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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/29497
Title: Efficacy and safety of generic and original pioglitazone in type 2 diabetes mellitus: A multicenter, a double-blinded, randomized-controlled study
Authors: Petch Rawdaree
Chaicharn Deerochanawong
Thavatchai Peerapatdit
Nuntakorn Thongtang
Sompongse Suwanwalaikorn
Ampai Khemkha
Yupin Benjasuratwong
Apussanee Boonyavarakul
Thanya Chetthakul
Rattana Leelawattana
Chardpraorn Ngarmukos
Chukiat Viwatwongkasem
Thongchai Pratipanawatr
Natapong Kosachunhanun
Vajira Hospital
Rajavithi Hospital
Mahidol University
Chulalongkorn University
Phramongkutklao College of Medicine
Maharaj Nakhon Ratchasima Hospital
Prince of Songkla University
Khon Kaen University
Chiang Mai University
Keywords: Medicine
Issue Date: 1-Nov-2010
Citation: Journal of the Medical Association of Thailand. Vol.93, No.11 (2010), 1249-1255
Abstract: 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.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=78649246535&origin=inward
http://repository.li.mahidol.ac.th/dspace/handle/123456789/29497
ISSN: 01252208
01252208
Appears in Collections:Scopus 2006-2010

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