Sacubitril/Valsartan Shows No Superiority Over Enalapril in Pediatric HF, Study Finds
Researchers have established that sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), is not superior to enalapril in the treatment of heart failure (HF) in children who have systemic left ventricular systolic dysfunction (LVSD). A recent trial known as the PANORAMA-HF trial, was published in the journal Circulation conducted by Shaddy R. and colleagues.
The objective of the PANORAMA-HF trial was to determine whether sacubitril/valsartan was better than enalapril in treating pediatric patients who suffered from HF due to LVSD. In this randomized trial, 375 children aged between 1 month and 18 years were assigned to sacubitril/valsartan or enalapril groups.
The main outcome measure was a global rank score, ranking the patients from worst to best on clinical endpoints that included death, urgent heart transplant listing, need for mechanical life support, worsening HF, NYHA/Ross class, Patient Global Impression of Severity (PGIS), and the Pediatric Quality of Life Inventory (PedsQL) physical functioning domain. Exploratory analyses included changes in NT-proBNP levels, a biomarker for heart failure.
375 children (mean age: 8.1±5.6 years, 52% female) were randomized to receive either sacubitril/valsartan (n=187) or enalapril (n=188) in the trial.
No statistically significant difference was established between the groups in the 52-week endpoint defined as the global rank, with a probability value of 0.52 (95% CI: 0.47-0.58) and odds at the Mann-Whitney test of 0.91 (95% CI: 0.72-1.14), evidencing no statistical superiority of sacubitril/valsartan over enalapril.
Both treatment groups showed marked reductions in NYHA/Ross classification, PGIS, Patient Global Impression of Change, and NT-proBNP levels at 52 weeks with no between-group differences.
Safety of both agents seems to be equivalent with adverse event rates reached by 88.8% in the sacubitril/valsartan and 87.8% in the enalapril; hence, sacubitril/valsartan seems very well tolerated in children.
The researchers concluded that both drugs are associated with clinically significant improvements over a period of 52 weeks, with similarities between their safety profiles; thus, safer alternatives for pediatric patients exist. Further research is needed to confirm potential benefits in specific pediatric populations with HF or with other drugs in addition to sacubitril/valsartan.
Reference:
Shaddy, R., Burch, M., Kantor, P. F., Solar-Yohay, S., Garito, T., Zhang, S., Kocun, M., Mao, C., Cilliers, A., Wang, X., Canter, C., Rossano, J., Wallis, G., Menteer, J., Daou, L., Kusa, J., Tokel, K., Dilber, D., Xu, Z., … Bonnet, D. (2024). Sacubitril/valsartan in pediatric heart failure (PANORAMA-HF): A randomized, multicenter, double-blind trial. Circulation. https://doi.org/10.1161/circulationaha.123.066605
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