Comparison of valsartan 160 mg with lisinopril 20 mg, given as monotherapy or in combination with a diuretic, for the treatment of hypertension: the Blood Pressure Reduction and Tolerability of Valsartan in Comparison with Lisinopril (PREVAIL) study.

Background: The goal of antihypertensive therapy is to provide good blood pressure (BP) control without eliciting adverse effects. Objective: This study compared the risk-benefit profile of the angiotensin II receptor blocker valsartan with that of the angiotensin-converting enzyme inhibitor lisinopril in patients with mild to severe hypertension. The primary objective was to show that the equipotent BP-lowering effect of the valsartan-based treatment is accompanied by a better tolerability profile. Methods: This 16-week, randomized, double-blind, parallel-group study was conducted at 88 outpatient centers across Italy After a 2-week placebo run-in period, patients aged >18 years with mild to severe hypertension (systolic BP [SBP], 160-220 mm Hg; diastolic BP [DBP], 93-110 mm Hg) were eligible. Patients were randomized to receive once-daily, oral, self-administered treatment with valsartan 160-rag capsules or lisinopril 20-rag capsules under double-blind conditions for 4 weeks. Responders continued monotherapy, whereas nonresponders had hydrochlorothiazide 12.3 mg added for the final 12 weeks of the study The 2 primary variables used to assess the equivalence of therapeutic efficacy of the 2 regimens were sitting SBP and sitting DBE which were measured at weeks 0 (baseline), 4, 8, and 16. The rate of drug-related adverse events (AEs) was used to assess whether 1 treatment had a better tolerability profile than the other. Tolerability was assessed by collecting information about AEs by means of questioning the patient or physical examination at each visit. Results: A total of 1213 patients were enrolled (633 men, 378 women; mean [SD] age, 34.3 [10.1] years [range, 28-78 years]). The study was completed by 1100 patients (333 receiving valsartan and 347 receiving lisinopril). Fifty-one patients (8.4%) treated with valsartan and 62 (1.2%) treated with lisinopril withdrew, mainly because of AEs (9 [1.3%] and 23 patients [3.8%], respectively). The valsartan- and lisinopril-based treatments were similarly effective in reducing sitting BE with mean SBP/DBP reductions of 31.2/13.9 mm Hg and 31.4/ 13.9 mm Hg, respectively At the end of the stud> BP was controlled in 82.7% of the patients receiving valsartan and 81.6 % of those receiving lisinopril. AEs were experienced by 3.1% of the patients treated with valsartan and 10.7% of those treated with lisinopril (P = 0.001), with dry cough observed in 1.0% and 7.2% of patients, respectively (P < 0.001).