In a small study involving 54 participants, omicron subvariants BA.2.12.1, BA.4, and BA.5 of SARS-CoV-2 were more likely to escape neutralizing antibodies induced by both vaccination and previous infection than were the prior omicron subvariants BA.1 and BA.2. The most trusted, influential source of new medical knowledge and clinical best practices in the world. ACE denotes angiotensin-converting enzyme, GLP-1 glucagon-like peptide 1, IQR interquartile range, and SGLT2 sodiumglucose cotransporter 2. In this multicenter, double-blind trial of convalescent plasma for early, symptomatic SARS-CoV-2 infection, 1225 patients were randomly assigned to receive convalescent plasma or control plasma within 9 days after the onset of symptoms. 24. Canadian data show that legalization of cannabis for adults has been associated with increased hospitalizations for unintentional cannabis poisoning in children, mostly after legalization of cannabis edibles. Early Remdesivir to Prevent Progression to Severe Covid We thank Jo Luscombe, Ph.D., of Chameleon Communications International for medical writing assistance with an earlier version of the manuscript. The most advanced way to teach, practice, and assess clinical reasoning skills. and Indiana University Hospital (G.W.S. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. J Clin Oncol 2008;26:721-728. Only the 1000 most recent citing articles are listed here. Characteristics of the Patients in the Intention-to-Treat Population at Baseline. Kidney Int 2018;93:1344-1355. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. 4. Overall, the frequency of adverse events was similar in the two groups. Kurian AW, Bondarenko I, Jagsi R, et al. In this ongoing household cohort study in Nicaragua, previous SARS-CoV-2 infection during a second Covid-19 wave provided some protection against symptomatic Covid-19, with greater protection against severe illness. Demographic and Clinical Characteristics of the Patients at Baseline.*. Further insight into the cardiorenal efficacy and safety of finerenone in patients with type 2 diabetes and less advanced CKD will be provided by the ongoing Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial.24. The first draft of the manuscript was prepared by the first author and was reviewed and edited by all the authors. Safety analyses were performed in the safety analysis set (all randomly assigned patients without critical Good Clinical Practice violations who received at least one dose of finerenone or placebo). S5 through S10 in the Supplementary Appendix). 22. Original ArticleGlycemia Reduction in Type 2 Diabetes Microvascular and Cardiovascular OutcomesEditorialAfter Metformin Next Steps for Type 2 Diabetes with Low Cardiovascular Risk. Stay connected to what's important in medical research and clinical practice, Subscribe to the most trusted and influential source ofmedical knowledge. The trial was designed to show noninferiority of endocrine therapy alone for invasive diseasefree survival (defined as freedom from invasive disease recurrence, second primary cancer, or death). Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. Women with a recurrence score of 10 or lower were assigned to receive endocrine therapy only, and women with a score of 26 or higher were assigned to receive chemotherapy plus endocrine (chemoendocrine) therapy. The number of patients with missing data was low, and a prespecified tipping-point analysis of the primary outcome supported the robustness of the results (Table S5 and Fig. Remove your gloves, rewash your hands, and put on another pair of gloves; then remove your mask and follow your institutional guidelines for disposal or reuse. Follow the CDC directions for direct processing of the swab specimen or placement of the swab in media with or without refrigeration. 4. Albain KS, Barlow WE, Shak S, et al. Finerenone or placebo was withheld if potassium concentrations exceeded 5.5 mmol per liter and restarted when potassium levels fell to 5.0 mmol per liter or less. The clinician is shown wearing the PPE required during collection of a nasopharyngeal swab specimen. After a third (booster) dose of SARS-CoV-2 vaccine, immunity waned more slowly than after two doses and even more slowly in persons with breakthrough Covid-19. Overall, adverse events that occurred during the treatment period were balanced between the two groups. ); Vanderbilt University, Nashville (I.A.M. