Lidocaine-medicated Plaster Research Articles

The PATCH trial: 5% lidocaine-medicated plaster for trigeminal neuralgia-Results of a multicentric, enriched enrollment, randomized withdrawal, double-blind, vehicle-controlled, parallel-group study.

To explore the efficacy and safety of 5% lidocaine-medicated plaster (LMP) in patients with trigeminal neuralgia (TN). TN is an excruciatingly painful type of neuropathic facial pain. Anti-epileptics are the first-line treatment for TN; however, these oral drugs alone sometimes fail to achieve satisfactory analgesic effects. Two retrospective studies have shown that LMP can be an effective and safe treatment option for some patients with TN. No other high-quality clinical studies have explored the effect and safety of LMP in patients with TN. The PATCH trial is an enriched enrollment with randomized withdrawal, double-blind, vehicle-controlled, parallel-group trial performed at five study centers. Eligible patients with TN received LMP during a 3-week initial open-label phase. Patients who met the response criteria entered the double-blind treatment phase and were randomly assigned for treatment with either LMP (LMP group) or vehicle patches (control group) at a 1:1 ratio. Patients who met the criteria for treatment failure were withdrawn from the double-blind treatment phase, and treatment was continued in the remaining patients for up to 28 days. The primary outcome was the number of treatment failures. The secondary endpoints were the time to loss of therapeutic response (LTR) in the double-blind phase and the weekly mean pain severity in both the open-label phase and the double-blind phase of the study. The first patient was enrolled in this study on May 1, 2021, and the enrollment of the last patient was completed on August 26, 2022. A total of 307 patients were initially screened, 226 (74.0%) of whom entered the open-label phase. Of the 226 respondents, 124 (55.0%) were randomized to the double-blind phase. In the double-blind phase, 62 patients were assigned to the LMP group, and 62 were assigned to the control group. For the primary endpoint, 16 (26.0%) patients with LMP and 36 (58.0%) patients with vehicle patches met the treatment failure criteria during the double-blind phase (relative risk, 0.48; 95% confidence interval [CI], 0.31 to 0.75; p < 0.001). The survival curve of the LTR showed that the LTR of LMP was significantly longer than that of the vehicle patches (hazard ratio, 0.275; 95% CI, 0.15 to 0.50; log-rank p < 0.001). LMP also significantly reduced the weekly mean pain severity in the double-blind phase of the study (p = 0.007). LMP produced partial relief of pain symptoms in some patients with TN. For responders, LMP may be used as an add-on therapy in a multidrug treatment protocol.

Effect of 5% lidocaine-medicated plaster in preventing chronic postsurgical pain after knee replacement: protocol for a randomized double-blind placebo-controlled trial.

With an aging population, knee arthroplasty is increasingly common; however, chronic postsurgical pain (CPSP) affects up to 30% of patients. This study aims to evaluate the efficacy of 5% lidocaine-medicated plaster (LP5) in preventing CPSP among patients undergoing knee arthroplasty. This is a dual-center, randomized, double-blind, placebo-controlled trial involving 128 adult patients scheduled for knee arthroplasty. Participants will be randomly assigned, stratified by center, to either the LP5 group or the placebo group (n = 64 per group). The LP5 or placebo group will apply the patch 1day before surgery and on postoperative days 1-3, with multimodal analgesia administered postoperatively. Multimodal analgesia will include intraoperative flurbiprofen axetil and postoperative patient-controlled sufentanil. The primary outcome is the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 3 months postoperatively. Secondary outcomes will include WOMAC stiffness, function, and total scales; Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale; 36-Item Short Form Health Survey (SF-36); postoperative pain scores; Visual Analog Scale (VAS) sleep scores; postoperative sufentanil consumption; need for rescue analgesia; length of Post-Anesthesia Care Unit (PACU) stay; length of hospital stay; and 90-day mortality. Safety outcomes will include assessments of hypotension, hypertension, bradycardia, tachycardia, arrhythmia, interventions for haemodynamic events, headache, dizziness, nausea, vomiting, local skin allergy, wound infection, and toxic reaction. Data will be analyzed following a modified intention-to-treat approach. This study aims to provide high-quality evidence for the efficacy and safety of LP5 in preventing CPSP in patients undergoing knee arthroplasty.

