Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study
Objective: To compare the efficacy and safety of generic (Utmos®) and original (Actos®) 30 mg Pioglitazone tablets. Study design: A multicenter, parallel randomized, double-blinded, controlled study. Material and Method: Type 2 diabetic patients, with glycosylated hemoglobin (HbA1c) ≥ 7.0%, who rece...
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th-cmuir.6653943832-36202014-08-30T02:35:07Z Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study Rawdaree P. Deerochanawong C. Peerapatdit T. Thongtang N. Suwanwalaikorn S. Khemkha A. Benjasuratwong Y. Boonyavarakul A. Chetthakul T. Leelawattana R. Ngarmukos C. Viwatwongkasem C. Pratipanawatr T. Kosachunhanun N. Objective: To compare the efficacy and safety of generic (Utmos®) and original (Actos®) 30 mg Pioglitazone tablets. Study design: A multicenter, parallel randomized, double-blinded, controlled study. Material and Method: Type 2 diabetic patients, with glycosylated hemoglobin (HbA1c) ≥ 7.0%, who received Metformin not less than 1,000 mg/day over three months were recruited. Patients were randomized to receive either generic or original Pioglitazone 30 mg/day for 24 weeks. Results: Eighty-five patients were enrolled, forty-four patients received generic Pioglitazone and forty-one received original Pioglitazone. There were no significant differences in baseline characteristics between generic and original Pioglitazone group. There were significantly reduced HbA1c, fasting plasma glucose (FPG) and significantly increased HDL-cholesterol from baseline (p < 0.0001) without statistically differences between the two groups. Headache and edema were found in both groups at comparable rates (p > 0.05). Conclusion: Generic Pioglitazone (Utmos®) is effective in controlling blood glucose and has similar effects on lipid profile as the original one. Both generic (Utmos®) and original (Actos®) 30 mg Pioglitazone tablets were not different in the efficacy and safety profiles. 2014-08-30T02:35:07Z 2014-08-30T02:35:07Z 2010 Article 1252208 21114202 JMTHB http://www.scopus.com/inward/record.url?eid=2-s2.0-78649246535&partnerID=40&md5=caba8fc5f4da12b89945f313a052fe98 http://cmuir.cmu.ac.th/handle/6653943832/3620 English |
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Objective: To compare the efficacy and safety of generic (Utmos®) and original (Actos®) 30 mg Pioglitazone tablets. Study design: A multicenter, parallel randomized, double-blinded, controlled study. Material and Method: Type 2 diabetic patients, with glycosylated hemoglobin (HbA1c) ≥ 7.0%, who received Metformin not less than 1,000 mg/day over three months were recruited. Patients were randomized to receive either generic or original Pioglitazone 30 mg/day for 24 weeks. Results: Eighty-five patients were enrolled, forty-four patients received generic Pioglitazone and forty-one received original Pioglitazone. There were no significant differences in baseline characteristics between generic and original Pioglitazone group. There were significantly reduced HbA1c, fasting plasma glucose (FPG) and significantly increased HDL-cholesterol from baseline (p < 0.0001) without statistically differences between the two groups. Headache and edema were found in both groups at comparable rates (p > 0.05). Conclusion: Generic Pioglitazone (Utmos®) is effective in controlling blood glucose and has similar effects on lipid profile as the original one. Both generic (Utmos®) and original (Actos®) 30 mg Pioglitazone tablets were not different in the efficacy and safety profiles. |
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Rawdaree P. Deerochanawong C. Peerapatdit T. Thongtang N. Suwanwalaikorn S. Khemkha A. Benjasuratwong Y. Boonyavarakul A. Chetthakul T. Leelawattana R. Ngarmukos C. Viwatwongkasem C. Pratipanawatr T. Kosachunhanun N. |
spellingShingle |
Rawdaree P. Deerochanawong C. Peerapatdit T. Thongtang N. Suwanwalaikorn S. Khemkha A. Benjasuratwong Y. Boonyavarakul A. Chetthakul T. Leelawattana R. Ngarmukos C. Viwatwongkasem C. Pratipanawatr T. Kosachunhanun N. Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study |
author_facet |
Rawdaree P. Deerochanawong C. Peerapatdit T. Thongtang N. Suwanwalaikorn S. Khemkha A. Benjasuratwong Y. Boonyavarakul A. Chetthakul T. Leelawattana R. Ngarmukos C. Viwatwongkasem C. Pratipanawatr T. Kosachunhanun N. |
author_sort |
Rawdaree P. |
title |
Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study |
title_short |
Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study |
title_full |
Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study |
title_fullStr |
Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study |
title_full_unstemmed |
Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study |
title_sort |
efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: a multicenter, a double-blinded, randomized-controlled study |
publishDate |
2014 |
url |
http://www.scopus.com/inward/record.url?eid=2-s2.0-78649246535&partnerID=40&md5=caba8fc5f4da12b89945f313a052fe98 http://cmuir.cmu.ac.th/handle/6653943832/3620 |
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