{"title":"Colchicine and Spironolactone in Acute Myocardial Infarction.","authors":"Daan J L van Twist, Yael Appelboom","doi":"10.1056/NEJMc2503896","DOIUrl":"https://doi.org/10.1056/NEJMc2503896","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"2072"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight.","authors":"Linong Ji,Hongwei Jiang,Yan Bi,Hua Li,Junhang Tian,Dexue Liu,Yuzhu Zhao,Wei Qiu,Chongbing Huang,Lei Chen,Shao Zhong,Jie Han,Yawei Zhang,Qiufang Lian,Ping Yang,Lingchun Lv,Jieyu Gu,Zihan Liu,Huan Deng,Yanqi Wang,Li Li,Lijuan Pei,Lei Qian,","doi":"10.1056/nejmoa2411528","DOIUrl":"https://doi.org/10.1056/nejmoa2411528","url":null,"abstract":"BACKGROUNDEvidence suggests that incretin-based dual agonist pharmacotherapy is helpful in persons with obesity. Mazdutide, a glucagon-like peptide-1 and glucagon receptor dual agonist, may have efficacy in persons with overweight or obesity.METHODSIn a phase 3, double-blind, placebo-controlled trial in China, we randomly assigned, in a 1:1:1 ratio, adults 18 to 75 years of age who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 28 or had a BMI of 24 to less than 28 plus at least one weight-related coexisting condition to receive 4 mg of mazdutide, 6 mg of mazdutide, or placebo for 48 weeks. The two primary end points were the percentage change in body weight from baseline and a weight reduction of at least 5% at week 32, as assessed in a treatment-policy estimand analysis (which assessed effects regardless of early discontinuation of mazdutide or placebo and the initiation of new antiobesity therapies).RESULTSAmong 610 participants, the mean body weight was 87.2 kg and the mean BMI was 31.1 at baseline. At week 32, the mean percentage change in body weight from baseline was -10.09% (95% confidence interval [CI], -11.15 to -9.04) in the 4-mg mazdutide group, -12.55% (95% CI, -13.64 to -11.45) in the 6-mg mazdutide group, and 0.45% (95% CI, -0.61 to 1.52) in the placebo group, and 73.9%, 82.0%, and 10.5% of the participants, respectively, had a weight reduction of at least 5% (P<0.001 for all comparisons with placebo). At week 48, the mean percentage change in body weight from baseline was -11.00% (95% CI, -12.27 to -9.73) in the 4-mg mazdutide group, -14.01% (95% CI, -15.36 to -12.66) in the 6-mg mazdutide group, and 0.30% (95% CI, -0.98 to 1.58) in the placebo group, and 35.7%, 49.5%, and 2.0% of the participants, respectively, had a weight reduction of at least 15% (P<0.001 for all comparisons with placebo). Beneficial effects on all prespecified cardiometabolic measures were seen with mazdutide. The most frequently reported adverse events were gastrointestinal and mostly mild to moderate in severity. The incidence of adverse events leading to discontinuation of the trial regimen was 1.5% with the 4-mg mazdutide dose, 0.5% with the 6-mg mazdutide dose, and 1.0% with placebo.CONCLUSIONSIn Chinese adults with overweight or obesity, once-weekly mazdutide at a dose of 4 mg or 6 mg for 32 weeks led to clinically relevant reductions in body weight. (Funded by Innovent Biologics; GLORY-1 ClinicalTrials.gov number, NCT05607680.).","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"51 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144146193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Overweight and Obesity - Capturing the Whole Picture.","authors":"Vanita R Aroda,Leigh Perreault","doi":"10.1056/nejme2505819","DOIUrl":"https://doi.org/10.1056/nejme2505819","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"43 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144146183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Primary Care - From Common Good to Free-Market Commodity.","authors":"Zirui Song,Jane M Zhu","doi":"10.1056/nejmp2501717","DOIUrl":"https://doi.org/10.1056/nejmp2501717","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"1 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144146185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Undermining a PACT - Federal Cuts at the VA.","authors":"Pavan V Ganapathiraju,Rebecca J Traylor","doi":"10.1056/nejmp2504204","DOIUrl":"https://doi.org/10.1056/nejmp2504204","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"35 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144146186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katherine Y Tossas,Bianca D Owens,Susan Hong,John Quillin,Stephen Adkins,Maria Thomson,Robert A Winn
