Background: In this prospective, multicenter, non-comparative observational study, the effectiveness and safety of the triple single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OM/AML/HCTZ) were evaluated in a real clinical practice setting in Korean patients with essential hypertension. Methods: A total of 3752 patients were enrolled and followed for 12 months after administration of OM/AML/HCTZ. Primary endpoint was change from baseline to month 6 in the mean systolic blood pressure (SBP). Secondary endpoints included changes from baseline in the mean SBP at month 3, 9, 12 and the mean diastolic blood pressure (DBP) at month 3, 6, 9, 12; changes in the mean SBP/DBP according to age and underlying risk factors; and blood pressure control rate (%) at different time points. Adherence to and satisfaction with OM/AML/HCTZ treatment among patients and physicians were assessed by medication possession ratio (MPR) and numeric rating scale, respectively, as exploratory endpoints. Safety was evaluated by the incidence and severity of adverse events (AEs) as well as the discontinuation rate due to AEs. Results: OM/AML/HCTZ administration led to significant reductions in the mean SBP/DBP by 11.5/6.6, 12.3/7.0, 12.3/7.2, and 12.8/7.4 mmHg from baseline to month 3, 6, 9 and 12, respectively (P < 0.0001). The BP reductions were maintained throughout the 1-year observation period in all patients with different age groups and risk factors (diabetes mellitus, cardiovascular disease, and renal disease). The BP control rate (%) of < 140/90 mmHg was 65.9, 67.9, 68.9, and 70.6% at month 3, 6, 9, and 12, respectively. The mean MPR during the observation period was 0.96. The safety results were consistent with the previously reported safety profile of OM/AML/HCTZ. Conclusions: Treatment with the triple SPC of OM/AML/HCTZ demonstrated significant effectiveness in reducing SBP/DBP and achieving target BP control with high adherence over the 1-year observation period in Korean hypertensive patients and was well-tolerated. Trial registration: CRIS, KCT0002196, Registered 3 May 2016.
|Publication status||Published - 2021 Dec|
Bibliographical noteFunding Information:
The authors greatly acknowledge the contribution of all the investigators and research coordinators at each participating institution. The authors also thank LSK Global Pharma Services Co., Ltd. for statistical analysis assistance. Authors details Investigators: Yun Sung Kim (Chosun University Hospital), Seong-Ill Woo (Inha University Hospital), Kyounghoon Lee (Gacheon University Gil Medical Center), Jung Ho Heo (Kosin University Gospel Hospital), Sang-Ho Park (Soonchunhyang University Cheonan Hospital), Euy Jin Choi (Bucheon St. Mary’s Hospital), Sun Ho Hwang (Gwangju Veterans Hospital), Yonh-Gu Chung (Korea University Anam Hospital), Young Jin Youn (Wonju Severance Christian Hospital), Eul-Soon Im (Dongsuwon General Hospital), Jong Sam Baik (Inje University Sanggye Paik Hospital), Nack-Cheon Choi (Gyeongsang National University Hospital), Jin Bae Lee (Daegu Catholic University Medical Center), Kyu-Hyung Ryu (Hallym University Dongtan Sacred Heart Hospital), Ji-Yong Jang (Konkuk University Chungju Hospital), Sung-Ji Park (Samsung Medical Center), Dong-Ick Shin (Chungbuk National University Hospital), Jin Oh Na (Korea University Guro Hospital), Yun Jae Chung (Chung-Ang University Hospital), Su Hyun Kim (St. Carollo Hospital), Jong-Young Lee (Kangbuk Samsung Hospital), Yoon-Sang Oh (Yeouido St. Mary’s Hospital), Jong Hwan Choi (Daegu Fatima Hospital), Hye Sun Seo (Soonchunhyang University Bucheon Hospital), Su Kyoung Kwon (Kosin University Gospel Hospital), Hyung-Jun Kim (Dongkang Medical Center), Jin-Sun Park (Ajou University Hospital), Kyoung-Ha Park (Hallym University Sacred Heart Hospital), Kyoung-Soo Lee (Samsung Changwon Hospital), Sung Chang Chung (Dongkang Medical Center), Han-Jin Cho (Pusan National University Hospital), Chang-Min Lee (Dankook University Hospital), Sung-Rae Kim (Bucheon St. Mary’s Hospital), Jinkwon Kim (CHA Bundang Medical Center), Hyeong-gyun Oh (Gwangju Veterans Hospital), Ik Seong Park (Bucheon St. Mary’s Hospital), Pil-Wook Chung (Kangbuk Samsung Hospital), Sung-Rae Cho (Changwon Fatima Hospital), Hyun-Seung Kang (Seoul National University Hospital), Seung Jin Lee (Soonchunhyang University Cheonan Hospital), Kyungil Park (Dong-A University Hospital), Si Won Lee (Busan Veterans Hospital), Jang-Won Son (Yeungnam University Medical Center), Soo Kyoung Kim (Gyeongsang National University Hospital), Joong-Hwa Chung (Chosun University Hospital), Jin-Soo Byon (Soonchunhyang University Gumi Hospital), Hong Euy Lim (Korea University Guro Hospital), Bum-Tae Kim (Soonchunhyang University Bucheon Hospital), Yu Jeong Choi (Eulji University Hospital), Soe Hee Ann (Ulsan University Hospital), Sang Min Sung (Pusan National University Hospital), Jun-Hee Lee (Kangdong Sacred Heart Hospital).
This study was funded by Daiichi Sankyo Korea Co., Ltd.
© 2021, The Author(s).
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Cardiology and Cardiovascular Medicine