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The first set included persistent, moderately elevated albuminuria (urinary albumin-to-creatinine ratio [with albumin measured in milligrams and creatinine measured in grams], 30 to <300), an estimated glomerular filtration rate (eGFR, calculated with the use of the Chronic Kidney Disease Epidemiology Collaboration formula, with adjustment for race in Black patients17) of 25 to less than 60 ml per minute per 1.73 m2 of body-surface area, and a history of diabetic retinopathy. The key secondary outcome, assessed in a time-to-event analysis, was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Images in Clinical Medicine Oct 27, 2022 Necrotizing Myositis M. Arajo and I. M. Gonalves More from the week of July 27, 2017 When given as a second booster, a bivalent vaccine including sequences from the Wuhan-Hu-1 and omicron BA.1 viral strains induced higher levels of neutralizing antibodies against BA.4/5 subtypes than a Wuhan-Hu-1 booster. For professionals who work with children and adolescents, policies like Floridas Dont Say Gay law have outsized cruelty even beyond the enormous harm they will do to the young people we serve. S12 and S13 in the Supplementary Appendix) but not for freedom of recurrence of breast cancer at a distant site or distant or localregional site. Evidence-based guidelines recommend that the use of the assay be considered in cases of hormone-receptorpositive, HER2-negative breast cancer and high clinical risk but not low clinical risk as defined in that trial.31 When the same clinical risk definitions were applied in our trial, 73.9% of the patients were at low clinical risk and 26.1% were at high clinical risk in the randomized treatment groups (Table 1), and we found no evidence suggesting a chemotherapy benefit in either risk group. Amid the drug-overdose crisis, the federal governments efforts to support evidence-based harm-reduction measures could be expanded to include encouraging states to repeal drug-paraphernalia laws. A study in Qatar assessed the effectiveness of previous infection, vaccination, and both against symptomatic SARS-CoV-2 caused by omicron BA.1 and BA.2 and against severe, critical, or fatal Covid-19. Already have an account? Among the 9719 eligible patients with follow-up information who were included in the main analysis set, 6711 (69%) had a recurrence score of 11 to 25, 1619 (17%) had a recurrence score of 10 or lower, and 1389 (14%) had a recurrence score of 26 or higher (Figure 1). Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. Investigators from Israel explored the effect of two vaccine doses, three vaccine doses, and previous SARS-CoV-2 infection (without vaccination and before or after vaccination) on subsequent SARS-CoV-2 infection and progression to severe illness. For the one in nine hospitalized U.S. adults who have SUD, hospital-based addiction care has critical health benefits. Many users begin chewing betel nut in adolescence and are unaware of its adverse effects. Acute kidney injuryrelated adverse events and serious adverse events were balanced between the two groups (Table 2). Hypertension 2017;69:870-878. Carlson RW, Brown E, Burstein HJ, et al. 2. Clinical utility of gene-expression signatures in early stage breast cancer. The rate of nonadherence to the assigned treatment was 11.8% overall, including 5.4% among patients who were randomly assigned to receive endocrine therapy alone and 18.4% among those who were randomly assigned to receive chemoendocrine therapy (Table 1). In this trial involving more than 24,000 participants, the efficacy of two doses of a viruslike-particle, plant-based vaccine with adjuvant was 69.5% against symptomatic Covid-19 and 78.8% against moderate-to-severe disease. By mid 2022, the vaccine supply will no longer be a limiting factor in efforts to provide more equitable coverage. We enrolled women who were 18 to 75 years of age; had hormone-receptorpositive, human epidermal growth factor receptor 2 (HER2)negative, axillary nodenegative breast cancer; and met National Comprehensive Cancer Network guidelines for the recommendation or consideration of adjuvant chemotherapy (the full list of inclusion and exclusion criteria is provided in the Supplementary Appendix). Stunning advances in human transplantation have been tempered by the immunologic consequences of histoincompatibility between donor and recipient namely, allograft rejection after solid-organ transplantation and graft-versus-host disease (GVHD) after hematopoietic stem-cell (bone marrow) transplantation (HSCT). A radiograph of the pelvis showed an irregularly shaped, radiopaque stone. 10. Outcomes were assessed in time-to-event analyses. Second, the trial designs differed: our trial allowed SGLT2 inhibitor treatment, whereas the CREDENCE trial excluded patients treated with mineralocorticoid receptor antagonists; our trial had a run-in period that allowed background medical therapies to be adjusted, including adjustment of ACE inhibitor or ARB therapy to a maximum labeled dose that did not cause unacceptable side effects. In addition to nasopharyngeal swabs, you will need personal protective equipment (PPE), including a gown, nonsterile gloves, a protective mask, and a face shield, as described below. Full inclusion and exclusion criteria are provided in the Supplementary Appendix, available at NEJM.org. S5). Information, resources, and support needed to approach rotations - and life as a resident. But most hospitals dont offer such care. Am J Nephrol 2019;50:333-344. Microvascular complications and foot care: Standards of Medical Care in Diabetes 2020. S4A). N Engl J Med 2016;375:717-729. *Shown are adverse events that occurred during the treatment period, defined as those that started or worsened during finerenone or placebo intake or up to 3 days after any temporary or permanent interruption. 