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Polypill for prevention of cardiovascular disease in an Urban Iranian population with special focus on nonalcoholic steatohepatitis: A pragmatic randomized controlled trial within a cohort (PolyIran - Liver) – Study protocol

Merat, S. and Poustchi, H. and Hemming, K. and Jafari, E. and Radmard, A.-R. and Nateghi, A. and Khuzani, A.S. and Khoshnia, M. and Marshall, T. and Malekzadeh, R. (2015) Polypill for prevention of cardiovascular disease in an Urban Iranian population with special focus on nonalcoholic steatohepatitis: A pragmatic randomized controlled trial within a cohort (PolyIran - Liver) – Study protocol. Archives of Iranian Medicine, 18 (8). pp. 515-523.

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Abstract

Background: Cardiovascular disease (CVD) is among the most common causes of mortality in all populations. Nonalcoholic steatohepatitis is a common finding in patients with CVD. Prevention of CVD in individual patients typically requires periodic clinical evaluation, as well as diagnosis and management of risk factors such as hypertension and hyperlipidemia. However, this is resource consuming and hard to implement, especially in developing countries. We designed a study to investigate the effects of a simpler strategy: a fixed-dose combination pill consisting of aspirin, valsartan, atorvastatin and hydrochlorthiazide (PolyPill) in an unselected group of persons aged over 50 years. Design: The PolyIran-Liver study was performed in Gonbad city as an open label pragmatic randomized controlled trial nested within the Golestan Cohort Study. We randomly selected 2,400 cohort study participants aged above 50 years, randomly assigned them to intervention or usual care and invited them to participate in an additional measurement study (if they met the eligibility criteria) to measure liver related outcomes. Those agreeing and randomized to the intervention arm were offered a daily single dose of PolyPill. We will follow participants for 5 years. The primary outcome is major cardiovascular events, secondary outcomes include all-cause mortality and liver related outcomes: liver stiffness and liver enzyme levels. Cardiovascular outcomes and mortality will be determined from the cohort study and liver-related outcomes in those consenting to follow up. Analysis will be by allocated group. Trial Status: Between October and December 2011, 1,320 intervention and 1,080 control participants were invited to participate in the additional measurement study. For all these participants, the major cardiovascular events will be determined using blind assessment of outcomes through the cohort study. In the intervention and control arms, 875 (66%) and 721 (67%) respectively, met the eligibility criteria and agreed to participate in the additional measurement study. Liver related outcomes will be measured in these participants. Of the 1,320 participants randomized to the intervention, 787 (60%) accepted the PolyPill. Conclusion: The PolyIran-liver urban study will provide us with important information on the effectiveness of PolyPill on major cardiovascular events, all-cause mortality and liver related outcomes. (ClinicalTrials.gov ID: NCT01245608). © 2015, Academy of Medical Sciences of I.R. Iran. All rights reserved.

Item Type: Article
Additional Information: cited By 1
Uncontrolled Keywords: acetylsalicylic acid; alanine aminotransferase; atorvastatin; hydrochlorothiazide; valsartan; acetylsalicylic acid; angiotensin 1 receptor antagonist; antithrombocytic agent; atorvastatin; diuretic agent; drug combination; hydrochlorothiazide; hydroxymethylglutaryl coenzyme A reductase inhibitor; valsartan, acute coronary syndrome; adult; aged; Article; blindness; cardiovascular disease; cohort analysis; controlled study; digestive system cancer; female; follow up; heart infarction; hospitalization; human; major clinical study; male; medical examination; mortality; nonalcoholic fatty liver; questionnaire; randomized controlled trial; Cardiovascular Diseases; drug combination; Iran; middle aged; Non-alcoholic Fatty Liver Disease; urban population, Angiotensin II Type 1 Receptor Blockers; Aspirin; Atorvastatin Calcium; Cardiovascular Diseases; Diuretics; Drug Combinations; Female; Humans; Hydrochlorothiazide; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Iran; Male; Middle Aged; Non-alcoholic Fatty Liver Disease; Platelet Aggregation Inhibitors; Urban Population; Valsartan
Subjects: مقالات نمایه شده محققین دانشگاه در سایت ,Web of Science ,Scopus
Divisions: معاونت تحقیقات و فناوری
Depositing User: GOUMS
Date Deposited: 08 Sep 2016 17:33
Last Modified: 16 Jan 2017 08:05
URI: http://eprints.goums.ac.ir/id/eprint/4675

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