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New England Journal of Medicine

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https://www.readbyqxmd.com/read/27805841/regulating-off-label-promotion-a-critical-test
#1
Christopher Robertson, Aaron S Kesselheim
In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range..
November 2, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27797298/treatment-of-left-main-coronary-artery-disease
#2
Eugene Braunwald
No abstract text is available yet for this article.
October 31, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27797291/everolimus-eluting-stents-or-bypass-surgery-for-left-main-coronary-artery-disease
#3
Gregg W Stone, Joseph F Sabik, Patrick W Serruys, Charles A Simonton, Philippe Généreux, John Puskas, David E Kandzari, Marie-Claude Morice, Nicholas Lembo, W Morris Brown, David P Taggart, Adrian Banning, Béla Merkely, Ferenc Horkay, Piet W Boonstra, Ad J van Boven, Imre Ungi, Gabor Bogáts, Samer Mansour, Nicolas Noiseux, Manel Sabaté, José Pomar, Mark Hickey, Anthony Gershlick, Pawel Buszman, Andrzej Bochenek, Erick Schampaert, Pierre Pagé, Ovidiu Dressler, Ioanna Kosmidou, Roxana Mehran, Stuart J Pocock, A Pieter Kappetein
Background Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. Methods We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients)...
October 31, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27788026/trial-of-amitriptyline-topiramate-and-placebo-for-pediatric-migraine
#4
Scott W Powers, Christopher S Coffey, Leigh A Chamberlin, Dixie J Ecklund, Elizabeth A Klingner, Jon W Yankey, Leslie L Korbee, Linda L Porter, Andrew D Hershey
Background Which, medication, if any, to use to prevent the headache of pediatric migraine has not been established. Methods We conducted a randomized, double-blind, placebo-controlled trial of amitriptyline (1 mg per kilogram of body weight per day), topiramate (2 mg per kilogram per day), and placebo in children and adolescents 8 to 17 years of age with migraine. Patients were randomly assigned in a 2:2:1 ratio to receive one of the medications or placebo. The primary outcome was a relative reduction of 50% or more in the number of headache days in the comparison of the 28-day baseline period with the last 28 days of a 24-week trial...
October 27, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27775504/red-cells-aging-gracefully-in-the-blood-bank
#5
Aaron A R Tobian, Paul M Ness
No abstract text is available yet for this article.
October 24, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27775503/effect-of-short-term-vs-long-term-blood-storage-on-mortality-after-transfusion
#6
Nancy M Heddle, Richard J Cook, Donald M Arnold, Yang Liu, Rebecca Barty, Mark A Crowther, P J Devereaux, Jack Hirsh, Theodore E Warkentin, Kathryn E Webert, David Roxby, Magdalena Sobieraj-Teague, Andrea Kurz, Daniel I Sessler, Priscilla Figueroa, Martin Ellis, John W Eikelboom
Background Randomized, controlled trials have suggested that the transfusion of blood after prolonged storage does not increase the risk of adverse outcomes among patients, although most of these trials were restricted to high-risk populations and were not powered to detect small but clinically important differences in mortality. We sought to find out whether the duration of blood storage would have an effect on mortality after transfusion in a general population of hospitalized patients. Methods In this pragmatic, randomized, controlled trial conducted at six hospitals in four countries, we randomly assigned patients who required a red-cell transfusion to receive blood that had been stored for the shortest duration (short-term storage group) or the longest duration (long-term storage group) in a 1:2 ratio...
October 24, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27774838/tranexamic-acid-in-patients-undergoing-coronary-artery-surgery
#7
Paul S Myles, Julian A Smith, Andrew Forbes, Brendan Silbert, Mohandas Jayarajah, Thomas Painter, D James Cooper, Silvana Marasco, John McNeil, Jean S Bussières, Shay McGuinness, Kelly Byrne, Matthew T V Chan, Giovanni Landoni, Sophie Wallace
Background Tranexamic acid reduces the risk of bleeding among patients undergoing cardiac surgery, but it is unclear whether this leads to improved outcomes. Furthermore, there are concerns that tranexamic acid may have prothrombotic and proconvulsant effects. Methods In a trial with a 2-by-2 factorial design, we randomly assigned patients who were scheduled to undergo coronary-artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the tranexamic acid comparison are reported here...
