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001-es BibID:BIBFORM103936
035-os BibID:(WoS)000868254300009 (Scopus)85143055930
Első szerző:Aggarwal, Rohit
Cím:Trial of Intravenous Immune Globulin in Dermatomyositis / Aggarwal Rohit, Charles-Schoeman Christina, Schessl Joachim, Bata-Csörgő Zsuzsanna, Dimachkie Mazen M., Griger Zoltan, Moiseev Sergey, Oddis Chester, Schiopu Elena, Vencovsky Jiri, Beckmann Irene, Clodi Elisabeth, Bugrova Olga, Dankó Katalin, Ernste Floranne, Goyal Namita A., Heuer Marvin, Hudson Marie, Hussain Yessar M., Karam Chafic, Magnolo Nina, Nelson Ronald, Pozur Nataliia, Prystupa Liudmyla, Sárdy Miklós, Valenzuela Guillermo, van der Kooi Anneke J., Vu Tuan, Worm Margitta, Levine Todd, ProDERM Trial Group
Dátum:2022
ISSN:0028-4793
Megjegyzések:Background: Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated. Methods: We conducted a randomized, placebo-controlled trial involving patients with active dermatomyositis. The patients were assigned in a 1:1 ratio to receive IVIG at a dose of 2.0 g per kilogram of body weight or placebo every 4 weeks for 16 weeks. The patients who received placebo and those without confirmed clinical deterioration while receiving IVIG could enter an open-label extension phase for another 24 weeks. The primary end point was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score reflecting the change in a core set of six measures of myositis activity over time; scores range from 0 to 100, with higher scores indicating greater improvement. Key secondary end points included at least moderate improvement (TIS ?40) and major improvement (TIS ?60), and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index. Results: A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events. Conclusions: In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal Of Medicine. - 387 : 14 (2022), p. 1264-1278. -
További szerzők:Charles-Schoeman, Christina Schessl, Joachim Bata-Csörgő Zsuzsanna Dimachkie, Mazen M. Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Moiseev, Sergey Oddis, Chester V. Schiopu, Elena Vencovsky, Jiri Beckmann, Irene Clodi, Elisabeth Bugrova, Olga Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Ernste, Floranne Goyal, Namita A. Heuer, Marvin Hudson, Marie Hussain, Yessar M. Karam, Chafic Magnolo, Nina Nelson, Ronald Pozur, Nataliia Prystupa, Liudmyla Sárdy Miklós Valenzuela, Guillermo van der Kooi, Anneke J. Vu, Tuan Worm, Margitta Levine, Todd ProDERM Trial Group
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2.

001-es BibID:BIBFORM033332
Első szerző:Alexander, John H.
Cím:Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome / Alexander John H., Lopes Renato D., James Stefan, Kilaru Rakhi, He Yaohua, Mohan Puneet, Bhatt Deepak L., Goodman Shaun, Verheugt Freek W., Flather Marcus, Huber Kurt, Liaw Danny, Husted Steen E., Lopez-Sendon Jose, De Caterina Raffaele, Jansky Petr, Darius Harald, Vinereanu Dragos, Cornel Jan H., Cools Frank, Atar Dan, Leiva-Pons Jose Luis, Keltai Matyas, Ogawa Hisao, Pais Prem, Parkhomenko Alexander, Ruzyllo Witold, Diaz Rafael, White Harvey, Ruda Mikhail, Geraldes Margarida, Lawrence Jack, Harrington Robert A., Wallentin Lars, for the APPRAISE-2 Investigators
Dátum:2011
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:New England Journal Of Medicine. - 365 : 8 (2011), p. 699-708. -
További szerzők:Lopes, Renato D. James, Stefan Kilaru, Rakhi He, Yaohua Mohan, Puneet Bhatt, Deepak L. Goodman, Shaun Verheugt, Freek W. Flather, Marcus Huber, Kurt Liaw, Danny Husted, Steen Lopez-Sendon, Jose De Caterina, Raffaele Jansky, Petr Darius, Harald Vinereanu, Dragos Cornel, Jan H. Cools, Frank Atar, Dan Leiva-Pons, Jose Luis Keltai Mátyás (1942-) (kardiológus) Ogawa, Hisao Pais, Prem Parkhomenko, Alexander Ruzyllo, Witold Diaz, Rafael White, Harvey Ruda, Mikhail Geraldes, Margarida Lawrence, Jack Harrington, Robert A. Wallentin, Lars Soltész Pál (1961-) (belgyógyász, kardiológus) for the APPRAISE-2 Investigators
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3.

