A PILOT DOUBLE-BLIND RANDOMISED PLACEBO-CONTROLLED TRIAL OF THE EFFECTS OF FIXED-DOSE COMBINATION THERAPY (‘POLYPILL’) ON CARDIOVASCULAR RISK FACTORS

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MAJED MASOUD; MORADMAND BADIE SINA

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Journal: ARCHIVES OF IRANIAN MEDICINE Year:2011 | Volume:14 | Issue:1 Page(s): 78-80

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Title

A PILOT DOUBLE-BLIND RANDOMISED PLACEBO-CONTROLLED TRIAL OF THE EFFECTS OF FIXED-DOSE COMBINATION THERAPY (‘POLYPILL’) ON CARDIOVASCULAR RISK FACTORS

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MAJED MASOUD | MORADMAND BADIE SINA | Issue Writer Certificate

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Abstract

Aim: Our objective was to investigate the effects and tolerability of xed-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 undertaken in residents of Kalaleh, Golestan, Iran. Following an eight week placebo run-in period, 475 participants, aged 50 to 79 years, who had no cardiovascular disease, hypertension or hyperlipidemia were randomised to xeddose 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 into account the baseline differences, at 12 months, the polypill was associated with statistically signicant 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 reported compliance. There is a case for a fully powered trial of the polypill for prevention of cardiovascular disease.

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APA: Copy

MAJED, MASOUD, & MORADMAND BADIE, SINA. (2011). A PILOT DOUBLE-BLIND RANDOMISED PLACEBO-CONTROLLED TRIAL OF THE EFFECTS OF FIXED-DOSE COMBINATION THERAPY (‘POLYPILL’) ON CARDIOVASCULAR RISK FACTORS. ARCHIVES OF IRANIAN MEDICINE, 14(1), 78-80. SID. https://sid.ir/paper/280723/en

Vancouver: Copy

MAJED MASOUD, MORADMAND BADIE SINA. A PILOT DOUBLE-BLIND RANDOMISED PLACEBO-CONTROLLED TRIAL OF THE EFFECTS OF FIXED-DOSE COMBINATION THERAPY (‘POLYPILL’) ON CARDIOVASCULAR RISK FACTORS. ARCHIVES OF IRANIAN MEDICINE[Internet]. 2011;14(1):78-80. Available from: https://sid.ir/paper/280723/en

IEEE: Copy

MASOUD MAJED, and SINA MORADMAND BADIE, “A PILOT DOUBLE-BLIND RANDOMISED PLACEBO-CONTROLLED TRIAL OF THE EFFECTS OF FIXED-DOSE COMBINATION THERAPY (‘POLYPILL’) ON CARDIOVASCULAR RISK FACTORS,” ARCHIVES OF IRANIAN MEDICINE, vol. 14, no. 1, pp. 78–80, 2011, [Online]. Available: https://sid.ir/paper/280723/en

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