{"title":"The GINA Gap - Implications for Access to Personalized Medicine among Native Americans.","authors":"Katherine Y Tossas,Bianca D Owens,Susan Hong,John Quillin,Stephen Adkins,Maria Thomson,Robert A Winn","doi":"10.1056/nejmp2415951","DOIUrl":"https://doi.org/10.1056/nejmp2415951","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"38 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144146184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intravenous Tenecteplase before Thrombectomy in Stroke.","authors":"Zhongming Qiu,Fengli Li,Hongfei Sang,Guangxiong Yuan,Dongjing Xie,Kai Zhou,Maohua Li,Zhaoyou Meng,Zhenyu Kong,Zhongfan Ruan,Chaoqun Li,Guangui Yang,Junxiong Wu,Chen Long,Bo Yang,Hai Hu,Yanling Li,Jun Luo,Zhonghua Shi,Xianjun Huang,Shunfu Jiang,Tingyu Yi,Guoyong Zeng,Jincheng Liu,Xiaojun Luo,Shudong Liu,Mingze Chang,Youlin Wu,Yufeng Tang,Zhenxuan Tian,Zhizhong Yan,Haojin Zhao,Yuqi Peng,Hongguo Dai,Peiyang Zhou,Huagang Li,Wenhua Liu,Dengwen Song,Bo Lei,Zhongbin Xia,Xiaolin Tan,Maojun Zhao,Xinggang Feng,Lingyu Cai,Qi Li,Yuelu Wu,Bingwu Jiang,Yan Tian,Linyu Li,Ling Jiang,Xingmin Long,Feng You,Jian Tao,Jin Zhou,Derong Wu,Chong Zheng,Congguo Yin,Duolao Wang,Mengjie Lu,Gregory W Albers,Raul G Nogueira,Bruce C V Campbell,Thanh N Nguyen,Jeffrey L Saver,Wenjie Zi,Qingwu Yang,","doi":"10.1056/nejmoa2503867","DOIUrl":"https://doi.org/10.1056/nejmoa2503867","url":null,"abstract":"BACKGROUNDThe safety and efficacy of treatment with intravenous tenecteplase before endovascular thrombectomy in patients with acute ischemic stroke due to large-vessel occlusion remain uncertain.METHODSIn this open-label trial conducted in China, we randomly assigned patients with acute ischemic stroke due to large-vessel occlusion who had presented within 4.5 hours after onset and were eligible for thrombolysis to receive either intravenous tenecteplase followed by endovascular thrombectomy or endovascular thrombectomy alone. The primary outcome was functional independence (a score of 0 to 2 on the modified Rankin scale; range, 0 to 6, with higher scores indicating more severe disability) at 90 days. Secondary outcomes included successful reperfusion before and after thrombectomy. Safety outcomes included symptomatic intracranial hemorrhage within 48 hours and death within 90 days.RESULTSA total of 278 patients were randomly assigned to the tenecteplase-thrombectomy group and 272 to the thrombectomy-alone group. Functional independence at 90 days was observed in 147 patients (52.9%) in the tenecteplase-thrombectomy group and in 120 patients (44.1%) in the thrombectomy-alone group (unadjusted risk ratio, 1.20; 95% confidence interval, 1.01 to 1.43; P = 0.04). A total of 6.1% of the patients in the tenecteplase-thrombectomy group and 1.1% of those in the thrombectomy-alone group had successful reperfusion before thrombectomy, and 91.4% and 94.1%, respectively, had successful reperfusion after thrombectomy. Symptomatic intracranial hemorrhage within 48 hours occurred in 8.5% of the patients in the tenecteplase-thrombectomy group and in 6.7% of those in the thrombectomy-alone group; mortality at 90 days was 22.3% and 19.9%, respectively.CONCLUSIONSAmong patients with acute ischemic stroke due to large-vessel occlusion who had presented within 4.5 hours after onset, the percentage of patients with functional independence at 90 days was higher with intravenous tenecteplase plus endovascular thrombectomy than with endovascular thrombectomy alone. (Funded by the Chongqing Science and Health Joint Medical Research Project and others; BRIDGE-TNK ClinicalTrials.gov number, NCT04733742.).","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"56 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144103638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An Evidence-Based Approach to Covid-19 Vaccination.","authors":"Vinay Prasad,Martin A Makary","doi":"10.1056/nejmsb2506929","DOIUrl":"https://doi.org/10.1056/nejmsb2506929","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"9 