Garassino, M.C., Piva, S., La Verde, N., Spagnoletti, I., Iorno, V., Carbone, C., . . . Farina, G. (2013). Randomised phase II trial (NCT00637975) evaluating activity and toxicity of two different escalating strategies for pregabalin and oxycodone combination therapy for neuropathic pain in cancer patients. PloS One, 8(4), e59981.

To evaluate two different dose escalation approaches for the combination of oxycodone and pregabalin

Patients were randomized to receive either 20 mg per day sustained-release oxycodone and escalating doses of pregabalin starting at 50 mg per day, or to pregabalin at 50 mg per day and escalating doses of oxycodone. Patients were observed for 14 days. The primary endpoint of the study was overall analgesia, defined as pain intensity reduction by at least one-third on a numeric rating scale.

• N = 67
• MEAN AGE = 67.5 years
• AGE RANGE = 39–85 years
• MALES: 56.7%, FEMALES: 43.3%
• KEY DISEASE CHARACTERISTICS: Lung, breast, and colon cancer were most prevalent.
• OTHER KEY SAMPLE CHARACTERISTICS: 72% had baseline pain scores of 6 or lower.

• SITE: Multi-site 
• SETTING TYPE: Outpatient 
• LOCATION: Italy

• APPLICATIONS: Palliative care

• Randomized, parallel group

• Pain numeric rating scale
• Allodynia recorded as present or absent by physical exam
• Patient diary for daily recording of pain severity, use of other medications, and episodes of breakthrough pain

Analgesia as defined was achieved in the pregabalin escalation group with a mean dose of 100 mg and in the other group with a mean dose of 60 mg oxycodone. No differences were seen between groups in use of rescue medication, other analgesics, or side effects.

Strategies for managing neuropathic pain with either dose escalation of pregabalin or escalation of sustained-release oxycodone when given in combination produced similar results.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Other limitations/explanation: Short duration of the study

Findings suggest that similar pain management effects can be achieved with either escalation of pregabalin or escalation of oxycodone when given in combination for neuropathic pain. These findings suggest that either approach may provide similar effects and that the approach used can be determined according to relevant patient characteristics and preferences.