A randomized, double-blind, active-controlled, double-dummy, parallel-group study
to determine the safety and efficacy of oxycodone/naloxone prolonged-release
tablets in patients with moderate/severe, chronic cancer pain.
Author(s): Ahmedzai SH, Nauck F, Bar-Sela G, Bosse B, Leyendecker P, Hopp M.
Affiliation(s): School of Medicine and Biomedical Sciences, University of Sheffield, Sheffield,
UK.
Publication date & source: 2012, Palliat Med. , 26(1):50-60
OBJECTIVE: An examination of whether oxycodone/naloxone prolonged-release tablets
(OXN PR) can improve constipation and maintain analgesia, compared with oxycodone
prolonged-release tablets (OxyPR) in patients with moderate/severe cancer pain.
METHODS: Randomized, double-blind, active-controlled, double-dummy,
parallel-group study in which 185 patients were randomized to receive up to 120
mg/day of OXN PR or OxyPR over 4 weeks. Efficacy assessments included Bowel
Function Index (BFI), Brief Pain Inventory Short-Form (BPI-SF), laxative and
rescue medication use. Quality of life (QoL) and safety assessments were
conducted.
RESULTS: After 4 weeks, mean BFI score was significantly lower with OXN PR; mean
total laxative intake was 20% lower with OXN PR. Mean BPI-SF scores were similar
for both treatments and the average rate of analgesic rescue medication use was
low and comparable. QoL assessments were stable and comparable with greater
improvements in constipation-specific QoL assessments with OXN PR. Overall, rates
of adverse drug reactions were similar.
CONCLUSIONS: OXN PR provides superior bowel function in cancer pain patients,
compared with OxyPR, without compromising analgesic efficacy or safety. This
study confirms that OXN PR is well tolerated and efficacious in cancer pain
patients and results are in line with those seen in non-malignant pain patients.
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