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1 1.12 医薬品部会

2 1.12 Page CTD PK PK ( GDFR) Comparison of hgh Pharmacokinetics Following Intravenous and Subcutaneous Administration of Humatrope in Japanese and Caucasian Healthy Subjects (Germany) ( K01A) LY [ ()] ( E003/4) Investigation of the Safety and Efficacy of Growth Hormone Replacement Therapy in Adults with Growth Hormone Deficiency Arising in Adult Life (France), (Netherland) ( E005/6) (France), Investigation of the Safety and Efficacy of Growth Hormone Replacement Therapy in Adults with Previously Treated Childhood Growth Hormone (Germany) Deficiency ( GDED) Investigation of the Safety and Efficacy of Human Growth Hormone Replacement Therapy in Adults in Relation to Diagnostic Criteria and Different Dosage Algorithms ( GDED) Investigation of the Safety and Efficacy of Human Growth Hormone Replacement Therapy in Adults in Relation to Diagnostic Criteria and Different Dosage Algorithms ( T002) Comparison of an Incremental Weight-Based Dose Regimen with an Individualized Dosage Adjusted According to the IGF-I Response in Adults with Growth Hormone Deficiency ( T002) Comparison of an Incremental Weight-Based Dose Regimen with an Individualized Dosage Adjusted According to the IGF-I Response in Adults with Growth Hormone Deficiency (Austria) (Austria) (France) (France)

3 1.12 Page ( K02A) LY [ ()] ( K01A K02A) LY [] Common Technical Document ( K01A K02A) LY [] Common Technical Document ( GDDY) The Effect of Growth Hormone Replacement Therapy in Childhood Onset (United States) Growth Hormone Deficient Patients Previously Treated to Final Height (Hypopituitary Developmental Outcome Study) ( GDDR) Investigation of the Safety and Efficacy of Human Growth Hormone Replacement Therapy in Adults in Relation to the Diagnostic Criteria of Growth Hormone Deficiency Syndrome ( GDDD) Growth Hormone Replacement Therapy Improves Body Composition and Increases Bone olism in Elderly Patients with Pituitary Disease (Germany) Karolinska Hospital ;85: GDET) Effect of Growth Hormone (GH) on Glycerol and Free Fatty Acid olism during Exhaustive Exercise in GH-Deficient Adults St. Thomas Hospital 2003;88: ( GDCH) Humatrope in Non-Growth Hormone Deficient Children with Short Stature ( E001) The Efficacy and Safety of Biosynthetic Authentic Human Growth Hormone in Short Prepubertal Children with Normal Growth Hormone Response to Standard Provocation Tests l

4 1.12 Page ( GDCG) Humatrope in Children with Defind Growth Hormone Status ( GDCP) Humatrope in Short Stature Children in Vitro Lipolysis (Annual Report 2001data lock) ( GDDQ) The Hypopituitary Control and Complication Study(HypoCCS) () ( GDDQ) The Hypopituitary Control and Complication Study(HypoCCS) () PSUR () PSR () ( K01A K02A) LY [ ()] ( K01A) LY [ ()]

5 1.12 Page K02A LY Coronary risk in growth hormone deficient hypopituitary adults: increased Abdu TAM et al predicted risk is due largely to lipid profile abnormalities 2001;55: Evaluation of the optimum dose of growth hormone (GH) for restoring bone mass in adult-onset GH deficiency: results from two 12-month randomized studies Abrahamsen B et al 2002;57: GH replacement in 1034 growth hormone deficient hypopituitary adults: demographic and clinical characteristics, dosing and safety Abs R et al 1999;50: The older man's heart and heart disease Aronow WS et al Med Clin North Am 1999;83: Patterns of IGF-I and IGFBP-3 levels in adult with GH deficiency (GHD) Attanasio AF et al during GH replacement: effects of dose, gender and onset Proceeding of ENDO The Endocrine Society 82nd Annual Canada, pp476, 2000Meeting, Toronto Adult growth hormone (GH)-deficient patients demonstrate heterogeneity between childhood onset and adult onset before and during human GH Attanasio AF et al treatment 1997;82: Treatment of adults with growth hormone (GH) deficiency with recombinant human GH Bengtsson BA et al: 76: 1993;76: The effect of growth hormone replacement therapy on bone metabolism in adult-onset growth hormone deficiency: a 2-year open randomized Bex M et al controlled multicenter trial J Bone Miner Res 2002;17: Body composition in growth hormone-deficient adults Binnerts A et al Am J Clin Nutr 1992;55: Quality of life of adults with growth hormone deficiency; A controlled study Björk S et al Acta Paediatr Scand(Suppl) 1989;356:55-9 4

