Results from an interim analysis of a randomised, controlled trial on efficacy and tolerability of a 5 per cent lidocaine-medicated plaster vs pregabalin in patients with post-herpetic neuralgia (PHN) and painful diabetic polyneuropathy (DPN).

Baron, R., Binder, A., Koroschetz, J., Serpell, M. and Steigerwald, I. (2009) Results from an interim analysis of a randomised, controlled trial on efficacy and tolerability of a 5 per cent lidocaine-medicated plaster vs pregabalin in patients with post-herpetic neuralgia (PHN) and painful diabetic polyneuropathy (DPN). In: Diabetes UK Annual Professional Conference, Glasgow, 11 - 13 Mar 2009,

Abstract

Aims: To compare the efficacy, tolerability and safety of topical 5% lidocaine medicated plaster with systemic pregabalin for the treatment of neuropathic pain in patients with PHN and DPN. Methods: In a pan-European study, 146 interim patients (55 with PHN, 91 with DPN) of 300 planned, were randomised to topical lidocaine(L) or oral pregabalin(P) (titrated to effect: to 300 or 600 mg/day) for 4 weeks. The primary efficacy endpoint (analgesic response) was a >=2 point reduction from baseline in NRS-3 (11- point NRS of recalled average pain intensity in the last 3 days) or an overall score of <4 after 4 weeks treatment. Results: Responder rates (n = 137) were comparable between L and P treatment groups across both indications (64.8%, n = 71 vs 63.6%; n = 66), and for DPN (65.9% vs 78.6%; n = 86). For PHN (n = 51), there was a trend for greater improvement with L as 63.0% of patients achieved an analgesic response compared with 37.5% for P (36.4% and 38.5% for 300 mg and 600 mg, respectively). Lidocaine treatment produced greater reductions in burning pain than pregabalin: change from baseline -2.6(L) (P <0.0001) vs -1.6(P)(P<0.02). Allodynia severity showed a trend for greater improvement with L treatment: all patients with 'no pain or discomfort to touch/uncomfortable, but tolerable to touch' increased from 54.9% to 90.4% for L and from 62.1% to 79.2% for P-patients. Significantly fewer L-patients experienced drug-related adverse events: 3.9% vs 39.2% for P (P<0.0001). Conclusions: The lidocaine plaster demonstrated comparable analgesic efficacy to pregabalin with improved tolerability profile in patients with PHN and DPN.

• Item Type: Conference Proceedings
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Serpell, Dr Michael
• Authors: Baron, R., Binder, A., Koroschetz, J., Serpell, M., and Steigerwald, I.
• College/School: College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing