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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

Authors
 Bum-Kee Hong  ;  Chang Gyu Park  ;  Ki Sik Kim  ;  Myeong Ho Yoon  ;  Ho Joong Yoon  ;  Jeong Han Yoon  ;  Joo Young Yang  ;  Young Jin Choi  ;  Prof. Seung Yun Cho 
Citation
 AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, Vol.12(3) : 189-195, 2012 
Journal Title
AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS
ISSN
 1175-3277 
Issue Date
2012
MeSH
Adult ; Amlodipine/administration & dosage ; Amlodipine/adverse effects ; Amlodipine/therapeutic use* ; Angiotensin II Type 1 Receptor Blockers/administration & dosage ; Angiotensin II Type 1 Receptor Blockers/adverse effects ; Angiotensin II Type 1 Receptor Blockers/therapeutic use ; Antihypertensive Agents/administration & dosage ; Antihypertensive Agents/adverse effects ; Antihypertensive Agents/therapeutic use* ; Blood Pressure/drug effects ; Calcium Channel Blockers/administration & dosage ; Calcium Channel Blockers/adverse effects ; Calcium Channel Blockers/therapeutic use ; Double-Blind Method ; Drug Combinations ; Female ; Humans ; Hypertension/drug therapy* ; Hypertension/physiopathology ; Losartan/administration & dosage ; Losartan/adverse effects ; Losartan/therapeutic use* ; Male ; Middle Aged ; Republic of Korea ; Time Factors ; Treatment Outcome
Keywords
Diastolic Blood Pressure ; Losartan ; Amlodipine ; Valsartan ; Combination Group
Abstract
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.
Full Text
http://link.springer.com/article/10.2165%2F11597410-000000000-00000
DOI
22462558
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Seung Yun(조승연)
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/89411
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