A RANDOMIZED, DOUBLE-BLIND COMPARISON OF THE ANGIOTENSIN-II RECEPTOR ANTAGONIST, IRBESARTAN, WITH THE FULL DOSE RANGE OF ENALAPRIL FOR THE TREATMENT OF MILD-TO-MODERATE HYPERTENSION

Objective: To compare the anti-hypertensive efficacy, safety, and tole rability of irbesartan with those of the full dose range of enalapril in patients with mild-to-moderate hypertension. Design and methods: A total of 200 patients were randomised to irbesartan 75 mg or enalapril 10 mg (once daily). Doses were doubled at Weeks 4 and/or 8 if seated diastolic blood pressure (DBP) was greater than or equal to 90 mm Hg. Trough blood pressure was measured after completion of a 4- to 5-week placebo lead-in period and again after 2, 4, 8, and 12 weeks of treatm ent. Main outcome measures: Efficacy was evaluated by determining the change from baseline in trough seated blood pressure and the proportio n of patients normalised (seated DBP <90 mm Hg) at Week 12. Safety and tolerability were assessed by adverse events reported by physicians, by patients in response to a specific-symptoms questionnaire, by open- ended questioning of patients by physicians, and by clinical laborator y evaluations, Results: Both treatments significantly lowered blood pr essure with no significant difference in efficacy between treatment gr oups. At Week 12, the percentage of patients titrated to either enalap ril 40 mg or irbesartan 300 mg was 24% and 28%, respectively. The freq uency of overall adverse events was similar in both groups. The incide nce of cough in the enalapril and irbesartan groups was 17% and 10%, r espectively. In contrast to other All receptor antagonists, there was no change in uric acid concentrations with irbesartan. Conclusions: Ir besartan was as effective as the full dose range of enalapril. Irbesar tan also demonstrated an excellent tolerability profile.