Clinical Characteristics and Outcome of Immediate-Release Versus SLOW-Release Carvedilol in Heart Failure Patient
Chan Soon Park1, Jin Joo Park2, Hae-Young Lee1
1Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Insights
Slow-release carvedilol (carvedilol-SR) is as effective as immediate-release carvedilol (carvedilol-IR) for heart failure with reduced ejection fraction (HFrEF). This study found carvedilol-SR non-inferior to carvedilol-IR in patients with HFrEF.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Carvedilol is effective for heart failure with reduced ejection fraction (HFrEF).
- Immediate-release carvedilol (carvedilol-IR) requires twice-daily dosing due to its short half-life.
- Slow-release carvedilol (carvedilol-SR) offers a potential alternative for improved patient compliance.
Purpose of the Study:
- To evaluate if once-daily carvedilol-SR is non-inferior to twice-daily carvedilol-IR in HFrEF patients.
- To compare clinical efficacy and safety outcomes between carvedilol-SR and carvedilol-IR.
Main Methods:
- A randomized trial comparing carvedilol-SR (once daily) and carvedilol-IR (twice daily) in HFrEF patients.
- Primary endpoint: change in N-terminal pro B-natriuretic peptide (NT-proBNP) at 6 months.
- Secondary endpoints included mortality, readmission rates, blood pressure, quality of life, and drug compliance.
Main Results:
- 272 patients were randomized; median follow-up was 173 days.
- No significant difference in NT-proBNP change between carvedilol-SR and carvedilol-IR groups.
- Similar rates of mortality, readmission, blood pressure control, quality of life, and drug compliance were observed. Adverse events did not differ.
Conclusions:
- Once-daily slow-release carvedilol (carvedilol-SR) is non-inferior to twice-daily immediate-release carvedilol (carvedilol-IR) in HFrEF patients.
- Carvedilol-SR offers a viable alternative for managing HFrEF, potentially improving adherence.
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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