New England Journal of Medicine

Ajay K. Singh, M.B., B.S., M.B.A., Kevin Carroll, Ph.D., John J.V. McMurray, M.D., Scott Solomon, M.D., Vivekanand Jha, M.D., Kirsten L. Johansen, M.D., Renato D. Lopes, M.D., Ph.D., Iain C. Macdougall, M.D., Gregorio T. Obrador, M.D., Sushrut S. Waikar, M.D., Christoph Wanner, M.D., David C. Wheeler, M.B., Ch.B., M.D., Andrzej Wi?cek, M.D., Ph.D., Allison Blackorby, M.Sc., Borut Cizman, M.D., Alexander R. Cobitz, M.D., Ph.D., Rich Davies, M.Sc., Tara L. DiMino, M.D., Lata Kler, Ph.D., Amy M. Meadowcroft, Pharm.D., Lin Taft, Ph.D., and Vlado Perkovic, M.B., B.S., Ph.D. for the ASCEND-ND Study Group*

doi : 10.1056/NEJMoa2113380

N Engl J Med 2021; 385:2313-2324

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor. In patients with chronic kidney disease (CKD) who are not undergoing dialysis, the efficacy and safety of daprodustat, as compared with the conventional erythropoiesis-stimulating agent darbepoetin alfa, are unknown.

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Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis

Ajay K. Singh, M.B., B.S., M.B.A., Kevin Carroll, Ph.D., Vlado Perkovic, M.B., B.S., Scott Solomon, M.D., Vivekanand Jha, M.D., Kirsten L. Johansen, M.D., Renato D. Lopes, M.D., Ph.D., Iain C. Macdougall, M.D., Gregorio T. Obrador, M.D., Sushrut S. Waikar, M.D., Christoph Wanner, M.D., David C. Wheeler, M.B., Ch.B., M.D., Andrzej Wi?cek, M.D., Ph.D., Allison Blackorby, M.Sc., Borut Cizman, M.D., Alexander R. Cobitz, M.D., Ph.D., Rich Davies, M.Sc., Jo Dole, Ph.D., Lata Kler, Ph.D., Amy M. Meadowcroft, Pharm.D., Xinyi Zhu, M.Sc., and John J.V. McMurray, M.D. for the ASCEND-D Study Group*

doi : 10.1056/NEJMoa2113379

N Engl J Med 2021; 385:2325-2335

Among patients with chronic kidney disease (CKD), the use of recombinant human erythropoietin and its derivatives for the treatment of anemia has been linked to a possibly increased risk of stroke, myocardial infarction, and other adverse events. Several trials have suggested that hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors (PHIs) are as effective as erythropoiesis-stimulating agents (ESAs) in increasing hemoglobin levels.

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21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer

Kevin Kalinsky, M.D., William E. Barlow, Ph.D., Julie R. Gralow, M.D., Funda Meric-Bernstam, M.D., Kathy S. Albain, M.D., Daniel F. Hayes, M.D., Nancy U. Lin, M.D., Edith A. Perez, M.D., Lori J. Goldstein, M.D., Stephen K.L. Chia, M.D., Sukhbinder Dhesy-Thind, M.D., Priya Rastogi, M.D., Emilio Alba, M.D., Ph.D., Suzette Delaloge, M.D., Miguel Martin, M.D., Catherine M. Kelly, M.B., Manuel Ruiz-Borrego, M.D., Miguel Gil-Gil, M.D., Claudia H. Arce-Salinas, M.D., Etienne G.C. Brain, M.D., Ph.D., Eun-Sook Lee, M.D., Jean-Yves Pierga, M.D., Ph.D., Begoña Bermejo, M.D., Manuel Ramos-Vazquez, M.D., Ph.D., Kyung-Hae Jung, M.D., Ph.D., Jean-Marc Ferrero, M.D., Anne F. Schott, M.D., Steven Shak, M.D., Priyanka Sharma, M.D., Danika L. Lew, M.A., Jieling Miao, M.S., Debasish Tripathy, M.D., Lajos Pusztai, M.D., Ph.D., and Gabriel N. Hortobagyi, M.D.

doi : 10.1056/NEJMoa2108873

N Engl J Med 2021; 385:2336-2347

The recurrence score based on the 21-gene breast-cancer assay has been clinically useful in predicting a chemotherapy benefit in hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative, axillary lymph-node–negative breast cancer. In women with positive lymph-node disease, the role of the recurrence score with respect to predicting a benefit of adjuvant chemotherapy is unclear.

