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Long-term improvement in physical function observed in the ACTION Trial: A randomized, multi-center study of once daily AVINZA® (morphine sulfate extended-release capsules) vs. twice daily OxyContin® (oxycodone hydrochloride controlled-release) for moderate to severe low back pain
Richard L. Rauck, MD, Department of Anesthesiology, Wake Forest University Health Sciences, 145 Kimel Park Dr., Suite 330, Winston Salem, NC 27103, Stephen A. Bookbinder, Ocala Rheumatology Research Center, 3210 SW 33rd Road, Suite 102, Ocala, FL 34474, Timothy A. Bunker, The Birmingham Pain Center, Ivy Center, 2057 Valleydale Rd., Suite 100, Birmingham, AL 35244, Christopher D. Alftine, Medford Medical Clinic, 555 Black Oak Drive, Suite 310, Medford, OR 97504, Steven L. Gershon, Hilltop Medical Center, Advanced Pain Management and Rehabilitation, 1788 Republic Rd., Suite 200, Virginia Beach, VA 23454, Richard G. Ghalie, Medical Affairs, Ligand Pharmaceuticals, 10275 Science Center Drive, San Diego, CA 92121, and Egbert De Jong, Anesthesia and Pain Management, Organon Pharmaceuticals USA, 56 Livingston Avenue, Roseland, NJ 07068.
The ACTION trial compared once daily AVINZA to twice daily OxyContin in subjects 30-70 years old with chronic moderate to severe low back pain. After opioid dose titration, subjects entered an 8-week evaluation phase followed by an optional 4-month extension phase. In addition to assessment of pain scores, sleep, opioid dose, and ibuprofen use for breakthrough pain, subjects completed the SF-12® quality of life questionnaire and the Work Limitations Questionnaire® (WLQ), at baseline, at the end of the dose-titration, and then monthly x6 months. Of 392 subjects enrolled, 266 entered the evaluation phase and 174 entered the extension phase.1 At the end of the dose titration, AVINZA (n=124) compared to OxyContin (n= 122) resulted in significantly better mean domain scores for physical functioning (8.1 vs. 6.7, p=0.0374), role physical (7.2 vs. 5.9, p=0.0341), bodily pain (10.8 vs. 6.5, p=0.0001), and physical component summary (7.6 vs. 5.5, p=0.0022) and there was a trend for continued better results in the AVINZA group throughout the extension phase. The mean bodily pain scores were significantly better in the AVINZA group at end-of-titration (p=0.001), evaluation Week 8 (p=0.0065) and extension phase Month 1 (p=0.0433) and Month 2 (p=0.0171). Both treatments resulted in improvement from baseline in the WLQ physical demands scores. The proportion of subjects unable to work due to pain decreased in the AVINZA group from 9.7% at baseline to 8.5% at the end of the evaluation phase, whereas for the same period the proportion of subjects unable to work in the OxyContin group increased from 6.8% to 19.4% (p=0.0149). In conclusion, AVINZA was significantly better than OxyContin for improving pain and physical functioning and for increasing patients' ability to work. The study was supported by a grant from Ligand Pharmaceuticals and Organon Pharmaceuticals USA. (1) Rauck R., J Opioid Management, 2006.