1,550 results on '"Califf RM"'
Search Results
2. Digitizing clinical trials
- Author
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Inan, OT, Tenaerts, P, Prindiville, SA, Reynolds, HR, Dizon, DS, Cooper-Arnold, K, Turakhia, M, Pletcher, MJ, Preston, KL, Krumholz, HM, Marlin, BM, Mandl, KD, Klasnja, P, Spring, B, Iturriaga, E, Campo, R, Desvigne-Nickens, P, Rosenberg, Y, Steinhubl, SR, and Califf, RM
- Subjects
Health Services and Systems ,Health Sciences ,Clinical Trials and Supportive Activities ,Clinical Research ,Generic health relevance ,Good Health and Well Being ,Clinical trials ,Translational research ,Health services and systems - Abstract
Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a "digital clinical trial" involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.
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- 2020
3. CTSA Consortium Consensus Scientific Review Committee (SRC) Working Group Report on the SRC Processes
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Selker, HP, Buse, JB, Califf, RM, Carter, R, Cooper, DM, Davis, J, Ford, DE, Galassetti, P, Guay-Woodford, L, Huggins, GS, Kasper, A, Kieburtz, K, Kirby, A, Klein, AK, Kline, J, O' Neill, RT, Rape, M, Reichgott, DJ, Rojevsky, S, Rosenthal, GE, Rubinstein, EP, Shepherd, A, Stacy, M, Terrin, N, Wallace, M, and Welch, L
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General Clinical Medicine ,Cardiorespiratory Medicine and Haematology ,Oncology and Carcinogenesis ,Other Medical and Health Sciences - Abstract
Human research projects must have a scientifically valid study design, analytic plan, and be operationally feasible in order to be successfully completed and thus to have translational impact. To ensure this, institutions that conduct clinical research should have a scientific review process prior to submission to the Institutional Review Committee (IRB). This paper reports the Clinical and Translational Science Award (CTSA) Consortium Scientific Review Committee (SRC) Consensus Working Group's proposed framework for a SRC process. Recommendations are provided for institutional support and roles of CTSAs, multisite research, criteria for selection of protocols that should be reviewed, roles of committee members, application process, and committee process. Additionally, to support the SCR process effectively, and to ensure efficiency, the Working Group recommends information technology infrastructures and evaluation metrics to determine outcomes are provided.
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- 2015
4. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes
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Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR, Josse RG, Califf RM, Goldstein BJ, Shapiro DR, Silverman R, Bethel A, Green J, Hayden S, Hannan K, Quintero K, Rorick T, Berdan L, Leloudis D, Califf S, Wilson M, McFarron D, Trollinger K, Pesarchick J, Eskenazi L, Campbell C, Townes O, Tolsma D, Keenan J, Milton J, Athwal R, Darbyshire J, Doran Z, Kennedy I, Gregory V, Lokhnygina Y, Prather K, Wolfley A, Usman M, Tajjar A, Gray R, Pfeffer MA, Gerstein HC, Groop L, McMurray JJ, Pocock SJ, Clayton T, Sinay I, Brieger D, Stranks S, Scheen A, Lopes R, Tankova T, Hramiak I, Grado CR, Wenying Y, Ge J, Aschner P, Skrha J, Ambos A, Strandberg T, Travert F, Hanefeld M, Riefflin A, Chan JC, Ofner P, Reddy NK, Christopher J, Mathur A, Arambam P, Mittal S, Manchanda M, Wainstein J, Ambrosio G, Pirags V, Jakuboniene N, Mohamed M, Scott R, White H, Cornel J, Halvorsen S, Tykarski A, Veresiu IA, Dreval AV, Misinkova I, Tai E, Krahulec B, Distiller L, Park Y, Rovira A, Alversson M, Chuang LM, Delibasi T, Adler A, Rodbard HW, Marre M, Goff D, Chacra A, DeVore A, Beaven A, Shah B, Hirsch B, Batch B, Bushnell C, Patel C, Melloni C, Henshaw C, Kong D, Bernecki G, Tillman H, Kang HJ, Hawes J, Strickler J, Piccini J, Wilder J, Alexander K, Mahaffey K, Patel K, Hyland K, Newby K, Jackson L, Cooper L, Armaganijan L, Szczeh L, Koshizaka M, Roe M, Morse M, Guimaraes P, Hess P, Tricoci P, Mehta R, Mathews R, Kociol R, Harrison R, Mentz R, Pokorney S, Leblanc T, Lazzarini V, Eapen Z, Truffa A, Fosbol E, Brito F, Katz M, Bahit M, Santos M, Barros P, Bernardez S, Alvarisqueta AF, Arias P, Cagide AL, Calella PR, Cantero MC, Canella JP, Cipullo MA, de Loredo L, Gelersztein ES, Gorban de Lapertosa SB, Klyver MI, Maffei LE, Maldonado N, Oviedo AI, Piskorz DL, Ridruejo MC, Saavedra SS, Sessa HA, Sinay IR, Sposetti GD, Ulla MR, Vico ML, Waitman JN, Binnekamp M, Carroll P, Cheung W, Colman P, Davis T, De Looze F, dEmden M, Fulcher G, Gerstman M, Hamilton A, Lehman S, Moses R, Proietto J, Roberts A, Shaw J, Simpson R, Sinha A, Tan Y, Topliss D, Vora P, Waites J, Crenier L, Descamps O, Keymeulen B, Mathieu C, Nobels F, Van den Bruel A, Van Gaal L, Borges JL, Costa e Forti A, Eliaschewitz FG, Felício JS, Griz LH, Hissa MN, Leite S, Panarotto D, Pimentel Filho P, Rassi N, Saraiva JK, Sgarbi JA, Silva RP, Tambascia M, Weber Silva DM, Bobeva R, Bostandzhieva R, Cinlikov I, Georgieva M, Iliev D, Ilieva E, Kovacheva S, Liubenova L, Nikitov Z, SHeinikova G, Slavcheva A, Spasova V, Temelkova-Kurktschiev T, Velichka D, Yakov A, Carpentier A, Chiasson JL, Constance C, Dumas R, Filteau P, Garceau C, Huynh T, Kaiser S, Kornder J, Leiter L, Mereu L, Miller D, Pandey S, Punthakee Z, Rabasa-Lhoret R, Robitaille Y, Saunders K, Sigal R, Sigalas J, Vizel S, Weisnagel S, Woo V, Yale JF, Yared K, Zinman B, Bunster Balocchi LB, Escobar Cerda EE, Garces Flores EE, Lanas Zanetti FT, Larrazabal Miranda Adel P, Morales Alvarado JM, Olivares Cañon CM, Potthoff Cárdenas SH, Raffo Grado CA, Rodriguez Venegas ME, Saavedra Gajardo VA, Westerberg Maldonado BH, Chen LL, Dong J, Guo X, Li QM, Shi B, Tang XL, Yang T, Yang WY, Zheng SX, Aschner Montoya P, Botero Lopez R, Coronel Arroyo JA, Cure CA, Gómez Medina AM, Molina DI, Perez Amador GA, Reyes Rincon A, Urina Triana MA, Valenzuela Rincon A, Vélez Pelaez S, Yupanqui Lozno H, Brabec T, Brychta T, Hasalova Zapletalova J, Havelkova J, Hejnicova K, Hola O, Hornackova M, Hrdina T, Kafkova D, Kellnerova I, Krystl T, Kutejova V, Mikulkova I, Nevrla J, Pantlikova C, Petr M, Racicka E, Sarbochova R, Smolenakova K, Turcinek R, Urbancova K, Vejvodova J, Vondrakova M, Zachoval R, Alt I, Kaasik Ü, Kiiroja K, Lanno R, Märtsin K, Past M, Vides H, Viitas L, Kantola I, Nieminen S, Perhonen M, Strand J, Valle T, Clergeot A, Couffinhal T, Courreges JP, Gouet D, Moulin P, Ziegler O, Badenhoop K, Behnke T, Bender G, Braun M, Dshabrailov J, Hamann A, Himpel-Boenninghoff A, Kamke W, Kasperk C, Luedemann J, Mayr P, Merkel M, Oerter EM, Ohlow MA, Ott P, Overhoff U, Paschen B, Remppis R, Rose L, Schumm-Draeger PM, Segiet T, Strotmann HJ, Stuchlik G, Stürmer W, Thinesse-Mallwitz M, Tytko A, Wendisch U, Wurziger J, Ho AY, Kam G, Kong AP, Lam YY, Lau EY, Lee S, Siu SC, Tomlinson B, Tsang CC, Yeung VT, Dezső E, Dudás M, Földesi I, Fülöp T, Késmárki N, Koranyi L, Nagy K, Oroszlán T, Pécsvárady Z, Ples Z, Taller A, Agarwal P, Ambulkar S, Aravind S, Balaji V, Kalra S, Kesavadev J, Kudalkar H, Kumar A, Misra A, Mithal A, Mohan V, Pitale S, Ramu M, Reddy N, Shah S, Shamanna P, Sharda A, Sharma A, Shunmugavelu M, Srikanta S, Suryaprakash G, Abramov G, Adawi F, Bashkin A, Darawsha M, Fuchs S, Harman-Boehm I, Hayek T, Jaffe A, Knobler H, Minuchin O, Mosseri M, Shechter M, Shimon I, Stern N, Tsur A, Vishlitzky V, Alfonsi F, Cavalot F, Del Vecchio L, Frisinghelli A, Gambardella S, Lauro D, Lembo G, Leotta S, Mondillo S, Novo S, Pedrinelli R, Piatti P, Salvioni A, Tritto I, Zavaroni DZ, Ahn KJ, Choi KM, Chung C, Han SJ, Kim DM, Kim IJ, Kim MH, Lee