Pain and Therapy最新文献

{"title":"A Retrospective Analysis of Disease Epidemiology, Comorbidity Burden, Treatment Patterns, and Healthcare Resource Utilization of Migraine in the United Arab Emirates.","authors":"Alessandro Terruzzi, Abubaker AlMadani, Suhail Al-Rukn, Mohamed Farghaly, Sara A Dallal, Mostafa Zayed, Nora Vainstein, Mohamed Fathy, Anup Uboweja, Ashok Natarajan, Kumaresan Subramanyam, Badrinath C Ramachandrachar, Ali Aljabban","doi":"10.1007/s40122-024-00634-1","DOIUrl":"10.1007/s40122-024-00634-1","url":null,"abstract":"<p><strong>Introduction: </strong>Migraine is a recurrent, disabling neurological disorder with a substantial global disease burden. However, limited real-world data are available on the patient characteristics, treatment patterns, comorbidities, and economic burden of migraine in the United Arab Emirates (UAE). In this study, we evaluated the disease burden, comorbidities, treatment patterns, specialties involved in migraine diagnosis, and healthcare resource utilization (HCRU) and associated costs in patients with migraine in Dubai, UAE.</p><p><strong>Methods: </strong>A retrospective, secondary database cohort study was conducted from 01 January 2014 to 31 March 2022 using the Dubai Real-World Database. Patients aged ≥ 18 years with at least one diagnosis claim for migraine with continuous enrollment during the study period were included. Patients were stratified into treatment sub-cohorts. Outcomes were evaluated in terms of clinical characteristics, comorbidities, specialists visited, treatment patterns, and HCRU.</p><p><strong>Results: </strong>The study included 203,222 patients (mean age: 40 years), with male predominance (55.4%). About 13.4% of patients had specific cardiovascular comorbidities. Frequently prescribed drug classes were nonsteroidal anti-inflammatory drugs (84.4%), triptans (29.8%), and beta-blockers (12.8%), while only 1.0% of patients with migraine were prescribed newer medications like calcitonin gene-related peptide antagonists. General medicine was the most frequently visited specialty on the index date (51.5%). The all-cause and migraine-specific median gross costs during the 12-month post-index period were US $1252.6 (2.4-564,740.7) and US $198.1 (0-168,903.3) respectively, with maximum contribution from inpatients. The contribution of migraine-specific median costs to all-cause median costs was highest for the diagnosis-related group (64.9%), followed by consumables (35.2%), medications (32.0%), procedures (24.5%), and services (24.5%).</p><p><strong>Conclusion: </strong>Migraine significantly impacts healthcare costs in the UAE. The role of newer therapies in migraine management should be explored to reduce the associated socioeconomic burden and improve patients' quality of life.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1235-1255"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141727655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Abdominal Aortic Calcification and Clinical Outcomes in LDH Patients Treated with Endoscopic Lumbar Discectomy.","authors":"Ying Zhang, Zhaoji Zhu, Xiaohong Jin, Peng Huang","doi":"10.1007/s40122-024-00633-2","DOIUrl":"10.1007/s40122-024-00633-2","url":null,"abstract":"<p><strong>Introduction: </strong>To determine any significant associations between abdominal aortic calcification (AAC) and clinical manifestations of pain symptoms following endoscopic lumbar discectomy.</p><p><strong>Methods: </strong>Patients sequentially presenting with a history of unilateral radiculopathy with or without back pain, and with magnetic resonance imaging (MRI)-confirmed diagnosis of posterolateral disc herniation between August 2021 and December 2023 were eligible for inclusion in the study. All patients underwent endoscopic discectomy at our center during the study period. AAC stages were classified based on the Kauppila classification system using lateral lumbar radiographs.</p><p><strong>Results: </strong>Between August 2021 and December 2023 a total of 120 patients were included in the study for analysis, of whom 82 (68.3%) exhibited mild AAC and 38 (31.7%) had moderate-severe AAC. Analyses using the multivariate linear regression model revealed a significant correlation between AAC comorbidity and postoperative clinical outcomes. At 1 year post-surgery, the mean change in leg pain following endoscopic lumbar discectomy was significantly less for patients with moderate-severe AAC (5.0 points) than for patients with mild ACC (p < 0.001). Even after adjusting for relevant confounders, this difference remained significant. Similar results were also observed in the postoperative improvement of back pain, the Oswestry Disability Index score, and the physical functioning, role physical, and bodily pain components of the 36-item Short Form Health Survey questionnaire. There was no significant difference in the rate of repeat surgery or post-surgical new-onset back pain between patients with different levels of severity of AAC at 1 year post-surgery.