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. When all recurrence-score cohorts (10, 11 to 25, and 26) and treatment-group assignments were considered, there were significant differences in the rates of invasive diseasefree survival, recurrence, and death (P<0.001), driven largely by the higher likelihood of having an event in the cohort with a recurrence score of 26 or higher (Fig. We conducted a prospective clinical trial sponsored by the National Cancer Institute that was coordinated by the Eastern Cooperative Oncology Group (ECOG) and subsequently by the ECOGAmerican College of Radiology Imaging Network (ACRIN) Cancer Research Group, with other federally funded groups participating, including the Southwest Oncology Group, Alliance for Clinical Trials in Oncology, NRG Oncology, and Canadian Cancer Trials Group. Dr. Bakris reports receiving steering committee fees, paid to the University of Chicago, from Novo Nordisk and Vascular Dynamics, consulting fees from Relypsa, Vifor Pharma, Merck, Ionis Pharmaceuticals, and Alnylam Pharmaceuticals, and steering committee fees, paid to the University of Chicago, and consulting fees from Bayer; Dr. Agarwal, receiving steering committee fees, consulting fees, and travel support from Akebia Therapeutics, Relypsa, Sanofi US Services, Sanofi-Aventis, and Reata Pharmaceuticals, steering committee fees, adjudication committee fees, consulting fees, and travel support from Janssen Research and Development, consulting fees and travel support from Vifor Fresenius Medical Care Renal Pharma, Eli Lilly, and Merck, adjudication committee fees, consulting fees, and travel support from Boehringer Ingelheim, fees for serving on a data and safety monitoring board, consulting fees, and travel support from AstraZeneca, fees for serving on a data and safety monitoring board from Ironwood Pharmaceuticals, lecture fees and travel support from Fresenius USA Marketing, meal reimbursement from Otsuka America Pharmaceutical, Opko Pharmaceuticals, and E.R. Interim guidelines for collecting, handling, and testing clinical specimens from persons for coronavirus disease 2019 (COVID-19). Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. Information, resources, and support needed to approach rotations - and life as a resident. both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G. The Trial Assigning Individualized Options for Treatment (TAILORx) was designed to address these gaps in our knowledge by determining whether chemotherapy is beneficial for women with a mid-range recurrence score of 11 to 25. Cardiovascular Risk Reduction with Icosapent Ethyl for Panel A shows the primary composite outcome of kidney failure, a sustained decrease of at least 40% in the estimated glomerular filtration rate (eGFR) from baseline, or death from renal causes in the finerenone and placebo groups. Adverse events that occurred during the treatment period were defined as those that started or worsened during finerenone or placebo intake or up to 3 days after any temporary or permanent interruption. In this retrospective cohort study involving pregnant women, those who had been vaccinated against Covid-19 did not have a higher risk of clinically serious adverse events than those who were unvaccinated. During the frightening early months of the Covid pandemic, a palliative care physician finds herself silently mouthing a familiar mantra: Im OK. Were OK. Well be OK. A greater treatment effect from adjuvant chemotherapy has been noted in younger women,7 which may be at least partly explained by an antiestrogenic effect associated with premature menopause induced by chemotherapy.27 We did not collect data on chemotherapy-induced menopause. Expanding Efforts to Improve Physician Well-Being, Mental Health Implications of Abortion Restrictions for Historically Marginalized Populations, Work Hours and Depression in U.S. These events were classified according to the standardized MedDRA Query term. Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P=0.001). The spread of the omicron variant produced an increase in Covid-19 in Israel in late 2021, and a second boost of BNT162b2 vaccine was authorized in early January 2022. During the next 19 months, multiple fractures of the metatarsal bones of the right foot occurred. Gritzfeld JF, Roberts P, Roche L, El Batrawy S, Gordon SB. 20. and University of Pittsburgh (A.M.B. Cancer Res 2017;78:Suppl:GS4-03-GS4-03. Patients frequently ask two questions about the asymptomatic stones: Will my stones ever become symptomatic? and How do we get those stones to come out before A 17-year-old girl was admitted because of prolonged fever and cough. A causal relationship between any adverse event and administration of finerenone or placebo was based on the opinion of the reporting investigator. Full definitions of all the end points are provided in the Supplementary Appendix. Selecting breast cancer patients for chemotherapy: the opening of the UK OPTIMA trial. Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. No fatal hyperkalemia adverse events were reported. Krop I, Ismaila N, Andre F, et al. Significantly fewer recipients of convalescent plasma had progression of Covid-19associated illness leading to hospitalization. Effect of finerenone on albuminuria in patients with diabetic nephropathy: a randomized clinical trial. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. 6. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. Unvaccinated persons without previous Covid-19 had the highest risk of omicron infection; those who had been infected after emergence of the delta variant and had received three mRNA vaccine doses were the most protected. N Engl J Med 1985;312:665-673. Early Transmission Dynamics in Wuhan, China Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkins Lymphoma, Early Amino Acids in Extremely Preterm Infants and Neurodisability at 2 Years, Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression, https://medlineplus.gov/ency/article/003747.htm, https://apps.who.int/iris/bitstream/handle/10665/331329/WHO-COVID-19-laboratory-2020.4-eng.pdf, https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html, Prone Positioning of Intubated Patients with an Elevated Body-Mass Index, Use of eFAST in Patients with Injury to the Thorax or Abdomen, Placement of a Double-Lumen Endotracheal Tube, Nasal Cauterization with Silver Nitrate for Recurrent Epistaxis, NEJM Catalyst Innovations in Care Delivery. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. The key secondary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. In part 2, nearly 4000 6-to-11-year-olds received two doses of vaccine or placebo and were followed for a median of 82 days. Bakris GL, Agarwal R, Anker SD, et al. This virus was also found in shrews. Swain SM, Jeong J-H, Geyer CE Jr, et al. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. A new equation to estimate glomerular filtration rate. Patients in the finerenone group also had a lower risk of a key secondary outcome event (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure). The New England Journal of Medicine Latest in Emergency Medicine. There had been 836 events of invasive disease recurrence, second primary cancer, or death (the components of invasive diseasefree survival, the primary end point) in the two randomly assigned treatment groups at the time of the final analysis, including 338 (40.4%) recurrences of breast cancer as the first event, of which 199 (23.8% of the total events) were distant recurrences (Tables S4 and S5 in the Supplementary Appendix). Tocilizumab in Giant-Cell Arteritis Patients in the finerenone group also had a significantly lower risk of a key secondary outcome event (death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure), which occurred in 367 patients (13.0%) in the finerenone group and 420 patients (14.8%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P=0.03) (Figure 2 and Fig. Kolkhof P, Delbeck M, Kretschmer A, et al. Patients were required to have a serum potassium level of 4.8 mmol per liter or less at the time of screening. Bakris GL, Agarwal R, Chan JC, et al. Aerosol and Surface Stability of SARS-CoV-2 as Compared with Our trial was a phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trial. Randomized comparison of adjuvant tamoxifen (T) plus ovarian function suppression (OFS) versus tamoxifen in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): update of the SOFT trial. Postal Service, and Genomic Health. NEW! The stratification factors that were used in randomization were tumor size (2 cm vs. >2 cm), menopausal status (pre- vs. postmenopausal), planned chemotherapy (taxane-containing vs. not), planned radiation therapy (whole breast and no boost irradiation planned vs. whole breast and boost irradiation planned vs. partial breast irradiation planned vs. no planned radiation therapy for patients who had undergone a mastectomy), and recurrence-score group (11 to 15 vs. 16 to 20 vs. 21 to 25), which was added midway through the trial. No one who is not an author contributed to the manuscript. Tilt the patients head back slightly, so that the nasal passages become more accessible. In a 6-month study in children while omicron was dominant, previous SARS-CoV-2 infection and the BNT162b2 vaccine lowered the risks of infection, hospitalization, and death, but protection against omicron declined rapidly. Lachin JM, Foulkes MA. NEW! But she is not OK. Welcome to books on Oxford Academic. 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