PMID- 26553421 OWN - NLM STAT- MEDLINE DCOM- 20161223 LR - 20220409 IS - 1573-7403 (Electronic) IS - 1386-341X (Linking) VI - 19 IP - 2 DP - 2016 Apr TI - Safety of long-term treatment with Pegvisomant: analysis of Spanish patients included in global ACROSTUDY. PG - 127-37 LID - 10.1007/s11102-015-0691-0 [doi] AB - PURPOSE: To evaluate the long-term safety of Pegvisomant (PEG) in the Spanish cohort of ACROSTUDY. METHODS: As of July 2013, 199 Spanish patients were included in ACROSTUDY, a global non interventional safety PEG surveillance study. Patients were observed for safety, biochemical outcome and magnetic resonance imaging evaluations. RESULTS: PEG was administered during an average period of 6.7 +/- 2.1 years and a mean daily dose of 15.5 +/- 7.5 mg. 48.2% of patients received PEG monotherapy. 90.9% of patients had received other medical treatment before PEG start. 195 adverse events (AEs) were reported in 88 patients (44.2%), and serious AEs were described in 31 patients (15.6%). There were no cases of liver tests >10 ULN, or permanent liver damage. Tumor size changes were locally reported in 61 cases (33.5%), with increases observed in 11 patients (6%). In acromegalic patients with diabetes mellitus a decrease in fasting serum glucose value was reported, reaching statistical significance after 1 and 4 years of treatment (-24.6 and -25.9 mg/dl, p = 0.04). After 60 months, normal or lower limit of normal (LLN) IGF-I levels were found in 67.9% of patients. 85.5% of patients showed an IGF-I normal or