Összesen 3 találat.


001-es BibID:BIBFORM038217
Első szerző:Antman, Elliott M.
Cím:Early administration of intravenous magnesium to high-risk patients with acute myocardial infarction in the Magnesium in Coronaries (MAGIC) Trial : a randomised controlled trial / Elliott M. Antman, The Magnesium in Coronaries (MAGIC) Trial Investigators
Megjegyzések:Background The benefits of supplemental administration of intravenous magnesium in patients with ST-elevation myocardial infarction (STEMI) are controversial. Despite promising results from work in animals and the ready availability of this simple, inexpensive treatment, conflicting results have been reported in clinical trials. Our aim was to compare short-term mortality in patients with STEMI who received either intravenous magnesium sulphate or placebo. Methods We did a randomised, double-blind trial in 6213 patients with acute STEMI who were assigned a 2 g intravenous bolus of magnesium sulphate administered over 15 min, followed by a 17 g infusion of magnesium sulphate over 24 h (n=3113), or matching placebo (n=3100). Our primary endpoint was 30-day all-cause mortality. At randomisation, patients were stratified by their eligibility for reperfusion therapy. The first stratum included patients who were aged 65 years or older and eligible for reperfusion therapy, and the second stratum included patients of any age who were not eligible for reperfusion therapy. Analysis was by intention-to-treat. Findings At 30 days, 475 (15.3%) patients in the magnesium group and 472 (15.2%) in the placebo group had died (odds ratio 1.0, 95% CI 0.9-1.2, p=0.96). No benefit or harm of magnesium was observed in eight prespecified subgroup analyses of patients and in 15 additional exploratory subgroup analyses. After adjustment for factors shown to effect mortality risk in a multivariate regression model, no benefit of magnesium was observed (1.0, 0.8-1.1, p=0.53). Interpretation Early administration of magnesium in high-risk patients with STEMI has no effect on 30-day mortality. In view of the totality of the available evidence, in current coronary care practice there is no indication for the routine administration of intravenous magnesium in patients with STEMI.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Lancet. - 360 : 9341 (2002), p. 1189-1196. -
További szerzők:Soltész Pál (1961-) (belgyógyász, kardiológus) The Magnesium in Coronaries (MAGIC) Trial Investigators
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001-es BibID:BIBFORM034117
Első szerző:Cohen, Alexander T.
Cím:Venous thromboembolism risk and prophylaxis int he avute hospital care setting (ENDORSE study) : a multinational cross-sectional study / Cohen A. T., Tapson V. F., Bergmann J. F., Goldhaber S. Z., Kakkar A. K., Deslandes B., Huang W., Zayaruzny M., Emery L., Anderson F. A. Jr., for the ENDORSE Investigators
Megjegyzések:BACKGROUND: Information about the variation in the risk for venous thromboembolism (VTE) and in prophylaxis practices around the world is scarce. The ENDORSE (Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting) study is a multinational cross-sectional survey designed to assess the prevalence of VTE risk in the acute hospital care setting, and to determine the proportion of at-risk patients who receive effective prophylaxis. METHODS: All hospital inpatients aged 40 years or over admitted to a medical ward, or those aged 18 years or over admitted to a surgical ward, in 358 hospitals across 32 countries were assessed for risk of VTE on the basis of hospital chart review. The 2004 American College of Chest Physicians (ACCP) evidence-based consensus guidelines were used to assess VTE risk and to determine whether patients were receiving recommended prophylaxis. FINDINGS: 68 183 patients were enrolled; 30 827 (45%) were categorised as surgical, and 37 356 (55%) as medical. On the basis of ACCP criteria, 35 329 (51.8%; 95% CI 51.4-52.2; between-country range 35.6-72.6) patients were judged to be at risk for VTE, including 19 842 (64.4%; 63.8-64.9; 44.1-80.2) surgical patients and 15 487 (41.5%; 41.0-42.0; 21.1-71.2) medical patients. Of the surgical patients at risk, 11 613 (58.5%; 57.8-59.2; 0.2-92.1) received ACCP-recommended VTE prophylaxis, compared with 6119 (39.5%; 38.7-40.3; 3.1-70.4) at-risk medical patients. INTERPRETATION: A large proportion of hospitalised patients are at risk for VTE, but there is a low rate of appropriate prophylaxis. Our data reinforce the rationale for the use of hospital-wide strategies to assess patients' VTE risk and to implement measures that ensure that at-risk patients receive appropriate prophylaxis.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Lancet. - 371 : 9610 (2008), p. 387-394. -
További szerzők:Tapson, Victor F. Bergmann, Jean-Francois Goldhaber, Samuel Z. Kakkar, Ajay K. Deslandes, Bruno Huang, Wei Zayaruzny, Maksim Emery, Leigh Anderson, Frederik A. Jr. Zeher Margit (1957-2018) (belgyógyász, allergológus és klinikai immunológus, reumatológus) for the ENDORSE Investigators
