COMPARISON OF AMLODIPINE AND BENAZEPRIL MONOTHERAPY TO AMLODIPINE PLUS BENAZEPRIL IN PATIENTS WITH SYSTEMIC HYPERTENSION - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY

A single-blind, run-in, randomized, double-blind, parallel-group, plac ebo-controlled comparison trial was conducted to assess the safety and efficacy of low-dose amlodipine 2.5 mg daily, low-dose benazepril 10 mg daily, and the combination of the two drugs at the same doses used once daily in patients (n = 401) with mild to moderate (stages I and I I) systemic hypertension, Both monotherapy regimens were shown to sign ificantly reduce both systolic and diastolic blood pressure compared w ith baseline placebo values, and the combination regimen was shown to be superior in lowering systolic and diastolic blood pressure when com pared with either of the monotherapy regimens. The combination therapy also resulted in a greater percentage of patients having successful c linical response in mean sitting diastolic blood pressure. The amlodip ine and benazepril regimen was also shown to be associated with a simi lar incidence of adverse experiences as the active monotherapy or plac ebo regimens, although the group given combination therapy appeared to have a lower incidence of edema than the group given amlodipine alone , Low-dose amlodipine (2.5 mg) plus benazepril (10 mg) provides greate r blood-pressure-lowering efficacy than either monotherapy, and has an excellent safety profile.