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BACKGROUND: Deoxygenated sickle hemoglobin (HbS) polymerization drives the pathophysiology of sickle cell disease. Therefore, direct inhibition of HbS polymerization has potential to favorably modify disease outcomes. Voxelotor is an HbS polymerization inhibitor. METHODS: In a multicenter, phase 3, double-blind, randomized, placebo-controlled trial, we compared the efficacy and safety of two dose levels of voxelotor (1500 mg and 900 mg, administered orally once daily) with placebo in persons with sickle cell disease. BACKGROUND: Establishing cardiovascular safety of new therapies for type 2 diabetes is important. Safety data are available for the subcutaneous form of the glucagon-like peptide-1 receptor agonist semaglutide but are needed for oral semaglutide. METHODS: We assessed cardiovascular outcomes of once-daily oral semaglutide in an event-driven, randomized, double-blind, placebo-controlled trial involving patients at high cardiovascular risk (age of ≥50 years with established cardiovascular or chronic kidney disease, or age of ≥60 years with cardiovascular risk factors only).
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BACKGROUND: Type 1 diabetes is a chronic autoimmune disease that leads to destruction of insulin-producing beta cells and dependence on exogenous insulin for survival. Some interventions have delayed the loss of insulin production in patients with type 1 diabetes, but interventions that might affect clinical progression before diagnosis are needed.
METHODS: We conducted a phase 2, randomized, placebo-controlled, double-blind trial of teplizumab (an Fc receptor-nonbinding anti-CD3 monoclonal antibody) involving relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for development of clinical disease. Anastassios G Pittas, Bess Dawson-Hughes, Patricia Sheehan, James H Ware, William C Knowler, Vanita R Aroda, Irwin Brodsky, Lisa Ceglia, Chhavi Chadha, Ranee Chatterjee, Cyrus Desouza, Rowena Dolor, John Foreyt, Paul Fuss, Adline Ghazi, Daniel S Hsia, Karen C Johnson, Sangeeta R Kashyap, Sun Kim, Erin S LeBlanc, Michael R Lewis, Emilia Liao, Lisa M Neff, Jason Nelson, Patrick O'Neil, Jean Park, Anne Peters, Lawrence S Phillips, Richard Pratley, Philip Raskin, Neda Rasouli, David Robbins, Clifford Rosen, Ellen M Vickery, Myrlene Staten. BACKGROUND: Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown.
METHODS: We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100 to 125 mg per deciliter; plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter; and glycated hemoglobin level, 5. BACKGROUND: Patients who have unresectable or metastatic melanoma with a BRAF V600E or V600K mutation have prolonged progression-free survival and overall survival when receiving treatment with BRAF inhibitors plus MEK inhibitors. However, long-term clinical outcomes in these patients remain undefined. To determine 5-year survival rates and clinical characteristics of the patients with durable benefit, we sought to review long-term data from randomized trials of combination therapy with BRAF and MEK inhibitors.
BACKGROUND: An earlier analysis of this phase 3 trial showed that the addition of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor to endocrine therapy provided a greater benefit with regard to progression-free survival than endocrine therapy alone in premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here we report the results of a protocol-specified interim analysis of the key secondary end point of overall survival.
Joseph A Sparano, Robert J Gray, Peter M Ravdin, Della F Makower, Kathleen I Pritchard, Kathy S Albain, Daniel F Hayes, Charles E Geyer, Elizabeth C Dees, Matthew P Goetz, John A Olson, Tracy Lively, Sunil S Badve, Thomas J Saphner, Lynne I Wagner, Timothy J Whelan, Matthew J Ellis, Soonmyung Paik, William C Wood, Maccon M Keane, Henry L Gomez Moreno, Pavan S Reddy, Timothy F Goggins, Ingrid A Mayer, Adam M Brufsky, Deborah L Toppmeyer, Virginia G Kaklamani, Jeffrey L Berenberg, Jeffrey Abrams, George W Sledge. BACKGROUND: The use of adjuvant chemotherapy in patients with breast cancer may be guided by clinicopathological factors and a score based on a 21-gene assay to determine the risk of recurrence. Whether the level of clinical risk of breast cancer recurrence adds prognostic information to the recurrence score is not known.
METHODS: We performed a prospective trial involving 9427 women with hormone-receptor-positive, human epidermal growth factor receptor 2-negative, axillary node-negative breast cancer, in whom an assay of 21 genes had been performed, and we classified the clinical risk of recurrence of breast cancer as low or high on the basis of the tumor size and histologic grade.
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