</p><p><strong>Conclusions: </strong>There is a significant association between the severity of AAC and clinical outcomes among patients with lumbar disk herniation who underwent endoscopic lumbar discectomy. AAC may serve as a prognostic factor in predicting surgical outcomes and guiding management strategies for patients with lumbar disk herniation following endoscopic lumbar discectomy.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1257-1269"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393253/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potential Cost Savings with 60-day Peripheral Nerve Stimulation Treatment in Chronic Axial Low Back Pain.","authors":"Samir J Sheth, William D Mauck, David P Russo, Eric L Keuffel, Candace L Gunnarsson, Mark Stultz, Meredith J McGee, Marc A Huntoon","doi":"10.1007/s40122-024-00630-5","DOIUrl":"10.1007/s40122-024-00630-5","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic axial low back pain (CLBP) that is not responsive to medication management or physical therapy often requires significant clinical intervention. Several interventional pain management options exist, including a 60-day peripheral nerve stimulation (PNS) treatment. This economic evaluation investigated the potential for projected cost savings associated with prioritizing 60-day PNS treatment relative to a 'standard of care' (SOC) approach (where patients do not have access to 60-day PNS).</p><p><strong>Methods: </strong>A decision tree (supervised machine learning) model tracked treatment progression across two hypothetical cohorts of US patients with CLBP in whom non-interventional options were ineffective (Cohort A: treatment starting with 60-day PNS followed by any additional interventional and surgical treatments versus Cohort B: standard of care interventional and surgical treatments without access to 60-day PNS). Treatment efficacy estimates were based on published success rates. Conditional on treatment failure, up to two additional interventions were considered within the 12-month time frame in both cohorts. SOC treatment options included epidural injection, radiofrequency ablation (RFA), basivertebral nerve ablation (BVNA), PNS permanent implant (PNS-PI), spinal cord stimulator (SCS) trial/implant, and spinal fusion surgery. Treatment choice probabilities in both cohort algorithms were based on clinician interviews. Costs were based on national Medicare reimbursement levels in the ambulatory surgery center (ASC) setting. Savings reflected the difference in projected costs between cohorts. A Monte Carlo simulation and sensitivity analyses were conducted to generate confidence intervals and identify important inputs.</p><p><strong>Results: </strong>The treatment algorithm which prioritized initial 60-day PNS treatment was projected to save $8056 (95% CI $6112-$9981) per patient during the first year of interventional treatment relative to the SOC approach.</p><p><strong>Conclusions: </strong>Use of the 60-day PNS treatment as an initial interventional treatment in patients with CLBP may result in significant savings for Medicare. Projected savings may be even larger for commercial payers covering non-Medicare patients.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1187-1202"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141559464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Response to: Letter to the Editor Regarding \"Comparison of Thoracoscopy-Guided Thoracic Paravertebral Block and Ultrasound-Guided Thoracic Paravertebral Block in Postoperative Analgesia of Thoracoscopic Lung Cancer Radical Surgery: A Randomized Controlled Trial\".","authors":"Xia Xu, Ying-Xin Xie, Meng Zhang, Jian-Hui Du, Jin-Xian He, Li-Hong Hu","doi":"10.1007/s40122-024-00638-x","DOIUrl":"10.1007/s40122-024-00638-x","url":null,"abstract":"","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1319-1321"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393362/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141627318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Kinesio Taping on Neck Pain: A Meta-Analysis and Systematic Review of Randomized Controlled Trials.","authors":"Qian Hu, Ying Liu, Shao Yin, Hui Zou, Houyin Shi, Fengya Zhu","doi":"10.1007/s40122-024-00635-0","DOIUrl":"10.1007/s40122-024-00635-0","url":null,"abstract":"<p><strong>Introduction: </strong>Neck pain constitutes a prevalent and burdensome health issue, substantially impairing patients' quality of life and functional capabilities. Kinesio taping (KT), a commonly employed intervention within physical therapy, holds promise for mitigating such symptoms; however, a comprehensive evaluation of its efficacy and evidence base is lacking. Therefore, this study endeavors to systematically investigate the therapeutic effects of KT on both subjective neck pain intensity and objective measures of physical activity limitations through a rigorous meta-analytic approach. By synthesizing existing literature and scrutinizing methodological nuances, we aim to furnish healthcare practitioners with evidence-informed insights, facilitating more judicious clinical decision-making and optimizing patient outcomes.