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Safety and efficacy study of delapril versus enalapril in patients with congestive heart failure
1Department of Internal Medicine, University of Padua Medical School, Italy.
Insights
Delapril and enalapril improved exercise capacity and cardiac function in patients with congestive heart failure (CHF). Delapril showed a greater decrease in left ventricular end-systolic volume and a higher rate of New York Heart Association (NYHA) class improvement.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Congestive heart failure (CHF) affects millions globally, necessitating effective treatments.
- Angiotensin-converting enzyme (ACE) inhibitors are a cornerstone therapy for CHF.
- Delapril and enalapril are ACE inhibitors with established efficacy.
Purpose of the Study:
- To compare the efficacy and safety of delapril versus enalapril in patients with CHF.
- To evaluate the impact of these treatments on exercise capacity, cardiac function, and clinical status.
Main Methods:
- Multicenter, randomized, open-label, parallel-group study.
- 1-year treatment duration with initial doses of delapril (7.5 mg BID) and enalapril (2.5 mg BID), with potential doubling up to 30 mg BID and 10 mg BID, respectively.
- Evaluations included New York Heart Association (NYHA) class, exercise testing, echocardiography, cardiothoracic ratio, ECG, and patient-reported outcomes.
Main Results:
- Both delapril and enalapril significantly improved exercise duration, workload, and work performed after 3 months.
- Significant improvements in ejection fraction and left ventricular wall stress were observed after 6 months.
- Delapril demonstrated a significant decrease in left ventricular end-systolic volume at 3 and 6 months.
- Improvement of at least one NYHA class was seen in 20% of delapril patients versus 14% of enalapril patients.
Conclusions:
- Delapril and enalapril are effective treatments for congestive heart failure (CHF) in patients with New York Heart Association (NYHA) classes II and III.
- Delapril showed a trend towards superior efficacy in reducing left ventricular end-systolic volume and improving NYHA class compared to enalapril.
Abstract:
The results after the first 6 months of the 1-year treatment of this multicenter, randomized, open, parallel-group design study of delapril versus enalapril in patients with congestive heart failure (CHF), New York Heart Association (NYHA) classes II and III, are presented. The initial dose of delapril (7.5 mg twice daily) and enalapril (2.5 mg twice daily) could be doubled on a 2-weekly basis (from the beginning of the study) to a maximum of 30 mg twice daily and 10 mg twice daily, respectively. The evaluation of the efficacy was based on the changes of NYHA class, results of exercise testing involving bicycle ergometry (duration of exercise, workload, work performed, double product) performed before and after 3 months' treatment, echocardiography (left ventricular end-diastolic volume and end-systolic volume, ejection fraction, and left ventricular wall stress) at baseline and after 3 and 6 months of treatment and changes in cardiothoracic ratio, electrocardiography, and NYHA class, and patient's opinion of efficacy. Safety was evaluated by monitoring the adverse reactions, laboratory tests, and blood pressure. At 3 months, both treatments had produced a significant improvement compared with baseline in the duration of exercise, workload, and work performed in the bicycle ergometry test as well as in the ejection fraction and in left ventricular wall stress after 6 months of treatment. In addition, after 3 and 6 months of treatment, delapril produced a significant decrease in left ventricular end-systolic volume. Improvement of at least one NYHA class was observed in 20% of delapril patients and 14% of enalapril patients.(ABSTRACT TRUNCATED AT 250 WORDS)