A Multi-Center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of an Olmesartan/Amlodipine Plus Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Dyslipidemia

Bong‐Ki Lee; Byeong‐Keuk Kim; Jae Hyoung Park; Jong‐Won Chung; Chang Gyu Park; Jin Won Kim; Young Dae Kim; Woo Jung Park; Sang–Hyoun Kim; Jae‐Kwan Cha; Cheol Ho Kim; Seung‐Woon Rha; Young Joon Hong; Mi‐Seung Shin; Seong Wook Cho; Young Hee Sung; Kiheon Lee; Jaemyung Yu; Dong Ryeol Ryu; Sungwook Yu; Tae-Jin Song; Bon D. Ku; Sin Gon Kim; Hwan-Cheol Park; Deok‐Kyu Cho; Byung‐Su Kim; Seongwoo Han; Sung‐Ji Park; Gyung‐Min Park

doi:10.3390/jcm14020308

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Why the study?

The study assessed the therapeutic effectiveness of a single-pill combination of olmesartan/amlodipine plus rosuvastatin for blood pressure and LDL-C control in patients with concomitant hypertension and dyslipidemia.

Does a single-pill combination of olmesartan/amlodipine plus rosuvastatin improve blood pressure and LDL-C goal achievement in adult patients with concomitant hypertension and dyslipidemia?

Key Points

To evaluate the real-world therapeutic effectiveness and safety of a single-pill combination of olmesartan, amlodipine, and rosuvastatin in patients with concurrent hypertension and dyslipidemia.
Conducted a prospective, multicenter observational study enrolling 5,476 adult patients receiving the combination pill, with 4,411 patients included in the effectiveness evaluation set.
Assessed primary endpoints at weeks 24–48 based on the proportion of patients achieving target goals for blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), or both.
At weeks 24–48, treatment goals were achieved by 67.93% (95% CI, 66.52–69.32) of patients for BP, 80.19% (95% CI, 78.85–81.49) for LDL-C, and 58.07% (95% CI, 56.43–59.7) for both targets concurrently.
Secondary outcomes demonstrated statistically significant reductions from baseline in blood pressure and lipid parameters across evaluated time points.
The single-pill regimen was well tolerated throughout the follow-up period with an acceptable safety profile.

Structured PICO

Does a single-pill combination of olmesartan/amlodipine plus rosuvastatin improve blood pressure and LDL-C goal achievement in adult patients with concomitant hypertension and dyslipidemia?

P

Population

5,476 adult patients (≥19 years) with concomitant hypertension and dyslipidemia across 46 centers in Korea (safety set n=5,401; effectiveness evaluation set n=4,411). Mean age 65.50 years, 56.80% male, mean BMI 25.91 kg/m². Exclusion criteria included requirement of ≥3 antihypertensive or ≥2 lipid-lowering medications, prior use of the study drug, severe hepatic impairment, active liver disease, biliary obstruction, severe renal impairment (CrCl < 30 mL/min), severe aortic stenosis, myopathy, concurrent cyclosporine administration, and pregnancy/lactation.

I

Intervention

Single-pill combination of olmesartan medoxomil/amlodipine besylate/rosuvastatin calcium at daily oral doses of 20/5/5, 20/5/10, 40/5/5, or 40/5/10 mg once daily (most commonly 20/5/10 mg in 62.08% of patients) for a mean administration duration of 227.64 days (evaluated at 24–48 weeks), prescribed as first-line, substitute, or add-on therapy.

O

Outcome

Proportion of patients achieving treatment goals for blood pressure (per 2018 Korean Society of Hypertension Guidelines), LDL-C (per Korean Guidelines for the Management of Dyslipidemia IV), and both BP and LDL-C at weeks 24–48.surrogate

In a large real-world Korean cohort, a single-pill combination of olmesartan, amlodipine, and rosuvastatin safely and effectively achieved dual blood pressure and LDL-C targets in 58.07% of patients with concomitant hypertension and dyslipidemia over 24 to 48 weeks.

Limitations

Potential confounding variables, such as lifestyle modifications, were not controlled due to the observational nature of the study.
Cannot prove causality as an observational study.
BP measurement method was not standardized, leading to potential variations from external factors, repeated measurements, and resting state differences.
Lipid parameter data for some patients were not documented, and fasting state was not evenly controlled before lipid panel measurements.
Myocardial overload parameters such as Troponin T and NT-proBNP were not included in the protocol.

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Implication

May support SPC for dual BP/LDL-C goals in hypertension with dyslipidemia; leaves open randomized confirmation.

Abstract

Introduction: This study assessed the therapeutic effectiveness of a single-pill combination (SPC) of olmesartan/amlodipine plus rosuvastatin for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) in patients with hypertension and dyslipidemia. Methods: Adult patients with hypertension and dyslipidemia who were decided to be treated with the study drug were eligible. The primary endpoint was the proportion of patients who achieved BP, LDL-C and both BP and LDL-C treatment goals at weeks 24–48. Secondary endpoints were assessed at weeks 24–48 and included changes in BP and LDL-C levels from baseline; the proportion of patients who achieved treatment goals who were initially classified as uncontrolled at baseline; changes and percent changes in lipid parameters; changes in both BP and LDL-C levels among patients who reached treatment goals who were followed for more than 24 weeks; and the overall safety profile. Results: A total of 5476 patients were enrolled, and 4411 patients comprised the effectiveness evaluation set. The proportions of patients who reached the treatment goals for BP, LDL-C levels, and both BP and LDL-C levels were 67.93% [95% confidence interval (CI) 66.52–69.32], 80.19% [95% CI 78.85–81.49], and 58.07% [95% CI 56.43–59.7], respectively. Secondary endpoints showed statistically significant changes. Overall, the treatment was well tolerated. Conclusions: The treatment of patients with hypertension and dyslipidemia with the olmesartan/amlodipine plus rosuvastatin SPC was associated with significant decreases in SBP/DBP and LDL-C levels, and a high proportion of patients achieved the BP and LDL-C treatment goals. The finding of this study is worthwhile in that this study evaluated the effectiveness and safety in a broad patient population representative of those seen in everyday clinical practice.

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Cite This Study

Lee et al. (2025) studied this question.

synapsesocial.com/papers/6a7cee02d47830742b91b05d https://doi.org/10.3390/jcm14020308

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A Multi-Center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of an Olmesartan/Amlodipine Plus Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Dyslipidemia

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Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

A Multi-Center, Prospective, Observational Study to Evaluate the Therapeutic Effectiveness and Safety of an Olmesartan/Amlodipine Plus Rosuvastatin Combination Treatment in Patients with Concomitant Hypertension and Dyslipidemia

Figures

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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