IK, Nam M, Park IeB, Park KS, Park TS, Rhee EJ, Yoo SJ, Andersone I, Balode A, Eglite R, Gersamija A, Kakurina N, Jegere B, Leitane I, Pastare S, Stalte V, Teterovska D, Baltramonaitiene K, Barsiene L, Ceponis J, Lasiene J, Levinger A, Sirutaviciene A, Sulskiene M, Urbanaviciene L, Valius L, Varanauskiene E, Velickiene D, Mahendran KA, Abu Hassan MR, Aziz NA, Hussein Z, Ismail IS, Kamaruddin NA, Nordin Z, Nayar SK, Ramanathan GR, Sothiratnam R, Beijerbacht H, Breedveld R, Cornel JH, Den Hartog F, Hermans W, Kietselaer B, Kooy A, Lenderink T, Nierop P, Remmen J, Rojas Lingan G, Ronner E, Van der Heijden R, Van Hessen M, van Kempen W, Voors-Pette C, Westendorp I, Baker J, Benatar J, Cutfield R, Krebs J, Leikis R, Lunt H, Manning P, Williams M, Birkeland K, Claudi T, Istad H, Karlsson T, Ossum Gronert J, Arciszewska M, Artemiuk E, Blach E, Blicharski T, Cypryk K, Dabrowska M, Górny G, Górska M, Jakubowska I, Jazwinska-Tarnawska E, Karczmarczyk A, Kitowska-Koterla J, Koltowski L, Krzyzagorska E, Pasternak D, Pentela-Nowicka J, Piesiewicz W, Przekwas-Jaruchowska M, Rajzer M, Salamon-Ferenc A, Sawicki A, Skowron T, Śmiałowski A, Albota A, Alexandru C, Crisan C, Dumitrescu A, Ferariu IE, Lupusoru DA, Munteanu M, Negru D, Nicolau A, Pintiliei E, Popescu A, Serban G, Voitec M, Babenko A, Barbarash O, Bondar I, Chizhov P, Demin A, Dora S, Dreval A, Ershova O, Gratsiansky N, Ketova G, Kotelnikov M, Levashov S, Morugova T, Mustafina S, Pekarskiy S, Raskina T, Rechkova E, Samoylova Y, Sazonova O, Sherenkov A, Shilkina N, Stetsyuk O, Tretyakova T, Turova E, Valeeva F, Zadionchenko V, Dalan R, Tan RS, Tay L, Buganova I, Fabry J, Jan C, Toserova E, Zak R, Zimanova J, Badat A, Bester F, Burgess L, De Jong D, Ellis G, Fouche L, Govender P, Govind U, Naidoo V, Nieuwoudt G, Nortje H, Rheeder P, Robertson L, Siddique N, Stapelberg AM, Trinder Y, Van Der Merwe A, Van Zyl L, Viljoen M, Wilhase A, Botella M, Civeira Murillo F, de Teresa L, Del Cañizo FJ, Extremera BG, Gimeno EJ, Martin-Hidalgo A, Morales C, Nubiola A, Tinahones Madueño F, Tranche S, Trescolí Serrano C, Alvarsson M, Eizyk E, Gillblad A, Johansson P, Löndahl M, Ohlsson-Önerud Å, Rautio A, Sundström U, Torstensson I, Chen JF, Chou CW, Ho LT, Hsieh IC, Huang BH, Huang CL, Huang CN, Lai WT, Lo PH, Pei D, Sheu WH, Wang SY, Araz M, Bakiner O, Comlekci A, Guler S, Sahin I, Sarac F, Tarkun I, Ukinc K, Yilmaz M, Abdulhakim E, Abraham P, Adamson K, Blagden M, Bundy C, Daly M, Davies M, Deshpande M, Gillings S, Harvey P, Horvathova V, Hristova D, Jaap A, Johnson A, Jones H, Kerrane J, Kilvert A, Ko T, Kumar J, Lindsay R, Litchfield J, McCrimmon R, McKnight J, Millward B, Oyesile B, Purewal T, Ravikumar C, Robinson A, Sathyapalan T, Simpson H, Thomas H, Turner W, Weaver J, Wilding J, Wiles P, Adkins K, Akpunonu B, Albu J, Anagnostis G, Anastasi L, Argoud G, Aroda V, Azizad M, Banerji MA, Bartkowiak A Jr, Bays H, Behn P, Bergenstal R, Bhargava A, Bias D, Bolster E, Buchanan P, Busch R, Chadha C, Chang M, Cheng C, Cohen A, Cohen J, Cole B, Connery L, Cooperman M, Cushman W, DAgostino R, Dayamani P, De Lemos J, De Meireles M, Dean J, DeHart D, Detweiler R, Donovan D, Dugano-Daphnis P, Dulin M, Dunn F, Eaton C, Erickson B, Estevez R, Feinglos M, Fonseca V, Force R, Forker A, Fox D, Gabriel J, Garcia R, Garvey T, Gaudiani L, Getaneh A, Goldberg A, Goldman S, Hairston K, Harris R, Haught W, Hidalgo H Jr, Higgins A, Houchin V, Ison R, Jacobs G, Jaffrani N, Jafry B, Kapsner P, Kaye W, Labroo A, Levinson L, Lewis S, Lillestol M, Luttrell L, Madu I, McNeill R, Merrick B, Metzger F, Nadar V, Nagelberg S, Nash S, Oparil S, Osei K, Papademetriou V, Patel N, Pedley C, Prentiss A, Radbill M, Raisinghani A, Rassouli N, Reddy R, Rees P, Rendell M, Robbins D, Rodbard H, Rohlf J, Roseman H, Rudolph L, Sadler L, Schnall A, Schramm R, Schubart U, Seneviratne T, Shanik M, Snyder H, Sorli C, Stich M, Sweeney ME, Tsao J, Ukwade P, Viswanath D, Vo A, Vogel C, Voyce S, Weintraub H, White J, Wood M, Wu P, Wysham C, Zimmerman R, Pathology/molecular and cellular medicine, Diabetes Pathology & Therapy, and Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR, Holman RR, Peterson ED, Holman RR, Peterson ED, Armstrong PW, Buse JB, Josse RG, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Engel SS, Califf RM, Goldstein BJ, Shapiro DR, Silverman R, Bethel A, Green J, Hayden S, Hannan K, Quintero K, Rorick T, Berdan L, Leloudis D, Califf S, Wilson M, McFarron D, Trollinger K, Pesarchick J, Eskenazi L, Campbell C, Townes O, Tolsma D, Keenan J, Milton J, Athwal R, Darbyshire J, Doran Z, Kennedy I, Gregory V, Garg J, Lokhnygina Y, Prather K, Wolfley A, Usman M, Tajjar A, Gray R, Pfeffer MA, Gerstein HC, Groop L, McMurray JJ, Pocock SJ, Clayton T, Sinay I, Brieger D, Stranks S, Scheen A, Lopes R, Tankova T, Hramiak I, Grado CR, Wenying Y, Ge J, Aschner P, Skrha J, Ambos A, Strandberg T, Travert F, Hanefeld M, Riefflin A, Chan JC, Ofner P, Reddy NK, Christopher J, Mathur A, Arambam P, Mittal S, Manchanda M, Wainstein J, Ambrosio G, Pirags V, Jakuboniene N, Mohamed M, Scott R, White H, Cornel J, Halvorsen S, Tykarski A, Veresiu IA, Dreval AV, Misinkova I, Tai E, Krahulec B, Distiller L, Park Y, Rovira A, Alversson M, Chuang LM, Delibasi T, Adler A, Rodbard HW, Marre M, Goff D, Chacra A, DeVore A, Beaven A, Shah B, Hirsch B, Batch B, Bushnell C, Patel C, Melloni C, Henshaw C, Kong D, McFarron D, Bernecki G, Tillman H, Kang HJ, Green J, Hawes J, Strickler J, Piccini J, Wilder J, Alexander K, Mahaffey K, Patel K, Hyland K, Newby K, Jackson L, Cooper L, Armaganijan L, Szczeh L, Koshizaka M, Roe M, Morse M, Guimaraes P, Hess P, Tricoci P, Mehta R, Lopes R, Mathews R, Kociol R, Harrison R, Mentz R, Pokorney S, Leblanc T, Lazzarini V, Eapen Z, Truffa A, Fosbol E, Brito F, Katz M, Bahit M, Santos M, Barros P, Bernardez S, Alvarisqueta AF, Arias P, Cagide AL, Calella PR, Cantero MC, Canella JP, Cipullo MA, de Loredo L, Gelersztein ES, Gorban de Lapertosa SB, Klyver MI, Maffei LE, Maldonado N, Oviedo AI, Piskorz DL, Ridruejo MC, Saavedra SS, Sessa HA, Sinay IR, Sposetti GD, Ulla MR, Vico ML, Waitman JN, Binnekamp M, Carroll P, Cheung W, Colman P, Davis T, De Looze F, dEmden M, Fulcher G, Gerstman M, Hamilton A, Lehman S, Moses R, Proietto J, Roberts A, Shaw J, Simpson R, Sinha A, Stranks S, Tan Y, Topliss D, Vora P, Waites J, Crenier L, Descamps O, Keymeulen B, Mathieu C, Nobels F, Scheen A, Van den Bruel A, Van Gaal L, Borges JL, Costa e Forti A, Eliaschewitz FG, Felício JS, Griz LH, Hissa MN, Leite S, Panarotto D, Pimentel Filho P, Rassi N, Saraiva JK, Sgarbi JA, Silva RP, Tambascia M, Weber Silva DM, Bobeva R, Bostandzhieva R, Cinlikov I, Georgieva M, Iliev D, Ilieva E, Kovacheva S, Liubenova L, Nikitov Z, SHeinikova G, Slavcheva A, Spasova V, Tankova T, Temelkova-Kurktschiev T, Velichka D, Yakov A, Carpentier A, Chiasson JL, Constance C, Dumas R, Filteau P, Garceau C, Hramiak I, Huynh T, Kaiser S, Kornder J, Leiter L, Mereu L, Miller D, Pandey S, Punthakee Z, Rabasa-Lhoret R, Robitaille Y, Saunders K, Sigal R, Sigalas J, Vizel S, Weisnagel S, Woo V, Yale JF, Yared K, Zinman B, Bunster Balocchi LB, Escobar Cerda EE, Garces Flores EE, Lanas Zanetti FT, Larrazabal Miranda Adel P, Morales Alvarado JM, Olivares Cañon CM, Potthoff Cárdenas SH, Raffo Grado CA, Rodriguez Venegas ME, Saavedra Gajardo VA, Westerberg Maldonado BH, Chen LL, Dong J, Guo X, Li QM, Shi B, Tang XL, Yang T, Yang WY, Zheng SX, Aschner Montoya P, Botero Lopez R, Coronel Arroyo JA, Cure CA, Gómez Medina AM, Molina DI, Perez Amador GA, Reyes Rincon A, Urina Triana MA, Valenzuela Rincon A, Vélez Pelaez S, Yupanqui Lozno H, Brabec T, Brychta T, Hasalova Zapletalova