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Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Essential Hypertension (RESOLVE): A Large, Observational, Retrospective, Cohort Study

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Abstract

Background

The efficacy and safety of a single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ) have been established previously through multiple studies. However, the real-world data in Korean patients are still limited. This study evaluated the effectiveness and safety of SPC of OLM/AML/HCTZ in a real practice setting in Korean patients with essential hypertension.

Methods

This was an observational, retrospective, multi-center, non-comparative cohort study. Medical records of 9749 patients with essential hypertension who had been prescribed OLM/AML/HCTZ within 1 year of the study were analyzed. The primary outcome was the achievement rate (%) of the target blood pressure goal of a systolic blood pressure (SBP) of < 140 mmHg and a diastolic blood pressure (DBP) of < 90 mmHg following administration of OLM/AML/HCTZ. The secondary outcomes included the rate of BP control measured at each visit, the amount of BP reduction compared to the index date, and the prescribing patterns of OLM/AML/HCTZ. Safety and tolerability were assessed by the incidence rate of adverse events (AEs) and discontinuation.

Results

In the effectiveness analysis set (n = 9604), the overall achievement rate of target BP was 82.56%. The mean SBP/DBP was significantly reduced compared to baseline at all visits (all p < 0.0001), with the greatest reduction occurring at week 2. The achievement rate of target BP was above 71%, regardless of the presence of risk factors (diabetes mellitus, DM; cardiovascular disease, CVD; chronic kidney disease, CKD). Patients with CVD and aged > 65 years showed a significantly higher achievement rate (p < 0.05). A significant relationship existed between the primary outcome and age (p < 0.0001). The achievement rate exceeded 74% in all different age groups. In the safety analysis set (n = 9661), AEs were reported in 8.46% of patients, with the most frequent AE being dizziness. Serious adverse events (SAEs) and unexpected adverse events (UAEs) occurred in 0.96% and 3.73% patients, respectively. This was consistent with the previously reported safety profile of OLM/AML/HCTZ. The majority of AEs were mild to moderate and resolved during the observation period. The discontinuation rate of OLM/AML/HCTZ due to AEs was 1.67%.

Conclusion

This study demonstrated significant effectiveness of OLM/AML/HCTZ in achieving target BP in Korean patients with essential hypertension. OLM/AML/HCTZ was well tolerated.

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Acknowledgements

The authors thank all clinical investigators and study coordinators at participating centers for involvement and contribution to the study. The authors also thank C&R Research Inc. for statistical analysis assistance.

Funding

This study and the Rapid Service Fee of the journal were funded by Daiichi Sankyo Korea Co., Ltd. (Seoul, Republic of Korea).

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Author Contributions

Daiichi Sankyo Korea Co., Ltd., has provided oversight in aspects of the study, including study design, data acquisition and compilation of the final report. Both authors have equally contributed to the review, analysis, interpretation of data and manuscript preparation.

Disclosures

Sung-Ji Park has received research funds from Daiichi Sankyo Korea Co., Ltd., and Si Jae Rhee is a full-time employee of Daiichi Sankyo Korea Co., Ltd. There are no other potential conflicts of interest to disclose.

Compliance with Ethics Guidelines

This study was conducted in accordance with the ethical standards of the Helsinki Declaration of 1976, and its later amendments, as well as with relevant regulations of the Korean Pharmaceutical Affairs Act. The study protocol and a waiver of patient consent were approved by the Institutional Review Board (IRB) at each participating center (see full list of IRBs in Table S1 of the electronic supplementary material). Data collection and analysis were performed after anonymization of the patient data.

Data Availability

The datasets generated during and/or analyzed during the current study are not publicly available due to the sponsor’s policies for the disclosure of clinical study data but are available from the study sponsor on reasonable request by qualified researchers.

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Authors and Affiliations

  1. Division of Cardiology, Department of Medicine, Cardiovascular Imaging Center, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Sung-Ji Park

  2. Medical Affairs Department, Daiichi Sankyo Korea Co., Ltd., Seoul, Republic of Korea

    Si Jae Rhee

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  1. Sung-Ji Park
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Correspondence to Sung-Ji Park.

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Park, SJ., Rhee, S.J. Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Essential Hypertension (RESOLVE): A Large, Observational, Retrospective, Cohort Study. Adv Ther 37, 3500–3514 (2020). https://doi.org/10.1007/s12325-020-01404-z

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