Journal
CURRENT MEDICAL RESEARCH AND OPINION
Volume 26, Issue 7, Pages 1607-1619Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1185/03007995.2010.483675
Keywords
Lidocaine plaster; Neuropathic pain; Post-herpetic neuralgia; Pregabalin
Funding
- Grunenthal GmbH, Aachen, Germany
- Pfizer
- Grunenthal
- Allergan
- Genzyme
- CMRO
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Objective: To compare efficacy and safety of 5% lidocaine medicated plaster with pregabalin in patients with post-herpetic neuralgia (PHN), and to assess the benefits of combining both drugs in patients not responding to either single agent. Study design and methods: This was a two-stage adaptive, randomised, open-label, multicentre, non-inferiority study (NCT 00414349). The subset of patients with PHN is reported here. Patients with an absolute value of >4 on the NRS-3 were randomly assigned to 4-week treatment with 5% lidocaine medicated plaster or twice-daily pregabalin capsules titrated to effect. Subsequently, patients sufficiently treated with monotherapy (patients with NRS-3 <= 4 at 4 weeks or a reduction on the NRS-3 from baseline of >= 2 points) continued with monotherapy; patients insufficiently treated with monotherapy received both drugs in combination for 8 weeks. Outcome measures: Pain according to SF-MPQ and NPSI, onset of effect, reduction in worst pain on the NRS; allodynia severity; quality of life (QoL) based on EQ-5D, SF-36; PGIC; rescue medication intake; adverse events (AEs) monitoring. Results: At 4 weeks, SF-MPQ total scores improved by -7.6 +/- 6.66 (mean +/- SD) under 5% lidocaine medicated plaster and by -5.3 +/- 7.93 under pregabalin. NPSI total scores declined by -1.6 +/- 1.73 under 5% lidocaine medicated plaster and -1.4 +/- 1.87 under pregabalin. Lidocaine plaster was also effective in reducing worst pain and showed a fast onset of effect. During combination treatment, SF-MPQ and NPSI scores, allodynia, EQ-5D and PGIC improved. Incidences of AEs were in line with previous reports for the two treatments and combination therapy was generally well-tolerated. Conclusions: Although this open-label study is lacking a placebo control group, the results suggest that 5% lidocaine medicated plaster is at least as effective as pregabalin for pain relief in PHN, with a favourable safety profile and a resulting positive benefit-risk ratio. In patients unresponsive to either monotherapy, combination therapy provides additional efficacy and is well-tolerated.
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