Results of increasing doses of hydrochlorothiazide in combination with an angiotensin receptor blocker in patients with uncontrolled hypertension

Abstract

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.

Figure 1

Mean change (95% confidence interval) in trough seated systolic blood pressure (SBP) and diastolic blood pressure (DBP) after double‐blind treatment with a fixed‐dose combination of telmisartan 80 mg/hydrochlorothiazide 25 mg (T80/H25) or telmisartan 80 mg/hydrochlorothiazide 12.5 mg (T80/H12.5). BP indicates blood pressure.

Figure 2

Percentage of patients in whom diastolic blood pressure (DBP) control (trough seated DBP <90 mm Hg), DBP response (trough seated DBP <90 mm Hg or a trough seated DBP reduction ≥10 mm Hg), systolic blood pressure (SBP) response (seated trough SBP <140 mm Hg or a seated trough SBP reduction ≥10 mm Hg), or SBP rigorous response (seated trough SBP <140 mm Hg or a seated trough reduction ≥20 mm Hg) was achieved after treatment with a fixed‐dose combination of telmisartan 80 mg/hydrochlorothiazide 25 mg (T80/H25) or telmisartan 80 mg/hydrochlorothiazide 12.5 mg (T80/H12.5).