Which patients with acromegaly are treated with pegvisomant? An overview of methodology and baseline data in ACROSTUDY

Eur J Endocrinol. 2009 Nov:161 Suppl 1:S11-7. doi: 10.1530/EJE-09-0333. Epub 2009 Aug 14.

Abstract

Context Pegvisomant (Somavert, Pfizer Inc.) is the first and only available GH receptor antagonist. ACROSTUDY is an international surveillance study that offers inclusion in a web-based registry to all patients with acromegaly treated with pegvisomant; it aims at monitoring long-term safety and efficacy of this compound. Patients and methods This report summarizes the main baseline characteristics of this particular population of patients. In February 2009, over 300 centres in 10 countries had contributed 792 patients. A gradual increase in cumulative patient recruitment was observed since the launching of ACROSTUDY in 2004: from 116 patients in 2005, it steeply increased to 792 at the latest data freeze in February 2009. At the time of enrolment, 91.8% of patients were already treated with pegvisomant but baseline was considered at the time of pegvisomant start. IGF1 concentrations were measured at local laboratories. Results Of all patients, 80% were reported to have had surgery and 33% to have received radiation therapy. Of the 792 patients, 14% had received no prior medical treatment before pegvisomant start, 65.9% had received somatostatin analogues and 18.6% dopamine agonists. Interestingly, 66.7% had received only pegvisomant at study start, while it was taken in association with dopamine agonists in 5.7%, with somatostatin analogues in 23.4% and with both types of agents in 3.8%. Mean IGF1 at baseline was 522 ng/ml. Conclusion Analysis of the baseline features of these patients treated with pegvisomant and reported in the ACROSTUDY database underscores the severity of the disease in this subset of the population of patients with acromegaly previously unresponsive to several medical, surgical or radiation treatment approaches.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acromegaly / blood
  • Acromegaly / drug therapy*
  • Acromegaly / etiology
  • Acromegaly / metabolism
  • Adolescent
  • Adult
  • Alanine Transaminase / blood
  • Aspartate Aminotransferases / blood
  • Biomarkers / blood
  • Blood Glucose / metabolism
  • Europe
  • Female
  • Glycated Hemoglobin / metabolism
  • Growth Hormone-Secreting Pituitary Adenoma / complications
  • Growth Hormone-Secreting Pituitary Adenoma / metabolism
  • Hormone Antagonists / administration & dosage
  • Hormone Antagonists / adverse effects
  • Hormone Antagonists / therapeutic use*
  • Human Growth Hormone / administration & dosage
  • Human Growth Hormone / adverse effects
  • Human Growth Hormone / analogs & derivatives*
  • Human Growth Hormone / therapeutic use
  • Humans
  • Insulin-Like Growth Factor I / metabolism
  • International Cooperation
  • Internet
  • Liver Function Tests
  • Male
  • Middle Aged
  • Pituitary Neoplasms / complications
  • Pituitary Neoplasms / metabolism
  • Receptors, Somatotropin / antagonists & inhibitors*
  • Registries
  • Severity of Illness Index
  • United States
  • Young Adult

Substances

  • Biomarkers
  • Blood Glucose
  • Glycated Hemoglobin A
  • Hormone Antagonists
  • Receptors, Somatotropin
  • Human Growth Hormone
  • Insulin-Like Growth Factor I
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • pegvisomant