Clinical Characteristics and Outcome of Immediate-Release Versus SLOW-Release Carvedilol in Heart Failure Patient (SLOW-HF): a Prospective Randomized, Open-Label, Multicenter Study
- Authors
- Park, Chan Soon; Park, Jin Joo; Lee, Hae-Young; Kang, Seok-Min; Yoo, Byung-Su; Jeon, Eun-Seok; Hong, Suk Keun; Shin, Joon-Han; Kim, Myung-A; Park, Dae-Gyun; Kim, Eung-ju; Hong, Soon-jun; Kim, Seok Yeon; Kim, Jae-Joong; Choi, Dong-Ju
- Issue Date
- Jun-2023
- Publisher
- Kluwer Academic Publishers
- Keywords
- Heart failure with reduced ejection fraction; Carvedilol; Slow release; Clinical efficacy; NT-proBNP
- Citation
- Cardiovascular Drugs and Therapy, v.37, no.3, pp 529 - 537
- Pages
- 9
- Indexed
- SCIE
SCOPUS
- Journal Title
- Cardiovascular Drugs and Therapy
- Volume
- 37
- Number
- 3
- Start Page
- 529
- End Page
- 537
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/55307
- DOI
- 10.1007/s10557-021-07238-3
- ISSN
- 0920-3206
1573-7241
- Abstract
- Purpose
Carvedilol demonstrated therapeutic benefits in patients with heart failure and reduced ejection fraction (HFrEF). However, it had a short half-life time mandating twice a day administration. We investigated whether slow-release carvedilol (carvedilol-SR) is non-inferior to standard immediate-release carvedilol (carvedilol-IR) in terms of clinical efficacy in patients with HFrEF.
Methods
We randomly assigned patients with HFrEF to receive carvedilol-SR once a day or carvedilol-IR twice a day. The primary endpoint was the change in N-terminal pro B-natriuretic peptide (NT-proBNP) level from baseline to 6 months after randomization. The secondary outcomes were proportion of patients with NT-proBNP increment > 10% from baseline, mortality rate, readmission rate, changes in blood pressure, quality of life, and drug compliance.
Results
A total of 272 patients were randomized and treated (median follow-up time, 173 days). In each group of patients taking carvedilol-SR and those taking carvedilol-IR, clinical characteristics were well balanced. No patient died during follow-up, and there was no significant difference in the change of NT-proBNP level between two groups (-107.4 [-440.2–70.3] pg/mL vs. -91.2 [-504.1–37.4] pg/mL, p = 0.101). Change of systolic and diastolic blood pressure, control rate and response rate of blood pressure, readmission rate, and drug compliance rate were also similar. For safety outcomes, the occurrence of adverse reactions did not differ between carvedilol-SR group and carvedilol-IR group.
Conclusion
Carvedilol-SR once a day was non-inferior to carvedilol-IR twice a day in patients with HFrEF.
Trial registration
ClinicalTrials.gov: NCT03209180 (registration date: July 6, 2017)
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- Appears in
Collections - 2. Clinical Science > Department of Cardiology > 1. Journal Articles
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