Localized Peripheral Neuropathic Pain: Topical Treatment with Lidocaine 700 mg Medicated Plaster in Routine Clinical Practice

Überall, Michael A.; Bösl, Irmgard; Hollanders, Els; Sabatschus, Ingo; Eerdekens, Mariëlle

doi:10.2217/pmt-2021-0117

Cited by 6 publications

(7 citation statements)

References 31 publications

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“…36 This subgroup analysis has all the limitations stated for the original non-interventional retrospective cohort study. 15 Briefly, propensity score matching was employed to eliminate the main confounding factors and to reduce selection bias; however, other confounders might have Pathophysiology/complications been present. The registry data capture the prescribed regimens/dosages of the medications under evaluation but do not provide information about treatment compliance or reasons for the prescription of concomitant analgesics.…”

Section: Discussionmentioning

confidence: 99%

“…The datasets in this subgroup analysis of patients with PDPN were included in a previously reported non-interventional study analyzing data of patients with localized peripheral neuropathic pain obtained from the GPeR. 15 Patients had been unsuccessfully treated with recommended 16 oral first-line medications (OM) and had been receiving a new treatment of either LMP or an OM and were then followed up for 24 weeks. 15 Based on individual patient needs and prior treatment experience, treating physicians solely decided about the selection of analgesic medication, initial dosing, dose adjustments, continuation or discontinuation based on individual response, and other treatment options.…”

Section: Methodsmentioning

confidence: 99%

“… 15 Patients had been unsuccessfully treated with recommended 16 oral first-line medications (OM) and had been receiving a new treatment of either LMP or an OM and were then followed up for 24 weeks. 15 Based on individual patient needs and prior treatment experience, treating physicians solely decided about the selection of analgesic medication, initial dosing, dose adjustments, continuation or discontinuation based on individual response, and other treatment options. Propensity score matching in the original study 15 provided 732 pairs of datasets from patients with a diagnosis of PDPN for a comparison of LMP and oral first-line medications.…”

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…Outcome parameters have already been described in detail for the original study and two previous subgroup analyses14 15 17 and included pain intensity, pain-related impairments in daily activities (modified Pain Disability Index (mPDI)), pain-related quality of life (Quality of Life Impairment by Pain (QLIP) Inventory Questionnaire), overall quality of life (Short Form 12 V.2, summarized in a Physical Component Score (PCS) and a Mental Component Score (MCS)),18 pain phenotype (painDETECT Questionnaire 7 (PDQ7)),19 change in health status (Patient Global Impression of Change (PGIC)),20 occurrence of drug-related adverse events (DRAEs), and treatment discontinuation due to DRAEs. Patient-reported/relevant outcomes were obtained with validated instruments (recommended by the German pain physician and pain patient organizations).…”

Section: Methodsmentioning

confidence: 99%

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

Überall¹,

Bösl

Hollanders

et al. 2022

BMJ Open Diab Res Care

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IntroductionPainful 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 methodsThis 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.ResultsThe 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).ConclusionsLMP 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 numberEUPAS 32826.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 3 more Smart Citations

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

Überall¹,

Bösl

Hollanders

et al. 2022

BMJ Open Diab Res Care

Self Cite

View full text Add to dashboard Cite

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Use of Structured Template and Reporting Tool for Real-World Evidence for Critical Appraisal of the Quality of Reporting of Real-World Evidence Studies: A Systematic Review

Khambholja¹,

Gehani²

2023

Value in Health

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Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study

Hans

Almeshal

Vanlommel

et al. 2023

Pain Research and Management

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Background. A qualitative evaluation study of the prematurely terminated PrEgabalin Lidocaine Capsaicin Neuropathic Pain (PELICAN) study was performed. The PELICAN study aimed to examine pain management for localized neuropathic pain (LNP), as epidemiological figures have shown a high percentage of LNP patients in Belgium. The study compared systemic and topical medications according to pain relief, adverse effects, and several measures of quality of life. Objective. Achieving better study patient recruitment through qualitative research. To investigate and determine the causes of the observed recruitment problems in the PELICAN study, pain centers involved in the study as well as nonrecruiting pain centers were included. Furthermore, it aimed to highlight the positive and negative lessons learned from the conducted study and the number of obstacles the team had to overcome. Methods. A qualitative study, using a mixed methods approach, was performed. Multiple pain centers in Belgium completed an online survey, after which a structured interview was conducted to elaborate the responses in more detail. The broad topics of these meetings were feedback about the study, reviewing survey answers, and actions undertaken to enhance recruitment. Results. Different factors contributed to the low recruitment rate in the PELICAN study, such as limited and late referral from the general practitioners to the Belgian pain centers, insufficient internal referrals from nonpain specialists, lack of specific expertise on LNP in some centers, scarcity of staff, limited reimbursement to administer complex analgesic schemes, overestimation of the patient population, and the reluctance of patients to participate in pain research. Additionally, shortcomings in the implemented study design and the need for more logistical investments were identified. Conclusion. The findings of the qualitative study demonstrate the need for further, more varied LNP research in Belgium, not limited to pharmacological studies. It also sheds important light on the recruitment obstacles that may be faced during these studies. Future studies could support this research by offering better proposals for feasibility and recruitment, for instance, by designing and conducting a compelling pilot study or applying social media during the recruitment phase. Clinical Trials. This trial is registered with NCT03348735. EUDRACT number 2018-003617-17.

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Localized Peripheral Neuropathic Pain: Topical Treatment with Lidocaine 700 mg Medicated Plaster in Routine Clinical Practice

Cited by 6 publications

References 31 publications

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

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

Use of Structured Template and Reporting Tool for Real-World Evidence for Critical Appraisal of the Quality of Reporting of Real-World Evidence Studies: A Systematic Review

Considerations on the Obstacles That Lead to Slow Recruitment in a Pain Management Clinical Trial: Experiences from the Belgian PELICAN (PrEgabalin Lidocaine Capsaicin Neuropathic Pain) Pragmatic Study

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