33. Krop I, Ismaila N, Andre F, et al. Investigators evaluating viral load rebound among high-risk patients found similar results with nirmatrelvirritonavir and placebo. Among the 14 patients for whom menopausal status was not reported, those who were 50 years of age or younger were classified as premenopausal. The authorized source of trusted medical research and education for the Chinese-language medical community. Clin Oncol (R Coll Radiol) 2013;25:109-116. Stay connected to what's important in medical research and clinical practice, Subscribe to the most trusted and influential source ofmedical knowledge. Correspondence from The New England Journal of Medicine Aerosol and Surface Stability of SARS-CoV-2 as Compared with SARS-CoV-1 Huang LM, Chan CC, et al. A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. A single 25-mg dose of psilocybin was more effective than a 1-mg dose at alleviating treatment-resistant depression over a period of 3 weeks. This video was published on April 17, 2020, and updated on May 1, 2020, at NEJM.org. Treatment effects are expressed as hazard ratios with corresponding confidence intervals from stratified Cox proportional-hazards models. The rate of nonadherence was similar to those in previous trials evaluating breast conservation or high-dose chemotherapy.23,24 Only 24% of first events included in the primary end point (invasive disease recurrence, second primary cancer, or death) were distant recurrences, the type of recurrence that is most influenced by adjuvant chemotherapy,7 which also has some effect in reducing other events, such as localregional recurrence or contralateral breast cancer.25,26, A total of 40% of women who were 50 years of age or younger had a recurrence score of 15 or lower, which was associated with a low rate of recurrence with endocrine therapy alone. See also the NEJM Covid-19 Vaccine Resources Center. Nasopharyngeal culture. Grune J, Beyhoff N, Smeir E, et al. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. In our trial involving patients with type 2 diabetes and advanced CKD, finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. Expanding Efforts to Improve Physician Well-Being, Mental Health Implications of Abortion Restrictions for Historically Marginalized Populations, Work Hours and Depression in U.S. If the recurrence score was 11 to 25, the patient underwent randomization and was assigned to receive either endocrine therapy or chemoendocrine therapy. A causal relationship between any adverse event and administration of finerenone or placebo was based on the opinion of the reporting investigator. Books from Oxford Scholarship Online, Oxford Handbooks Online, Oxford Medicine Online, Oxford Clinical Psychology, and Very Short Introductions, as well as the AMA Manual of Style, have all migrated to Oxford Academic.. Read more about books migrating to Oxford Academic.. You can now search across all these OUP Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services. Gritzfeld JF, Roberts P, Roche L, El Batrawy S, Gordon SB. First, remove your gown and gloves. J Clin Oncol 1998;16:3486-3492. The analysis was also performed according to the actual treatment given in order to explore the effect of nonadherence. NEW! In this study, SARS-CoV-2 infection before vaccination was found to elicit mucosal IgA, which protects against infection. Diabetologia 2011;54:2978-2986. After randomization, trial visits were conducted at month 1, month 4, then every 4 months until trial completion. Distant recurrence was associated with recurrence score as a continuous variable between 11 and 25, but there was no significant interaction between chemotherapy treatment and recurrence score in this range (Figs. Images in Clinical Medicine Oct 27, 2022 Necrotizing Myositis M. Arajo and I. M. Gonalves More from the week of July 27, 2017 Bakris GL, Agarwal R, Anker SD, et al. The most trusted, influential source of new medical knowledge and clinical best practices in the world. The effects on finerenone and placebo on the least-squares mean change from baseline in the eGFR slope are shown in Figure S6. Panel B shows a sustained decrease of at least 40% in the eGFR from baseline maintained for at least 4 weeks (a component of the primary composite outcome). Valuable tools for building a rewarding career in health care. Subscribe now. ); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen both in Denmark (P.R. NEW! A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. Additional details on efficacy and safety analyses are provided in the trial protocol and the statistical analysis plan. Endocrine therapy was likewise noninferior to chemoendocrine therapy in the analyses of other end points, including freedom from recurrence of breast cancer at a distant site (hazard ratio for recurrence, 1.10; P=0.48) (Figure 2B), freedom from recurrence of breast cancer at a distant or localregional site (hazard ratio for recurrence, 