Effectiveness of the lidocaine patch 5% on pain qualities in three chronic pain states: assessment with the Neuropathic Pain Scale

SUMMARY Objective: To determine the impact of the lidocaine patch 5% on pain qualities associated with chronic pain from post-herpetic neuralgia (PHN), painful diabetic neuropathy (DN), and low-back pain (LBP), using the Neuropathic Pain Scale (NPS). Patients and methods: Patients with PHN, painful DN, and LBP were enrolled if they had partial response to gabapentin-containing analgesic regimens and if they reported moderate-to-severe pain on the NPS at study enrollment. Eligible patients were included in an open-label, non-randomized, prospective, 2-week study across 7 clinical trial sites in the United States. The lidocaine patch 5% was applied to the area of maximal pain, using no more than a total of 4 patches changed every 24 h. Patients were maintained on their other analgesic regimens with no dose adjustment or additions allowed. Treatment effect was measured by change from baseline to Week 2 in 4 composite measures of the NPS: NPS-10, NPS-4, NPS-8, and NPS-non-allodynia. Safety was assessed by adverse events (AEs), dermal assessment of application site(s), and skin sensory testing. Results: In the combined patient population (n = 77), 2 weeks of treatment with the lidocaine patch 5% significantly improved all 4 composite measures ( p < 0.01). In the subgroup analyses, the lidocaine patch 5% demonstrated numerical advantage for all 4 NPS composite measures for the PHN patients (n = 8), and significantly improved all 4 composite measures for the painful DN patients (n = 41; p < 0.001) and LBP patients (n = 28; p ≤ 0.005). Overall, 8 patients (10%) experienced mild-to-moderate treatment-related AEs. Conclusions: The lidocaine patch 5% effectively reduces the intensity of all common pain qualities in patients with moderate-to-severe chronic pain resulting from PHN, painful DN, or LBP. Treatment is well tolerated in combination with other analgesic regimens, with no reports of serious AEs or adverse drug interactions. Assessment scales such as the NPS may offer the possibility to differentiate between various pain states and to assess treatment outcomes for various pain qualities associated with a given pain state.

[1]  A. Woolf,et al.  Burden of major musculoskeletal conditions. , 2003, Bulletin of the World Health Organization.

[2]  Wilfrid Jänig,et al.  Peripheral nerve injury triggers noradrenergic sprouting within dorsal root ganglia , 1993, Nature.

[3]  K. Schmader.  Postherpetic neuralgia in immunocompetent elderly people. , 1998, Vaccine.

[4]  C. C. Lin.  Comparison of the effects of perceived self-efficacy on coping with chronic cancer pain and coping with chronic low back pain. , 1998, The Clinical journal of pain.

[5]  M. Rowbotham,et al.  Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia , 1996, Pain.

[6]  Ricardo Pietrobon,et al.  Estimates and Patterns of Direct Health Care Expenditures Among Individuals With Back Pain in the United States , 2004, Spine.

[7]  C. Pasero.  Lidocaine patch 5%. , 2003, The American journal of nursing.

[8]  M. Rowbotham,et al.  The Lidocaine Patch 5% Effectively Treats All Neuropathic Pain Qualities: Results of a Randomized, Double-Blind, Vehicle-Controlled, 3-Week Efficacy Study With Use of the Neuropathic Pain Scale , 2002, The Clinical journal of pain.

[9]  C. Argoff.  TOPICAL ANALGESICS: A REVIEW OF RECENT CLINICAL TRIALS AND THEIR APPLICATION TO CLINICAL PRACTICE * , 2003 .

[10]  Mario Saltarelli,et al.  Advances in neuropathic pain: diagnosis, mechanisms, and treatment recommendations. , 2003, Archives of neurology.

[11]  A. J. Carter,et al.  Analgesic activity of a novel use‐dependent sodium channel blocker, crobenetine, in mono‐arthritic rats , 2001, British journal of pharmacology.

[12]  M. Rowbotham,et al.  Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. , 1998, JAMA.

