Key result
Adding hydrochlorothiazide 25 mg to olmesartan/amlodipine 40/10 mg significantly reduced seated diastolic blood pressure by an additional 2.8 mm Hg compared to dual therapy alone in patients with inadequately controlled hypertension.
Why the study?
Does adding hydrochlorothiazide 12.5 mg or 25 mg reduce blood pressure in hypertensive patients inadequately controlled on olmesartan/amlodipine 40/10 mg?
RCT (n=808)
Double-blind
1:1:1
Yes
Does adding hydrochlorothiazide 12.5 mg or 25 mg reduce blood pressure in hypertensive patients inadequately controlled on olmesartan/amlodipine 40/10 mg?
Adding hydrochlorothiazide 25 mg to olmesartan/amlodipine 40/10 mg significantly improves blood pressure control in patients inadequately controlled on dual therapy.
Supports adding hydrochlorothiazide 25 mg for better control on dual therapy; extends evidence for triple regimens in resistant hypertension.
This randomized, parallel-group study in patients inadequately controlled on olmesartan medoxomil/amlodipine (OLM/AML) 40/10 mg assessed the effects of adding hydrochlorothiazide (HCTZ) 12.5 mg and 25 mg, using seated blood pressure (SeBP) measurements and ambulatory blood pressure (BP) monitoring. Enrolled patients were screened and tapered off of therapy if required. All patients received OLM/AML 40/10 mg and those with mean seated BP (SeBP) ≥140/90 mm Hg after 8 weeks (n=808) were randomized (1:1:1) to continue with OLM/AML 40/10 mg or receive OLM/AML/HCTZ 40/10/12.5 or 40/10/25 mg for a further 8 weeks. The primary endpoint was the change in seated diastolic BP (SeDBP) from the start to the end of the randomized treatment period. The addition of HCTZ 25 mg significantly reduced SeDBP (-2.8 mm Hg; P<.0001), lowered seated systolic BP (SeSBP) and ambulatory DBP and SBP, and improved BP goal rates. In patients uncontrolled on OLM/AML 40/10 mg, adding HCTZ led to further BP reductions, particularly in ambulatory BP.
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Rump et al. (2015) conducted an RCT in Hypertension (n=808). Hydrochlorothiazide added to Olmesartan/Amlodipine vs. Olmesartan/Amlodipine 40/10 mg was evaluated on Change in mean seated diastolic blood pressure (SeDBP) from baseline to week 16 (MD -2.8 mm Hg, 95% CI -4.0 to -1.6, p=<.0001). Adding hydrochlorothiazide 25 mg to olmesartan/amlodipine 40/10 mg significantly reduced seated diastolic blood pressure by an additional 2.8 mm Hg compared to dual therapy alone in patients with inadequately controlled hypertension.
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