J, Havelkova J, Hejnicova K, Hola O, Hornackova M, Hrdina T, Kafkova D, Kellnerova I, Krystl T, Kutejova V, Mikulkova I, Nevrla J, Pantlikova C, Petr M, Racicka E, Sarbochova R, Skrha J, Smolenakova K, Turcinek R, Urbancova K, Vejvodova J, Vondrakova M, Zachoval R, Alt I, Ambos A, Kaasik Ü, Kiiroja K, Lanno R, Märtsin K, Past M, Vides H, Viitas L, Kantola I, Nieminen S, Perhonen M, Strand J, Strandberg T, Valle T, Clergeot A, Couffinhal T, Courreges JP, Gouet D, Moulin P, Travert F, Ziegler O, Badenhoop K, Behnke T, Bender G, Braun M, Dshabrailov J, Hamann A, Hanefeld M, Himpel-Boenninghoff A, Kamke W, Kasperk C, Luedemann J, Mayr P, Merkel M, Oerter EM, Ohlow MA, Ott P, Overhoff U, Paschen B, Remppis R, Riefflin A, Rose L, Schumm-Draeger PM, Segiet T, Strotmann HJ, Stuchlik G, Stürmer W, Thinesse-Mallwitz M, Tytko A, Wendisch U, Wurziger J, Ho AY, Kam G, Kong AP, Lam YY, Lau EY, Lee S, Siu SC, Tomlinson B, Tsang CC, Yeung VT, Dezső E, Dudás M, Földesi I, Fülöp T, Késmárki N, Koranyi L, Nagy K, Ofner P, Oroszlán T, Pécsvárady Z, Ples Z, Taller A, Agarwal P, Ambulkar S, Aravind S, Balaji V, Christopher J, Kalra S, Kesavadev J, Kudalkar H, Kumar A, Misra A, Mithal A, Mohan V, Pitale S, Ramu M, Reddy N, Shah S, Shamanna P, Sharda A, Sharma A, Shunmugavelu M, Srikanta S, Suryaprakash G, Abramov G, Adawi F, Bashkin A, Darawsha M, Fuchs S, Harman-Boehm I, Hayek T, Jaffe A, Knobler H, Minuchin O, Mosseri M, Shechter M, Shimon I, Stern N, Tsur A, Vishlitzky V, Wainstein J, Alfonsi F, Cavalot F, Del Vecchio L, Frisinghelli A, Gambardella S, Lauro D, Lembo G, Leotta S, Mondillo S, Novo S, Pedrinelli R, Piatti P, Salvioni A, Tritto I, Zavaroni DZ, Ahn KJ, Choi KM, Chung C, Han SJ, Kim DM, Kim IJ, Kim MH, Lee IK, Nam M, Park IeB, Park KS, Park TS, Park Y, Rhee EJ, Yoo SJ, Andersone I, Balode A, Eglite R, Gersamija A, Kakurina N, Jegere B, Leitane I, Pastare S, Pirags V, Stalte V, Teterovska D, Baltramonaitiene K, Barsiene L, Ceponis J, Jakuboniene N, Lasiene J, Levinger A, Sirutaviciene A, Sulskiene M, Urbanaviciene L, Valius L, Varanauskiene E, Velickiene D, Mahendran KA, Abu Hassan MR, Aziz NA, Hussein Z, Ismail IS, Kamaruddin NA, Mohamed M, Nordin Z, Nayar SK, Ramanathan GR, Sothiratnam R, Beijerbacht H, Breedveld R, Cornel JH, Den Hartog F, Hermans W, Kietselaer B, Kooy A, Lenderink T, Nierop P, Remmen J, Rojas Lingan G, Ronner E, Van der Heijden R, Van Hessen M, van Kempen W, Voors-Pette C, Westendorp I, Baker J, Benatar J, Cutfield R, Krebs J, Leikis R, Lunt H, Manning P, Scott R, Williams M, Birkeland K, Claudi T, Halvorsen S, Istad H, Karlsson T, Ossum Gronert J, Arciszewska M, Artemiuk E, Blach E, Blicharski T, Cypryk K, Dabrowska M, Górny G, Górska M, Jakubowska I, Jazwinska-Tarnawska E, Karczmarczyk A, Kitowska-Koterla J, Koltowski L, Krzyzagorska E, Pasternak D, Pentela-Nowicka J, Piesiewicz W, Przekwas-Jaruchowska M, Rajzer M, Salamon-Ferenc A, Sawicki A, Skowron T, Śmiałowski A, Tykarski A, Albota A, Alexandru C, Crisan C, Dumitrescu A, Ferariu IE, Lupusoru DA, Munteanu M, Negru D, Nicolau A, Pintiliei E, Popescu A, Serban G, Veresiu IA, Voitec M, Babenko A, Barbarash O, Bondar I, Chizhov P, Demin A, Dora S, Dreval A, Ershova O, Gratsiansky N, Ketova G, Kotelnikov M, Levashov S, Morugova T, Mustafina S, Pekarskiy S, Raskina T, Rechkova E, Samoylova Y, Sazonova O, Sherenkov A, Shilkina N, Stetsyuk O, Tretyakova T, Turova E, Valeeva F, Zadionchenko V, Dalan R, Tan RS, Tay L, Buganova I, Fabry J, Jan C, Krahulec B, Toserova E, Zak R, Zimanova J, Badat A, Bester F, Burgess L, De Jong D, Distiller L, Ellis G, Fouche L, Govender P, Govind U, Naidoo V, Nieuwoudt G, Nortje H, Rheeder P, Robertson L, Siddique N, Stapelberg AM, Trinder Y, Van Der Merwe A, Van Zyl L, Viljoen M, Wilhase A, Botella M, Civeira Murillo F, de Teresa L, Del Cañizo FJ, Extremera BG, Gimeno EJ, Martin-Hidalgo A, Morales C, Nubiola A, Rovira A, Tinahones Madueño F, Tranche S, Trescolí Serrano C, Alvarsson M, Eizyk E, Gillblad A, Johansson P, Löndahl M, Ohlsson-Önerud Å, Rautio A, Sundström U, Torstensson I, Chen JF, Chou CW, Chuang LM, Ho LT, Hsieh IC, Huang BH, Huang CL, Huang CN, Lai WT, Lo PH, Pei D, Sheu WH, Wang SY, Araz M, Bakiner O, Comlekci A, Delibasi T, Guler S, Sahin I, Sarac F, Tarkun I, Ukinc K, Yilmaz M, Abdulhakim E, Abraham P, Adamson K, Adler A, Blagden M, Bundy C, Daly M, Davies M, Deshpande M, Gillings S, Harvey P, Horvathova V, Horvathova V, Hristova D, Jaap A, Johnson A, Jones H, Kerrane J, Kilvert A, Ko T, Kumar J, Lindsay R, Litchfield J, McCrimmon R, McKnight J, Millward B, Oyesile B, Purewal T, Ravikumar C, Robinson A, Sathyapalan T, Simpson H, Thomas H, Turner W, Weaver J, Wilding J, Wiles P, Adkins K, Akpunonu B, Albu J, Anagnostis G, Anastasi L, Argoud G, Aroda V, Azizad M, Banerji MA, Bartkowiak A Jr, Bays H, Behn P, Bergenstal R, Bhargava A, Bias D, Bolster E, Buchanan P, Busch R, Chadha C, Chang M, Cheng C, Cohen A, Cohen J, Cole B, Connery L, Cooperman M, Cushman W, DAgostino R, Davies M, Dayamani P, De Lemos J, De Meireles M, Dean J, DeHart D, Detweiler R, Donovan D, Dugano-Daphnis P, Dulin M, Dunn F, Eaton C, Erickson B, Estevez R, Feinglos M, Fonseca V, Force R, Forker A, Fox D, Gabriel J, Garcia R, Garvey T, Gaudiani L, Getaneh A, Goff D, Goldberg A, Goldman S, Hairston K, Harris R, Haught W, Hidalgo H Jr, Higgins A, Houchin V, Ison R, Jacobs G, Jaffrani N, Jafry B, Kapsner P, Kaye W, Labroo A, Levinson L, Lewis S, Lillestol M, Luttrell L, Madu I, McNeill R, Merrick B, Metzger F, Nadar V, Nagelberg S, Nash S, Oparil S, Osei K, Papademetriou V, Patel N, Pedley C, Prentiss A, Radbill M, Raisinghani A, Rassouli N, Reddy R, Rees P, Rendell M, Robbins D, Rodbard H, Rohlf J, Roseman H, Rudolph L, Sadler L, Schnall A, Schramm R, Schubart U, Seneviratne T, Shanik M, Snyder H, Sorli C, Stich M, Sweeney ME, Tsao J, Ukwade P, Viswanath D, Vo A, Vogel C, Voyce S, Weintraub H, White J, Wood M, Wu P, Wysham C, Zimmerman R
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Oral ,medicine.medical_specialty ,Heart diseases ,Glycosylated ,Administration, Oral ,heart failure ,Type 2 diabetes ,Dipeptidyl peptidase-4 inhibitor ,Kaplan-Meier Estimate ,Placebo ,Sitagliptin Phosphate ,Sitagliptin, Cardiovascular Outcomes ,chemistry.chemical_compound ,Drug Therapy ,Double-Blind Method ,Internal medicine ,Diabetes Mellitus ,medicine ,Humans ,Hypoglycemic Agents ,Glycated Hemoglobin ,Hemoglobin A, Glycosylated ,Cardiovascular Diseases ,Diabetes Mellitus, Type 2 ,Drug Therapy, Combination ,Follow-Up Studies ,Heart Diseases ,Heart Failure ,Hospitalization ,Pyrazines ,Triazoles ,Medicine (all) ,business.industry ,Semaglutide ,Hemoglobin A ,General Medicine ,ta3121 ,medicine.disease ,Surgery ,Cardiovascular diseases ,chemistry ,Sitagliptin ,Administration ,Combination ,Glycated hemoglobin ,business ,Type 2 ,Alogliptin ,medicine.drug - Abstract
BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to-0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P
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- 2015
5. INFLUENCES ON SERIOUSLY ILL PATIENTS' MEDICAL DECISIONS
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Bito, S, Wenger, NS, Connors, AF, Phillips, RS, Desbiens, N, Califf, RM, Lynn, J, Liu, HH, and Oye, RK
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- 1996
6. ACUTE EXACERBATION OF SEVERE HEART FAILURE: HOSPITAL AND LONG TERM OUTCOMES
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Jaagosild, P, Dawson, NV, Connors, AF, Jr, Thomas, C, Califf, RM, Goldman, L, Vidaillet, H, Knaus, WA, and Wenger, NS
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- 1996
7. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes
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Holman, Rr, Bethel, Ma, Mentz, Rj, Thompson, Vp, Lokhnygina, Y, Buse, Jb, Chan, Jc, Choi, J, Gustavson, Sm, Iqbal, N, Maggioni, Ap, Marso, Sp, Öhman, P, Pagidipati, Nj, Poulter, N, Ramachandran, A, Zinman, B, Hernandez, Af, EXSCEL Study Group, : Califf RM, Patel, R, George, J, Sourij, H, Wong, Yw, Hannan, K, Sellers, Ma, Gottlieb, P, Lavender, P, Leloudis, D, Meadows, Y, Larson, D, Anderson, H, Elkins, M, Stone, A, Tisch, A, Perkins, L, Sanders, K, Campbell, C, Kennedy, I, Heal, P, Masterson, M, Darbyshire, J, Mumtaz, L, Athwal, R, Ferch, A, Batra, P, Durborow, L, Vincent, J, Woodall, A, Flanagan, T, Katona, B, Reicher, B, Pozzi, E, Oulhaj, A, Coleman, R, Rouleau, Jl, Pocock, Sj, Gorelick, F, Mcmurray, J, Riddle, M, Gagel, R, Collier, T, Markovic, T, Kong, Aps, Hian, Sk, Scott, R, Panelo, A, Yoon, Kh, Sheu, W, Sritara, P, Linong, J, Pan, C, Yong, H, Schernthaner, G, Mathieu, C, Tankova, T, Widimsky, P, Hanefeld, M, Keltai, M, Wainstein, J, del Prato, S, Pirags, V, Jakuboniene, N, Kooy, A, Dziemidok, P, Veresiu, Ia, Dreval, Av, Murin, J, Torello, Al, Sattar, N, Parkhomenko, O, Omar, M, Diaz, R, Lopes, R, Lanas, F, Urina Triana, M, Leiva-Pons, Jl, Aguliera, D, Bergenstal, R, Goodman, S, Yale, Jf, Caterson, I, Weng, J, Hu, D, Junbo, G, Zannad, F, Anoop, M, Ambrish, M, Gallegos, Ja, Green, Jb, Akerblom, A, Alexander, K, Al-Khatib, S, Armaganijan, L, Barros, P, Batit, M, Bernacki, G, Bernandez, S, Bloomfield, G, Clausen, E, De Souza Brito, F, Devore, A, Dombrowski, K, Eapen, Z, Gellad, Z, George, D, Guimaraes, P, Halim, S, Harrison, R, Hawes, J, Hess, C, Hyland, K, Jackson, L, Jones, S, Jordan, D, Katz, M, Kong, D, Koshizaka, M, Lakey, W, Leblanc, T, Leonardi, S, Luo, N, Mahaffey, K, Mandawat, A, Mehta, R, Melloni, C, Morse, M, Pagidpati, N, Patel, C, Patel, K, Pokorney, S, Posvic, T, Rao, M, Roe, M, Shah, B, Tillmann, H, Truffa, A, Zazula, A, Zeitler, E, Sicer, M, Ulla, Mr, Maffei, L, Klyver, Mi, Calella, P, Alvarisqueta, A, De La Fuente RL, Aizenberg, D, Roque, F, Cruciani, A, Frechtel, G, Gelersztein, E, Villarino, A, Mallagray, M, Nardone, L, Zaidman, C, Novaretto, L, Bartolacci, I, de Salvo, M, Delcourt, C, Crimmins, D, Jackson, R, O’Neal, D, Colman, P, Jeffries, W, Mah, Pm, Wittert, G, Proietto, J, Amerena, J, Marks, S, Tan, R, Colquhoun, D, Pieber, T, Drexel, H, Prager, R, Schnack, C, Hoppichler, F, Fasching, P, Francesconi, C, Luger, A, Schoenherr, Hr, Ebenbichler, C, Paulweber, B, Shernthaner, G, Verhaegen, A, Vanuytsel, J, Thissen, Jp, e Silva P, Barros, Gonzaga, C, Borges, J, Hissa, M, Rea, R, Rossi, P, Chacra, A, Eliaschewitz, F, Garbelini, B, Felicio, J, Rassi, N, Rossi, F, Nunes dos Santos, M, e Farias F, Bandeira, Lisboa, H, e Forti A, Costa, Saraiva, Jk, Kovacheva, S, Levterov, G, Sheinkova, G, Ilieva, E, Lyubenova, L, Damyanova, V, Gushterova, V, Mincheva, L, Illiev, D, Ivanov, V, Bobeva, R, Nikitov, Z, Shumkova, R, Lefterov, In, Zaharieva, S, Videva, V, Yakov, A, Cheung, S, Elliott, T, Mehta, P, Ross, S, Sigal, R, Woo, V, Jaffer, S, Kuritsky, R, Bell, A, Dumas, R, Gosselin, G, Robitaille, Y, Greenspoon, A, Lochnan, H, Tytus, R, Leiter, L, Pandey, A, Punthakee, Z, Dube, F, Sigalas, J, Pearce, M, Woodford, T, Paul, P, Bourgeois, R, Conway, R, Mazza, G, Hatheway, R, Misterski, J, Raffo, C, Olivares, C, Godoy, J, Potthoff, S, Santibañez, C, Larenas Yanez GJ, Gu, W, Shen, F, Ma, J, Guo, X, Li, Q, Du, Y, Hu, J, Ji, L, Li, Y, Deng, H, Feng, Y, Liu, L, Mu, Y, Ma, C, Qu, S, Wang, J, Wang, Y, Yuan, Z, Zhang, L, Zhou, S, Yang, T, Dong, Y, Liu, D, Coronel Arroyo, J, Perez Amador, G, Botero Lopes, R, Jaramilo, C, Orozco Linares, A, Cure Cure CA, Hernandez Triana, E, Molina de Salazar DI, Marin, Cr, Jaramilo Gomez CJ, Kellinerova, I, Adamkova, V, Krami, P, Brychta, T, Havelkova, J, Pantikova, K, Schoper, F, Pohl, W, Schumm-Draeger, Pm, Julius, U, Tschöpe, D, Hamann, A, Seissler, J, Schellong, S, Rose, L, Becker, B, Linn, T, Oerter, Em, Strotmann, Hj, Mölle, A, Pfutzner, A, Forst, T, Schäufele, T, Mugge, A, Lehrke, M, Meyer-Pannwitt, U, Mehling, H, Simon-Wagner, I, Schenkenberger, I, Busch, K, Hermes, S, Milek, K, Landers, B, Grueneberg, M, Braun, M, Nothroff, J, Kamke, W, Hergdt, G, Duengen, Hd, Kleinertz, K, Kuesters, D, Boenninghoff, Ah, Appel, Kf, Schaefer, A, Bieler, T, Ozaki, R, Luk, Aoy, Chu, Dw, Cheung-Wong, Mm, Siu, Dc, Yan, Bpy, Kung, K, Wong, Sys, Tsang, Cc, Yeung, Vt, Cheung, Bm, Tse, Hf, Hodi, G, Nagy, K, Lippai, J, Takacs, J, Fulop, T, Gaal, Z, Pauker, Z, Foldesi, I, Simon, J, Oroszan, T, Futo, L, Bezzegh, K, Nagy, A, Vandorfi, G, Kiss, J, Kesmarki, N, Kis, E, Papp, A, Kovacs, A, Szakal, I, Palinkas, A, Czegany, Z, Voros, P, Reiber, I, Kerenyi, Z, Dezso, E, Wittman, I, Penzes, J, Ples, Z, Taller, A, Farago, K, Kis, Jt, Zilahi, Z, Molnar, M, Barkai, L, Mileder, M, Szentpeteri, I, Peterfai, E, Lovasz, O, Mosenzon, O, Minuchin, O, Jaffe, A, Vishlitsky, V, Shimon, I, Bashkin, A, Stern, N, Elias, N, Bental, T, Butnaru, A, Lewis, B, Adawi, F, Nseir, W, Klainman, E, Herskovits, T, Cignarelli, M, Rotella, Cm, Ambrosio, G, Pozzilli, P, Genovese, S, Cavarape, A, Salvioni, A, Sokolova, J, Strautina, I, Teterovska, D, Stalte, V, Pastare, S, Leitane, I, Lagzdina, L, Andersone, I, Eglite, R, Stelmane, I, Levinger, A, Barsiene, L, Sulskiene, M, Varanauskiene, E, Danyte, E, Urbanaviciene, E, Urbanavicius, V, Zabuliene, L, Juskiene, R, Velaviciene, A, Kakariekiene, V, Augusteniene, A, Velickiene, D, Lasiene, J, Dauksiene, D, Caponis, J, Tan, At, Ramanathan, L, Hassan, Mra, Tan, F, Ong, Tk, Foo, Sh, Ghani, Ra, Cheah, Wk, Sanchez Mijangos JH, Cabrera Jardines, R, Barrientos Perez, M, Sauque Reyna, L, Alcocer Gamba MA, Villeda Espinosa, E, Tamez Perez HE, De La Garza Hernandez NE, Lopes, Sm, Ramirez Diaz SP, Reyes Sanchez, R, Márquez-Rodriguez, E, Köse, V, Voors-Pette, C, Oldenburg-Ligtenberg, Pc, van Kempen WW, Cox, K, Hoogendyk, J, Swinkels-Diepenmaat, L, Rojas-Lingan, G, Kentgens, S, Schipperen, S, de Valk HW, Swart, H, van Bemmel, B, Hoogslag, Pam, Diamant, M, Serné, Eh, Hamer, A, Wilson, S, Fisher, N, Dixon, P, Chaudhri, O, Crawford, V, Quinn, D, Nirmalaraj, K, Dunn, P, Gillies, J, Cutfield, R, Krebs, J, Helm, C, Kerr, J, Pryke, J, Ebo, G, Denopol, M, Ang, E, Uy, N, Jimeno, C, Mirasoi, R, Paz Pacheco, E, Custodio, M, Nicodemus, N Jr, Catindig, Ea, Magno, M, Tirador, L, Cylkowska, B, Stasinksa, T, Silwinska, T, Sroka, M, Piepiorka, M, Korzeniak, R, Mirecka, H, Zaluska, R, Pupek-Musialik, D, Homenda, W, Grabowska, A, Okopien, B, Niegowska, J, Pogorzelska, H, Mikolajczyk-Swatko, A, Sikorski, M, Sowinski, D, Tahk, Sj, Kim, Yn, Nam, Cw, Rim, Sj, Kim, Cj, Choi, Km, Lee, Ik, Kim, Ij, Namgung, J, Moon, Kw, Kim, Ks, Oh, Bh, Lee, Wy, Choi, Sh, Kim, Es, Moon, S, Mindrescu, Nm, Aron, G, Graur, M, Hancu, N, Mlitaru, C, Nafornita, V, Szilagyi, I, Popa, Ar, Angelescu, Lm, Negrisanu, Gd, Zaharie, Dg, Culman, Mi, Vacaru, G, Munteanu, M, Constantinescu, S, Tivadar, S, Dreval, A, Barbarash, O, Strongin, L, Dogadin, S, Suplotova, L, Izmozherova, N, Marasaev, V, Khokhlov, A, Repin, A, Turova, E, Bondar, I, Samoylova, Y, Sherenkov, A, Smolenskaya, O, Zrahevskiy, K, Koshelskaya, O, Obrezan, A, Dzupina, A, Stevlik, J, Buganova, I, Pella, D, Vinanska, D, Jascur, J, Micko, K, Sosovec, D, Philippiova, A, Olexa, P, Fedacko, J, Selecky, J, Nicolau, J, Mediavilla Garcia, J, Botella Serrano, M, Lecube, A, Arguelles, I, Sabán, J, Gómez Cerezo, F, Soto, A, Bellido, D, Sucunza Alfonso, N, Vendrell Ortega, J, Alvarez, L, Garcia Puig, J, Angustias Quesada, M, Contreras Gilbert, J, Almeida, Ca, Tinahones, Fj, Garcia Ortiz, L, Gómez Marcos MA, Aomar, I, Fernández