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1. Antibiotic treatment of infections caused by carbapenem-resistant Gram-negative bacilli: an international ESCMID cross-sectional survey among infectious diseases specialists practicing in large hospitals

Author

Abbo, L., Abgueguen, P., Almirante, B., Azzini, A.M., Bani-Sadr, F., Bassetti, M., Ben-Ami, R., Beović, B., Béraud, G., Botelho-Nevers, E., Bou, G., Boutoille, D., Cabié, A., Cacopardo, B., Cascio, A., Cassir, N., Castelli, F., Cecala, M., Charmillon, A., Chirouze, C., Cisneros, J.M., Colmenero, J.D., Coppola, N., Corcione, S., Daikos, G.L., Dalla Gasperina, D., De la Calle Cabrera, C., Delobel, P., Di Caprio, D., Durante Mangoni, E., Dupon, M., Ettahar, N., Falagas, M.E., Falcone, M., Fariñas, M.C., Faure, E., Forestier, E., Foti, G., Gallagher, J., Gattuso, G., Gendrin, V., Gentile, I., Giacobbe, D.R., Gogos, C.A., Grandiere Perez, L., Hansmann, Y., Horcajada, J.P., Iacobello, C., Jacob, J.T., Justo, J.A., Kernéis, S., Komnos, A., Kotnik Kevorkijan, B., Lebeaux, D., Le Berre, R., Lechiche, C., Le Moxing, V., Lescure, F.X., Libanore, M., Martinot, M., Merino de Lucas, E., Mondain, V., Mondello, P., Montejo, M., Mootien, J., Muñoz, P., Nir-Paz, R., Pan, A., Paño-Pardo, J.R., Patel, G., Paul, M., Pérez Rodríguez, M.T., Piroth, L., Pogue, J., Potoski, B.A., Pourcher, V., Pyrpasopoulou, A., Rahav, G., Rizzi, M., Rodríguez-Baño, J., Salavert, M., Scheetz, M., Sims, M., Spahija, G., Stefani, S., Stefos, A., Tamma, P.D., Tattevin, P., Tedesco, A., Torre-Cisneros, J., Tripolitsioti, P., Tsiodras, S., Uomo, G., Verdon, R., Viale, P., Vitrat, V., Weinberger, M., Wiener-Well, Y., Papst, L., Pulcini, C., Durante-Mangoni, E., Kaye, K.S., and Raka, L.

Published
2018
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2. Practical thematic analysis : a guide for multidisciplinary health services research teams engaging in qualitative analysis

Author

Saunders, C. H., Sierpe, A., Von Plessen, C., Kennedy, Alice M., Leviton, L. C., Bernstein, S. L., Goldwag, J., King, J. R., Marx, C. M., Pogue, J. A., Saunders, R. K., Van Citters, A., Yen, R. W., Elwyn, G., Leyenaar, J. K., Saunders, C. H., Sierpe, A., Von Plessen, C., Kennedy, Alice M., Leviton, L. C., Bernstein, S. L., Goldwag, J., King, J. R., Marx, C. M., Pogue, J. A., Saunders, R. K., Van Citters, A., Yen, R. W., Elwyn, G., and Leyenaar, J. K.

Abstract

Qualitative research methods explore and provide deep contextual understanding of real world issues, including people's beliefs, perspectives, and experiences. Whether through analysis of interviews, focus groups, structured observation, or multimedia data, qualitative methods offer unique insights in applied health services research that other approaches cannot deliver. However, many clinicians and researchers hesitate to use these methods, or might not use them effectively, which can leave relevant areas of inquiry inadequately explored. Thematic analysis is one of the most common and flexible methods to examine qualitative data collected in health services research. This article offers practical thematic analysis as a step-by-step approach to qualitative analysis for health services researchers, with a focus on accessibility for patients, care partners, clinicians, and others new to thematic analysis. Along with detailed instructions covering three steps of reading, coding, and theming, the article includes additional novel and practical guidance on how to draft effective codes, conduct a thematic analysis session, and develop meaningful themes. This approach aims to improve consistency and rigor in thematic analysis, while also making this method more accessible for multidisciplinary research teams.

Published
2023
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5. Independent risk factors for the co-colonization of vancomycin-resistant Enterococcus faecalis and methicillin-resistant Staphylococcus aureus in the region most endemic for vancomycin-resistant Staphylococcus aureus isolation

Author

Hayakawa, K., Marchaim, D., Bathina, P., Martin, E. T., Pogue, J. M., Sunkara, B., Kamatam, S., Ho, K., Willis, L. B., Ajamoughli, M., Patel, D., Khan, A., Lee, K. P., Suhrawardy, U., Jagadeesh, K. K., Reddy, S. M. L., Levine, M., Ahmed, F., Omotola, A. M., Mustapha, M., Moshos, J. A., Rybak, M. J., and Kaye, K. S.

Published
2013
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6. Antibiotic treatment of infections caused by carbapenem-resistant Gram-negative bacilli: an international ESCMID cross-sectional survey among infectious diseases specialists practicing in large hospitals

Author

Papst, Lea, Beović, Bojana, Pulcini, Céline, Durante-Mangoni, Emanuele, Rodríguez-Baño, Jesús, Kaye, Keith S, Daikos, George L, Raka, Lul, Paul, Mical, Esgap, Esgbis, ESGIE and the CRGNB treatment survey study group collaborators: Abbo, L, Abgueguen, P, Almirante, B, Azzini, Am, Bani-Sadr, F, Bassetti, M, Ben-Ami, R, Beović, B, Béraud, G, Botelho-Nevers, E, Bou, G, Boutoille, D, Cabié, A, Cacopardo, B, Cascio, A, Cassir, N, Castelli, F, Cecala, M, Charmillon, A, Chirouze, C, Cisneros, Jm, Colmenero, Jd, Coppola, N, Corcione, S, Daikos, Gl, Dalla Gasperina, D, De la Calle Cabrera, C, Delobel, P, Di Caprio, D, Durante Mangoni, E, Dupon, M, Ettahar, N, Falagas, Me, Falcone, M, Fariñas, Mc, Faure, E, Forestier, E, Foti, G, Gallagher, J, Gattuso, G, Gendrin, V, Gentile, I, Giacobbe, Dr, Gogos, Ca, Grandiere Perez, L, Hansmann, Y, Horcajada, Jp, Iacobello, C, Jacob, Jt, Justo, Ja, Kernéis, S, Komnos, A, Kotnik Kevorkijan, B, Lebeaux, D, Le Berre, R, Lechiche, C, Le Moing, V, Lescure, Fx, Libanore, M, Martinot, M, Merino de Lucas, E, Mondain, V, Mondello, P, Montejo, M, Mootien, J, Muñoz, P, Nir-Paz, R, Pan, A, Paño-Pardo, Jr, Patel, G, Paul, M, Pérez Rodríguez MT, Piroth, L, Pogue, J, Potoski, Ba, Pourcher, V, Pyrpasopoulou, A, Rahav, G, Rizzi, M, Rodríguez-Baño, J, Salavert, M, Scheetz, M, Sims, M, Spahija, G, Stefani, S, Stefos, A, Tamma, Pd, Tattevin, P, Tedesco, A, Torre-Cisneros, J, Tripolitsioti, P, Tsiodras, S, Uomo, G, Verdon, R, Viale, P, Vitrat, V, Weinberger, M, Wiener-Well, Y, Papst L., Beovic B., Pulcini C., Durante-Mangoni E., Rodriguez-Bano J., Kaye K.S., Daikos G.L., Raka L., Paul M., Abbo L., Abgueguen P., Almirante B., Azzini A.M., Bani-Sadr F., Bassetti M., Ben-Ami R., Beraud G., Botelho-Nevers E., Bou G., Boutoille D., Cabie A., Cacopardo B., Cascio A., Cassir N., Castelli F., Cecala M., Charmillon A., Chirouze C., Cisneros J.M., Colmenero J.D., Coppola N., Corcione S., Dalla Gasperina D., De la Calle Cabrera C., Delobel P., Di Caprio D., Durante Mangoni E., Dupon M., Ettahar N., Falagas M.E., Falcone M., Farinas M.C., Faure E., Forestier E., Foti G., Gallagher J., Gattuso G., Gendrin V., Gentile I., Giacobbe D.R., Gogos C.A., Grandiere Perez L., Hansmann Y., Horcajada J.P., Iacobello C., Jacob J.T., Justo J.A., Kerneis S., Komnos A., Kotnik Kevorkijan B., Lebeaux D., Le Berre R., Lechiche C., Le Moxing V., Lescure F.X., Libanore M., Martinot M., Merino de Lucas E., Mondain V., Mondello P., Montejo M., Mootien J., Munoz P., Nir-Paz R., Pan A., Pano-Pardo J.R., Patel G., Perez Rodriguez M.T., Piroth L., Pogue J., Potoski B.A., Pourcher V., Pyrpasopoulou A., Rahav G., Rizzi M., Salavert M., Scheetz M., Sims M., Spahija G., Stefani S., Stefos A., Tamma P.D., Tattevin P., Tedesco A., Torre-Cisneros J., Tripolitsioti P., Tsiodras S., Uomo G., Verdon R., Viale P., Vitrat V., Weinberger M., Wiener-Well Y., University Medical Centre Ljubljana [Ljubljana, Slovenia] (UMCL), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université de Lorraine (UL), Monaldi Hospital, Hospital Virgen Macarena, University of Michigan Medical School [Ann Arbor], University of Michigan [Ann Arbor], University of Michigan System-University of Michigan System, National and Kapodistrian University of Athens (NKUA), University Clinical Center of Kosova, Rambam Health Care Campus, Jackson Memorial Hospital, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Vall d'Hebron University Hospital [Barcelona], University of Verona (UNIVR), Centre Hospitalier Universitaire de Reims (CHU Reims), Ospedale 'Santa Maria della Misericordia' = University Hospital 'Santa Maria della Misericordia', Tel Aviv Sourasky Medical Centre, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Hospital Universitario, A Coruña, Centre hospitalier universitaire de Nantes (CHU Nantes), CHU de la Martinique [Fort de France], ARNAS 'Garibaldi, S. Luigi-Currò, Ascoli-Tomaselli', Università degli studi di Palermo - University of Palermo, Assistance Publique-Hôpitaux de Marseille (AP-HM), ASST Spedali Civili of Brescia, ARNAS Civico Palermo, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Hospital Universitario Virgen del Rocío [Sevilla], Hospital Regional Universitario de Málaga [Spain], Università degli studi della Campania 'Luigi Vanvitelli', University of Turin, University of Insubria, Varese, Hospital Clínic de Barcelona, Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], AO San Sebastiano, CHU Bordeaux [Bordeaux], CH Valenciennes, Henry Dunant Hospital, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Hospital Marques de Valdecillas, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Métropole Savoie [Chambéry], Ospedale di Reggio Calabria, Children’s Hospital of Philadelphia (CHOP ), Carlo Poma Hospital Mantova (ASST Mantova ), CH Belfort-Montbéliard, University of Naples Federico II, AUO San Martino IST Ist Nazl Ric Canc, I-16132 Genoa, Italy, University of Patras [Patras], Centre Hospitalier Le Mans (CH Le Mans), CHU Strasbourg, IMIM-Hospital del Mar, Generalitat de Catalunya, Cannizzaro Hospital, Emory University School of Medicine, Emory University [Atlanta, GA], University of South Carolina [Columbia], AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), General Hospital of Larissa, University medical centre Maribor (UKC Maribor), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), AP-HP - Hôpital Bichat - Claude Bernard [Paris], University of Ferrara at St. Anna Hospital, CH Colmar, Hospital General Universitario de Alicante, CHU Nice [Cimiez], Hôpital Cimiez [Nice] (CHU), AOU Policlinico 'G. Martino', Messina, Italy, Hospital Universitario Cruces = Cruces University Hospital, Centre Hospitalier Emile Muller [Mulhouse] (CH E.Muller Mulhouse), Groupe Hospitalier de Territoire Haute Alsace (GHTHA), Hospital General Universitario 'Gregorio Marañón' [Madrid], Hadassah Hebrew University Medical Center [Jerusalem], Azienda Istituti Ospitalieri di Cremona, Lozano Blesa Clinical Hospital [Zaragoza, Spain], Mount Sinai Hospital [Toronto, Canada] (MSH), Complejo Hospitalario de Vigo, CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Detroit Medical Center, University of Pittsburgh Medical Center [Pittsburgh, PA, États-Unis] (UPMC), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hippokration General Hospital, Sheba Medical Centre, Ramat Gan, Israel, ASST Papa Giovanni XXIII [Bergamo, Italy], Hospital Universitario La Fe, Valencia, Northwestern Hospital Chicago, Beaumont Hospital, Lagjia e Universitetit, Rruga 1, nr.32, 10000 Prishtina, Kosovo, parent, Università degli studi di Catania [Catania], Larissa University Hospital, Johns Hopkins University School of Medicine [Baltimore], CHU Pontchaillou [Rennes], Ospedale Fracastoro San Bonifacio [Verona], Hospital Reina Sofia, Cordoba, Agioi Anargiroi Hospital, Attikon University Hospital, Ospedale Cardarelli, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Alma Mater Studiorum Università di Bologna [Bologna] (UNIBO), CH Annecy Genevois, Assah Harofeh Medical Centre, Zerifin, Israel, Shaare Zedek Medical Centre, Jerusalem, Israel, National Institutes of Health (US), Instituto de Salud Carlos III, Ministerio de Economía, Industria y Competitividad (España), Red Española de Investigación en Patología Infecciosa, European Commission, Papst, Lea, Beović, Bojana, Pulcini, Céline, Durante-Mangoni, Emanuele, Rodríguez-Baño, Jesú, Kaye, Keith S, Daikos, George L, Raka, Lul, Paul, Mical, Papst, L., Beovic, B., Pulcini, C., Durante-Mangoni, E., Rodriguez-Bano, J., Kaye, K. S., Daikos, G. L., Raka, L., Paul, M., Abbo, L., Abgueguen, P., Almirante, B., Azzini, A. M., Bani-Sadr, F., Bassetti, M., Ben-Ami, R., Beraud, G., Botelho-Nevers, E., Bou, G., Boutoille, D., Cabie, A., Cacopardo, B., Cascio, A., Cassir, N., Castelli, F., Cecala, M., Charmillon, A., Chirouze, C., Cisneros, J. M., Colmenero, J. D., Coppola, N., Corcione, S., Dalla Gasperina, D., De la Calle Cabrera, C., Delobel, P., Di Caprio, D., Dupon, M., Ettahar, N., Falagas, M. E., Falcone, M., Farinas, M. C., Faure, E., Forestier, E., Foti, G., Gallagher, J., Gattuso, G., Gendrin, V., Gentile, I., Giacobbe, D. R., Gogos, C. A., Grandiere Perez, L., Hansmann, Y., Horcajada, J. P., Iacobello, C., Jacob, J. T., Justo, J. A., Kerneis, S., Komnos, A., Kotnik Kevorkijan, B., Lebeaux, D., Le Berre, R., Lechiche, C., Le Moxing, V., Lescure, F. X., Libanore, M., Martinot, M., Merino de Lucas, E., Mondain, V., Mondello, P., Montejo, M., Mootien, J., Munoz, P., Nir-Paz, R., Pan, A., Pano-Pardo, J. R., Patel, G., Perez Rodriguez, M. T., Piroth, L., Pogue, J., Potoski, B. A., Pourcher, V., Pyrpasopoulou, A., Rahav, G., Rizzi, M., Salavert, M., Scheetz, M., Sims, M., Spahija, G., Stefani, S., Stefos, A., Tamma, P. D., Tattevin, P., Tedesco, A., Torre-Cisneros, J., Tripolitsioti, P., Tsiodras, S., Uomo, G., Verdon, R., Viale, P., Vitrat, V., Weinberger, M., Wiener-Well, Y., Università degli studi di Verona = University of Verona (UNIVR), Assistance Publique - Hôpitaux de Marseille (APHM), Hospital Regional Universitario de Málaga = Regional University Hospital of Malaga [Spain], and Università degli studi di Torino = University of Turin (UNITO)