</p><p><strong>Methods: </strong>According to the PRISMA guidelines, we conducted searches on PubMed, Cochrane Library, Embase, and Web of Science for randomized controlled trials (RCTs) investigating the efficacy of KT in treating neck pain. Screening was performed based on predefined inclusion and exclusion criteria. Characteristics of the included RCTs were extracted. Trial heterogeneity was assessed using the I² statistic. Meta-analysis was conducted using Stata 17 software. Risk of bias and methodological quality were evaluated using the Cochrane Risk of Bias 2 tool and the PEDro scale, respectively.</p><p><strong>Results: </strong>In our analysis of 10 RCTs involving 620 patients meeting our inclusion criteria, KT demonstrated significant beneficial effects on neck pain, notably surpassing conventional treatment (weighted mean difference = -0.897, 95% CI -1.30 to -0.49, P < 0.001). Subgroup analysis further revealed that KT exhibited particularly pronounced efficacy in the treatment of nonspecific neck pain and mechanical neck pain, with a more substantial effect observed after 4 weeks of KT intervention compared to 1 week. Moreover, KT demonstrated superior efficacy in alleviating pain symptoms compared to both conventional treatment and sham interventions.</p><p><strong>Conclusion: </strong>KT has demonstrated efficacy in reducing neck pain and improving cervical dysfunction among patients. Prolonged KT treatment or its combination with other therapeutic modalities may potentially enhance therapeutic outcomes.</p><p><strong>Systematic review registration: </strong>PROSPERO CRD42024524685.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1031-1046"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393280/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141748854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying and Evaluating Biological Markers of Postherpetic Neuralgia: A Comprehensive Review.","authors":"Yunze Li, Jiali Jin, Xianhui Kang, Zhiying Feng","doi":"10.1007/s40122-024-00640-3","DOIUrl":"10.1007/s40122-024-00640-3","url":null,"abstract":"<p><p>Postherpetic neuralgia (PHN) manifests as persistent chronic pain that emerges after a herpes zoster outbreak and greatly diminishes quality of life. Unfortunately, its treatment efficacy has remained elusive, with many therapeutic efforts yielding less than satisfactory results. The research to discern risk factors predicting the onset, trajectory, and prognosis of PHN has been extensive. However, these risk factors often present as nonspecific and diverse, indicating the need for more reliable, measurable, and objective detection methods. The exploration of potential biological markers, including hematological indices, pathological insights, and supportive tests, is increasing. This review highlights potential biomarkers that are instrumental for the diagnosis, management, and prognosis of PHN while also delving deeper into its genesis. Drawing from prior research, aspects such as immune responsiveness, neuronal injury, genetic makeup, cellular metabolism, and pain signal modulation have emerged as prospective biomarkers. The immune spectrum spans various cell subtypes, with an emphasis on T cells, interferons, interleukins, and other related cytokines. Studies on nerve injury are directed toward pain-related proteins and the density and health of epidermal nerve fibers. On the genetic and metabolic fronts, the focus lies in the detection of predisposition genes, atypical protein manifestations, and energy-processing dynamics, with a keen interest in vitamin metabolism. Tools such as functional magnetic resonance imaging, electromyography, and infrared imaging have come to the forefront in the pain signaling domain. This review compiles the evidence, potential clinical implications, and challenges associated with these promising biomarkers, paving the way for innovative strategies for predicting, diagnosing, and addressing PHN.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1095-1117"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393369/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141913662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Novel Combination Strategy of Ultrasound-Guided Percutaneous Radiofrequency Ablation and Corticosteroid Injection for Treating Recalcitrant Plantar Fasciitis: A Retrospective Comparison Study.","authors":"Yinfeng Zheng, Tianyi Wang, Lei Zang, Peng Du, Xiaochuan Kong, Gang Hong, Le Zhang, Jian Li","doi":"10.1007/s40122-024-00629-y","DOIUrl":"10.1007/s40122-024-00629-y","url":null,"abstract":"<p><strong>Introduction: </strong>The best treatment yielding clinical benefits was still equivocal and controversial for the treatment of recalcitrant plantar fasciitis (PF). This study aimed to propose a novel combination strategy of ultrasound-guided percutaneous radiofrequency ablation (RFA) and corticosteroid injection (CI) for recalcitrant PF, and to compare its therapeutic effects with CI alone and continued conservative management.