrav, MoscowState Research Center for Preventive Medicine of Roszdrav, MoscowState Research Center for Preventive Medicine of Roszdrav, MoscowState Research Center for Preventive Medicine of Roszdrav, MoscowState Research Center for Preventive Medicine of Roszdrav, MoscowState Research Center for Preventive Medicine of Roszdrav, MoscowAim. To assess in a short-term study efficiency and safety of hypolipidemic therapy with atorvastatine generic, Tulip, in comparison with simvastatine generic, Vasilip, in hyperlipidemic patients.Material and methods. Open, randomized, comparative, cross over study included 87 patients with hyperlipidemia, who didn’t receive hypolipidemic drugs within 6 weeks, or followed hypolipidemic diet for 4 weeks. Each patient received therapy with one of the studied drugs within 6 weeks. Then after 4-week wash-out period the second therapy with the other drug was held. Consequence of courses with each drug was set by randomization. Initial dose of both drugs was 10 mg daily. Dose was adjusted after 3 weeks. The dose was increased to 20 mg daily if cholesterol of low density lipoproteid (CLDL) hadn’t reached target level (< 115 mg/dl). of Treatment safety was assessed on the basis of clinical data, hepatic enzymes activity and creatine phosphokinase levels.Results. It is shown, that to reach target figures of plasma lipid spectrum, Vasilip dose was increased significantly more often, than Tulip dose. Average Tulip dose after titration was 14,8 mg daily, Vasilip dose – 15,6 mg daily. Patients with initially higher level of triglycerides (TG > 170 mg/dl) after 6 weeks with Tulip treatment showed TG reduction by 38% and with Vasilip treatment – by 20%. Both drugs showed good tolerance, no significant differences in number of side-effects were observed.Conclusion. 6-week treatment with atorvastatine generic Tulip shows significant hypolipidemic effect, which appears in significant reduction of CLDL, total cholesterol, TG compared to the initial levels. Degree of total cholesterol reduction is significantly higher with Tulip treatment compared to Vasilip treatment. Analyses shown that target levels of the assessed figures were reached in more patients, treated with Tulip. Side-effects in Tulip treatment were not severe.https://www.rpcardio.online/jour/article/view/365hyperlipidemiahypolipidemic therapysimvastatineatorvastatine |
| spellingShingle | J. E. Semyonova S. Y. Martsevich N. V. Perova A. M. Olferiev N. P. Kutishenko N. Y. Ivanenkova N. A. Dmitrieva A. A. Serazhim EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA Рациональная фармакотерапия в кардиологии hyperlipidemia hypolipidemic therapy simvastatine atorvastatine |
| title | EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA |
| title_full | EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA |
| title_fullStr | EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA |
| title_full_unstemmed | EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA |
| title_short | EFFICIENCY AND SAFETY ASSESSMENT OF GENERIC ATORVASTATINE IN PATIENTS WITH HYPERLIPIDEMIA |
| title_sort | efficiency and safety assessment of generic atorvastatine in patients with hyperlipidemia |
| topic | hyperlipidemia hypolipidemic therapy simvastatine atorvastatine |
| url | https://www.rpcardio.online/jour/article/view/365 |
| work_keys_str_mv | AT jesemyonova efficiencyandsafetyassessmentofgenericatorvastatineinpatientswithhyperlipidemia AT symartsevich efficiencyandsafetyassessmentofgenericatorvastatineinpatientswithhyperlipidemia AT nvperova efficiencyandsafetyassessmentofgenericatorvastatineinpatientswithhyperlipidemia AT amolferiev efficiencyandsafetyassessmentofgenericatorvastatineinpatientswithhyperlipidemia AT npkutishenko efficiencyandsafetyassessmentofgenericatorvastatineinpatientswithhyperlipidemia AT nyivanenkova efficiencyandsafetyassessmentofgenericatorvastatineinpatientswithhyperlipidemia AT nadmitrieva efficiencyandsafetyassessmentofgenericatorvastatineinpatientswithhyperlipidemia AT aaserazhim efficiencyandsafetyassessmentofgenericatorvastatineinpatientswithhyperlipidemia |