Topical Lidocaine Medicated Plaster 5% and Pregabalin for the Treatment of Post-Herpetic Neuralgia: A Systematic Review and Meta-Analysis

Background and objectives: Post-herpetic neuralgia is common severe pain that leads to poor quality of life. Various topical and systemic drugs were in use including topical lidocaine medicated plaster 5% (05% LMP. This is the first meta-analysis to compare 5% lidocaine medicated plaster and pregabalin. Thus, this study aimed to assess the effectiveness of 5% LMP and pregabalin in PHN and compare these medications regarding the same.&#x0D; Methods: We searched PubMed, MEDLINE, Google Scholar, EBSCO, and Cochrane Library for publications assessing 5% lidocaine medicated plaster and pregabalin drugs on post-herpetic neuralgia. We included articles published in English from inception up to February 2022. All types of studies were included except case reports, case series, studies on animals, and experimental studies. The terms used were: 5% lidocaine medicated plaster, pregabalin, post-herpetic neuralgia, pain relief, pain reduction, and pain scores. We identified 579 articles and the number stood at 435 after duplication removal, of them, 45 full texts were screened. Eight cohorts from seven studies were included in the final meta-analysis. The most recent RevMan system was used for data analysis.&#x0D; Results: The pain score was significantly lower among patients receiving topical lidocaine compared to placebo or pre and post-intervention (odd ratio, -1.91, 95% CI, -3.77-0.04). Lidocaine Medicated Plaster 5% and pregabalin were effective for pain relief in PHN. However, 5% LMP was more effective (odd ratio, 2.11, 95% CI, 1.41-3.17).&#x0D; Interpretation and Conclusion: Five % lidocaine medicated plaster was effective for the treatment of post-herpetic neuralgia. In addition, the drug was more beneficial than placebo and pregabalin. Further randomized controlled studies assessing the use of LMP 5% on acute herpes zoster and post-herpetic neuralgia are recommended.

Cost-effectiveness analysis of 5% lidocaine-medicated plaster compared with pregabalin for the treatment of post-herpetic neuralgia in China.

Post-herpetic neuralgia (PHN) is the most common complication of herpes zoster and is defined as pain that lasts for one month or more after the outbreak itself heals. While the annual incidence of herpes zoster is approximately 3-5%, 9-34% of these patients will develop PHN. Approximately 30-50% of these cases last for more than a year but some cases can persist for 10 years or more. To date, the economic burden of PHN in China has not been studied. The first-line topical therapy for PHN is application of lidocaine-medicated plasters (LMPs) which have shown good efficacy and tolerability. Furthermore, LMPs were added to China's National Health Insurance List in 2019, thereby significantly relieving the financial burden on patients. A cost-effectiveness analysis was performed on LMPs compared with pregabalin in the treatment of PHN to provide a reference for the basis for clinical treatments and health decisions in patients with PHN. A Markov model was built according to the PHN disease characteristics. The efficacy data were extracted from a randomized controlled trial conducted in China, and the transition probability, utility value, and medical cost of each state in the model were collected through a systematic review of the literature and public databases. The outcome measure was cost per quality-adjusted life year (QALY) gained. The incremental cost-effectiveness ratios (ICERs) were calculated. Sensitivity analysis was conducted to confirm the robustness of the model. In the base case analysis, treatment for a 6-month period with pregabalin and lidocaine plasters led to a mean QALY gain of 0.34012 and 0.42543, respectively, and mean incremental costs of 5,720 Chinese Yuan (CNY) and 3690 CNY, respectively. The ICER of treatment with 5% lidocaine plaster was negative, indicating that lidocaine plasters had absolute advantage. Monte Carlo simulation resulted in an estimate of 90% probability that the 5% lidocaine plaster treatment was cost-effective. Within the Chinese medical and health system, LMPs can reduce the economic burden of patients with PHN. LMPs are more cost-effective and more efficient in absolute terms compared to the first-line treatment systemic drug pregabalin in the treatment of PHN.

The efficacy and safety profile of capsaicin 8% patch versus 5% Lidocaine patch in patients with diabetic peripheral neuropathic pain: a randomized, placebo-controlled study of south Asian male patients.

Diabetic peripheral neuropathy affects up to 60% of individuals and often leads to foot ulceration and eventual amputation. When oral therapy has failed to achieve pain relief, the first line local treatment is the 5% lidocaine-medicated plaster which provides local relief. Capsaicin 8% patch is considered a promising topical treatment for diabetic peripheral neuropathy. The present study investigated the efficacy, safety and tolerability of capsaicin 8% patch vs 5% lidocaine patch treatments over 24weeks in South Asian male diabetic patients with established peripheral diabetic neuropathy. Analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN question 4) and Patient Global Impression of Change (PGIC). All patients received 4% lidocaine gel/cream for 60min prior to patch application. The trial was probably underpowered, taking into account the smaller than expected number of participants from the calculated 350 sample size required for the whole study. Two hundred ninety-one individuals were divided into three groups based on treatment regimen; Group LL (Lidocaine + Lidocaine), Group LP (Lidocaine + Placebo), Group LC (Lidocaine + Capsaicin). The treatment procedure was conducted once initially and then repeated once at 12weeks. The patients were followed up on alternate weeks till 24weeks after the initial treatment. Group LC experienced a more significant reduction in the average pain intensity (p < 0.05) during the last twenty-four hours. Group LC showed more significant reduction of pain compared to control (p < 0.01), a baseline score of 5.4 ± 1.2 dropped to 3.2 ± 1.5 by week 24 of treatment. The change in mean daily pain intensity was - 2.2 ± 1.5 [95% CI: -2.45, -1.5]. Group LL and LC experienced a significant overall improvement (slightly, much or very much) in the health status during the study. After the second week of the treatment, patient satisfaction scores were 2.1 ± 1.1 in Group LL which increased to 3.2 ± 1.2 by week 24 of treatment. The capsaicin 8% patch appears to be reasonably well tolerated since there were no discontinuations because of serious drug-related treatment emergent adverse event (TEAEs). The aim of the present study was to assess the efficacy, safety and tolerability of the 8% capsaicin patch in patients with established painful diabetic neuropathy. There was a sustained treatment response to the initial and repeat treatment of the capsaicin 8% patch over the 24weeks. The study population was very specific so further studies are required to investigate the generalizability of the results for patients experiencing painful diabetic neuropathy. The patch could be considered as an effective long-term treatment option in individuals with painful diabetic neuropathy, particularly those experiencing inadequate pain relief or side effects from systemic therapies.

Effectiveness and safety of 5% lidocaine-medicated plaster on localized neuropathic pain after knee surgery: a randomized, double-blind controlled trial.

Localized neuropathic pain symptoms are reported after knee surgery in 30% to 50% of patients. 5% lidocaine plaster (LP5) is recommended for localized neuropathic pain, but evidence in postsurgery neuropathic pain is missing. This study focuses on the effectiveness of LP5 on allodynia, hyperalgesia, and thermal stimuli in postsurgery knee localized neuropathic pain. A randomized double-blind, 2 parallel groups, controlled trial (NCT02763592) took place in 36 patients (age, 69.4 ± 7.3 years) at the Clinical Pharmacology Center, University Hospital Clermont-Ferrand, France. Patients randomly received LP5 or placebo plaster during 3 months. Neuropathic pain intensity and several parameters (dynamic mechanical allodynia, mechanical [von Frey], heat and cold detection and pain thresholds [Pathway Medoc], and size of the allodynic area were recorded at each visit [inclusion, day 7, 15, month 1, 2, and 3]). From day 7 onwards, dynamic mechanical allodynia diminished progressively of ≥ 30% over 3 months (P = 0.003) in 96% of patients (23/24) and of ≥ 50% in 83% of patients (20/24). Cold pain and maximal mechanical pain thresholds improved over 3 months (P = 0.001 and P = 0.007, respectively). This study shows for the first time the effectiveness of LP5 on dynamic mechanical allodynia, pain, pressure, and cold thresholds over 3 months in knee localized neuropathic pain. Beyond the inhibition of sodium channels by LP5, these findings suggest the involvement of cold and mechanical receptors that participate to pain chronicisation and also of the non-negligible placebo effect of the patch, items that need to be explored further and challenged in other etiologies of localized neuropathic pain.