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Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine

Ann R. Falsey, M.D., Magdalena E. Sobieszczyk, M.D., M.P.H., Ian Hirsch, Ph.D., Stephanie Sproule, M.Math., Merlin L. Robb, M.D., Lawrence Corey, M.D., Kathleen M. Neuzil, M.D., William Hahn, M.D., Julie Hunt, Ph.D., Mark J. Mulligan, M.D., Charlene McEvoy, M.D., M.P.H., Edwin DeJesus, M.D., Michael Hassman, D.O., Susan J. Little, M.D., Barbara A. Pahud, M.D., M.P.H., Anna Durbin, M.D., Paul Pickrell, M.D., Eric S. Daar, M.D., Larry Bush, M.D., Joel Solis, M.D., Quito Osuna Carr, M.D., Temitope Oyedele, M.D., Susan Buchbinder, M.D., Jessica Cowden, M.D., M.S.P.H., Sergio L. Vargas, M.D., Alfredo Guerreros Benavides, M.D., Robert Call, M.D., Michael C. Keefer, M.D., Beth D. Kirkpatrick, M.D., John Pullman, M.D., Tina Tong, M.S., Margaret Brewinski Isaacs, M.D., M.P.H., David Benkeser, Ph.D., Holly E. Janes, Ph.D., Martha C. Nason, Ph.D., Justin A. Green, M.D., Ph.D., Elizabeth J. Kelly, Ph.D., Jill Maaske, M.D., Nancy Mueller, Ph.D., Kathryn Shoemaker, M.S., Therese Takas, B.S., Richard P. Marshall, M.D., Ph.D., Menelas N. Pangalos, F.Med.Sci, Ph.D., Tonya Villafana, Ph.D., M.P.H., and Antonio Gonzalez-Lopez, M.D., Ph.D., M.P.H. for the AstraZeneca AZD1222 Clinical Study Group*

doi : 10.1056/NEJMoa2105290

N Engl J Med 2021; 385:2348-2360

The safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known.

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Effectiveness of mRNA Covid-19 Vaccine among U.S. Health Care Personnel

Tamara Pilishvili, Ph.D., M.P.H., Ryan Gierke, M.P.H., Katherine E. Fleming-Dutra, M.D., Jennifer L. Farrar, M.P.H., Nicholas M. Mohr, M.D., David A. Talan, M.D., Anusha Krishnadasan, Ph.D., Karisa K. Harland, Ph.D., Howard A. Smithline, M.D., Peter C. Hou, M.D., Lilly C. Lee, M.D., Stephen C. Lim, M.D., Gregory J. Moran, M.D., Elizabeth Krebs, M.D., Mark T. Steele, M.D., David G. Beiser, M.D., Brett Faine, Pharm.D., John P. Haran, M.D., Ph.D., Utsav Nandi, M.D., M.S.C.I., Walter A. Schrading, M.D., Brian Chinnock, M.D., Daniel J. Henning, M.D., M.P.H., Frank Lovecchio, D.O., M.P.H., Jane Lee, M.P.H., Devra Barter, M.Sc., Monica Brackney, M.S., Scott K. Fridkin, M.D., Kaytlynn Marceaux-Galli, M.P.H., Sarah Lim, M.B., B.Ch., Erin C. Phipps, D.V.M., M.P.H., Ghinwa Dumyati, M.D., Rebecca Pierce, Ph.D., Tiffanie M. Markus, Ph.D., Deverick J. Anderson, M.D., M.P.H., Amanda K. Debes, Ph.D., Michael Y. Lin, M.D., M.P.H., Jeanmarie Mayer, M.D., Jennie H. Kwon, D.O., Nasia Safdar, M.D., Ph.D., Marc Fischer, M.D., Rosalyn Singleton, M.D., Nora Chea, M.D., Shelley S. Magill, M.D., Ph.D., Jennifer R. Verani, M.D., M.P.H., and Stephanie J. Schrag, D.Phil. for the Vaccine Effectiveness among Healthcare Personnel Study Team*

doi : 10.1056/NEJMoa2106599

N Engl J Med 2021; 385:e90

The prioritization of U.S. health care personnel for early receipt of messenger RNA (mRNA) vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (Covid-19), allowed for the evaluation of the effectiveness of these new vaccines in a real-world setting.

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