The Efficacy and Safety of the Fentanyl Iontophoretic Transdermal System (IONSYS®) in the Geriatric Population: Results of a Meta-Analysis of Phase III and IIIb Trials

BACKGROUND AND OBJECTIVES: ) was similar in geriatric (≥65 years) and non-geriatric (<65 years) patients. METHODS: Efficacy and safety data from three randomized, double-blind, placebo-controlled trials and four randomized, open-label, active-comparator trials were utilized for this analysis. Efficacy was assessed via the patient global assessment (PGA) and the investigator global assessment (IGA) scales. The PGA and IGA are categorical 4-point scales (excellent, good, fair, or poor) with treatment success defined as excellent or good. Safety was evaluated via adverse events. RESULTS: A total of 1763 patients were assigned to the fentanyl ITS treatment group. Of the 1763 patients in the fentanyl ITS group, 499 patients were ≥65 years of age; 65.1% were 65-74 years of age, 31.7% were 75-84 years of age, and 3.2% were ≥85 years of age. In the fentanyl ITS treatment groups, there were no statistically significant differences between the non-geriatric and geriatric patients in terms of patients reporting success on the PGA at 24 h (80.0 vs. 83.0%, respectively; p = 0.3415). There were no statistically significant differences between the groups in success rates on the IGA at study discharge (82.8 vs. 87.5%, respectively; p = 0.1195). The safety profile was similar between the age groups. CONCLUSIONS: Overall, efficacy and safety of the fentanyl ITS were similar between the geriatric and non-geriatric patients.