001-es BibID:BIBFORM126574
035-os BibID:(scopus)85211967365
Első szerző:Bardia, Aditya
Cím:Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer / Bardia Aditya, Hu Xichun, Dent Rebecca, Yonemori Kan, Barrios Carlos H., O'Shaughnessy Joyce A., Wildiers Hans, Pierga Jean-Yves, Zhang Qingyuan, Saura Cristina, Biganzoli Laura, Sohn Joohyuk, Im Seock-Ah, Lévy Christelle, Jacot William, Begbie Natasha, Ke Jun, Patel Gargi, Curigliano Giuseppe, DESTINY-Breast06 Trial Investigators
Dátum:2024
ISSN:0028-4793
Megjegyzések:Background: Outcomes in patients with hormone receptor-positive metastatic breast cancer worsen after one or more lines of endocrine-based therapy. Trastuzumab deruxtecan has shown efficacy in patients with metastatic breast cancer with low expression of human epidermal growth factor receptor 2 (HER2) after previous chemotherapy. Methods: We conducted a phase 3, multicenter, open-label trial involving patients with hormone receptor-positive metastatic breast cancer with low HER2 expression (a score of 1+ or 2+ on immunohistochemical [IHC] analysis and negative results on in situ hybridization) or ultralow HER2 expression (IHC 0 with membrane staining) who had received one or more lines of endocrine-based therapy and no previous chemotherapy for metastatic breast cancer. Patients were randomly assigned in a 1:1 ratio to receive trastuzumab deruxtecan or the physician's choice of chemotherapy. The primary end point was progression-free survival (according to blinded independent central review) among the patients with HER2-low disease. Secondary end points included progression-free survival among all the patients who had undergone randomization, overall survival, and safety. Results: Of the 866 patients who underwent randomization, 713 had HER2-low disease, and 153 had HER2-ultralow disease. Among the patients with HER2-low disease, the median progression-free survival was 13.2 months (95% confidence interval [CI], 11.4 to 15.2) in the trastuzumab deruxtecan group and 8.1 months (95% CI, 7.0 to 9.0) in the chemotherapy group (hazard ratio for disease progression or death, 0.62; 95% CI, 0.52 to 0.75; P<0.001); the results were consistent in the exploratory HER2-ultralow population. Data for overall survival were immature. Adverse events of grade 3 or higher occurred in 52.8% of the patients in the trastuzumab deruxtecan group and in 44.4% of those in the chemotherapy group. Adjudicated interstitial lung disease or pneumonitis occurred in 49 patients (11.3%; three events were grade 5 in severity) and in 1 patient (0.2%; grade 2), respectively. Conclusions: Among patients with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer who had received one or more lines of endocrine-based therapy, treatment with trastuzumab deruxtecan resulted in longer progression-free survival than chemotherapy. No new safety signals were identified. (Funded by AstraZeneca and Daiichi Sankyo; DESTINY-Breast06 ClinicalTrials.gov number, NCT04494425.).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
metastatic breast cancer
trastuzumab deruxtecan
endocrine treatment
Megjelenés:New England Journal Of Medicine. - 391 : 22 (2024), p. 2110-2122. -
További szerzők:Hu, Xichun Dent, Rebecca Yonemori, Kan Barrios, Carlos H. O'Shaughnessy, Joyce A. Wildiers, Hans Pierga, Jean-Yves Zhang, Qingyuan Saura, Cristina Biganzoli, Laura Sohn, Joo Hyuk Im, Seock-Ah Lévy, Christelle Jacot, William Begbie, Natasha Ke, Jun Patel, Gargi Curigliano, Giuseppe Furka Andrea (1976-) (sebész) DESTINY-Breast06 Trial Investigators
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4.

