What question did this study set out to answer?

To evaluate the efficacy and tolerability of initiating treatment with combination valsartan/hydrochlorothiazide versus valsartan monotherapy in patients with stage-1 or stage-2 hypertension.

December 10, 2009Journal of Human HypertensionOpen Access

Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Stage-1 or stage-2 hypertension (n=648). Intervention: Valsartan/hydrochlorothiazide vs. Valsartan monotherapy (80 mg or 160 mg). Primary outcome: Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 4 (p=<0.001).

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Key result

Initiating therapy with valsartan/hydrochlorothiazide combination resulted in a significantly greater reduction in systolic blood pressure at week 4 (-26.0 mm Hg) compared to low-dose (-15.3 mm Hg) or high-dose (-22.0 mm Hg) valsartan monotherapy.

Why the study?

Does initial combination therapy with valsartan/hydrochlorothiazide improve blood pressure reduction and control compared to valsartan monotherapy in patients with stage-1 or stage-2 hypertension?

Key Points

To evaluate the efficacy and tolerability of initiating treatment with combination valsartan/hydrochlorothiazide versus valsartan monotherapy in patients with stage-1 or stage-2 hypertension.
In a prospective, 6-week, multicenter, double-blind trial, 648 patients with stage-1 or stage-2 hypertension were randomized to valsartan 80 mg, valsartan 160 mg, or valsartan/HCTZ 160/12.5 mg.
Elective dose titrations were performed at weeks 2 and 4 up to a maximum dose of valsartan/HCTZ 160/25 mg if blood pressure remained >140/90 mm Hg.
Initial valsartan/HCTZ achieved higher blood pressure control rates (63%) and greater mean reductions (-27.7±13/-15.1±8 mm Hg) than valsartan 80 mg (46%, -21.2±13/-11.4±8 mm Hg; P<0.0001) and valsartan 160 mg (51%, -24.0±13/-12.0±10 mm Hg; P<0.01).
Patients starting on combination therapy reached target blood pressure (<140/90 mm Hg) faster (2.8 weeks) than those starting on valsartan 80 mg (4.3 weeks) or valsartan 160 mg (3.9 weeks; P<0.0001) and required fewer titrations (63% vs 86%).
Overall adverse event rates were 53.1% with combination therapy, 50.5% with valsartan 80 mg, and 50.7% with valsartan 160 mg, with drug-related adverse events occurring in 14.1%, 13.8%, and 11.8% of patients, respectively.

Study Design

Type

RCT (n=648)

Blinding

Double-blind

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does initial combination therapy with valsartan/hydrochlorothiazide improve blood pressure reduction and control compared to valsartan monotherapy in patients with stage-1 or stage-2 hypertension?

Population

648 adults with stage-1 or stage-2 uncomplicated hypertension were randomized to initial therapy with valsartan/hydrochlorothiazide or valsartan monotherapy and followed for 6 weeks.

Intervention

Initial combination therapy with valsartan/hydrochlorothiazide 160/12.5 mg, electively titrated after weeks 2 and 4 to a maximum of 160/25 mg if blood pressure remained >140/90 mm Hg, for 6 weeks.

Comparator

Initial monotherapy with valsartan 80 mg (V-low) or valsartan 160 mg (V-high), electively titrated after weeks 2 and 4 to the next dosage level (adding hydrochlorothiazide) if blood pressure remained >140/90 mm Hg, for 6 weeks.

Outcome

Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 4.surrogate

Main Result

Absolute Event Rate: -26% vs -15.3%

p-value: p=<0.001

Initiating therapy with a valsartan/hydrochlorothiazide combination provides faster and greater blood pressure reduction than valsartan monotherapy in stage-1 or stage-2 hypertension, without increasing adverse events.

Limitations

Study did not include the maximum dose of valsartan (320 mg) in combination with HCTZ.
Short study duration of 6 weeks.
Dose titration period was only 2 weeks, which did not allow achievement of the maximum antihypertensive effect.

Discussion

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Implication

Supports initial valsartan/HCTZ for faster systolic BP reduction in stage 1-2 hypertension; confirms benefit of early dual therapy over monotherapy in RCTs.

Cite This Study

Zappe et al. (2009) conducted an RCT in Stage-1 or stage-2 hypertension (n=648). Valsartan/hydrochlorothiazide vs. Valsartan monotherapy (80 mg or 160 mg) was evaluated on Change in mean sitting systolic blood pressure (MSSBP) from baseline to week 4 (p=<0.001). Initiating therapy with valsartan/hydrochlorothiazide combination resulted in a significantly greater reduction in systolic blood pressure at week 4 (-26.0 mm Hg) compared to low-dose (-15.3 mm Hg) or high-dose (-22.0 mm Hg) valsartan monotherapy.

synapsesocial.com/papers/6a9167a8f4a38da3d533f160 https://doi.org/10.1038/jhh.2009.90

Topics

Hypertension management

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Implication

Supports initial valsartan/HCTZ for faster systolic BP reduction in stage 1-2 hypertension; confirms benefit of early dual therapy over monotherapy in RCTs.

Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

Topics

Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Implication

Cite This Study

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Topics

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