Balsells, M, Distiller, L, Padayachee, T, Badat, A, Ebrahim, I, Naiker, P, Ranjith, N, Kelfkens, Y, Makan, H, Mogashoa, S, Fulat, M, Carim-Ganey, N, Coetzee, K, Govender, T, Nortje, H, Wilhase, A, Seedat, S, Gani, M, Ellis, G, Rheeder, P, Wing, J, Blignaut, S, Kaplan, H, Lottering, H, Pillai, P, Louw, C, Coetzer, T, Sheu, Whh, Chen, Jf, Yang, Cy, Tseng, St, Wang, Cy, Lai, Wt, Hung, Yj, Hsieh, Ic, Su, Sl, Pei, D, Benjasuratwong, Y, Purewal, T, Milward, A, Dimitropoulos, I, Kumar, S, Barber, T, Wiles, P, Dang, C, Adler, A, Philip, S, Bellary, S, Price, D, Oelbaum, R, Heller, S, Sathayapalan, T, Clark, J, Leese, G, Simpson, H, Kilvert, A, Dawson, A, Hall, T, Takhar, A, Bundy, C, Harvey, P, Maxwell, S, Asamoah-Owusu, Nj, Mcknight, J, Chatterjee, S, Calvert, J, Wright, A, Macrury, S, Macfarlane, D, Johnson, A, Litchfield, J, Field, B, Koval, O, Larin, O, Levchenko, O, Martynyuk, L, Maslyanko, V, Rudyk, I, Suprun, Y, Tseluyko, V, Botsyurko, V, Vatutin, M, Fushtey, I, Grishyna, O, Kuskalo, P, Panina, S, Pererva, L, Prysupa, L, Teliatnikova, Z, Sokolova, L, Vlasenko, M, Berenfus, V, Gyrina, O, Kopytsya, M, Vizir, V, Vayda, M, Shanik, M, Headapohl, D, Pahl, J, Aronoff, S, Bartkowiak, A Jr, Chang, A, Gaudiani, L, Kayne, D, Look, M, Patel, N, Moran, J, Stout, E, Tsao, J, Struble, R, Fishman, N, Rodbard, H, Lucas, K, Dugano-Daphnis, P, Merrick, B, Nadar, V, Severa, L, Sorli, C, Chang, M, Reed, J III, Grunberger, G, Bain, C, Bestermann, W Jr, Morawski, E, White, J, Azizad, M, Ukwade, P, Anekwe, A, Jimenez, A, Weiss, D, Green, S, Overcash, J, Eaton, C, Roseman, H, Soler, N, Mikell, F, Manos, P, Levinson, L, Claxton, E Jr, Weiss, R, Argoud, G, Bickel, L, Wilson, J, Short, B, Webster, B, Mcneill, R, Schnall, A, Force, R, Phillips, L, Bybee, K, Forker, A, Denham, D, Vonderhaar, T, Pullman, J, Kruger, D, Whitehouse, F, Wysham, C, Baron, M, Kravitz, A, Dushkin, H, Manning, Mb, Wine, A, Jaffrani, N, Chadha, C, Sperl-Hillen, J, Busch, R, Estevez, R, Robbins, D, Rassouli, N, Garvey, T, Oparil, S, Eckel, R, Mcdermott, M, Rasouli, N, Mcgill, J, Corder, C, Klonoff, D, Mills, R, Earl, J, Kessel, J, Cuddihy, R, Zimmerman, R, Dayamani, P, Oral, E, Zimering, M, Marks, J, Farnsworth, K, Sugimoto, D, Toth, P, Bhargava, A, Mcguire, D, Rohatgi, A, Davies, M, Peden, E, Wyne, K, Alfonso, L, Seyoum, B, Akpunonu, B, Feinglos, M, Reaven, P, Soule, J, Luttrell, L, Schactman, B, Canadas, R, Boggs, B, Abbott, L, Herring, C, Roberts, L, Hage-Korban, E, Schubart, U, Taylon, A, Tannenbaum, A, Kingsley, J, Lenhard, J, Biscoveanu, M, Cohen, J, Donovan, D, Laferrere, B, Thompson, N, Wade, T, Detweiler, R, Henson, B, White, A, Cavale, A, Ravi, C, Thomas, A, Goodman, H, Kalen, V, Fox, D, Dauber, I, Rizvi, S, Marcus, A, Mulford, M, Higgins, A, Chane, M, Bland, V, Osunkoya, A, Suresh, D, Khan, S, Anastasi, L, Bajaj, M, Eisen, H, Mudaliar, Sr, Powell, S, Carr, K, Tripathy, D, Azad, N, Wakefield, P, Acheatel, R, Bressler, P, Dean, J, El Shahawy, M, Gilbert, J, Haque, I, Humiston, D, Ison, R, Karounos, D, Lillestol, M, Ferrier, N, Labroo, A, Vo, A, D’Agostino, R, Dulin, M, Mcwilliams, A, Hargrove, J, Blumberg, E, Jackson, B, Staniloae, C, Salacata, A, Hidalgo, H Jr, Nicol, P, Digiovanna, M, Soufer, J, Mahabadi, V, Akinboboye, O, Arauz-Pacheco, C, Neutel, J, Dungan, K, Benson, M, Powell, T, Gandy, W, Rovner, S, Berk, M, Khan, A, Ledesma, G, Madu, I, Erickson, B, Radbill, M, Graves, M, Kaczmarek, G, Giep, S, Baldauf, C, Golden, G, Lesh, K, Davis, C, Godbole, N, Kirby, W, Razzaque, N, Bhatt, B, Wilson, M., Internal medicine, ACS - Diabetes & metabolism, and ACS - Microcirculation
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Male ,medicine.medical_specialty ,EXSCEL Study Group ,Injections, Subcutaneous ,030209 endocrinology & metabolism ,Type 2 diabetes ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,Placebo ,Article ,Drug Administration Schedule ,GLP1-agonists ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Interquartile range ,Internal medicine ,Diabetes mellitus ,General & Internal Medicine ,medicine ,Humans ,Hypoglycemic Agents ,Least-Squares Analysis ,Aged ,Glycated Hemoglobin ,business.industry ,Venoms ,Semaglutide ,Incidence ,Type 2 diabetes, GLP1-agonists, exenatide, cardiovascular effects ,General Medicine ,11 Medical And Health Sciences ,Middle Aged ,medicine.disease ,Surgery ,Albiglutide ,Editorial ,Diabetes Mellitus, Type 2 ,Cardiovascular Diseases ,Exenatide ,Dulaglutide ,Female ,business ,Peptides ,cardiovascular effects ,medicine.drug - Abstract
BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P
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- 2017
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8. Relations between Baseline Physical Activity by Pedometer Counts and Future Cardiovascular Events in the NAVIGATOR Study
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Kraus, WF, Califf, RM, Tuomilehto, J, Sun, J-L, Thomas, L, Yates, T, Davies, M, Holman, R, McMurray, JJ, Bethel, A, and Haffner, SM
- Published
- 2016
9. Rationale and design of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS)
- Author
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Bethel, MA, Green, J, Califf, RM, and Holman, RR
- Published
- 2016
10. Risk factors for fatal and non-fatal cardiovascular events in 9306 subjects in the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial
- Author
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Mcmurray, JJV, Laakso, M, Standl, E, Tognoni, G, Holman, RR, Giles, T, Martinez, F, Thomas, L, Haffner, SM, and Califf, RM
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- 2016
11. People at increased risk of cardiovascular disease screened for the NAVIGATOR trial frequently have undiagnosed diabetes or impaired glucose tolerance
- Author
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Califf, RM, Holman, R, and Comm, NTS
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- 2016
12. Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes
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Giugliano, Rp, White, Ja, Bode, C, Armstrong, Pw, Montalescot, G, Lewis, Bs, VAN 'T HOF, A, Berdan, Lg, Lee, Kl, Strony, Jt, Hildemann, S, Veltri, E, VAN DE WERF, F, Braunwald, E, Harrington, Ra, Califf, Rm, Newby, Lk, and Berni, Andrea
- Subjects
medicine.medical_specialty ,Acute coronary syndrome ,medicine.diagnostic_test ,business.industry ,Unstable angina ,medicine.medical_treatment ,Placebo-controlled study ,General Medicine ,medicine.disease ,Pharmacotherapy ,Angioplasty ,Internal medicine ,Eptifibatide ,medicine ,Cardiology ,Myocardial infarction ,business ,Electrocardiography ,medicine.drug - Abstract
Background Glycoprotein IIb/IIIa inhibitors are indicated in patients with acute coronary syndromes who are undergoing an invasive procedure. The optimal timing of the initiation of such therapy is ...
- Published
- 2009
13. Case Study for Lean Management in the Public Sector: Improving Combination Product Review at the Food & Drug Administration
- Author
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Rappel, MJ, primary, Hunter, NL, additional, Alexandrow, AI, additional, Hair, KO, additional, Sherman, RE, additional, and Califf, RM, additional
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- 2017
- Full Text
- View/download PDF
14. Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation: Data From ROCKET AF
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Pokorney, SD, Piccini, JP, Stevens, SR, Patel, MR, Pieper, KS, Halperin, JL, Breithardt, G, Singer, DE, Hankey, GJ, Hacke, W, Becker, RC, Berkowitz, SD, Nessel, CC, Mahaffey, KW, Fox, KAA, Califf, RM, Pokorney, SD, Piccini, JP, Stevens, SR, Patel, MR, Pieper, KS, Halperin, JL, Breithardt, G, Singer, DE, Hankey, GJ, Hacke, W, Becker, RC, Berkowitz, SD, Nessel, CC, Mahaffey, KW, Fox, KAA, and Califf, RM