5% Lidocaine-medicated plaster for the treatment of chronic peripheral neuropathic pain: complex regional pain syndrome and other neuropathic conditions.

ObjectivesChronic neuropathic pain and chronic complex regional pain syndrome (CRPS), in particular, are debilitating and difficult-to-treat conditions that have a strong impact on patient’s quality of life. The aim of this study was to evaluate the effectiveness of 5% lidocaine-medicated plaster as add-on therapy in patients with chronic peripheral neuropathic pain conditions, including CRPS.Patients and methodsThis was a single-center, prospective, observational study set in a specialized pain unit of a tertiary hospital in Spain. A total of 56 patients with long-standing peripheral neuropathic pain, ten of them with CRPS, received 5% lidocaine-medicated plaster as add-on analgesic therapy for 6 months.ResultsAfter 6 months of treatment, a ≥50% reduction in pain intensity was attained by 75% of patients, as measured by numeric rating scale (NRS) for pain. The average NRS score was reduced by 61% (4.7 points), from a baseline mean score of 7.8 to an end point mean score of 3.1. Marked improvements were also observed in the CRPS group: six out of ten patients achieved a ≥50% reduction in NRS score, and the average NRS score for patients with CRPS was reduced by 51% (4.0 points), from a baseline mean score of 7.9 to an end point mean score of 3.9. The improvements in pain intensity were partially translated into a decrease in disability index and in anxiety levels.Conclusion5% Lidocaine-medicated plaster may be useful as add-on therapy for a number of peripheral neuropathic pain conditions, including CRPS.

Building a diagnostic algorithm on localized neuropathic pain (LNP) and targeted topical treatment: focus on 5% lidocaine-medicated plaster.

Within the broad definition of neuropathic pain, the refinement of clinical diagnostic procedures has led to the introduction of the concept of localized neuropathic pain (LNP). It is characterized by consistent and circumscribed area(s) of maximum pain, which are associated with negative or positive sensory signs and/or spontaneous symptoms typical of neuropathic pain. This description outlines the clinical features (currently lacking in guidelines and treatment recommendations) in patients for whom topical targeted treatment with 5% lidocaine-medicated plaster is suggested as first-line therapy. Few epidemiologic data are present in the literature but it is generally estimated that about 60% of neuropathic pain conditions are localized, and therefore identifiable as LNP. A mandatory clinical criterion for the diagnosis of LNP is that signs and symptoms must be present in a clearly identified and defined area(s). Cartographic recordings can help to define each area and to assess variations. The diagnosis of LNP relies on careful neurological examination more than on pain questionnaires, but it is recognized that they can be extremely useful for recording the symptom profiles and establishing a more targeted treatment. The most widely studied frequent/relevant clinical presentations of LNP are postherpetic neuralgia, diabetic neuropathy, and neuropathic postoperative pain. They successfully respond to treatment with 5% lidocaine-medicated plaster with equal if not better pain control but with fewer side effects versus conventional systemic treatments. Generally, the more localized the pain (ie, the area of an A4 sheet of paper) the better the results of topical treatment. This paper proposes an easy-to-understand algorithm to identify patients with LNP and to guide targeted topical treatments with 5% lidocaine medicated plaster.

Can treatment success with 5% lidocaine medicated plaster be predicted in cancer pain with neuropathic components or trigeminal neuropathic pain?

An expert group of 40 pain specialists from 16 countries performed a first assessment of the value of predictors for treatment success with 5% lidocaine-medicated plaster in the management of cancer pain with neuropathic components and trigeminal neuropathic pain. Results were based on the retrospective analysis of 68 case reports (sent in by participants in the 4 weeks prior to the conference) and the practical experience of the experts. Lidocaine plaster treatment was mostly successful for surgery or chemotherapy-related cancer pain with neuropathic components. A dose reduction of systemic pain treatment was observed in at least 50% of all cancer pain patients using the plaster as adjunct treatment; the presence of allodynia, hyperalgesia or pain quality provided a potential but not definitively clear indication of treatment success. In trigeminal neuropathic pain, continuous pain, severe allodynia, hyperalgesia, or postherpetic neuralgia or trauma as the cause of orofacial neuropathic pain were perceived as potential predictors of treatment success with lidocaine plaster. In conclusion, these findings provide a first assessment of the likelihood of treatment benefits with 5% lidocaine-medicated plaster in the management of cancer pain with neuropathic components and trigeminal neuropathic pain and support conducting large, well-designed multicenter studies.

Use of 5% lidocaine medicated plaster to treat localized neuropathic pain secondary to traumatic injury of peripheral nerves

ObjectiveThe efficacy of 5% lidocaine medicated plaster (LMP) has previously been demonstrated in post-traumatic localized neuropathic pain. This study evaluated the use of LMP in localized neuropathic pain secondary to traumatic peripheral nerve injury.Patients and methodsThis prospective observational study enrolled patients with traumatic injuries to peripheral nerves that were accompanied by localized neuropathic pain of more than 3 months duration. Demographic variables, pain intensity (measured using the numeric rating scale; NRS), answers to the Douleur Neuropathique 4 (DN4) questionnaire, and the size of the painful area were recorded.ResultsNineteen patients were included, aged (mean ± standard deviation) 41.4 ± 15.7 years. Nerve injuries affected the upper (eight patients) or lower (11 patients) limbs. The mean duration of pain before starting treatment with LMP was 22.6 ± 43.5 months (median 8 months). Mean baseline values included: NRS 6.7 ± 1.6, painful area 17.8 ± 10.4 cm2 (median 18 cm2), and DN4 score 6.7 ± 1.4. The mean duration of treatment with LMP was 19.5 ± 10.0 weeks (median 17.4 weeks). Mean values after treatment were: NRS 2.8 ± 1.5 (≥3 point reduction in 79% of patients, ≥50% reduction in 57.9% of patients) and painful area 2.1 ± 2.3 cm2 (median 1 cm2, ≥50% reduction in 94.7% of patients). Functional improvement after treatment was observed in 14/19 patients (73.7%).ConclusionLMP effectively treated traumatic injuries of peripheral nerves which presented with chronic localized neuropathic pain, reducing both pain intensity and the size of the painful area.

Treatment of Neuropathic Pain with 5% Lidocaine‐Medicated Plaster: Five Years of Clinical Experience

Neuropathic pain is often severe and adversely affects patients' quality of life. To perform a retrospective, observational study investigating the efficacy and safety of treating refractory chronic neuropathic pain with 5% lidocaine-medicated plaster, in patients attending pain centres. Medical records from 467 patients treated with 5% lidocaine-medicated plaster were evaluated for efficacy (maximum and minimum pain intensities and coanalgesic consumption) and adverse events. Data from an initial assessment and at least one follow-up visit had to be available, and separate analyses were conducted for the general population and the subpopulation older than 70 years of age. Of the patients enrolled, 25.0% were older than 70 years of age. While 20.6% had postherpetic neuralgia, 76.3% had other types of peripheral pain. Approximately 78.1% of cases of peripheral neuropathic pain followed surgery, and 23% were post-traumatic pain. The time from onset to referral was more than one year in two- thirds of cases. All patients experienced pain of at least moderate severity (mean [± SD] 11-point numerical rating scale score 5.2 ± 2.4 to 8.2 ± 1.6). Treatment with 5% lidocaine-medicated plaster reduced pain intensity by more than 50% in 45.5% of patients, and by at least 30% in 82.2%. Of note, the consumption of analgesics and coanalgesics was significantly reduced. Results were similar in both the general population and the subpopulation older than 70 years of age, at high risk and often receiving multiple medications. Treatment of refractory neuropathic pain with 5% lidocaine-medicated plaster clearly demonstrated efficacy and an excellent safety profile in patients with refractory neuropathic pain.

