Real-world evidence on the strategy of olmesartan-based triple single-pill combination in Korean hypertensive patients: a prospective, multicenter, observational study (RESOLVE-PRO)
Authors: Sohn Il Suk , Ihm Sang-Hyun , Kim Gee Hee , Park Sang Min , Hong Bum-Kee , Lee Chang Hoon , Lee Sang Hyun , Chang Dae-Il , Joo Sung-Pil , Lee Sang-Chan , Lee Yong-ho , Jeon Dong Woon , Jung Kyung Tae , Rhee Si Jae , Cho Yoon-Jin , Kim Chong-Jin ,   Investigators, Kim Yun Sung , Woo Seong-Ill , Lee Kyounghoon , Heo Jung Ho , Park Sang-Ho , Choi Euy Jin , Hwang Sun Ho , Chung Yonh-Gu , Youn Young Jin , Im Eul-Soon , Baik Jong Sam , Choi Nack-Cheon , Lee Jin Bae , Ryu Kyu-Hyung , Jang Ji-Yong , Park Sung-Ji , Shin Dong-Ick , Na Jin Oh. , Chung Yun Jae , Kim Su Hyun , Lee Jong-Young , Oh Yoon-Sang , Choi Jong Hwan , Seo Hye Sun , Kwon Su Kyoung , Kim Hyung-Jun , Park Jin-Sun , Park Kyoung-Ha , Lee Kyoung-Soo , Chung Sung Chang , Cho Han-Jin , Lee Chang-Min , Kim Sung-Rae , Kim Jinkwon , Oh Hyeong-gyun , Park Ik Seong , Chung Pil-Wook , Cho Sung-Rae , Kang Hyun-Seung , Lee Seung Jin , Park Kyungil , Lee Si Won , Son Jang-Won , Kim Soo Kyoung , Chung Joong-Hwa , Byon Jin-Soo , Lim Hong Euy , Kim Bum-Tae , Choi Yu Jeong , Ann Soe Hee , Sung Sang Min , Lee Jun-Hee 
Published: November 2021

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.