title: Growth hormone (GH) replacement therapy in adult-onset gh deficiency: effects on body composition in men and women in a double-blind, randomized, placebo-controlled trial.
abstract: Adult GH deficiency (AGHD) is characterized by an altered body composition, an atherogenic lipid profile, decreased exercise capacity, and diminished quality of life. We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes. GH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months. Primary measures of efficacy included body composition, strength and endurance, and quality of life. Additional parameters included serum IGF-I concentrations, serum lipids, and bone mineral density. After 12 months, 79% of subjects remained on GH 0.0125 mg/kg.d, whereas 21% received 0.00625 mg/kg.d. GH-treated men and women demonstrated significant decreases in total body and trunk fat and increases in lean body mass over baseline. In GH-treated men, mean IGF-I SD scores exceeded age-adjusted normal ranges, whereas similar doses produced a smaller response in women. GH treatment was associated with significant improvements in total cholesterol and low-density lipoprotein (P < 0.05 for all). No significant treatment effects were observed in strength and endurance, quality of life, or bone mineral density. GH treatment was generally well tolerated. Subjects with AGHD should receive individualized GH therapy to maintain IGF-I between the mean value and +2 SD and improve body composition and cardiovascular risk factors.
authors.affiliation: Veterans Affairs Palo Alto Health Care System and Stanford University, Palo Alto, California 94304, USA. arhoffman@stanford.edu
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Hoffman
authors.forename: Joyce E
authors.initials: JE
authors.lastname: Kuntze
authors.forename: Joyce
authors.initials: J
authors.lastname: Baptista
authors.forename: Howard B A
authors.initials: HB
authors.lastname: Baum
authors.forename: Gerhard P
authors.initials: GP
authors.lastname: Baumann
authors.forename: Beverly M K
authors.initials: BM
authors.lastname: Biller
authors.forename: Richard V
authors.initials: RV
authors.lastname: Clark
authors.forename: David
authors.initials: D
authors.lastname: Cook
authors.forename: Silvio E
authors.initials: SE
authors.lastname: Inzucchi
authors.forename: David
authors.initials: D
authors.lastname: Kleinberg
authors.forename: Anne
authors.initials: A
authors.lastname: Klibanski
authors.forename: Lawrence S
authors.initials: LS
authors.lastname: Phillips
authors.forename: E Chester
authors.initials: EC
authors.lastname: Ridgway
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Robbins
authors.forename: Janet
authors.initials: J
authors.lastname: Schlechte
authors.forename: Meeta
authors.initials: M
authors.lastname: Sharma
authors.forename: Michael O
authors.initials: MO
authors.lastname: Thorner
authors.forename: Mary Lee
authors.initials: ML
authors.lastname: Vance
mesh_terms: D000328:Adult; D000368:Aged; D000886:Anthropometry; D001823:Body Composition / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000172:deficiency* / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008055:Lipids / Q000097:blood; D008297:Male; D008661:Metabolism, Inborn Errors / Q000188:drug therapy / Q000473:pathology / Q000503:physiopathology; D008875:Middle Aged; D018482:Muscle, Skeletal / Q000503:physiopathology; D010807:Physical Endurance; D010919:Placebos; D011788:Quality of Life; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D008055:Lipids; D010919:Placebos; D011994:Recombinant Proteins; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I