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Lilly Research Laboratories (M.R., W.F.B., D.J.E., D.V., A.F.A.), Eli Lilly and Co., Indianapolis, Indiana 46285; Pharma Support, Inc. (E.P.S.), St. Petersburg 191119, Russia; Ziekenhuis Dijkzigt (S.W.J.L.), 3015 GD Rotterdam, The Netherlands; Department of Internal Medicine (E.M.E.), Division of Diabetology and Endocrinology, University Hospital, S-221 85 Lund, Sweden; Hospital Santa Creu i Sant Pau (S.M.W.), Autonomous University of Barcelona, 08025 Barcelona, Spain; Department of Medicine (R.J.R.), Northern General Hospital, Sheffield S5 7AU, United Kingdom; Department of Clinical Molecular Medicine (K.C.), Kobe University Graduate School of Medicine, Chuo-ku Kobe 650-0017, Japan; and Institut und Poliklinik für Psychosomatische Medizin (G.H., P.H.), Medizinische Psychologie und Psychotherapie, 81675 Munich, Germany
Address all correspondence and requests for reprints to: Myriam Rosilio, M.D., Lilly France, 13 rue Pagès, 92158 Suresnes Cedex, France. E-mail: rosilio_myriam{at}lilly.com.
Questions on Life Satisfaction-Hypopituitarism (QLS-H) is a new quality-of-life (QoL) questionnaire developed for adults with hypopituitarism. To determine the effects of long-term GH treatment on QoL, we evaluated QLS-H Z-scores in 576 adult patients with GH deficiency (GHD) enrolled in HypoCCS, an international observational study, using data from five countries in which comparative QLS-H data from the general population were available.
Baseline QLS-H Z-scores were significantly lower in GH-deficient patients than in the general population of the same age, gender, and nationality. Z-scores were also significantly lower in female patients vs. males (P = 0.006) and in adult-onset vs. childhood-onset GHD (P = 0.002). Multivariate analysis associated female gender, multiple pituitary hormone deficiencies, low serum IGF-I values (<75 µg/liter), and concomitant antidepressant medication with low baseline Z-scores.
QLS-H Z-scores increased from 1.02 ± 1.43 (SD) at baseline to 0.25 ± 1.34 (SD) after 1 yr of GH treatment (P < 0.001) and were no longer significantly different from the general population after 4 yr of treatment. There was no correlation between change in Z-score and GH dose or changes in IGF-I and IGF binding protein-3 during treatment. This study demonstrates that 1) improvements in QoL, as measured by the QLS-H, are maintained during long-term GH replacement therapy of adults with GHD, and 2) the QLS-H is a useful tool for evaluating QoL in hypopituitary patients treated in clinical practice. The authors suggest that evaluation of QoL should be a part of the routine clinical management of adult GH-deficient patients, complementing the measurement of surrogate biological markers or other clinical end points.
This work was supported by Eli Lilly & Co.
Abbreviations: ADM, Antidepressant medication; AO, adult onset; BMI, body mass index; CO, childhood onset; GHD, GH deficiency; HypoCCS, European Hypopituitary Control and Complications Study; IGFBP, IGF binding protein; OR, odds ratio; QLS-H, Questions on Life Satisfaction-Hypopituitarism; QoL, quality of life; QOL-AGHDA, Assessment of Growth Hormone Deficiency in Adults.
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