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144103642","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Progress through Persistence - Turning the Page in Pulmonary Fibrosis Clinical Trials.","authors":"Joyce S Lee","doi":"10.1056/nejme2505760","DOIUrl":"https://doi.org/10.1056/nejme2505760","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"12 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144097755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Craig LaForce, Frank Albers, Anna Danilewicz, Allison Jeynes-Ellis, Monica Kraft, Reynold A Panettieri, Robert Rees, Samuel Bardsley, Lynn Dunsire, Tim Harrison, Olami Sobande, Raulin Surujbally, Frank Trudo, Christy Cappelletti, Alberto Papi, Richard Beasley, Bradley E Chipps, Elliot Israel, Hitesh Pandya, Martin Clancy, Leonard B Bacharier
{"title":"As-Needed Albuterol-Budesonide in Mild Asthma.","authors":"Craig LaForce, Frank Albers, Anna Danilewicz, Allison Jeynes-Ellis, Monica Kraft, Reynold A Panettieri, Robert Rees, Samuel Bardsley, Lynn Dunsire, Tim Harrison, Olami Sobande, Raulin Surujbally, Frank Trudo, Christy Cappelletti, Alberto Papi, Richard Beasley, Bradley E Chipps, Elliot Israel, Hitesh Pandya, Martin Clancy, Leonard B Bacharier","doi":"10.1056/NEJMoa2504544","DOIUrl":"https://doi.org/10.1056/NEJMoa2504544","url":null,"abstract":"<p><strong>Background: </strong>As-needed use of albuterol-budesonide has been shown to result in a significantly lower risk of severe asthma exacerbation than as-needed use of albuterol alone among patients with moderate-to-severe asthma. Data on albuterol-budesonide in mild asthma are needed.</p><p><strong>Methods: </strong>We conducted a fully virtual, decentralized, phase 3b, multicenter, double-blind, event-driven trial involving persons 12 years of age or older with disease that was uncontrolled despite treatment for mild asthma with a short-acting β<sub>2</sub>-agonist (SABA) with or without a low-dose inhaled glucocorticoid or leukotriene-receptor antagonist. Participants were randomly assigned in a 1:1 ratio to a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide (with each dose consisting of two inhaler actuations of 90 μg and 80 μg, respectively) or 180 μg of albuterol (with each dose consisting of two inhaler actuations of 90 μg) on an as-needed basis for up to 52 weeks. The primary end point was the first severe asthma exacerbation, assessed in a time-to-event analysis, in the on-treatment efficacy population, and the key secondary end point was the first severe exacerbation in the intention-to-treat population. Secondary end points included the annualized rate of severe asthma exacerbations and exposure to systemic glucocorticoids.</p><p><strong>Results: </strong>A total of 2516 participants underwent randomization; 1797 (71.4%) completed the trial. Of 2421 participants in the full analysis population (1209 assigned to the albuterol-budesonide group and 1212 to the albuterol group), 97.2% were 18 years of age or older; 74.4% used a SABA alone at baseline. The trial was stopped for efficacy at a prespecified interim analysis. A severe exacerbation occurred in 5.1% of the participants in the albuterol-budesonide group and in 9.1% of those in the albuterol group in the on-treatment efficacy population (hazard ratio, 0.53; 95% confidence interval [CI], 0.39 to 0.73) and in 5.3% and 9.4%, respectively, in the intention-to-treat population (hazard ratio, 0.54; 95% CI, 0.40 to 0.73) (P<0.001 for both comparisons). The annualized rate of severe asthma exacerbations was lower with albuterol-budesonide than with albuterol (0.15 vs. 0.32; rate ratio, 0.47; 95% CI, 0.34 to 0.64), as was the mean annualized total dose of systemic glucocorticoids (23.2 vs. 61.9 mg per year). Adverse events were similar in the two treatment groups.</p><p><strong>Conclusions: </strong>As-needed use of albuterol-budesonide resulted in a lower risk of a severe asthma exacerbation than as-needed use of albuterol alone among participants with disease that was uncontrolled despite treatment for mild asthma. (Funded by Bond Avillion 2 Development and AstraZeneca; BATURA ClinicalTrials.gov number, NCT05505734.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144103235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}