Fixed-dose combination of zofenopril plus hydrochlorothiazide vs. irbesartan plus hydrochlorothiazide in hypertensive patients with established metabolic syndrome uncontrolled by previous monotherapy. the ZAMES study (Zofenopril in Advanced M Etabolic Syndrome)

ZAMES (Zofenopril in Advanced MEtabolic Syndrome) Study Group

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: Whether all antihypertensive drugs are equally effective in patients with metabolic syndrome is still unclear. The goal of the Zofenopril in Advanced MEtabolic Syndrome (ZAMES) study was to investigate whether treatment with the fixed-dose combination of sulphydril containing angiotensin-converting enzyme inhibitor zofenopril plus hydrochlorothiazide is at least as effective as that with the angiotensin receptor blocker irbesartan plus hydrochlorothiazide in patients with metabolic syndrome and essential hypertension, uncontrolled by a previous monotherapy. Methods: We enrolled 721 patients in a multicenter, international (Italy and Romania), randomized, doubleblind, parallel group, phase III study. Following a 1-week screening withdrawal period, 482 patients (mean age 59-10 years, 53% men) bearing a SBP at least 140mmHg and/or DBP at least 90mmHg plus metabolic syndrome (ATP-III criteria) were randomly allocated to a fixed-dose combination of zofenopril 30mg plus hydrochlorothiazide 12.5mg or irbesartan 150mg plus hydrochlorothiazide 12.5mg once daily for a cumulative period of 24 weeks. After 8 and 16 weeks, zofenopril and irbesartan doses were doubled in nonnormalized study participants. The study endpoint was the office DBP reduction at study end. In 20% of patients, an ambulatory blood pressure monitoring was performed. Results: The prevalence of diabetes at baseline was significantly (P
Original languageEnglish
Pages (from-to)2287-2297
Number of pages11
JournalJournal of Hypertension
Volume34
Issue number11
DOIs
Publication statusPublished - 2016

Keywords

  • Ambulatory blood pressure monitoring
  • Angiotensin II receptor blockers
  • Angiotensin-converting enzyme inhibitors
  • Essential hypertension
  • Hydrochlorothiazide
  • Irbesartan
  • Metabolic syndrome
  • Office blood pressure
  • Thiazide diuretics
  • Zofenopril

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