Clinical therapeutics最新文献

{"title":"Correlation Between Vitamin D, Inflammatory Markers, and T Lymphocytes With the Severity of Chronic Obstructive Pulmonary Disease and its Effect on the Risk of Acute Exacerbation: A Single Cross-sectional Study","authors":"Yeqian Jiang ,&nbsp;Mingzhu Li ,&nbsp;Yan Yu ,&nbsp;Hejun Liu ,&nbsp;Qianbing Li MM","doi":"10.1016/j.clinthera.2024.10.003","DOIUrl":"10.1016/j.clinthera.2024.10.003","url":null,"abstract":"<div><h3>Purpose</h3><div>Chronic obstructive pulmonary disease (COPD) will become the fourth largest cause of death of chronic diseases in the world in 2030. The incidence of COPD ranked top among chronic diseases in the world. At present, there is a lack of simple and effective drugs for the treatment of COPD and for slowing the progression of the disease. The application of vitamin D as a drug in clinical treatment has been a research hotspot. In this study, we investigated the correlation between serum 25-hydroxyvitamin D (25(OH)D), inflammatory markers, and T lymphocytes with the severity of COPD and its effect on the risk of acute exacerbation.</div></div><div><h3>Methods</h3><div>In this study, we recruited hospital inpatients and outpatient clinic patients with COPD. Their levels of 25(OH)D, inflammatory markers, and T lymphocytes were assessed. We built a nomogram model to evaluate the risk of acute exacerbation of COPD.</div></div><div><h3>Findings</h3><div>The inflammatory mediators were higher in patients with acute exacerbation of COPD (AECOPD) than those in patients with COPD, but 25(OH)D showed the opposite phenomenon. In logistic regression analysis, high levels of neutrophil-lymphocyte ratio, C-reactive protein, and partial pressure of carbon dioxide and low levels of vitamin D, partial pressure of oxygen, and forced expiratory volume in the first as a percentage of predicted were regarded as independent risk factors for AECOPD. These variables were used for the construction of the nomogram model. The AUCs of the model were 0.971 (95% CI, 0.952–0.989), and 0.981 (95% CI, 0.959–1.000) in the training and testing set respectively, demonstrating that the model exhibited high accuracy for the prediction of the risk of acute exacerbation of COPD. The calibration curve of the nomogram found a high degree of consistency between the expected and actual values. The decision curve analysis and clinical impact curve indicated that the nomogram has clinical applicable for patients with COPD.</div></div><div><h3>Implications</h3><div>A considerable percentage of patients with COPD were found to have insufficient vitamin D levels. Patients with AECOPD reported more symptoms than those with COPD. The variables neutrophil-lymphocyte ratio, C-reactive protein, partial pressure of carbon dioxide, 25(OH)D, partial pressure of oxygen, and forced expiratory volume in the first as a percentage of predicted can be used for the prediction of AECOPD. Accordingly, this study provided experimental rationales for the role of 25(OH)D in the prevention and the potential anti-inflammatory mechanisms involved in the control of the COPD process.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 44-54"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616368","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-effectiveness Analysis of Tumor Treating Fields Therapy Combined With Immune Checkpoint Inhibitor in Metastatic Non-small-cell Lung Cancer","authors":"Mengwei Zhang ,&nbsp;Ping Yue ,&nbsp;Yuanying Feng ,&nbsp;Yuan Gao ,&nbsp;Chao Sun ,&nbsp;Peng Chen","doi":"10.1016/j.clinthera.2024.09.022","DOIUrl":"10.1016/j.clinthera.2024.09.022","url":null,"abstract":"<div><h3>Background</h3><div>The LUNAR clinical trial revealed that incorporating Tumor Treating Fields (TTFields) therapy alongside immune checkpoint inhibitor (ICI) significantly prolonged the overall survival of patients with metastatic, platinum-resistant non-small-cell lung cancer (NSCLC). However, the cost of TTFields therapy is high and may further increase the financial burden for patients. Our research aims to evaluate the cost-effectiveness of TTFields therapy addition with ICI for metastatic NSCLC.</div></div><div><h3>Methods</h3><div>We constructed a Markov model to evaluate the healthcare costs associated with TTFields therapy combined with ICI for the treatment of advanced NSCLC. In this model, the clinical data utilized came from the LUNAR trial, while drug costs and health state utility values were extracted from public databases and relevant scholarly publications. The major outcomes incorporated costs, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER).