Efficacy and Safety of Coadministered Ezetimibe–Rosuvastatin plus Telmisartan in South Korean Patients with Dyslipidemia and Hypertension: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase III Trial

Abstract

Background: The introduction of a fixed-dose combination (FDC) is expected to improve treatment compliance. Methods: There were 181 subjects who were randomized to three groups: ezetimibe–rosuvastatin 10/20 mg + telmisartan 80 mg, ezetimibe–rosuvastatin 10/20 mg, and telmisartan 80 mg. The primary outcomes were change in mean sitting systolic blood pressure (MSSBP) and percentage change in low-density-lipoprotein cholesterol (LDL-C) compared to baseline at week 8. Results: The least-square mean (SE) in MSSBP changes between the ezetimibe–rosuvastatin 10/20 mg + telmisartan 80 mg group and the ezetimibe–rosuvastatin 10/20 mg group were −25.81 (2.34) mmHg and −7.66 (2.45) mmHg. There was a significant difference between the two groups (−18.15 (2.83) mmHg, 95% CI −23.75 to −12.56, p < 0.0001). Changes in least-square mean (SE) in LDL-C between the ezetimibe–rosuvastatin 10/20 mg + telmisartan 80 mg group and the telmisartan 80 mg group were −63.82 (2.87)% and −2.48 (3.12)%. A significant difference was observed between the two groups (−61.34 (3.33)%, 95% CI −67.91 to −54.78, p < 0.0001). No serious adverse events were observed. Conclusions: Ezetimibe–rosuvastatin plus telmisartan treatment is effective and safe when compared to either ezetimibe–rosuvastatin or telmisartan.

Efficacy and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe in patients with dyslipidemia and hypertension: A randomized, double‐blind, multicenter, therapeutic confirmatory, phase III clinical trial

“…Furthermore, a previous study showed that ezetimibe‐rosuvastatin with telmisartan therapy is effective and safe compared to either ezetimibe‐rosuvastatin double therapy or telmisartan monotherapy. 51 The triple combination yielded improvements in the primary endpoints of msSBP and LDL‐C levels compared to their respective control groups. The efficacy results were consistent with this study, and no clinically significant differences were observed in the safety outcomes in both studies.…”