Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study

Abstract There lacks real‐world study with a large sample size assessing olmesartan medoxomil‐amlodipine besylate (OM‐AML) tablet. Therefore, this study aimed to evaluate the efficacy and safety of OM‐AML tablet in patients with essential hypertension. Totally, 1341 patients from 36 medical centers...

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Main Authors: Zhaoqiang Cui, Zhaohui Qiu, Wenli Cheng, Wei Hu, Genshan Ma, Xiaojun Cai, Yafei Jin, Yi Zhao, Liqun He, Ying Li, Peili Bu, Xiaoping Chen, Ruxing Wang, Lin Chen, Peng Dong, Liuliu Feng, Xuebin Han, Mei Hong, Yinglong Hou, Minlei Liao, Mingliang Wang, Xiaoyan Wang, Jianhong Xie, Yawei Xu, Zhenxing Wang, Kai Huang, Yongle Li, Dongsheng Li, Xiaojun Ji, Jing Huang, Jun Wang, Danhong Fang, Jian'an Wang, Lijiang Tang, Yingwu Liu, Guosheng Fu, Juan Du, Ling Wang, Mengqi Liu, Junbo Ge
Format: Article
Language:English
Published: Wiley 2024-01-01
Series:The Journal of Clinical Hypertension
Subjects:
Online Access:https://doi.org/10.1111/jch.14700
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author Zhaoqiang Cui
Zhaohui Qiu
Wenli Cheng
Wei Hu
Genshan Ma
Xiaojun Cai
Yafei Jin
Yi Zhao
Liqun He
Ying Li
Peili Bu
Xiaoping Chen
Ruxing Wang
Lin Chen
Peng Dong
Liuliu Feng
Xuebin Han
Mei Hong
Yinglong Hou
Minlei Liao
Mingliang Wang
Xiaoyan Wang
Jianhong Xie
Yawei Xu
Zhenxing Wang
Kai Huang
Yongle Li
Dongsheng Li
Xiaojun Ji
Jing Huang
Jun Wang
Danhong Fang
Jian'an Wang
Lijiang Tang
Yingwu Liu
Guosheng Fu
Juan Du
Ling Wang
Mengqi Liu
Junbo Ge
author_facet Zhaoqiang Cui
Zhaohui Qiu
Wenli Cheng
Wei Hu
Genshan Ma
Xiaojun Cai
Yafei Jin
Yi Zhao
Liqun He
Ying Li
Peili Bu
Xiaoping Chen
Ruxing Wang
Lin Chen
Peng Dong
Liuliu Feng
Xuebin Han
Mei Hong
Yinglong Hou
Minlei Liao
Mingliang Wang
Xiaoyan Wang
Jianhong Xie
Yawei Xu
Zhenxing Wang
Kai Huang
Yongle Li
Dongsheng Li
Xiaojun Ji
Jing Huang
Jun Wang
Danhong Fang
Jian'an Wang
Lijiang Tang
Yingwu Liu
Guosheng Fu
Juan Du
Ling Wang
Mengqi Liu
Junbo Ge
author_sort Zhaoqiang Cui
collection DOAJ
description Abstract There lacks real‐world study with a large sample size assessing olmesartan medoxomil‐amlodipine besylate (OM‐AML) tablet. Therefore, this study aimed to evaluate the efficacy and safety of OM‐AML tablet in patients with essential hypertension. Totally, 1341 patients from 36 medical centers with essential hypertension who took OM‐AML (20/5 mg) tablet were analyzed in the current prospective, single‐arm, multi‐center, real‐world study (SVK study). Seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) at baseline, week (W)4 and W8 were measured. The mean (±SE) change of SeSBP/SeDBP was ‐10.8 ± 0.4/‐6.6 ± 0.3 mmHg at W4 and ‐12.7 ± 0.5/‐7.6 ± 0.3 mmHg at W8, respectively. At W4, 78.8% and 29.0% patients achieved BP target by China and American Heart Association (AHA) criteria; at W8, 84.7% and 36.5% patients reached blood pressure (BP) target by China and AHA criteria, accordingly. Meanwhile, 80.2% and 86.4% patients achieved BP response at W4 and W8, respectively. Home‐measured SeSBP and SeDBP decreased from W1 to W8 (both p < .001). Besides, patients’ and physicians’ satisfaction were elevated at W8 compared with W0 (both p < .001). The medication possession rate was 94.8% from baseline to W4 and 91.3% from baseline to W8. The most common drug‐related adverse events were nervous system disorders (4.6%), vascular disorders (2.6%), and general disorders and administration site conditions (2.3%) by system organ class, which were generally mild and manageable. In conclusion, OM‐AML tablet is one of the best antihypertensive agents in patients with essential hypertension.