6 1.12 Page Decreased quality of life in adult patients with growth hormone deficiency compared with general populations using the new, validated, Blum WF et al self-weighted questionnaire, questions on life satisfaction hypopituitarism module 2003;88: Abnormal vascular reactivity in growth hormone deficiency Capaldo B et al Circulation 2001;103: Increased arterial intima-media thickness in childhood-onset growth hormone deficiency Capaldo B et al 1997;82: Plasma insulin-like growth factor-i and prostate cancer risk: a prospective Chan JM et al study Science 1998;279: Defects of insulin action and skeletal muscle glucose metabolism in growth hormone-deficient adults persist after 24 months of recombinant human growth hormone therapy Christopher M et al 1998;83: Does the GH-IGF axis play a role in cancer pathogenesis? Cohen P et al Growth Horm & IGF Res 2000;10: The cardiovascular risk of adult GH deficiency (GHD) improved after GH replacement and worsened in untreated GHD: A 12-month prospective Colao A et al study 2002;87: The cardiovascular risk of GH-deficient adolescents Colao A et al 2002;87: Special editorial: Growth hormone treatment and neoplasia-coincidence or consequence? Committee of the Lawson Wilkins Pediatric Endocrine Society J Clin Endocrin 2002;87: Consensus guidelines for the diagnosis and treatment of adults with growth hormone deficiency: Summary statement of the Growth Hormone Research Society workshop on Adult Growth Hormone Deficiency 1998;83: Route of estrogen administration helps to determine growth hormone (GH) replacement dose in GH-deficient adults Cook DM et al 1999;84: Critical evaluation of the safety of recombinant human growth hormone administration: statement from the Growth Hormone Research Society 2001;86: The growth hormone deficiency syndrome in adults Cuneo RC et al 1992;37:

7 1.12 Page Body composition in adult growth hormone-deficient men, assessed by arthropometry and bioimpedance analysis De Boer H et al 1992;75: Clinical aspects of growth hormone deficiency in adults De Boer H et al: Endocrine Rev 1995;16: Serum lipid levels in growth hormone deficient men De Boer H et al olism 1994;43: Is vascular mortality increased in hypopituitarism? Erfurth EMT et al Pituitary 2000;3: Growth hormone replacement therapy improves body composition and increases bone metabolism in elderly patients with pituitary disease Fernholm R et al 2000;85: Sustained reduction in circulating cholesterol in adult hypopituitary patients given low dose titrated growth hormone replacement therapy: A two year study Florakis D et al 2000;53: Hypothalamo-pituitary surveillance imaging in hypopituitary patients receiving long-term GH replacement therapy Frajese G et al J Clin Endocrin 2001;86: Prospective study of 5 years of GH replacement therapy in GH-deficient adults : Sustained effects on body composition, bone mass, and metabolic Gotherstrom G et al indices 2001;86: Effects of growth hormone and insulin-like growth factor-i singly and in combination on in vivo capacity of urea synthesis, gene expression of urea Grøfte T et al cycle enzymes, and organ nitrogen contents in rats Hepatology 1997;25: Circulating concentrations of insulin-like growth factor-i and risk of breast cancer Hankinson SE et al. Lancet 1998;351: Deaths, cancers and intracranial tumor recurrences reported during prospective multicenter surveillance of 2301 GH-deficient (GHD) adults: Hartman ML et al effect of GH replacement therapy Prospective multicenter safety surveillance of GH replacement in 2033 GH-deficient (GHD) adults Hartman ML et al Proceeding of ENDO The Endocrine Society 85th Annual Meeting, Philadelphia USA, pp453, 2003 Proceeding of ENDO 2001-The Endocrine Society 83 rd Annual Meeting, Colorado USA, pp ,