001-es BibID:BIBFORM020688
Első szerző:Barrett-Connor, Elizabeth
Cím:Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women / Barrett-Connor E., Mosca L., Collins P., Geiger M. J., Grady D., Kornitzer M., McNabb M. A., Wenger N. K., the Raloxifene Use for The Heart (RUTH) Trial Investigators
Dátum:2006
Megjegyzések:The effect of raloxifene, a selective estrogen-receptor modulator, on coronary heart disease (CHD) and breast cancer is not established. METHODS: We randomly assigned 10,101 postmenopausal women (mean age, 67.5 years) with CHD or multiple risk factors for CHD to 60 mg of raloxifene daily or placebo and followed them for a median of 5.6 years. The two primary outcomes were coronary events (i.e., death from coronary causes, myocardial infarction, or hospitalization for an acute coronary syndrome) and invasive breast cancer. RESULTS: As compared with placebo, raloxifene had no significant effect on the risk of primary coronary events (533 vs. 553 events; hazard ratio, 0.95; 95 percent confidence interval, 0.84 to 1.07), and it reduced the risk of invasive breast cancer (40 vs. 70 events; hazard ratio, 0.56; 95 percent confidence interval, 0.38 to 0.83; absolute risk reduction, 1.2 invasive breast cancers per 1000 women treated for one year); the benefit was primarily due to a reduced risk of estrogen-receptor-positive invasive breast cancers. There was no significant difference in the rates of death from any cause or total stroke according to group assignment, but raloxifene was associated with an increased risk of fatal stroke (59 vs. 39 events; hazard ratio, 1.49; 95 percent confidence interval, 1.00 to 2.24; absolute risk increase, 0.7 per 1000 woman-years) and venous thromboembolism (103 vs. 71 events; hazard ratio, 1.44; 95 percent confidence interval, 1.06 to 1.95; absolute risk increase, 1.2 per 1000 woman-years). Raloxifene reduced the risk of clinical vertebral fractures (64 vs. 97 events; hazard ratio, 0.65; 95 percent confidence interval, 0.47 to 0.89; absolute risk reduction, 1.3 per 1000). CONCLUSIONS: Raloxifene did not significantly affect the risk of CHD. The benefits of raloxifene in reducing the risks of invasive breast cancer and vertebral fracture should be weighed against the increased risks of venous thromboembolism and fatal stroke. (ClinicalTrials.gov number, NCT00190593 [ClinicalTrials.gov].).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:The New England Journal of Medicine. - 355 : 2 (2006), p. 125-137. -
További szerzők:Mosca, Lori Collins, Peter Geiger, Mary Jane Grady, Deborah Kornitzer, Marcel McNabb, Michelle A. Wenger, Nanette K. Czuriga István (1948-2018) (kardiológus) the Raloxifene Use for The Heart (RUTH) Trial Investigators
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5.

001-es BibID:BIBFORM134785
035-os BibID:(scopus)105027106259 (wos)001611140600001
Első szerző:Bohula, Erin A.
Cím:Evolocumab in Patients without a Previous Myocardial Infarction or Stroke / Bohula Erin A., Marston Nicholas A., Bhatia Ajay K., De Ferrari Gaetano M., Leiter Lawrence A., Nicolau Jose C., Park Jeong-Gun, Kuder Julia F., Murphy Sabina A., Walsh Emileigh, Wang Huei, Blaha Vladimir, Budaj Andrzej, Cornel Jan H., Goudev Assen, Kiss Robert Gabor, Lorenzatti Alberto J., Parkhomenko Alexander, Cyrille Marcoli, Paiva da Silva Lima Gabriel, Ohman E. Magnus, Giugliano Robert P., Sabatine Marc S., VESALIUS-CV Investigators
Dátum:2026
ISSN:0028-4793
Megjegyzések:Background: The proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor evolocumab reduces the risk of major adverse cardiovascular events (MACE) among patients with a previous myocardial infarction, stroke, or symptomatic peripheral artery disease. The effect of evolocumab on the risk of MACE among patients without a previous myocardial infarction or stroke is unknown. Methods: We conducted an international, double-blind, randomized, placebo-controlled trial of evolocumab in patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke who had a low-density lipoprotein cholesterol level of at least 90 mg per deciliter. Patients were randomly assigned in a 1:1 ratio to receive evolocumab at a dose of 140 mg every 2 weeks or placebo. The two primary end points were a composite of death from coronary heart disease, myocardial infarction, or ischemic stroke (3-point MACE) and a composite of 3-point MACE or ischemia-driven arterial revascularization (4-point MACE). Results: A total of 12,257 patients were randomly assigned to receive evolocumab (6129 patients) or placebo (6128) and were included in the efficacy analyses. The median age of the patients was 66 years, 43% were women, and 93% were White. The median follow-up was 