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

Clinical Hypertension

Research

Moo-Yong Rhee¹  Su-Eun Han²  Seok-Yeon Kim³  Moo Hyun Kim⁴  Jin-Ok Jeong⁵  Hyung-Seop Kim⁶  Jinho Shin⁷  Kwang-il Kim⁸  Hae-Young Lee⁹  Hyoung-Mo Yang^1,10  Sang Wook Lim^1,11  Tae-Soo Kang^1,12  Kihwan Kwon^1,13  Seung Hwan Han^1,14  Ki Chul Sung^1,15  Eun-Seok Jeon^1,16  Geu Ru Hong^1,17 

[1] Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea;Clinical Strategy Department, Boryung Corporation, 136 Changgyeonggung-ro, Jongno-gu, Seoul, Republic of Korea;Department of Cardiology, Cardiovascular Center, Seoul Medical Center, Seoul, Republic of Korea;Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea;Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea;Department of Internal Medicine, Dongsan Medical Center, Keimyung University, Deagu, Republic of Korea;Department of Internal Medicine, Hanyang University Hospital, Seoul, Republic of Korea;Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea;Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea;Division of Cardiology, Ajou University Hospital, Suwon, Republic of Korea;Division of Cardiology, Bundang Cha Hospital, Cha University, Seongnam, Republic of Korea;Division of Cardiology, Dankook Unversity Hospital, Cheonan, Republic of Korea;Division of Cardiology, Ewha Womans University College of Medicine, Seoul, Republic of Korea;Division of Cardiology, Gachon University Gil Medical Center, Incheon, Republic of Korea;Division of Cardiology, Kangbuk Samsung Hospital, Seoul, Republic of Korea;Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea;Division of Cardiology, Yonsei University College of Medicine, Seoul, Republic of Korea;

关键词: Hypertension;    Dyslipidemias;    Fimasartan;    Amlodipine;    Rosuvastatin;    Combination drug therapy;   

DOI  :  10.1186/s40885-022-00223-4

 received in 2022-06-03, accepted in 2022-08-31,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundTo 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.MethodsThis 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.ResultsOf 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 < 0.001). The change in SiSBP at week 8 were greater reduce in the FMS/ALD + RSV group than in the FMS + RSV group (both P < 0.001). For the safety evaluation, there were no differences among the treatment groups in the incidence of adverse drug reactions.ConclusionsThe 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.Trial registrationNCT03156842, Registered 17 May 2017

【 授权许可】

CC BY   
© The Author(s) 2022

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