Effectiveness and Safety of a Fixed-Dose Combination of Valsartan and Rosuvastatin (Rovatitan


Journal

Drug design, development and therapy
ISSN: 1177-8881
Titre abrégé: Drug Des Devel Ther
Pays: New Zealand
ID NLM: 101475745

Informations de publication

Date de publication:
2023
Historique:
received: 17 10 2022
accepted: 23 02 2023
medline: 14 4 2023
entrez: 13 4 2023
pubmed: 14 4 2023
Statut: epublish

Résumé

This study aimed to assess the effectiveness and safety of a fixed-dose combination of rosuvastatin and valsartan (Rovatitan A total of 1008 eligible patients with concomitant hypertension and hyperlipidemia were enrolled and treated for 12 weeks. Both upward and downward drug dose titrations were allowed based on the investigator's discretion. This study evaluated the effectiveness of the study drug, defined by the percentage of patients achieving the blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) treatment targets. Additionally, regression analyses were conducted to evaluate the factors associated with the effectiveness and safety of the study drug. Of the 1008 patients enrolled in the study, 911 were analyzed for clinical effectiveness. At 12 weeks, 84.6% and 75.9% of patients treated with the study drug achieved their BP and LDL-C targets, respectively, and 64.8% of patients achieved both targets simultaneously. Furthermore, the percentage of patients who achieved their BP and LDL-C treatment targets demonstrated a trend across the respective risk groups; the higher the risk group, the lower the success of attaining the respective target. This trend was also observed regardless of the prior antihypertensive and/or lipid-lowering treatments. According to regression analysis, poor metabolic profiles, including a higher body mass index (BMI) and higher BP and LDL-C levels at baseline, were significantly associated with treatment failure for BP. Among the 1005 patients included in the safety analysis, 17 patients (1.7%) experienced serious adverse events; however, none were considered related to the study drug. The study drug used for the treatment of concomitant hypertension and hyperlipidemia in a real-world setting was effective and was well tolerated. Therefore, the study drug is suggested as a good alternative to increase patient convenience and compliance, particularly in those taking multiple medications.

Identifiants

pubmed: 37051292
doi: 10.2147/DDDT.S391288
pii: 391288
pmc: PMC10084874
doi:

Substances chimiques

Rosuvastatin Calcium 83MVU38M7Q
Valsartan 80M03YXJ7I
Cholesterol, LDL 0
Antihypertensive Agents 0

Types de publication

Observational Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1047-1062

Informations de copyright

© 2023 Lee et al.

Déclaration de conflit d'intérêts

The authors report no conflicts of interest in this work.

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Auteurs

Kwang Je Lee (KJ)

Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.

Jae-Kean Ryu (JK)

Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea.

Yun-Hyeong Cho (YH)

Cardiovascular Center, Myongji Hospital, Goyang, Korea.

Won Yong Shin (WY)

Department of Cardiology, Soon Chun Hyang University Hospital Cheonan, Cheonan, Korea.

Jeong Su Kim (JS)

Cardiovascular Center, Pusan National University Yangsan Hospital, Yangsan, Korea.

Young Won Yoon (YW)

Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

Ji Yong Jang (JY)

Department of Cardiology, National Health Insurance Service Ilsan Hospital, Ilsan, Korea.

Won Ho Kim (WH)

Eulji University School of Medicine, Daejeon, Korea.

Jong Wook Beom (JW)

Department of Cardiology, Jeju National University Hospital, Jeju, Korea.

Seok-Min Kang (SM)

Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.

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