4.6 years. A 3-point MACE event occurred in 336 patients (5-year Kaplan-Meier estimate, 6.2%) in the evolocumab group, as compared with 443 (8.0%) in the placebo group (hazard ratio, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). A 4-point MACE event occurred in 747 patients (5-year Kaplan-Meier estimate, 13.4%) in the evolocumab group, as compared with 907 (16.2%) in the placebo group (hazard ratio, 0.81; 95% CI, 0.73 to 0.89; P<0.001). No evidence of a between-group difference was seen in the incidence of safety events. Conclusions: PCSK9 inhibition with evolocumab led to a lower risk of first cardiovascular events than placebo among patients with atherosclerosis or diabetes and without a previous myocardial infarction or stroke. (Funded by Amgen; VESALIUS-CV ClinicalTrials.gov number, NCT03872401.).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal Of Medicine. - 394 : 2 (2026), p. 117-127. -
További szerzők:Marston, Nicholas A. Bhatia, Ajay K. De Ferrari, Gaetano M. Leiter, Lawrence A. Nicolau, José Carlos Park, Jeong-Gun Kuder, Julia F. Murphy, Sabina A. Walsh, Emileigh Wang, Huei Blaha, Vladimir Budaj, Andrzej Cornel, Jan H. Goudev, Assen Kiss Róbert Gábor Lorenzatti, Alberto J. Parkhomenko, Alexander Cyrille, Marcoli da Silva Lima, Gabriel Paiva Ohman, E. Magnus Giugliano, Robert P. Sabatine, Marc S. Harangi Mariann (1974-) (belgyógyász, endokrinológus) VESALIUS-CV Investigators
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6.

001-es BibID:BIBFORM099099
Első szerző:Bonaca, Marc P.
Cím:Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction / Bonaca Marc P., Bhatt Deepak L., Cohen Marc, Steg Philippe Gabriel, Storey Robert F., Jensen Eva C., Magnani Giulia, Bansilal Sameer, Fish M. Polly, Im Kyungah, Bengtsson Olof, Ophuis Ton Oude, Budaj Andrzej, Theroux Pierre, Ruda Mikhail, Hamm Christian, Goto Shinya, Spinar Jindrich, Nicolau José Carlos, Kiss Robert G., Murphy Sabina A., Wiviott Stephen D., Held Peter, Braunwald Eugene, Sabatine Marc S., PEGASUS-TIMI 54 Steering Committee and Investigators
Dátum:2015
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:New England Journal Of Medicine. - 372 : 19 (2015), p. 1791-1800. -
További szerzők:Bhatt, Deepak L. Cohen, Marc A. Steg, Philippe Gabriel Storey, Robert F. Jensen, Eva C. Magnani, Giulia Bansilal, Sameer Fish, M. Polly Im, Kyungah Bengtsson, Olof Ophuis, Ton Oude Budaj, Andrzej Theroux, Pierre Ruda, Mikhail Hamm, Christian Goto, Shinya Špinar, Jindrich Nicolau, José Carlos Kiss Róbert Gábor Murphy, Sabina A. Wiviott, Stephen D. Held, Peter Braunwald, Eugene Sabatine, Marc S. Jenei Csaba (1976-) (kardiológus) PEGASUS-TIMI 54 Steering Committee and Investigators
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7.

001-es BibID:BIBFORM013545
Első szerző:Boztug, Kaan
Cím:Stem-cell gene therapy for the Wiskott-Aldrich syndrome / Kaan Boztug, Manfred Schmidt, Adrian Schwarzer, Pinaki P. Banerjee, Inés Avedillo Díez, Ricardo A. Dewey, Marie Böhm, Ali Nowrouzi, Claudia R. Ball, Hanno Glimm, Sonja Naundorf, Klaus Kühlcke, Rainer Blasczyk, Irina Kondratenko, László Maródi, Jordan S. Orange, Christof von Kalle, Christoph Klein
Dátum:2010
ISSN:0028-4793
Megjegyzések:The Wiskott-Aldrich syndrome (WAS) is an X-linked recessive primary immunodeficiency disorder associated with thrombocytopenia, eczema, and autoimmunity. We treated two patients who had this disorder with a transfusion of autologous, genetically modified hematopoietic stem cells (HSC). We found sustained expression of WAS protein expression in HSC, lymphoid and myeloid cells, and platelets after gene therapy. T and B cells, natural killer (NK) cells, and monocytes were functionally corrected. After treatment, the patients' clinical condition markedly improved, with resolution of hemorrhagic diathesis, eczema, autoimmunity, and predisposition to severe infection. Comprehensive insertion-site analysis showed vector integration that targeted multiple genes controlling growth and immunologic responses in a persistently polyclonal hematopoiesis. (Funded by Deutsche Forschungsgemeinschaft and others; German Clinical Trials Register number, DRKS00000330.).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:New England Journal of Medicine. - 363 : 20 (2010), p. 1918-1927. -
További szerzők:Schmidt, Manfred Schwarzer, Adrian Banerjee, Pinaki P. Avedillo Díez, Inés Dewey, Ricardo A. Böhm, Marie Nowrouzi, Ali Ball, Claudia Regina Glimm, Hanno Naundorf, Sonja Kühlcke, Klaus Blasczyk, Rainer Kondratenko, Irina Maródi László (1949-) (gyermekgyógyász infektológus, immunológus) Orange, Jordan S. Kalle, Christof, von Klein, Christoph
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8.