Subjects
0301 basic medicine, Acinetobacter baumannii, Carbapenem, Antibiotics, Drug Resistance, Drug resistance, Tigecycline, Carbapenem-resistant Gram-negative bacilli, Combination therapy, Enterobacteriaceae, Polymyxin, Pseudomonas aeruginosa, Survey, 0302 clinical medicine, Surveys and Questionnaires, polycyclic compounds, 030212 general & internal medicine, Anti-Bacterial Agents, Carbapenems, Cross Infection, Cross-Sectional Studies, Drug Resistance, Bacterial, Gram-Negative Bacteria, Gram-Negative Bacterial Infections, Hospitals, Humans, Microbial Sensitivity Tests, Microbiology (medical), Infectious Diseases, biology, Microbial Sensitivity Test, Bacterial, antibiotic management, carbapenem-resistant Gram-negative bacteria, General Medicine, 3. Good health, medicine.drug, Human, medicine.medical_specialty, medicine.drug_class, 030106 microbiology, Fosfomycin, carbapenem-resistant Gram-negative bacteria, 03 medical and health sciences, Hospital, Internal medicine, Anti-Bacterial Agent, medicine, Gram-Negative Bacterial Infection, Cross-Sectional Studie, business.industry, biochemical phenomena, metabolism, and nutrition, biology.organism_classification, bacterial infections and mycoses, Infectious disease (medical specialty), Carbapenem-resistant gram-negative bacilli, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, antibiotic management, business, Rifampicin
Abstract

ESGAP, ESGBIS, ESGIE and the CRGNB treatment survey study group., [Objectives] To explore contemporary antibiotic management of infections caused by carbapenem-resistant Gram-negative bacteria in hospitals., [Methods] Cross-sectional, internet-based questionnaire survey. We contacted representatives of all hospitals with more than 800 acute-care hospital beds in France, Greece, Israel, Italy, Kosovo, Slovenia, Spain and selected hospitals in the USA. We asked respondents to describe the most common actual practice at their hospital regarding management of carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa through close-ended questions., [Results] Between January and June 2017, 115 of 141 eligible hospitals participated (overall response rate 81.6%, country-specific rates 66.7%–100%). Most were tertiary-care (99/114, 86.8%), university-affiliated (110/115, 89.1%) hospitals and most representatives were infectious disease specialists (99/115, 86.1%). Combination therapy was prescribed in 114/115 (99.1%) hospitals at least occasionally. Respondents were more likely to consider combination therapy when treating bacteraemia, pneumonia and central nervous system infections and for Enterobacteriaceae, P. aeruginosa and A. baumannii similarly. Combination of a polymyxin with a carbapenem was used in most cases, whereas combinations of a polymyxin with tigecycline, an aminoglycoside, fosfomycin or rifampicin were also common. Monotherapy was used for treatment of complicated urinary tract infections, usually with an aminoglycoside or a polymyxin. The intended goal of combination therapy was to improve the effectiveness of the treatment and to prevent development of resistance. In general, respondents shared the misconception that combination therapy is supported by strong scientific evidence., [Conclusions] Combination therapy was the preferred treatment strategy for infections caused by carbapenem-resistant Gram-negative bacteria among hospital representatives, even though high-quality evidence for carbapenem-based combination therapy is lacking., EDM received funding by NIH for project HHSN272201000039C. JRB received funding for research from Plan Nacional de I + D + i 2013–2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Economía, Industria y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001)—co-financed by European Development Regional Fund A way to achieve Europe, Operative Programme Intelligent Growth 2014–2020.

Published
2018

7. Reply from the authors

Author

Leslie, K., Myles, P., Devereaux, P., Williamson, E., Rao-Melancini, P., Forbes, A., Xu, S., Foex, P., Pogue, J., Arrieta, M., Bryson, G., Paul, J., Paech, M., Merchant, R., Choi, P., Badner, N., Peyton, P., Sear, J., and Yang, H.

Published
2014
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15. The slowing of visual processing by hypoxia

Author

Banner, Fowler J. and Pogue, J.

Subjects
Vision disorders -- Research, Reaction time -- Physiological aspects, Cerebral anoxia -- Research, Human information processing -- Physiological aspects, Architecture and design industries, Business
Abstract

An experiment was conducted to ascertain whether hypoxia retards visual processing. Fourteen subjects breathed in a low oxygen mixture that generated arterial oxyhemoglobin saturations from 64-66 percent. Hypoxia was found to disrupt light intensity that retards visual processing which is a function of response time. A possible explanation is that hypoxia minimized the effective stimulus intensity and visual contrast. This is congruous to the anatomical evidence that hypoxia affects retinal sensitivity. Large light intensity and hypoxia interaction signify slow visual functioning.

