ICEECE2012 Oral Communications Pituitary Clinical I (6 abstracts)
1Catholic University, Rome, Italy; 2University of Turin, Turin, Italy; 3University of Pisa, Pisa, Italy; 4University Federico, Naples, Italy; 5University of Padova, Padova, Italy; 6University of Messina, Messina, Italy; 7Acrostudy Centers, Italy, Italy.
ACROSTUDY is an international observational study to evaluate efficacy and safety of long-term treatment with pegvisomant (PEGA) in acromegaly. ACROSTUDY Italy was started in 2007 and we report data from the first 185 patients (93M, 92F, mean age, range, 49.9 y; 1783.8 y) treated with PEGA (mean duration, range, 3.2 y, 0.18.5 y), from 24 centers, until 01/2010. Before and during PEGA, IGF1, GH-Ab, liver enzymes, metabolic parameters and pituitary MRI were assessed. Before PEGA, 70 patients had undergone surgery, 15 radiation therapy, 161 had received SSA±DA and in 24 subjects no previous medical treatment of acromegaly was documented. At the start of treatment, 43.2% of patients received PEGA alone, 49.9% in association with SSA and 10% SSA + DA. During treatment, a progressive increase in the subjects receiving PEGA alone was observed. In 87% of cases PEGA was used in daily administration. The mean dose of PEGA received alone (mean starting dose 12.2 mg/day, at 5 y 18.5 mg/day) was not significantly different (P=NS) from that used in association with SSA±DA (mean starting dose 12.4 mg/day, at 5 y 19.3 mg/day). In 74.4 and 75.5% of patients, IGF1 levels were normalized after 1 and after 5 y of therapy respectively. During PEGA, an increase in tumor lesion in 11 cases and a reduction in 16 cases was observed, but the centralized blinded reassessment confirmed the increase in three cases and a reduction in one case. In no case a significant and sustained transaminases elevation was reported. Discontinuation of treatment for serious adverse events was required in two cases. In conclusion, our data confirm that long-term PEGA therapy is highly effective in acromegalic patients resistant to other treatment and shows an excellent safety profile.
Declaration of interest: The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project.
Funding: This research did not receive any specific grant from any funding agency in the public, commercial or not-for-profit sector.