Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO)

Investigators

doi:10.1186/s40885-021-00177-z

Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO)

Investigators

Internal Medicine

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

Abstract

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.

Original language	English
Article number	21
Journal	Clinical Hypertension
Volume	27
Issue number	1
DOIs	https://doi.org/10.1186/s40885-021-00177-z
Publication status	Published - 2021 Dec

Bibliographical note

Funding 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).

Funding Information:
This study was funded by Daiichi Sankyo Korea Co., Ltd.

Publisher Copyright:
© 2021, The Author(s).

All Science Journal Classification (ASJC) codes

Internal Medicine
Cardiology and Cardiovascular Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1186/s40885-021-00177-z

Cite this

@article{1c2ab8893c464cb0979a0b43b70a030a,

title = "Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO)",

abstract = "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.",

author = "Investigators and Sohn, {Il Suk} and Ihm, {Sang Hyun} and Kim, {Gee Hee} and Park, {Sang Min} and Hong, {Bum Kee} and Lee, {Chang Hoon} and Lee, {Sang Hyun} and Chang, {Dae Il} and Joo, {Sung Pil} and Lee, {Sang Chan} and Lee, {Yong ho} and Jeon, {Dong Woon} and Jung, {Kyung Tae} and Rhee, {Si Jae} and Cho, {Yoon Jin} and Kim, {Chong Jin} and Kim, {Yun Sung} and Woo, {Seong Ill} and Kyounghoon Lee and Heo, {Jung Ho} and Park, {Sang Ho} and Choi, {Euy Jin} and Hwang, {Sun Ho} and Chung, {Yonh Gu} and Youn, {Young Jin} and Im, {Eul Soon} and Baik, {Jong Sam} and Choi, {Nack Cheon} and Lee, {Jin Bae} and Ryu, {Kyu Hyung} and Jang, {Ji Yong} and Park, {Sung Ji} and Shin, {Dong Ick} and Na, {Jin Oh} and Chung, {Yun Jae} and Kim, {Su Hyun} and Lee, {Jong Young} and Oh, {Yoon Sang} and Choi, {Jong Hwan} and Seo, {Hye Sun} and Kwon, {Su Kyoung} and Kim, {Hyung Jun} and Park, {Jin Sun} and Park, {Kyoung Ha} and Lee, {Kyoung Soo} and Chung, {Sung Chang} and Cho, {Han Jin} and Lee, {Chang Min} and Kim, {Sung Rae} and Jinkwon Kim",

note = "Funding 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{\textquoteright}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{\textquoteright}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{\textquoteright}s Hospital), Jinkwon Kim (CHA Bundang Medical Center), Hyeong-gyun Oh (Gwangju Veterans Hospital), Ik Seong Park (Bucheon St. Mary{\textquoteright}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). Funding Information: This study was funded by Daiichi Sankyo Korea Co., Ltd. Publisher Copyright: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = dec,

doi = "10.1186/s40885-021-00177-z",

language = "English",

volume = "27",

journal = "Clinical Hypertension",

issn = "2056-5909",

publisher = "BioMed Central Ltd.",

number = "1",

}

TY - JOUR

T1 - Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients

T2 - a prospective, multicenter, observational study (RESOLVE-PRO)

AU - Investigators

AU - Sohn, Il Suk

AU - Ihm, Sang Hyun

AU - Kim, Gee Hee

AU - Park, Sang Min

AU - Hong, Bum Kee

AU - Lee, Chang Hoon

AU - Lee, Sang Hyun

AU - Chang, Dae Il

AU - Joo, Sung Pil

AU - Lee, Sang Chan

AU - Lee, Yong ho

AU - Jeon, Dong Woon

AU - Jung, Kyung Tae

AU - Rhee, Si Jae

AU - Cho, Yoon Jin

AU - Kim, Chong Jin

AU - Kim, Yun Sung

AU - Woo, Seong Ill

AU - Lee, Kyounghoon

AU - Heo, Jung Ho

AU - Park, Sang Ho

AU - Choi, Euy Jin

AU - Hwang, Sun Ho

AU - Chung, Yonh Gu

AU - Youn, Young Jin

AU - Im, Eul Soon

AU - Baik, Jong Sam

AU - Choi, Nack Cheon

AU - Lee, Jin Bae

AU - Ryu, Kyu Hyung

AU - Jang, Ji Yong

AU - Park, Sung Ji

AU - Shin, Dong Ick

AU - Na, Jin Oh

AU - Chung, Yun Jae

AU - Kim, Su Hyun

AU - Lee, Jong Young

AU - Oh, Yoon Sang

AU - Choi, Jong Hwan

AU - Seo, Hye Sun

AU - Kwon, Su Kyoung

AU - Kim, Hyung Jun

AU - Park, Jin Sun

AU - Park, Kyoung Ha

AU - Lee, Kyoung Soo

AU - Chung, Sung Chang

AU - Cho, Han Jin

AU - Lee, Chang Min

AU - Kim, Sung Rae

AU - Kim, Jinkwon

N1 - Funding 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). Funding Information: This study was funded by Daiichi Sankyo Korea Co., Ltd. Publisher Copyright: © 2021, The Author(s).

PY - 2021/12

Y1 - 2021/12

N2 - 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.

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.

UR - http://www.scopus.com/inward/record.url?scp=85127089084&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85127089084&partnerID=8YFLogxK

U2 - 10.1186/s40885-021-00177-z

DO - 10.1186/s40885-021-00177-z

M3 - Article

AN - SCOPUS:85127089084

SN - 2056-5909

VL - 27

JO - Clinical Hypertension

JF - Clinical Hypertension

IS - 1

M1 - 21

ER -

Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO)

Abstract

Bibliographical note

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UN SDGs

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