Published
1993

17. Antibiotic treatment of infections caused by carbapenem-resistant Gram-negative bacilli: an international ESCMID cross-sectional survey among infectious diseases specialists practicing in large hospitals

Author

Papst, L. Beovic, B. Pulcini, C. Durante-Mangoni, E. Rodríguez-Baño, J. Kaye, K.S. Daikos, G.L. Raka, L. Paul, M. Abbo, L. Abgueguen, P. Almirante, B. Azzini, A.M. Bani-Sadr, F. Bassetti, M. Ben-Ami, R. Béraud, G. Botelho-Nevers, E. Bou, G. Boutoille, D. Cabié, A. Cacopardo, B. Cascio, A. Cassir, N. Castelli, F. Cecala, M. Charmillon, A. Chirouze, C. Cisneros, J.M. Colmenero, J.D. Coppola, N. Corcione, S. Dalla Gasperina, D. De la Calle Cabrera, C. Delobel, P. Di Caprio, D. Dupon, M. Ettahar, N. Falagas, M.E. Falcone, M. Fariñas, M.C. Faure, E. Forestier, E. Foti, G. Gallagher, J. Gattuso, G. Gendrin, V. Gentile, I. Giacobbe, D.R. Gogos, C.A. Grandiere Perez, L. Hansmann, Y. Horcajada, J.P. Iacobello, C. Jacob, J.T. Justo, J.A. Kernéis, S. Komnos, A. Kotnik Kevorkijan, B. Lebeaux, D. Le Berre, R. Lechiche, C. Le Moxing, V. Lescure, F.X. Libanore, M. Martinot, M. Merino de Lucas, E. Mondain, V. Mondello, P. Montejo, M. Mootien, J. Muñoz, P. Nir-Paz, R. Pan, A. Paño-Pardo, J.R. Patel, G. Pérez Rodríguez, M.T. Piroth, L. Pogue, J. Potoski, B.A. Pourcher, V. Pyrpasopoulou, A. Rahav, G. Rizzi, M. Salavert, M. Scheetz, M. Sims, M. Spahija, G. Stefani, S. Stefos, A. Tamma, P.D. Tattevin, P. Tedesco, A. Torre-Cisneros, J. Tripolitsioti, P. Tsiodras, S. Uomo, G. Verdon, R. Viale, P. Vitrat, V. Weinberger, M. Wiener-Well, Y. ESGAP, ESGBIS, ESGIE the CRGNB treatment survey study group

Abstract

Objectives: To explore contemporary antibiotic management of infections caused by carbapenem-resistant Gram-negative bacteria in hospitals. Methods: Cross-sectional, internet-based questionnaire survey. We contacted representatives of all hospitals with more than 800 acute-care hospital beds in France, Greece, Israel, Italy, Kosovo, Slovenia, Spain and selected hospitals in the USA. We asked respondents to describe the most common actual practice at their hospital regarding management of carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa through close-ended questions. Results: Between January and June 2017, 115 of 141 eligible hospitals participated (overall response rate 81.6%, country-specific rates 66.7%–100%). Most were tertiary-care (99/114, 86.8%), university-affiliated (110/115, 89.1%) hospitals and most representatives were infectious disease specialists (99/115, 86.1%). Combination therapy was prescribed in 114/115 (99.1%) hospitals at least occasionally. Respondents were more likely to consider combination therapy when treating bacteraemia, pneumonia and central nervous system infections and for Enterobacteriaceae, P. aeruginosa and A. baumannii similarly. Combination of a polymyxin with a carbapenem was used in most cases, whereas combinations of a polymyxin with tigecycline, an aminoglycoside, fosfomycin or rifampicin were also common. Monotherapy was used for treatment of complicated urinary tract infections, usually with an aminoglycoside or a polymyxin. The intended goal of combination therapy was to improve the effectiveness of the treatment and to prevent development of resistance. In general, respondents shared the misconception that combination therapy is supported by strong scientific evidence. Conclusions: Combination therapy was the preferred treatment strategy for infections caused by carbapenem-resistant Gram-negative bacteria among hospital representatives, even though high-quality evidence for carbapenem-based combination therapy is lacking. © 2018 European Society of Clinical Microbiology and Infectious Diseases

Published
2018

18. Systolic and diastolic blood pressure changes in relation with myocardial infarction and stroke in patients with coronary artery disease

Author

Verdecchia, P, Reboldi, G, Angeli, F, Trimarco, B, Mancia, G, Pogue, J, Gao, P, Peter, S, Teo, K, Yusuf, S, Verdecchia P., Reboldi G., Angeli F., Trimarco B., Mancia G., Pogue J., Gao P., Peter S., Teo K., Yusuf S., Verdecchia, P, Reboldi, G, Angeli, F, Trimarco, B, Mancia, G, Pogue, J, Gao, P, Peter, S, Teo, K, Yusuf, S, Verdecchia P., Reboldi G., Angeli F., Trimarco B., Mancia G., Pogue J., Gao P., Peter S., Teo K., and Yusuf S.

Abstract

Excessively high and low achieved blood pressure (BP) may be associated with a bad outcome in patients with coronary artery disease, the J curve phenomenon. The effect of BP changes from baseline in relation with the subsequent risk of stroke and myocardial infarction (MI) is unknown. Of the 25 620 patients randomized in the Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET) study, we selected 19 102 patients with coronary artery disease at baseline. BP at entry was 141/82 mm Hg, and its average decrease during follow-up was 7/6 mm Hg. BP entered the analysis as time-varying variable modeled with restricted cubic splines. After adjustment for several potential determinants of reverse causality, a change in BP from baseline by -34/-21 mm Hg (10th percentile) was associated with a lesser risk of stroke without any significant increase in the risk of MI. A rise in systolic/diastolic BP from baseline by 20/10 mm Hg (90th percentile) was associated with an increased risk of stroke, whereas the risk of MI increased with systolic BP and not with diastolic BP. In conclusion, in patients with coronary artery disease and initially free from congestive heart failure, a BP reduction from baseline over the examined BP range had little effect on the risk of MI and predicted a lower risk of stroke. An increase in systolic BP from baseline increased the risk of stroke and MI. The relationships of BP with risk were much steeper for stroke than for MI. A treatment-induced BP reduction over the explored range seems to be safe in patients with coronary artery disease.

Published
2015

19. Aspirin in Patients Undergoing Noncardiac Surgery

Author

Devereaux, Pj, Mrkobrada, M, Sessler, Di, Leslie, K, Alonso Coello, P, Kurz, A, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, Cs, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, DeBeer J, POISE 2 I. n. v. e. s. t. i. g. a. t. o. r. s., Patel, A, Dechert, W, Jackson, P, Allard, R, Dumerton Shore, D, Mccourt, J, Jones, Pm, Lavi, R, Lavi, S, Moor, R, Dresser, Gk, Gros, Ml, Schumann, Vc, Baur, M, Macdonald, C, Wirzba, B, Regalado, O, Srinathan, Sk, Ong, Dd, Todd, A, Abbas, S, Beattie, Ws, Chan, Vw, Chin, Kj, Wijeysundera, Dn, Graham, Mm, Irwin, M, Jacka, M, El Beheiry, H, Mcmullen, Sm, Macdonald, P, Akhtar, Z, Ayad, S, Buttar, M, Deroee, A, Eshraghi, Y, Fergany, A, Finnigan, P, Fu, A, Grady, M, Helper, S, Hesler, B, Honar, H, Hutcherson, M, Krebs, V, Lee, J, Malik, M, Podolyak, A, Salmasi, V, Arora, H, Coombs, Rf, Martinelli, Sm, Bergese, Sd, Melibary, Sb, Uribe, Aa, Jordan, M, Miller, Sa, Cata, Jp, Nemergut, Ec, Candiotti, Ka, Memtsoudis, Sg, Mckay, Re, Montes, Fr, Parra, Ga, Rojas, Mf, Plata, R, Vásquez, Sm, Sarquis, T, Haider, Z, Jane, Nb, Lanjewar, Pp, Rahate, Pv, Mehra, Br, Premendaran, B, Abraham, V, George, P, Kumar, P, Gaikwad, Sb, Mohan, Nv, Sidhu, G, Alvarez, J, Gonzalez, R, Maestre, M, Popova, E, Urrutia, G, de Nadal, M, González Suárez, S, González Tallada, A, Plou, P, Mena, E, Riveira, C, del Valle, S, Tena, B, Lang, Sa, Ludbrook, Gl, Painter, Tw, Terblanche, Nc, Osborne, C, Mahood, Jr, Myles, Ps, Sivalingam, P, Riedel, B, Elhalawani, I, Drummond, L, Mugabi, A, Naidoo, P, Myburgh, Al, Porrill, Os, Diedericks, Bj, Turton, Ew, Bøgeskov, M, Dahl, Rm, Madsen, Mv, Søndergaard, Es, Bauer, Ne, Martinsen, Kr, Choi, Gy, Gin, T, Ng, Ss, Bidgoli, Sj, Van der Linden PJ, De Kock, M, Kabon, B, Luf, F, Radonic, M, Ishtiaq, O, Safdar, J, Acuna Villaorduna, A, Barrionuevo, P, Castaneda Guarderas, A, Caballero, Ja, Lau, Ve, Aphang Lam MR, Lembo, R, Gossetti, Bruno, Jara, X, Leon, P, Ong, Gs, Lee, Hs, Seeberger, Ee, Seeberger, Md, Alfonsi, P, Coriat, P, Piriou, V, Vizcaychipi, Mp, Rech, Rl, Bergo, Rr, Walker, S, Rodseth, R, Lemanach, Y, Díaz, R, Cortés, Ol, Wetterslev, J, Hoeft, A, Wittmann, M, Chan, M, Landoni, G, Conen, D, Balaji, P, Sovereign, T, Blake, L, Sephton, J, Serra, A, Agrippa, C, Lawrence, M, Biccard, B, Gluud, C, Karthikeyan, G, Auerbach, A, Beattie, S, Buckley, N, Douketis, J, Gerstein, H, Ghali, W, Hart, R, Hill, M, Mcalister, F, Mcauley, D, Miller, S, O'Donnell, M, Pais, P, Parlow, J, Schricker, T, Sessler, D, Simunovic, M, Teoh, K, Walsh, M, Wijeysundera, D, Yang, H, Alshalash, S, Bessissow, A, Duceppe, E, Khalid, Z, Khan, J, Lauw, M, Martinsen, K, Neary, J, Oczkowski, W, Papina, M, Seeberger, M, Tandon, V, Thomas, S, Friedman, L, Cheng, D, Johnstone, D, Lowenstein, E, Roberts, R., Devereaux, Pj, Mrkobrada, M, Sessler, Di, Leslie, K, Alonso Coello, P, Kurz, A, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, C, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir M, Eikelboom J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Baigent, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, and Landoni, Giovanni

Subjects
Male, Myocardial Infarction, Kaplan-Meier Estimate, noncardiac surgery, postoperative period, law.invention, low drug dose, hazard ratio, Postoperative Complications, Randomized controlled trial, law, Myocardial infarction, Treatment Failure, Aspirin, Medicine (all), Hazard ratio, drug effect, article, risk assessment, General Medicine, Middle Aged, female, priority journal, Anesthesia, drug withdrawal, factorial design, Surgical Procedures, Operative, Platelet aggregation inhibitor, Female, medicine.drug, hospitalization, heart infarction, perioperative period, preoperative treatment, Postoperative Hemorrhage, Perioperative Care, length of stay, death, medicine, Humans, follow up, controlled study, human, clonidine, outcome assessment, Aged, treatment duration, Vascular disease, business.industry, Platelet Aggregation Inhibitor, patient care, acetylsalicylic acid, medicine.disease, bleeding, major clinical study, Confidence interval, purl.org/pe-repo/ocde/ford#3.02.00 [https], Clinical research, multicenter study, randomized controlled trial, placebo, Postoperative Complication, business, Platelet Aggregation Inhibitors
Abstract

BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not. METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P = 0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P = 0.04). The primary and secondary outcome results were similar in the two aspirin strata. CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.) Copyright © 2014 Massachusetts Medical Society.

