Background: CinnaTropin® (CinnaGen, Iran) is a recombinant human GH manufactured in Iran. Herein, we compared the efficacy and safety of the CinnaTropin® with the corresponding reference (Nordilet® Norditropin, Novo Nordisk, Denmark) in children with idiopathic GH deficiency (IGHD) and multiple pituitary hormone deficiency (MPHD).
Methods: This was a randomized, open-label and cross-over study. Eligible patients (aged 416 years) were randomized to receive CinnaTropin® or Nordilet® for three months. Each patient was then crossed over to the other arm to receive the other product for further three months. The Efficacy of the treatment was assessed in terms of height, height standard deviation score (HSDS), height velocity (HV), and HVSDS. The Safety was also studied through evaluating incidence of adverse events by physical examination, patient complaints, and laboratory parameters during the treatment period.
Results: Thirty patients participated and completed the study. The mean age of participants was 8.80±2.19 in the CinnaTropin® and 9.01±1.78 years in the Nordilet® group. The mean±S.D. of height velocity for three months of treatment was 6.57±2.42 and 7.50±2.16 (P=0.12), HSDS was 0.06±0.13 and 0.11±0.12 (P=0.13), HVSDS was 0.45±2.85 and 1.83±3.15 (P=0.09) for the CinnaTropin® and the Nordilet® groups, respectively for each item. The incidence of adverse events was similar between the studied groups.
Conclusions: Our obtained findings indicate that CinnaTropin® has comparable efficacy and safety profile in comparison with the corresponding reference product (Nordilet®) in both children and adolescents with IGHD and MPHD.
27 - 29 Sep 2018
European Society for Paediatric Endocrinology