부산대학교 도서관

Aims To assess the single-dose pharmacokinetics and tolerability of pegylated interferon-α2b (PEG-Intron) in young and elderly healthy subjects. Methods In this parallel-design study, a single 1 µg kg-1 PEG-Intron dose was given subcutaneously to 24 subjects in the age groups 20–45, 65–69, 70–74 and 75–80 years (n = 6/group). Blood sampling and tolerability assessments were performed up to 168 h postdose. Results The pharmacokinetic parameters were similar in all age groups. The elderly to young subject ratios for C max were 91.1, 79.5, and 107% for the 65–69 years, 70–74 years and 75–80 years groups, respectively. The corresponding values for AUC(0–∞) and CL/F were 111, 102 and 108%, and 82.5, 95.8 and 86.4%, respectively. Mean differences from the 20 to 45 years group and the 65–69 years, 70–74 years and 75–80 years groups for PEG-Intron V d/F were 108, 128 and 104%, respectively. None of these differences was statistically significant based on ANOVA. Results from a Dunnett's test (as post hoc assessment) confirmed that the pharmacokinetic parameters of Group II, Group III or Group IV were not different from those of Group I. Almost all (23/24; 96%) subjects reported typical interferon-α side-effects (flu-like symptoms, headache). One elderly patient had a myocardial infarction 12 h postdose, but recovered fully. Conclusions There are no pharmacokinetic reasons for initial dose adjustment of PEG-Intron based on age. [ABSTRACT FROM AUTHOR]