Published
2014

20. Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial

Author

Mann, Jf, Schmieder, Re, Mcqueen, M, Dyal, L, Schumacher, H, Pogue, J, Wang, X, Maggioni, A, Budaj, A, Chaithiraphan, S, Dickstein, K, Keltai, M, Metsärinne, K, Oto, A, Parkhomenko, A, Piegas, Ls, Svendsen, Tl, Teo, Kk, Yusuf, S, Lembo, Giuseppe, and Ontarget, Investigators

Subjects
Ramipril, medicine.medical_specialty, Combination therapy, Urology, Renal function, Angiotensin-Converting Enzyme Inhibitors, Pharmacology, Kidney, Benzoates, chemistry.chemical_compound, Double-Blind Method, Diabetes Mellitus, medicine, Humans, Telmisartan, Aged, Creatinine, Proteinuria, biology, business.industry, Angiotensin-converting enzyme, General Medicine, Middle Aged, chemistry, Cardiovascular Diseases, ACE inhibitor, biology.protein, Benzimidazoles, Drug Therapy, Combination, medicine.symptom, business, Angiotensin II Type 1 Receptor Blockers, Follow-Up Studies, Glomerular Filtration Rate, medicine.drug
Abstract

Angiotensin receptor blockers (ARB) and angiotensin converting enzyme (ACE) inhibitors are known to reduce proteinuria. Their combination might be more effective than either treatment alone, but long-term data for comparative changes in renal function are not available. We investigated the renal effects of ramipril (an ACE inhibitor), telmisartan (an ARB), and their combination in patients aged 55 years or older with established atherosclerotic vascular disease or with diabetes with end-organ damage.The trial ran from 2001 to 2007. After a 3-week run-in period, 25 620 participants were randomly assigned to ramipril 10 mg a day (n=8576), telmisartan 80 mg a day (n=8542), or to a combination of both drugs (n=8502; median follow-up was 56 months), and renal function and proteinuria were measured. The primary renal outcome was a composite of dialysis, doubling of serum creatinine, and death. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00153101.784 patients permanently discontinued randomised therapy during the trial because of hypotensive symptoms (406 on combination therapy, 149 on ramipril, and 229 on telmisartan). The number of events for the composite primary outcome was similar for telmisartan (n=1147 [13.4%]) and ramipril (1150 [13.5%]; hazard ratio [HR] 1.00, 95% CI 0.92-1.09), but was increased with combination therapy (1233 [14.5%]; HR 1.09, 1.01-1.18, p=0.037). The secondary renal outcome, dialysis or doubling of serum creatinine, was similar with telmisartan (189 [2.21%]) and ramipril (174 [2.03%]; HR 1.09, 0.89-1.34) and more frequent with combination therapy (212 [2.49%]: HR 1.24, 1.01-1.51, p=0.038). Estimated glomerular filtration rate (eGFR) declined least with ramipril compared with telmisartan (-2.82 [SD 17.2] mL/min/1.73 m(2)vs -4.12 [17.4], p0.0001) or combination therapy (-6.11 [17.9], p0.0001). The increase in urinary albumin excretion was less with telmisartan (p=0.004) or with combination therapy (p=0.001) than with ramipril.In people at high vascular risk, telmisartan's effects on major renal outcomes are similar to ramipril. Although combination therapy reduces proteinuria to a greater extent than monotherapy, overall it worsens major renal outcomes.

Published
2008

21. Can virtual reality enhance academic success while learning about the canine stifle joint?

Author

Motta, T, Pogue, J, Margulieux, K, and Dyce, J

Subjects
ddc: 610, ComputingMilieux_COMPUTERSANDEDUCATION, 610 Medical sciences, Medicine
Abstract

Visual-spatial ability in veterinary students has been shown to be a key skill necessary for educational success and long-term knowledge. Research has shown that students who employed a multitude of study methods over a single study method had greater academic success and a deeper processing of material.[for full text, please go to the a.m. URL], InVeST 2015: International Veterinary Simulation in Teaching Conference

Published
2015
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22. Blood-Pressure Lowering in Intermediate-Risk Persons without Cardiovascular Disease.

Author

Lonn, E., Bosch, J., López-Jaramillo, P., Zhu, J., Liu, L., Pais, P., Diaz, R., Xavier, D., Sliwa, K., Dans, A., Avezum, A., Piegas, L., Keltai, K., Keltai, M., Chazova, I., Peters, R., Held, C., Yusoff, K., Lewis, B., Jansky, P., Parkhomenko, A., Khunti, K., Toff, W., Reid, Christopher, Varigos, J., Leiter, L., Molina, D., McKelvie, R., Pogue, J., Wilkinson, J., Jung, H., Dagenais, G., Yusuf, S., HOPE-3 Investigators, Lonn, E., Bosch, J., López-Jaramillo, P., Zhu, J., Liu, L., Pais, P., Diaz, R., Xavier, D., Sliwa, K., Dans, A., Avezum, A., Piegas, L., Keltai, K., Keltai, M., Chazova, I., Peters, R., Held, C., Yusoff, K., Lewis, B., Jansky, P., Parkhomenko, A., Khunti, K., Toff, W., Reid, Christopher, Varigos, J., Leiter, L., Molina, D., McKelvie, R., Pogue, J., Wilkinson, J., Jung, H., Dagenais, G., Yusuf, S., and HOPE-3 Investigators

Abstract

BACKGROUND: Antihypertensive therapy reduces the risk of cardiovascular events among high-risk persons and among those with a systolic blood pressure of 160 mm Hg or higher, but its role in persons at intermediate risk and with lower blood pressure is unclear. METHODS: In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to receive either candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke; the second coprimary outcome additionally included resuscitated cardiac arrest, heart failure, and revascularization. The median follow-up was 5.6 years. RESULTS: The mean blood pressure of the participants at baseline was 138.1/81.9 mm Hg; the decrease in blood pressure was 6.0/3.0 mm Hg greater in the active-treatment group than in the placebo group. The first coprimary outcome occurred in 260 participants (4.1%) in the active-treatment group and in 279 (4.4%) in the placebo group (hazard ratio, 0.93; 95% confidence interval [CI], 0.79 to 1.10; P=0.40); the second coprimary outcome occurred in 312 participants (4.9%) and 328 participants (5.2%), respectively (hazard ratio, 0.95; 95% CI, 0.81 to 1.11; P=0.51). In one of the three prespecified hypothesis-based subgroups, participants in the subgroup for the upper third of systolic blood pressure (>143.5 mm Hg) who were in the active-treatment group had significantly lower rates of the first and second coprimary outcomes than those in the placebo group; effects were neutral in the middle and lower thirds (P=0.02 and P=0.009, respectively, for trend in the two outcomes).CONCLUSIONS: Therapy with candesartan at a dose of 16 mg per day plus hydrochlorothiazide at a dose of 12.5 mg per day was not associated with a lower rate of major cardiovascular event

Published
2016

23. Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease

Author

Yusuf, S., Lonn, E., Pais, P., Bosch, J., López-Jaramillo, P., Zhu, J., Xavier, D., Avezum, A., Leiter, L., Piegas, L., Parkhomenko, A., Keltai, M., Keltai, K., Sliwa, K., Chazova, I., Peters, R., Held, C., Yusoff, K., Lewis, B., Jansky, P., Khunti, K., Toff, W., Reid, Christopher, Varigos, J., Accini, J., McKelvie, R., Pogue, J., Jung, H., Liu, L., Diaz, R., Dans, A., Dagenais, G., HOPE-3 Investigators, Yusuf, S., Lonn, E., Pais, P., Bosch, J., López-Jaramillo, P., Zhu, J., Xavier, D., Avezum, A., Leiter, L., Piegas, L., Parkhomenko, A., Keltai, M., Keltai, K., Sliwa, K., Chazova, I., Peters, R., Held, C., Yusoff, K., Lewis, B., Jansky, P., Khunti, K., Toff, W., Reid, Christopher, Varigos, J., Accini, J., McKelvie, R., Pogue, J., Jung, H., Liu, L., Diaz, R., Dans, A., Dagenais, G., and HOPE-3 Investigators

Abstract

BACKGROUND: Elevated blood pressure and elevated low-density lipoprotein (LDL) cholesterol increase the risk of cardiovascular disease. Lowering both should reduce the risk of cardiovascular events substantially. METHODS: In a trial with 2-by-2 factorial design, we randomly assigned 12,705 participants at intermediate risk who did not have cardiovascular disease to rosuvastatin (10 mg per day) or placebo and to candesartan (16 mg per day) plus hydrochlorothiazide (12.5 mg per day) or placebo. In the analyses reported here, we compared the 3180 participants assigned to combined therapy (with rosuvastatin and the two antihypertensive agents) with the 3168 participants assigned to dual placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally included heart failure, cardiac arrest, or revascularization. The median follow-up was 5.6 years. RESULTS: The decrease in the LDL cholesterol level was 33.7 mg per deciliter (0.87 mmol per liter) greater in the combined-therapy group than in the dual-placebo group, and the decrease in systolic blood pressure was 6.2 mm Hg greater with combined therapy than with dual placebo. The first coprimary outcome occurred in 113 participants (3.6%) in the combined-therapy group and in 157 (5.0%) in the dual-placebo group (hazard ratio, 0.71; 95% confidence interval [CI], 0.56 to 0.90; P=0.005). The second coprimary outcome occurred in 136 participants (4.3%) and 187 participants (5.9%), respectively (hazard ratio, 0.72; 95% CI, 0.57 to 0.89; P=0.003). Muscle weakness and dizziness were more common in the combined-therapy group than in the dual-placebo group, but the overall rate of discontinuation of the trial regimen was similar in the two groups.CONCLUSIONS: The combination of rosuvastatin (10 mg per day), candesartan (16 mg per day), and hydrochlorothiazide (12.5 mg per day) was associated with a significant

