Localized peripheral neuropathic pain: topical treatment with lidocaine 700 mg medicated plaster in routine clinical practice.

Aim: To provide real-world evidence for the effectiveness and tolerability of lidocaine 700 mg medicated plaster (LMP) in localized peripheral neuropathic pain (l-PNP) treatment compared with first-line oral medications (OM). Patients & methods: This was a noninterventional, retrospective 6-month cohort study in patients refractory to at least one recommended OM, using anonymized medical care data from the German Pain eRegistry. Treatment groups were matched by propensity scoring, considering seven predefined confounding factors. The primary effectiveness end point was the absolute change in average pain intensity index from baseline at weeks 4, 12 and 24 of treatment and over the treatment period. Results: A total of 3081 datasets were retained per treatment group. LMP provided superior pain reductions and significantly greater improvements in pain-related impairments of daily living and quality of life with significantly better tolerability (p < 0.001 for all parameters) than OM. Conclusion: These real-world data confirm the effectiveness and good tolerability of LMP for l-PNP treatment under routine medical care.

Conditions such as shingles, diabetes and surgery may lead to chronic localized neuropathic pain. This pain is often described as burning or stabbing and can limit functioning in daily activities and diminish quality of life. Several oral and topical medications are available for neuropathic pain treatment. The current study compared the effectiveness and tolerability of lidocaine 700 mg medicated plaster applied directly at the painful skin area with oral medications. Anonymized patient data collected in a German pain registry were selected based on predefined criteria (3081 patient data sets per treatment). Lidocaine plaster treatment resulted in superior pain relief, significantly fewer restrictions in daily life activities and better quality of life than the oral medications evaluated and was significantly better tolerated. This study showed that lidocaine 700 mg medicated plaster is effective and well tolerated in the treatment of chronic localized neuropathic pain in routine medical practice.

Painful diabetic peripheral neuropathy: real-world comparison between topical treatment with lidocaine 700 mg medicated plaster and oral treatments.

INTRODUCTION: Painful diabetic peripheral neuropathy (PDPN), a common complication of diabetes mellitus, is challenging to treat. Efficacy and tolerability of the topical lidocaine 700 mg medicated plaster (LMP) and well-established first-line oral medications (OM) were compared in refractory PDPN patients. RESEARCH DESIGN AND METHODS: This is a subgroup analysis of a non-interventional, retrospective 24-week cohort study using anonymized routine medical care data from the German Pain eRegistry. Propensity score matching provided 732 datasets per treatment group. Primary effectiveness endpoint was the absolute change in average 24-hour Pain Intensity Index (0-100 mm) from baseline after 4, 12 and 24 weeks of treatment and over the entire treatment period. RESULTS: The majority of this multimorbid and polymedicated study population of patients with PDPN had suffered pain for more than a year and presented with a high pain burden despite a median of seven previous analgesic medications. LMP treatment resulted in significant reductions in pain intensity and improvements in daily functioning already after 4 treatment weeks. Effectiveness was maintained over the treatment period even when concomitant analgesics were reduced or discontinued and quality of life improved. Mean change in the primary effectiveness parameter over the 24-week treatment period was -30.2 mm (SE 0.38) and -17.0 mm (SE 0.51) in the LMP and OM groups, respectively. Improvements in all effectiveness parameters were significantly greater under LMP than under OM treatment (p<0.001). Significantly fewer patients under LMP than OM experienced drug-related adverse events (DRAEs; 9.6% vs 61.6%, p<0.001) and discontinued treatment due to DRAEs (4.4% vs 35.8%, p<0.001). CONCLUSIONS: LMP was effective and well tolerated in routine clinical care of patients with PDPN. The more favorable benefit/risk profile and greater reduction in intake of concomitant analgesics compared with OM suggest LMP as a useful treatment option for PDPN. TRIAL REGISTRATION NUMBER: EUPAS 32826.

Lidocaine 700 mg medicated plaster for postherpetic neuralgia: real-world data from the German Pain e-Registry.

Aim: To provide real-world evidence for the effectiveness and tolerability of lidocaine 700 mg medicated plaster (LMP) compared with oral systemic first-line medications (OSM) in postherpetic neuralgia treatment. Patients & methods: Retrospective cohort study in patients refractory to at least one recommended OSM (single drug or a combination of drugs) using anonymized routine medical care data from the German Pain e-Registry. A matched pair approach using propensity score matching was employed. Results: A total of 1711 data sets of postherpetic neuralgia patients were identified per treatment group. The majority (>60%) had experienced pain for more than a year and reported a high burden of pain and reduced quality of life. Six months of LMP treatment provided significantly greater pain reductions, improvements in pain-related impairments and quality of life than OSM treatment (p < 0.001 for all parameters). Drug-related adverse events and treatment discontinuation due to drug-related adverse events also occurred less frequently under LMP treatment (p < 0.001). Conclusion: These real-world data confirm the effectiveness and good tolerability of LMP under routine medical care. The treatment was significantly more effective when compared with first-line oral systemic medications.

