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Post-herpetic neuralgia: 5% lidocaine medicated plaster, pregabalin, or a combination of both? A randomized, open, clinical effectiveness study.
Curr Med Res Opin. 2010 Jul; 26(7):1607-19.CM

Abstract

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=4 at 4 weeks or a reduction on the NRS-3 from baseline of >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.

Authors+Show Affiliations

Universitätsklinikum Schleswig-Holstein, Kiel, Germany.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20429825

Citation

Rehm, Stefanie, et al. "Post-herpetic Neuralgia: 5% Lidocaine Medicated Plaster, Pregabalin, or a Combination of Both? a Randomized, Open, Clinical Effectiveness Study." Current Medical Research and Opinion, vol. 26, no. 7, 2010, pp. 1607-19.
Rehm S, Binder A, Baron R. Post-herpetic neuralgia: 5% lidocaine medicated plaster, pregabalin, or a combination of both? A randomized, open, clinical effectiveness study. Curr Med Res Opin. 2010;26(7):1607-19.
Rehm, S., Binder, A., & Baron, R. (2010). Post-herpetic neuralgia: 5% lidocaine medicated plaster, pregabalin, or a combination of both? A randomized, open, clinical effectiveness study. Current Medical Research and Opinion, 26(7), 1607-19. https://doi.org/10.1185/03007995.2010.483675
Rehm S, Binder A, Baron R. Post-herpetic Neuralgia: 5% Lidocaine Medicated Plaster, Pregabalin, or a Combination of Both? a Randomized, Open, Clinical Effectiveness Study. Curr Med Res Opin. 2010;26(7):1607-19. PubMed PMID: 20429825.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-herpetic neuralgia: 5% lidocaine medicated plaster, pregabalin, or a combination of both? A randomized, open, clinical effectiveness study. AU - Rehm,Stefanie, AU - Binder,Andreas, AU - Baron,Ralf, PY - 2010/5/1/entrez PY - 2010/5/1/pubmed PY - 2010/9/30/medline SP - 1607 EP - 19 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 26 IS - 7 N2 - 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=4 at 4 weeks or a reduction on the NRS-3 from baseline of >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. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/20429825/Post_herpetic_neuralgia:_5_lidocaine_medicated_plaster_pregabalin_or_a_combination_of_both_A_randomized_open_clinical_effectiveness_study_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007995.2010.483675 DB - PRIME DP - Unbound Medicine ER -