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Although oral morphine remains the opioid of choice for the management of moderate to severe cancer pain, controlled-release morphine fonnulations have only enabled dosing every 8 to 12 hours. Kadian™/Kapanol™ (K) is novel polymer-coated morphine sulfate pellets (20, 50, 100 mg) in a capsule designed for 12 to 24 hourly dosing. This randomized, double-blind, double-dummy, parallel group study compared the efficacy and safety of K q12h or q24h to MS Conlin® tablets (MSC) q12h. Eligible patients with cancer pain were titrated to adequate analgesia with a stable dose of immediate-release morphine sulfate (IRMS) over a 3 to 14 day lead-in, then randomized to one of the three treatments for 7 ± 1 days. Rescue medication was IRMS tablets. Primary measures of efficacy on the final day were time to first rescue medication and total dose of rescue as a % of total daily dose (TDD) of morphine (%IRMS). Secondary measures were: daily—visual analogue scale (VAS) of pain intensity, quality of sleep, and incidence of morphine-related side effects; final day–VAS and verbal rating scale (VRS) of pain intensity, VRS of pain control, and patient global assessment of pain control and investigator global asssessment of efficacy. 152 patients completed final day assessments at 28 centres in the U.S.A.. Mean age was 61 yrs and TDD of morphine was 138 mg. 54 patients were treated with K q24h, 45 with K q12h, 53 with MSC. The number requiring rescue on the final day was K q24h 46%, K q12h 51%, MSC 55%. Time to first rescue was K q24h 6.8 h, K q12h 7.5 h, MSC 6.3 h. %IRMS was K q24h 39.2, K q12h 29.2, MSC 42.9. There were no significant differences for all measures. Patient global assessment (good or very good) significantly favoured K q24h over MSC (K q24h 89%, K q12h 76%, MSC 68%, P = 0.018). There were no significant differences for other secondary measures. Kadian™/Kapanol™ q24h and q12h had efficacy and safety similar to MSC q12h but had the added advantage of 12 to 24 hourly administration with a trend to less rescue medication use. Patient global assessment significantly favoured Kapanol™/KadianTM. |
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