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 TrialsReport as inadecuate




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 - Download this document for free, or read online. Document in PDF available to download.

Drugs and Aging

, Volume 33, Issue 12, pp 901–912

First Online: 27 October 2016

Abstract

Background and ObjectivesAcute postoperative pain management in the geriatric patient can be challenging, including their response to medications. The purpose of this analysis was to evaluate whether the efficacy and safety profile of fentanyl iontophoretic transdermal system ITS IONSYS was similar in geriatric ≥65 years and non-geriatric <65 years patients.

MethodsEfficacy 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.

ResultsA 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.

ConclusionsOverall, efficacy and safety of the fentanyl ITS were similar between the geriatric and non-geriatric patients.

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Author: Eugene R. Viscusi - Li Ding - Loretta M. Itri

Source: https://link.springer.com/



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