</p><p><strong>Methods: </strong>We retrospectively reviewed consecutive patients with recalcitrant PF who underwent combined strategy (RFA + CI), CI alone, and continue conservative treatment at our institution between October 2021 and February 2023. The technical pearls were described elaborately. A comparison of demographic data and clinical outcomes, including visual analog scale (VAS), Ankle-Hindfoot Scale (AOFAS-AHS), and plantar fascia thickness, were conducted among the three groups.</p><p><strong>Results: </strong>Seventy-one eligible patients were enrolled in this study, with 17 in the combined strategy group, 25 in the CI group, and 29 in the continued conservative treatment group. Both the combined strategy group and the CI group showed significant improvements in VAS scores, AOFAS-AHS scores, and significant reductions in plantar fascia thickness during the 12-month follow-up period compared to those preoperatively (P < 0.05). The combined strategy group achieved comparable immediate pain relief to the CI group after the intervention ([25.7 ± 15.7] vs. [20.6 ± 17.6], P = 0.850). However, the combined strategy group demonstrated superior improvement in symptom and function compared to the CI group at the 3-month (VAS: [21.9 ± 13.5] vs. [39.6 ± 20.4]; AOFAS-AHS: [77.9 ± 12.4] vs. [60.5 ± 17.4], P < 0.05) and 12-month follow-up (VAS: [15.7 ± 12.0] vs. [56.8 ± 17.5]; AOFAS-AHS: [84.5 ± 10.7] vs. [53.8 ± 12.4], P < 0.05). Obvious adverse effects or complications were not identified in either group, while two cases (11.8%) in the combined strategy group and five cases (20.0%) in the CI group experienced unsatisfactory symptom remission.</p><p><strong>Conclusions: </strong>We introduced and detailed a novel combination strategy involving ultrasound-guided percutaneous RFA and CI for treating recalcitrant PF. The strategy is both effective and safe in alleviating pain and enhancing function throughout the entire treatment course.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1137-1149"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393219/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141498678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Change in Endogenous Pain Modulation Depending on Emotional States in Healthy Subjects: A Randomized Controlled Trial.","authors":"Kordula Lang-Illievich, Christoph Klivinyi, Julia Ranftl, Ala Elhelali, Sascha Hammer, Istvan S Szilagyi, Helmar Bornemann-Cimenti","doi":"10.1007/s40122-024-00642-1","DOIUrl":"10.1007/s40122-024-00642-1","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic pain is a public health issue, leading to substantial healthcare costs and diminished quality of life for sufferers. While the role of anxiety in pain modulation has been extensively studied, the effects of other emotional states on the body's pain control mechanisms remain less understood. This study sought to explore how different emotions (happiness, anger, sadness, and interest) affect conditioned pain modulation (CPM) and the wind-up phenomenon in healthy adults.</p><p><strong>Methods: </strong>This randomized controlled, cross-over trial involved 28 healthy participants aged 18-60. Participants watched video clips designed to induce specific emotions: happiness, anger, sadness, and interest. Emotional states were assessed using a 7-point Likert scale. Pain modulation was measured using CPM and the wind-up phenomenon. CPM was assessed with a hot water bath as the conditioning stimulus and pressure pain tolerance as the test stimulus. Wind-up was measured using pinprick needle stimulators and a visual analog scale. Data were analyzed using paired t tests to compare pre- and post-emotion induction values.</p><p><strong>Results: </strong>Significant changes in emotional self-assessment values were observed for all emotions. Happiness increased CPM (4.6 ± 11.4, p = 0.04277), while sadness - 9.9 ± 23.1, p = 0.03211) and anger - 9.1 ± 23.3, p = 0.04804) decreased it. Interest did not significantly alter CPM (- 5.1 ± 25.8, p = 0.31042). No significant effects were found for the wind-up phenomenon across any emotional states.</p><p><strong>Conclusion: </strong>This study shows that emotional states significantly affect the body's ability to modulate pain. Positive emotions like happiness enhance pain inhibition, while negative emotions such as sadness and anger impair it. These findings suggest that emotional modulation techniques could be integrated into pain management strategies to improve patient outcomes. Further research should explore a broader range of emotions and include objective measures to validate these results.