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).

Malacco, E., Santonastaso, M., Varì, N.a., Gargiulo, A., Spagnuolo, V., Bertocchi, F., et al. (2004). 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. CLINICAL THERAPEUTICS, 26, 855-865.

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.

NAMI, RENATO
2004-01-01

Abstract

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).
2004
Malacco, E., Santonastaso, M., Varì, N.a., Gargiulo, A., Spagnuolo, V., Bertocchi, F., et al. (2004). 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. CLINICAL THERAPEUTICS, 26, 855-865.
File in questo prodotto:
File Dimensione Formato  
comparison of valsartan R. Nami.pdf

non disponibili

Tipologia: Post-print
Licenza: NON PUBBLICO - Accesso privato/ristretto
Dimensione 834.86 kB
Formato Adobe PDF
834.86 kB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11365/19710
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo