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.
Author(s): Hong BK, Park CG, Kim KS, Yoon MH, Yoon HJ, Yoon JH, Yang JY, Choi YJ, Cho SY.
Affiliation(s): Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine,
Seoul, Korea.
Publication date & source: 2012, Am J Cardiovasc Drugs. , 12(3):189-95
BACKGROUND: Fixed-dose combination drugs may enhance blood pressure (BP) goal
attainment through complementary effects and reduced side effects, which leads to
better compliance.
OBJECTIVE: This study aimed to evaluate the efficacy and safety profiles of
once-daily combination amlodipine/losartan versus losartan.
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 100 mg were administered
amlodipine/losartan 5 mg/100 mg combination versus losartan 100 mg. 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 ± 7.9 mmHg), which was significantly greater in the
amlodipine/losartan 5 mg/100 mg combination (n = 70) group (p < 0.0001).
Additionally, the amlodipine/losartan 5 mg/100 mg combination group achieved
significantly greater reductions in SBP at week 8 and in SBP and DBP at week 4
compared with the losartan 100 mg (n = 72) group (all p < 0.0001). Response rates
were significantly higher in the amlodipine/losartan 5 mg/100 mg group versus the
losartan 100 mg 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.
CONCLUSION: Switching to a fixed-dose combination therapy of amlodipine/losartan
5 mg/100 mg was associated with significantly greater reductions in BP and
superior achievement of BP goals compared with a maintenance dose of losartan 100
mg in Korean patients with essential hypertension inadequately controlled on
losartan 100 mg.
CLINICAL TRIAL REGISTRATION: Registered at Clinicaltrials.gov as NCT00940680.
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