NEJM evidence最新文献

{"title":"Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors in Kidney Disease.","authors":"Jeffrey T Ha, Swapnil Hiremath, Min Jun, Suetonia C Green, David C Wheeler, Daniel W Coyne, Vlado Perkovic, Sunil V Badve","doi":"10.1056/EVIDoa2300189","DOIUrl":"10.1056/EVIDoa2300189","url":null,"abstract":"<p><strong>Background: </strong>Hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors are an oral treatment for anemia of chronic kidney disease (CKD). In this systematic review and meta-analysis, we assessed long-term safety of HIF prolyl hydroxylase inhibitors.</p><p><strong>Methods: </strong>We searched MEDLINE, Embase, and Cochrane databases for randomized trials comparing HIF prolyl hydroxylase inhibitors with an erythropoiesis-stimulating agent (ESA) or placebo with greater than or equal to 48 weeks of follow-up. The primary outcome was major adverse cardiovascular event (MACE), defined as a composite of all-cause death, myocardial infarction, or stroke. Treatment effects were pooled using random-effects models.</p><p><strong>Results: </strong>Twenty-five trials involving 26,478 participants were included. Of these, 13 trials enrolled 13,230 participants with dialysis-dependent CKD, and 12 trials enrolled 13,248 participants with nondialysis-dependent CKD. There was no evidence that HIF prolyl hydroxylase inhibitors and ESA had different effects on MACE in people with dialysis-dependent CKD (risk ratio, 0.99; 95% confidence interval [CI], 0.92 to 1.08) or people with nondialysis-dependent CKD (risk ratio, 1.08; 95% CI, 0.95 to 1.22). Similarly, there was no evidence that HIF prolyl hydroxylase inhibitors and placebo had different effects on MACE (risk ratio, 1.10; 95% CI, 0.96 to 1.27) in people with nondialysis-dependent CKD. The lack of difference between HIF prolyl hydroxylase inhibitors and ESA or placebo was observed for individual components of MACE and cardiovascular death. Safety of HIF prolyl hydroxylase inhibitors for other outcomes was comparable with ESA in dialysis-dependent CKD. In nondialysis-dependent CKD, dialysis access thrombosis, venous thromboembolism, infections, and hyperkalemia occurred more frequently with HIF prolyl hydroxylase inhibitors in placebo-controlled trials but not in ESA-controlled trials.</p><p><strong>Conclusions: </strong>There was no evidence of a difference in the long-term cardiovascular safety profile of HIF prolyl hydroxylase inhibitors and ESA in adults with dialysis-dependent CKD and adults with nondialysis-dependent CKD. (PROSPERO registration number, CRD42021278011.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDoa2300189"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Looking in the Mirror - My Experience in a Clinical Trial for the Treatment of Pancreatic Cancer.","authors":"Bernice Blanchard","doi":"10.1056/EVIDpp2400264","DOIUrl":"https://doi.org/10.1056/EVIDpp2400264","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDpp2400264"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"\"Permanent\" Contraception - Reexamining Modern Tubal Sterilization Effectiveness.","authors":"Julia Tasset, Maria Rodriguez","doi":"10.1056/EVIDe2400263","DOIUrl":"https://doi.org/10.1056/EVIDe2400263","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDe2400263"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Host-Directed Therapies for Posttuberculosis Lung Disease.","authors":"Akshay N Gupte, Edward A Nardell","doi":"10.1056/EVIDe2400181","DOIUrl":"https://doi.org/10.1056/EVIDe2400181","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDe2400181"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How Factorial Design Works.","authors":"Suellen Li, Juned Siddique, Emily Ling, Daniel Muller, C Corey Hardin, Chana A Sacks","doi":"10.1056/EVIDstat2400279","DOIUrl":"https://doi.org/10.1056/EVIDstat2400279","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDstat2400279"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Case for Access to Data Monitoring Committee Charters.","authors":"Deborah Zarin, Janet T Wittes, Thomas R Fleming, Frank Rockhold, Susan Ellenberg, David L DeMets","doi":"10.1056/EVIDctw2400058","DOIUrl":"10.1056/EVIDctw2400058","url":null,"abstract":"<p><p>AbstractClinical trials investigating novel or high-risk interventions often use data monitoring committees (DMCs) to ensure that the participants' best interests are safeguarded. The typical DMC charter describes procedures by which the DMC operates, including important details concerning organizational structure, membership, meeting frequency, statistical monitoring guidelines, and contents of DMC reports for interim review. These charters, however, are not routinely publicly available; in some cases, their access could be important to the interpretation of trial results. We recommend including DMC charters for such trials in ClinicalTrials.gov at the time of trial completion; trial protocols, informed consent documents, and statistical analysis plans are already available in this repository.