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Published on: May 26, 2022
Candesartan plus hydrochlorothiazide fixed combination vs previous monotherapy plus diuretic in poorly controlled
Giuseppe Mancia1, Stefano Omboni,
1Dipartimento di Medicina Clinica, Prevenzione e Biotecnologie Sanitarie, Università degli Studi di Milano-Bicocca, Ospedale San Gerardo, Monza, Italy. giuseppe.mancia@unimib.it
Insights
The fixed combination of candesartan cilexetil (CC) plus hydrochlorothiazide (HCTZ) effectively controlled hypertension, showing a higher normalization rate than previous monotherapy plus HCTZ. This combination offers a safe and effective alternative for managing blood pressure.
Area of Science:
- Cardiology
- Pharmacology
- Hypertension Management
Background:
- Hypertension is a major risk factor for cardiovascular diseases.
- Effective blood pressure control is crucial for reducing morbidity and mortality.
- Optimizing antihypertensive drug combinations is essential for patient management.
Purpose of the Study:
- To compare the efficacy and tolerability of a fixed-dose combination of candesartan cilexetil (CC) plus hydrochlorothiazide (HCTZ) against previous monotherapy (PM) plus HCTZ in hypertensive patients.
- To evaluate blood pressure reduction and treatment normalization rates in patients receiving CC + HCTZ versus PM + HCTZ.
Main Methods:
- A PROBE multicenter trial randomized 409 outpatients with uncontrolled hypertension to receive either CC 16 mg + HCTZ 12.5 mg or PM + HCTZ 12.5 mg for 8 weeks.
- Hydrochlorothiazide dosage was increased in non-responders after 4 weeks.
- Blood pressure was measured using an automatic oscillometric device.
Main Results:
- Both CC + HCTZ and PM + HCTZ significantly reduced diastolic and systolic blood pressure.
- The CC + HCTZ group achieved a higher rate of normalized blood pressure (DBP <90 and/or SBP <140 mmHg) after 8 weeks (82.0% vs 72.6%).
- The rate of HCTZ dose doubling was lower in the CC + HCTZ group (18.1% vs 31.2%).
- Adverse event rates were low and comparable between groups.
Conclusions:
- The fixed combination of candesartan cilexetil plus hydrochlorothiazide is an effective and safe antihypertensive treatment.
- This combination demonstrates superior efficacy in achieving blood pressure normalization compared to previous monotherapy plus HCTZ.
- CC + HCTZ offers a valuable alternative for patients whose blood pressure is not adequately controlled by monotherapy or other combinations.
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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