title: The benefit of long-term growth hormone (GH) replacement therapy in hypopituitary adults with GH deficiency: results of the German KIMS database.
abstract: OBJECTIVE
  To evaluate the treatment effects of long-term growth hormone (GH) replacement therapy in adults with GH deficiency (GHD) who were followed in KIMS Germany (Pfizer International Metabolic Database), a national surveillance study.
  
  
  METHODS
  The analysis was performed using baseline and long-term data (range: 4-10 years) of 440 consecutively documented patients (216 women and 224 men) with GHD, aged 20 to 49 years, enrolled in KIMS Germany. Serum insulin-like growth factor I (IGF-I), fasting blood glucose, fasting serum total cholesterol and low-density lipoprotein cholesterol (LDL-C) as well as body mass index (BMI), waist circumference (WC) and hip circumference (HC) at baseline and at last visit were studied. Furthermore, QoL-AGHDA score was determined to assess quality-of-life (QoL).
  
  
  RESULTS
  The mean dose of GH over all years was 0.41 mg per day in women and 0.37 mg per day in men. IGF-I and IGF-I SDS levels (standard deviation score) increased significantly (p<0.001) during GH treatment. The QoL-AGHDA score decreased significantly (p<0.001), indicating long-lasting improvement in QoL. In total cholesterol, LDL-C and fasting blood glucose, no significant changes were found. Only six patients developed type 2 diabetes during follow-up. Females and males similarly increased significantly in BMI, WC and HC. During GH treatment, recurrences of pituitary or central nervous system tumours or further de novo neoplasia were reported in 6 or 11 patients, respectively. The number of the most frequently reported GH treatment-associated adverse events was low.
  
  
  CONCLUSIONS
  These observational data show long-term beneficial effects of GH replacement therapy on QoL and show no significant effects on total cholesterol, LDL-C or BMI, WC and HC. Additionally, our data indicate that GH replacement therapy in adults is well tolerated.
authors.affiliation: Institute of Clinical Chemistry and Laboratory Medicine, University of Greifswald, Germany. christin.spielhagen@uni-greifswald.de
authors.forename: Christin
authors.initials: C
authors.lastname: Spielhagen
authors.forename: Christian
authors.initials: C
authors.lastname: Schwahn
authors.forename: Kristin
authors.initials: K
authors.lastname: Möller
authors.forename: Nele
authors.initials: N
authors.lastname: Friedrich
authors.forename: Thomas
authors.initials: T
authors.lastname: Kohlmann
authors.forename: Jörn
authors.initials: J
authors.lastname: Moock
authors.forename: Maria
authors.initials: M
authors.lastname: Kołtowska-Häggström
authors.forename: Matthias
authors.initials: M
authors.lastname: Nauck
authors.forename: Michael
authors.initials: M
authors.lastname: Buchfelder
authors.forename: Henri
authors.initials: H
authors.lastname: Wallaschofski
mesh_terms: D000328:Adult; D001837:Body Weights and Measures; D016208:Databases, Factual / Q000706:statistics & numerical data; D004305:Dose-Response Relationship, Drug; D004393:Dwarfism, Pituitary / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D020249:Hormone Replacement Therapy / Q000009:adverse effects; D019382:Human Growth Hormone / Q000009:adverse effects / Q000097:blood / Q000172:deficiency / Q000627:therapeutic use*; D006801:Humans; D007018:Hypopituitarism / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D018570:Risk Assessment; D013997:Time Factors; D055815:Young Adult
chemical_list: D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I