COMPARISON OF A ONCE-A-DAY SUSTAINED-RELEASE MORPHINE FORMULATION WITH STANDARD ORAL MORPHINE-TREATMENT FOR CANCER PAIN

Kadian(TM)/Kapanol(TM) (K) is a capsule formulation of morphine design ed for 12- or 24-hourly dosing. This double-blind study compared the e fficacy and safety of K every 24 hr to K every 12 hr and MS Contin(R) tablets (MSC) every 12 hr. One hundred fifty-two patients with cancer pain were titrated to adequate analgesia with immediate-release morphi ne (IRM) solution. Stabilized patients were randomized to one of the t hree treatments for 7 +/- 1 days. Rescue medication was IRM tablets. E fficacy and safety were assessed by time to first remedication and tot al dose of rescue medication, pain scores, global assessments, and inc idence of morphine-related side effects. Fifty-four patients were trea ted with K every 24 hr, 45 with K every 12 hr, and 53 with MSC every 1 2 hr. Mean age was 61 years and mean total daily dose of morphine was 138 mg. Forty-six percent of the K every 24 hr patients, 51% of the K every 12 hr patients, and 55% of the MSC every 12 hr patients required rescue medication on the final day. Time to remedication was 16.0 hr for K every 24 hr, 9.1 hr for K every 12 hr, and 8.7 hr for MSC every 12 hr (P = 0.018). There were no statistically significant differences among the treatments for any morphine-related side effects when adjus ted for baseline. K had efficacy and safety profiles similar to MSC ev ery 12 hr but had the advantage of 12- or 24-hourly administration. (C ) U.S. Cancer Pain Relief Committee, 1997.