Comparison of a once-a-day sustained-release morphine formulation with standard oral morphine treatment for cancer pain.
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 randonized to one of the three treatments 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, pain scores, global assessments, 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 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 = 0.0010). Patient global assessment significantly favored 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.
Broomhead
A
A
F.H. Faulding & Co. Limited, Adelaide, Australia.
Kerr
R
R
Tester
W
W
O'Meara
P
P
Maccarrone
C
C
Bowles
R
R
Hodsman
P
P
D000284:Administration, Oral; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage* / Q000627:therapeutic use; D009369:Neoplasms / Q000188:drug therapy*; D010166:Palliative Care
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D009020:Morphine