Effect of aliskiren addition to amlodipine on ankle edema in hypertensive patients: a three-way crossover study

Expert Opin Pharmacother. 2011 Jun;12(9):1351-8. doi: 10.1517/14656566.2011.580276. Epub 2011 Apr 22.

Abstract

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Amides / administration & dosage*
  • Amlodipine / administration & dosage*
  • Ankle / pathology
  • Ankle Joint / pathology
  • Antihypertensive Agents / administration & dosage*
  • Blood Pressure / drug effects
  • Calcium Channel Blockers / administration & dosage*
  • Calcium Channel Blockers / adverse effects
  • Cross-Over Studies
  • Drug Synergism
  • Drug Therapy, Combination
  • Edema / blood
  • Edema / chemically induced
  • Edema / complications
  • Edema / drug therapy*
  • Female
  • Fumarates / administration & dosage*
  • Humans
  • Hypertension / blood
  • Hypertension / complications
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Norepinephrine / blood
  • Prospective Studies
  • Renin / antagonists & inhibitors
  • Renin / blood
  • Renin-Angiotensin System / drug effects

Substances

  • Amides
  • Antihypertensive Agents
  • Calcium Channel Blockers
  • Fumarates
  • Amlodipine
  • aliskiren
  • Renin
  • Norepinephrine