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Candesartan plus hydrochlorothiazide fixed combination vs previous monotherapy plus diuretic in poorly controlled essential hypertensive patients.

Author(s): Mancia G, Omboni S, CARDIO (CAndesaRtan combined with DIuretic in hypertensiOn) Study Group

Affiliation(s): Dipartimento di Medicina Clinica, Prevenzione e Biotecnologie Sanitarie, Universita degli Studi di Milano-Bicocca, Ospedale San Gerardo, Monza, Italy. giuseppe.mancia@unimib.it

Publication date & source: 2004-12, Blood Press Suppl., 2:11-7.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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 < or =110 mmHg; systolic blood pressure, SBP < or =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 > or =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.

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