Fixed-Dose Combination Therapy with StatinsStrengths, Limitations, and Clinical and Regulatory Considerations

The obvious strengths of fixed-dose drug combinations include the potential advantages of increased compliance, convenience, and cost savings. In contrast, potential disadvantages include reduced flexibility in dosing, exposure of some patients to therapies they do not require, and possible increased risks of adverse effects without added benefits. With respect to fixed-dose drug combinations of HMG-CoA reductase inhibitors (statins), the totality of evidence is far less for the non-statin component leading to possible over utilization of two drugs when single-agent efficacy will suffice to maximize the benefit and minimize the risks.