Polypills: an essential medicine for cardiovascular disease

Abstract

Adoption of the notion of a polypill, or fixed-dose combination treatment, to prevent cardiovascular disease has been slow. In today's Lancet, and ahead of the American College of Cardiology meeting in Washington, DC, USA (March 17–19), we publish a Series of articles that discusses evidence for the use of polypills in the prevention of cardiovascular disease, barriers to acceptance, and ongoing challenges to their widespread use. Randomised trials have shown that polypills combining a statin with one or more antihypertensive drugs and aspirin improve treatment adherence rates and safely reduce cardiovascular risk factors in patients with established cardiovascular disease. Yet, in contrast to conditions such as HIV, asthma, and migraine, for which combination treatments have gained universal acceptance, the idea of a polypill for cardiovascular disease prevention, while popular among patients, has proved less so among specialist physicians. Reasons for this include negative perceptions about lack of flexibility in dosing and concerns about loss of autonomy in clinical decision making. And until recently there has been little appetite from pharmaceutical companies to develop polypills because of perceived low financial margins, despite a huge target population. The tide seems to be turning, however, with the recent approval of a polypill containing aspirin, ramipril, and atorvastatin in more than 30 countries across Latin America and Europe. The world is facing an epidemic of non-communicable diseases with more than 80% of premature deaths from cardiovascular disease occurring in low-income and middle-income countries (LMICs). More than 30 million people worldwide do not have access to appropriate secondary prevention, mostly in LMICs. Thus, the availability and use of an affordable polypill would be welcome to help achieve the WHO target of cutting the number of deaths from non-communicable diseases by 25% by 2025. The next iteration of WHO's essential medicines list is scheduled to be discussed on March 27–31; inclusion of the polypill on this list is a necessary and important step to pave the way for improved access worldwide. For the essential medicines application see http://www.who.int/selection_medicines/committees/expert/21/applications/s12_aspirin_atorvastatin_ramipril_add.pdf For the essential medicines application see http://www.who.int/selection_medicines/committees/expert/21/applications/s12_aspirin_atorvastatin_ramipril_add.pdf Uses of polypills for cardiovascular disease and evidence to datePolypills have been approved in more than 30 countries, but worldwide experience with and availability of polypills remain limited, unlike fixed-dose combinations in other diseases such as HIV, tuberculosis, and malaria. In this Series review, we aim to propose a guide for the use of polypills in future research and clinical activities and to synthesise contemporary evidence supporting the use of polypills for prevention of atherosclerosis. Polypill uses can be categorised by population and indication, both of which influence the balance between benefits and risks. Full-Text PDF Putting polypills into practice: challenges and lessons learnedRegulatory approvals for cardiovascular polypills are increasing rapidly across more than 30 countries. The evidence clearly shows polypills improve adherence and cardiovascular disease risk factors for patients with indications for use of polypill components—ie, those with established cardiovascular disease or at high risk. However, the implementation of polypills into clinical practice has many challenges. The clinical trials literature provides insights into the clinical impact of a polypill strategy, including cost-effectiveness, safety of use, substantial improvement in adherence, and better risk factor control than usual care. Full-Text PDF Are ACE inhibitors acceptable ingredients in polypills?The Lancet suggested in their Editorial (March 11, p 984)1 that an affordable polypill would be welcomed in the more than 30 million people worldwide who do not have access to appropriate secondary prevention. When considering such numbers, balance between benefits and harms becomes exceedingly important. As can be estimated by the number needed to treat, most people taking a polypill for years or decades will never be benefited by it. They nevertheless have to put up with adverse events, which are up to 16% higher (risk ratio 1·16, 95% CI 1·09–1·25) in participants randomly assigned polypills than in those assigned usual care. Full-Text PDF