</div></div><div><h3>Results</h3><div>Compared with ICI therapy alone, ICI combination with TTFields therapy resulted in 0.42 QALYs at the cost of $167,329, with an ICER of $398,402.38 per year. The calculated ICER surpassed the generally accepted US willingness-to-pay (WTP) threshold of 150,000 per QALY. One-way sensitivity analyses demonstrated that the utility of progression disease is the most influential factor, followed by the cost of TTFields therapy, the utility of progression-free survival, the cost of ICI, and the cost of adverse events in TTFields therapy combined with ICI. Only when the cost of TTFields therapy is reduced by approximately 80.48%, it would be cost-effective within the commonly accepted WTP threshold of $150,000/QALY.</div></div><div><h3>Conclusions</h3><div>According to the US WTP, the combination of TTFields therapy with ICI does not currently represent a cost-effective strategy for metastatic NSCLC followed progression on platinum-resistant therapy. Considering its promising clinical outcomes for metastatic NSCLC, it is necessary to control the expenses of this therapeutic strategy in future applications.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 15-20"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496507","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"When Politics Influence Access to Care: The United States Maternal and Infant Health Divide","authors":"Jill L. Maron MD, MPH","doi":"10.1016/j.clinthera.2024.11.025","DOIUrl":"10.1016/j.clinthera.2024.11.025","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 1-2"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of Remimazolam on Preventing Adverse Reactions Caused by Carboprost Tromethamine During Cesarean Section","authors":"Jianjun Fan MD,&nbsp;Zhiguo Zhang MD,&nbsp;Jie Wang BD,&nbsp;Dianwei Han BD,&nbsp;Yongbo Zhen BD,&nbsp;Jinpei Fan BD,&nbsp;Shuai Wang BD,&nbsp;Fei Wang BD","doi":"10.1016/j.clinthera.2024.09.020","DOIUrl":"10.1016/j.clinthera.2024.09.020","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the effectiveness of remimazolam in preventing adverse reactions triggered by carboprost tromethamine during cesarean section procedures.</div></div><div><h3>Methods</h3><div>A total of 200 parturients scheduled for cesarean sections at risk of postpartum hemorrhage in our hospital from October 2022 to July 2023 were included. The participants were assigned via random number table method to either a study group or a control group, resulting in 100 cases in each. All parturients received combined spinal and epidural anesthesia (CSEA) during cesarean section, followed by administration of carboprost tromethamine (250 µg) for preventing postpartum hemorrhage after childbirth. CSEA was performed with 1.8 to 2 mL of 0.5% bupivacaine and 7 to 10 mL of 2% lidocaine. The study group was given remimazolam via intravenous infusion at a rate of 0.3 mg/kg/h commencing at 1 minute prior to CSEA and concluding with a final dosage adjustment 20 minutes preceding the end of surgery, while the control group was given the same volume of saline within this time frame. Primary outcome measures were adverse reactions and sedative effects of the parturients.</div></div><div><h3>Findings</h3><div>Nausea and vomiting were the only adverse reactions that exhibited significant differences between groups. The study group reported significantly fewer cases (32 cases) of nausea and vomiting when compared to the 48 cases observed in the control group. Moreover, the use of remimazolam appeared to alleviate the severity of nausea and vomiting, as evidenced by the significantly lower incidence of Grade III event and the higher risk of Grade I event in comparison with the control group (<em>P</em> &lt; 0.05). The Apgar scores of newborns at birth and 5 minutes after birth were compared, and no statistically significant difference was found (<em>P</em> &gt; 0.05). Parturients receiving remimazolam exhibited better effective sedation outcomes and were more satisfied with the treatment when compared with controls (<em>P</em> &lt; 0.05). There were no significant differences in postpartum bleeding volume at 2 and 12 hours postpartum, as well as in the duration of postpartum bleeding between the two groups (<em>P</em> &gt; 0.05).</div></div><div><h3>Implications</h3><div>Intravenous administration of remimazolam effectively prevents adverse reactions induced by carboprost tromethamine during cesarean section performed under CSEA, thereby improving sedative effects.