Key result
Candesartan cilexetil/hydrochlorothiazide and amlodipine achieved similar blood pressure control (84.2% vs 84.5%; p=1.00), but CC/HCTZ had fewer adverse event discontinuations (1% vs 12.7%; p<0.001).
Why the study?
Does candesartan cilexetil/hydrochlorothiazide improve blood pressure reduction and tolerability compared to amlodipine in patients with poorly controlled mild-to-moderate essential hypertension?
RCT (n=203)
Double-blind
randomised
Yes
Does candesartan cilexetil/hydrochlorothiazide improve blood pressure reduction and tolerability compared to amlodipine in patients with poorly controlled mild-to-moderate essential hypertension?
Absolute Event Rate: 84.2% vs 84.5%
p-value: p=1.00
Candesartan/hydrochlorothiazide provides similar blood pressure reduction to amlodipine but with significantly better tolerability and less peripheral edema in patients with inadequately controlled hypertension.
Comparable BP control with fewer discontinuations favors CC/HCTZ over amlodipine; confirms superior tolerability of ARB/diuretic combinations in hypertension.
The antihypertensive efficacy and tolerability of combination therapy with candesartan cilexetil, 16 mg plus hydrochlorothiazide (CC/HCTZ), 12.5 mg was compared with that of amlodipine, in a multicentre, double-blind, randomised, parallel-group study in patients with mild-to-moderate essential hypertension inadequately controlled by monotherapy. After a two week run-in period on existing therapy, patients with a sitting diastolic blood pressure (DBP) of 90-110 mmHg and a sitting systolic blood pressure (SBP) <or= 180 mmHg were switched to either CC/HCTZ (n=101) or amlodipine (n=102), once-daily by mouth. After eight weeks of treatment, both regimens reduced mean trough blood pressure (BP) by a similar amount: mean sitting SBP/DBP reductions were -15.4/-11.9 mmHg for CC/HCTZ, and -15.7/-12.0 mmHg for amlodipine (group differences, p=0.835/0.963). The BP of 84.2% of patients on CC/HCTZ and 84.5% on amlodipine was controlled (sitting DBP < 90 mmHg and sitting SBP < 140 mmHg) (p=1.00). Six (5.9%) patients on CC/HCTZ and 18 (17.6%) on amlodipine discontinued treatment, including one (1%) and 13 (12.7%) owing to adverse events (p<0.001). The most common adverse event was peripheral oedema, which occurred in two patients on CC/HCTZ and 19 on amlodipine. In conclusion, CC/HCTZ and amlodipine were equally effective in reducing BP in hypertensive patients not controlled by monotherapy, but CC/HCTZ was much better tolerated. Tolerance is an important clinical consideration in the chronic treatment of an asymptomatic disease.
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Fogari et al. (2007) conducted an RCT in mild-to-moderate essential hypertension (n=203). candesartan cilexetil/hydrochlorothiazide vs. amlodipine was evaluated on blood pressure control (sitting DBP < 90 mmHg and sitting SBP < 140 mmHg) (p=1.00). Candesartan cilexetil/hydrochlorothiazide and amlodipine achieved similar blood pressure control (84.2% vs 84.5%; p=1.00), but CC/HCTZ had fewer adverse event discontinuations (1% vs 12.7%; p<0.001).
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