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spelling doaj.art-8d675c93ba9d40cfa31c783badc025962024-01-18T11:56:09ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762024-01-0126151610.1111/jch.14700Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world studyZhaoqiang Cui0Zhaohui Qiu1Wenli Cheng2Wei Hu3Genshan Ma4Xiaojun Cai5Yafei Jin6Yi Zhao7Liqun He8Ying Li9Peili Bu10Xiaoping Chen11Ruxing Wang12Lin Chen13Peng Dong14Liuliu Feng15Xuebin Han16Mei Hong17Yinglong Hou18Minlei Liao19Mingliang Wang20Xiaoyan Wang21Jianhong Xie22Yawei Xu23Zhenxing Wang24Kai Huang25Yongle Li26Dongsheng Li27Xiaojun Ji28Jing Huang29Jun Wang30Danhong Fang31Jian'an Wang32Lijiang Tang33Yingwu Liu34Guosheng Fu35Juan Du36Ling Wang37Mengqi Liu38Junbo Ge39Department of Cardiology Zhongshan Hospital, Fudan University ShanghaiChinaDepartment of Cardiology Shanghai Tongren Hospital ShanghaiChinaDepartment of Cardiology Beijing Anzhen Hospital, Capital Medical University BeijingChinaDepartment of Cardiology Central Hospital of Minhang District ShanghaiChinaDepartment of Cardiology Zhongda Hospital Affiliated to Southeast University NanjingChinaDepartment of Cardiology Jinan Central Hospital JinanChinaDepartment of Cardiology The First Affiliated Hospital of Sun Yat‐sen University GuangzhouChinaDepartment of Cardiology Dalian Jinzhou First People's Hospital DalianChinaDepartment of Cardiology Wuhan No. 1 Hospital WuhanChinaDepartment of Cardiology Shanghai East Hospital ShanghaiChinaDepartment of Cardiology Qilu Hospital of Shandong University JinanChinaDepartment of Cardiology West China Hospital of Sichuan University ChengduChinaDepartment of Cardiology Wuxi People's Hospital WuxiChinaDepartment of CardiologyThird Affiliated Hospital of Sun Yat‐Sen UniversityGuangzhouChinaDepartment of Cardiology Beijing Aviation General Hospital BeijingChinaDepartment of CardiologyShidong Hospital, Yangpu DistrictShanghaiChinaDepartment of CardiologyShanxi Cardiovascular Hospital (Shanxi Cardiovascular Diseases Institute)TaiyuanChinaDepartment of CardiologyThe Second Clinical Medical College of Nanjing Medical UniversityNanjingChinaDepartment of CardiologyThe First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan HospitalJinanChinaDepartment of CardiologyBaoshan Branch, Shanghai General Hospital Shanghai ChinaDepartment of CardiologyPutuo People's Hospital, Tongji University Shanghai ChinaDepartment of CardiologyWuxi Third People's HospitalWuxiChinaDepartment of CardiologyZhejiang Provincial People's HospitalHangzhouChinaDepartment of CardiologyShanghai Tenth People's HospitalShanghaiChinaDepartment of Cardiology Jiangsu Province Hospital of Chinese Medicine NanjingChinaDepartment of Cardiology Union Hospital, Tongji Medical College, Huazhong University of Science and Technology WuhanChinaDepartment of Cardiology Tianjin Medical University General Hospital Tianjin ChinaDepartment of Cardiology Wuhan Third Hospital WuhanChinaDepartment of Cardiology Wenzhou Central Hospital WenzhouChinaDepartment of CardiologyThe Second Affiliated Hospital of Chongqing Medical UniversityChongqingChinaDepartment of CardiologyJing'an District Central Hospital of ShanghaiShanghaiChinaDepartment of Cardiology The First Affiliated Hospital of Wenzhou Medical University WenzhouChinaDepartment of Cardiology The Second Affiliated Hospital of Zhejiang University School of Medicine HangzhouChinaDepartment of Cardiology Zhejiang Hospital HangzhouChinaDepartment of Cardiology Tianjin Third Central Hospital TianjinChinaDepartment of Cardiology Sir Run Run Shaw Hospital of Zhejiang University School of Medicine