Park, Chang-Gyu; Youn, Ho-Joong; Chae, Shung-Chull; Yang, Joo-Young; Kim, Moo-Hyun; Hong, Taek-Jong; Kim, Cheol Ho; Kim, Jae Joong; Hong, Bum-Kee; Jeong, Jin-Won; Park, Si-Hoon; Kwan, Jun; Choi, Young-Jin; Cho, Seung-Yun
American journal of cardiovascular drugs : drugs, devices, and other interventions
2012Feb ; 12 ( 1 ) :35-47.
PMID : 22217192
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Park, Chang-Gyu -
Youn, Ho-Joong -
Chae, Shung-Chull -
Yang, Joo-Young -
Kim, Moo-Hyun -
Hong, Taek-Jong -
Kim, Cheol Ho -
Kim, Jae Joong -
Hong, Bum-Kee -
Jeong, Jin-Won -
Park, Si-Hoon -
Kwan, Jun -
Choi, Young-Jin -
Cho, Seung-Yun -
ABSTRACT
BACKGROUND: Despite recommendations for more intensive treatment and the availability of several effective treatments, hypertension remains uncontrolled in many patients. OBJECTIVE: The aim of this study was to determine the dose-response relationship and assess the efficacy and safety of amlodipine or losartan monotherapy and amlodipine camsylate/losartan combination therapy in patients with essential hypertension.
METHODS: This was an 8-week, randomized, double-blind, factorial design, phase II, multicenter study conducted in outpatient hospital clinics among adult patients aged 18-75 years with essential hypertension. At screening, patients received placebo for 2-4 weeks. Eligible patients (n=320) were randomized to one of eight treatment groups: amlodipine 5?mg or 10?mg, losartan 50?mg or 100?mg, amlodipine camsylate/losartan 5?mg/50?mg, 5?mg/100?mg, 10?mg/50?mg, or 10?mg/100?mg. MAIN OUTCOME MEASURES: The assumption of strict superiority was estimated using the mean change in sitting diastolic blood pressure (DBP) at 8 weeks. Safety was monitored through physical examinations, vital signs, laboratory test results, ECG, and adverse events.
RESULTS: The reduction in DBP at 8 weeks was significantly greater in patients treated with the combination therapies compared with the respective monotherapies for all specified comparisons except amlodipine camsylate/losartan 10?mg/100?mg versus amlodipine 10?mg. The incidence of adverse events in the group of patients treated with the amlodipine camsylate/losartan 10?mg/50?mg combination tended to be higher than for any other group (27.9%, 12/43); however, the effect was not statistically significant. CONCLUSION: Combination amlodipine camsylate/losartan (5?mg/50?mg, 5?mg/100?mg and 10?mg/50?mg) resulted in significantly greater BP lowering compared with amlodipine or losartan monotherapy, and was determined to be generally safe and tolerable in patients with essential hypertension. CLINICAL TRIAL REGISTRATION: Registered at clinicaltrials.gov: NCT00942344.
Diastolic Blood Pressure, Essential Hypertension, Losartan, Amlodipine, Responder Rate
MESH
Adult, Aged, Amlodipine/*administration & dosage, Antihypertensive Agents/*administration & dosage, Blood Pressure/drug effects/physiology, Double-Blind Method, Drug Combinations, Drug Therapy, Combination, Female, Humans, Hypertension/*drug therapy/physiopathology, Losartan/*administration & dosage, Male, Middle Aged
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