Key result
Adding aliskiren to amlodipine reduced amlodipine-induced increases in ankle-foot volume and pretibial subcutaneous tissue pressure.
Why the study?
Does the addition of aliskiren to amlodipine reduce ankle edema compared to amlodipine alone in patients with grade 1-2 hypertension?
RCT (n=120)
Crossover
Does the addition of aliskiren to amlodipine reduce ankle edema compared to amlodipine alone in patients with grade 1-2 hypertension?
Adding aliskiren to amlodipine significantly reduces the severity of calcium-channel blocker-induced ankle edema while providing additive blood pressure lowering.
Answers are grounded in this paper and cite their sources.
Enhances amlodipine tolerability in hypertension; extends aliskiren evidence to CCB side-effect mitigation.
OBJECTIVE: The aim of this study was to assess the effect of aliskiren and amlopidine on ankle-foot volume (AFV) and pretibial subcutaneous tissue pressure (PSTP). RESEARCH DESIGN AND METHODS: After 4-week placebo, 120 outpatients with grade 1 - 2 hypertension were randomized to amlodipine 10 mg or aliskiren 300 mg or their combination for 8 weeks in three crossover periods. At the end of each treatment, blood pressure, AFV, PSTP, plasma renin activity (PRA) and norepinephrine were assessed. RESULTS: Both monotherapies similarly reduced systolic blood pressure (SBP; p < 0.001) and diastolic blood pressure (DBP; p < 0.001), but the reduction was greater with amlodipine/aliskiren combination (SBP: - 24.6 mmHg, p < 0.001 vs monotherapy; DBP: -20.9 mmHg, p < 0.01 vs monotherapy). Amlodipine increased both AFV (+ 28.4%, p < 0.01) and PSTP (+ 80.4%, p < 0.01), while the combination produced a less marked increase in AFV (+ 6.6%, p < 0.01 vs amlodipine) and PSTP (+ 20.1%, p < 0.01 vs amlodipine). Plasma norepinephrine increased with amlodipine (+ 53.5%, p < 0.01) and this increase was not reduced by aliskiren addition. PRA was unaffected by amlodipine, while it was reduced by both aliskiren monotherapy (- 77.7%, p < 0.01) and aliskiren/amlodipine combination (- 75.7%, p < 0.01). CONCLUSIONS: Direct renin inhibition by aliskiren partially counteracts the microcirculatory changes responsible for calcium-channel-induced edema formation, possibly through preferential vasodilation of venous capacitance vessels.
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Fogari et al. (2011) conducted an RCT in Grade 1-2 hypertension (n=120). Aliskiren and amlodipine combination vs. Amlodipine 10 mg monotherapy was evaluated on Increase in ankle-foot volume (AFV) (p=<0.01). Adding aliskiren to amlodipine reduced amlodipine-induced increases in ankle-foot volume and pretibial subcutaneous tissue pressure.
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