Pain and Therapy最新文献

{"title":"Neurological Deficits Following Regional Anesthesia and Pain Interventions: Reviewing Current Standards of Care.","authors":"Salah N El-Tallawy, Rania S Ahmed, Gehan I Salem, Tariq A Alzahrani, Mamdouh M Haddara, Radwa H Ahmed, Mohamed S Nagiub, Abdullah T Alsubaie, Mohamed M Ali, Mahmoud M Elbasha, Ahmed A Ahmed","doi":"10.1007/s40122-025-00726-6","DOIUrl":"10.1007/s40122-025-00726-6","url":null,"abstract":"<p><p>Regional anesthesia (RA) has become an integral part of modern anesthesia practice and acute pain management strategies. It provides effective pain relief, reduces opioid consumption, and facilitates enhanced recovery after surgery. However, like any medical intervention, RA is not without risks. RA is associated with potential complications, including neurological deficits which can range from mild and transient to severe and permanent. These neurological deficits may result from non-adherence to established standards of care and deviations from the clinical practice guidelines. An online database search was conducted across multiple websites to identify the relevant articles. The inclusion criteria were articles in English, published between January 2010 and July 2024. The search included various study types, such as case series, observational studies, cross-sectional analyses, cohort studies, longitudinal studies, systematic reviews, and practice guidelines. A total of 38 articles met the inclusion criteria and were included in this comprehensive review which examines the neurological complications associated with regional anesthesia and pain interventions, with a particular focus on how deviations from the standards of care contribute to adverse neurological outcomes. Furthermore, it highlights preventive strategies aimed at minimizing the risks of these complications and improving patient safety.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"817-839"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085444/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721026","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":"Trends in Opioid and Non-opioid Prescriptions in Austria (2016-2021): A Nationwide Study on Utilization and Concomitant Benzodiazepine Use.","authors":"Aylin Bilir, Lorenz Kapral, Andrea Michalek-Sauberer, Razvan Bologheanu, Felix Gruber, Oliver Kimberger","doi":"10.1007/s40122-025-00736-4","DOIUrl":"10.1007/s40122-025-00736-4","url":null,"abstract":"<p><strong>Introduction: </strong>Although global opioid consumption is decreasing, high-income populations are experiencing an increase. Data on specific opioid-prescribed and at-risk patient groups in Austria are lacking.</p><p><strong>Methods: </strong>We performed a retrospective observational population-based study analysing health insurance data between January 2016 and December 2021. The dataset included demographic information; hospital data, including coded primary and secondary discharge diagnoses; and prescription data for all legally available opioids and nonopioid analgesics. The primary objective was to describe trends in opioid and nonopioid analgesic prescriptions. Logistic regression analysis was conducted to identify potential risk factors for receiving an opioid prescription.</p><p><strong>Results: </strong>The study cohort included 7,274,651 individuals. During the observation period, the percentage of individuals receiving an opioid prescription decreased by 14.69% (4.22-3.60%). The number of individuals receiving an opioid prescription was consistently greatest for tramadol. A particularly strong positive correlation was observed between opioid prescriptions and the concurrent use of benzodiazepines (odds ratio [OR], 1.45 [95% confidence interval {CI}, 1.43-1.47]). Furthermore, a history of persistent somatoform pain disorder (OR, 1.28 [95% CI, 1.21-1.36]) and a diagnosis of pain disorder (OR, 1.26 [95% CI, 1.25-1.28]) were identified as significant risk factors. In 2021, general practitioners were the predominant initial opioid prescribers, issuing 82.17% of the prescriptions, followed by hospital staff and orthopaedic specialists.</p><p><strong>Conclusion: </strong>Prescription opioid use decreased from 2016 to 2021, with tramadol representing the most prevalent opioid. The study revealed a strong link between opioid and benzodiazepine prescriptions and an association with persistent somatoform pain disorder, where opioid use is typically not recommended. Interactive map available for this article.