Efficacy and safety of controlled-release oxycodone/naloxone versus controlled-release oxycodone in Korean patients with cancer-related pain: a randomized controlled trial
10.1186/s40880-017-0241-4
- Author:
Lee KYUNG-HEE
1
;
Kim Won TAE
;
Kang JUNG-HUN
;
Kim JIN-SOO
;
Ahn JIN-SEOK
;
Kim SUN-YOUNG
;
Yun HWAN-JUNG
;
Eum YOUNG-JUN
;
Koh Ae SUNG
;
Kim Kyoung MIN
;
Hong Sang YONG
;
Kim Eun JEONG
;
Lee GYEONG-WON
Author Information
1. Department of Hematology-Oncology
- Keywords:
Constipation;
Naloxone;
Oxycodone;
Quality of life;
Safety
- From:Chinese Journal of Cancer
2017;36(11):609-617
- CountryChina
- Language:Chinese
-
Abstract:
Background: Controlled-release oxycodone/naloxone (OXN-CR) maintains the effect of opioid-induced analge-sia through oxycodone while reducing the occurrence rate of opioid-induced constipation through naloxone. The present study was designed to assess the non-inferiority of OXN-CR to controlled-release oxycodone (OX-CR) for the control of cancer-related pain in Korean patients. Methods: In this randomized, open-labeled, parallel-group, phase IV study, we enrolled patients aged 20 years or older with moderate to severe cancer-related pain [numeric rating scale (NRS) pain score≥4] from seven Korean oncology/hematology centers. Patients in the intention-to-treat (ITT) population were randomized (1:1) to OXN-CR or OX-CR groups. OXN-CR was administered starting at 20 mg/10 mg per day and up-titrated to a maximum of 80 mg/40 mg per day for 4 weeks, and OX-CR was administered starting at 20 mg/day and up-titrated to a maximum of 80 mg/day for 4 weeks. The primary efficacy endpoint was the change in NRS pain score from baseline to week 4, with non-inferiority margin of?1.5. Secondary endpoints included analgesic rescue medication intake, patient-reported change in bowel habits, laxative intake, quality of life (QoL), and safety assessments. Results: Of the ITT population comprising 128 patients, 7 with missing primary efficacy data and 4 who violated the eligibility criteria were excluded from the efficacy analysis. At week 4, the mean change in NRS pain scores was not significantly different between the OXN-CR group (n= 58) and the OX-CR group (n= 59) (?1.586 vs.?1.559, P= 0.948). The lower limit of the one-sided 95％ confidence interval (?0.776 to 0.830) for the difference exceeded the non-inferiority margin (P < 0.001). The OXN-CR and OX-CR groups did not differ significantly in terms of analgesic rescue medication intake, change in bowel habits, laxative intake, QoL, and safety assessments. Conclusions: OXN-CR was non-inferior to OX-CR in terms of pain reduction after 4 weeks of treatment and had a similar safety profile. Studies in larger populations of Korean patients with cancer-related pain are needed to further investigate the effectiveness of OXN-CR for long-term pain control and constipation alleviation.
