Assessment of quality of life on 4-year growth hormone therapy in Japanese patients with adult growth hormone deficiency: A post-marketing, multicenter, observational study

Objective: Improvement of quality of life (QOL) by growth hormone (GH) therapy was not demonstrated in Japanese adult growth hormone deficiency (AGHD) patients by either the QOL Assessment of Growth Hormone Deficiency in Adults or the Questions on Life Satisfaction-Hypopituitarism, which are widely used to evaluate QOL in Western AGHD patients. We therefore evaluated QOL in Japanese AGHD patients receiving recombinant GH, Norditropin (Novo Nordisk A/S, Denmark), using the newly developed Adult Hypopituitarism Questionnaire (AHQ). Design: This multicenter, non-interventional, observational study in Japanese patients with severe AGHD was conducted from 1 October 2009 to 30 September 2014. Patients with severe AGHD already receiving somatropin and somatropin-naive patients were included. GH therapy (Norditropin (R)) was initiated as injections of 0.021 mg/kg/week divided into 6-7 doses/week, and was adjusted according to clinical responses. Demographic/clinical data were obtained from medical records or by patient recall. QOL was assessed using the AHQ at baseline; 3, 6, and 12 months; and annually up to 4 years. Results: Of 387 registered patients, 161 were eligible for QOL analysis. AHQ scores significantly improved after 3 months of treatment. Improvements in the psycho-social and physical domains were statistically significant throughout the 4-year study period. Although the GH dose was increased in females such that insulin-like growth factor-1 levels reached those of males, QOL improvements in females did not reach those of males. Despite the greater GH dose in child-onset patients, limited QOL improvements were observed in child-onset vs adult-onset cases. Conclusions: Four-year GH treatment in Japanese AGHD patients elicits sustained improvement in QOL as assessed by AHQ scores.