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SAFETY OF ENALAPRIL IN INFANTS: DATA FROM THE PEDIATRIC HEART NETWORK INFANT WITH SINGLE VENTRICLE TRIAL
572 JACC March 21, 2017 Volume 69, Issue 11
Congenital Heart Disease SAFETY OF ENALAPRIL IN INFANTS: DATA FROM THE PEDIATRIC HEART NETWORK INFANT WITH SINGLE VENTRICLE TRIAL Moderated Poster Contributions Congenital Heart Disease and Pulmonary Hypertension Moderated Poster Theater, Poster Hall, Hall C Saturday, March 18, 2017, 12:45 p.m.-12:55 p.m. Session Title: Therapeutic Advances in Congenital Heart Disease Abstract Category: 10. Congenital Heart Disease: Pediatric Presentation Number: 1220M-05 Authors: Kanika Mathur, Jacqueline Lamour, Daphne Hsu, Scott I. Aydin, Children’s Hospital at Montefiore, Bronx, NY, USA
Background: Angiotension converting enzyme (ACE) inhibitor therapy has been shown to improve ventricular function and clinical outcomes in adult patients with heart failure. Despite the lack of safety and efficacy data, empiric use of ACE inhibitor therapy is common in infants and children with cardiomyopathy and congenital heart disease. The Pediatric Heart Network Infant with Single Ventricle (ISV) trial provides the opportunity to describe the safety and adverse effects of enalapril in a large group of infants with complex congenital heart disease. Methods: Neonates with a single ventricle (SV) were prospectively enrolled in a randomized trial of enalapril vs. placebo. Patients were followed to 14 months of age and data including demographics, survival, drug administration and safety were collected. Descriptive statistics and univariate analyses were performed using student t-test, chi-square, Mann-Whitney-U, and Fisher’s exact tests.
Results: The ISV trial randomized 230 patients, 185 of whom completed the study. Median age at drug initiation was 19 days [7, 46]. Initial enalapril dose was 0.025 - 0.05 mg/kg/dose and mean dose was 0.31 ± 0.13 mg/kg/day. There was no significant difference in mean percent change in blood pressure (BP) from baseline to lowest BP at initiation of drug (-11 ± 11 vs. -12 ± 11, p = 0.51) between placebo and enalapril. There was no difference in percent change in BP during re-initiation of study drug after the Glenn or any temporary stop (-9 ± 12 vs. -10 ± 11, p = 0.55). There was no difference in percent change of BP during all dose adjustments (-11 ± 7 vs. -12 ± 8, p = 0.39). The number of patients who suffered hyperkalemia (49% vs. 57%, p = 0.24), renal dysfunction (0% vs. 3%, p = 0.12), or neutropenia (33% vs. 28%, p = 0.39) was no different between the placebo and enalapril cohorts. There was no difference in the number of reported adverse events (23% vs. 28%, p = 0.45), temporary stops (31% vs. 34%, p = 0.67), or permanent stops (47% vs. 37%, p = 0.14) between placebo and enalapril groups. Conclusions: In this group of infants with a SV, enalapril use was not associated with significant adverse events. Enalapril use appears to be low risk in infants and children with significant heart disease.
Congenital Heart Disease SAFETY OF ENALAPRIL IN INFANTS: DATA FROM THE PEDIATRIC HEART NETWORK INFANT WITH SINGLE VENTRICLE TRIAL Moderated Poster Contributions Congenital Heart Disease and Pulmonary Hypertension Moderated Poster Theater, Poster Hall, Hall C Saturday, March 18, 2017, 12:45 p.m.-12:55 p.m. Session Title: Therapeutic Advances in Congenital Heart Disease Abstract Category: 10. Congenital Heart Disease: Pediatric Presentation Number: 1220M-05 Authors: Kanika Mathur, Jacqueline Lamour, Daphne Hsu, Scott I. Aydin, Children’s Hospital at Montefiore, Bronx, NY, USA
Background: Angiotension converting enzyme (ACE) inhibitor therapy has been shown to improve ventricular function and clinical outcomes in adult patients with heart failure. Despite the lack of safety and efficacy data, empiric use of ACE inhibitor therapy is common in infants and children with cardiomyopathy and congenital heart disease. The Pediatric Heart Network Infant with Single Ventricle (ISV) trial provides the opportunity to describe the safety and adverse effects of enalapril in a large group of infants with complex congenital heart disease. Methods: Neonates with a single ventricle (SV) were prospectively enrolled in a randomized trial of enalapril vs. placebo. Patients were followed to 14 months of age and data including demographics, survival, drug administration and safety were collected. Descriptive statistics and univariate analyses were performed using student t-test, chi-square, Mann-Whitney-U, and Fisher’s exact tests.
Results: The ISV trial randomized 230 patients, 185 of whom completed the study. Median age at drug initiation was 19 days [7, 46]. Initial enalapril dose was 0.025 - 0.05 mg/kg/dose and mean dose was 0.31 ± 0.13 mg/kg/day. There was no significant difference in mean percent change in blood pressure (BP) from baseline to lowest BP at initiation of drug (-11 ± 11 vs. -12 ± 11, p = 0.51) between placebo and enalapril. There was no difference in percent change in BP during re-initiation of study drug after the Glenn or any temporary stop (-9 ± 12 vs. -10 ± 11, p = 0.55). There was no difference in percent change of BP during all dose adjustments (-11 ± 7 vs. -12 ± 8, p = 0.39). The number of patients who suffered hyperkalemia (49% vs. 57%, p = 0.24), renal dysfunction (0% vs. 3%, p = 0.12), or neutropenia (33% vs. 28%, p = 0.39) was no different between the placebo and enalapril cohorts. There was no difference in the number of reported adverse events (23% vs. 28%, p = 0.45), temporary stops (31% vs. 34%, p = 0.67), or permanent stops (47% vs. 37%, p = 0.14) between placebo and enalapril groups. Conclusions: In this group of infants with a SV, enalapril use was not associated with significant adverse events. Enalapril use appears to be low risk in infants and children with significant heart disease.