PMID- 34719392 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20211105 IS - 2056-5909 (Print) IS - 2056-5909 (Electronic) IS - 2056-5909 (Linking) VI - 27 IP - 1 DP - 2021 Nov 1 TI - Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO). PG - 21 LID - 10.1186/s40885-021-00177-z [doi] LID - 21 AB - 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. CI - (c) 2021. The Author(s). FAU - Sohn, Il Suk AU - Sohn IS AUID- ORCID: 0000-0001-8004-5185 AD - Department of Internal Medicine, Division of Cardiology, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea. FAU - Ihm, Sang-Hyun AU - Ihm SH AUID- ORCID: 0000-0001-5017-5421 AD - Department of Internal Medicine, Division of Cardiology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea. FAU - Kim, Gee Hee AU - Kim GH AUID- ORCID: 0000-0002-0279-7370 AD - Department of Internal Medicine, Division of Cardiology, St. Vincent's Hospital, Suwon, Republic of Korea. FAU - Park, Sang Min AU - Park SM AUID- ORCID: 0000-0001-6521-303X AD - Department of Cardiology, Nowon Eulji Medical Center, Eulji University, Seoul, Republic of Korea. FAU - Hong, Bum-Kee AU - Hong BK AUID- ORCID: 0000-0002-6456-0184 AD - Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. FAU - Lee, Chang Hoon AU - Lee CH AUID- ORCID: 0000-0002-1622-272X AD - Department of Internal Medicine, Division of Cardiology, Veterans Health Service Medical Center, Seoul, Republic of Korea. FAU - Lee, Sang Hyun AU - Lee SH AUID- ORCID: 0000-0001-7196-2643 AD - Department of Internal Medicine, Division of Cardiology, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea. FAU - Chang, Dae-Il AU - Chang DI AUID- ORCID: 0000-0001-7638-5830 AD - Department of Neurology, Kyung Hee University Hospital, Seoul, Republic of Korea. FAU - Joo, Sung-Pil AU - Joo SP AUID- ORCID: 0000-0002-4983-0174 AD - Department of Neurosurgery, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea. FAU - Lee, Sang-Chan AU - Lee SC AUID- ORCID: 0000-0001-9190-5267 AD - Department of Neurology, Dong-Eui Hospital, Busan, Republic of Korea. FAU - Lee, Yong-Ho AU - Lee YH AUID- ORCID: 0000-0002-6219-4942 AD - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. FAU - Jeon, Dong Woon AU - Jeon DW AUID- ORCID: 0000-0001-7409-4378 AD - Department of Internal Medicine, Division of Cardiology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea. FAU - Jung, Kyung Tae AU - Jung KT AUID- ORCID: 0000-0002-4295-7092 AD - Department of Internal Medicine, Division of Cardiology, Eulji University Hospital, Daejeon, Republic of Korea. FAU - Rhee, Si Jae AU - Rhee SJ AUID- ORCID: 0000-0003-3117-8963 AD - Medical Affairs Department, Daiichi Sankyo Korea Co., Ltd., Seoul, Republic of Korea. FAU - Cho, Yoon-Jin AU - Cho YJ AUID- ORCID: 0000-0003-0347-4773 AD - Medical Affairs Department, Daiichi Sankyo Korea Co., Ltd., Seoul, Republic of Korea. FAU - Kim, Chong-Jin