Lay abstract Postherpetic neuralgia is the most common complication of shingles. It is a chronic condition causing burning pain that persists long after the shingles rash disappears. There are several oral and topical medications available for pain treatment. Our study compared the effectiveness and tolerability of the topical lidocaine 700 mg medicated plaster with oral medications using anonymized patient data from German clinical practices collected in a pain registry (1711 patient data sets per treatment). Six months of treatment with the lidocaine plaster resulted in better pain relief, fewer restrictions in daily life activities, and better quality of life for the patients than the oral medications investigated. The lidocaine plaster was also significantly better tolerated. The lidocaine 700 mg medicated plaster is effective and well tolerated in routine medical practice.

Postsurgical neuropathic pain: lidocaine 700 mg medicated plaster or oral treatments in clinical practice.

Aim: To compare the effectiveness and tolerability of the lidocaine 700 mg medicated plaster (LMP) and oral first-line medications (OM) for the treatment of postsurgical neuropathic pain (PSNP) in routine clinical practice. Patients & methods: Data from a noninterventional, retrospective 24-week cohort study in patients with localized peripheral NP refractory to at least one recommended OM using anonymized German Pain eRegistry data were retrieved. A subgroup analysis was conducted on 531 datasets of PSNP patients. Results: Pain relief, improvements in pain-related impairments of daily living and quality of life, and tolerability were significantly greater under LMP than under OM (p < 0.001 for all parameters). Conclusion: These real-world data show the effectiveness and good tolerability of LMP for PSNP treatment in routine clinical practice.

Surgical procedures may lead to chronic postsurgical neuropathic pain often described as burning or shooting pain. This pain can be treated with medications that are swallowed (oral) or applied to the skin (topical). Our study compared the effectiveness and tolerability of the topical lidocaine 700 mg medicated plaster with oral medications in 531 anonymized patient data sets from a German pain registry. Patients on the lidocaine 700 mg medicated plaster had significantly better pain relief, significantly lower impact of pain on activities of daily life and quality of life and tolerated their treatment significantly better than those on oral medications. The lidocaine 700 mg medicated plaster can be considered as an alternative effective and well-tolerated treatment option for postsurgical neuropathic pain in routine clinical practice.

Comparative Benefit-Risk Assessment for Lidocaine 700 mg Medicated Plaster and Pregabalin in Peripheral Neuropathic Pain Following a Structured Framework Approach.

INTRODUCTION: Peripheral neuropathic pain (PNP) is difficult to treat. Several oral drugs are recommended as first-line treatments. Nevertheless, many patients cannot obtain sufficient pain relief or do not tolerate systemically active treatments. Topical treatments, with a lower risk of systemic side effects such as lidocaine 700 mg medicated plaster, are also recommended in treatment guidelines. This analysis compares the benefit-risk balance of topical 700 mg lidocaine medicated plaster with the benefit-risk balance of oral pregabalin administration for the treatment of PNP following current recommendations on benefit-risk assessment (BRA) methodology. METHODS: The Benefit-Risk Action Team (BRAT) framework was used as structured approach. Selection of key benefits and risks was supported by a patient survey. Published randomized controlled clinical trials were the main source to identify data related to key benefits and risks. The outcome of randomized clinical trials was compared with real-world evidence (RWE) data for consistency. RESULTS: Identified key benefits were pain reduction and improvement in quality of life. Key risks identified were application site reactions, dizziness, confusion, weight gain, peripheral edema, and blurred vision. Overall, there was similarity in key benefits between the comparators; however, a clear advantage regarding key risks in favor of lidocaine 700 mg medicated plaster was observed. This observation was consistent across data from a direct comparison trial, randomized placebo-controlled trials, as well as data from RWE studies. The low number of randomized controlled trials for lidocaine 700 mg medicated plaster was the main limitation. CONCLUSION: Guided by the opinion of patients regarding key benefits and risks deemed important for treatments of peripheral neuropathic pain, our analysis showed that lidocaine 700 mg medicated plaster has a more favorable benefit-risk balance compared to pregabalin (300 and 600 mg daily).

Topical 5% lidocaine (lignocaine) medicated plaster treatment for post-herpetic neuralgia: results of a double-blind, placebo-controlled, multinational efficacy and safety trial.

