title: Treatment with high doses of pegvisomant in 56 patients with acromegaly: experience from ACROSTUDY.
abstract: OBJECTIVE
  To investigate the characteristics of patients who need more or less pegvisomant (PEGV) to normalize serum IGF-I.
  
  
  METHODS
  ACROSTUDY is a global noninterventional safety surveillance study of long-term treatment outcomes in patients treated with PEGV. As of June, 2014, ACROSTUDY included data on 2016 patients. All patients treated for at least 6weeks at a dose above 30mg/day and who had two consecutive normal serum IGF-I values were included in the 'high'-dose group (H; n=56; mean daily dose 44±12.5; median dose 40, 35-60 (10-90%)). Patients with two consecutive normal IGF-I values and who never received a PEGV dose above 10mg/day were included in the 'low'-dose group (L; n=368; mean daily dose 7.5±2.5; median dose 8.6, 4.3-10 (10-90%)).
  
  
  RESULTS
  Patients in the H group were significantly younger (median 47 vs 52years) and had a significantly higher BMI (median 31.8 vs 26.5kg/m(2)). They had more diabetes (55% vs 21%), sleep apnea (25% vs 14 %) and more hypertension (61% vs 43%). The incidence of (serious) adverse events was low and was not different between the groups.
  
  
  CONCLUSIONS
  Patients who need more PEGV to normalize IGF-I have more aggressive disease, as they are younger, have higher baseline IGF-I levels, more hypertension, more sleep apnea and diabetes and are more overweight. A better understanding of this dose-efficacy relationship of PEGV might avoid inappropriate dosing and prevent serum IGF-I levels from remaining unnecessarily uncontrolled.
authors.affiliation: Department of MedicineErasmus University MC, Rotterdam, The Netherlands a.vanderlelij@erasmusmc.nl.
authors.forename: Aart Jan
authors.initials: AJ
authors.lastname: van der Lely
authors.affiliation: Pfizer Endocrine CarePfizer Health AB, Sollentuna, Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Jönsson
authors.affiliation: Pfizer Endocrine CareStockholm, Sweden.
authors.forename: Patrick
authors.initials: P
authors.lastname: Wilton
authors.affiliation: Pfizer Endocrine CarePfizer Health AB, Sollentuna, Sweden.
authors.forename: Ann-Charlotte
authors.initials: AC
authors.lastname: Åkerblad
authors.affiliation: Endocrine CarePfizer Inc., New York, New York, USA.
authors.forename: José
authors.initials: J
authors.lastname: Cara
authors.affiliation: University of TurinTurin, Italy.
authors.forename: Ezio
authors.initials: E
authors.lastname: Ghigo
mesh_terms: D000172:Acromegaly / Q000097:blood / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D005260:Female; D019382:Human Growth Hormone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I; C406545:pegvisomant