- Abstract
BACKGROUND: Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. METHODS AND RESULTS: In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intention-to-treat population. The median age was 73 years, and the mean CHADS2 score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51-1.90, P<0.0001) were associated with higher all-cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C-index 0.677). CONCLUSIONS: In a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival. CLINICAL TRIAL REGIST
- Published
- 2016
15. Does eptifibatide confer a greater benefit to patients with unstable angina than with non-ST segment elevation myocardial infarction? Insights from the PURSUIT trial
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Chang, W-C, Harrington, RA, Simoons, Maarten, Califf, RM, Lincoff, AM, Armstrong, PW, PURSUIT Investigators,, and Cardiology
- Subjects
Adult ,Male ,medicine.medical_specialty ,Acute coronary syndrome ,medicine.medical_treatment ,Myocardial Infarction ,Eptifibatide ,Infarction ,Angina ,Electrocardiography ,Sex Factors ,Risk Factors ,Internal medicine ,Angioplasty ,medicine ,Humans ,Angina, Unstable ,cardiovascular diseases ,Myocardial infarction ,Aged ,Probability ,Proportional Hazards Models ,Randomized Controlled Trials as Topic ,business.industry ,Unstable angina ,Age Factors ,Percutaneous coronary intervention ,Middle Aged ,Prognosis ,medicine.disease ,Survival Analysis ,Logistic Models ,Treatment Outcome ,Cardiology ,Female ,Peptides ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
Aims To evaluate the differential effects of eptifibatide therapy on unstable angina vs non-ST elevation myocardial infarction at enrollment, since the separate impact on these two major diagnostic subsets of acute coronary syndrome patients has not been fully investigated. Methods and Results We examined the 9461 patients in the PURSUIT trial (conducted between 1995 and 1997) to compare the effects of eptifibatide on unstable angina and myocardial infarction. The study showed greater and more consistent effects of eptifibatide therapy on unstable angina than non-ST elevation myocardial infarction in reducing 30-day death/(re)infarction (from the unadjusted rate of 13·0% to 11·2%, P =0·059 for unstable angina; and 18·9% to 17·9%, P =0·387 for myocardial infarction), especially among patients who underwent early percutaneous coronary intervention (odds ratios=0·49 and 0·86, 95% confidence intervals=0·30–0·80 and 0·53–1·42, respectively, for unstable angina and myocardial infarction). The only subgroup for whom the benefit of eptifibatide was not evident was female myocardial infarction patients who did not undergo early percutaneous coronary intervention. Conclusions These data suggest that eptifibatide benefited unstable angina patients more than myocardial infarction patients, especially among those who underwent early percutaneous coronary intervention, and support its use as concomitant therapy with early percutaneous coronary intervention especially in female myocardial infarction patients.
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- 2002
16. Discussion
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Califf Rm
- Subjects
medicine.medical_specialty ,Psychoanalysis ,business.industry ,Internal medicine ,media_common.quotation_subject ,Cardiology ,Medicine ,Conversation ,Cardiology and Cardiovascular Medicine ,business ,media_common - Published
- 1998
17. Rivaroxaban compared with warfarin in patients with atrial fibrillation and prior stroke or transient ischaemic attack: a prespecified subgroup analysis of the ROCKET AF trial
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Hankey, Gj, Patel, Mr, Stevens, Sr, Becker, Rc, Breithardt, G, Carolei, Antonio, Diener, H. C., Donnan, Ga, Halperin, Jl, Mahaffey, Kw, Mas, J. L., Massaro, A, Nessel, Cc, Paolini, Jf, Roine, R, Singer, De, Wong, L, Califf, Rm, Fox, Kaa, Hacke, W, on behalf of the ROCKET AF Steering Committee, and Investigators
- Published
- 2012
18. Geographic Variation in Clinical Course Among Patients Hospitalized for Acute Heart Failure: Insights From ASCEND-HF
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Metra, Marco, Hernandez, Af, Heizer, Gm, Clausell, N, Corbalan, R, Costanzo, Mr, Dunlap, Me, Ezekowitz, Ja, Howlett, Jg, Krum, H, Voors, Aa, Armstrong, Pw, Massie, Bm, Nieminen, Ms, Komajda, M, Mcmurray, Jj, Swedberg, K, Starling, Rc, O'Connor, Cm, Califf, Rm, and Teerlink, Jr
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- 2011
19. Baseline Cystatin C is Associated with Short-Term Adverse Events in Acute Heart Failure but Does Not Predict Treatment Effects with Nesiritide Therapy
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Tang, Whw, Felker, Gm, Hernandez, Af, Hsu, Ap, Gottlieb, Ss, Voors, Aa, Butler, J, Metra, Marco, Anker, Sd, Troughton, Rw, Mcmurray, Jj, Armstrong, Pw, Massie, Bm, Califf, Rm, O'Connor, Cm, and Starling, Rc
- Published
- 2011
20. High Sensitivity Troponin I in Acute Decompensated Heart Failure: Insights from the ASCEND-HF Study
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Felker, Gm, Tang, Whw, Hernandez, A, Hasselblad, V, Armstrong, Pw, Fonarow, Gc, Voors, Aa, Metra, Marco, Butler, J, Dickstein, K, Troughton, Rw, Anker, Sd, Heizer, Gm, Massie, Bm, Mcmurray, Jj, Califf, Rm, Starling, Rc, and O'Connor, Cm
- Published
- 2011
21. Exploration of rapid bedside monitoring of coagulation and fibrinolysis parameters during thrombolytic therapy
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Bovill Eg, N. J. Gresalfi, C. S. Greenberg, Califf Rm, Enney-O'Mara La, B. J. Oberhardt, and David C. Sane
- Subjects
medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Hemorrhage ,Pilot Projects ,Fibrinogen ,Tissue plasminogen activator ,Fibrin ,Internal medicine ,Fibrinolysis ,medicine ,Humans ,Thrombolytic Therapy ,Blood Coagulation ,Monitoring, Physiologic ,Prothrombin time ,biology ,medicine.diagnostic_test ,business.industry ,Hematology ,General Medicine ,Thrombolysis ,Surgery ,Coagulation ,Prothrombin Time ,biology.protein ,Cardiology ,Partial Thromboplastin Time ,Blood Coagulation Tests ,business ,circulatory and respiratory physiology ,medicine.drug ,Partial thromboplastin time - Abstract
Monitoring coagulation parameters during thrombolytic therapy could be useful for prediction and treatment of haemorrhagic episodes. Technology based on dry reagent chemistry has been developed that allows rapid (less than 10 min) assays on small samples of whole blood. The assay principle is based on the restriction of motion of paramagnetic particles during fibrin polymerization, and subsequent liberation of particle motion during fibrinolysis. This technology was used to monitor prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen levels and fibrinolysis profiles during thrombolytic therapy with tissue plasminogen activator for acute myocardial infarction. The PT and aPTT obtained with the COAG-1 correlated well with conventional assays (r = 0.93 and 0.92 for PT and aPTT, respectively; p = 0.0001). Fibrinogen estimates, obtained by COAG-2 also correlated well with modified Clauss assays (r = 0.86, p = 0.0001). The rapid determination of the aPTT may improve management of adjunctive anticoagulant therapy following thrombolysis. The fibrinolysis profile may be useful during thrombolytic therapy to verify that a lytic state has been achieved, to monitor the lytic state throughout therapy, and to verify that the lytic state normalizes once therapy has been completed.
