All-in-one hearty pill

Besides being affordable, clinicians believe that a fixed-dose combination (FDC) pill will simplify dosage adjustment for physicians and improve patient follow-up and adherence. This hypothesis was tested under the aegis of the EU-funded FOCUS (Fixed dose combination drugs for secondary cardiovascular prevention) project.

Scientists developed and tested FDC pills containing specific doses of ramipril, simvastatin and acetylsalicylic acid to cost-effectively treat heart conditions.

Researchers carried out a study on post-myocardial infarct patients in two phases, beginning with an observational study followed by a clinical trial. Safety, efficacy and efficiency of FDC pills over multiple pill combinations were assessed at multiple sites in Europe and South America.

Study outcomes revealed that younger age, depression and complex drug combinations lead to poorer medication adherence, whereas good insurance coverage and social support improved patient compliance.

A key finding is the confirmation that FDC pills significantly enhance patient adherence in comparison to patients on a complex drug treatment plan. FDC pills could therefore be more effective at secondary cardiovascular prevention than an optimised multiple-drug regimen.

Project findings were presented at the European Society of Cardiology (ESC) congress and published in the Journal of the American College of Cardiology. FOCUS also published recommendations on FDC pill usage to improve patient medication adherence as well as access to cardiovascular prevention medication.

The industrial partner in the FOCUS project will work on commercialising the FDC pill at an affordable price. Rapid adoption of the FDC concept for secondary cardiovascular prevention and enhanced access to FDC pills in developed and developing countries could potentially save millions of lives. Moreover, substantial cost savings for both patient and national health systems should facilitate widespread application of the FDC pill treatment.

Study outcomes also indicate that this polypill approach could be adopted for the treatment of other chronic diseases like diabetes. This has significant socioeconomic implications.