title: Safety of long-term treatment with Pegvisomant: analysis of Spanish patients included in global ACROSTUDY.
abstract: OBJECTIVE
  To evaluate the long-term safety of Pegvisomant (PEG) in the Spanish cohort of ACROSTUDY.
  
  
  METHODS
  As of July 2013, 199 Spanish patients were included in ACROSTUDY, a global non interventional safety PEG surveillance study. Patients were observed for safety, biochemical outcome and magnetic resonance imaging evaluations.
  
  
  RESULTS
  PEG was administered during an average period of 6.7 ± 2.1 years and a mean daily dose of 15.5 ± 7.5 mg. 48.2% of patients received PEG monotherapy. 90.9% of patients had received other medical treatment before PEG start. 195 adverse events (AEs) were reported in 88 patients (44.2%), and serious AEs were described in 31 patients (15.6%). There were no cases of liver tests >10 ULN, or permanent liver damage. Tumor size changes were locally reported in 61 cases (33.5%), with increases observed in 11 patients (6%). In acromegalic patients with diabetes mellitus a decrease in fasting serum glucose value was reported, reaching statistical significance after 1 and 4 years of treatment (-24.6 and -25.9 mg/dl, p = 0.04). After 60 months, normal or lower limit of normal (LLN) IGF-I levels were found in 67.9% of patients. 85.5% of patients showed an IGF-I normal or <LLN at any time after PEG start. Most patients with uncontrolled IGF-I levels were on submaximal PEG doses.
  
  
  CONCLUSIONS
  ACROSTUDY carried out with the Spanish cohort confirmed that PEG has a favorable safety and efficacy profile. The percentage of patients considered under control was similar to data reported globally and in other local ACROSTUDY results.
authors.affiliation: Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Bernabeu
authors.affiliation: Hospital General Universitario de Alicante, Alicante, Spain. antonio.pico@goumh.umh.es.
authors.forename: A
authors.initials: A
authors.lastname: Pico
authors.affiliation: Hospital Universitario Virgen del Rocío, Seville, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Venegas
authors.affiliation: Hospital Universitario Puerta de Hierro - Majadahonda, Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Aller
authors.affiliation: Hospital Universitario La Paz, Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Alvarez-Escolá
authors.affiliation: Hospital Regional Universitario de Málaga, Málaga, Spain.
authors.forename: J A
authors.initials: JA
authors.lastname: García-Arnés
authors.affiliation: Hospital Universitario de La Princesa, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Marazuela
authors.affiliation: Pfizer Endocrine Care, Sollentuna, Sweden.
authors.forename: P
authors.initials: P
authors.lastname: Jonsson
authors.affiliation: Pfizer Medical Department, Madrid, Spain.
authors.forename: N
authors.initials: N
authors.lastname: Mir
authors.affiliation: Pfizer Medical Department, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: García Vargas
mesh_terms: D000172:Acromegaly / Q000188:drug therapy*; D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006727:Hormone Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D019382:Human Growth Hormone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012042:Registries; D013030:Spain / Q000453:epidemiology; D013997:Time Factors
chemical_list: D006727:Hormone Antagonists; D019382:Human Growth Hormone; C406545:pegvisomant
keywords: ACROSTUDY; Acromegaly; IGF-I; Pegvisomant; Safety