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 3-8"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Factors for INtubation-SURfactant-Extubation Failure in Infants With Neonatal Respiratory Distress Syndrome","authors":"Haoming Chen MSc,&nbsp;Qingfei Hao MD,&nbsp;Jing Zhang MD,&nbsp;Yanna Du MD,&nbsp;Hafiz Muhammad Sohail Sarwar MSc,&nbsp;Jing Li MSc,&nbsp;Tiantian Yang MSc,&nbsp;Xiuyong Cheng MD","doi":"10.1016/j.clinthera.2024.10.009","DOIUrl":"10.1016/j.clinthera.2024.10.009","url":null,"abstract":"<div><h3>Purpose</h3><div>To identify clinical characteristics predictive of failure or success of the INtubation-SURfactant-Extubation (INSURE) strategy, to distinguish infants who could be managed using this strategy to prevent mechanical ventilation (MV).</div></div><div><h3>Methods</h3><div>Infants with a gestational age &lt;32 weeks were classified into two groups according to whether they required reintubation and MV within 72 h after birth. The clinical characteristics of the two groups were subsequently analyzed.</div></div><div><h3>Results</h3><div>INSURE was unsuccessful in 77 infants (20.7%). Infants in the INSURE failure group had a higher incidence of severe respiratory distress syndrome, as evidenced by radiological grade; lower blood pH, partial oxygen pressure, and base excess (BE) levels; higher partial carbon dioxide pressure levels at the first arterial blood gas analysis; lower Apgar scores at 1 and 5 min; lower use of antenatal steroids; and higher occurrence of gestational diabetes mellitus, versus those in the INSURE success group. Multiple regression analysis confirmed severe radiological grade, lower BE levels at the first arterial blood gas analysis, and decreased use of antenatal steroids as independent risk factors for INSURE failure. Compared with infants in the INSURE success group, those in the INSURE failure group also had higher mortality.</div></div><div><h3>Conclusions</h3><div>We successfully identified specific predictors of an unsuccessful INSURE strategy. Maintaining high-risk preterm infants with one or several predictors intubated and treated with MV after surfactant administration can prevent reintubation and reduce mortality.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 1","pages":"Pages 9-14"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681265","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Changes to In-hospital Drug Formularies on Out-of-hospital Prescription Rates and Cost: A Systematic Review","authors":"Eduardo Carracedo-Martínez PhD ,&nbsp;Nuria Choren-Alvarez MSc ,&nbsp;Raquel Vázquez-Mourelle PhD ,&nbsp;Adolfo Figueiras PhD","doi":"10.1016/j.clinthera.2024.12.005","DOIUrl":"10.1016/j.clinthera.2024.12.005","url":null,"abstract":"<div><h3>Purpose</h3><div>One of the main goals of an in-hospital drug formulary (in-HDF) is to modulate hospitalized patients’ drug utilization. Theoretically, however, in-HDFs could also have an impact on out-of-hospital prescriptions in several ways, including discharged patients taking chronic medications that were initiated during hospitalization, hospital physicians prescribing to outpatients as if in-HDFs were equally applicable to the latter (“spillover effect”), and primary care physicians subsequently not changing such prescriptions (“induced prescription”). The aim of this study was thus to conduct a systematic review of papers that studied the impact of changes to in-HDF on out-of-hospital prescriptions.</div></div><div><h3>Methods</h3><div>We conducted a search of the PubMed and Embase databases. To be eligible for inclusion, studies had to be reported in English, Spanish, French, or Portuguese; as their designated aim, studies had to seek to evaluate the impact of a change in at least 1 active ingredient in the in-HDF on out-of-hospital prescriptions; and studies had to have at least 1 control period before the in-HDF change or a control group without any such change.</div></div><div><h3>Findings</h3><div>A total of 8 studies met the inclusion criteria: in 7 of these, out-of-hospital drug-utilization rates changed in line with the changes made to in-HDFs, with a decrease if the drug had been removed or restricted and an increase if the drug had been included and/or the opposite for competitor me-too medicines. Only 4 papers analyzed the impact on costs, half of which reported no statistically significant result.</div></div><div><h3>Implications</h3><div>Changes to in-HDFs have an impact on out-of-hospital prescription rates. Further studies are needed to examine the cost aspect since a research gap has been identified.