October 23, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27771985/five-year-outcomes-after-off-pump-or-on-pump-coronary-artery-bypass-grafting
#8
André Lamy, P J Devereaux, Dorairaj Prabhakaran, David P Taggart, Shengshou Hu, Zbynek Straka, Leopoldo S Piegas, Alvaro Avezum, Ahmet R Akar, Fernando Lanas Zanetti, Anil R Jain, Nicolas Noiseux, Chandrasekar Padmanabhan, Juan-Carlos Bahamondes, Richard J Novick, Liang Tao, Pablo A Olavegogeascoechea, Balram Airan, Toomas-Andres Sulling, Richard P Whitlock, Yongning Ou, Peggy Gao, Shirley Pettit, Salim Yusuf
Background We previously reported that there was no significant difference at 30 days or at 1 year in the rate of the composite outcome of death, stroke, myocardial infarction, or renal failure between patients who underwent coronary-artery bypass grafting (CABG) performed with a beating-heart technique (off-pump) and those who underwent CABG performed with cardiopulmonary bypass (on-pump). We now report the results at 5 years (the end of the trial). Methods A total of 4752 patients (from 19 countries) who had coronary artery disease were randomly assigned to undergo off-pump or on-pump CABG...
October 23, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27732126/structural-racism-and-supporting-black-lives-the-role-of-health-professionals
#9
Rachel R Hardeman, Eduardo M Medina, Katy B Kozhimannil
On July 7, 2016, in our Minneapolis community, Philando Castile was shot and killed by a police officer in the presence of his girlfriend and her 4-year-old daughter. Acknowledging the role of racism in Castile’s death, Minnesota Governor Mark Dayton asked rhetorically, "Would this have happened if..
October 12, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27732125/undermining-value-based-purchasing-lessons-from-the-pharmaceutical-industry
#10
Leemore S Dafny, Christopher J Ody, Matthew A Schmitt
In 2015, the U.S. Department of Health and Human Services announced a goal of linking at least 50% of Medicare spending to value-based payment models such as accountable care organizations. Health care providers are now scrambling to reorganize in a way that delivers value while preserving or..
October 12, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27723434/mapping-plasmodium-falciparum-mortality-in-africa-between-1990-and-2015
#11
Peter W Gething, Daniel C Casey, Daniel J Weiss, Donal Bisanzio, Samir Bhatt, Ewan Cameron, Katherine E Battle, Ursula Dalrymple, Jennifer Rozier, Puja C Rao, Michael J Kutz, Ryan M Barber, Chantal Huynh, Katya A Shackelford, Matthew M Coates, Grant Nguyen, Maya S Fraser, Rachel Kulikoff, Haidong Wang, Mohsen Naghavi, David L Smith, Christopher J L Murray, Simon I Hay, Stephen S Lim
Background Malaria control has not been routinely informed by the assessment of subnational variation in malaria deaths. We combined data from the Malaria Atlas Project and the Global Burden of Disease Study to estimate malaria mortality across sub-Saharan Africa on a grid of 5 km(2) from 1990 through 2015. Methods We estimated malaria mortality using a spatiotemporal modeling framework of geolocated data (i.e., with known latitude and longitude) on the clinical incidence of malaria, coverage of antimalarial drug treatment, case fatality rate, and population distribution according to age...