8 1.12 Page Healthcare consumption decreases in parallel with improvements in quality of life during GH replacement in hypopituitariy adults with GH deficiency Hernberg-Stahl E et al 2001;86: GH is needed for the maturation of muscle mass and strength in adolescents Hulthén L et al 2001;86: Growth hormone (GH) replacement reduces total body fat and normalizes insulin sensitivity in GH-deficient adults: a report of one-year clinical Hwu CM et al experience 1997;82: Detection of cardiovascular risk factors by indices of obesity obtained from anthropometry and dual-energy X-ray absorptiometry in Japanese individuals Ito H et al Int J Obes 2003;27: Relation between body composition and age in healthy Japanese subjects Ito H et al Eur J Clin Nutr 2001;55: Two years of growth hormone(gh) treatment increases bone mineral content and density in hypopituitary patients with adult-onset GH deficiency Johannsson G et al 1996;81: Effects of growth hormone therapy on thyroid function of growth hormone-deficient adults with and without concomitant thyroxine-substituted central hypothyroidism Jørgensen JOL et al. J Clin Endcrinol 1989;69: Beneficial effects of growth hormone treatment in GH-deficient adults Jørgensen JOL et al Lancet: 1989;333: Three year of growth hormone treatment in growth hormone-deficient Jørgensen JOL et al Eur adults: near normalization of body composition and physical performance J Endocrinol 1994;130: Low serum insulin-like growth factor I is associated with increased risk of ischemic heart disease Juul A et al Circulation 2002;106: Epidemiology of heart failure Kannel WB et al Am Heart J 1991;121: Bone mineral status in growth hormone-deficient males with isolated and Kaufman JM et al multiple pituitary deficiencies of childhood onset 1992;74: Growth hormone, insulin-like growth factor-1 and the aging cardiovascular system Khan AS et al Cardiovascular Res 2002;54:

9 1.12 Page Unfavourable impact of growth hormone (GH) discontinuation on body composition and cholesterol profiles after the completion of height growth Kohno H et al in GH-deficient young adults Diabetes Obes. 1999; 1: Growth hormone (GH) therapy in GH-deficient adults influences the response to a dietary load of cholesterol and saturated fat in terms of cholesterol synthesis, but nor serum low density lipoprotein cholesterol levels Leonsson M et al 1999;84: The insulin-like growth factor-i generation test: peripheral responsiveness Lissett CA et al to growth hormone is not decreased with ageing 2003;58: Prospective study of colorectal cancer risk in men and plasma levels of insulin-like growth factor (IGF)-I and IGF-binding protein-3 Ma J et al J Natl Cancer Inst 1999;91: Alterations in the pulsatile properties of circulating growth hormone concentrations during puberty in boys Martha Jr PM et al 1989;69: Visceral fat accumulation and cardiovascular disease Matsuzawa Y et al Obes Res 1995;3: Quality of life assessment before and after growth hormone treatment in adults with growth hormone deficiency McGauley GA et al Acta Paediatr Scand(Suppl) 1989;356: Psychological effects of withdrawal of growth hormone therapy from adults with growth hormone deficiency McMillan CV Clin Endocirnol 2003;59: Long-term experience with GH replacement therapy: Efficacy and safety Monson JP et al Eur J Endocrinol 2003;148: A study of carotid intima-media thickness in GH-deficient Japanese adults Murata M et al during onset among adults and children Eur J Endocrinol 2003;148: Low-dose GH replacement improves the adverse lipid profile associated with the adult GH deficiency syndrome Murray RD et al 2002;56: Effects of growth hormone (hgh) replacement therapy on physical work capacity and cardiac and pulmonary function in patients with hgh deficiency acquired in adulthood Nass R et al 1995;80: Mortality and cancer incidence in acromegaly: a retrospective cohort study Orme SM et al 1998;83:

