Candesartan plus hydrochlorothiazide fixed combination vs previous monotherapy plus diuretic in poorly controlled essential hypertensive patients
Authors: Mancia, Giuseppe; Omboni, Stefano
Source: Blood Pressure, Volume 13, Supplement 2, Supplement 2/November 2004 , pp. 11-17(7)
Publisher: Informa Healthcare
Abstract:Objective: To assess efficacy and tolerability of candesartan cilexetil (CC) plus hydrochlorothiazide (HCTZ) fixed combination vs previous monotherapy (PM) plus HCTZ in hypertension. Design and Methods: After 2-4 weeks of run in, 409 outpatients (diastolic blood pressure, DBP >90 and ≤110 mmHg; systolic blood pressure, SBP ≤180 mmHg), aged 26-79 years, under monotherapy, were randomized in a PROBE multicenter trial to CC 16 mg plus HCTZ 12.5 mg or PM plus HCTZ 12.5 mg for 8 weeks. HCTZ was doubled after the first 4 weeks in non-responders (DBP ≥90 mmHg or SBP >180 mmHg). Results: Automatic oscillometric (Omron 705 CP) DBP and SBP were similarly reduced by CC + HCTZ and PM + HCTZ after 4 (12/15 and 10/13 mmHg) and 8 weeks (13/20 and 12/18 mmHg) in the intention-to-treat (ITT, n = 398) population. HCTZ dose was doubled in 18.1 and 31.2% of patients in the CC + HCTZ and PM + HCTZ group, respectively (p < 0.05). Rate of normalized patients (DBP <90 and/or SBP <140 mmHg) after 8 weeks of treatment was greater (p < 0.05) under CC + HCTZ (82.0 vs 72.6% vs PM + HCTZ). Pulse pressure was comparably reduced by CC + HCTZ and PM + HCTZ, at 4 (3 mmHg for both) and 8 weeks (7 and 6 mmHg, respectively). Heart rate was unchanged. Results of per-protocol analysis (n = 316) did not differ from those of ITT analysis. Rate of adverse events was low and comparable between groups. Conclusions: CC plus HCTZ fixed combination is an effective and safe alternative to other antihypertensive drugs, given either as monotherapy or in combination when they do not satisfactorily control patient's blood pressure.
Document Type: Research Article
Publication date: Supplement 2/November 2004