PMID- 20429825 OWN - NLM STAT- MEDLINE DCOM- 20100928 LR - 20151119 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 26 IP - 7 DP - 2010 Jul TI - Post-herpetic neuralgia: 5% lidocaine medicated plaster, pregabalin, or a combination of both? A randomized, open, clinical effectiveness study. PG - 1607-19 LID - 10.1185/03007995.2010.483675 [doi] AB - 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 or=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. FAU - Rehm, Stefanie AU - Rehm S AD - Universitatsklinikum Schleswig-Holstein, Kiel, Germany. FAU - Binder, Andreas AU - Binder A FAU - Baron, Ralf AU - Baron R LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Anesthetics, Combined) RN - 0 (Anesthetics, Local) RN - 0 (Dosage Forms) RN - 0 (Placebos) RN - 55JG375S6M (Pregabalin) RN - 56-12-2 (gamma-Aminobutyric Acid) RN - 98PI200987 (Lidocaine) SB - IM MH - Administration, Topical MH - Aged MH - Anesthetics, Combined/administration & dosage/adverse effects MH - Anesthetics, Local/administration & dosage/adverse effects MH - Dosage Forms MH - Female MH - Humans MH - Lidocaine/*administration & dosage/adverse effects MH - Male MH - Middle Aged MH - Neuralgia, Postherpetic/*drug therapy MH - Osmolar Concentration MH - Pain Measurement MH - Placebos MH - Pregabalin MH - Treatment Outcome MH - gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs & derivatives EDAT- 2010/05/01 06:00 MHDA- 2010/09/30 06:00 CRDT- 2010/05/01 06:00 PHST- 2010/05/01 06:00 [entrez] PHST- 2010/05/01 06:00 [pubmed] PHST- 2010/09/30 06:00 [medline] AID - 10.1185/03007995.2010.483675 [doi] PST - ppublish SO - Curr Med Res Opin. 2010 Jul;26(7):1607-19. doi: 10.1185/03007995.2010.483675.