Key result
Telmisartan 80 mg plus hydrochlorothiazide 25 mg significantly reduced trough seated diastolic blood pressure by an additional 1.6 mm Hg compared to the 12.5 mg dose in uncontrolled hypertension.
Why the study?
Does increasing the hydrochlorothiazide dose to 25 mg in combination with telmisartan 80 mg improve blood pressure reduction in patients with uncontrolled hypertension on the 12.5 mg dose?
RCT (n=713)
Double-blind, double-dummy
1:1
Yes
Does increasing the hydrochlorothiazide dose to 25 mg in combination with telmisartan 80 mg improve blood pressure reduction in patients with uncontrolled hypertension on the 12.5 mg dose?
Mean Difference: -1.6 (95% CI -2.5–-0.6)
Absolute Event Rate: -7.1% vs -5.5%
p-value: p=0.0012
Increasing the hydrochlorothiazide dose to 25 mg in combination with telmisartan 80 mg provides additional blood pressure reduction and is well tolerated in patients with uncontrolled hypertension on the lower dose combination.
Supports hydrochlorothiazide uptitration to 25 mg for further BP control in telmisartan combinations; extends dose-response data for fixed ARB-diuretic regimens.
This study examined the effects of increasing the thiazide diuretic dose in a fixed-dose ARB/diuretic combination in patients with uncontrolled hypertension despite 6 weeks' open-label treatment with the ARB/diuretic combination, telmisartan 80 mg/hydrochlorothiazide 12.5 mg (T80/H12.5). 713 patients with trough seated DBP =90 mmHg were then randomized to 8 weeks' double-blind treatment with telmisartan 80 mg and an increased dose of 25 mg of hydrochlorothiazide (T80/H25) or T80/H12.5. Adjusted mean seated DBP changes from baselines of 95.3 (T80/H25) and 95.0 mmHg (T80/H12.5) were -7.1 and --5.5 mmHg (difference: 1.6 mm Hg), respectively (P=.0012). Changes in systolic blood pressure from 147.9 mmHg (T80/H25) and 147.4 mmHg (T80/H12.5) were -9.8 and -7.1 mmHg (difference: 2.7 mm Hg) (P=.0003). Adverse events occurred in 31.5% (T80/H25) and 29.6% (T80/H12.5), with serious events in 1.4% and 0.8%, respectively. Hypokalemia was rare. These results show that higher-dose thiazide diuretic in combination with T80 in patients with hypertension uncontrolled by T80/H12.5 provides additional blood pressure reductions and is well tolerated.
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Neldam et al. (2008) conducted an RCT in Uncontrolled hypertension (n=713). Telmisartan/hydrochlorothiazide vs. Telmisartan 80 mg / hydrochlorothiazide 12.5 mg was evaluated on Change in trough seated diastolic blood pressure from baseline (MD -1.6, 95% CI -2.5 to -0.6, p=0.0012). Telmisartan 80 mg plus hydrochlorothiazide 25 mg significantly reduced trough seated diastolic blood pressure by an additional 1.6 mm Hg compared to the 12.5 mg dose in uncontrolled hypertension.
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