- Published
- 1992
22. Mortality and morbidity remain high despite captopril and/or valsartan therapy in elderly patients with left ventricular systolic dysfunction, heart failure, or both after acute myocardial infarction - Results from the Valsartan in Acute Myocardial Infarction Trial (VALIANT)
- Author
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White, HD, Aylward, PEG, Huang, Z, Dalby, AJ, Weaver, WD, Barvik, S, Marin-Neto, JA, Murin, J, Nordlander, RO, van Gilst, WH, Zannad, F, McMurray, JJV, Califf, RM, Pfeffer, MA, and Cardiovascular Centre (CVC)
- Subjects
RISK ,CONVERTING-ENZYME-INHIBITORS ,aging ,BLOCKER ,ACE-INHIBITORS ,CARE ,valsartan ,RANDOMIZED-TRIAL ,CANDESARTAN ,angiotensin-converting enzyme inhibitors ,captopril ,myocardial infarction ,ENALAPRIL ,SURVIVAL ,LOSARTAN - Abstract
Background - The elderly constitute an increasing proportion of acute myocardial infarction patients and have disproportionately high mortality and morbidity. Those with heart failure or impaired left ventricular left ventricular function after acute myocardial infarction have high complication and mortality rates. Little is known about outcomes with contemporary therapies in these patients. Methods and Results - The Valsartan in Acute Myocardial Infarction Trial ( VALIANT) randomized 14 703 patients with heart failure and/ or left ventricular ejection fraction = 85 ( n = 383) years. With increasing age, 3- year mortality almost quadrupled ( 13.4%, 26.3%, 36.0%, and 52.1%, respectively), composite end- point events more than doubled ( 25.2%, 41.0%, 52.3%, and 66.8%), and hospital admissions for heart failure almost tripled ( 12.0%, 23.1%, 31.3%, and 35.4%). Outcomes did not differ between the 3 study treatments in any age group. Adverse events associated with captopril and valsartan were more common in the elderly and in patients receiving combination therapy. With increasing age, use of aspirin, beta- blockers, and statins declined, and use of digoxin, calcium- channel blockers, and non - potassium- sparing diuretics increased. On 3- year multivariable analysis, each 10- year age increase was associated with a hazard ratio of 1.49 ( 95% CI, 1.426 to 1.557; P
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- 2005
23. Six-month outcomes of percutaneous coronary balloon angioplasty in acute coronary syndromes: Results from the PURSUIT trial
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Labinaz, M, Kaul, P, Harrington, RA, Chang, W-C, Kleinman, NS, Simoons, Maarten, Boersma, Eric, Akkerhuis, Martijn, Califf, RM, Armstrong, PW, PURSUIT Investigators,, and Cardiology
- Published
- 2004
24. Early angioplasty in acute coronary syndromes without persistent ST-segment elevation improves outcome but increases the need for six-month repeat revascularization - An analysis of the PURSUIT trial
- Author
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Ronner, E, Boersma, Eric, Laarman, GJ (GertJan), Somsen, GA, Harrington, RA, Deckers, Jaap, Topol, EJ, Califf, RM, Simoons, Maarten, and Cardiology
- Published
- 2002
25. Systematic adjudication of myocardial infarction end-points in an international clinical trial
- Author
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Mahaffey, KW, Harrington, RA, Akkerhuis, Martijn, Kleiman, NS, Berdan, LG, Crenshaw, BS, Tardiff, BE, Granger, CB, DeJong, I, Bhapkar, M, Widimsky, P, Corbalon, R, Lee, KL, Deckers, Jaap, Simoons, Maarten, Topol, EJ, Califf, RM, PURSUIT Investigators,, and Cardiology
- Published
- 2001
26. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study
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Mahaffey, KW, Harrington, RA, Akkerhuis, Martijn, Kleiman, NS, Berdan, LG, Crenshaw, BS, Tardiff, BE, Granger, CB, DeJong, I, Bhapkar, M, Widimsky, P, Corbalon, R, Lee, KL, Deckers, Jaap, Simoons, Maarten, Topol, EJ, Califf, RM, PURSUIT Investigators,, and Cardiology
- Published
- 2001
27. Therapeutic value of eptifibatide at community hospitals transferring patients to tertiary referral centers early after admission for acute coronary syndromes. PURSUIT Investigators
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Greenbaum, AB, Harrington, RA, Hudson, MP, MacAulay, CM, Wilcox, RG, Simoons, Maarten, Berdan, LG, Guerci, A, Cokkinos, DV, Kitt, MM, Lincoff, AM, Topol, EJ, Califf, RM, Ohman, EM, PURSUIT Investigators,, and Cardiology
- Published
- 2001
28. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF
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Hankey, GJ, Patel, MR, Stevens, SR, Becker, RC, Breithardt, G, Carolei, A, Diener, H-C, Donnan, GA, Halperin, JL, Mahaffey, KW, Mas, J-L, Massaro, A, Norrving, B, Nessel, CC, Paolini, JF, Roine, RO, Singer, DE, Wong, L, Califf, RM, Fox, KAA, Hacke, W, Hankey, GJ, Patel, MR, Stevens, SR, Becker, RC, Breithardt, G, Carolei, A, Diener, H-C, Donnan, GA, Halperin, JL, Mahaffey, KW, Mas, J-L, Massaro, A, Norrving, B, Nessel, CC, Paolini, JF, Roine, RO, Singer, DE, Wong, L, Califf, RM, Fox, KAA, and Hacke, W
- Abstract
BACKGROUND: In ROCKET AF, rivaroxaban was non-inferior to adjusted-dose warfarin in preventing stroke or systemic embolism among patients with atrial fibrillation (AF). We aimed to investigate whether the efficacy and safety of rivaroxaban compared with warfarin is consistent among the subgroups of patients with and without previous stroke or transient ischaemic attack (TIA). METHODS: In ROCKET AF, patients with AF who were at increased risk of stroke were randomly assigned (1:1) in a double-blind manner to rivaroxaban 20 mg daily or adjusted dose warfarin (international normalised ratio 2·0-3·0). Patients and investigators were masked to treatment allocation. Between Dec 18, 2006, and June 17, 2009, 14 264 patients from 1178 centres in 45 countries were randomly assigned. The primary endpoint was the composite of stroke or non-CNS systemic embolism. In this substudy we assessed the interaction of the treatment effects of rivaroxaban and warfarin among patients with and without previous stroke or TIA. Efficacy analyses were by intention to treat and safety analyses were done in the on-treatment population. ROCKET AF is registered with ClinicalTrials.gov, number NCT00403767. FINDINGS: 7468 (52%) patients had a previous stroke (n=4907) or TIA (n=2561) and 6796 (48%) had no previous stroke or TIA. The number of events per 100 person-years for the primary endpoint in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (2·79% rivaroxaban vs 2·96% warfarin; hazard ratio [HR] 0·94, 95% CI 0·77-1·16) and those without (1·44%vs 1·88%; 0·77, 0·58-1·01; interaction p=0·23). The number of major and non-major clinically relevant bleeding events per 100 person-years in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (13·31% rivaroxaban vs 13·87% warfarin; HR 0·96, 95% CI 0·87-1·07) and those without (16·69%vs 15·19%; 1·10, 0·99-1·21; interaction p=0·08
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- 2012
29. Geographic variability in outcomes within an international trial of glycoprotein IIb/IIIa inhibition in patients with acute coronary syndromes
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Akkerhuis, Martijn, Deckers, Jaap, Boersma, Eric, Harrington, RA, Stepinska, J, Mahaffey, KW, Wilcox, RG, Lincoff, AM, Keltai, M, Topol, EJ, Califf, RM, Simoons, Maarten, PURSUIT Investigators,, and Cardiology
- Published
- 2000
30. Predictors of outcome in patients with acute coronary syndromes without persistent ST-segment elevation
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Boersma, Eric, Pieper, KS, Steyerberg, Ewout, Wilcox, RG, Chang, W-C, Lee, KL, Akkerhuis, Martijn, Harrington, R, Deckers, Jaap, Armstrong, PW, Lincoff, AM, Califf, RM, Topol, EJ, Simoons, Maarten, PURSUIT Investigators,, Cardiology, and Public Health
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- 2000
31. Early percutaneous coronary intervention, platelet inhibition with eptifibatide, and clinical outcomes in patients with acute coronary syndromes
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Kleiman, NS, Lincoff, AM, Flaker, GC, Pieper, KS, Wilcox, RG, Berdan, LG, Lorenz, TJ, Cokkinos, DV, Simoons, Maarten, Boersma, Eric, Topol, EJ, Califf, RM, Harrington, RA, PURSUIT Investigators,, and Cardiology
- Published
- 2000
32. Management of patients with acute coronary syndromes in the United States by platelet glycoprotein IIb/IIIa inhibition
