title: Zofenopril or irbesartan plus hydrochlorothiazide in elderly patients with isolated systolic hypertension untreated or uncontrolled by previous treatment: a double-blind, randomized study.
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).
  
  
  CONCLUSIONS
  Elderly patients with ISH respond well to both low and high-dose Z or I combined with H.
authors.affiliation: aDepartment of Clinical and Experimental Medicine, Careggi Hospital, University of Florence, Florence bItalian Institute of Telemedicine, Varese cThe ZEUS Study Group, Italy dThe ZEUS Study Group, Romania.
authors.forename: Pietro A
authors.initials: PA
authors.lastname: Modesti
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.forename: Stefano
authors.initials: S
authors.lastname: Taddei
authors.forename: Sergio
authors.initials: S
authors.lastname: Ghione
authors.forename: Francesco
authors.initials: F
authors.lastname: Portaluppi
authors.forename: Paolo
authors.initials: P
authors.lastname: Pozzilli
authors.forename: Massimo
authors.initials: M
authors.lastname: Volpe
authors.forename: Marcello
authors.initials: M
authors.lastname: Arca
authors.forename: Paolo
authors.initials: P
authors.lastname: Calabrò
authors.forename: Paolo L Dessì
authors.initials: PL
authors.lastname: Fulgheri
authors.forename: Marco
authors.initials: M
authors.lastname: Bucci
authors.forename: Sergio
authors.initials: S
authors.lastname: Berra
authors.forename: Giovanni Q
authors.initials: GQ
authors.lastname: Villani
authors.forename: Mircea
authors.initials: M
authors.lastname: Vladoianu
authors.forename: Elena
authors.initials: E
authors.lastname: Popescu
authors.forename: Valerica G
authors.initials: VG
authors.lastname: Velican
authors.forename: Octavian
authors.initials: O
authors.lastname: Pirvu
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000627:therapeutic use*; D001794:Blood Pressure; D018660:Blood Pressure Monitoring, Ambulatory; D002216:Captopril / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D000077405:Irbesartan; D008297:Male; D013599:Systole; D013777:Tetrazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D059289:Vascular Stiffness
chemical_list: D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D013777:Tetrazoles; D006852:Hydrochlorothiazide; C044958:zofenopril; D002216:Captopril; D000077405:Irbesartan