October 10, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27718781/adjuvant-sunitinib-in-high-risk-renal-cell-carcinoma-after-nephrectomy
#12
Alain Ravaud, Robert J Motzer, Hardev S Pandha, Daniel J George, Allan J Pantuck, Anup Patel, Yen-Hwa Chang, Bernard Escudier, Frede Donskov, Ahmed Magheli, Giacomo Carteni, Brigitte Laguerre, Piotr Tomczak, Jan Breza, Paola Gerletti, Mariajose Lechuga, Xun Lin, Jean-Francois Martini, Krishnan Ramaswamy, Michelle Casey, Michael Staehler, Jean-Jacques Patard
Background Sunitinib, a vascular endothelial growth factor pathway inhibitor, is an effective treatment for metastatic renal-cell carcinoma. We sought to determine the efficacy and safety of sunitinib in patients with locoregional renal-cell carcinoma at high risk for tumor recurrence after nephrectomy. Methods In this randomized, double-blind, phase 3 trial, we assigned 615 patients with locoregional, high-risk clear-cell renal-cell carcinoma to receive either sunitinib (50 mg per day) or placebo on a 4-weeks-on, 2-weeks-off schedule for 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal...
October 9, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27718875/divide-and-conquer-to-treat-lung-cancer
#13
Bruce E Johnson
No abstract text is available yet for this article.
October 8, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27718847/pembrolizumab-versus-chemotherapy-for-pd-l1-positive-non-small-cell-lung-cancer
#14
Martin Reck, Delvys Rodríguez-Abreu, Andrew G Robinson, Rina Hui, Tibor Csőszi, Andrea Fülöp, Maya Gottfried, Nir Peled, Ali Tafreshi, Sinead Cuffe, Mary O'Brien, Suman Rao, Katsuyuki Hotta, Melanie A Leiby, Gregory M Lubiniecki, Yue Shentu, Reshma Rangwala, Julie R Brahmer
Background Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1). Methods In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene to receive either pembrolizumab (at a fixed dose of 200 mg every 3 weeks) or the investigator's choice of platinum-based chemotherapy...
October 8, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27718784/nivolumab-for-recurrent-squamous-cell-carcinoma-of-the-head-and-neck
#15
Robert L Ferris, George Blumenschein, Jerome Fayette, Joel Guigay, A Dimitrios Colevas, Lisa Licitra, Kevin Harrington, Stefan Kasper, Everett E Vokes, Caroline Even, Francis Worden, Nabil F Saba, Lara C Iglesias Docampo, Robert Haddad, Tamara Rordorf, Naomi Kiyota, Makoto Tahara, Manish Monga, Mark Lynch, William J Geese, Justin Kopit, James W Shaw, Maura L Gillison
Background Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum chemotherapy have a very poor prognosis and limited therapeutic options. Nivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, was assessed as treatment for this condition. Methods In this randomized, open-label, phase 3 trial, we assigned, in a 2:1 ratio, 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab)...
October 8, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27717299/niraparib-maintenance-therapy-in-platinum-sensitive-recurrent-ovarian-cancer
#16
Mansoor R Mirza, Bradley J Monk, Jørn Herrstedt, Amit M Oza, Sven Mahner, Andrés Redondo, Michel Fabbro, Jonathan A Ledermann, Domenica Lorusso, Ignace Vergote, Noa E Ben-Baruch, Christian Marth, Radosław Mądry, René D Christensen, Jonathan S Berek, Anne Dørum, Anna V Tinker, Andreas du Bois, Antonio González-Martín, Philippe Follana, Benedict Benigno, Per Rosenberg, Lucy Gilbert, Bobbie J Rimel, Joseph Buscema, John P Balser, Shefali Agarwal, Ursula A Matulonis
Background Niraparib is an oral poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) 1/2 inhibitor that has shown clinical activity in patients with ovarian cancer. We sought to evaluate the efficacy of niraparib versus placebo as maintenance treatment for patients with platinum-sensitive, recurrent ovarian cancer. Methods In this randomized, double-blind, phase 3 trial, patients were categorized according to the presence or absence of a germline BRCA mutation (gBRCA cohort and non-gBRCA cohort) and the type of non-gBRCA mutation and were randomly assigned in a 2:1 ratio to receive niraparib (300 mg) or placebo once daily...
