STUDY OF THE EFFICACY AND SAFETY OF THE COMBINATION RAMIPRIL 2.5-MG PLUS HYDROCHLOROTHIAZIDE 12.5-MG IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION

In a double-blind, parallel-group multicentre study, the efficacy and safety of a fixed low-dose combination of ramipril 2.5 mg and hydrochl orothiazide (HCT) 12.5 mg was compared with each of the component drug s when given as monotherapy. After a four-week placebo run-in, patient s were randomized to receive either ramipril 2.5 mg (n = 218) or HCT 1 2.5 mg (n = 220), or the fixed-dose combination of ramipril 2.5 mg and HCT 12.5 mg (n = 222), for a period of eight weeks. At the end of the study, in which 624 patients had completed treatment, it was found th at the decrease in supine diastolic blood pressure (the main efficacy parameter) was greater in the ramipril-HCT combination group than in e ither the ramipril or the HCT monotherapy groups, the difference being statistically significant when compared with the HCT group (-14.3, -1 3.1 and -12.4 mm Hg, respectively). Reductions in standing DBP and sup ine and standing systolic blood pressure (SBP) were also greatest in t he combination group. The incidence of adverse events was lower in the combination group than in either of the monotherapy groups, and there were no serious clinically significant laboratory abnormalities in th e combination group.