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Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy.
Curr Med Res Opin. 2009 Jul; 25(7):1677-87.CM

Abstract

OBJECTIVE

Neuropathic pain is often difficult to treat due to a complex pathophysiology. This study evaluated the efficacy, tolerability and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin for neuropathic pain in patients with post-herpetic neuralgia (PHN) or painful diabetic polyneuropathy (DPN).

METHODS

Patients completing 4-week monotherapy with 5% lidocaine medicated plaster or pregabalin were enrolled in an 8-week combination phase. Patients with adequate response to monotherapy (recalled average pain intensity of 4 or less on 11-point numeric rating scale in the previous 3 days [NRS-3 score]) continued their previous therapy, whereas those with insufficient response received combination therapy. Efficacy endpoints included change in NRS-3 from combination phase baseline, Patient and Clinical Global Impression of Change (PGIC/CGIC), and patient's satisfaction with treatment. Safety evaluation included adverse events (AEs), drug-related AEs (DRAEs), and withdrawal due to AEs.

CLINICAL TRIAL REGISTRATION

EudraCT No. 2006-003132-29.

RESULTS

Of 229 patients in the per-protocol set (PPS: 68 PHN and 161 DPN), 71 received 5% lidocaine medicated plaster monotherapy, 57 had pregabalin added to 5% lidocaine medicated plaster, 57 pregabalin monotherapy and 44 received 5% lidocaine medicated plaster in addition to continued pregabalin treatment. There were no meaningful differences in demographic data between the treatment groups. Patients continuing on monotherapy demonstrated additional decreases in NRS-3 scores. Patients receiving combination therapy achieved clinically relevant reduction in NRS-3 values in addition to improvement achieved during the 4 weeks of monotherapy. Improvement was similar between the two combination therapy groups. Considerable improvements in patients' treatment satisfaction were reported. Incidences of AEs were in line with previous reports for the two treatments and combination therapy was generally well tolerated.

CONCLUSIONS

In patients with PHN and painful DPN failing to respond to monotherapy, combination therapy with 5% lidocaine medicated plaster and pregabalin provides additional clinically relevant pain relief and is safe and well-tolerated.

Authors+Show Affiliations

Division of Neurological Pain Research and Therapy, Department of Neurology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany. r.baron@neurologie.uni-kiel.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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

19480610

Citation

Baron, Ralf, et al. "Efficacy and Safety of Combination Therapy With 5% Lidocaine Medicated Plaster and Pregabalin in Post-herpetic Neuralgia and Diabetic Polyneuropathy." Current Medical Research and Opinion, vol. 25, no. 7, 2009, pp. 1677-87.
Baron R, Mayoral V, Leijon G, et al. Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy. Curr Med Res Opin. 2009;25(7):1677-87.
Baron, R., Mayoral, V., Leijon, G., Binder, A., Steigerwald, I., & Serpell, M. (2009). Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy. Current Medical Research and Opinion, 25(7), 1677-87. https://doi.org/10.1185/03007990903048078
Baron R, et al. Efficacy and Safety of Combination Therapy With 5% Lidocaine Medicated Plaster and Pregabalin in Post-herpetic Neuralgia and Diabetic Polyneuropathy. Curr Med Res Opin. 2009;25(7):1677-87. PubMed PMID: 19480610.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy. AU - Baron,Ralf, AU - Mayoral,Victor, AU - Leijon,Göran, AU - Binder,Andreas, AU - Steigerwald,Ilona, AU - Serpell,Michael, PY - 2009/6/2/entrez PY - 2009/6/2/pubmed PY - 2009/12/16/medline SP - 1677 EP - 87 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 25 IS - 7 N2 - OBJECTIVE: Neuropathic pain is often difficult to treat due to a complex pathophysiology. This study evaluated the efficacy, tolerability and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin for neuropathic pain in patients with post-herpetic neuralgia (PHN) or painful diabetic polyneuropathy (DPN). METHODS: Patients completing 4-week monotherapy with 5% lidocaine medicated plaster or pregabalin were enrolled in an 8-week combination phase. Patients with adequate response to monotherapy (recalled average pain intensity of 4 or less on 11-point numeric rating scale in the previous 3 days [NRS-3 score]) continued their previous therapy, whereas those with insufficient response received combination therapy. Efficacy endpoints included change in NRS-3 from combination phase baseline, Patient and Clinical Global Impression of Change (PGIC/CGIC), and patient's satisfaction with treatment. Safety evaluation included adverse events (AEs), drug-related AEs (DRAEs), and withdrawal due to AEs. CLINICAL TRIAL REGISTRATION: EudraCT No. 2006-003132-29. RESULTS: Of 229 patients in the per-protocol set (PPS: 68 PHN and 161 DPN), 71 received 5% lidocaine medicated plaster monotherapy, 57 had pregabalin added to 5% lidocaine medicated plaster, 57 pregabalin monotherapy and 44 received 5% lidocaine medicated plaster in addition to continued pregabalin treatment. There were no meaningful differences in demographic data between the treatment groups. Patients continuing on monotherapy demonstrated additional decreases in NRS-3 scores. Patients receiving combination therapy achieved clinically relevant reduction in NRS-3 values in addition to improvement achieved during the 4 weeks of monotherapy. Improvement was similar between the two combination therapy groups. Considerable improvements in patients' treatment satisfaction were reported. Incidences of AEs were in line with previous reports for the two treatments and combination therapy was generally well tolerated. CONCLUSIONS: In patients with PHN and painful DPN failing to respond to monotherapy, combination therapy with 5% lidocaine medicated plaster and pregabalin provides additional clinically relevant pain relief and is safe and well-tolerated. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/19480610/Efficacy_and_safety_of_combination_therapy_with_5_lidocaine_medicated_plaster_and_pregabalin_in_post_herpetic_neuralgia_and_diabetic_polyneuropathy_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007990903048078 DB - PRIME DP - Unbound Medicine ER -