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  • Title: Zofenopril or irbesartan plus hydrochlorothiazide in elderly patients with isolated systolic hypertension untreated or uncontrolled by previous treatment: a double-blind, randomized study.
    Author: Modesti PA, Omboni S, Taddei S, Ghione S, Portaluppi F, Pozzilli P, Volpe M, Arca M, Calabrò P, Fulgheri PL, Bucci M, Berra S, Villani GQ, Vladoianu M, Popescu E, Velican VG, Pirvu O.
    Journal: J Hypertens; 2016 Mar; 34(3):576-87; discussion 587. PubMed ID: 26703917.
    Abstract:
    OBJECTIVE: To compare zofenopril + hydrochlorothiazide (Z + H) vs. irbesartan + hydrochlorothiazide (I + H) efficacy on daytime SBP in elderly (>65 years) patients with isolated systolic hypertension (ISH), untreated or uncontrolled by a previous monotherapy. METHODS: After a 1-week run-in, 230 ISH patients (office SBP ≥ 140  mmHg and DBP < 90  mmHg + daytime SBP ≥ 135  mmHg and daytime DBP < 85  mmHg) were randomized double-blind to 18-week treatment with Z + H (30 + 12.5  mg) or I + H (150 + 12.5  mg) once daily, in an international, multicenter study. Z and I doses could be doubled after 6 and 12 weeks, and nitrendipine 20  mg added at 12 weeks in nonnormalized patients. RESULTS: In the full analysis set (n = 216) baseline-adjusted average (95% confidence interval) daytime SBP reductions after 6 weeks (primary study end point) were similar (P = 0.888) with Z + H [7.7 (10.7, 4.6)  mmHg, n = 107] and I + H [7.9 (10.7, 5.0)  mmHg, n = 109]. Daytime SBP reductions were sustained during the study, and larger (P = 0.028) with low-dose Z + H at study end [16.2 (20.0, 12.5)  mmHg vs. 11.2 (14.4, 7.9)  mmHg I + H]. Daytime SBP normalization (<135 mmHg) rate was similar under Z + H and I + H at 6 and 12 weeks, but more common under Z + H at 18 weeks (68.2 vs. 56.0%, P = 0.031). Both drugs equally reduced SBP in the last 6 h of the dosing interval and homogeneously reduced SBP throughout the 24 h. The proportion of patients reporting drug-related adverse events was low (Z + H: 4.4% vs. I + H: 6.0%; P = 0.574). CONCLUSION: Elderly patients with ISH respond well to both low and high-dose Z or I combined with H.
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