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1131-1145"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085738/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993886","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":"Efficacy and Safety of Mirogabalin in Patients with Neuropathic Pain Due to Cervical Spondylotic Radiculopathy: Miro-Cens, A Randomized, Controlled, Interventional Study.","authors":"Takashi Hirai, Atsushi Okawa, Hiroshi Takahashi, Kazuhito Shiosakai, Toshitaka Yoshii","doi":"10.1007/s40122-025-00722-w","DOIUrl":"10.1007/s40122-025-00722-w","url":null,"abstract":"<p><strong>Introduction: </strong>There are few studies of pharmacotherapy of neuropathic pain in cervical spondylotic radiculopathy (CSR). Miro-Cens aimed to examine the efficacy and safety of mirogabalin for treating pain in patients with CSR on non-steroidal anti-inflammatory drugs (NSAIDs), compared with NSAIDs alone.</p><p><strong>Methods: </strong>Miro-Cens was a 12-week, multicenter, randomized, controlled, open-label, interventional study in Japan. Eligible patients with CSR having upper limb pain (visual analog scale score ≥ 40 mm) were randomly assigned in a 1:1 ratio to the mirogabalin add-on to NSAIDs group and the NSAIDs alone group. The primary endpoint was the change in the weekly average numerical rating scale (NRS) score for upper limb pain from baseline at Week 12.</p><p><strong>Results: </strong>The mirogabalin add-on group and NSAIDs alone group included 72 and 70 patients, respectively. The mirogabalin add-on group had a significantly greater reduction in the NRS score for upper limb pain than the NSAIDs alone group: estimated changes from baseline at Week 12, - 2.63 [95% confidence interval (CI) - 3.14, - 2.11] in the mirogabalin add-on group; - 1.07 (- 1.62, - 0.53) in the NSAIDs alone group; intergroup difference, - 1.55 (- 2.31, - 0.80; p < 0.001). The responder rate on the NRS score at Week 12 was significantly higher in the mirogabalin add-on group than in the NSAIDs alone group: ≥ 30% improvement, 71.7% vs. 39.6%; ≥ 50% improvement, 58.3% vs. 22.6% (both p < 0.001). The frequent treatment-emergent adverse drug reactions in the mirogabalin add-on group were the known ones (somnolence and dizziness), with most being mild or moderate in severity.</p><p><strong>Conclusion: </strong>In patients with CSR, combination therapy with mirogabalin and NSAIDs significantly improved neuropathic pain compared with NSAID monotherapy. No new safety concerns were identified, although caution should be exercised regarding somnolence and dizziness. These findings suggest that concomitant use of mirogabalin with NSAIDs could be tolerable and a novel treatment option for CSR patients with insufficient analgesic effects on NSAIDs.</p><p><strong>Trial registration number: </strong>jRCTs031210629.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1063-1079"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085725/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025838","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":"Outcomes of Cooled Radiofrequency Ablation of Lumbar Nerves as Treatment for Chronic Low Back Pain.","authors":"Alaa Abd-Elsayed, Trevor N Johnson, Kylie K Ruprecht, Tristan R Argall, Lukas J Henjum, Kenneth J Fiala","doi":"10.1007/s40122-025-00717-7","DOIUrl":"10.1007/s40122-025-00717-7","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Worldwide, 23% of adults suffer from chronic lower back pain, which is defined as pain persisting for more than 3-6 months [Merskey in Can J Psychiatry 34:329-336, 1989]. The lifetime prevalence of back pain is as high as 84% in adults [Casiano VE, Sarwan G, Dydyk AM, et al. Back Pain. [Updated 2023 Dec 11]. In: Stat Pearls [Internet]. Treasure Island (FL): Stat Pearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538173/ ]. Conservative treatment options for chronic low back pain include as needed or scheduled analgesics, physical therapy, anticonvulsants, exercise, weight loss, muscle relaxants, and much more. With chronic pain that is refractory to the aforementioned treatments, more invasive procedures may be indicated. Cooled radiofrequency ablation (CRFA), a minimally invasive therapy, utilizes internally cooled radiofrequency probes to deliver targeted thermal energy that causes neurolysis, disrupting the transmission of pain stimuli along nociceptive pathways, thus resulting in pain relief [Walker in J Spinal Disord 13:205-217, 2000 June]. This study investigates whether patients receiving CRFA for relief of chronic low back pain caused by lumbar facet arthropathy experience a reduction in pain scores, the length of this reduction in pain scores, and the magnitude of this reduction in pain.