Published
2016

24. Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease

Author

Yusuf, S., Bosch, J., Dagenais, G., Zhu, J., Xavier, D., Liu, L., Pais, P., López-Jaramillo, P., Leiter, L., Dans, A., Avezum, A., Piegas, L., Parkhomenko, A., Keltai, K., Keltai, M., Sliwa, K., Peters, R., Held, C., Chazova, I., Yusoff, K., Lewis, B., Jansky, P., Khunti, K., Toff, W., Reid, Christopher, Varigos, J., Sanchez-Vallejo, G., McKelvie, R., Pogue, J., Jung, H., Gao, P., Diaz, R., Lonn, E., HOPE-3 Investigators, Yusuf, S., Bosch, J., Dagenais, G., Zhu, J., Xavier, D., Liu, L., Pais, P., López-Jaramillo, P., Leiter, L., Dans, A., Avezum, A., Piegas, L., Parkhomenko, A., Keltai, K., Keltai, M., Sliwa, K., Peters, R., Held, C., Chazova, I., Yusoff, K., Lewis, B., Jansky, P., Khunti, K., Toff, W., Reid, Christopher, Varigos, J., Sanchez-Vallejo, G., McKelvie, R., Pogue, J., Jung, H., Gao, P., Diaz, R., Lonn, E., and HOPE-3 Investigators

Abstract

BACKGROUND: Previous trials have shown that the use of statins to lower cholesterol reduces the risk of cardiovascular events among persons without cardiovascular disease. Those trials have involved persons with elevated lipid levels or inflammatory markers and involved mainly white persons. It is unclear whether the benefits of statins can be extended to an intermediate-risk, ethnically diverse population without cardiovascular disease. METHODS: In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants in 21 countries who did not have cardiovascular disease and were at intermediate risk to receive rosuvastatin at a dose of 10 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally included revascularization, heart failure, and resuscitated cardiac arrest. The median follow-up was 5.6 years. RESULTS: The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the rosuvastatin group than in the placebo group. The first coprimary outcome occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91; P=0.002). The results for the second coprimary outcome were consistent with the results for the first (occurring in 277 participants [4.4%] in the rosuvastatin group and in 363 participants [5.7%] in the placebo group; hazard ratio, 0.75; 95% CI, 0.64 to 0.88; <0.001).The results were also consistent in subgroups defined according to cardiovascular risk at baseline, lipid level, C-reactive protein level, blood pressure, and race or ethnic group. In the rosuvastatin group, there was no excess of diabetes or cancers, but there was an excess of cataract surgery (in 3.8% of the participants, vs. 3.1% in the placebo group; P=0.02) and muscle symptoms (in 5.8% of the par

Published
2016

25. Irbesartan in patients with atrial fibrillation

Author

PIZZOLATO, GILBERTO, Yusuf S, Healey JS, Pogue J, Chrolavicius S, Flather M, Hart RG, Hohnloser SH, Joyner CD, Pfeffer MA, Connolly S.J., Pizzolato, Gilberto, Yusuf, S, Healey, J, Pogue, J, Chrolavicius, S, Flather, M, Hart, Rg, Hohnloser, Sh, Joyner, Cd, Pfeffer, Ma, and Connolly, S. J.

Subjects
atrial fibrittation, stroke
Published
2011

26. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes

Author

CURRENT OASIS 7 Investigators, [investigator]Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Eikelboom JW, Fox KA, Granger CB, Jolly S, Joyner CD, Rupprecht HJ, Widimsky P, Afzal R, Pogue J, Yusuf S., PIZZOLATO, GILBERTO, CURRENT OASIS, 7 Investigator, Pizzolato, Gilberto, [investigator]mehta, Sr, Bassand, Jp, Chrolavicius, S, Diaz, R, Eikelboom, Jw, Fox, Ka, Granger, Cb, Jolly, S, Joyner, Cd, Rupprecht, Hj, Widimsky, P, Afzal, R, Pogue, J, and Yusuf, S.

Subjects
cardiovascular
Published
2010

27. Direct thrombin inhibitors in acute coronary syndromes: principal results of a meta-analysis based on individual patients' data

Author

Yusuf, S, Granger, C, Eikelboom, J, Mehta, S, Pogue, J, Tait, P, Behar, S, Benderly, M, Hod, H, Kaplinsky, E, Barrett, N, Bilke, R, Luz, M, Marhoefer, M, Roi, L, Trenery, D, Bittl, JA, Boersma, H, Flather, M, Baigent, C, Simoons, ML, Califf, R, Pieper, K, Topol, EJ, Weitz, J, Serruys, PW, White, HD, Neuhaus, KL, Zeymer, U, Simes, J, Close, P, Edwards, S, Gallo, P, Henis, M, Anand, S, Kimball, W, Meanwell, C, Villiger, J, Antman, EM, Braunwald, E, Gibson, M, Murphy, S, Grip, L, Held, P, Trialist, DTI, and Cardiology

Subjects
medicine.medical_specialty, medicine.medical_treatment, Hirudin, Glycine, Myocardial Infarction, Pharmacology, Arginine, Argatroban, Antithrombins, Piperidines, Hirudin Therapy, Internal medicine, medicine, Bivalirudin, Humans, Myocardial infarction, Angina, Unstable, Randomized Controlled Trials as Topic, Sulfonamides, business.industry, Heparin, Thrombin, Percutaneous coronary intervention, General Medicine, Hirudins, medicine.disease, Peptide Fragments, Recombinant Proteins, Survival Rate, Direct thrombin inhibitor, Pipecolic Acids, Cardiology, business, Oligopeptides, medicine.drug, Discovery and development of direct thrombin inhibitors
Abstract

BACKGROUND: To obtain more reliable and precise estimates of the effect of direct thrombin inhibitors in the management of acute coronary syndromes, including patients undergoing percutaneous coronary intervention, we undertook a meta-analysis based on individual patients' data from randomised trials comparing a direct thrombin inhibitor (hirudin, bivalirudin, argatroban, efegatran, or inogatran) with heparin. METHODS: We included trials that involved at least 200 patients. The primary efficacy outcome was death or myocardial infarction, and the primary safety outcome was major bleeding. Data from individual trials were combined by use of a modified Mantel-Haenszel method. FINDINGS: In 11 randomised trials, 35,970 patients were assigned up to 7 days' treatment with a direct thrombin inhibitor or heparin and followed up for at least 30 days. Compared with heparin, direct thrombin inhibitors were associated with a lower risk of death or myocardial infarction at the end of treatment (4.3% vs 5.1%; odds ratio 0.85 [95% CI 0.77-0.94]; p=0.001) and at 30 days (7.4% vs 8.2%; 0.91 [0.84-0.99]; p=0.02). This was due primarily to a reduction in myocardial infarctions (2.8% vs 3.5%; 0.80 [0.71-0.90]; p

Published
2002

28. Clonidine in patients undergoing noncardiac surgery

Author

Devereaux, Pj, Sessler, Di, Leslie, K, Kurz, A, Mrkobrada, M, Alonso Coello, P, Villar, Jc, Sigamani, A, Biccard, Bm, Meyhoff, Cs, Parlow, Jl, Guyatt, G, Robinson, A, Garg, Ax, Rodseth, Rn, Botto, F, Lurati Buse, G, Xavier, D, Chan, Mt, Tiboni, M, Cook, D, Kumar, Pa, Forget, P, Malaga, G, Fleischmann, E, Amir, M, Eikelboom, J, Mizera, R, Torres, D, Wang, Cy, Vanhelder, T, Paniagua, P, Berwanger, O, Srinathan, S, Graham, M, Pasin, L, Le Manach, Y, Gao, P, Pogue, J, Whitlock, R, Lamy, A, Kearon, C, Chow, C, Pettit, S, Chrolavicius, S, Yusuf, S, Debeer, J, Patel, A, Dechert, W, Jackson, P, Allard, R, Dumerton Shore, D, Mccourt, J, Jones, Pm, Lavi, R, Lavi, S, Moor, R, Dresser, Gk, Gros, Ml, Schumann, Vc, Baur, M, Macdonald, C, Wirzba, B, Regalado, O, Srinathan, Sk, Ong, Dd, Todd, A, Abbas, S, Beattie, Ws, Chan, Vw, Chin, Kj, Wijeysundera, Dn, Graham, Mm, Irwin, M, Jacka, M, El Beheiry, H, Mcmullen, Sm, Macdonald, P, Akhtar, Z, Ayad, S, Buttar, M, Deroee, A, Eshraghi, Y, Fergany, A, Finnigan, P, Fu, A, Grady, M, Helper, S, Hesler, B, Honar, H, Hutcherson, M, Krebs, V, Lee, J, Malik, M, Podolyak, A, Salmasi, V, Arora, H, Coombs, Rf, Martinelli, Sm, Bergese, Sd, Melibary, Sb, Uribe, Aa, Jordan, M, Miller, Sa, Cata, Jp, Nemergut, Ec, Candiotti, Ka, Memtsoudis, Sg, Mckay, Re, Montes, Fr, Parra, Ga, Rojas, Mf, Plata, R, Vásquez, Sm, Sarquis, T, Haider, Z, Jane, Nb, Lanjewar, Pp, Rahate, Pv, Mehra, Br, Premendaran, B, Abraham, V, George, P, Kumar, P, Gaikwad, Sb, Mohan, Nv, Sidhu, G, Alvarez, J, Gonzalez, R, Maestre, M, Popova, E, Urrutia, G, de Nadal, M, González Suárez, S, González Tallada, A, Plou, P, Mena, E, Riveira, C, del Valle, S, Tena, B, Lang, Sa, Ludbrook, Gl, Painter, Tw, Terblanche, Nc, Osborne, C, Mahood, Jr, Myles, Ps, Sivalingam, P, Riedel, B, Elhalawani, I, Drummond, L, Mugabi, A, Naidoo, P, Myburgh, Al, Porrill, Os, Diedericks, Bj, Turton, Ew, Bøgeskov, M, Dahl, Rm, Madsen, Mv, Søndergaard, Es, Bauer, Ne, Martinsen, Kr, Choi, Gy, Gin, T, Ng, Ss, Bidgoli, Sj, Van der Linden PJ, De Kock, M, Kabon, B, Luf, F, Radonic, M, Ishtiaq, O, Safdar, J, Acuna Villaorduna, A, Barrionuevo, P, Castaneda Guarderas, A, Caballero, Ja, Lau, Ve, Aphang Lam MR, Lembo, R, Gossetti, Bruno, Jara, X, Leon, P, Ong, G, Lee, Hs, Seeberger, Ee, Seeberger, Md, Alfonsi, P, Coriat, P, Piriou, V, Vizcaychipi, Mp, Rech, Rl, Bergo, Rr, Walker, S, Rodseth, R, Lemanach, Y, Díaz, R, Cortés, Ol, Wetterslev, J, Hoeft, A, Wittmann, M, Chan, M, Landoni, G, Conen, D, Balaji, P, Sovereign, T, Blake, L, Sephton, J, Serra, A, Agrippa, C, Lawrence, M, Biccard, B, Gluud, C, Baigent, C, Karthikeyan, G, Auerbach, A, Beattie, S, Buckley, N, Douketis, J, Gerstein, H, Ghali, W, Hart, R, Hill, M, Mcalister, F, Mcauley, D, Miller, S, O'Donnell, M, Pais, P, Parlow, J, Schricker, T, Sessler, D, Simunovic, M, Teoh, K, Walsh, M, Wijeysundera, D, Yang, H, Alshalash, S, Bessissow, A, Duceppe, E, Khalid, Z, Khan, J, Lauw, M, Martinsen, K, Neary, J, Oczkowski, W, Papina, M, Seeberger, M, Tandon, V, Thomas, S, Friedman, L, Cheng, D, Johnstone, D, Lowenstein, E, and Roberts, R.

