Comparison of the efficacy and safety of fixed-dose amlodipine/losartan and losartan in hypertensive patients inadequately controlled with losartan: a randomized, double-blind, multicenter study

American Journal of Cardiovascular Drugs, 05/16/2012

Switching to a fixed–dose combination therapy of amlodipine/losartan 5mg/100mg was associated with significantly greater reductions in blood pressure (BP) and superior achievement of BP goals compared with a maintenance dose of losartan 100mg in Korean patients with essential hypertension inadequately controlled on losartan 100mg.

Methods

  • This was an 8–week, double–blind, multicenter, randomized phase III study conducted in outpatient hospital clinics.
  • Korean patients with essential hypertension inadequately controlled on losartan 100mg were administered amlodipine/losartan 5mg/100mg combination versus losartan 100mg.
  • The main outcome measures were changes in sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP) and BP response rate from baseline values, which were assessed after 4 and 8 weeks of treatment. Safety and tolerability were also assessed.

Results

  • At week 8, both groups achieved significant reductions from baseline in DBP (11.7±7.0 and 3.2±7.9mmHg), which was significantly greater in the amlodipine/losartan 5mg/100mg combination (n=70) group (p<0.0001).
  • Additionally, the amlodipine/losartan 5mg/100mg combination group achieved significantly greater reductions in SBP at week 8 and in SBP and DBP at week 4 compared with the losartan 100mg (n=72) group (all p<0.0001).
  • Response rates were significantly higher in the amlodipine/losartan 5mg/100mg group versus the losartan 100mg group (81.4% vs 63.9% at week 4, p<0.0192; 90.0% vs 66.7% at week 8, p<0.001).
  • Both treatments were generally well tolerated.

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