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study was a retrospective analysis of data extracted from UW-Health Electronic Medical Health records (EMR), encompassing lumbar CRFA procedures performed from 2015 through April of 2024. Patient data was obtained, including diagnosis, preoperative pain score, postoperative pain score, duration of relief, patient age, sex, and BMI. A two-tailed paired t test was used to statistically analyze the preoperative and postoperative pain scores, in which a p value ≤ 0.05 was considered significant.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 1450 lumbar CRFA procedures were reviewed, and 206 were excluded due to absent pre- or post-op pain scores. An additional eight procedures were excluded due to weekly lidocaine infusions in between their procedure and reporting of their post-op score. 1026 CRFA patients were included in the analysis, comprising 584 females and 442 males with an average age of 59.81 ± 13.40 and a BMI of 31.67 ± 7.13. The average pre-procedure visual analog scale (VAS) pain score was 6.44 (6.44 ± 1.67, n = 1236), and the average post-procedure VAS pain score was 3.21 (3.21 ± 2.45, n = 1236) this achieved statistical significance (p &lt; 0.0001). Improvement of pain symptoms was reported in 85.92% (n = 1062), 14.08% (n = 174) reported complete pain remission, 7.61% (n = 94) reported no change, and 6.47% (n = 80) reported worsening symptoms. For effective procedures (those with any amount of pain relief, n = 1062) with an available postoperative pain score, the mean percentage improvement was 60.56 ± 27.21%. The average duration of improvement wa","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"949-956"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143597514","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":"The Use of Opioids in an Acute Palliative Care Unit to Re-assess Prescriptions.","authors":"Sebastiano Mercadante, Giorgio Sapienza, Alessio Lo Cascio, Alessandra Casuccio","doi":"10.1007/s40122-025-00728-4","DOIUrl":"10.1007/s40122-025-00728-4","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to re-assess opioid prescriptions in an acute palliative care unit (APCU) 12 years after a previous audit.</p><p><strong>Methods: </strong>Consecutive patients with advanced cancer who were admitted to the APCU for a period of 5 months for uncontrolled pain were analyzed. Information regarding opioids, and route of administration, prescribed prior to admission, during admission, and at time of discharge was recorded. Opioids, doses, and routes were changed according to the clinical need to obtain the maximum benefit, individualizing the treatment. The opioid escalation index was calculated in milligrams (OEImg) and as a percentage (OEI%).</p><p><strong>Results: </strong>A total of 113 patients were assessed. The mean pain intensity at admission and at time of discharge was 6.4 (SD 1.8) and 2.3 (SD 1.4), respectively (P < 0.0005). The mean opioid dose expressed as oral morphine equivalent (OME) by patients who were receiving opioids before admission was 128 mg/day (SD 120). There was no statistical difference in OME between admission and discharge time. Sixty-one and 20 patients were prescribed a second and a third opioid/route, respectively. Mean OEI% and OEImg were 9.3% (SD = 22.5) and 4.0 mg/day (SD = 24.1), respectively. Only a minority of patients had a breakthrough pain prescription at admission. Intravenous morphine was more frequently prescribed at beginning, then replaced by oral morphine and fentanyl preparations at discharge.</p><p><strong>Conclusions: </strong>An intensive and careful use of opioids in the APCU allows for the achievement of adequate analgesia in all examined patients within a short time, without increasing OME. These findings should encourage further studies in APCUs as well as in other palliative care settings.