Dataset Information

Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China.

ABSTRACT: INTRODUCTION:Painful diabetic peripheral neuropathy (PDN) is a growing public health problem in China. Despite recent progress in treatment, there has been no nationwide study evaluating current medical practices and compliance with treatment guidelines. The primary aims of this study are to investigate the clinical characteristics and treatment practices for PDN and associated anxiety and depression in China. METHODS AND ANALYSIS:Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts is a cross-sectional, multicentre registry study with a target sample size of approximately 1500 people experiencing PDN. People with PDN will be treated according to current guidelines and local practices. The demographics, medical histories, Visual Analogue Scale pain scores, Patient Health Questionnaire-9 results, Generalised Anxiety Disorder-7 scores and therapies will be recorded to evaluate clinical characteristics of PDN and current treatment practices for pain, anxiety and depression. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Peking University Third Hospital Medical Science Research Ethics Committee (2018-182).The results of this study will be disseminated through peer-reviewed publications and scientific presentations. TRIAL REGISTRATION NUMBER:NCT03520608.

SUBMITTER: Zhang Y

PROVIDER: S-EPMC6500332 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China.

Zhang Yuanjin Y Li Nan N Zhao Yiming Y Fan Dongsheng D

BMJ open 20190408 4

<h4>Introduction</h4>Painful diabetic peripheral neuropathy (PDN) is a growing public health problem in China. Despite recent progress in treatment, there has been no nationwide study evaluating current medical practices and compliance with treatment guidelines. The primary aims of this study are to investigate the clinical characteristics and treatment practices for PDN and associated anxiety and depression in China.<h4>Methods and analysis</h4>Painful Diabetic Peripheral Neuropathy Study of Ch ...[more]

PMID: 30962233

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Project description:IntroductionThis aim of this study was to delineate current clinical scenarios of painful diabetic peripheral neuropathy (PDN) and associated anxiety and depression among patients in Mainland China, and to report current therapy and clinical practices.MethodsA total of 1547 participants were enrolled in the study between 14 June 2018 and 11 November 2019. Recruitment was conducted using a multilevel sampling method. Participants' demographics, medical histories, glucose parameters, Douleur Neuropathique 4 Questionnaire (DN4) scores, visual analogue scale (VAS) pain scores, Patient Health Questionnaire 9 (PHQ-9) scores, Generalised Anxiety Disorder 7 (GAD-7) scores and therapies were recorded.ResultsThe male-to-female ratio was 1.09:1 (807:740), and the mean age at onset was 61.28 ± 11.23 years. The mean DN4 score (± standard deviation) was 4.91 ± 1.88. The frequencies of DN4 sub-item phenotypes were: numbness, 81%; tingling, 68.71%; pins and needles, 62.90%; burning, 53.59%; hypoaesthesia to touch, 50.16%; electronic shocks, 43.31%; hypoaesthesia to pinprick, 37.94%; brushing, 37.82%; painful cold, 29.61%; and itching, 25.86%. Age, diabetic duration, depression history, PHQ-9 score and GAD-7 score were identified as risk factors for VAS pain score. Peripheral artery disease (PAD) was a protective factor for VAS pain score. For all participants currently diagnosed with PDN and for those previously diagnosed PDN, fasting blood glucose (FBG) was a risk factor for VAS; there was no association between FBG and VAS pain score for PDN diagnosed within 3 months prior to recruitment. Utilisation rate of opium therapies among enrolled participants was 0.71% , contradiction of first-line guideline recommendation for pain relief accounted for 9.43% (33/350) and contradiction of second-line guideline recommendation for opium dosage form was 0.57% (2/350).ConclusionModerate to severe neuropathic pain in PDN was identified in 73.11% of participants. Age, diabetic duration, depression history, PHQ-9 score, GAD-7 score and FBG were risk factors for VAS pain scores. PAD was protective factor. The majority of pain relief therapies prescribed were in accordance with guidelines.Trial registrationClinicalTrials.gov identifier, NCT03520608, retrospectively registered, 2018-05-11.

Project description:BackgroundPainful diabetic peripheral neuropathy (PDPN) affects up to 26% of patients with diabetes mellitus, with major impacts on their general health and well-being. Most available drugs fail to deliver acceptable pain reduction in the majority of patients and are often poorly tolerated. NRD.E1 is a novel product that has shown anti-nociceptive preclinical effects and good tolerability in healthy volunteer studies.MethodsThis phase 2a, randomized, dose-finding, Proof of Concept study enrolled patients with PDPN of ≥3 months duration. After at least one treatment-free week (WO week), 88 patients entered a 1-week single-blind (SB)-placebo run-in period, followed by 3 weeks' double-blind (DB) treatment, during which they received NRD.E1 at 10, 40 or 150 mg/day or placebo.ResultsThe primary endpoint (change from SB-placebo run-in week to week 3 in weekly mean of daily average numerical rating scale [NRS] pain intensity) showed clinically relevant placebo-corrected treatment effect pain reductions at 40 mg and 150 mg/day of 0.82 (95% CI: 0.07, 1.58, p = 0.034) and 0.66 (95% CI: -0.03, 1.35; p = 0.061) NRS points, respectively, though did not meet the pre-specified value of p = 0.016 required due to multiplicity. An additional post hoc endpoint looking at the change from WO baseline to week 3 in weekly mean of daily average NRS showed the placebo-corrected treatment effect was 1.46 (95% CI: 0.26, 2.66), and 1.20 (95% CI: 0.10, 2.29) NRS points, respectively. Secondary and post hoc analyses of NRS pain data (including 30 & 50% responder rate and NNT), sleep interference, Short-form McGill pain questionnaire (especially pain intensity assessed on Visual Analogue Scale), Patient's and Clinician's Global Impression of Change showed effects consistent with the primary findings. NRD.E1 was well tolerated, with only headache reported in more than two patients and more frequently on NRD.E1 than placebo.ConclusionsThe data suggest that NRD.E1 potentially represents a novel non-opioid therapeutic option for patients with PDPN, with at least similar efficacy and better tolerability than available therapies, justifying its further evaluation in larger-scale confirmatory studies.SignificanceNRD.E1 is a novel non-opioid therapeutic which is being developed for the treatment of PDPN. In this randomized, controlled, dose-finding, Proof of Concept study, NRD.E1 induced a clinically relevant pain reduction and it was well tolerated. Available data suggest that NRD.E1 has at least similar efficacy and better tolerability than the currently available therapies, potentially offering a promising new therapeutic option to patients with PDPN and possibly other neuropathic pain indications.

Dataset Information

Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China.

Publications

Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnts (PDN-SCOPE): protocol for a multicentre cross-sectional registry study of clinical characteristics and treatment in China.

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