Enalapril (1) – Aqumeldi®

• Clinical trials
  • To assess the additional benefit of enalapril compared with the appropriate comparator therapy for the treatment of heart failure in children from birth up to and including 17 years of age, the pharmaceutical manufacturer has submitted the single-arm studies WP08, WP09 and the extension study WP10.

a) Children and adolescents aged 1 year and over up to ≤ 17 years with heart failure

• Captopril or sacubitril/valsartan was designated as the appropriate comparator therapy.
• An additional benefit is not proven.
• The single-arm studies submitted are not suitable for a benefit assessment due to the lack of comparison with the appropriate comparator therapy.
• Overall assessment
  • In the overall assessment, the pharmaceutical manufacturer has therefore not provided any data that would allow a comparison of enalapril with the appropriate comparator therapy.
  • An additional benefit of enalapril compared with the appropriate comparator therapy is therefore not proven.

b) Children from birth to < 1 year of age with heart failure

• Captopril was identified as the appropriate comparator therapy.
• An additional benefit is not proven.
• The single-arm studies submitted are not suitable for a benefit assessment due to the lack of comparison with the appropriate comparator therapy.
• Overall assessment
  • In the overall review, the pharmaceutical manufacturer therefore does not provide any data that would allow a comparison of enalapril with the appropriate comparator therapy.
  • An additional benefit of enalapril compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.