RAMIPRIL AND FELODIPINE - A COMPARISON OF THE EFFICACY AND SAFETY OF MONOTHERAPY VERSUS COMBINATION THERAPY

A multinational, double-blind, randomised study was conducted to inves tigate the efficacy and safety of a low-dose combination of the angiot ensin converting enzyme inhibitor, ramipril, and the calcium antagonis t, felodipine ER, in 642 patients with mild to moderate hypertension [ supine diastolic blood pressure (DBP) = 95-115 mm Hg]. After a 4-week single-blind placebo run-in, patients were randomly allocated to once- daily felodipine extended release (ER; 2.5 mg), ramipril (2.5 mg) or f elodipine ER/ramipril (2.5/2.5 mg) for 12 weeks. In the intention-to-t reat analysis, mean DBP decreased significantly (p < 0.0001) after fel odipine ER, ramipril and the combination (-9.1, -9.8 and -11.4 mm Hg, respectively). The decrease was significantly greater with the combina tion than with felodipine ER monotherapy (p = 0.02). The number of res ponding patients (final DBP less than or equal to 90 mm Hg or a decrea se of greater than or equal to 10 mm Hg) was also higher with the comb ination than with felodipine ER or ramipril monotherapy (65.1%, 53.1%, 55.7%, respectively). There were no differences between the three gro ups with respect to the incidence of adverse events overall or those c onsidered treatment-related. There were fewer cases of peripheral oede ma with combination therapy than with felodipine ER monotherapy. Thirt y-three patients (5.1%) withdrew from the study because of adverse eve nts, but there was no clear pattern with regard to the specific events leading to withdrawal. There were no clinically relevant changes in l aboratory or clinical safety variables. Ramipril/felodipine ER 2.5/2.5 mg is an appropriate starting dosage when initiating combination anti hypertensive therapy.