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

Abstract

AIM:

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.

• Authors: F Malekzadeh, T Marshall, A Pourshams, M Gharravi, A Aslani, A Nateghi, M Rastegarpanah, M Khoshnia, S Semnani, R Salahi, G N Thomas, B Larijani, K K Cheng, R Malekzadeh
• Journal: International journal of clinical practice (Int J Clin Pract) Vol. 64 Issue 9 Pg. 1220-7 (Aug 2010) ISSN: 1742-1241 [Electronic] India
• PMID: 20653798 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticholesteremic Agents
• Antihypertensive Agents
• Cholesterol, LDL
• Drug Combinations
• Heptanoic Acids
• Platelet Aggregation Inhibitors
• Pyrroles
• Tablets
• Hydrochlorothiazide
• Enalapril
• Atorvastatin
• Aspirin

Topics

• Aged
• Anticholesteremic Agents (administration & dosage, pharmacology)
• Antihypertensive Agents (administration & dosage, pharmacology)
• Aspirin (administration & dosage, pharmacology)
• Atorvastatin
• Blood Pressure (drug effects)
• Cardiovascular Diseases (etiology)
• Cholesterol, LDL (drug effects)
• Chronic Disease
• Double-Blind Method
• Drug Combinations
• Enalapril (administration & dosage, pharmacology)
• Female
• Heptanoic Acids (administration & dosage, pharmacology)
• Humans
• Hydrochlorothiazide (administration & dosage, pharmacology)
• Male
• Middle Aged
• Pilot Projects
• Platelet Aggregation Inhibitors (administration & dosage, pharmacology)
• Pyrroles (administration & dosage, pharmacology)
• Risk Factors
• Tablets