title: ACROSTUDY: the Italian experience.
abstract: ACROSTUDY is a world-wide non-interventional, post marketing surveillance study performed to monitor the safety and outcomes of pegvisomant (PEG) in clinical practice. We report data from acromegaly patients who have been included in the Italian ACROSTUDY registry. The data of 341 acromegaly patients (171 males) were available for analysis using data freeze (12/9/2012). Patients were enrolled in 25 Italian endocrine centres. Before and during PEG treatment IGF-I, liver enzymes, metabolic parameters, and pituitary MRI were assessed. Before PEG, 54.3% patients had been treated with medical therapy and surgery, 22.9% medical therapy only, and 15.8% medical plus radiation and surgical therapy. 199 adverse events were reported in 98 patients (28.7%). Serious adverse events were documented in 29 patients (8.5%). 71.1% of patients had no significant change in tumor volume. Central MRI reading was performed in 34 patients; in 7 patients, an increase in tumor volume was found. Hormonal efficacy progressively increased since the start of PEG. After 6 years, normal IGF-I levels were found in 70.9% of patients (mean daily dose 18.1 mg). 87.1% of patients were treated with daily PEG although in 8.8% of patients, it was administered 2-6 times per week and in 3.8% with weekly injections. 74.8% received a PEG dose 10-15 mg/daily. PEG is a drug with a favorable safety profile which is efficacious also considering that in Italy it is currently available as third-line therapy.
authors.affiliation: Divisione di Endocrinologia, Diabetologia e Metabolismo, Dipartimento di Scienze Mediche, AO Città della Salute e della Scienza di Torino, Università di Torino, C.so AM Dogliotti 14, 10126, Turin, Italy, ninagro@yahoo.it.
authors.forename: S
authors.initials: S
authors.lastname: Grottoli
authors.forename: P
authors.initials: P
authors.lastname: Maffei
authors.forename: F
authors.initials: F
authors.lastname: Bogazzi
authors.forename: S
authors.initials: S
authors.lastname: Cannavò
authors.forename: A
authors.initials: A
authors.lastname: Colao
authors.forename: E
authors.initials: E
authors.lastname: Ghigo
authors.forename: R
authors.initials: R
authors.lastname: Gomez
authors.forename: E
authors.initials: E
authors.lastname: Graziano
authors.forename: M
authors.initials: M
authors.lastname: Monterubbianesi
authors.forename: P
authors.initials: P
authors.lastname: Jonsson
authors.forename: L
authors.initials: L
authors.lastname: De Marinis
mesh_terms: D000172:Acromegaly / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D006727:Hormone Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D019382:Human Growth Hormone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D007558:Italy; D008099:Liver / Q000201:enzymology; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012042:Registries; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006727:Hormone Antagonists; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I; C406545:pegvisomant