April - June 2020, Volume 16, Issue 2

Dumitrescu CP, Procopiuc C, Dumitriu N, Micle I, Anton M, Moisuc A

COMPLIA: a 12-Month Prospective, Multicentre, Non-Interventional Study to Evaluate Treatment Adherence and Treatment Satisfaction in a Growth Hormone Deficient Paediatric Population Treated with NutropinAq® a Somatropin Analogue

Acta Endo (Buc) 2020, 16 (2): 192-198
doi: 10.4183/aeb.2020.192

Background/Aims. Growth hormone deficiency (GHD) in children and adolescents is managed with growth hormone (GH) therapy and aims to achieve optimal height development. However, treatment adherence can be poor, reducing the likelihood of a successful outcome. Adherence varies between geographic regions. This observational study assessed satisfaction and adherence to NutropinAq (somatropin, recombinant human GH) treatment in Romanian children with GHD. Methods. Patients ≥3 years of age with GHD for which GH replacement therapy with NutropinAq had been initiated were recruited from 13 centres in Romania (protocol number: A-38-58035-016). The primary variable was patient/caregiver-reported treatment adherence (assessed at 3, 6 and 12 months on a 5-item Likert scale), secondary variables included treatment satisfaction assessed by the treating physician and patient/caregiver on a 5-point scale. Results. Most patients did not miss any treatment injections in any 3-month period between assessments (≥79.8% of patients were 100% compliant). The incidence of missed injections was higher among patients <7 years of age than older children, but no differences between genders was observed. At study end, 94.3% of patients/caregivers and 94.3% of physicians reported complete satisfaction with treatment. Conclusions. Overall treatment adherence to NutropinAq was high in the Romanian GHD paediatric population, and a high level of treatment satisfaction was reported by patients/caregivers. This suggests reliable treatment outcomes can be anticipated in this population.

Keywords: Somatropin analogue, growth hormone, NutropinAq®, growth hormone deficiency (GDH), paediatric.

Correspondence: Armand Moisuc MD, Ipsen Pharma Romania SRL - Medical, Sapientei 17, bl 103A, ap 9, Bucharest, 050132, Romania, E-mail: armand.moisuc@gmail.com