Subjects
Male, hypotension, drug safety, Heart disease, Myocardial Infarction, Kaplan-Meier Estimate, high risk patient, noncardiac surgery, surgery, low drug dose, hazard ratio, Postoperative Complications, dose response, Adrenergic alpha-2 Receptor Agonists, Myocardial infarction, Treatment Failure, risk reduction, Aspirin, Hazard ratio, drug effect, article, risk assessment, General Medicine, Middle Aged, Clonidine, aged, female, priority journal, Anesthesia, factorial design, Surgical Procedures, Operative, Female, Hypotension, medicine.drug, medicine.medical_specialty, heart infarction, perioperative period, preoperative treatment, Placebo, bradycardia, Perioperative Care, length of stay, death, medicine, Humans, controlled study, human, Aged, treatment duration, business.industry, Perioperative, Vascular surgery, acetylsalicylic acid, medicine.disease, major clinical study, purl.org/pe-repo/ocde/ford#3.02.00 [https], drug efficacy, multicenter study, randomized controlled trial, incidence, treatment outcome, placebo, business, heart arrest
Abstract

Background: Marked activation of the sympathetic nervous system occurs during and after noncardiac surgery. Low-dose clonidine, which blunts central sympathetic outflow, may prevent perioperative myocardial infarction and death without inducing hemodynamic instability. Methods: We performed a blinded, randomized trial with a 2-by-2 factorial design to allow separate evaluation of low-dose clonidine versus placebo and low-dose aspirin versus placebo in patients with, or at risk for, atherosclerotic disease who were undergoing noncardiac surgery. A total of 10,010 patients at 135 centers in 23 countries were enrolled. For the comparison of clonidine with placebo, patients were randomly assigned to receive clonidine (0.2 mg per day) or placebo just before surgery, with the study drug continued until 72 hours after surgery. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days. Results: Clonidine, as compared with placebo, did not reduce the number of primary-outcome events (367 and 339, respectively; hazard ratio with clonidine, 1.08; 95% confidence interval [CI], 0.93 to 1.26; P=0.29). Myocardial infarction occurred in 329 patients (6.6%) assigned to clonidine and in 295 patients (5.9%) assigned to placebo (hazard ratio, 1.11; 95% CI, 0.95 to 1.30; P=0.18). Significantly more patients in the clonidine group than in the placebo group had clinically important hypotension (2385 patients [47.6%] vs. 1854 patients [37.1%]; hazard ratio 1.32; 95% CI, 1.24 to 1.40; P

Published
2014

29. Novel Approaches in Primary Cardiovascular Disease Prevention: The HOPE-3 Trial Rationale, Design, and Participants' Baseline Characteristics

Author

Lonn, E., Bosch, J., Pogue, J., Avezum, A., Chazova, I., Dans, A., Diaz, R., Fodor, G., Held, C., Jansky, P., Keltai, M., Keltai, K., Kunti, K., Kim, J., Leiter, L., Lewis, B., Liu, L., Lopez-Jaramillo, P., Pais, P., Parkhomenko, A., Peters, R., Piegas, L., Reid, Christopher, Sliwa, K., Toff, W., Varigos, J., Xavier, D., Yusoff, K., Zhu, J., Dagenais, G., Yusuf, S., HOPE-3 Investigators, Lonn, E., Bosch, J., Pogue, J., Avezum, A., Chazova, I., Dans, A., Diaz, R., Fodor, G., Held, C., Jansky, P., Keltai, M., Keltai, K., Kunti, K., Kim, J., Leiter, L., Lewis, B., Liu, L., Lopez-Jaramillo, P., Pais, P., Parkhomenko, A., Peters, R., Piegas, L., Reid, Christopher, Sliwa, K., Toff, W., Varigos, J., Xavier, D., Yusoff, K., Zhu, J., Dagenais, G., Yusuf, S., and HOPE-3 Investigators

Abstract

BACKGROUND: Cholesterol and blood pressure (BP) can be effectively and safely lowered with statin drugs and BP-lowering drugs, reducing major cardiovascular (CV) events by 20%-30% within 5 years in high-risk individuals. However, there are limited data in lower-risk populations. The Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial is evaluating whether cholesterol lowering with a statin drug, BP lowering with low doses of 2 antihypertensive agents, and their combination safely reduce major CV events in individuals at intermediate risk who have had no previous vascular events and have average cholesterol and BP levels. METHODS: A total of 12,705 women 65 years or older and men 55 years or older with at least 1 CV risk factor, no known CV disease, and without any clear indication or contraindication to the study drugs were randomized to rosuvastatin 10 mg/d or placebo and to candesartan/hydrochlorothiazide 16/12.5 mg/d or placebo (2 × 2 factorial design) and will be followed for a mean of 5.8 years. The coprimary study outcomes are the composite of CV death, nonfatal myocardial infarction (MI), and nonfatal stroke and the composite of CV death, nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, heart failure, and arterial revascularization. RESULTS: Participants were recruited from 21 countries in North America, South America, Europe, Asia, and Australia. Mean age at randomization was 66 years and 46% were women. CONCLUSIONS: The HOPE-3 trial will provide new information on cholesterol and BP lowering in intermediate-risk populations with average cholesterol and BP levels and is expected to inform approaches to primary prevention worldwide (HOPE-3 ClinicalTrials.govNCT00468923).

Published
2015

30. The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study

Author

Connolly, S.J. Wallentin, L. Ezekowitz, M.D. Eikelboom, J. Oldgren, J. Reilly, P.A. Brueckmann, M. Pogue, J. Alings, M. Amerena, J.V. Avezum, A. Baumgartner, I. Budaj, A.J. Chen, J.-H. Dans, A.L. Darius, H. Di Pasquale, G. Ferreira, J. Flaker, G.C. Flather, M.D. Franzosi, M.G. Golitsyn, S.P. Halon, D.A. Heidbuchel, H. Hohnloser, S.H. Huber, K. Jansky, P. Kamensky, G. Keltai, M. Kim, S.S. Lau, C.-P. Le Heuzey, J.-Y. Lewis, B.S. Liu, L. Nanas, J. Omar, R. Pais, P. Pedersen, K.E. Piegas, L.S. Raev, D. Smith, P.J. Talajic, M. Tan, R.S. Tanomsup, S. Toivonen, L. Vinereanu, D. Xavier, D. Zhu, J. Wang, S.Q. Duffy, C.O. Themeles, E. Yusuf, S.

Abstract

BACKGROUND - : During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses. METHODS AND RESULTS - : Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomly assigned to receive dabigatran in RE-LY and 86% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46% and 1.60%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95% confidence interval, 0.69-1.20). Rates of major hemorrhage were 3.74% and 2.99%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95% confidence interval, 1.04-1.53). Rates of death were 3.02% and 3.10%/y (hazard ratio, 0.97; 95% confidence interval, 0.80-1.19). Rates of hemorrhagic stroke were 0.13% and 0.14%/y. CONCLUSIONS - : During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death. CLINICAL TRIAL REGISTRATION - : URL: http://www.clinicaltrials.gov. Unique identifier: NCT00808067. © 2013 American Heart Association, Inc.

Published
2013

34. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes

Author

CURRENT OASIS, 7 Investigators, Pizzolato, Gilberto, [investigator]mehta, Sr, Bassand, Jp, Chrolavicius, S, Diaz, R, Eikelboom, Jw, Fox, Ka, Granger, Cb, Jolly, S, Joyner, Cd, Rupprecht, Hj, Widimsky, P, Afzal, R, Pogue, J, and Yusuf, S.

Subjects
cardiovascular
Published
2010

35. Aliskiren alone or with other antihypertensives in the elderly with borderline and stage 1 hypertension: The APOLLOtrial

Author

Teo, K, Pfeffer, M, Mancia, G, O'Donnell, M, Dagenais, G, Diaz, R, Dans, A, Liu, L, Bosch, J, Joseph, P, Copland, I, Jung, H, Pogue, J, Yusuf, S, Teo, Koon K., Pfeffer, Marc, Mancia, Giuseppe, O'Donnell, Martin, Dagenais, Gilles, Diaz, Rafael, Dans, Antonio, Liu, Lisheng, Bosch, Jackie, Joseph, Philip, Copland, Ingrid, Jung, Hyejung, Pogue, Janice, Yusuf, Salim, Teo, K, Pfeffer, M, Mancia, G, O'Donnell, M, Dagenais, G, Diaz, R, Dans, A, Liu, L, Bosch, J, Joseph, P, Copland, I, Jung, H, Pogue, J, Yusuf, S, Teo, Koon K., Pfeffer, Marc, Mancia, Giuseppe, O'Donnell, Martin, Dagenais, Gilles, Diaz, Rafael, Dans, Antonio, Liu, Lisheng, Bosch, Jackie, Joseph, Philip, Copland, Ingrid, Jung, Hyejung, Pogue, Janice, and Yusuf, Salim

