Comparison of the efficacy and safety of an oral combination of losartan, hydrochlorothiazide and simvastatin against separated components, in hypertensive and dyslipidemic patients

Abstract

Hypertension is an important health problem that frequently requires multidrug treatment, whether due to monotherapy failure or in a concomitant manner. This situation has impulsed the development of some fixed dose combination products with the idea of improve the efficacy, the safety or the adherence of the treatment. In this study, the efficacy and safety of a fixed dose combination product composed by losartan, hydrochlorothiazide and simvastatin was compared with the mixture of losartan and hydrochlorothiazide plus simvastatin, in hypertensive and hypercholesterolemia patients. In this double-blinded, randomized and controlled clinical trial, one hundred and forty four (144) hypertensive and hypercholesterolemia patients received a daily capsule with losartan 50 mg, hydrochlorothiazide 12.5 mg and simvastatin 20 mg plus a tablet of placebo; or a daily tablet with losartan 50 mg and hydrochlorothiazide 12.5 mg plus a capsule of simvastatin 20 mg, during 81 days. Both treatments produced similar reductions on blood pressure and low-density lipoprotein-cholesterol levels, and more than 90% of treated patients achieved recommended values in these parameters. It is concluded that the fixed dose combination of losartan, hydrochlorothiazide and simvastatin, is as effective and safe as the fixed dose of losartan and hydrochlorothiazide plus simvastatin, in hypertensive and hypercholesterolemic patients.