LONG-TERM ADMINISTRATION OF CONTROLLED-RELEASE OXYCODONE TABLETS FOR THE TREATMENT OF CANCER PAIN

We conducted a study of the safety of controlled-release (CR) oxycodon e tablets (OxyContin(R) Tablets) administered chronically to patients with cancer-related pain in a usual clinical setting. These patients h ad participated in 1 of 2 double-blind active-control studies. Our stu dy was an open, 3-month treatment study that included 87 patients. Pat ients received CR oxycodone tablets every 12 hr in a manner that refle cted typical clinical practice. Supplemental immediate-release (IR) ox ycodone was available PRN for breakthrough pain. Patients recorded med ication use, adverse events, and evaluations of pain intensity and acc eptability of therapy in a daily diary. Forty-four patients (51%) comp leted all 12 weeks of study; 43 patients (49%) discontinued participat ion, At baseline mid throughout the study period the overall mean pain -intensity score was slight to moderate. A comparison of initial and f inal doses showed a significant but modest increase in total daily CR oxycodone dose. An increase or decrease in titration of the oxycodone dose occurred for 66 patients (84%) at least once during the 12-week s tudy period, primarily for increased pain. Forty-four patients (56%) d id not undergo dose titration when the latter was indicated. Half of t he patients used IR oxycodone rescue almost daily; the mean number of rescue doses per day was 1.5. Despite stable pain control and an incre asing total daily CR oxycodone dose, the percentage of patients report ing common opioid-related adverse events decreased over the course of the stimy. CR oxycodone tablets administered every 12 hr Mere successf ully used to manage cancer pain over a 12-week period. Importantly, si de effects diminished over time without a concomitant change in effica cy.