Abstract

Aims: We studied the unclear question whether blood pressure (BP) lowering reduces cardiovascular disease (CVD) in elderly individuals with systolic BP<160 mm Hg. Methods and results: We initiated a randomized placebo-controlled stratified 2 × 2 factorial clinical trial evaluating the effects of BP lowering in 11 000 elderly individuals with systolic blood pressure (SBP) between 130 and 159 mm Hg, for 5 years. Following 5-week active run-in, participants were randomized to aliskiren (300 mg) or placebo, and to an additional antihypertensive [hydrochlorothiazide (25 mg) or amlodipine (5 mg)], or their respective placeboes. Study was terminated by sponsor after 1759 subjects (age 72.1+5.2 years, 88% receiving at least one antihypertensive) were randomized and followed for 0.6 year. Study drugs were well tolerated with few serious adverse events during run-in and after randomization, with no significant differences between treatment groups. By design, three levels of BP reductionswere achieved, adjustedmean BP reductions of 3.5/1.7 mm Hg (P< 0.001) by aliskiren, 6.8/3.3 mm Hg (P< 0.001) by hydrochlorothiazide or amlodipine, and 10.3/5.0 mm Hg (P< 0.001) by double therapy compared with placebo. Twenty-five major CVD events occurred. Non-significant trends towards fewer CVD events with greater BP reductions are evident: hazard ratios (HR) 0.82 [95% confidence interval (CI): 0.37-1.81] for 3.5 mm Hg SBP reduction; HR 0.45 (95% CI: 0.19-1.04) for 6.8 mm Hg; and HR 0.25 (0.05-1.18) for 10.3 mm Hg reduction for primary composite of CV death, MI, stroke, or significant heart failure. Conclusions: Sizeable reductions in BP, with potential for substantial CVD reduction, can be safely achieved using combinations of BP drugs in the elderly with normal high and Stage 1 hypertension. Clinical trial registration: NCT01259297. © The Author 2014.

Published
2014

39. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial

Author

Yusuf, S., Mehta, S.R., Chrolavicius, S., Afzal, R., Pogue, J., Granger, C.B., Budaj, A., Peters, RJG., Bassand, J.P., Wallentin, L., Joyner, C., and Fox, K.A.A.

Subjects
ST-segment elevation myocardial infarction, fondaparinux, enoxaparin
Abstract

CONTEXT: Despite many therapeutic advances, mortality in patients with acute ST-segment elevation myocardial infarction (STEMI) remains high. The role of additional antithrombotic agents is unclear, especially among patients not receiving reperfusion therapy. OBJECTIVE: To evaluate the effect of fondaparinux, a factor Xa inhibitor, when initiated early and given for up to 8 days vs usual care (placebo in those in whom unfractionated heparin [UFH] is not indicated [stratum 1] or unfractionated heparin for up to 48 hours followed by placebo for up to 8 days [stratum 2]) in patients with STEMI. DESIGN, SETTING, AND PARTICIPANTS: Randomized double-blind comparison of fondaparinux 2.5 mg once daily or control for up to 8 days in 12, 092 patients with STEMI from 447 hospitals in 41 countries (September 2003-January 2006). From day 3 through day 9, all patients received either fondaparinux or placebo according to the original randomized assignment. MAIN OUTCOME MEASURES: Composite of death or reinfarction at 30 days (primary) with secondary assessments at 9 days and at final follow-up (3 or 6 months). RESULTS: Death or reinfarction at 30 days was significantly reduced from 677 (11.2%) of 6056 patients in the control group to 585 (9.7%) of 6036 patients in the fondaparinux group (hazard ratio [HR], 0.86 ; 95% confidence interval [CI], 0.77-0.96 ; P = 0.008) ; absolute risk reduction, 1.5% ; 95% CI, 0.4%-2.6%). These benefits were observed at 9 days (537 [8.9%] placebo vs 444 [7.4%] fondaparinux ; HR, 0.83 ; 95% CI, 0.73-0.94 ; P = 0.003, and at study end (857 [14.8%] placebo vs 756 [13.4%] fondaparinux ; HR, 0.88 ; 95% CI, 0.79-0.97 ; P = 0.008). Mortality was significantly reduced throughout the study. There was no heterogeneity of the effects of fondaparinux in the 2 strata by planned heparin use. However, there was no benefit in those undergoing primary percutaneous coronary intervention. In other patients in stratum 2, fondaparinux was superior to unfractionated heparin in preventing death or reinfarction at 30 days (HR, 0.82 ; 95% CI, 0.66-1.02 ; P = 0.08) and at study end (HR, 0.77 ; 95% CI, 0.64-0.93 ; P = 0.008). Significant benefits were observed in those receiving thrombolytic therapy (HR, 0.79 ; P = 0.003) and those not receiving any reperfusion therapy (HR, 0.80 ; P = 0.03). There was a tendency to fewer severe bleeds (79 for placebo vs 61 for fondaparinux ; P = 0.13), with significantly fewer cardiac tamponade (48 vs 28 ; P = 0.02) with fondaparinux at 9 days. CONCLUSION: In patients with STEMI, particularly those not undergoing primary percutaneous coronary intervention, fondaparinux significantly reduces mortality and reinfarction without increasing bleeding and strokes.

Published
2006

40. Comparison of Fondaparinux and Enoxaparin in Acute Coronary Syndromes

Author

Yusuf, S., Mehta, S.R., Bassand, J.P., Budaj, A., Chrolavicius, S., Fox, K.A.A., Granger, C.B., Joyner, C., Peters, R.J.G., Wallentin, L., Avezum, A., Boden, W., Cardona, E., Ceremuzynski, L., Col, J., Commerford, P.J., Diaz, R., Faxon, D., Flather, M., Fodor, G., Franzosi, M.G., Granger, C., Halon, D., Hunt, D., Karatzas, N., Keltai, M., Kenda, M., Kim, J.H., Lanas, F., Lau, C.P., Lewis, B.S., Morais, J., Moccetti, T., Pais, P., Paolasso, E., Parkhomenko, A., Petrauskiene, B., Piegas, L., Pipilis, A., Robaayah, D., Ruda, M., Rumboldt, Zoran, Rupprecht, H.J., Sitkei, E., Steg, P.G., Swahn, E., Theroux, P., Valentin, V., Varigos, J., Weitz, J., White, H., Widimsky, P., Xavier, D., Zhu, J.R., Ameriso, S., Bonilla, C., Braekken, S., Chan, Y.K., Chen, W., Chenniappan, M., Cohen, E., Cottin, Y., Csiba, L., Czepiel, A., de Raedt, H., Finet, G., Gardinale, E., Gaxiola, E., Gorecki, A., Gregor, P., Happola, O., Heras, M., Himbert, D., Irkin, O., Isaaz, K., Iyengar, S.S., Kalvach, P., Kevers, L., Klosiewicz-Wasek , B., Laine, M., Leys, D., Lundstrom, E., Lušić, Ivo, Lutay, Y., Maggioni, A., Massaro, A., Mayosi, B.M., Moulin, T., Narendra, J., Naslund, U., Peeters, A., Penicka, M., Perakis, A., Petersen, P., Polić, S., Radhakrishnan, S., Renkin, J., Stockins, B., Sundararajan, R., Thygesen, K., Turazza, F., van Belle, E., Vik-Mo, H., Zaborski, J., Sleight, P., Anderson , J.L., Johnstone D., Hirsh, J., de Mets, D., Holmes, D.R., Meeks, B., Afzal, R., Pogue, J., Boccalon, S., Chrysler, K., Cracknell, B., Horsman, C., Hoskin, T., Jedrzejowski. B., Johnson, J., Kotlan, S., Lawrence, M., Smiley, M., Stevens, C., Yallup, R., Connolly, S., Demers, C., Devereaux, P.J., Healey, J., Lonn, E., Magloire, P., McKelvie, R., Morillo, C., Natarajan, M., Rokoss, M., Teo, K., Valettas, N., Velianou, J., Bakula, Miro, Bergovec, M, Lukin Ajvor, Miličević, Goran, Padovan, Milko, and Raguž, M.

Subjects
ST-segment elevation, high-risk patients, unfractionated heparin, myocardial infarction, collaborative metaanalysis, randomized trials, initial treatment, american-college, task-force, prevention
Abstract

The combined use of anticoagulants, antiplatelet agents, and invasive coronary procedures reduces ischemic coronary events but also increases bleeding in patients with acute coronary syndromes. We therefore assessed whether fondaparinux would preserve the anti-ischemic benefits of enoxaparin while reducing bleeding. We randomly assigned 20, 078 patients with acute coronary syndromes to receive either fondaparinux (2.5 mg daily) or enoxaparin (1 mg per kilogram of body weight twice daily) for a mean of six days and evaluated death, myocardial infarction, or refractory ischemia at nine days (the primary outcome) ; major bleeding ; and their combination. Patients were followed for up to six months. The number of patients with primary-outcome events was similar in the two groups (579 with fondaparinux [5.8 percent] vs. 573 with enoxaparin [5.7 percent] ; hazard ratio in the fondaparinux group, 1.01 ; 95 percent confidence interval, 0.90 to 1.13), satisfying the noninferiority criteria. The number of events meeting this combined outcome showed a nonsignificant trend toward a lower value in the fondaparinux group at 30 days (805 vs. 864, P=0.13) and at the end of the study (1222 vs. 1308, P=0.06). The rate of major bleeding at nine days was markedly lower with fondaparinux than with enoxaparin (217 events [2.2 percent] vs. 412 events [4.1 percent] ; hazard ratio, 0.52 ; P

Published
2006

42. Neuraxial Block, Death, and Serious Cardiovascular Morbidity in the Perioperative Ischemia Evaluation Trial

Author

Leslie, K., primary, Myles, P., additional, Devereaux, P., additional, Williamson, E., additional, Rao-Melancini, P., additional, Forbes, A., additional, Xu, S., additional, Foex, P., additional, Pogue, J., additional, Arrieta, M., additional, Bryson, G., additional, Paul, J., additional, Paech, M., additional, Merchant, R., additional, Choi, P., additional, Badner, N., additional, Peyton, P., additional, Sear, J., additional, and Yang, H., additional

Published
2014
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44. The long-term multicenter observational study of dabigatran treatment in patients with atrial fibrillation (RELY-ABLE) study

