RESUMO
OBJECTIVE: To compare zofenoprilâ+âhydrochlorothiazide (Zâ+âH) vs. irbesartanâ+âhydrochlorothiazide (Iâ+âH) 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 SBPâ≥â140â mmHg and DBPâ<â90 âmmHgâ+âdaytime SBPâ≥â135 âmmHg and daytime DBPâ<â85 âmmHg) were randomized double-blind to 18-week treatment with Zâ+âH (30â+â12.5 âmg) or Iâ+âH (150â+â12.5â mg) once daily, in an international, multicenter study. Z and I doses could be doubled after 6 and 12 weeks, and nitrendipine 20 âmg added at 12 weeks in nonnormalized patients. RESULTS: In the full analysis set (nâ=â216) baseline-adjusted average (95% confidence interval) daytime SBP reductions after 6 weeks (primary study end point) were similar (Pâ=â0.888) with Zâ+âH [7.7 (10.7, 4.6) âmmHg, nâ=â107] and Iâ+âH [7.9 (10.7, 5.0) âmmHg, nâ=â109]. Daytime SBP reductions were sustained during the study, and larger (Pâ=â0.028) with low-dose Zâ+âH at study end [16.2 (20.0, 12.5) âmmHg vs. 11.2 (14.4, 7.9)â mmHg Iâ+âH]. Daytime SBP normalization (<135âmmHg) rate was similar under Zâ+âH and Iâ+âH at 6 and 12 weeks, but more common under Zâ+âH at 18 weeks (68.2 vs. 56.0%, Pâ=â0.031). Both drugs equally reduced SBP in the last 6âh of the dosing interval and homogeneously reduced SBP throughout the 24âh. The proportion of patients reporting drug-related adverse events was low (Zâ+âH: 4.4% vs. Iâ+âH: 6.0%; Pâ=â0.574). CONCLUSION: Elderly patients with ISH respond well to both low and high-dose Z or I combined with H.