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ACROSTUDY: the Italian experience.

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Pegvisomant (PEG) is a safe and effective treatment for acromegaly patients in Italy, showing good hormonal control and a favorable safety profile even as a third-line therapy.

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Area of Science:

  • Endocrinology
  • Pharmacology

Background:

  • Acromegaly is a chronic hormonal disorder characterized by excessive growth hormone production.
  • Pegvisomant (PEG) is a growth hormone receptor antagonist used in acromegaly treatment.

Purpose of the Study:

  • To monitor the safety and outcomes of pegvisomant in clinical practice within the Italian ACROSTUDY registry.
  • To assess the efficacy and safety profile of pegvisomant as a post-marketing surveillance study.

Main Methods:

  • A non-interventional, post-marketing surveillance study of 341 acromegaly patients in 25 Italian endocrine centers.
  • Data collection included IGF-I levels, liver enzymes, metabolic parameters, and pituitary MRI before and during pegvisomant treatment.
  • Adverse events and tumor volume changes were systematically recorded.

Main Results:

  • Pegvisomant demonstrated progressive hormonal efficacy, with 70.9% of patients achieving normal IGF-I levels after 6 years at a mean daily dose of 18.1 mg.
  • The drug exhibited a favorable safety profile, with 28.7% of patients reporting adverse events and 8.5% experiencing serious adverse events.
  • Tumor volume showed no significant change in 71.1% of patients, with a slight increase noted in only 7 out of 34 patients with central MRI review.

Conclusions:

  • Pegvisomant is an efficacious drug with a favorable safety profile for acromegaly patients in Italy.
  • Its effectiveness in achieving normal IGF-I levels supports its use, particularly as a third-line therapy option.