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 less than or equal to 110 mmHg; systolic blood pressure, SBP less than or equal to 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 greater than or equal to 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.
Mancia, G., Omboni, S., CARDIO Study, G. (2004). Candesartan plus hydrochlorothiazide fixed combination vs previous monotherapy plus diuretic in poorly controlled essential hypertensive patients. BLOOD PRESSURE, 13(Suppl.), 11-17 [10.1080/08038020410035574].
Candesartan plus hydrochlorothiazide fixed combination vs previous monotherapy plus diuretic in poorly controlled essential hypertensive patients
MANCIA, GIUSEPPE;
2004
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 less than or equal to 110 mmHg; systolic blood pressure, SBP less than or equal to 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 greater than or equal to 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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