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.
RCT Entities:
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: Ehete Bahiru; Angharad N de Cates; Matthew Rb Farr; Morag C Jarvis; Mohan Palla; Karen Rees; Shah Ebrahim; Mark D Huffman Journal: Cochrane Database Syst Rev Date: 2017-03-06
Authors: P Bramlage; W März; D Westermann; B Weisser; J H Wirtz; U Zeymer; P Baumgart; G van Mark; U Laufs; B K Krämer; T Unger Journal: Herz Date: 2017-03-24 Impact factor: 1.443
Authors: Abdullah Gandomkar; Hossein Poustchi; Maryam Moini; Mohsen Moghadami; Hadi Imanieh; Mohammad Reza Fattahi; Seyyed Mohammad Taghi Ayatollahi; Mohammad Mahdi Sagheb; Amir Anushiravani; Roozbeh Mortazavi; Sadaf Ghajarieh Sepanlou; Reza Malekzadeh Journal: Int J Public Health Date: 2016-06-28 Impact factor: 3.380
Authors: Sadaf G Sepanlou; Arash Etemadi; Farin Kamangar; Alireza Sepehr; Akram Pourshams; Hossein Poustchi; Farhad Islami; Alireza Sadjadi; Dariush Nasrollahzadeh; Shahryar Semnani; Farrokh Saidi; Christian C Abnet; Bruce Ponder; Paul D Pharoah; Nicholas E Day; Paul Brennan; Paolo Boffetta; Sanford M Dawsey; Reza Malekzadeh Journal: Arch Iran Med Date: 2013-01 Impact factor: 1.354