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Eur J Pain. 2008 Aug;12(6):804-13. doi: 10.1016/j.ejpain.2007.12.010. Epub 2008 Feb 8.

Prolonged-release oxycodone enhances the effects of existing gabapentin therapy in painful diabetic neuropathy patients.

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1
Pain Clinical Research Hub, King's College Hospital, Denmark Hill Campus, Bessemer Road, London SE5 9PJ, UK. magdi.hanna@kcl.ac.uk

Abstract

BACKGROUND:

Neuropathic pain remains one of the most challenging pain syndromes; under-diagnosed, poorly managed and associated with significant co-morbidity. With standard therapeutic treatments, responders rarely exceed 50% pain relief and the majority suffer from residual pain. Titration to optimum dose is often limited by dose-related adverse events.

AIMS:

This randomized, double-blind, placebo-controlled study assessed the potential benefit of adding oxycodone (OxyContin tablets) to gabapentin. The primary endpoint was to evaluate the analgesic efficacy of co-administration of gabapentin and prolonged-release oxycodone, whilst also evaluating the use of escape medication, sleep quality and global assessment of pain.

METHODS:

Three hundred and thirty eight patients with moderate to severe painful diabetic neuropathy despite receiving their maximum tolerated dose of gabapentin, had oral prolonged-release oxycodone or placebo tablets added to their therapy for up to 12 weeks.

RESULTS:

Oxycodone-gabapentin reduced pain score by 33% from baseline to end of treatment. The overall treatment effect was greater with oxycodone-gabapentin than with placebo-gabapentin (P = 0.007). Oxycodone-gabapentin also significantly improved pain relief vs gabapentin alone (P = 0.003). Oxycodone-gabapentin co-administration was associated with less escape medication use (P = 0.03) and fewer nights of disturbed sleep (P < 0.05). Discontinuations due to lack of therapeutic effect were much lower (14% vs 54%) with oxycodone-gabapentin. The commonly seen opiate-induced adverse events were not exacerbated by the combination of oxycodone and gabapentin.

CONCLUSIONS:

This study provides the first evidence that co-administration of prolonged-release oxycodone and existing gabapentin therapy has a clinically meaningful effect in painful diabetic neuropathy.

PMID:
18262450
DOI:
10.1016/j.ejpain.2007.12.010
[Indexed for MEDLINE]
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