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"999-1006"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143743565","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":"Psychosocial Assessment as a Key Component in an Integrated, Personalized Care Pathway: A Protocol for a Low Back Pain Randomized Controlled Trial.","authors":"Anna Anselmo, Maria Pagano, Francesco Corallo, Irene Cappadona, Davide Cardile, Fabrizio Russo, Alice Laudisio, Giuseppe F Papalia, Angelo Quartarone, Rocco S Calabrò","doi":"10.1007/s40122-025-00741-7","DOIUrl":"10.1007/s40122-025-00741-7","url":null,"abstract":"<p><strong>Introduction: </strong>Low back pain (LBP) is the primary factor contributing to years lived with disability. In view of the close correlation between the functions of the body, which cannot be examined piecemeal but as an integrated system, a holistic approach allows for a comprehensive assessment of the patient. The main objective of this study is to evaluate the impact of face-to-face or remote rehabilitation treatment on the psychosocial aspects of patients with chronic low back pain (CLBP) examining all possible related dimensions: cognitive function, anxiety and depression, pain perception, treatment adherence, the sexual sphere, family dynamics, social support, dysfunctional communication, quality of life (QoL), while also considering attribution of causes.</p><p><strong>Methods: </strong>This prospective, randomized, controlled trial with blinded outcome assessors evaluates the psychosocial functioning of 86 patients with chronic LBP. Participants divided into two groups to compare tele-rehabilitation with face-to-face rehabilitation with a 1:1 randomization based on a web-based system will all undergo neuropsychological, psychological, and associated clinical condition assessment through standardized tests and ad hoc questionnaires at enrollment (T0), after 1 month (T1), 2 months (T2), and 6 months (T3). The analysis involves descriptive statistics, ANOVA, and correlation tests to evaluate treatment effects and psychosocial outcomes at multiple time points.</p><p><strong>Planned outcomes: </strong>We expect this study to provide a comprehensive, in-depth, and integrated understanding of the patient, shedding light on the challenges they may face in managing chronic LBP (CLBP). Repeated administration of the questionnaires will allow us to monitor the patient over time, assess any changes in their health status, and structure an intervention tailored to their needs. By emphasizing these often neglected areas through a comprehensive, multi-step assessment, it will be possible to quantify and analyze how these risk factors can affect patients' wellbeing and hinder the treatment process and recovery.</p><p><strong>Trial registration: </strong>Registered on Clinicaltrials.gov (ID: NCT06895317).</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1155-1168"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085730/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025958","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":"Exploring the Role of the Cerebellum in Pain Perception: A Narrative Review.","authors":"Orita Manda, Marios Hadjivassiliou, Giustino Varrassi, Periklis Zavridis, Panagiotis Zis","doi":"10.1007/s40122-025-00724-8","DOIUrl":"10.1007/s40122-025-00724-8","url":null,"abstract":"<p><p>This systematic review aims to reassess the expanding role of the cerebellum in pain perception, challenging its traditional and simplistic association with the motor domain. Pain perception is a complex experience shaped by sensory, emotional, and cognitive factors, with recent findings underlining the cerebellum's influence over these systems. This paper evaluates findings from 24 relevant studies to elucidate key findings with regard to pain and their potential clinical applications. The cerebellum's role in pain processing is assessed through its interaction with nociceptive pathways, pain anticipation, and the intonation of pain-related emotional responses. Key cerebellar regions such as Crus I, lobules VI and VIII, and the vermis, are persistently activated during pain perception and anticipation. These regions are linked to sensory-discriminative and affective-motivational elements of pain. Studies on patients with migraines, chronic low back pain, and irritable bowel syndrome (IBS) demonstrated increased cerebellar activation, suggesting its role in chronic pain conditions. Non-invasive neurostimulation techniques, such as transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), administered onto these cerebellar regions, show potential in modulation of pain and clinical application. Future research should aim to standardise methodologies, explore the cerebellum's role in acute pain, and investigate long-term effects of cerebellar-targeted treatments. Understanding the cerebellum's multifaceted role in pain perception can advance diagnostic and therapeutic strategies, offering a more comprehensive approach to pain management. This review underscores the need for further investigation into cerebellar mechanisms and their clinical applications, potentially transforming pain treatment paradigms.