AU - Kim CJ AUID- ORCID: 0000-0003-3922-7846 AD - Department of Cardiology, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, South Korea. chongjinkim@naver.com. CN - Investigators LA - eng PT - Journal Article DEP - 20211101 PL - England TA - Clin Hypertens JT - Clinical hypertension JID - 101669508 PMC - PMC8559412 OTO - NOTNLM OT - Amlodipine OT - Hydrochlorothiazide OT - Hypertension OT - Korea OT - Observational study OT - Olmesartan OT - Real-world OT - Single-pill combination COIS- All authors received research funds from Daiichi Sankyo Korea Co., Ltd. SJR and YJC are full-time employees of Daiichi Sankyo Korea Co., Ltd. There are no further conflicts of interests to declare. FIR - Kim, Yun Sung IR - Kim YS FIR - Woo, Seong-Ill IR - Woo SI FIR - Lee, Kyounghoon IR - Lee K FIR - Heo, Jung Ho IR - Heo JH FIR - Park, Sang-Ho IR - Park SH FIR - Choi, Euy Jin IR - Choi EJ FIR - Hwang, Sun Ho IR - Hwang SH FIR - Chung, Yonh-Gu IR - Chung YG FIR - Youn, Young Jin IR - Youn YJ FIR - Im, Eul-Soon IR - Im ES FIR - Baik, Jong Sam IR - Baik JS FIR - Choi, Nack-Cheon IR - Choi NC FIR - Lee, Jin Bae IR - Lee JB FIR - Ryu, Kyu-Hyung IR - Ryu KH FIR - Jang, Ji-Yong IR - Jang JY FIR - Park, Sung-Ji IR - Park SJ FIR - Shin, Dong-Ick IR - Shin DI FIR - Na, Jin Oh IR - Na JO FIR - Chung, Yun Jae IR - Chung YJ FIR - Kim, Su Hyun IR - Kim SH FIR - Lee, Jong-Young IR - Lee JY FIR - Oh, Yoon-Sang IR - Oh YS FIR - Choi, Jong Hwan IR - Choi JH FIR - Seo, Hye Sun IR - Seo HS FIR - Kwon, Su Kyoung IR - Kwon SK FIR - Kim, Hyung-Jun IR - Kim HJ FIR - Park, Jin-Sun IR - Park JS FIR - Park, Kyoung-Ha IR - Park KH FIR - Lee, Kyoung-Soo IR - Lee KS FIR - Chung, Sung Chang IR - Chung SC FIR - Cho, Han-Jin IR - Cho HJ FIR - Lee, Chang-Min IR - Lee CM FIR - Kim, Sung-Rae IR - Kim SR FIR - Kim, Jinkwon IR - Kim J FIR - Oh, Hyeong-Gyun IR - Oh HG FIR - Park, Ik Seong IR - Park IS FIR - Chung, Pil-Wook IR - Chung PW FIR - Cho, Sung-Rae IR - Cho SR FIR - Kang, Hyun-Seung IR - Kang HS FIR - Lee, Seung Jin IR - Lee SJ FIR - Park, Kyungil IR - Park K FIR - Lee, Si Won IR - Lee SW FIR - Son, Jang-Won IR - Son JW FIR - Kim, Soo Kyoung IR - Kim SK FIR - Chung, Joong-Hwa IR - Chung JH FIR - Byon, Jin-Soo IR - Byon JS FIR - Lim, Hong Euy IR - Lim HE FIR - Kim, Bum-Tae IR - Kim BT FIR - Choi, Yu Jeong IR - Choi YJ FIR - Ann, Soe Hee IR - Ann SH FIR - Sung, Sang Min IR - Sung SM FIR - Lee, Jun-Hee IR - Lee JH EDAT- 2021/11/02 06:00 MHDA- 2021/11/02 06:01 PMCR- 2021/11/01 CRDT- 2021/11/01 05:25 PHST- 2021/02/17 00:00 [received] PHST- 2021/08/22 00:00 [accepted] PHST- 2021/11/01 05:25 [entrez] PHST- 2021/11/02 06:00 [pubmed] PHST- 2021/11/02 06:01 [medline] PHST- 2021/11/01 00:00 [pmc-release] AID - 10.1186/s40885-021-00177-z [pii] AID - 177 [pii] AID - 10.1186/s40885-021-00177-z [doi] PST - epublish SO - Clin Hypertens. 2021 Nov 1;27(1):21. doi: 10.1186/s40885-021-00177-z.