001-es BibID:BIBFORM132645
035-os BibID:(WoS)001414719200001 (Scopus)85219076359
Első szerző:Brown, Jennifer R.
Cím:Fixed-Duration Acalabrutinib Combinations in Untreated Chronic Lymphocytic Leukemia / J. R. Brown, J. F. Seymour, W. Jurczak, A. Aw, M. Wach, A. Illes, A. Tedeschi, C. Owen, A. Skarbnik, D. Lysak, Ki-Seong Eom, M. Šimkovič, M. A. Pavlovsky, A. P. Kater, B. Eichhorst, K. Miller, V. Munugalavadla, T. Yu, M. de Borja, P. Ghia, AMPLIFY investigators
Dátum:2025
ISSN:0028-4793
Tárgyszavak:Orvostudományok Egészségtudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal Of Medicine. - 392 : 8 (2025), p. 748-762. -
További szerzők:Seymour, John F. Jurczak, Wojciech Aw, Andrew Wach, Malgorzata Illés Árpád (1959-) (belgyógyász, haematológus, onkológus) Tedeschi, Alessandra Owen, Carolyn Skarbnik, Alan P. Lysak, Daniel Eom, Ki-Seong Simkovic, Martin Pavlovsky, Miguel Arturo Kater, Arnon Philip Eichhorst, Barbara Miller, Kara Munugalavadla, Veerendra Yu, Ting Borja, Marianne de Ghia, Paolo AMPLIFY investigators
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9.

001-es BibID:BIBFORM124642
035-os BibID:(scopus)85201910340 (wos)001301684200012
Első szerző:Choueiri, Toni K.
Cím:Belzutifan versus Everolimus for Advanced Renal-Cell Carcinoma / Choueiri Toni K., Powles Thomas, Peltola Katriina, de Velasco Guillermo, Burotto Mauricio, Suarez Cristina, Ghatalia Pooja, Iacovelli Roberto, Lam Elaine T., Verzoni Elena, Gümüş Mahmut, Stadler Walter M., Kollmannsberger Christian, Melichar Bohuslav, Venugopal Balaji, Gross-Goupil Marine, Poprach Alexandr, De Santis Maria, Schutz Fabio A., Park Se Hoon, Nosov Dmitry A., Porta Camillo, Lee Jae Lyun, Garcia-del-Muro Xavier, Biscaldi Elisa, Manneh Kopp Ray, Oya Mototsugu, He Li, Wang Aobo, Perini Rodolfo F., Vickery Donna, Albiges Laurence, Rini Brian, LITESPARK-005 Investigators
Dátum:2024
ISSN:0028-4793
Megjegyzések:BACKGROUND Belzutifan, a hypoxia-inducible factor 2? inhibitor, showed clinical activity in clear-cell renal-cell carcinoma in early-phase studies. METHODS In a phase 3, multicenter, open-label, active-controlled trial, we enrolled participants with advanced clear-cell renal-cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies and randomly assigned them, in a 1:1 ratio, to receive 120 mg of belzutifan or 10 mg of everolimus orally once daily until disease progression or unacceptable toxic effects occurred. The dual primary end points were progression-free survival and overall survival. The key secondary end point was the occurrence of an objective response (a confirmed complete or partial response). RESULTS A total of 374 participants were assigned to belzutifan, and 372 to everolimus. At the first interim analysis (median follow-up, 18.4 months), the median progression-free survival was 5.6 months in both groups; at 18 months, 24.0% of the participants in the belzutifan group and 8.3% in the everolimus group were alive and free of progression (two-sided P=0.002, which met the prespecified significance criterion). A confirmed objective response occurred in 21.9% of the participants (95% confidence interval [CI], 17.8 to 26.5) in the belzutifan group and in 3.5% (95% CI, 1.9 to 5.9) in the everolimus group (P<0.001, which met the prespecified significance criterion). At the second interim analysis (median follow-up, 25.7 months), the median overall survival was 21.4 months in the belzutifan group and 18.1 months in the everolimus group; at 18 months, 55.2% and 50.6% of the participants, respectively, were alive (hazard ratio for death, 0.88; 95% CI, 0.73 to 1.07; two-sided P=0.20, which did not meet the prespecified significance criterion). Grade 3 or higher adverse events of any cause occurred in 61.8% of the participants in the belzutifan group (grade 5 in 3.5%) and in 62.5% in the everolimus group (grade 5 in 5.3%). Adverse events led to discontinuation of treatment in 5.9% and 14.7% of the participants, respectively. CONCLUSIONS Belzutifan showed a significant benefit over everolimus with respect to progression-free survival and objective response in participants with advanced clear-cell renal-cell carcinoma who had previously received immune checkpoint and antiangiogenic therapies. Belzutifan was associated with no new safety signals. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; LITESPARK-005 ClinicalTrials.gov number, NCT04195750.)
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
hypoxia-inducible factor 2α inhibitor
clear-cell renal-cell carcinoma
Megjelenés:New England Journal Of Medicine. - 391 : 8 (2024), p. 710-721. -
További szerzők:Powles, Thomas Peltola, Katriina de Velasco, Guillermo Burotto, Mauricio Suárez, C. Ghatalia, Pooja Iacovelli, Roberto Lam, Elaine T. Verzoni, Elena Gümüş, Mahmut Stadler, Walter M. Kollmannsberger, Christian Melichar, Bohuslav Venugopal, Balaji Gross-Goupil, Marine Poprach, Alexandr De Santis, Maria Schutz, Fabio A. Park, S. H. Nosov, Dmitry Porta, Camillo Lee, Jae Lyun Garcia-del-Muro, Xavier Biscaldi, Elisa Manneh Kopp, Ray Oya, Mototsugu He, Li Wang, Aobo Perini, Rodolfo F. Vickery, Donna Albiges, Laurence Rini, Brian I. Furka Andrea (1976-) (sebész) LITESPARK-005 Investigators
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10.

001-es BibID:BIBFORM077367
035-os BibID:(WoS)000423233400006 (Scopus)85041389324
Első szerző:Connors, Joseph M.
Cím:Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin's Lymphoma / J. M. Connors, W. Jurczak, D. J. Straus, S. M. Ansell, W. S. Kim, A. Gallamini, A. Younes, S. Alekseev, Á. Illés, M. Picardi, E. Lech-Maranda, Y. Oki, T. Feldman, P. Smolewski, K. J. Savage, N. L. Bartlett, J. Walewski, R. Chen, R. Ramchandren, P. L. Zinzani, D. Cunningham, A. Rosta, N. C. Josephson, E. Song, J. Sachs, R. Liu, H. A. Jolin, D. Huebner, J. Radford, ECHELON-1 Study Group
Dátum:2018
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal of Medicine. - 378 : 9 (2018), p. 331-344. -
További szerzők:Jurczak, Wojciech Straus, David J. Ansell, Stephen M. Kim, Won Seog Gallamini, Andrea Younes, Anas Alekseev, Sergey Illés Árpád (1959-) (belgyógyász, haematológus, onkológus) Picardi, Marco Lech-Maranda, Ewa Oki, Yasuhiro Feldman, Tatyana Smolewski, Piotr Savage, Kerry J. Bartlett, Nancy L. Walewski, Jan Chen, Robert Ramchandren, Radhakrishnan Zinzani, Pier Luigi Cunningham, David Rosta András Josephson, Neil C. Song, Eric Sachs, Jessica Liu, Rachael Jolin, Hina A. Huebner, Dirk Radford, John ECHELON-1 Study Group
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Intézményi repozitóriumban (DEA) tárolt változat
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11.