HangzhouChinaMedical Department Daiichi Sankyo (China) Holdings Co., Ltd ShanghaiChinaMedical Department Daiichi Sankyo (China) Holdings Co., Ltd ShanghaiChinaMedical Department Daiichi Sankyo (China) Holdings Co., Ltd ShanghaiChinaDepartment of Cardiology Zhongshan Hospital, Fudan University ShanghaiChinaAbstract There lacks real‐world study with a large sample size assessing olmesartan medoxomil‐amlodipine besylate (OM‐AML) tablet. Therefore, this study aimed to evaluate the efficacy and safety of OM‐AML tablet in patients with essential hypertension. Totally, 1341 patients from 36 medical centers with essential hypertension who took OM‐AML (20/5 mg) tablet were analyzed in the current prospective, single‐arm, multi‐center, real‐world study (SVK study). Seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) at baseline, week (W)4 and W8 were measured. The mean (±SE) change of SeSBP/SeDBP was ‐10.8 ± 0.4/‐6.6 ± 0.3 mmHg at W4 and ‐12.7 ± 0.5/‐7.6 ± 0.3 mmHg at W8, respectively. At W4, 78.8% and 29.0% patients achieved BP target by China and American Heart Association (AHA) criteria; at W8, 84.7% and 36.5% patients reached blood pressure (BP) target by China and AHA criteria, accordingly. Meanwhile, 80.2% and 86.4% patients achieved BP response at W4 and W8, respectively. Home‐measured SeSBP and SeDBP decreased from W1 to W8 (both p < .001). Besides, patients’ and physicians’ satisfaction were elevated at W8 compared with W0 (both p < .001). The medication possession rate was 94.8% from baseline to W4 and 91.3% from baseline to W8. The most common drug‐related adverse events were nervous system disorders (4.6%), vascular disorders (2.6%), and general disorders and administration site conditions (2.3%) by system organ class, which were generally mild and manageable. In conclusion, OM‐AML tablet is one of the best antihypertensive agents in patients with essential hypertension.https://doi.org/10.1111/jch.14700adverse eventsblood pressure targetessential hypertensionOlmesartan medoxomil‐amlodipine besylate tabletsatisfaction
spellingShingle Zhaoqiang Cui
Zhaohui Qiu
Wenli Cheng
Wei Hu
Genshan Ma
Xiaojun Cai
Yafei Jin
Yi Zhao
Liqun He
Ying Li
Peili Bu
Xiaoping Chen
Ruxing Wang
Lin Chen
Peng Dong
Liuliu Feng
Xuebin Han
Mei Hong
Yinglong Hou
Minlei Liao
Mingliang Wang
Xiaoyan Wang
Jianhong Xie
Yawei Xu
Zhenxing Wang
Kai Huang
Yongle Li
Dongsheng Li
Xiaojun Ji
Jing Huang
Jun Wang
Danhong Fang
Jian'an Wang
Lijiang Tang
Yingwu Liu
Guosheng Fu
Juan Du
Ling Wang
Mengqi Liu
Junbo Ge
Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study
The Journal of Clinical Hypertension
adverse events
blood pressure target
essential hypertension
Olmesartan medoxomil‐amlodipine besylate tablet
satisfaction
title Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study
title_full Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study
title_fullStr Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study
title_full_unstemmed Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study
title_short Efficacy and safety of olmesartan medoxomil‐amlodipine besylate tablet in Chinese patients with essential hypertension: A prospective, single‐arm, multi‐center, real‐world study
title_sort efficacy and safety of olmesartan medoxomil amlodipine besylate tablet in chinese patients with essential hypertension a prospective single arm multi center real world study
topic adverse events
blood pressure target
essential hypertension
Olmesartan medoxomil‐amlodipine besylate tablet
satisfaction
url https://doi.org/10.1111/jch.14700
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