Key result
Adding hydrochlorothiazide 12.5 mg to telmisartan/amlodipine significantly reduced trough-seated diastolic blood pressure by an additional 3.9 mm Hg compared to telmisartan/amlodipine alone.
Why the study?
Does the addition of hydrochlorothiazide 12.5 mg to telmisartan 80 mg/amlodipine 5 mg reduce blood pressure in Japanese patients with essential hypertension uncontrolled on dual therapy?
RCT (n=309)
Double-blind
Interactive Response Technology
Yes
Does the addition of hydrochlorothiazide 12.5 mg to telmisartan 80 mg/amlodipine 5 mg reduce blood pressure in Japanese patients with essential hypertension uncontrolled on dual therapy?
Mean Difference: -3.9 (95% CI -5.3–-2.4)
Absolute Event Rate: -8.4% vs -4.5%
p-value: p=<0.0001
Adding hydrochlorothiazide to telmisartan/amlodipine significantly reduces blood pressure and improves control rates in patients with uncontrolled hypertension.
Supports adding low-dose hydrochlorothiazide for improved control in dual nonresponders; extends triple-therapy evidence from prior RCTs.
The efficacy and safety of telmisartan 80 mg/amlodipine 5 mg plus hydrochlorothiazide 12.5 mg (T80/A5/H12.5) was examined for its ability to treat hypertension in Japanese patients whose hypertension is uncontrolled with telmisartan 80 mg/amlodipine 5 mg (T80/A5). Patients aged ⩾20 years who had essential hypertension despite taking two or three antihypertensive drugs entered a 6-week run-in period on T80/A5. Patients whose hypertension remained uncontrolled were randomly assigned to either the T80/A5/H12.5 group (n=149) or the T80/A5 group (n=160), once daily for 8 weeks. After 8 weeks, patients in the T80/A5/H12.5 group showed a significantly greater adjusted mean reduction in both seated diastolic blood pressure and seated systolic blood pressure than those in the T80/A5 group. Furthermore, more patients achieved a diastolic/systolic blood pressure of <90/140 mm Hg in the T80/A5/H12.5 group compared with the T80/A5 group. The most common adverse events were nasopharyngitis, elevated blood uric acid levels and hyperuricemia, and the latter two events were more frequent in the T80/A5/H12.5 group than in the T80/A5 group. Overall, T80/A5/H12.5 administered for 8 weeks significantly reduced systolic and diastolic blood pressure and was well tolerated by patients with hypertension uncontrolled with T80/A5.
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Higaki et al. (2016) conducted an RCT in Essential hypertension uncontrolled with telmisartan/amlodipine (n=309). Telmisartan/amlodipine/hydrochlorothiazide vs. Telmisartan 80 mg / amlodipine 5 mg once daily was evaluated on Reduction from reference baseline in mean seated DBP at trough after 8 weeks (MD -3.9 mm Hg, 95% CI -5.3 to -2.4, p=<0.0001). Adding hydrochlorothiazide 12.5 mg to telmisartan/amlodipine significantly reduced trough-seated diastolic blood pressure by an additional 3.9 mm Hg compared to telmisartan/amlodipine alone.
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