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
{"title":"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）","authors":"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","doi":"10.1016/j.curtheres.2024.100735","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Hypertension and dyslipidemia significantly contribute to cardiovascular disease development. Their coexistence poses challenges in managing multiple medications, influencing treatment adherence.</p></div><div><h3>Objective</h3><p>This study aimed to assess the efficacy and safety of a combined treatment approach using a fixed-dose combination therapy.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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 (<em>P</em> = 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; <em>P</em> < .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; <em>P</em> < .001). No severe adverse events were observed.</p></div><div><h3>Conclusions</h3><p>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. (<em>Curr Ther Res Clin Exp</em>. 2024; XX:XXX–XXX). ClinicalTrials.gov identifier: NCT03860220.</p></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":null,"pages":null},"PeriodicalIF":1.6000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0011393X24000055/pdfft?md5=e2b898a8aaa84b6faae79ae87558da24&pid=1-s2.0-S0011393X24000055-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension: A Multicenter Randomized Clinical Trial\",\"authors\":\"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\",\"doi\":\"10.1016/j.curtheres.2024.100735\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Hypertension and dyslipidemia significantly contribute to cardiovascular disease development. Their coexistence poses challenges in managing multiple medications, influencing treatment adherence.</p></div><div><h3>Objective</h3><p>This study aimed to assess the efficacy and safety of a combined treatment approach using a fixed-dose combination therapy.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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 (<em>P</em> = 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; <em>P</em> < .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; <em>P</em> < .001). No severe adverse events were observed.</p></div><div><h3>Conclusions</h3><p>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. (<em>Curr Ther Res Clin Exp</em>. 2024; XX:XXX–XXX). 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Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension: A Multicenter Randomized Clinical Trial
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.
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