5% lidocaine-medicated plaster vs other relevant interventions and placebo for post-herpetic neuralgia (PHN): a systematic review

Several pharmacological treatments are used to manage post-herpetic neuralgia (PHN). The use of topical analgesics, such as 5% lidocaine-medicated plaster (5% LMP), may be preferable to systemic treatments in that they are formulated to produce a local pain relieving effect with minimal systemic absorption. However, direct head-to-head comparisons are relatively few, and a rigorous assessment of the relative efficacy and safety of the various treatment options is lacking. The objective of this study was to compare 5% LMP for the relief of PHN with other relevant interventions and placebo. Six databases were searched up to May 2010. Quantitative methods for data synthesis were used, and a network meta-analysis was conducted. Twenty unique studies (32 publications) were included. Placebo-controlled studies showed 5% LMP to be effective in providing pain relief and reducing allodynia while adverse event rates were generally low. A comparison between 5% LMP and pregabalin indicated the non-inferiority of 5% LMP for pain reduction and showed greater improvement of quality of life for 5% LMP. Adverse events (AE) were significantly fewer with 5% LMP. In the network meta-analysis, only 5% LMP and gabapentin were associated with a greater change in pain from baseline than placebo [-15.50 (95% CI -18.85 to -12.16) and -7.56 (95% CI -12.52 to -2.59) respectively]. 5% LMP was shown to be more effective than capsaicin [-16.45 (95% CI -20.04 to -12.86)], gabapentin [-7.95 (95% CI -13.29 to -2.61)] and pregabalin [-13.45 (95% CI -19.19 to -7.71)]. For pain relief, two comparators were more effective than placebo [mean pain relief, gabapentin: 32.77 (95% CI 15.57-49.97); 5% LMP: 26.77 (95% CI 9.11-44.43)]. 5% LMP was shown to be comparable to gabapentin [-6.00 (95% CI -25.32-13.32)]. The results suggest that 5% LMP and gabapentin have similar effects on pain relief and that 5% LMP is more effective than capsaicin and pregabalin (change in pain from baseline). Topical agents, such as 5% LMP, are associated with fewer and less clinically significant AE than is the case for systemic agents. However, small numbers, and limited size and quality of included studies should be taken into account. Further studies are needed.

Lidocaine-medicated plaster a cost-effective option for PHN

Lidocaine-medicated plaster a cost-effective option for PHN

583 COMBINATION THERAPY OF POST-HERPETIC NEURALGIA (PHN) AND PAINFUL DIABETIC POLYNEUROPATHY (DPN) WITH 5% LIDOCAINE-MEDICATED PLASTER AND PREGABALIN

European Journal of PainVolume 13, Issue S1 p. S170c-S171 583 COMBINATION THERAPY OF POST-HERPETIC NEURALGIA (PHN) AND PAINFUL DIABETIC POLYNEUROPATHY (DPN) WITH 5% LIDOCAINE-MEDICATED PLASTER AND PREGABALIN Ví. Mayoral, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorP.D. Rogers, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorG. Leijon, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorI. Steigerwald, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorR. Baron, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this author Ví. Mayoral, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorP.D. Rogers, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorG. Leijon, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorI. Steigerwald, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorR. Baron, Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this author First published: 12 January 2012 https://doi.org/10.1016/S1090-3801(09)60586-3Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume13, IssueS1September 2009Pages S170c-S171 RelatedInformation

