90 research outputs found

    Effects of Anacetrapib in Patients with Atherosclerotic Vascular Disease

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    BACKGROUND: Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin-based treatment of low-density lipoprotein (LDL) cholesterol levels. The inhibition of cholesteryl ester transfer protein (CETP) by anacetrapib reduces LDL cholesterol levels and increases high-density lipoprotein (HDL) cholesterol levels. However, trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter (1.58 mmol per liter), a mean non-HDL cholesterol level of 92 mg per deciliter (2.38 mmol per liter), and a mean HDL cholesterol level of 40 mg per deciliter (1.03 mmol per liter). The patients were assigned to receive either 100 mg of anacetrapib once daily (15,225 patients) or matching placebo (15,224 patients). The primary outcome was the first major coronary event, a composite of coronary death, myocardial infarction, or coronary revascularization. RESULTS: During the median follow-up period of 4.1 years, the primary outcome occurred in significantly fewer patients in the anacetrapib group than in the placebo group (1640 of 15,225 patients [10.8%] vs. 1803 of 15,224 patients [11.8%]; rate ratio, 0.91; 95% confidence interval, 0.85 to 0.97; P=0.004). The relative difference in risk was similar across multiple prespecified subgroups. At the trial midpoint, the mean level of HDL cholesterol was higher by 43 mg per deciliter (1.12 mmol per liter) in the anacetrapib group than in the placebo group (a relative difference of 104%), and the mean level of non-HDL cholesterol was lower by 17 mg per deciliter (0.44 mmol per liter), a relative difference of -18%. There were no significant between-group differences in the risk of death, cancer, or other serious adverse events. CONCLUSIONS: Among patients with atherosclerotic vascular disease who were receiving intensive statin therapy, the use of anacetrapib resulted in a lower incidence of major coronary events than the use of placebo. (Funded by Merck and others; Current Controlled Trials number, ISRCTN48678192 ; ClinicalTrials.gov number, NCT01252953 ; and EudraCT number, 2010-023467-18 .)

    Safeguards issues in spent fuel consolidation facilities

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    In the nuclear power industry, the fuel assembly is the basic unit for nuclear material accountancy. The safeguards procedures for the spent fuel assemblies, therefore, are based on an item accountancy approach. When fuel consolidation occurs in at-reactor'' or away-from-reactor'' facilities, the fuel assemblies are disassembled and cease to be the basic unit containing nuclear material. Safeguards can no longer be based on item accountancy of fuel assemblies. The spent fuel pins containing plutonium are accessible, and the possibilities for diversion of spent fuel for clandestine reprocessing to recover the plutonium are increased. Thus, identifying the potential safeguards concerns created by operation of these facilities is necessary. Potential safeguards techniques to address these concerns also must be identified so facility designs may include the equipment and systems required to provide an acceptable level of assurance that the international safeguards objectives can be met when these facilities come on-line. The objectives of this report are (1) to identify the safeguards issues associated with operation of spent fuel consolidation facilities, (2) to provide a preliminary assessment of the assessment of the safeguards vulnerabilities introduced, and (3) to identify potential safeguards approaches that could meet international safeguards requirements. The safeguards aspects of spent fuel consolidation are addressed in several recent reports and papers. 11 refs., 3 figs., 3 tabs

    Recommendations to the NRC on acceptable standard format and content for the Fundamental Nuclear Material Control (FNMC) Plan required for low-enriched uranium enrichment facilities

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    A new section, 10 CFR 74.33, has been added to the material control and accounting (MC A) requirements of 10 CFR Part 74. This new section pertains to US Nuclear Regulatory Commission (NRC)-licensed uranium enrichment facilities that are authorized to produce and to possess more than one effective kilogram of special nuclear material (SNM) of low strategic significance. The new section is patterned after 10 CFR 74.31, which pertains to NRC licensees (other than production or utilization facilities licensed pursuant to 10 CFR Part 50 and 70 and waste disposal facilities) that are authorized to possess and use more than one effective kilogram of unencapsulated SNM of low strategic significance. Because enrichment facilities have the potential capability of producing SNM of moderate strategic significance and also strategic SNM, certain performance objectives and MC A system capabilities are required in 10 CFR 74.33 that are not contained in 10 CFR 74.31. This document recommends to the NRC information that the licensee or applicant should provide in the fundamental nuclear material control (FNMC) plan. This document also describes methods that should be acceptable for compliance with the general performance objectives. While this document is intended to cover various uranium enrichment technologies, the primary focus at this time is gas centrifuge and gaseous diffusion
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