Comparison of a once-a-day sustained-release morphine formulation with standard oral morphine treatment for cancer pain

Abstract

Kadian™/Kapanol™ (K) is a capsule formulation of morphine designed for 12- or 24-hourly dosing. This double-blind study compared the efficacy and safety of K every 24 hr to K every 12 hr and MS Contin® tablets (MSC) every 12 hr. One hundred fifty-two patients with cancer pain were titrated to adequate analgesia with immediate-release morphine (IRM) solution. Stabilized patients were randomized to one of the three treatment for 7 ± 1 days. Rescue medication was IRM tablets. Efficacy and safety were assessed by time to first remedication and total dose of rescue medication, past score, global comments, and incidence of morphine-related side effects. Fifty-four patients were treated with K every 24 hr, 45 with K every 12 hr, and 53 with MSC every 12 hr. Mean age was 61 years and mean total daily dose of morphine was 138 mg. Forty-six parents of the K every 24 hr patients 51% of the K every 12 hr patients, and 55% of the MSC every 12 hr patients expired 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 8.7hr for MSC every 12 hr ( P = 0.0010). Patient global assessment significantly forward K every 24 hr over MSC every 12 hr ( P = 0.018). There were no statistically significant differences among the treatments for any morphine-related side effects when adjusted for baseline. K had efficacy and safety profiles similar to MSC every 12 hr but had the advantage of 12- or 24-hourly administration.