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

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Sungjoon Park MD , Doyeon Hwang MD , Jeehoon Kang MD , Jung-Kyu Han MD , Han-Mo Yang MD , Kyung Woo Park MD , Hyun-Jae Kang MD , Bon-Kwon Koo MD , Jin-Man Cho MD , Byung-Ryul Cho MD , Sung Gyun Ahn MD , Seok-Min Kang MD , Jung-Hoon Sung MD , Ung Kim MD , Namho Lee MD , Hyo-Soo Kim MD
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引用次数: 0

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.

替米沙坦/阿莫地平/瑞舒伐他汀三联疗法对血脂异常和高血压患者的疗效和安全性:多中心随机临床试验(S-TAROS)
背景高血压和血脂异常是导致心血管疾病的重要原因。方法这项多中心、为期 8 周、随机、双盲、IV 期试验被命名为 "替米沙坦/阿莫地平/瑞舒伐他汀",由三金药业公司进行,旨在评估固定剂量联合疗法对原发性高血压和血脂异常患者的疗效和安全性。经过冲洗/磨合期后,他们被随机分配到两个固定剂量联合治疗组:替米沙坦 40 毫克/氨氯地平 5 毫克/瑞舒伐他汀 10 毫克(TEL/ALD/RSV)或氨氯地平 5 毫克/阿托伐他汀 10 毫克(ALD/ATV)。主要结果是药物治疗 8 周后平均坐位收缩压的变化和低密度脂蛋白胆固醇的百分比变化。结果 在接受筛选的 304 名患者中,252 人被随机分配到 TEL/ALD/RSV 组(125 人)和 ALD/ATV 组(127 人)。TEL/ALD/RSV组和ALD/ATV组的平均年龄(标清)分别为67.4(11.3)岁和68.2(10.6)岁(P = 0.563)。两组间平均坐位收缩压变化的最小二乘均值(SE)分别为:TEL/ALD/RSV 组 -16.27 (0.93) mm Hg,ALD/ATV 组 -6.85 (0.92) mm Hg(LSM 差 = -9.42 mm Hg;95% CI,-11.99 至 -6.84;P < .001)。在低密度脂蛋白胆固醇水平变化方面,两组之间存在显著差异:TEL/ALD/RSV组为-50.03%(1.18%),ALD/ATV组为-39.60%(1.17%)(LSM差异=-10.43%;95% CI,-13.70至-7.16;P <.001)。结论事实证明,与 ALD/ATV 相比,TEL/ALD/RSV 能更有效地降低高血压和血脂异常患者的血压和 LDL-C 水平,且无明显的安全性问题。(Curr Ther Res Clin Exp. 2024; XX:XXX-XXX)。ClinicalTrials.gov 标识符:NCT03860220。
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来源期刊
CiteScore
3.50
自引率
0.00%
发文量
31
审稿时长
3 months
期刊介绍: We also encourage the submission of manuscripts presenting preclinical and very preliminary research that may stimulate further investigation of potentially relevant findings, as well as in-depth review articles on specific therapies or disease states, and applied health delivery or pharmacoeconomics. CTR encourages and supports the submission of manuscripts describing: • Interventions designed to understand or improve human health, disease treatment or disease prevention; • Studies that focus on problems that are uncommon in resource-rich countries; • Research that is "under-published" because of limited access to monetary resources such as English language support and Open Access fees (CTR offers deeply discounted English language editing); • Republication of articles previously published in non-English journals (eg, evidence-based guidelines) which could be useful if translated into English; • Preclinical and clinical product development studies that are not pursued for further investigation based upon early phase results.
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