Key result
Initial combination therapy with valsartan/hydrochlorothiazide reduced systolic blood pressure significantly more than valsartan monotherapy (mean difference 9.3 mm Hg) at 4 weeks in elderly patients.
Why the study?
Does single-pill valsartan/hydrochlorothiazide improve systolic BP reduction in patients 70 years and older with systolic hypertension compared to either monotherapy?
RCT (n=384)
Double-blind
1:1:1
Yes
Does single-pill valsartan/hydrochlorothiazide improve systolic BP reduction in patients 70 years and older with systolic hypertension compared to either monotherapy?
Mean Difference: 9.3 (95% CI 5–13.6)
Absolute Event Rate: -17.3% vs -8.6%
p-value: p=<.0001
Initiating treatment with combination valsartan/hydrochlorothiazide achieves faster and greater systolic blood pressure reduction than valsartan monotherapy in elderly patients with systolic hypertension.
Supports initial combination over monotherapy for faster systolic BP control in elderly hypertensives; extends prior evidence to patients ≥70 years.
This 16-week trial investigated the efficacy and safety of single-pill valsartan/hydrochlorothiazide (HCTZ) vs. the individual components in patients 70 years and older with systolic hypertension. Patients were randomized to valsartan/HCTZ 160/12.5 mg (n=128), HCTZ 12.5 mg (n=128), or valsartan 160 mg (n=128) for 4 weeks. Patients whose blood pressure (BP) was ≥140/90 mm Hg at weeks 4, 8, or 12 were up-titrated to a maximum of valsartan/HCTZ 320/25 mg. Week 4 systolic BP reduction (primary efficacy outcome) was greater with valsartan/HCTZ than valsartan (-17.3 mm Hg vs. -8.6 mm Hg, P <.0001) but only marginally greater than HCTZ (-13.6 mm Hg, P =.096). Median time to BP control was shorter with valsartan/HCTZ (4 weeks) vs HCTZ (8 weeks, P<.05) or valsartan (12 weeks, P<.0001). Thiazide monotherapy was more effective than angiotensin receptor blocker monotherapy (by about 5 mm Hg), but greater antihypertensive efficacy was achieved by initiating treatment with combination valsartan/HCTZ in the elderly.
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Izzo et al. (2011) conducted an RCT in Systolic hypertension (n=384). Valsartan/hydrochlorothiazide vs. Valsartan 160 mg or hydrochlorothiazide 12.5 mg monotherapy was evaluated on Change in mean sitting systolic blood pressure (MSSBP) from baseline to Week 4 (MD 9.3 mm Hg, 95% CI 5.0-13.6, p=<.0001). Initial combination therapy with valsartan/hydrochlorothiazide reduced systolic blood pressure significantly more than valsartan monotherapy (mean difference 9.3 mm Hg) at 4 weeks in elderly patients.
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