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1287-1298"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393222/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141889903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy.","authors":"Jason E Pope, Ajay Antony, Erika A Petersen, Steven M Rosen, Dawood Sayed, Corey W Hunter, Johnathan H Goree, Chau M Vu, Harjot S Bhandal, Philip M Shumsky, Todd A Bromberg, G Lawson Smith, Christopher M Lam, Hemant Kalia, Jennifer M Lee, Abeer Khurram, Ian Gould, Dean M Karantonis, Timothy R Deer","doi":"10.1007/s40122-024-00631-4","DOIUrl":"10.1007/s40122-024-00631-4","url":null,"abstract":"<p><strong>Introduction: </strong>Drawbacks of fixed-output spinal cord stimulation (SCS) screening trials may lead to compromised trial outcomes and poor predictability of long-term success. Evoked compound action potential (ECAP) dose-controlled closed-loop (CL) SCS allows objective confirmation of therapeutic neural activation and pulse-to-pulse stimulation adjustment. We report on the immediate patient-reported and neurophysiologic treatment response post-physiologic CL-SCS and feasibility of early SCS trial responder prediction.</p><p><strong>Methods: </strong>Patient-reported pain relief, functional improvement, and willingness to proceed to permanent implant were compared between the day of the trial procedure (Day 0) and end of trial (EOT) for 132 participants in the ECAP Study undergoing a trial stimulation period. ECAP-based neurophysiologic measurements from Day 0 and EOT were compared between responder groups.</p><p><strong>Results: </strong>A high positive predictive value (PPV) was achieved with 98.4% (60/61) of patients successful on the Day 0 evaluation also responding at EOT. The false-positive rate (FPR) was 5.6% (1/18). ECAP-based neurophysiologic measures were not different between patients who passed all Day 0 success criteria (\"Day 0 successes\") and those who did not (\"needed longer to evaluate the therapy\"). However, at EOT, responders had higher therapeutic usage and dose levels compared to non-responders.</p><p><strong>Conclusions: </strong>The high PPV and low FPR of the Day 0 evaluation provide confidence in predicting trial outcomes as early as the day of the procedure. Day 0 trials may be beneficial for reducing patient burden and complication rates associated with extended trials. ECAP dose-controlled CL-SCS therapy may provide objective data and rapid-onset pain relief to improve prognostic ability of SCS trials in predicting outcomes.</p><p><strong>Trial registration: </strong>The ECAP Study is registered with ClinicalTrials.gov (NCT04319887).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1173-1185"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393271/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141559463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of Rimegepant in Adults with Migraine and Cardiovascular Risk Factors: Analysis of a Multicenter, Long-Term, Open-Label Study.","authors":"David True, Kathleen Mullin, Robert Croop","doi":"10.1007/s40122-024-00626-1","DOIUrl":"10.1007/s40122-024-00626-1","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiovascular (CV) risk factors can limit treatment options for migraine. Rimegepant is an orally administered small-molecule calcitonin gene-related peptide receptor antagonist that does not induce vasoconstriction. The aim of these post hoc subgroup analyses was to assess the safety of rimegepant according to CV risk.</p><p><strong>Methods: </strong>In a multicenter, long-term, open-label, phase II/III safety study, participants with a history of 2-14 migraine attacks per month of moderate or severe pain intensity self-administered rimegepant 75 mg, orally, to treat migraine up to once daily for up to 52 weeks. Uncontrolled, unstable, or recently diagnosed CV disease was part of the exclusion criteria. Safety was assessed across subgroups according to number of CV risk factors (0, 1, or ≥ 2) and Framingham Risk Score (< 10% or ≥ 10%).</p><p><strong>Results: </strong>Of 1800 treated participants, 28.8% had one CV risk factor and 12.1% had ≥ 2 CV risk factors; 7.0% had Framingham Risk Score ≥ 10%. Across the subgroups with 0, 1, and ≥ 2 CV risk factors and Framingham Risk Score < 10% and ≥ 10%, respectively, proportions of participants reporting adverse events (AEs; 59.6%, 61.4%, 62.2%, 59.9%, 67.5%) and serious AEs (2.7%, 2.5%, 2.3%, 2.6%, 2.4%) were consistent, and AEs leading to study drug discontinuation were low (1.9%, 3.1%, 5.5%, 2.5%, 4.8%).</p><p><strong>Conclusions: </strong>Rimegepant showed favorable safety and tolerability in adults with migraine and CV risk factors, including those with moderate to high CV risk.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03266588.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1203-1218"},"PeriodicalIF":4.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11393218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141564035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}