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"803-816"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143649957","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":"Evaluating the Real-World Use of Topical Diclofenac Sodium Gel 1% Using US Longitudinal Electronic Health Records Database: A study supporting OTC switch.","authors":"Nicholas M Sicignano, Frédérique Bariguian Revel, Richard Petruschke, Francis P Barbone, Karin Nicholson, Jess D Edison","doi":"10.1007/s40122-025-00723-9","DOIUrl":"10.1007/s40122-025-00723-9","url":null,"abstract":"<p><strong>Introduction: </strong>Musculoskeletal conditions are a significant health challenge and second leading cause of disability worldwide. Diclofenac sodium topical gel 1% (DSG1%) provides effective relief of arthritis pain. While clinical studies show that DSG1% is safe and well-tolerated, long-term safety and tolerability in real-world settings are limited. This study aimed to profile users and prescribers of DSG1% and to evaluate its safety and tolerability over a screening period of 8.5 years with an average follow-up of nearly 1 year. The focus was on patients with risk factors and comorbidities, especially those taking concomitant medication in addition to topical nonsteroidal anti-inflammatory drugs (NSAIDs).</p><p><strong>Methods: </strong>This retrospective, longitudinal cohort study used the US Department of Defense (DoD) electronic health records (EHR) database. The database included 521,593 individuals with ≥ 1 prescription for DSG1% for either indicated or non-indicated conditions with mean (standard deviation; SD) follow-up of 348.4 (562.4) days. The primary outcome measure assessed the incidence of predefined events of interest (EOIs), including gastrointestinal, hepatic, renal diseases, cardiovascular events, hypertension, skin reaction, misuse, abuse, and death (all-cause mortality).</p><p><strong>Results: </strong>The average age of subjects was 56.7 years (SD = 18.1), with women comprising 60.4% of population. During study-period, 74.2% of subjects experienced no adverse EOIs after initiating treatment with DSG1%. Among the remaining 25.8%, average time to first EOI was 244.0 (SD = 368.6) days. Notably, the frequency of reported EOIs increased with age. Additionally, subjects with conditions such as rheumatoid arthritis, systemic lupus erythematosus, or diabetes had a higher incidence of cardiovascular EOIs.</p><p><strong>Conclusions: </strong>The study results indicate that DSG demonstrated a favorable safety profile, particularly for patients with comorbidities and high-risk factors and when used with other medications. Despite an older population and high baseline risk factors (93%), only 26% DSG1% users experienced a predefined EOI, observed on average 244.0 (368.6) days from index date. These findings confirm the long-term tolerability of topical DSG1% for musculoskeletal disorders.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1007-1024"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085454/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143764589","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":"Adverse Reactions Following First-Dose Administration of Co-Crystal of Tramadol-Celecoxib Versus Tramadol Alone for Moderate-To-Severe Acute Pain.","authors":"Adelaida Morte, Mariano Sust, Anna Vaqué, Jesús Cebrecos, José María Giménez-Arnau","doi":"10.1007/s40122-025-00730-w","DOIUrl":"10.1007/s40122-025-00730-w","url":null,"abstract":"<p><strong>Introduction: </strong>Phase 3 clinical trials in moderate-to-severe acute pain have shown that co-crystal of tramadol-celecoxib (CTC) has improved efficacy and comparable tolerability versus immediate-release tramadol 50 mg alone, with a similar tramadol daily dose, over a 48-h treatment period. However, it is not known how first-dose tolerability compares, given that the administered dose of tramadol is higher in CTC 200 mg (88 mg) versus immediate-release tramadol 50 mg. This was explored in a post hoc analysis of a pivotal phase 3 trial.