Fixed Dose Combination Drug (Polypill)for Secondary Cardiovascular Prevention.

Summary

The aim of the FOCUS project is to test the Fixed Dose Combination concept for cardiovascular prevention in populations of different socio-economic characteristics. At the same time, FOCUS aims to understand the factors determining inappropriate prescribing for secondary cardiovascular prevention and those for poor patients adherence to treatment. This will allow FOCUS to establish recommendations for a better use of medication in patients with ischemic heart disease. In addition, after a successful completion of FOCUS, secondary prevention medication will be available and affordable for a large number of patients in both developed as well as developing countries. There are two Phases in this study: Phase 1: Is a descriptive, non interventional study. Phase 2: Is an interventional, randomized trial with prospective economic evaluation.

Timeline

Start

2012-01

Primary completion

2014-05

Completion

2014-06

Outcome

Met primary endpoint

paper Compared with the 3 drugs given separately, the use of a polypill strategy met the primary endpoint for adherence for secondary prevention following an acute MI. PMID 25193393 ↗

Publications

• Background World Health Organization. Price, availability and affordability. An international comparison of chronic disease medicines. Background report prepared for the WHO Plannig Meeting on the Global Initiative for Treatment of Chronic Diseases, Cairo, December 2005
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• Background EUROASPIRE I and II Group; European Action on Secondary Prevention by Intervention to Reduce Events. Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. EUROASPIRE I and II Group. European Action on Secondary Prevention by Intervention to Reduce Events. Lancet. 2001 Mar 31;357(9261):995-1001. doi: 10.1016/s0140-6736(00)04235-5.
• Background Heras M, Marrugat J, Aros F, Bosch X, Enero J, Suarez MA, Pabon P, Ancillo P, Loma-Osorio A, Rodriguez JJ, Subirana I, Vila J; en representacion de los investigadores del estudio PRIAMHO. [Reduction in acute myocardial infarction mortality over a five-year period]. Rev Esp Cardiol. 2006 Mar;59(3):200-8. Spanish.
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• Background Pharma 2020: the vision. Which path will you take? (Accessed at http://www.pwc.com/pharma.)
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• Background DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med. 2000 Jul 24;160(14):2101-7. doi: 10.1001/archinte.160.14.2101.
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• Background Danchin N, Cambou JP, Hanania G, Kadri Z, Genes N, Lablanche JM, Blanchard D, Vaur L, Clerson P, Gueret P; USIC 2000 investigators. Impact of combined secondary prevention therapy after myocardial infarction: data from a nationwide French registry. Am Heart J. 2005 Dec;150(6):1147-53. doi: 10.1016/j.ahj.2005.01.058.
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• Background Wise J. Polypill holds promise for people with chronic disease. Bull World Health Organ. 2005 Dec;83(12):885-7. Epub 2006 Jan 30. No abstract available.
• Background Sleight P, Pouleur H, Zannad F. Benefits, challenges, and registerability of the polypill. Eur Heart J. 2006 Jul;27(14):1651-6. doi: 10.1093/eurheartj/ehi841. Epub 2006 Apr 7.
• Background Reddy KS. Is a multidrug regimen cost-effective for the prevention of cardiovascular disease in resource-poor countries? Nat Clin Pract Cardiovasc Med. 2007 Mar;4(3):130-2. doi: 10.1038/ncpcardio0799. Epub 2007 Jan 30. No abstract available.
• Background Reddy KS. The preventive polypill--much promise, insufficient evidence. N Engl J Med. 2007 Jan 18;356(3):212. doi: 10.1056/NEJMp068219. No abstract available.
• Background Herrick TM, Million RP. Tapping the potential of fixed-dose combinations. Nat Rev Drug Discov. 2007 Jul;6(7):513-4. doi: 10.1038/nrd2334. No abstract available.
• Background Fuster V, Sanz G. A polypill for secondary prevention: time to move from intellectual debate to action. Nat Clin Pract Cardiovasc Med. 2007 Apr;4(4):173. doi: 10.1038/ncpcardio0858. No abstract available.
• Background Combination Pharmacotherapy and Public Health Research Working Group. Combination pharmacotherapy for cardiovascular disease. Ann Intern Med. 2005 Oct 18;143(8):593-9. doi: 10.7326/0003-4819-143-8-200510180-00010.
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• Background Dickson M, Plauschinat CA. Compliance with antihypertensive therapy in the elderly: a comparison of fixed-dose combination amlodipine/benazepril versus component-based free-combination therapy. Am J Cardiovasc Drugs. 2008;8(1):45-50. doi: 10.2165/00129784-200808010-00006.
• Background Pan F, Chernew ME, Fendrick AM. Impact of fixed-dose combination drugs on adherence to prescription medications. J Gen Intern Med. 2008 May;23(5):611-4. doi: 10.1007/s11606-008-0544-x. Epub 2008 Feb 21.
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• Background Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N; Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD). Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003 Jun 18;289(23):3106-16. doi: 10.1001/jama.289.23.3106.
• Castellano JM, Sanz G, Penalvo JL, Bansilal S, Fernandez-Ortiz A, Alvarez L, Guzman L, Linares JC, Garcia F, D'Aniello F, Arnaiz JA, Varea S, Martinez F, Lorenzatti A, Imaz I, Sanchez-Gomez LM, Roncaglioni MC, Baviera M, Smith SC Jr, Taubert K, Pocock S, Brotons C, Farkouh ME, Fuster V. A polypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2071-82. doi: 10.1016/j.jacc.2014.08.021. Epub 2014 Sep 1.
• Sanz G, Fuster V, Guzman L, Guglietta A, Arnaiz JA, Martinez F, Sarria A, Roncaglioni MC, Taubert K. The fixed-dose combination drug for secondary cardiovascular prevention project: improving equitable access and adherence to secondary cardiovascular prevention with a fixed-dose combination drug. Study design and objectives. Am Heart J. 2011 Nov;162(5):811-817.e1. doi: 10.1016/j.ahj.2011.08.012.

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