Prime Time for a Polypill After Myocardial Infarction? Valentin Fuster

EDITORIAL ◉ ◉ Focus on the polypill www.nature.com/clinicalpractice/cardio Prime time for a polypill after myocardial infarction? Valentin Fuster Cardiovascular disease is the leading cause “...controversy a statin, and an angiotensin-converting- of death in developed, as well as develop- about the true enzyme inhibitor for secondary prevention in ing, countries. Patients with key risk factors, patients who have already suffered an acute and those who have a history of acute myo- value of a MI. The product is in the final stages of devel- cardial infarction (MI), are at high risk of cardiovascular opment and will be made available at a price coronary events. The efficacy of secondary ‘Polypill’ has that will allow this Polypill to be accessible to cardiovascular prevention therapy in these been rife since patients in low-income countries. Although populations is well documented, but is ham- Wald and Law originally proposed a pill com- 2003 when pered by limited availability and inadequate bining half-doses of three antihypertensive prescription of medication, poor adherence to Wald and drugs together with a statin, folic acid, and treatment, limited availability of medications, Law originally aspirin for primary prevention, our Polypill will and unaffordable treatment costs. The use of proposed the include 100 mg aspirin, 40 mg simvastatin, fixed-dose combination drugs could circumvent idea.” and ramipril at three different doses (2.5 mg, these problems; however, controversy about 5 mg, and 10 mg), to facilitate dose titration. the true value of a cardiovascular ‘polypill’ has Our fixed-dose combination therapy will been rife since 2003 when Wald and Law origi- be targeted towards high-risk patients who nally proposed the idea (Wald NJ and Law MR have had an MI and who should already have [2003] BMJ 326: 1419). Four articles in this received these agents, as recommended issue of Nature Clinical Practice Cardiovascular by various guidelines. Although β-blockers Medicine readdress the concept of a cardio- should be routinely administered in patients vascular polypill and provide new light for the following MI, we decided do not include them immediate future of this controversial therapy. in our Polypill, as the addition of a β-blocker In his Viewpoint article, Lennart Forslund, would increase the difficulties in galaenic for- from the Medical Products Agency in Uppsala, mulation and bioequivalence. Furthermore, Sweden, points out that the implementation of a a four-component combined therapy would polypill requires a new way of thinking on aspects narrow the target population and increase the such as treatment paradigms, drug develop- difficultly of dose titration. ment, and study design. Such changes in think- Also in this issue of the journal, Salim Yusuf ing will require interactions, not only between and colleagues describe the Indian Polycap sponsors and regulatory agencies, but also the Study, which comprehensively tests Wald and between the scientific community, health-care Law’s hypothesis with a five-drug combination systems and political systems as a whole. as part of a multicenter, randomized, control- A Review by Drs Guglietta and Guerrero from led, double-blind trial in a primary prevention Ferrer Laboratories, Barcelona, Spain address setting. The ‘Polycap’ contains atenolol, thi- the unique challenges in the pharmaceutical azide, ramipril, simvastatin, and aspirin. Many V Fuster is the Editor- development of a cardiovascular polypill, such in-Chief of Nature will argue that this combination of agents is as the one they have developed for Centro Clinical Practice unnecessary for primary cardiovascular preven- Nacional de Investigaciones Cardiovasculares. Cardiovascular tion. A fixed-dose polypill for use by patients The final decision on which, and how many, Medicine. with MI is, however, less controversial because active drugs should be included in the Polypill each component is required for treatment of depends on how developers prioritize clinical, Competing interests these individuals, adherence to therapy could The author declared no pharmaceutical, and commercial issues. competing interests. be improved, and the cost of treatment could be In our Review, Ginés Sanz and I propose a reduced, thus making therapy more affordable www.nature.com/clinicalpractice three-component polypill, comprising aspirin, doi:10.1038/ncpcardio1443 in low-income countries. FEBRUARY 2009 VOL 6 NO 2 NATURE CLINICAL PRACTICE CARDIOVASCULAR MEDICINE 83.

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