Benefits, challenges, and registerability of the polypill.
Guidelines for the management of cardiovascular disease (CVD) stress the importance of treating global risk, rather than individual risk, factors. Patients at high cardiovascular (CV) risk, for example, benefit from a combination of aspirin, antihypertensive agents, lipid-lowering drugs, and possibly folic acid. As the number of medications that a patient requires increases, adherence and compliance to therapy are likely to decrease. The use of affordable, multiple-target, fixed-combination 'polypills', which concomitantly reduce multiple risk factors without increasing the pill burden or the risk of adverse effects, has the potential to improve CV risk factor management, thereby reducing the incidence of CVD. This review discusses the benefits of the polypill and the challenges and requirements for its success and registerability. Discussions with regulatory bodies are required in order to obtain some 'balance' between an overcautious registration approach and the potentially large public health benefits that are likely to arise from the use of polypills.
Sleight
Peter
P
Cardiac Department, John Radcliffe Hospital, Headington, Oxford OX3 9DU, UK. peter.sleight@attglobal.net
Pouleur
Hubert
H
Zannad
Faiez
F
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage; D001241:Aspirin / Q000008:administration & dosage; D001291:Attitude of Health Personnel; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D017277:Drug Approval; D004338:Drug Combinations; D016527:Drug Costs; D005492:Folic Acid / Q000008:administration & dosage; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D008875:Middle Aged; D017060:Patient Satisfaction; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D017410:Practice Guidelines as Topic; D049993:Sodium Chloride Symporter Inhibitors / Q000008:administration & dosage; D016896:Treatment Outcome
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010975:Platelet Aggregation Inhibitors; D049993:Sodium Chloride Symporter Inhibitors; D005492:Folic Acid; D001241:Aspirin