What does this research mean for the field?

Combination treatment with aliskiren and hydrochlorothiazide is superior to both component monotherapies in reducing blood pressure, and aliskiren neutralizes the compensatory rise in plasma renin activity induced by hydrochlorothiazide. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To assess the antihypertensive efficacy, safety, and effects on plasma renin activity of the direct renin inhibitor aliskiren alone and combined with hydrochlorothiazide.

November 30, 2006Journal of Hypertension

Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Hypertension (n=2776). Intervention: Aliskiren alone or in combination with hydrochlorothiazide (HCTZ) vs. Placebo and component monotherapies. Primary outcome: Change in mean sitting diastolic blood pressure (MSDBP) from baseline to week 8 (p=<0.001).

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Key result

Combination treatment with aliskiren and hydrochlorothiazide was superior to both component monotherapies in reducing blood pressure, with a maximum reduction of 21.2/14.3 mmHg.

Why the study?

Does aliskiren alone or in combination with hydrochlorothiazide reduce blood pressure in hypertensive patients?

Population

2,776 hypertensive patients aged ≥18 years with mean sitting diastolic blood pressure (MSDBP) 95-109 mmHg

Comparison

Aliskiren once daily, alone or in combination… vs Placebo or component monotherapies

Design

RCT, randomized in a factorial design, double-blind, placebo-controlled

Follow-up

8 weeks

Authors

AVAlberto S. VillamilArgerich Hospital SCSteven G. ChrysantUniversity of Oklahoma Health Sciences Center DCDavid A. CalhounGeneral Cardiology

Discussion

Member takes

Implication

Supports aliskiren-HCTZ combination for enhanced BP control in hypertension; extends randomized evidence for renin inhibitor-diuretic regimens.

Key Points

To assess the antihypertensive efficacy, safety, and effects on plasma renin activity of the direct renin inhibitor aliskiren alone and combined with hydrochlorothiazide.
An 8-week, double-blind, placebo-controlled factorial trial randomized 2,776 hypertensive patients aged ≥18 years with mean sitting diastolic blood pressure (MSDBP) of 95–109 mmHg.
Participants received once-daily aliskiren (75, 150, or 300 mg), hydrochlorothiazide (6.25, 12.5, or 25 mg), combination therapy, or placebo, with primary evaluation of MSDBP change and plasma renin activity (PRA) at selected centers.
Aliskiren monotherapy was superior to placebo in reducing MSDBP and mean sitting systolic blood pressure (MSSBP) (P < 0.001 by overall Dunnett's test) and decreased PRA by up to 65% from baseline.
Combination therapy achieved superior blood pressure lowering compared with both monotherapies, reaching a maximum MSSBP/MSDBP reduction of 21.2/14.3 mmHg with aliskiren/hydrochlorothiazide 300/25 mg, and improved response and control rates (<140/90 mmHg).
Hydrochlorothiazide monotherapy increased PRA by up to 72%, but coadministration with aliskiren neutralized this rise and decreased PRA across all combination groups with good overall tolerability.

Study Design

Type

RCT (n=2,776)

Blinding

Double-blind

Randomization

factorial design

Multicenter

Yes

Structured PICO

Does aliskiren alone or in combination with hydrochlorothiazide reduce blood pressure in hypertensive patients?

Population

2,776 hypertensive patients aged ≥18 years with mean sitting diastolic blood pressure (MSDBP) 95-109 mmHg

Intervention

Aliskiren (75, 150 or 300 mg) once daily, alone or in combination with hydrochlorothiazide (6.25, 12.5 or 25 mg) once daily for 8 weeks

Comparator

Placebo or component monotherapies (aliskiren alone or hydrochlorothiazide alone)

Outcome

Change in mean sitting diastolic blood pressure (MSDBP) from baseline to week 8surrogate

Main Result

p-value: p=<0.001

Aliskiren provides significant blood pressure lowering that is enhanced when combined with hydrochlorothiazide, while neutralizing the HCTZ-induced rise in plasma renin activity.

Cite This Study

Villamil et al. (2006) conducted an RCT in Hypertension (n=2,776). Aliskiren alone or in combination with hydrochlorothiazide (HCTZ) vs. Placebo and component monotherapies was evaluated on Change in mean sitting diastolic blood pressure (MSDBP) from baseline to week 8 (p=<0.001). Combination treatment with aliskiren and hydrochlorothiazide was superior to both component monotherapies in reducing blood pressure, with a maximum reduction of 21.2/14.3 mmHg.

synapsesocial.com/papers/6a1d7f751024216094057230 https://doi.org/10.1097/hjh.0b013e3280103a6b

Topics

Hypertension management

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Implication

Supports aliskiren-HCTZ combination for enhanced BP control in hypertension; extends randomized evidence for renin inhibitor-diuretic regimens.

Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider