Background: Long-term safety data (1998 to mid-2016) are reported for adult patients with GHD treated with GH (Norditropin® (somatropin), Novo Nordisk) as prescribed by treating physicians in the real-life clinical setting and enrolled in NordiNet® International Outcome Study (IOS) (NCT00960128), a non-interventional, multicentre study.
Objective and hypotheses: To describe and report safety data and incidence rates (IRs) (events/1000 patient-years) of adverse drug reactions (ADRs), serious adverse events (SAEs) and serious ADRs (SADRs).
Method: Events were classified by MedDRA Preferred Term/System Organ Class (SOC). IRs during GH treatment were calculated.
Results: Data for 2438 patients (adult-onset, 90.1%; female 44.0%; mean (S.D.) age at treatment start, 43.3 (17.8) years; duration of follow-up, 5.8 (4.7) years; GH dose, 0.41 (0.32) mg/day) were analysed. Overall, 197 adverse events (AEs) were reported in 150 patients. Among these patients, mean (S.D.) treatment duration to first AE was 4.7 (4.1) years and GH dose at AE onset was 0.36 (0.31) mg/day. After the first AE, GH dose was unchanged in 55.3%, discontinued in 26.4% and decreased in 7.6% of patients (not reported/other for 10.7%). IRs were 11.91 for SAEs, 1.89 for SADRs and 5.52 for ADRs. Most frequently reported (n≥10) AEs by SOC (n, %) were nervous system disorders (n=43, 21.8%), neoplasms (benign, malignant and unspecified) (n=35, 17.8%), musculoskeletal and connective tissue disorders (n=20; 10.2%); general disorders and administration-site conditions or infections and infestations (each n=15, 7.6%); and cardiac disorders (n=14, 7.1%). Type 2 diabetes was reported as an AE in four patients. Twelve deaths (one possibly related) were reported.
Conclusions: IRs of SAEs, ADRs and SADRs were low. Data from NordiNet® IOS revealed no new safety signals, further supporting the favourable safety profile of GH replacement in adults with GHD.
20 - 23 May 2017
European Society of Endocrinology