Clin Hypertens.  2021;27(1):21. 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)

Affiliations
  • 1Department of Internal Medicine, Division of Cardiology, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea
  • 2Department of Internal Medicine, Division of Cardiology, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.
  • 3Department of Internal Medicine, Division of Cardiology, St. Vincent’s Hospital, Suwon, Republic of Korea.
  • 4Department of Cardiology, Nowon Eulji Medical Center, Eulji University, Seoul, Republic of Korea
  • 5Division of Cardiology, Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
  • 6Department of Internal Medicine, Division of Cardiology, Veterans Health Service Medical Center, Seoul, Republic of Korea
  • 7Department of Internal Medicine, Division of Cardiology, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
  • 8Department of Neurology, Kyung Hee University Hospital, Seoul, Republic of Korea
  • 9Department of Neurosurgery, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea.
  • 10Department of Neurology, Dong-Eui Hospital, Busan, Republic of Korea
  • 11Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
  • 12Department of Internal Medicine, Division of Cardiology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.
  • 13Department of Internal Medicine, Division of Cardiology, Eulji University Hospital, Daejeon, Republic of Korea.
  • 14Medical Affairs Department, Daiichi Sankyo Korea Co., Ltd., Seoul, Republic of Korea
  • 15Department of Cardiology, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, South Korea.

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.

Keyword

Hypertension; Observational study; Olmesartan; Amlodipine; Hydrochlorothiazide; Real-world; Single-pill; combination; Korea
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