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

The introduction of a fixed-dose combination (FDC) is expected to improve treatment compliance. 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 i...

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Published in:Journal of clinical medicine 2023-03, Vol.12 (6), p.2377
Main Authors: Song, Zhao-Yan, Kim, Moo-Hyun, Lee, Han-Cheol, Park, Sung-Ji, Rhee, Moo-Yong, Choi, Jong-Il, Kim, Sang-Hyun, Chae, In-Ho, Hong, Young-Joon, Lee, Nam-Ho, Hwang, Gyo-Seung, Hur, Seung-Ho, Son, Jung-Woo, Chae, Jei-Keon, Kim, Hyo-Soo
Format: Article
Language:English
Subjects:
Angioplasty
Blood pressure
Cardiovascular disease
Cardiovascular diseases
Care and treatment
Cholesterol
Clinical medicine
Complications and side effects
Coronary vessels
Diagnosis
Dosage and administration
Double-blind studies
Drug therapy, Combination
Dyslipidemias
Hypertension
Metabolic disorders
Patient outcomes
Prevention
Risk factors
Rosuvastatin
Statins
Telmisartan
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Summary:The introduction of a fixed-dose combination (FDC) is expected to improve treatment compliance. 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. 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, < 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, < 0.0001). No serious adverse events were observed. Ezetimibe-rosuvastatin plus telmisartan treatment is effective and safe when compared to either ezetimibe-rosuvastatin or telmisartan.
ISSN:2077-0383
2077-0383
DOI:10.3390/jcm12062377