Curr Ther Res Clin Exp. 2024;100:100735.

Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension: A Multicenter Randomized Clinical Trial.

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제1저자 박성준, 황도연 · 교신저자 김효수

PMID 38380420 PMC10878781 DOI 10.1016/j.curtheres.2024.100735 IF 3 순환기내과

소속 (8)

Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital and Seoul National University College of Medicine, Seoul, Korea.
Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, Seoul, South Korea.
Division of Cardiology, Department of Internal Medicine, Kangwon National University Hospital, Kangwon National University School of Medicine, Chuncheon, South Korea.
Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, South Korea.
Division of Cardiology, Department of Internal Medicine, Severance Hospital, Seoul, South Korea.
Department of Cardiology, CHA Bundang Medical Center, Seongnam, South Korea.
Division of Cardiology, Department of Internal Medicine, Yeung-nam University Hospital, Daegu, South Korea.
Division of Cardiology, Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, South Korea.

Abstract

BACKGROUND Hypertension and dyslipidemia significantly contribute to cardiovascular disease development. Their coexistence poses challenges in managing multiple medications, influencing treatment adherence.

OBJECTIVE This study aimed to assess the efficacy and safety of a combined treatment approach using a fixed-dose combination therapy.

METHODS This multicenter, 8-week, randomized, double-blind, Phase IV trial was named Telmisartan/Amlodipine/Rosuvastatin from Samjin Pharmaceuticals and evaluated the efficacy and safety of fixed-dose combination treatment in patients with essential hypertension and dyslipidemia. They were randomly assigned to 2 fixed-dose combination therapy groups, telmisartan 40 mg/amlodipine 5 mg/rosuvastatin 10 mg (TEL/ALD/RSV) or amlodipine 5 mg/atorvastatin 10 mg (ALD/ATV) after washout/run-in period. The primary outcomes were the change in mean sitting systolic blood pressure and the percentage change of LDL-C after 8 weeks of medical treatment. Adverse drug reactions and events were assessed.

RESULTS Of a total of 304 patients who underwent screening, 252 were randomized to the TEL/ALD/RSV group (125 patients) and the ALD/ATV group (127 patients). The mean (SD) ages of the TEL/ALD/RSV group and the ALD/ATV group were 67.4 (11.3) and 68.2 (10.6) years, respectively (P = 0.563). The least-squares mean (SE) in mean sitting systolic blood pressure changes between the 2 groups were -16.27 (0.93) mm Hg in the TEL/ALD/RSV group, -6.85 (0.92) mm Hg in the ALD/ATV group (LSM difference = -9.42 mm Hg; 95% CI, -11.99 to -6.84; P < .001). For LDL-C level changes, a significant difference was noted between the 2 groups: -50.03% (1.18%) in the TEL/ALD/RSV group, -39.60% (1.17%) in the ALD/ATV group (LSM difference = -10.43%; 95% CI, -13.70 to -7.16; P < .001). No severe adverse events were observed.

CONCLUSIONS TEL/ALD/RSV proved to be more efficient than ALD/ATV in lowering blood pressure and reducing LDL-C levels among patients with hypertension and dyslipidemia, with no notable safety concerns. (Curr Ther Res Clin Exp. 2024; XX:XXX-XXX). ClinicalTrials.gov identifier: NCT03860220.

Keywords

LDL-Catorvastatindyslipidemiahypertensionrosuvastatintelmisartan

Figures

**Fig 1** Study design. BP = blood pressure.

**Fig. 3** Changes from baseline in mean sitting systolic blood pressure (msSBP) at week 8 between the telmisartan 40 mg/amlodipine 5 mg/rosuvastatin 10 mg (TEL/ALD/RSV) group and amlodipine 5 mg/atorvastatin 10 mg (ALD/ATV) group. LSM = least-square mean.

**Fig 4** Percent change from baseline in LDL-C at week 8 between the telmisartan 40 mg/amlodipine 5 mg/rosuvastatin 10 mg (TEL/ALD/RSV) group and amlodipine 5 mg/atorvastatin 10 mg (ALD/ATV) group. LSM = least-square mean.

그림 출처: PubMed Central 공개 논문 (PMC10878781)

Conflict of interest statement

This research was supported by a grant of Seoul National University Hospital (SNUH 06-2019-1110), which was donated by Samjin Pharmaceutical Company. The donor of the grant did not participate in the design, data collection, analysis, or data interpretation of the study. The authors have indicated that they have no other conflicts of interest regarding the content of this article.

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