What question did this study set out to answer?

To evaluate the safety, pharmacokinetics, and neurohormonal suppressive effects of the oral nonpeptidic direct renin inhibitor aliskiren in healthy humans.

January 1, 2002Hypertension

Angiotensin II Suppression in Humans by the Orally Active Renin Inhibitor Aliskiren (SPP100)

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Why the study?

Does Aliskiren reduce plasma Angiotensin II levels in healthy volunteers?

Population

18 healthy volunteers on a constant 100 mmol/d sodium diet

Comparison

Aliskiren orally for 8 days vs Randomized placebo or enalapril 20 mg/d

Design

RCT, Randomized to placebo or enalapril in a 3-way crossover protocol…

Follow-up

8 days per treatment period

Authors

JNJuerg NussbergerUniversity of Lausanne GWGrégoire WuerznerPreventive Cardiology CJC. JensenUniversity College Dublin

Discussion

Member takes

Implication

Aliskiren achieves direct renin inhibition in humans; confirms mechanism and supports clinical development in hypertension.

Key Points

To evaluate the safety, pharmacokinetics, and neurohormonal suppressive effects of the oral nonpeptidic direct renin inhibitor aliskiren in healthy humans.
Conducted a double-blind, 3-way crossover study in 18 healthy normotensive volunteers maintained on a constant 100 mmol/d sodium diet.
Administered aliskiren at sequential doses (40 and 80 mg/d or 160 and 640 mg/d), randomized placebo, or 20 mg/d enalapril over three 8-day periods separated by 6-day washouts.
Aliskiren dose-dependently reduced plasma renin activity, angiotensin I, and angiotensin II, achieving maximal decreases in angiotensin II of 89% on Day 1 and 75% on Day 8 at 640 mg compared with placebo.
Plasma active renin concentration rose up to 34-fold at the 640 mg dose, while plasma and urinary aldosterone levels decreased at doses ≥80 mg and after enalapril.
Aliskiren at 160 mg and 640 mg enhanced Day 1 natriuresis by +45% and +62%, respectively, relative to placebo (87±11 mmol/24h) and enalapril (+54%), without altering kaliuresis, blood pressure, or heart rate.

Structured PICO

Does Aliskiren reduce plasma Angiotensin II levels in healthy volunteers?

Population

18 healthy volunteers on a constant 100 mmol/d sodium diet

Intervention

Aliskiren (40, 80, 160, or 640 mg/d) orally for 8 days

Comparator

Randomized placebo or enalapril 20 mg/d

Outcome

Plasma Angiotensin II levelssurrogate

Aliskiren is an orally active renin inhibitor that effectively and dose-dependently decreases Angiotensin II levels in healthy volunteers, with effects comparable to enalapril.

Cite This Study

Nussberger et al. (2002) studied this question.

synapsesocial.com/papers/6a1a1cf6443d3ecd7cdf5ce7 https://doi.org/10.1161/hy0102.102293

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Angiotensin II Suppression in Humans by the Orally Active Renin Inhibitor Aliskiren (SPP100)

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Angiotensin II Suppression in Humans by the Orally Active Renin Inhibitor Aliskiren (SPP100)

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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