Cuomo, A., Russo, G., Esposito, G., Forte, C.A., Connola, M., & Marcassa, C. (2014). Efficacy and gastrointestinal tolerability of oral oxycodone/naloxone combination for chronic pain in outpatients with cancer: An observational study. American Journal of Hospice and Palliative Medicine, 31, 867–876. 

To evaluate the efficacy and tolerability of prolonged-released (PR), fixed-dose oxycodone-naloxone

Patients were prescribed an oral PR oxycodone-naloxone combination for pain control at a dose according to level of pain, age, health status, and previous opioid use.

• N = 206  
• MEAN AGE = 61.3 years (SD = 2.9 years), 89 (43.2%) g5 years or older
• MALES: 47.1%, FEMALES: 52.9%
• KEY DISEASE CHARACTERISTICS: Advanced cancer; moderate to  severe chronic pain
• OTHER KEY SAMPLE CHARACTERISTICS: Constipation

• SITE: Single site  
• SETTING TYPE: Outpatient
• LOCATION: Clinic

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care and palliative care 

• Retrospective, 28-day, observational analysis

• Visual Analog Scale (VAS)
• Bowel Function Index (BFI)

The reported pain at baseline was severe (VAS = 70.9, SD = 7.8, range = 55–94). Less than a fourth of patients reported somatic or visceral pain only. The majority of patients (73.3%) complained of mixed neuropathic and nociceptive pain. At the first visit, 37.6% of patients reported one to four BTCP episodes (mean = 0.9 + 1.2) during background treatment. The mean baseline BFI score was 43.2 + 14.8, indicating that some degree of bowel dysfunction was already present before starting the new PR oxycodone-naloxone treatment. Almost all (97.6%) patients had abnormal baseline BFI values (i.e. > 28.8, 26), and 41% of patients were already taking laxatives.

This combination was a highly effective analgesic in ambulatory outpatients with cancer experiencing chronic pain. Combination PR oxycodone-naloxone was not associated with adverse effects on bowel function and was equally efficacious and well-tolerated in and opioid-naive and -experienced patients and in young and old patients alike.

• Findings not generalizable
• Other limitations/explanation: Retrospective observational design; short time of observation; and the single-center nature of the study

This study may provide useful guidance for the daily management of outpatients with advanced cancer experiencing chronic pain. The long-term effectiveness of fixed-combination PR oxycodone-naloxone deserves additional investigation.