Why the study?
Does a candesartan cilexetil/hydrochlorothiazide 16/12.5 mg combination tablet improve blood pressure control compared to candesartan monotherapy in patients with mild to moderate primary hypertension inadequately controlled on monotherapy?
Does a candesartan cilexetil/hydrochlorothiazide 16/12.5 mg combination tablet improve blood pressure control compared to candesartan monotherapy in patients with mild to moderate primary hypertension inadequately controlled on monotherapy?
Adding hydrochlorothiazide 12.5 mg to candesartan 16 mg provides significant additional blood pressure reduction in hypertensive patients inadequately controlled on candesartan monotherapy.
Supports adding HCTZ to candesartan for further DBP reduction in uncontrolled hypertension; extends RCT evidence for ARB-diuretic combinations.
In this double-blind, placebo-controlled, randomised, parallel-group study, a combination tablet of candesartan cilexetil/hydrochlorothiazide (HCTZ), 16/12.5 mg once daily, reduced sitting diastolic blood pressure (DBP) significantly more (p = 0.037) than candesartan cilexetil/placebo, 16 mg once daily, in patients with mild to moderate primary hypertension (n = 328) who had not reached target blood pressure with candesartan cilexetil, 16 mg once daily. At the end of the 8-week double-blind treatment period, the adjusted mean reductions in sitting DBP, 24 h post dose, were 7.5 mm Hg in the candesartan cilexetil/HCTZ treatment group and 5.5 mm Hg in the candesartan cilexetil/placebo treatment group, corresponding to an adjusted mean difference between treatments of 2.0 mm Hg in favour of candesartan cilexetil/HCTZ (95% CI 0.1-3.8 mm Hg, p = 0.037). The adjusted mean reductions in sitting systolic blood pressure, 24 h post dose, were 12.0 mm Hg and 7.5 mm Hg, respectively, corresponding to an adjusted mean difference between treatments of 4.5 mm Hg (95% CI 1.1-8.0, p = 0.01). Consistent with the placebo-like tolerability of candesartan cilexetil reported in other studies, both treatments were very well tolerated, with a similar pattern and low frequency of adverse events in both treatment groups.
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Campbell et al. (2001) studied this question.