</p><p><strong>Methods: </strong>A randomized, double-blind, factorial, active- and placebo-controlled phase 3 trial was conducted in patients with moderate-to-severe acute postoperative pain (NCT03108482) and has been previously reported. This post hoc analysis evaluated the prevalence of the four most common study drug-related, opioid-associated, treatment-emergent adverse reactions reported in phase 3 CTC clinical trials: somnolence, nausea, dizziness, and vomiting. Prevalence was evaluated in 2-h intervals, up to 6 h post first dose (just before second-dose administration) of CTC 200 mg or immediate-release tramadol 50 mg p.o. Descriptive analysis was performed.</p><p><strong>Results: </strong>Each group comprised 183 participants for analysis. The proportions of patients reporting drug-related, treatment-emergent adverse reactions of somnolence, nausea, dizziness, and vomiting were similar between treatment groups at 2, 4, and 6 h following the first dose.</p><p><strong>Conclusions: </strong>This post hoc analysis indicates that the higher dose of tramadol (88 mg) given in CTC 200 mg did not result in an increase in drug-related adverse reactions after first-dose administration, and had a similar tolerability profile, compared with immediate-release tramadol 50 mg alone (the lowest dose recommended for the management of moderate-to-severe acute pain). This is in line with earlier findings for the 48-h treatment period of this phase 3 trial and may be explained by CTC's differentiated physiochemical properties related to its co-crystal structure. These findings may have utility for practicing clinicians.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT03108482.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1147-1154"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085740/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993766","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":"Naldemedine Use and Healthcare Resource Utilization in Patients treated with Opioid Analgesics for Chronic Non-Cancer Pain: Results of a Real-world Study in the USA.","authors":"Antonio De Vincentis, Bin Cai, Marco Moscarda, Peter M F Barnes, Raffaele Antonelli Incalzi","doi":"10.1007/s40122-025-00720-y","DOIUrl":"10.1007/s40122-025-00720-y","url":null,"abstract":"<p><strong>Introduction: </strong>Opioid-induced constipation (OIC) is a common side effect of chronic opioid therapy that significantly impacts quality of life and healthcare costs. Naldemedine, a peripherally acting mu-opioid receptor antagonist, has shown efficacy in treating OIC. However, real-world evidence on naldemedine use in the United States is limited, particularly in older adults. We aimed to describe naldemedine use in real-world settings in the US, focusing on clinical characteristics, comorbidity profiles, co-prescribed medications, and healthcare resource utilization (HCRU), with a specific emphasis on older adults.</p><p><strong>Methods: </strong>This retrospective study analyzed data from the 2017-2022 Merative™ MarketScan^® Commercial and Medicare Databases. We identified 2110 naldemedine users aged ≥ 30 years on chronic opioid therapy. Demographic and clinical characteristics, co-prescribed medications, and HCRU were evaluated. Subgroup analysis focused on patients aged ≥ 65 years.</p><p><strong>Results: </strong>The study cohort (66% women, median age 56 years, 14% aged ≥ 65 years) presented a significant comorbidity burden, with 57% having hypertension, 36% diabetes, and 25% chronic pulmonary disease with a Charlson Comorbidity Index ≥ 2 in 38% of subjects. Polypharmacy (i.e., use of five or more distinct drugs, excluding naldemedine) was very common (76%, 82% in ≥ 65 years). The most frequent indications for naldemedine were chronic back pain and radiculopathy. Oxycodone, hydrocodone, and morphine were the most commonly prescribed opioids. After initiating naldemedine, 30% of patients showed a reduction in hospitalizations per patient per year, with a more pronounced effect in older adults (37%). Potential drug-drug interactions with CYP3A4 inducers or inhibitors were infrequent and did not appear to impact HCRU.</p><p><strong>Conclusions: </strong>This real-world study demonstrates that naldemedine is predominantly used in middle-aged adults with comorbidities and polypharmacy. Naldemedine use was associated with reduced HCRU, particularly in older adults, suggesting potential benefits in managing OIC. The findings support the safety and effectiveness of naldemedine in real-world settings, including in older patients with multiple comorbidities.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"957-969"},"PeriodicalIF":4.1,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085462/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143616757","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}