Golestan University of Medical Sciences Repository

A pilot double-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy ('polypill') on cardiovascular risk factors

Malekzadeh, F. and Marshall, T. and Pourshams, A. and Gharravi, M. and Aslani, A. and Nateghi, A. and Rastegarpanah, M. and Khoshnia, M. and Semnani, S. and Salahi, R. and Thomas, G.N. and Larijani, B. and Cheng, K.K. and Malekzadeh, R. (2010) A pilot double-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy ('polypill') on cardiovascular risk factors. International Journal of Clinical Practice, 64 (9). pp. 1220-1227. ISSN 13685031 (ISSN)

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Abstract

SummaryAim: Our objective was to investigate the effects and tolerability of fixed-dose combination therapy on blood pressure and LDL in adults without elevated blood pressure or lipid levels. Methods: This was a double-blind randomised placebo-controlled trial in residents of Kalaleh, Golestan, Iran. Following an 8-week placebo run-in period, 475 participants, aged 50 to 79 years, without cardiovascular disease, hypertension or hyperlipidaemia were randomised to fixed-dose combination therapy with aspirin 81 mg, enalapril 2.5 mg, atorvastatin 20 mg and hydrochlorothiazide 12.5 mg (polypill) or placebo for a period of 12 months. The primary outcomes were changes in LDL-cholesterol, systolic and diastolic blood pressure and adverse reactions. Analysis was by intention-to-treat basis. Results: At baseline, there were differences in systolic blood pressure (6 mmHg). Taking account of baseline differences, at 12 months, polypill was associated with statistically significant reductions in blood pressure (4.5/1.6 mmHg) and LDL-cholesterol (0.46 mmol/l). The study drug was well tolerated, but resulted in the modest reductions in blood pressure and lipid levels. Conclusion: The effects of the polypill on blood pressure and lipid levels were less than anticipated, raising questions about the reliability of the reported compliance. There is a case for a fully powered trial of a polypill for the prevention of cardiovascular disease. © 2010 Blackwell Publishing Ltd.

Item Type: Article
Additional Information: Unmapped bibliographic data: LA - English [Field not mapped to EPrints] J2 - Int. J. Clin. Pract. [Field not mapped to EPrints] C2 - 20653798 [Field not mapped to EPrints] AD - Digestive Disease Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran [Field not mapped to EPrints] AD - Unit of Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, United Kingdom [Field not mapped to EPrints] AD - Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran [Field not mapped to EPrints] AD - Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran [Field not mapped to EPrints] AD - Endocrine and Metabolism Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran [Field not mapped to EPrints] DB - Scopus [Field not mapped to EPrints]
Uncontrolled Keywords: acetylsalicylic acid, acetylsalicylic acid plus atorvastatin plus enalapril plus hydrochlorothiazide, atorvastatin, enalapril, glucose, high density lipoprotein cholesterol, hydrochlorothiazide, low density lipoprotein cholesterol, placebo, triacylglycerol, unclassified drug, adult, aged, article, cardiovascular disease, cardiovascular risk, clinical trial, controlled clinical trial, controlled study, coughing, diastolic blood pressure, double blind procedure, drug effect, drug formulation, drug tolerability, female, human, Iran, liver disease, liver function test, major clinical study, male, myopathy, patient compliance, polypill, priority journal, randomized controlled trial, side effect, systolic blood pressure, uric acid blood level, Aged, Anticholesteremic Agents, Antihypertensive Agents, Aspirin, Blood Pressure, Cardiovascular Diseases, Cholesterol, LDL, Chronic Disease, Double-Blind Method, Drug Combinations, Enalapril, Female, Heptanoic Acids, Humans, Hydrochlorothiazide, Male, Middle Aged, Pilot Projects, Platelet Aggregation Inhibitors, Pyrroles, Risk Factors, Tablets
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
موارد کلی
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 18 Apr 2015 05:10
Last Modified: 05 Apr 2017 09:57
URI: http://eprints.goums.ac.ir/id/eprint/2195

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