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KMID : 1812120220280010040
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Clinical Hypertension
2022 Volume.28 No. 1 p.40 ~ p.40
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A randomized, double-blind, multicenter, phase III study on the efficacy and safety of a combination treatment involving fimasartan, amlodipine, rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy
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Jeon Eun-Seok
Lim Sang-Wook
Kim Seok-Yeon
Yang Hyoung-Mo
Kim Moo-Hyun
Rhee Moo-Yong
Han Seung-Hwan
Shin Jin-Ho
Kim Kwang-Il
Jeong Jin-Ok
Sung Ki-Chul
Hong Geu-Ru
Kim Hyung-Seop
Kwon Ki-Hwan
Kang Tae-Soo
Lee Hae-Young
Han Su-Eun
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Abstract
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Background : To assess the efficacy and safety of a combination therapy involving fimasartan, amlodipine, and rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond to fimasartan monotherapy.
Methods : This phase III, randomized, double-blind, multicenter study was conducted in adults aged 19?70 years. Patients who voluntarily consented were screened for eligibility to enroll in the study. Patients who failed to respond to 4 weeks of fimasartan monotherapy were randomized with a 1:1:1 ratio to the fimasartan 60 mg/amlodipine 10 mg?+?rosuvastatin 20 mg (FMS/ALD?+?RSV) as study group, fimasartan 60 mg/amlodipine 10 mg (FMS/ALD) as control 1 group, and fimasartan 60 mg?+?rosuvastatin 20 mg (FMS?+?RSV) as control 2 group. The primary efficacy endpoints were the change in the sitting systolic blood pressure and the rate of change in the low-density lipoprotein cholesterol (LDL-C) level from baseline to 8 weeks. The adverse events, adverse drug reactions, physical examination findings, laboratory test results, electrocardiograms, and vital signs were evaluated to assess safety in the study.
Results : Of 138 randomized patients, 131 were conducted efficacy analysis, and 125 completed the study. For the change in LDL-C and sitting SBP (SiSBP) as primary efficacy assessments, the change in LDL-C at week 8 was significantly reduce in the FMS/ALD?+?RSV group than in the control 1 group (P?
Conclusions : The fimasartan/amlodipine?+?rosuvastatin combination therapy can effectively and safely lower blood pressure and improve lipid levels in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy.
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KEYWORD
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Hypertension, Dyslipidemias, Fimasartan, Amlodipine, Rosuvastatin, Combination drug therapy
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