1.11; P=0.33), and overall survival (hazard ratio for death, 0.99; P=0.89). The incidence was lower among White adults with diabetes than among most other adults with diabetes. Ann Intern Med 2009;150:604-612. There was no significant between-group difference in the risk of death from any cause (, Overall hyperkalemia-related adverse events were twice as frequent with finerenone as with placebo (18.3% and 9.0%, respectively), and the frequency of hyperkalemia leading to discontinuation of the trial regimen was also higher with finerenone (2.3% and 0.9% in the respective groups) (, Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension, Progression of Atrial Fibrillation after Cryoablation or Drug Therapy, Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia, Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease, Duration of Device-Based Fever Prevention after Cardiac Arrest. Letters responding to this article are now published: Fourth Dose of BNT162b2 mRNA Covid-19 Vaccine. August 4, 2022N Engl J Med 2022; 387:470-472 Eligible patients were then randomly assigned in a 1:1 ratio to receive oral finerenone or placebo; patients with an eGFR of 25 to less than 60 ml per minute per 1.73 m2 at the screening visit received an initial dose of 10 mg once daily, and those with an eGFR of 60 ml per minute per 1.73 m2 or more at the screening visit received an initial dose of 20 mg once daily. The authorized source of trusted medical research and education for the Chinese-language medical community. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. Shown is the swab in a collection tube placed in a biohazard bag. 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. N Engl J Med 2013;369:1892-1903. With policymakers targeting members of sexual and gender minority groups, the health care sector can mitigate resulting harm and advocate for evidence-based policies protecting health and well-being. Levels of antibodies to SARS-CoV-2 had waned 5 months after a third dose, and the fourth dose boosted antibodies to the maximum level observed after the third dose but no higher. Gun violence in the United States causes traumatic responses in those who are directly exposed and contaminates the consciousness of young people, particularly those with serious mental health problems. 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. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. The most advanced way to teach, practice, and assess clinical reasoning skills. A booster dose of mRNA-1273 after the initial two-dose vaccination resulted in neutralization titers against the BA.2.75 variant that were similar to those against BA.1 and BA.2 and higher than those against BA.5. These results suggest that in patients with CKD and type 2 diabetes, finerenone may be an effective treatment for kidney and cardiovascular protection. Gliflozins sodiumglucose cotransporter 2 inhibitors lower blood glucose and glycated hemoglobin in patients with type 2 diabetes without causing hypoglycemia. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. Zhang and H. Li and Mr. Jiang contributed equally to this letter. 26. Hudis CA, Barlow WE, Costantino JP, et al. In this trial involving overweight or obese outpatients with Covid-19, investigators found that none of three repurposed drugs (metformin, ivermectin, and fluvoxamine) reduced the risk of serious disease. Li H, Lu W, Wang A, Jiang H, Lyu J. We performed exploratory analyses to determine whether any subgroups might have derived some benefit from chemotherapy in the intention-to-treat population, with a focus on covariates that were prognostic or associated with greater benefit from chemotherapy, such as younger age (Section 6F and Fig. 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). During the next 19 months, multiple fractures of the metatarsal bones of the right foot occurred. 6. Rates of severe illness were reduced by a factor of 3.5 in the fourth week after the second boost. Details of the trial design have been published previously,16 and the protocol is available with the full text of this article at NEJM.org. Key secondary end points included freedom from recurrence of breast cancer at a distant site (which corresponds to the STEEP definition of distant recurrencefree interval), freedom from recurrence of breast cancer at a distant or localregional site (which corresponds to the STEEP definition of recurrence-free interval), and overall survival. 2. Then put on a protective mask with a rating of N95 or higher, as recommended by the CDC. Eur Heart J (in press). The effects of finerenone on the primary outcome were generally consistent across prespecified subgroups (Fig. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. Francis PA, Regan MM, Fleming GF, et al. Panel D shows the secondary composite kidney outcome of kidney failure, a sustained decrease of at least 57% in the eGFR from baseline (equivalent to a doubling of the serum creatinine level) maintained for at least 4 weeks, or death from renal causes. Overall, adverse events that occurred during the treatment period were balanced between the two groups. Isolates obtained from 4 patients showed a mutation associated with resistance to sotrovimab in the receptor-binding domain, and cultures were positive at 2 to 3 weeks after treatment. NEW! This randomized, controlled trial evaluated AZD7442 (a combination of tixagevimab and cilgavimab, monoclonal antibodies targeting the SARS-CoV-2 spike protein) for the prevention of Covid-19 in adults at high risk for SARS-CoV-2 infection. An increase in the dose from 10 to 20 mg once daily was encouraged after 1 month, provided the serum potassium level was 4.8 mmol per liter or less and the eGFR was stable; a decrease in the dose from 20 to 10 mg once daily was allowed any time after the initiation of finerenone or placebo. DOI: 10.1056/NEJMoa2025845, Tap into groundbreaking research and clinically relevant insights. These events were classified according to the standardized MedDRA Query term. ), QUICK TAKEEffect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes02:02. Drs. Finerenone had modest effects on blood pressure: the changes in mean systolic blood pressure from baseline to month 1 and to month 12 were 3.0 and 2.1 mm Hg, respectively, with finerenone and 0.1 and 0.9 mm Hg, respectively, with placebo (Fig. Dr. Marty reports receiving grant support from Gilead and Ansun, consulting fees from Regeneron, and fees for trial design from Allovir, Janssen, Kyorin, and ReViral. Estimated Survival Rates According to Recurrence Score and Assigned Treatment among Women 50 Years of Age or Younger in the Intention-to-Treat Population. Consumption of betel nut, a carcinogen, has increased throughout the AsiaPacific region. Fleming G, Francis PA, Lng I, et al. Requiring new, well-designed warning labels on alcohol containers could provide information to consumers and reduce harm. 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, NEJM Catalyst Innovations in Care Delivery. Finerenone, a novel selective nonsteroidal mineralocorticoid receptor antagonist protects from rat cardiorenal injury. NEW! Make sure that all sample tubes have been labeled and that the appropriate requisition forms have been filled out before starting the procedure. Remdesivir, molnupiravir, and nirmatrelvir may also be effective. Editorial Covid-19 Vaccination during Pregnancy Two for the Price of One. In the present trial, patients with CKD and type 2 diabetes who received finerenone had a lower risk of a primary outcome event (kidney failure, a sustained decrease of 40% in the eGFR from baseline, or death from renal causes) than those who received placebo. Information and tools for librarians about site license offerings. The New England Journal of Medicine Latest in Emergency Medicine. both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G. American Diabetes Association. NEW! ); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A. Mamounas EP, Tang G, Liu Q. Mansour EG, Gray R, Shatila AH, et al. Effects of screening and systemic adjuvant therapy on ER-specific US breast cancer mortality. Population-based studies have shown a recurrence-score distribution similar to that observed in this prospective trial, along with no apparent benefit from chemotherapy in the recurrence-score range of 11 to 25 and a significant association between recurrence score and recurrence or 5-year breast cancerspecific mortality, which indicates the generalizability of our findings to clinical practice.21,22 Although the rate of nonadherence to the assigned treatment was 12% overall, the sample size was adjusted to compensate for this, and the as-treated analysis produced results similar to those of the intention-to-treat analysis. Women with a midrange score of 11 to 25 underwent randomization and were assigned to receive either endocrine therapy alone or chemoendocrine therapy. The most trusted, influential source of new medical knowledge and clinical best practices in the world. S5 through S10 in the Supplementary Appendix). J Natl Cancer Inst 2008;100:32-40. J Am Coll Cardiol 2020;75:422-434. 17, Oct 27, 2022 Mental Health Implications of Abortion Restrictions for Historically Marginalized Populations L. Ogbu-Nwobodo and Others In a secondary analysis comparing the effect of insulin glargine, glimepiride, liraglutide, and sitagliptin, added to metformin, on the incidences of microvascular complications and death, no material between-group differences were seen. Howlader N, Altekruse SF, Li CI, et al. However, its long-term effects on kidney and cardiovascular outcomes are unknown. The content of this site is intended for health care professionals. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). ); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M. ), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) 11. The endocrine therapy regimens among postmenopausal women most commonly included an aromatase inhibitor (91%); among premenopausal women, endocrine therapy regimens most commonly included either tamoxifen alone or tamoxifen followed by an aromatase inhibitor (78%), and suppression of ovarian function was used in 13% of premenopausal women (Table S2 in the Supplementary Appendix). 12. Sign In or Create Account to save this article, Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension, Progression of Atrial Fibrillation after Cryoablation or Drug Therapy, Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia, Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease, Duration of Device-Based Fever Prevention after Cardiac Arrest. Original Article from The New England Journal of Medicine Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke ); University of North Carolina, Chapel Hill (E.C.D. 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