550 5% LIDOCAINE-MEDICATED PLASTER VS. PREGABALIN IN PATIENTS WITH POST-HERPETIC NEURALGIA (PHN) AND PAINFUL DIABETIC POLYNEUROPATHY (DPN): A RANDOMIZED, CONTROLLED TRIAL

European Journal of PainVolume 13, Issue S1 p. S161c-S162 550 5% LIDOCAINE-MEDICATED PLASTER VS. PREGABALIN IN PATIENTS WITH POST-HERPETIC NEURALGIA (PHN) AND PAINFUL DIABETIC POLYNEUROPATHY (DPN): A RANDOMIZED, CONTROLLED TRIAL R. Baron, R. Baron Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorMá.M. Rosa, Má.M. Rosa Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorI. Steigerwald, I. Steigerwald Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorM. Serpell, M. Serpell Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this author R. Baron, R. Baron Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorMá.M. Rosa, Má.M. Rosa Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorI. Steigerwald, I. Steigerwald Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this authorM. Serpell, M. Serpell Division of Neurological Pain Research and Therapy, Kiel, GermanySearch for more papers by this author First published: 12 January 2012 https://doi.org/10.1016/S1090-3801(09)60553-XRead the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume13, IssueS1September 2009Pages S161c-S162 RelatedInformation

Cost-Effectiveness Analysis of a Lidocaine 5% Medicated Plaster Compared with Gabapentin and Pregabalin for Treating Postherpetic Neuralgia

This study set out to assess the cost effectiveness of using a 5% lidocaine (lignocaine) medicated plaster for the treatment of postherpetic neuralgia (PHN) compared with gabapentin, pregabalin 300 mg/day or 600 mg/day in German primary care. The analysis took the perspective of the Statutory Health Insurance scheme (GKV). A Markov model was used to calculate the costs (2007) and benefits of the lidocaine plaster, gabapentin 1800 mg/day and pregabalin 300 or 600 mg/day over a 6-month time horizon in elderly patients with PHN who experienced insufficient pain relief with standard analgesics and could not tolerate or had contraindications to tricyclic antidepressants. The model calculated the cost per quality-adjusted life-year (QALY) gained and the cost per additional month without symptoms or intolerable adverse effects. The majority of transition probabilities were obtained from randomized controlled trials identified from a systematic literature review. Further model inputs, including resource use, concomitant medication and long-term efficacy/adherence data, were obtained from a Delphi panel. Utility values were taken from a previous study and age adjusted. Cost data were obtained from official price tariffs. Mortality, indirect costs and costs associated with inpatient treatment were not considered in the present analysis due to the perspective and time horizon employed. Over the 6-month period modelled, the mean total therapy cost per patient treated with the lidocaine plaster was euro911, compared with euro728 for gabapentin, euro875 for pregabalin 300 mg/day and euro977 for pregabalin 600 mg/day. Treatment with the lidocaine plaster was related to greater numbers of QALYs and more months without symptoms or intolerable adverse effects (mean 0.300 QALYs and 4.06 months per patient) than with gabapentin (mean 0.247 QALYs and 2.72 months), pregabalin 300 mg/day (mean 0.253 QALYs and 3.02 months) or pregabalin 600 mg/day (mean 0.256 QALYs and 3.22 months). The lidocaine plaster cost euro3453/QALY gained and euro137 per additional month without adverse effects or symptoms relative to gabapentin and euro766/QALY and euro35 per month without adverse effects or symptoms relative to pregabalin 300 mg/day. The lidocaine plaster dominated pregabalin 600 mg/day, being less costly and more effective. Probabilistic sensitivity analysis indicated that there is a 99.36% chance that the lidocaine plaster is the most clinically effective treatment considered in the analysis and a 99.09% chance that the lidocaine plaster is the most cost-effective treatment of the four therapies considered in the analysis if the GKV is willing to pay at least euro20 000/QALY gained. Extensive deterministic sensitivity analyses demonstrated that the findings are robust. The 5% lidocaine-medicated plaster is a cost-effective treatment option for the management of PHN in Germany compared with gabapentin and both 300 and 600 mg/day of pregabalin.