10 1.12 Page Plasma insulin-like growth factor-i (IGF-1) concentrations in human breast cancer Peyrat JP et al Eur J Cancer 1993; 29A: Growth hormone (GH) treatment reverses early atherosclerotic changes in Pfeifer M et al GH-deficient adults 1999;84: Dual-energy X-ray absorptiometry body composition model: review of physical concepts Pietrobelli A et al Am J Physiol Endocrinol 1996;271:E Recombinant human GH replacement therapy and thyroid function in a large group of adult GH-deficient patients: when does L-T4 therapy become mandatory? Porretti S et al 2002;87: Spontaneous growth hormone secretion increases during puberty in normal girls and boys Rose SR et al 1991;73: Premature mortality due to cardiovascular disease in hypopituitarism Rosen T et al Lancet 1990;336: Decreased psychological well-being in adult patients with growth hormone deficiency Rosén T et al 1994;40: The effects of treatment with recombinant human growth hormone on body composition and metabolism in adults with growth hormone deficiency Salomon F et al N Engl J Med 1989;321: Effect of growth hormone (GH) treatment on bone in postpubertal GH-deficient patients: A 2-year randomized, controlled, dose-ranging study Shalet SM et al 2003;88: IGFs and human cancer: implications regarding the risk of growth hormone therapy Shim M et al Horm Res 1999;51(Suppl3): Growth hormone replacement therapy for adults: Into the new millennium Simpson H et al GH and IGF Res 2002;12: Effects of GH replacement on endothelial function and large-artery stiffness in GH-deficient adults: a randomized, double-blind, placebo-controlled study Smith JC et al 2002;56: Gender difference in insulin-like growth factor I response to growth hormone (GH) treatment in GH-deficient adults: Role of sex hormone replacement Span JPT et al 2000;85:

11 1.12 Page Effects of seven years of GH-replacement therapy on insulin sensitivity in Svensson J et al GH-deficient adults 2002;87: Growth hormone treatment of children with brain tumors and risk of tumor recurrence Swerdlow AJ et al 2000;85: Growth hormone induces cellular insulin resistance by uncoupling phosphatidylinositol 3-kinase and its downstream signals in 3T3-L1 adipocytes Takano A et al Diabetes 2001;50: Long-term effects of growth hormone (GH) replacement in men with childhood-onset GH deficiency Ter Maaten JC et al 1999;84: Growth hormone replacement therapy in the elderly with hypothalamic-pituitary disease: A dose-finding study Toogood AA et al 1999;84: Effects of growth hormone replacement therapy on levels of cortisol and cortisol-binding globulin in hypopituitary adults Tschöp M et al Eur J Endocrinol 2000;143: Adult-onset growth hormone deficiency : relation of postprandial dyslipidemia to premature atherosclerosis Twickler TB et al 2003;88: Growth hormone (GH) dose-response in young adults with childhood-onset GH deficieny: A two-year, multicenter, multiple-dose, placebo-controlled study Underwood LE, et al 2003;88: A polymorphism in the gene for IGF-I: functional properties and risk for type 2 diabetes and myocardial infarction Vaessen N et al Diabetes 2001;50: Continuation of growth hormone (GH) replacement in GH-deficient patients during transition from childhood to adulthood: A two-year placebo-controlled study Vahl N at al 2000;85: Neoplasms reported during growth hormone replacement in KIMS Wilton P et al Proceeding of ENDO The Endocrine Society 85 th Annual Meeting, pp87, Philadelphia USA, pp87, Growth hormone (GH) replacement therapy in GH-deficient women during pregnancy Wiren L et al 2002;57: Oral estrogen antagonizes the metabolic actions of growth hormone in growth hormone-deficient women Wolthers T et al Am J Physiol Endocrinol 2001;281:E1191- E6 10

12 1.12 Page The influence of age on the 24-hour integrated concentration of growth hormone in normal individuals Zadik Z et al 1985;60: GH 6 ; p ; 25: IRMA IGF-I, IGF-II, IGFBP ;44: ; 2003, p ; 2002, p ; 22: ; 2002, p

13 1.12 Page LY LY LY

C/NC : committed/noncommitted

C/NC : committed/noncommitted 110 time post-icd implant 1) The Cardiac Arrhythmia Suppression Trial (CAST) Investigators Preliminary report : Effect of encainaide and flecainide on mortality in a