Fixed combination drugs for cardiovascular disease risk reduction: regulatory approach.

The use of combination drug therapy for cardiovascular (CV) disease risk reduction is the established approach to multiple risk factor reduction. The spectrum of rational combination products in CV disease prevention and treatment alone is extremely broad. Development of fixed-dose combination drug products requires information beyond that needed for approval of single active ingredient products. Establishing the rationale and target populations for novel combinations, as well as the contributions of the component drugs to the claimed effects, and characterizing the pharmacokinetics, the pharmacodynamics, and clinical safety and efficacy of the combination are all necessary to support approval.