BACKGROUND AND OBJECTIVE: Post-herpetic neuralgia (PHN) is a distressing neuropathic pain condition mainly affecting elderly patients. Neuropathic pain symptoms can be of a burning, shooting and stabbing nature, and may continue for prolonged periods and are often poorly controlled by polymedication. The aim of this study was to evaluate the analgesic efficacy and safety of topical analgesic treatment (5% lidocaine [lignocaine] medicated plaster) compared with placebo plaster in patients with PHN. METHODS: This was a double-blind, placebo plaster-controlled, parallel-group, multicentre study employing enriched enrolment with randomized withdrawal methodology. After an initial 8-week open-label, active run-in phase, responders entered a 2-week randomized, double-blind, placebo-controlled phase. The study was conducted at 33 outpatient investigational centres in 12 European countries. Patients with PHN were selected who were aged >/=50 years, had experienced neuropathic pain persisting for >/=3 months after rash healing, and had a mean pain intensity of >/=4 on an 11-point numerical rating scale. A total of 265 patients entered the open-label phase and subsequently a pre-defined number of 71 patients entered the randomized phase. Patients applied up to three 5% lidocaine medicated plasters for up to 12 hours per day. The primary endpoint of the study was time-to-exit due to a >/=2-point reduction in pain relief on two consecutive days of plaster application using a 6-point verbal rating scale. RESULTS: Of the 265 patients entering the run-in phase, 51.7% achieved at least moderate pain relief. In the double-blind phase (full analysis set, n = 71), median times-to-exit were 13.5 (range 2-14) and 9.0 (range 1-14) days for lidocaine and placebo plaster groups, respectively (p = 0.151). For per-protocol patients (n = 34), median time-to-exit was 14.0 (range 3-14) and 6.0 (range 1-14) days for lidocaine and placebo plaster groups, respectively (p = 0.0398). Drug-related adverse events occurred in 13.6% of patients. Treatment with 5% lidocaine medicated plaster was associated with improvements in pain, allodynia, quality of life and sleep measures. CONCLUSIONS: This study adds to a growing body of evidence that the 5% lidocaine medicated plaster can be considered a valuable treatment option for patients with PHN, providing beneficial effects on pain, allodynia, quality of life and sleep, with minimal adverse effects.

Treatment of postherpetic neuralgia with 5% lidocaine medicated plaster in elderly patients - subgroup analyses from three European clinical trials.

OBJECTIVE: To investigate short- and long-term effectiveness and safety of the 5% lidocaine medicated plaster in the treatment of postherpetic neuralgia (PHN) in elderly patients (≥70 years of age). METHODS: Data from three European clinical trials was compared after stratification according to age (<70 years and ≥70 years). Length of study phase investigated was 4 weeks for study 1, 8 weeks for study 2, and up to 12 months for study 3. Effectiveness outcome measures were pain intensity, pain relief, allodynia severity, Clinical Global Impression of Change, and Patient Global Impression of Change. Safety was assessed by adverse event documentation. RESULTS: Mean average pain intensity improved in the elderly by -2.1 (SD 2.1) vs. -2.5 (SD 2.0) for <70 year old patients after 4 weeks, by -1.4 (SD 1.8) vs. -1.7 (SD 1.3) after 8 weeks, and by -1.5 (SD 1.9) vs. -2.7 (SD 2.2) after 12 months. Most patients presented with allodynia (>85% of elderly, >78% of younger patients) which was described by >51% as painful or extremely painful. Allodynia severity was markedly reduced in both groups during all three trials. Drug-related adverse events occurred in <20% of elderly and <15% of <70 year old patients and were mainly skin related. CONCLUSIONS: The 5% lidocaine medicated plaster provided pain relief and marked reductions in allodynia severity in elderly PHN patients with an excellent safety profile under short- and long-term treatment supporting the addition of the plaster to the treatment armamentarium for this age group. STUDY LIMITATIONS: All analyzed study phases were open-label and lacking a placebo control group.

5% Lidocaine Medicated Plaster for the Treatment of Postherpetic Neuralgia: A Review of the Clinical Safety and Tolerability.

Postherpetic neuralgia (PHN) is a common, very painful, and often long-lasting complication of herpes zoster which is frequently underdiagnosed and undertreated. It mainly affects the elderly, many of whom are already treated for comorbidities with a variety of systemic medications and are thus at high risk of drug-drug interactions. An efficacious and safe treatment with a low interaction potential is therefore of high importance. This review focuses on the safety and tolerability of the 5% lidocaine medicated plaster, a topical analgesic indicated for the treatment of PHN. The available literature (up to June 2014) was searched for publications containing safety data regarding the use of the 5% lidocaine medicated plaster in PHN treatment; unpublished clinical safety data were also included in this review. The 5% lidocaine medicated plaster demonstrated good short- and long-term tolerability with low systemic uptake (3 ± 2%) and minimal risk for systemic adverse drug reactions (ADRs). ADRs related to topical lidocaine treatment were mainly application site reactions of mild to moderate intensity. The treatment discontinuation rate was generally below 5% of patients. In one trial, the 5% lidocaine medicated plaster was better tolerated than systemic treatment with pregabalin. The 5% lidocaine medicated plaster provides a safe alternative to systemic medications for PHN treatment, including long-term pain treatment.