title: Pegvisomant treatment in patients with acromegaly in clinical practice: The French ACROSTUDY.
abstract: OBJECTIVE
  To monitor long-term pegvisomant treatment of patients with acromegaly in routine clinical practice.
  
  
  METHODS
  The French ACROSTUDY is part of the global ACROSTUDY, an observational post-authorization safety surveillance study of acromegaly treatment with pegvisomant.
  
  
  RESULTS
  The median duration of follow-up of the 292 included patients was 5.2 years. Overall 272 (93%) patients received somatostatin analogues before initiation of pegvisomant. The most prescribed initial dose of pegvisomant (after possible administration of a loading dose) was 10mg/day and, starting from the 2nd year, the median dose was 20mg/day. Serum IGF-1 concentration decreased as soon as pegvisomant was started and after 5 years there was a 62% mean decrease in serum IGF-1 concentration. The percentage of patients with serum IGF-1 concentration within normal ranges (for age and sex) of the local laboratory shifted from 11% at start of pegvisomant to 43% at 6 months and 63% after 5 years. The last available imaging (242 patients) showed an increased or decreased tumor size in 4 and 10% of patients, respectively. Mean weight increased by 3 kg over the 5-year period (P<10(-3)). Mean fasting blood glucose significantly decreased over time (P<0.05), while HbA1c level remained unchanged. Tolerance profile was generally good and similar to that described in clinical studies.
  
  
  CONCLUSIONS
  This analysis showed a significant decrease in IGF-1 levels throughout the follow-up period, and confirmed that pegvisomant treatment is safe in acromegaly. The results of this interim analysis remain to be confirmed by the final analysis.
authors.affiliation: Université Paris-Saclay, Université Paris-Sud, Unité Mixte de Recherche S1185, Faculté de Médecine Paris-Sud, 63, rue Gabriel-Péri, 94276 Le Kremlin-Bicêtre, France; Service d'endocrinologie et des maladies de la reproduction, Assistance Publique-Hôpitaux de Paris, hôpital de Bicêtre, 78, rue du Général-Leclerc, 94275 Le Kremlin-Bicêtre, France. Electronic address: philippe.chanson@bct.aphp.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Chanson
authors.affiliation: Unité Mixte de Recherche 7286, Aix-Marseille University, Centre de Recherche en Neurobiologie et Neurophysiologie de Marseille (CRN2M), Centre National de la Recherche Scientifique, Faculté de Médecine de Marseille, 13284 Marseille, France; Department of Endocrinology, Centre de Référence des Maladies Rares d'Origine Hypophysaire, Assistance Publique-Hôpitaux de Marseille (APHM), Hôpital de la Conception, 13005 Marseille, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Brue
authors.affiliation: Service d'endocrinologie, diabète et nutrition, Hôpital Robert-Debré, CHU de Reims, avenue du Général-Koenig, 51092 Reims Cedex, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Delemer
authors.affiliation: Service d'Endocrinologie, Maladies métaboliques et Nutrition, Pôle Cardio-Vasculaire et Métabolique, CHU Larrey, 24, chemin de Pouvourville, 31059 Toulouse cedex 09, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Caron
authors.affiliation: Hospices Civils de Lyon, Fédération d'Endocrinologie du pôle Est, Lyon, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Borson-Chazot
authors.affiliation: Pfizer France, Paris, France.
authors.forename: Hichem
authors.initials: H
authors.lastname: Zouater
mesh_terms: D000172:Acromegaly / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D005215:Fasting; D005260:Female; D005602:France; D019382:Human Growth Hormone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011986:Receptors, Somatotropin / Q000037:antagonists & inhibitors*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D011986:Receptors, Somatotropin; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I; C406545:pegvisomant
keywords: ACROSTUDY; Acromegaly; Acromégalie; Cohort Study; Observational Study; Pegvisomant; Étude de cohorte; Étude observationnelle