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 219-225"},"PeriodicalIF":3.2,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Persistence Among Anti-Tumor Necrosis Factor–experienced Patients With Ulcerative Colitis Switching to a Biologic With a Different Mode of Action or Cycling to Another Anti–Tumor Necrosis Factor Agent","authors":"Maryia Zhdanava MA ,&nbsp;Sabree Burbage PharmD, MPH ,&nbsp;Porpong Boonmak MD, MPHS, PhD ,&nbsp;Sumesh Kachroo PhD ,&nbsp;Aditi Shah MA ,&nbsp;Bridget Godwin MD ,&nbsp;Dominic Pilon MA","doi":"10.1016/j.clinthera.2024.12.002","DOIUrl":"10.1016/j.clinthera.2024.12.002","url":null,"abstract":"<div><h3>Purpose</h3><div>In ulcerative colitis (UC), anti–tumor necrosis factor (TNF) agents often are first-line biologic therapy. Switching to a biologic with a different mode of action (ustekinumab and vedolizumab) or cycling to another anti–TNF agent (adalimumab, infliximab, and golimumab) is necessary if an initial anti–TNF fails. This study compared real-world persistence in patients with UC who switched to a biologic with a different mode of action or cycled with another anti–TNF after nonresponse to an anti–TNF.</div></div><div><h3>Methods</h3><div>Adults with UC treated with an anti–TNF, who switched or cycled (index date) between October 21, 2019, and March 02, 2022, were selected from the IQVIA PharMetrics® Plus database. Patients had ≥12 months of continuous insurance eligibility before the first anti–TNF without UC-indicated biologics or advanced therapies. During the 12 months before the index date (baseline period), patients had no other immune disorders and discontinued the first anti–TNF. Baseline characteristics were balanced using inverse probability of treatment weights. Persistence on the index biologic was defined as no therapy exposure gaps &gt;120 days (ustekinumab, vedolizumab, and infliximab) or &gt;60 days (adalimumab and golimumab) between days of supply. Composite end points were persistence while corticosteroid-free (&lt;14 consecutive days of corticosteroid supply after day 90 post-index) and persistence while on monotherapy (no immunomodulators/nonindex biologics/advanced therapies). End points were assessed with weighted Kaplan-Meier and Cox proportional hazards models 12 months after the maintenance phase started.</div></div><div><h3>Findings</h3><div>The switch cohort included 488 patients (mean age: 41.4 years; 44.9% female), and the cycle cohort included 129 patients (mean age: 40.7 years; 43.8% female). At 12 months after the maintenance phase started, the proportions of persistent patients (switch cohort: 79.6%; cycle cohort: 64.9%) and persistent patients on monotherapy (switch cohort: 74.6%; cycle cohort: 48.0%) were significantly higher in the switch versus cycle cohort; the proportions of persistent patients while corticosteroid-free was also higher in the switch (60.1%) versus cycle cohort (49.3%) but was not significant. In the switch cohort, the rate of persistence was 1.92 times higher (hazard ratio [HR] = 1.92; 95% CI, 1.31−2.82), the rate of persistence while on monotherapy was 2.56 times higher (HR = 2.56; 95% CI, 1.86−3.53), and the rate of persistence and being corticosteroid-free was 1.31 times higher (HR = 1.31; 95% CI, 0.98−1.77) than in the cycle cohort.</div></div><div><h3>Implications</h3><div>Patients with UC who switched from an anti–TNF agent to a biologic with a different mode of action were more persistent on treatment than patients who cycled to another anti–TNF agent. Findings may aid physicians whose patients experience treatment failure on the first anti–TNF agent.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 204-211"},"PeriodicalIF":3.2,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Amoxicillin Blood Concentration in High-Dose Intravenous Discontinuous Amoxicillin: Look Beyond Numbers. Max-Amox Study","authors":"Mélissa Clément MD ,&nbsp;Florence Anglade MD ,&nbsp;Lucie Gibold MD ,&nbsp;Delphine Martineau MSc ,&nbsp;Claude Dubray PhD ,&nbsp;Marc Ruivard PdD ,&nbsp;Marc André PhD ,&nbsp;Anne Tournadre PhD ,&nbsp;Guillaume Clerfond MD ,&nbsp;Etienne Geoffroy MD ,&nbsp;Xavier Moisset PhD ,&nbsp;Claire Dupuis MD ,&nbsp;Bruno Pereira MSc ,&nbsp;Damien Richard MD ,&nbsp;Magali Vidal MD","doi":"10.1016/j.clinthera.2024.12.003","DOIUrl":"10.1016/j.clinthera.2024.12.003","url":null,"abstract":"<div><h3>Purpose</h3><div>High doses of amoxicillin are recommended to treat severe infections such as endocarditis. Amoxicillin causes dose-dependent toxicities, in particular crystal nephropathy. Toxicity could be avoided by monitoring of amoxicillin trough plasma concentrations (ATPC). However, the relevance of ATPC testing in routine medical practice remains poorly studied.</div></div><div><h3>Methods</h3><div>We conducted a prospective clinical trial in adults treated with high doses of discontinuous intravenous amoxicillin in a French university hospital. The primary outcome was the distribution of ATPCs over three days during the first week of treatment. Urine tests for amoxicillin crystalluria (AC), pH, and density were also performed.