Call for wider appreciation of polypills for secondary prevention of CV disease
Polypills: Essential Medicines for Cardiovascular Disease Secondary Prevention?
Huffman MD, Yusuf S.
J Am Coll Cardiol. 2014 Apr 15;63(14):1368-1370
In light of the “25 x 25” goal of the World Health Organisation (WHO) to reduce the number of premature deaths (<70 years) due to noncommunicable chronic disease (NCDs) by 25% by the year 2025, the authors of this viewpoint advocate the wider use of fixed-dose combination, or polypill, for secondary cardiovascular disease (CVD) prevention. The authors propose for the polypill to be included in the Model List of Essential Medicines, which was developed by the WHO to guide countries in the creation of national formularies and policies for access, quality, and use of essential medicines as part of achieving the ‘universal right to the highest attainable standard of health’.
The polypill can include statins, antiplatelet agents, beta-blockers and blood pressure-lowering drugs. Despite the proven efficacy of these agents in patients with prior ischemic heart disease or stroke, the majority of patients do not receive all or not even some of these therapies.
Advantages of polypills for secondary prevention of CVD over single compounds administered separately include improved adherence by 33%, and polypills may be less expensive. Although fixed-dose combination therapy per se has not been tested for efficacy in secondary prevention of CVD, each of the components has been shown to be beneficial when given in combination with other proven drugs. Benefits of the different components are additive, and trials indicate that their concomitant use is well tolerated. Similar or improved efficacy, tolerance, and adherence have been demonstrated both in individuals with prior CVD, in individuals without prior CVD and in patients with other medical conditions. Thus, based on the currently available data, consensus is that fixed-dose combination therapy should be considered as secondary prevention of CVD.
Supported by many colleagues, in November 2012, the authors submitted an application to the WHO 18th Expert Committee on the Selection and Use of Essential Medicines to recommend that fixed-dose combination, be added to this WHO Model List for the secondary prevention of CVD (ischemic heart disease and thrombotic stroke). The application was not accepted and the updated 18th Model List of Essential Medicines did not include polypill therapy.
The authors believe that inclusion of fixed-dose combination therapy would emphasize its benefit, and stimulate pharmaceutical manufacturers to develop and test various polypills, and that it would encourage regulators in being more flexible in developing a practical pathway to approvals of a polypill. Inclusion in the list would furthermore facilitate its access, which has the potential of avoiding many premature deaths and morbidity from CVD, at low cost.
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