PMID- 15262456 OWN - NLM STAT- MEDLINE DCOM- 20041221 LR - 20190922 IS - 0149-2918 (Print) IS - 0149-2918 (Linking) VI - 26 IP - 6 DP - 2004 Jun TI - 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. PG - 855-65 AB - 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 > or = 18 years with mild to severe hypertension (systolic BP [SBP], 160-220 mm Hg; diastolic BP [DBP], 95-110 mm Hg) were eligible. Patients were randomized to receive once-daily, oral, self-administered treatment with valsartan 160-mg capsules or lisinopril 20-mg capsules under double-blind conditions for 4 weeks. Responders continued monotherapy, whereas nonresponders had hydrochlorothiazide 12.5 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 DBP, 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 (635 men, 578 women; mean [SD] age, 54.5 [10.1] years [range, 28-78 years]). The study was completed by 1100 patients (553 receiving valsartan and 547 receiving lisinopril). Fifty-one patients (8.4%) treated with valsartan and 62 (10.2%) [corrected] treated with lisinopril withdrew, mainly because of AEs (9 [1.5%] and 23 patients [3.8%], respectively). The valsartan- and lisinopril-based treatments were similarly effective in reducing sitting BP, with mean SBP/DBP reductions of 31.2/15.9 mm Hg and 31.4/15.9 mm Hg, respectively. At the end of the study, BP was controlled in 82.6% [corrected] of the patients receiving valsartan and 81.6% of those receiving lisinopril. AEs were experienced by 5.1% of the patients treated with valsartan and 10.7% of those treated with lisinopril (P=.0001), with dry cough observed in 1.0% and 7.2% of patients, respectively (P<0.001). CONCLUSIONS: Valsartan and lisinopril were both highly effective in controlling BP in these patients with mild to severe hypertension, but valsartan was associated with a significantly reduced risk for AEs, especially cough. FAU - Malacco, Ettore AU - Malacco E AD - Division of Internal Medicine, L. Sacco Hospital, University of Milan, Milan, Italy. FAU - Santonastaso, Massimo AU - Santonastaso M FAU - Vari, Natale A AU - Vari NA FAU - Gargiulo, Anna AU - Gargiulo A FAU - Spagnuolo, Vitaliano AU - Spagnuolo V FAU - Bertocchi, Federico AU - Bertocchi F FAU - Palatini, Paolo AU - Palatini P CN - Blood Pressure Reduction and Tolerability of Valsartan in Comparison with Lisinopril Study LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Clin Ther JT - Clinical therapeutics JID - 7706726 RN - 0 (Antihypertensive Agents) RN - 0 (Diuretics) RN - 0 (Tetrazoles) RN - 80M03YXJ7I (Valsartan) RN - E7199S1YWR (Lisinopril) RN - HG18B9YRS7 (Valine) SB - IM EIN - Clin Ther. 2004 Jul;26(7):1185 EIN - Clin Ther. 2005 Jan;27(1):142 MH - Adult MH - Aged MH - Antihypertensive Agents/adverse effects/*therapeutic use MH - Blood Pressure/*drug effects MH - Chi-Square Distribution MH - Diuretics/*therapeutic use MH - Double-Blind Method MH - Drug Therapy, Combination MH - Female MH - Humans MH - Hypertension/*drug therapy MH - Italy MH - Lisinopril/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Tetrazoles/adverse effects/*therapeutic use MH - Treatment Outcome MH - Valine/adverse effects/*analogs & derivatives/*therapeutic use MH - Valsartan EDAT- 2004/07/21 05:00 MHDA- 2004/12/22 09:00 CRDT- 2004/07/21 05:00 PHST- 2004/03/12 00:00 [accepted] PHST- 2004/07/21 05:00 [pubmed] PHST- 2004/12/22 09:00 [medline] PHST- 2004/07/21 05:00 [entrez] AID - S0149291804901294 [pii] AID - 10.1016/s0149-2918(04)90129-4 [doi] PST - ppublish SO - Clin Ther. 2004 Jun;26(6):855-65. doi: 10.1016/s0149-2918(04)90129-4.