October 7, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27717298/prolonged-survival-in-stage-iii-melanoma-with-ipilimumab-adjuvant-therapy
#17
Alexander M M Eggermont, Vanna Chiarion-Sileni, Jean-Jacques Grob, Reinhard Dummer, Jedd D Wolchok, Henrik Schmidt, Omid Hamid, Caroline Robert, Paolo A Ascierto, Jon M Richards, Céleste Lebbé, Virginia Ferraresi, Michael Smylie, Jeffrey S Weber, Michele Maio, Lars Bastholt, Laurent Mortier, Luc Thomas, Saad Tahir, Axel Hauschild, Jessica C Hassel, F Stephen Hodi, Corina Taitt, Veerle de Pril, Gaetan de Schaetzen, Stefan Suciu, Alessandro Testori
Background On the basis of data from a phase 2 trial that compared the checkpoint inhibitor ipilimumab at doses of 0.3 mg, 3 mg, and 10 mg per kilogram of body weight in patients with advanced melanoma, this phase 3 trial evaluated ipilimumab at a dose of 10 mg per kilogram in patients who had undergone complete resection of stage III melanoma. Methods After patients had undergone complete resection of stage III cutaneous melanoma, we randomly assigned them to receive ipilimumab at a dose of 10 mg per kilogram (475 patients) or placebo (476) every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred...
October 7, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27705084/levosimendan-for-the-prevention-of-acute-organ-dysfunction-in-sepsis
#18
Anthony C Gordon, Gavin D Perkins, Mervyn Singer, Daniel F McAuley, Robert M L Orme, Shalini Santhakumaran, Alexina J Mason, Mary Cross, Farah Al-Beidh, Janis Best-Lane, David Brealey, Christopher L Nutt, James J McNamee, Henrik Reschreiter, Andrew Breen, Kathleen D Liu, Deborah Ashby
Background Levosimendan is a calcium-sensitizing drug with inotropic and other properties that may improve outcomes in patients with sepsis. Methods We conducted a double-blind, randomized clinical trial to investigate whether levosimendan reduces the severity of organ dysfunction in adults with sepsis. Patients were randomly assigned to receive a blinded infusion of levosimendan (at a dose of 0.05 to 0.2 μg per kilogram of body weight per minute) for 24 hours or placebo in addition to standard care. The primary outcome was the mean daily Sequential Organ Failure Assessment (SOFA) score in the intensive care unit up to day 28 (scores for each of five systems range from 0 to 4, with higher scores indicating more severe dysfunction; maximum score, 20)...
October 5, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27690741/two-phase-3-trials-of-dupilumab-versus-placebo-in-atopic-dermatitis
#19
Eric L Simpson, Thomas Bieber, Emma Guttman-Yassky, Lisa A Beck, Andrew Blauvelt, Michael J Cork, Jonathan I Silverberg, Mette Deleuran, Yoko Kataoka, Jean-Philippe Lacour, Külli Kingo, Margitta Worm, Yves Poulin, Andreas Wollenberg, Yuhwen Soo, Neil M H Graham, Gianluca Pirozzi, Bolanle Akinlade, Heribert Staudinger, Vera Mastey, Laurent Eckert, Abhijit Gadkari, Neil Stahl, George D Yancopoulos, Marius Ardeleanu
Background Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important drivers of atopic or allergic diseases such as atopic dermatitis. Methods In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1 and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment. Patients were randomly assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg) or placebo weekly or the same dose of dupilumab every other week alternating with placebo...
September 30, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27681881/my-vision-for-universal-quality-affordable-health-care
#20
Hillary Clinton
The editors invited the Democratic and Republican presidential nominees, Hillary Clinton and Donald Trump, to answer the following question for Journal readers: What specific changes in policy do you support to improve access to care, improve quality of care, and control health care costs for our..
September 28, 2016: New England Journal of Medicine
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