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

Zhao Yan Song, Moo Hyun Kim, Han Cheol Lee, Sung Ji Park, Moo Yong Rhee, Jong Il Choi, Sang Hyun Kim, In Ho Chae, Young Joon Hong, Nam Ho Lee, Gyo Seung Hwang, Seung Ho Hur, Jung Woo Son, Jei Keon Chae, Hyo Soo Kim

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2 Citations (Scopus)

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.

Original languageEnglish
Article number2377
JournalJournal of Clinical Medicine
Volume12
Issue number6
DOIs
Publication statusPublished - 2023 Mar
Externally publishedYes

Bibliographical note

Funding Information:
This research was supported by Yuhan Corporation.

Publisher Copyright:
© 2023 by the authors.

Keywords

  • dyslipidemia
  • ezetimibe
  • hypertension
  • rosuvastatin
  • telmisartan

ASJC Scopus subject areas

  • General Medicine

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