</div></div><div><h3>Findings</h3><div>Seventy patients were included. Overall intra-class correlation (ICC) was 0.35 IC95% [0.21; 0.53] with the following pairwise concordances: D1-D4 (n= 55) 0.23 IC95% [-0.02; 0.47], D1-D7 (n= 47) 0.41 IC95% [0.19; 0.63], and D4-D7 (n= 50) 0.17 IC95% [-0.10; 0.43]. Inter-individual variability was also significant, with coefficients of variation being 0.87 at D1, 1.20 at D4, and 1.35 at D7. AC occurred in 32 patients (47.8%). Risk of AC increased when pH was below or equal to 6 (<em>P</em> = 0.002). ATPCs were higher in patients with AC and/or acute kidney injury.</div></div><div><h3>Implications</h3><div>Variability in ATPC was high and ATPC cannot be considered as the only monitoring tool to adjust amoxicillin dosage. High ATPC, low urinary pH, and presence of AC can alert physicians to a potential iatrogenic effect and lead to the decision to hydrate the patient, alkalinize urine and decrease the dosage of amoxicillin.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 212-218"},"PeriodicalIF":3.2,"publicationDate":"2024-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142902622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polyneuropathy in Parkinson's Disease is Highly Prevalent and Not Related to Treatment","authors":"Valeria Sajin MD ,&nbsp;Uwe Jahnke MD ,&nbsp;Uazman Alam MPHe, FRCP(UK), PhD ,&nbsp;Antonella Macerollo MD, PhD, FRCP (London), FEBN","doi":"10.1016/j.clinthera.2024.12.004","DOIUrl":"10.1016/j.clinthera.2024.12.004","url":null,"abstract":"<div><h3>Purpose</h3><div>An increased prevalence of peripheral polyneuropathy (PN) in Parkinson's disease (PD) associated with greater functional impairment has previously been reported. A possible cause has been suggested as levodopa therapy. The aim of this real-world study was to assess the prevalence and the characteristics of PN in PD and to investigate the putative association between PN and oral levodopa.</div></div><div><h3>Methods</h3><div>A cohort of 692 consecutive patients with idiopathic PD had routine clinical, laboratory, and lower limb clinical neurophysiology assessment when attending the certified tertiary Parkinson center, Schön Klinik Neustadt, Neustadt in Holstein, Germany, between 2016 and 2019. Patients were sent by general neurologists for the medication adjustment, physiotherapy, ergotherapy, and logopaedic treatment. A retrospective cross-sectional review of the data was performed.</div></div><div><h3>Findings</h3><div>The mean age of the cohort was 72.6 (8.44) years (range, 44–90 years) and 60% were male. The age of the first PD manifestation was 65.22 (10.09) years (range, 31–88 years). Of 692 patients with PD, 507 (73.27%) had clinical signs of neuropathy and PN was first diagnosed 6.3 (5.7) years after the PD onset. Of these 507 patients, 446 (87.96%) underwent the electrophysiological investigations with PN confirmed in 396 patients (88.79% out of 446 electrophysiologically investigated patients with PD). Peripheral polyneuropathy was ruled out in 50 patients (11.21% of 446 electrophysiologically investigated patients with PD). The half of patients had moderate and severe sensory axonal PN (201 patients or 53.03% of all 396 with confirmed PN). The mean motor examination part of the Movement Disorders Society's Unified PD Rating Scale score in patients with PN was significantly higher (off, 30.48 [11.60] points; on, 19.92 [10.27] points), than in patients without PN (off, 27.17 [14.57] points; on, 17.14 [11.98] points), with <em>P</em> &lt; 0.01 in the both off and on states.</div><div>The mean levodopa daily dosage was similar in patients with PN and without PN (565 mg vs 556 mg, <em>P</em> = nonsignificant). No difference between other dopaminergic medication in PN and non-PN group was found.</div></div><div><h3>Implications</h3><div>PN is highly prevalent in patients with PD. There was no association between oral levodopa or other dopaminergic medication and PN. More awareness of PN in PD clinics and further understanding of the pathophysiology, which leads to the development of an axonal polyneuropathy in PD, are required.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages e13-e21"},"PeriodicalIF":3.2,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on “Pancreatitis and Pancreatic Cancer Risk Among Patients With Type 2 Diabetes Receiving Dipeptidyl Peptidase 4 Inhibitors: An Updated Meta-Analysis of Randomized Controlled Trials”","authors":"Yuki Nakano PhD ,&nbsp;Kazuki Adachi B. Pharm ,&nbsp;Kazumasa Kotake B. Pharm","doi":"10.1016/j.clinthera.2024.08.021","DOIUrl":"10.1016/j.clinthera.2024.08.021","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"46 12","pages":"Page 1086"},"PeriodicalIF":3.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}