Why the study?
Hypertension and dyslipidemia frequently coexist and pose challenges in managing multiple medications, which affects treatment adherence.
Does a triple fixed-dose combination of telmisartan 40 mg/amlodipine 5 mg/rosuvastatin 10 mg reduce mean sitting systolic blood pressure and LDL-C levels more effectively than amlodipine 5 mg/atorvastatin 10 mg in patients with essential hypertension and dyslipidemia?
Does a triple fixed-dose combination of telmisartan 40 mg/amlodipine 5 mg/rosuvastatin 10 mg reduce mean sitting systolic blood pressure and LDL-C levels more effectively than amlodipine 5 mg/atorvastatin 10 mg in patients with essential hypertension and dyslipidemia?
A single-pill triple fixed-dose combination of telmisartan/amlodipine/rosuvastatin provides superior blood pressure and LDL-C lowering compared to dual amlodipine/atorvastatin therapy over 8 weeks with comparable tolerability in patients with coexisting hypertension and dyslipidemia.
Answers are grounded in this paper and cite their sources.
Supports triple fixed-dose combination over dual therapy for hypertension with dyslipidemia; extends evidence for polypill strategies in comorbid patients.
Hypertension and dyslipidemia significantly contribute to cardiovascular disease development. Their coexistence poses challenges in managing multiple medications, affecting treatment adherence. This study aimed to assess the efficacy and safety of a combined treatment approach using a fixed-dose combination (FDC) therapy. This multicenter, 8-week, randomized, double-blind, phase Ⅳ trial was named as S-TAROS and evaluated the efficacy and safety of FDC treatment in patients with essential hypertension and dyslipidemia. They were randomly assigned to two FDC groups, Telmisartan 40mg/Amlodipine 5mg/Rosuvastatin 10mg (TEL/ALD/RSV) or Amlodipine 5mg/Atorvastatin 10mg (ALD/ATV) after washout/run-in period. The primary outcomes were the change in mean sitting systolic blood pressure (msSBP) and the percentage change of low-density lipoprotein cholesterol (LDL-C) after 8 weeks of medical treatment. Adverse drug reactions and events were assessed. 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 ages of the TEL/ALD/RSV group and the ALD/ATV group were 67.4 ± 11.3 and 68.2 ± 10.6 years old, respectively (P value = 0.563). The least-squares mean (LSM) (Standard error, SE) in msSBP changes between the two groups were -16.27 (0.93) mmHg in the TEL/ALD/RSV group, -6.85 (0.92) mmHg in the ALD/ATV group (LSM difference -9.42mmHg, 95% CI -11.99 to -6.84; P value < 0.001). For LDL-C level changes, a significant difference was noted between the two 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 value < 0.001). No severe adverse events were observed. 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. ClinicalTrials.gov identifier: NCT03860220
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Park et al. (2024) studied this question.
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