P3-7-3 - Retrospective study of safety and efficacy of oxycodone for oxycodone-naive patients with or without hepatic dysfunction

Abstract

Background: Oxycodone clearance decreases in patients with hepatic dysfunction (HD), compared to in patients with normal liver function. However, safety and efficacy of oxycodone for HD patients have been unknown. The aim of this study was to evaluate the safety and efficacy of oxycodone controlled-release tablet (OXC) for OXC-naive patients with or without HD.Methods: Subjects were inpatient who were firstly administered OXC 10 mg/day from September 2013 to September 2014. Patients who took prophylactic antiemetics, anti-tumor therapy within 1 week, and radiation therapy within 1 month were excluded. We retrospectively reviewed the safety and efficacy of OXC during first 3 days after the OXC administration. The profiles were analyzed in patients with HD (group A) and in patients without HD (group B).Results: Fifty one patients were analyzed (female: 39.2%, mean age: 69.9 years, group A: 15 patients, group B: 36 patients). Nausea and vomiting frequently occurred in the group A (60.0% and 33.3%), compared to the group B (26.5% and 0%) (p= 0.025 and p< 0.001, respectively). However, constipation and analgesic effect had no statistical differences between the group A and the group B (57.1% vs 37.1%, p= 0.201 and 66.7% vs 38.5%, p= 0.252).Conclusion: This study firstly showed HD increased nausea and vomiting of OXC for oxycodone-naive patients. However, the analgesic effect were not affected. Pharmacists should carefully observe the occurrence of nausea and vomiting of OXC for oxycodone-naive patients with HD. Background: Oxycodone clearance decreases in patients with hepatic dysfunction (HD), compared to in patients with normal liver function. However, safety and efficacy of oxycodone for HD patients have been unknown. The aim of this study was to evaluate the safety and efficacy of oxycodone controlled-release tablet (OXC) for OXC-naive patients with or without HD. Methods: Subjects were inpatient who were firstly administered OXC 10 mg/day from September 2013 to September 2014. Patients who took prophylactic antiemetics, anti-tumor therapy within 1 week, and radiation therapy within 1 month were excluded. We retrospectively reviewed the safety and efficacy of OXC during first 3 days after the OXC administration. The profiles were analyzed in patients with HD (group A) and in patients without HD (group B). Results: Fifty one patients were analyzed (female: 39.2%, mean age: 69.9 years, group A: 15 patients, group B: 36 patients). Nausea and vomiting frequently occurred in the group A (60.0% and 33.3%), compared to the group B (26.5% and 0%) (p= 0.025 and p< 0.001, respectively). However, constipation and analgesic effect had no statistical differences between the group A and the group B (57.1% vs 37.1%, p= 0.201 and 66.7% vs 38.5%, p= 0.252). Conclusion: This study firstly showed HD increased nausea and vomiting of OXC for oxycodone-naive patients. However, the analgesic effect were not affected. Pharmacists should carefully observe the occurrence of nausea and vomiting of OXC for oxycodone-naive patients with HD.