Lazzari, M., Greco, M.T., Marcassa, C., Finocchi, S., Caldarulo, C., & Corli, O. (2015). Efficacy and tolerability of oral oxycodone and oxycodone/naloxone combination in opioid-naive cancer patients: A propensity analysis. Drug Design, Development and Therapy, 9, 5863–5872. 

DOI Link

Study Purpose

To compare the analgesic efficacy and safety, and quality of life of oxycodone (OXY) compared with oxycodone/naloxone (OXN) combination in treating opioid-naïve patients

Intervention Characteristics/Basic Study Process

Patients were seen at three or four different times when starting long-acting oxycodone products.

Sample Characteristics

  • N = 131   
  • AGE = 62 years
  • MALES: 52.1%, FEMALES: 47.9%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Solid tumor
  • OTHER KEY SAMPLE CHARACTERISTICS: Pain

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Rome, Italy

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Retrospective, observational, three data collection time periods—T0, T30, and T60. T15 available for patients who needed closer monitoring.

Measurement Instruments/Methods

  • Pain intensity
  • Neuropathic pain using Douleur Neuropathique 4 questionnaire
  • Daily dose of medications
  • Dose increments
  • Quality of life
  • Chronic Pain Sleep Inventory
  • Physical and Mental Component Summary scores of the Short Form-12 Health Survey Questionnaire
  • Bowel Function Index
  • Safety evaluations

Results

The patients who received OXN had better early improvement in bowel function than the patients who received OXY (p < 0.001).

Conclusions

OXN and OXY have similar analgesic effects, but OXN seems to have better bowel outcomes.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results 
  • Measurement/methods not well described
  • Subject withdrawals ≥ 10%

Nursing Implications

OXN may have better bowel function outcomes compared with OXY in patients starting analgesics.