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 9","pages":"EVIDctw2400058"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intensive Glucose Control in Critically Ill Patients - How Low Do We Go?","authors":"Shohinee Sarma","doi":"10.1056/EVIDe2400196","DOIUrl":"https://doi.org/10.1056/EVIDe2400196","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDe2400196"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A 53-Year-Old Woman with Axillary Lymphadenopathy.","authors":"Liem Pham, Javier Gomez Farias, Jennifer Bacci, Asina Wahab, Anish Nihalani","doi":"10.1056/EVIDmr2400040","DOIUrl":"10.1056/EVIDmr2400040","url":null,"abstract":"<p><p>AbstractMorning Report is a time-honored tradition where physicians-in-training present cases to their colleagues and clinical experts to collaboratively examine an interesting patient presentation. The Morning Report section seeks to carry on this tradition by presenting a patient's chief concern and story, inviting the reader to develop a differential diagnosis and discover the diagnosis alongside the authors of the case. This report examines the story of a 53-year-old woman with a history of breast cancer who presented with abnormal axillary lymph nodes detected on surveillance imaging. Using history, physical examination, and diagnostic workup, an illness script for her presentation emerges. A differential diagnosis is developed and refined until a final diagnosis is confirmed.</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDmr2400040"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Exchange about \"Population-Based Disease Odds for E-Cigarettes and Dual Use versus Cigarettes\".","authors":"","doi":"10.1056/EVIDe2400220","DOIUrl":"https://doi.org/10.1056/EVIDe2400220","url":null,"abstract":"","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":"3 8","pages":"EVIDe2400220"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141749878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Operative versus Nonoperative Treatment of Proximal Hamstring Avulsions.","authors":"Elsa Pihl, Sofia Laszlo, Anne-Mari Rosenlund, Målfrid Holen Kristoffersen, Jörg Schilcher, Carl Johan Hedbeck, Mikael Skorpil, Chiara Micoli, Martin Eklund, Olof Sköldenberg, Frede Frihagen, Kenneth B Jonsson","doi":"10.1056/EVIDoa2400056","DOIUrl":"10.1056/EVIDoa2400056","url":null,"abstract":"<p><strong>Background: </strong>Operative treatment is widely used for acute proximal hamstring avulsions, but its effectiveness compared with that of nonoperative treatment has not been shown in randomized trials.</p><p><strong>Methods: </strong>In this noninferiority trial at 10 centers in Sweden and Norway, we enrolled patients 30 to 70 years of age with a proximal hamstring avulsion in a randomized trial and a parallel observational cohort. Treatments were operative reinsertion of the tendons or nonoperative management. The primary end point was the Perth Hamstring Assessment Tool (PHAT) at 2 years of follow-up. Secondary outcomes included scores on the Lower Extremity Functional Scale (LEFS).</p><p><strong>Results: </strong>A total of 119 patients were enrolled in the randomized trial and 97 patients in the observational cohort. In the per-protocol analysis of the randomized trial, the mean (±standard deviation) PHAT scores were 79.9±19.5 and 78.5±19.4 in the operative and nonoperative groups, respectively (PHAT scores range from 0 to 100, with higher scores indicating higher function). The prespecified noninferiority limit of 10 points was not crossed (mean difference, -1.2; 95% confidence interval [CI], -8.6 to 6.2; P=0.009 for noninferiority). Analyses of secondary outcomes, including a mean difference in the LEFS score of -1.6 (95% CI, -5.2 to 2.0), aligned with the primary outcome. The observed numbers of adverse events in the randomized trial were nine in the operative group versus three in the nonoperative group (odds ratio, 0.3; 95% CI, 0.1 to 1.2). In the analysis of the observational cohort, the mean PHAT score difference between the nonoperative and operative treatment groups was -2.6 (95% CI, -9.9 to 4.6).</p><p><strong>Conclusions: </strong>In patients 30 to 70 years of age with proximal hamstring avulsions, nonoperative treatment was noninferior to operative treatment. (Funded by Afa Försäkring and others; ClinicalTrials.gov number, NCT03311997.).</p>","PeriodicalId":74256,"journal":{"name":"NEJM evidence","volume":" ","pages":"EVIDoa2400056"},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141636046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}