Author

Connolly, SJ, Wallentin, L, Ezekowitz, MD, Eikelboom, J, Oldgren, J, Reilly, PA, Brueckmann, M, Pogue, J, Alings, M, Amerena, John, Avezum, A, Baumgartner, I, Budaj, AJ, Chen, JH, Dans, AL, Darius, H, Di Pasquale, G, Ferreira, J, Flaker, GC, Flather, MD, Franzosi, MG, Golitsyn, SP, Halon, DA, Heidbuchel, H, Hohnloser, SH, Huber, K, Jansky, P, Kamensky, G, Keltai, M, Kim, SS, Lau, CP, Le Heuzey, JY, Lewis, BS, Liu, L, Nanas, J, Omar, R, Pais, P, Pedersen, KE, Piegas, LS, Raev, D, Smith, PJ, Talajic, M, Tan, RS, Tanomsup, S, Toivonen, L, Vinereanu, D, Xavier, D, Zhu, J, Wang, SQ, Duffy, CO, Themeles, E, Yusuf, S, Connolly, SJ, Wallentin, L, Ezekowitz, MD, Eikelboom, J, Oldgren, J, Reilly, PA, Brueckmann, M, Pogue, J, Alings, M, Amerena, John, Avezum, A, Baumgartner, I, Budaj, AJ, Chen, JH, Dans, AL, Darius, H, Di Pasquale, G, Ferreira, J, Flaker, GC, Flather, MD, Franzosi, MG, Golitsyn, SP, Halon, DA, Heidbuchel, H, Hohnloser, SH, Huber, K, Jansky, P, Kamensky, G, Keltai, M, Kim, SS, Lau, CP, Le Heuzey, JY, Lewis, BS, Liu, L, Nanas, J, Omar, R, Pais, P, Pedersen, KE, Piegas, LS, Raev, D, Smith, PJ, Talajic, M, Tan, RS, Tanomsup, S, Toivonen, L, Vinereanu, D, Xavier, D, Zhu, J, Wang, SQ, Duffy, CO, Themeles, E, and Yusuf, S

Abstract

Background— During follow-up of between 1 and 3 years in the Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, 2 doses of dabigatran etexilate were shown to be effective and safe for the prevention of stroke or systemic embolism in patients with atrial fibrillation. There is a need for longer-term follow-up of patients on dabigatran and for further data comparing the 2 dabigatran doses. Methods and Results— Patients randomly assigned to dabigatran in RE-LY were eligible for the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow-up, 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomly assigned to receive dabigatran in RE-LY and 86% of RELY-ABLE–eligible patients. Rates of stroke or systemic embolism were 1.46% and 1.60%/y on dabigatran 150 and 110 mg twice daily, respectively (hazard ratio, 0.91; 95% confidence interval, 0.69–1.20). Rates of major hemorrhage were 3.74% and 2.99%/y on dabigatran 150 and 110 mg (hazard ratio, 1.26; 95% confidence interval, 1.04–1.53). Rates of death were 3.02% and 3.10%/y (hazard ratio, 0.97; 95% confidence interval, 0.80–1.19). Rates of hemorrhagic stroke were 0.13% and 0.14%/y. Conclusions— During 2.3 years of continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily in comparison with 110 mg, and similar rates of stroke and death. Clinical Trial Registration—

Published
2013

45. Irbesartan in patients with atrial fibrillation

Author

UCL - (MGD) Service de cardiologie, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, Yusuf, S., Healey, J.S., Pogue, J., Chrolavicius, S., Flather, M., Hart, R.G., Hohnloser, S.H., Joyner, C.D., Pfeffer, M.A., Connolly, S.J., De Roy, Luc, UCL - (MGD) Service de cardiologie, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, Yusuf, S., Healey, J.S., Pogue, J., Chrolavicius, S., Flather, M., Hart, R.G., Hohnloser, S.H., Joyner, C.D., Pfeffer, M.A., Connolly, S.J., and De Roy, Luc

Abstract

BACKGROUND: The risk of cardiovascular events among patients with atrial fibrillation is high. We evaluated whether irbesartan, an angiotensin-receptor blocker, would reduce this risk. METHODS: We randomly assigned patients with a history of risk factors for stroke and a systolic blood pressure of at least 110 mm Hg to receive either irbesartan at a target dose of 300 mg once daily or double-blind placebo. These patients were already enrolled in one of two trials (of clopidogrel plus aspirin versus aspirin alone or versus oral anti-coagulants). The first coprimary outcome was stroke, myocardial infarction, or death from vascular causes; the second was this composite outcome plus hospitalization for heart failure. RESULTS: A total of 9016 patients were enrolled and followed for a mean of 4.1 years. The mean reduction in systolic blood pressure was 2.9 mm Hg greater in the irbesartan group than in the placebo group, and the mean reduction in diastolic blood pressure was 1.9 mm Hg greater. The first coprimary outcome occurred at a rate of 5.4% per 100 person-years in both groups (hazard ratio with irbesartan, 0.99; 95% confidence interval [CI], 0.91 to 1.08; P = 0.85). The second coprimary outcome occurred at a rate of 7.3% per 100 person-years among patients receiving irbesartan and 7.7% per 100 person-years among patients receiving placebo (hazard ratio, 0.94; 95% CI, 0.87 to 1.02; P = 0.12). The rates of first hospitalization for heart failure (a pre-specified secondary outcome) were 2.7% per 100 person-years among patients receiving irbesartan and 3.2% per 100 person-years among patients receiving placebo (hazard ratio, 0.86; 95% CI, 0.76 to 0.98). Among patients who were in sinus rhythm at baseline, there was no benefit of irbesartan in preventing hospitalization for atrial fibrillation or atrial fibrillation recorded on 12-lead electrocardiography, nor was there a benefit in a subgroup that underwent transtelephonic monitoring. More patients in the irbesartan gro

Published
2011

46. Dabigatran versus Warfarin in Patients with Atrial Fibrillation.

Author

Connolly, SJ, Ezekowitz, MD, Yusuf, S, Eikelboom, J, Oldgren, J, Parekh, A, Pogue, J, Reilly, PA, Themeles, E, Varrone, J, Wang, S, Alings, M, Xavier, D, Zhu, J, Diaz, R, Lewis, BS, Darius, H, Diener, H-C, Joyner, CD, Wallentin, L, Connolly, SJ, Ezekowitz, MD, Yusuf, S, Eikelboom, J, Oldgren, J, Parekh, A, Pogue, J, Reilly, PA, Themeles, E, Varrone, J, Wang, S, Alings, M, Xavier, D, Zhu, J, Diaz, R, Lewis, BS, Darius, H, Diener, H-C, Joyner, CD, and Wallentin, L

Abstract

BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. RESULTS: Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). CONCLUSIONS: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of maj

Published
2009

48. Combination neurohormonal blockade with ACE inhibitors, angiotensin II antagonists and beta-blockers in patients with congestive heart failure: design of the Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) Pilot Study

Author

Rt, Tsuyuki, Yusuf S, Jl, Rouleau, Aldo Pietro Maggioni, Rs, Mckelvie, Em, Wiecek, Wang Y, Pogue J, Kk, Teo, White M, Avezum A, Latini R, Held P, Lindgren E, and Probstfield J

Subjects
Heart Failure, Renin-Angiotensin System, Ventricular Dysfunction, Left, Angiotensin II, Adrenergic beta-Antagonists, Humans, Angiotensin-Converting Enzyme Inhibitors, Pilot Projects
Abstract

The Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD) Pilot Study is a trial of combination neurohormonal blockade using an angiotensin II antagonist (candesartan), an angiotensin-converting enzyme inhibitor (enalapril) and a beta-blocker (metoprolol) in patients with congestive heart failure (CHF).Primary objectives of stage I are to determine the efficacy (via the 6 min walk test) and safety of candesartan alone, and in combination with enalapril, versus enalapril alone. Secondary objectives are to determine the effect of the above combinations on neurohormones, ventricular function, quality of life and symptoms. Stage II objectives are similar, evaluating the effect of the addition of metoprolol or placebo to the above medication(s).Randomized, two-stage trial consisting of a three-way comparison (stage I), followed by a 3 x 2 partial factorial design (stage II).Sixty out-patient clinics in five countries.Patients with symptoms of CHF (New York Heart Association functional classes II to IV), ejection fraction less than 40% and 6 min walk distance of 500 m or less.In stage I, 770 patients are randomized to receive candesartan alone, enalapril alone, or candesartan plus enalapril. After five months (end of stage I), patients are assessed for eligibility to be randomized in stage II. Those who are not candidates for randomization to beta-blocker or placebo are followed on their stage I medications until the end of the study. In stage II, patients are randomized to receive metoprolol or placebo for a further six months in addition to their stage I medications. Endpoints are measured at baseline, end of stage I (week 20) and end of stage II (week 46). STUDY STATUS: The study has recently completed follow-up in both stages. The findings from this study will be used to design a large scale mortality study that will help further define the role of neurohormonal blockade in patients with CHF.

Published
1998

50. Safety outcomes in meta-analyses of phase 2 vs phase 3 randomized trials: Intracranial hemorrhage in trials of bolus thrombolytic therapy.

Author

Eikelboom JW, Mehta SR, Pogue J, Yusuf S, Eikelboom, J W, Mehta, S R, Pogue, J, and Yusuf, S

Abstract

Context: Recent studies have reported disagreement between meta-analysis of small trials and subsequent large trials addressing the same question. However, disagreement for uncommon but serious adverse safety outcomes has not been examined.Objective: To explore disagreement for serious adverse safety (intracranial hemorrhage [ICH]) and efficacy outcomes between meta-analysis of phase 2 (small) vs meta-analysis of phase 3 (large) randomized controlled trials comparing the efficacy of bolus thrombolytic therapy with infusion for acute myocardial infarction (AMI).Data Sources: Electronic databases (MEDLINE, Cochrane Database of Clinical Trials) between January 1980 and December 1999 using the search terms thrombolysis, thrombolytic therapy, and myocardial infarction; conference proceedings; and reference lists.Study Selection: Fifteen randomized trials comparing thrombolytic agents administered by bolus injection with standard infusion therapy in patients with AMI.Data Extraction: Data on ICH, other causes of stroke, total mortality, and reinfarction were independently extracted from each study by 2 observers.Data Synthesis: Meta-analysis of 9 phase 2 trials (n = 3956) revealed a lower risk of ICH with bolus thrombolytic therapy (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.27-1.01), which was not statistically significant. Meta-analysis of 6 phase 3 trials (n = 62 673) indicated a significant increase in risk of ICH (OR, 1.25; 95% CI, 1.06-1.49). These results were significantly different (P =.01). There was no disagreement for efficacy outcomes. Phase 2 trials included younger and heavier patients with lower baseline blood pressures, and were more often open-label. Subgroup analyses suggested that each of these factors was associated with a lower estimate of risk of ICH with bolus agents.Conclusions: Our results suggest that when therapeutic interventions are associated with a potential for uncommon but serious adverse safety outcomes, there may be differences between small phase 2 and large phase 3 trials that result in their disagreement for safety but not necessarily efficacy outcomes. Further investigation of the frequency and causes of disagreement between small and large trials for safety outcomes is warranted. [ABSTRACT FROM AUTHOR]

Published
2001
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