[13]  B. Lee,et al.  Sympathetic sprouting in the dorsal root ganglia of the injured peripheral nerve in a rat neuropathic pain model , 1996, The Journal of comparative neurology.

[14]  M. Weinblatt.  Drug interactions with non steroidal anti-inflammatory drugs (NSAIDs). , 1989, Scandinavian journal of rheumatology. Supplement.

[15]  J. Bogousslavsky,et al.  Efficacy of lidocaine patch 5% in the treatment of focal peripheral neuropathic pain syndromes: a randomized, double-blind, placebo-controlled study , 2003, Pain.

[16]  M. Drass,et al.  Lidocaine patch 5% with systemic analgesics such as gabapentin: a rational polypharmacy approach for the treatment of chronic pain. , 2003, Pain medicine.

[17]  R. Hines,et al.  Use of lidocaine patch 5% for chronic low back pain: a report of four cases. , 2002, Pain medicine.

[18]  B. Galer,et al.  Safety and Tolerability of the Lidocaine Patch 5%, a Targeted Peripheral Analgesic: A Review of the Literature , 2003, Journal of clinical pharmacology.

[19]  T. Jensen,et al.  Proceedings of the 7th World Congress on Pain , 1997 .

[20]  M. Rowbotham,et al.  Topical lidocaine patch relieves postherpetic neuralgia more effectively than a vehicle topical patch: results of an enriched enrollment study , 1999, Pain.

[21]  F. Burch,et al.  Lidocaine patch 5% improves pain, stiffness, and physical function in osteoarthritis pain patients. A prospective, multicenter, open-label effectiveness trial. , 2004, Osteoarthritis and cartilage.

[22]  A. Gammaitoni,et al.  Pharmacokinetics and Tolerability of Lidocaine Patch 5% with Extended Dosing , 2002, The Annals of pharmacotherapy.

[23]  B. Galer,et al.  Development and preliminary validation of a pain measure specific to neuropathic pain , 1997, Neurology.

[24]  K. Schmader.  Epidemiology and Impact on Quality of Life of Postherpetic Neuralgia and Painful Diabetic Neuropathy , 2002, The Clinical journal of pain.

[25]  B. Galer,et al.  Topical lidocaine patch relieves a variety of neuropathic pain conditions: an open-label study. , 2000, The Clinical journal of pain.

[26]  D. Lee,et al.  Gabapentin for the Treatment of Postherpetic Neuralgia , 1999 .

[27]  B. Gertz,et al.  Renal Effects of COX-2-Selective Inhibitors , 2001, American Journal of Nephrology.

[28]  M. Moskowitz.  Pharmacotherapy of neuropathic low back pain , 2003, Current pain and headache reports.

[29]  J. Rizzo,et al.  The labor productivity effects of chronic backache in the United States. , 1998, Medical care.

[30]  L. C. Russell,et al.  The effect of intravenous lidocaine, tocainide, and mexiletine on spontaneously active fibers originating in rat sciatic neuromas , 1989, Pain.

[31]  B. Galer,et al.  Painful diabetic polyneuropathy: epidemiology, pain description, and quality of life. , 2000, Diabetes research and clinical practice.

[32]  V Putz-Anderson,et al.  Back pain among workers in the United States: national estimates and workers at high risk. , 1995, American journal of industrial medicine.

[33]  Y. Masubuchi,et al.  Structural requirements for the hepatotoxicity of nonsteroidal anti-inflammatory drugs in isolated rat hepatocytes. , 1998, The Journal of pharmacology and experimental therapeutics.

[34]  R. Deyo,et al.  Drug Therapy for Back Pain: Which Drugs Help Which Patients? , 1996, Spine.

[35]  J. Lidbeck.  Central hyperexcitability in chronic musculoskeletal pain: a conceptual breakthrough with multiple clinical implications. , 2002, Pain research & management.

[36]  Jun-Ming Zhang,et al.  Decreasing sympathetic sprouting in pathologic sensory ganglia: a new mechanism for treating neuropathic pain using lidocaine , 2004, Pain.