001-es BibID:BIBFORM105335
035-os BibID:(WoS)000888836400009 (Scopus)85144448744
Első szerző:Das Pradhan, Aruna
Cím:Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk / Das Pradhan Aruna, Glynn Robert J., Fruchart Jean-Charles, MacFadyen Jean G., Zaharris Elaine S., Everett Brendan M., Campbell Stuart E., Oshima Ryu, Amarenco Pierre, Blom Dirk J., Brinton Eliot A., Eckel Robert H., Elam Marshall B., Felicio Joao S., Ginsberg Henry N., Goudev Assen, Ishibashi Shun, Joseph Jacob, Kodama Tatsuhiko, Koenig Wolfgang, Leiter Lawrence A., Lorenzatti Alberto J., Mankovsky Boris, Marx Nikolaus, Nordestgaard Børge G., Páll Dénes, Ray Kausik K., Santos Raul D., Soran Handrean, Susekov Andrey, Tendera Michal, Yokote Koutaro, Paynter Nina P., Buring Julie E., Libby Peter, Ridker Paul M., PROMINENT Investigators
Dátum:2022
ISSN:0028-4793
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal Of Medicine. - 387 : 21 (2022), p. 1923-1934. -
További szerzők:Glynn, Robert J. Fruchart, Jean-Charles MacFadyen, Jean G. Zaharris, Elaine S. Everett, Brendan M. Campbell, Stuart E. Oshima, Ryu Amarenco, Pierre Blom, Dirk J. Brinton, Eliot A. Eckel, Robert H. Elam, Marshall B. Felicio, Joāo S. Ginsberg, Henry N. Goudev, Assen Ishibashi, Shun Joseph, Jacob Kodama, Tatsuhiko Koenig, Wolfgang Leiter, Lawrence A. Lorenzatti, Alberto J. Mankovsky, Boris N. Marx, Nikolaus Nordestgaard, Børge G. Páll Dénes (1967-) (belgyógyász, kardiológus) Ray, Kausik K. Santos, Raul D. Soran, Handrean Susekov, Andrey Tendera, Michal Yokote, Koutaro Paynter, Nina P. Buring, Julie E. Libby, Peter Ridker, Paul M. PROMINENT Investigators
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12.

001-es BibID:BIBFORM013825
Első szerző:Decousus, Hervé
Cím:Fondaparinux for the Treatment of Superficial-Vein Thrombosis in the Legs / Hervé Decousus, Paolo Prandoni, Patrick Mismetti, Rupert M. Bauersachs, Zoltán Boda, Benjamin Brenner, Silvy Laporte, Lajos Matyas, Saskia Middeldorp, German Sokurenko, Alain Leizorovicz, The CALISTO Study Group
Dátum:2010
Megjegyzések:The efficacy and safety of anticoagulant treatment for patients with acute, symptomaticsuperficial-vein thrombosis in the legs, but without concomitant deep-veinthrombosis or symptomatic pulmonary embolism at presentation, have not been established.MethodsIn a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux,administered subcutaneously at a dose of 2.5 mg once daily, or placebo for45 days. The primary efficacy outcome was a composite of death from any cause orsymptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomaticextension to the saphenofemoral junction or symptomatic recurrence ofsuperficial-vein thrombosis at day 47. The main safety outcome was major bleeding.The patients were followed until day 77.ResultsThe primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinuxgroup and 88 of 1500 patients (5.9%) in the placebo group (relative riskreduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001).The incidence of each component of the primary efficacy outcome was significantlyreduced in the fondaparinux group as compared with the placebo group, except forthe outcome of death (0.1% in both groups). The rate of pulmonary embolism ordeep-vein thrombosis was 85% lower in the fondaparinux group than in the placebogroup (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions wereobserved at day 77. A total of 88 patients would need to be treated to prevent oneinstance of pulmonary embolism or deep-vein thrombosis. Major bleeding occurredin one patient in each group. The incidence of serious adverse events was 0.7% withfondaparinux and 1.1% with placebo.ConclusionsFondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatmentof patients with acute, symptomatic superficial-vein thrombosis of the legsand did not have serious side effects.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:The New England Journal of Medicine. - 363 : 13 (2010), p. 1222-1232. -
További szerzők:Prandoni, Paolo Mismetti, Patrick Bauersachs, Rupert M. Boda Zoltán (1947-) (belgyógyász, haematologus, klinikai onkológus) Brenner, Benjamin Laporte, Silvy Mátyás Lajos Middeldorp, Saskia Sokurenko, German Leizorovicz, Alain The CALISTO Study Group
Internet cím:Intézményi repozitóriumban (DEA) tárolt változat
DOI
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