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001-es BibID:BIBFORM091877
Első szerző:Fisher, Benjamin
Cím:Assessment of the anti-CD40 antibody iscalimab in patients with primary Sjögren's syndrome : a multicentre, randomised, double-blind, placebo-controlled, proof-of-concept study / Benjamin A. Fisher, Antonia Szanto, Wan-Fai Ng, Michele Bombardieri, Maximilian G. Posch, Athena S. Papas, Arwa M. Farag, Thomas Daikeler, Bettina Bannert, Diego Kyburz, Alan J. Kivitz, Steven E. Carsons, David A. Isenberg, Francesca Barone, Simon J. Bowman, Pascal Espié, David Floch, Cyrielle Dupuy, Xiaohui Ren, Petra M. Faerber, Andrew M. Wright, Hans-Ulrich Hockey, Michael Rotte, Julie Milojevic, Alexandre Avrameas, Marie-Anne Valentin, James S. Rush, Peter Gergely
Megjegyzések:Background Primary Sjogren's syndrome is an autoimmune disease that presents as dryness of the mouth and eyes due to impairment of the exocrine glands. To our knowledge, no systemic therapies for primary Sjogren's syndrome have shown efficacy. CD40-CD154-mediated T cell-B cell interactions in primary Sjogren's syndrome contribute to aberrant lymphocyte activation in inflamed tissue, leading to sialadenitis and other tissue injury. Therefore, we investigated the safety and preliminary efficacy of iscalimab (CFZ533), a novel anti-CD40 monoclonal antibody, in patients with primary Sjogren's syndrome. Methods This multicentre, randomised, double-blind, placebo-controlled, proof-of-concept study took place at ten investigational sites across Europe (UK, n=4; Germany, Switzerland, and Hungary, n=1 each) and the USA (n=3). Eligible patients were aged 18-75 years and fulfilled the 2002 American European consensus group diagnostic dassification criteria for primary Sjogren's syndrome. In the double-blind phase of the trial, patients were randomly assigned (2:1) via computer-generated unique randomisation numbers to receive subcutaneous iscalimab (3 mg/kg) or placebo at weeks 0, 2, 4, and 8 (cohort 1) or intravenous iscalimab (10 mg/kg) or placebo at weeks 0, 2, 4, and 8 (cohort 2). Randomisation was stratified according to baseline intake of oral corticosteroids. At week 12, patients in both cohorts received open-label iscalimab (same dose and route) for 12 weeks. The primary objectives of the study were to assess the safety, tolerability, and efficacy of multiple doses of iscalimab in the two sequential dose cohorts. Safety and tolerability were assessed by adverse events and efficacy of iscalimab versus placebo was assessed by dinical disease activity, as measured by the change in European League Against Rheumatism Sjogren's syndrome disease activity index (ESSDAI) score after 12 weeks of treatment. Analyses were done on a per-protocol basis. The trial was registered with, NCT02291029. Findings Between Oct 22, 2014, and June 28, 2016, we assessed 82 patients for eligibility (25 for cohort 1 and 57 for cohort 2). 38 patients were excluded because of ineligibility. In cohort 1, 12 patients were randomly assigned to receive either 3 mg/kg doses of iscalimab (n=8) or placebo (n=4), and in cohort 2, 32 patients were randomly assigned to receive either intravenous 10 mg/kg doses of iscalimab (n=21) or placebo (n=11). Adverse events were similar between iscalimab treatment groups and placebo groups, with adverse events occurring in all patients in cohort 1, and in 52% and 64% of the iscalimab and placebo groups, respectively, in cohort 2. Two serious adverse events were reported (one case of bacterial conjunctivitis in cohort 1 and one case of atrial fibrillation in cohort 2), which were unrelated to treatment with iscalimab. Intravenous treatment with iscalimab resulted in a mean reduction of 5.21 points (95% CI 0.96-9.46; one-sided p=0.0090) in ESSDAI score compared with placebo. There was no signficiant difference in ESSDAI score between subcutaneous iscalimab and placebo. Interpretation To our knowledge, this is the first randomised, placebo-controlled proof-of-concept study of a new investigational drug for primary Sjogren's syndrome that indicates preliminary efficacy. Our data suggest a role of CD40-CD154 interactions in primary Sjogren's syndrome pathology and the therapeutic potential for CD40 blockade in this disease should be investigated further. Copyright (C) 2020 Elsevier Ltd. All rights reserved
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:The Lancet Rheumatology. - 2 : 3 (2020), p. 142-152. -
További szerzők:Szántó Antónia (1977-) (belgyógyász, allergológus és klinikai immunológus) Ng, Wan Fai Bombardieri, Michele Posch, Maximilian G. Papas, Athena S. Farag, Arwa M. Daikeler, Thomas Bannert, Bettina Kyburz, Diego Kivitz, Alan J. Carsons, Steven E. Isenberg, David A. Barone, Francesca Bowman, Simon J. Espié, Pascal Floch, David Dupuy, Cyrielle Ren, Xiaohui Faerber, Petra M. Wright, Andrew M. Hockey, Hans-Ulrich Rotte, Michael Milojevic, Julie Avrameas, Alexandre Valentin, Marie-Anne Rush, James S. Gergely Péter (1974-) (igazságügyi orvosszakértő)
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