Use of oxycodone controlled-release immediately after NSAIDs: a new approach to obtain good pain control.

INTRODUCTION Opioids are recommended as appropriate therapy for the treatment of cancer pain and chronic non-malignant pain. Oxycodone is an alternative agent to its parent compound, morphine, and is available in a controlled-release (CR) formulation that allows convenient twice-daily dosing. The aim of this study was to evaluate the efficacy and tolerability of oxycodone CR as first-line therapy in patients with chronic cancer or non-cancer pain that was not relieved by non-steroidal anti-inflammatory drugs (NSAIDs). METHODS This was a prospective, open-label, multicentre trial carried out in 8 pain and oncology centres in Italy. Patients (n = 309) with NSAID-refractory chronic cancer (55.7%), noncancer (39.4%) or mixed (4.9%) pain (rating of 4-10 on a numerical rating scale [NRS] from 0-10) were enrolled. Patients were treated with oral oxycodone CR twice daily for at least 28 days. Dosage was individualized for each patient and up-titrated over the first week of treatment. The primary endpoint was reduction in NRS score for pain. Secondary endpoints were tolerability, quality of life and patient assessment of treatment efficacy. RESULTS A significant decrease (57%) in pain intensity was recorded during the first week of therapy (decrease in NRS score from 7.85 +/- 1.4 to 3.35 +/- 1.8; p < 0.00001). Overall, there was a 72.3% reduction in NRS pain score from baseline at the end of the study. Quality of life significantly (p < 0.005) improved during oxycodone therapy, and 91% of patients rated treatment as "effective" or "very effective". Five patients stopped oxycodone CR treatment because of adverse events, and one stopped treatment because of dysphagia. CONCLUSIONS The results of this study demonstrate the efficacy and tolerability of oxycodone CR in patients with moderate-to-severe pain of a variety of aetiologies and confirm the feasibility and effectiveness of moving directly from step I to step III on the WHO analgesic treatment ladder.