- Author
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Lincoff, AM, Harrington, RA, Califf, RM, Hochman, JS, Guerci, AD, Ohman, EM, Pepine, CJ, Kopecky, SL, Kleiman, NS, Pacchiana, CM, Berdan, LG, Kitt, MM, Simoons, Maarten, Topol, EJ, PURSUIT Investigators,, and Cardiology
- Published
- 2000
33. Effects of stroke on medical resource use and costs in acute myocardial infarction
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Tung, CY, Granger, CB, Sloan, MA, Topol, EJ, Knight, JD, Weaver, WD, Mahaffey, KW, White, HD, Clapp-Channing, N, Simoons, Maarten, Gore, JM, Califf, RM, Mark, DB, GUSTO Investigators, THE, and Cardiology
- Published
- 1999
34. Stroke in patients with acute coronary syndromes. Incidence and outcomes in the platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using integrilin therapy (PURSUIT) trial
- Author
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Mahaffey, KW, Harrington, R, Simoons, Maarten, Granger, CB, Graffagnino, C, Alberts, MJ, Laskowitz, DT, Miller, JM, Sloan, MA, Berdan, LG, Mac Aulay, CM, Lincoff, AM, Deckers, Jaap, Topol, EJ, Califf, RM, PURSUIT Investigators,, and Cardiology
- Published
- 1999
35. Clinical significance of thrombocytopenia during a non-ST-elevation acute coronary syndrome. The platelet glycoprotein IIb/IIIa in unstable angina: receptor suppression using integrilin therapy (PURSUIT) trial experience
- Author
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Mc Clure, MW, Berkowitz, SD, Sparapani, R, Tuttle, R, Kleiman, NS, Berdan, LG, Lincoff, AM, Deckers, Jaap, Diaz, R, Karsch, KR, Gretler, D, Kitt, M, Simoons, Maarten, Topol, EJ, Califf, RM, Harrington, RA, PURSUIT Investigators,, and Cardiology
- Published
- 1999
36. Neurosurgical evacuation of intracranial hemorrhage after thrombolytic therapy for acute myocardial infarction: experience from the GUSTO-1 trial
- Author
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Mahaffey, KW, Granger, CB, Sloan, MA, Green, CL, Gore, JM, Weaver, WD, White, HD, Simoons, Maarten, Barbash, GI, Topol, EJ, Califf, RM, GUSTO Investigators, THE, and Cardiology
- Published
- 1999
37. Prior aspirin use predicts worse outcomes in patients with non-ST-elevation acute coronary syndromes
- Author
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Alexander, JH, Harrington, RA, Tuttle, R, Berdan, LG, Lincoff, AM, Deckers, Jaap, Simoons, Maarten, Guerci, A, Hochman, JS, Wilcox, RG, Kitt, M, Eisenberg, PR, Califf, RM, Topol, EJ, Karsch, KR, Ruzyllo, W, Stepinska, J, Widimsky, P, Boland, JB, Armstrong, PW, PURSUIT Investigators,, and Cardiology
- Published
- 1999
38. Prevention of diabetes and cardiovascular disease in patients with impaired glucose tolerance : rationale and design of the Nateglinide And Valsartan in impaired Glucose Tolerance Outcomes Research (NAVIGATOR)
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Califf, RM, Boolell, M, Sandström, Herbert et al, Califf, RM, Boolell, M, and Sandström, Herbert et al
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- 2008
39. Prediction of 30-day mortality among patients with thrombolysis-related intracranial hemorrhage
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Sloan, MA, Sila, CA, Mahaffey, KW, Granger, CB, Longstreth, WT, Koudstaal, Peter, White, HD, Gore, JM, Simoons, Maarten, Weaver, WD, Green, CL, Topol, EJ, Califf, RM, GUSTO-1 Investigators,, Neurology, and Cardiology
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- 1998
40. Comprehensive cardiovascular medicine
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Topol, EJ, Califf, RM, Isner, JM, Prystowsky, EN, Serruys, PWJC (Patrick), Swain, JL, Thomas, JD, Thompson, PD, Young, JD, and Cardiology
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- 1998
41. Effects of platelet glycoprotein IIb/IIIa receptor blockers in non-ST segment elevation acute coronary syndromes: benefit and harm in different age subgroups
- Author
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Hernandez, AV (Adrián), Westerhout, CM, Steyerberg, Ewout, Ioannidis, JPA, Bueno, H, White, H, Theroux, P, Moliterno, DJ, Armstrong, PW, Califf, RM, Wallentin, LC, Simoons, Maarten, Boersma, Eric, Hernandez, AV (Adrián), Westerhout, CM, Steyerberg, Ewout, Ioannidis, JPA, Bueno, H, White, H, Theroux, P, Moliterno, DJ, Armstrong, PW, Califf, RM, Wallentin, LC, Simoons, Maarten, and Boersma, Eric
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- 2007
42. Selection of reperfusion therapy for individual patients with evolving myocardial infarction
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VanderWerf, F, Vahanian, A, Gulba, DC, Muller, J, Arnold, AER, Bar, F, Vermeer, F, Verheugt, FWA, Boersma, H, VanEs, GA, Deckers, JW, Lenderink, T, Simoons, ML, Steyerberg, E, VanderZwaan, C, deBoer, MJ, Zijlstra, F, Wilcox, RD, Sleight, P, Selker, HP, Califf, RM, Granger, C, Lee, KL, Ohman, ME, Weaver, DW, Love, T, White, H, Califf, R, and Collins, R
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- 1997
43. Perspectives on Large-Scale Cardiavascular Clinical Trials for the New Millenium
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Topol, EJ, Califf, RM, van der Werf, F, Simoons, Maarten, Hampton, J, Lee, KL, White, HD, Simes, J, Armstrong, PW, and Cardiology
- Published
- 1997
44. Selection of thrombolytic therapy for individual patients: development of a clinical model
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Califf, RM, Woodlief, LH, Harrell, FE, Lee, KL, White, HD, Guerci, A, Barbash, GI, Simes, J, Weaver, WD, Simoons, Maarten, and Cardiology
- Published
- 1997
45. High-risk patients with acute coronary syndromes treated with low-molecular-weight or unfractionated heparin - Outcomes at 6 months and 1 year in the SYNERGY trial
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UCL, Mahaffey, KW, Cohen, M., Garg, J, Antman, E., Kleiman, NS, Goodman, SG, Berdan, LG, Reist, CJ, Langer, A, White, HD, Aylward, PE, Col, JJ., Ferguson, JJ, Califf, RM., UCL, Mahaffey, KW, Cohen, M., Garg, J, Antman, E., Kleiman, NS, Goodman, SG, Berdan, LG, Reist, CJ, Langer, A, White, HD, Aylward, PE, Col, JJ., Ferguson, JJ, and Califf, RM.
- Abstract
Context The SYNERGY trial comparing enoxaparin and unfractionated heparin in high-risk patients with acute coronary syndromes (ACS) showed that enoxaparin was not inferior to unfractionated heparin in reducing death or nonfatal myocardial infarction (MI) at 30 days. Objective To evaluate continued risk in this patient cohort through 6-month and 1-year follow-up. Design, Setting, and Patients Overall, 9978 patients were randomized from August 2001 through December 2003 in 487 hospitals in 12 countries. Patients were followed up for 6 months and for 1 year. Main Outcome Measures Six-month outcomes were death, nonfatal MI, revascularization procedures, stroke, and site-investigator-reported need for rehospitalization; 1-year outcome was all-cause death. Results Six-month and 1-year follow-up data were available for 9957 (99.8%) and 9608 (96.3%) of 9978 patients, respectively; 541 patients (5.4%) had died at 6 months and 739 (7.4%) at 1 year. Death or nonfatal MI at 6 months occurred in 872 patients receiving enoxaparin (17.6%) vs 884 receiving unfractionated heparin (17.8%) (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.89-1.07; P = .65). In the subgroup of patients receiving consistent therapy, ie, only enoxaparin or unfractionated heparin during the index hospitalization (n = 6138), a reduction in death or nonfatal MI with enoxaparin was maintained at 180 days (HR, 0.85; 95% CI, 0.75-0.95; P = .006). Rehospitalization within 180 days occurred in 858 patients receiving enoxaparin (17.9%) and 911 receiving unfractionated heparin (19.0%) (HR, 0.94; 95% CI, 0.85-1.03; P = .17). One-year all-cause death rates were similar in the 2 treatment groups (380/4974 [7.6%] for enoxaparin vs 359/4948 [7.3%] for unfractionated heparin; HR, 1.06; 95% CI, 0.92-1.22; P = .44). One-year death rates in patients receiving consistent therapy were also similar (251/3386 [7.4%] for enoxaparin vs 213/2720 [7.8%] for unfractionated heparin; HR, 0.95; 95% CI, 0.79-1.14; P = .55). Con
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- 2005
46. Creatine kinase-MB elevation after percutaneous coronary intervention predicts adverse outcomes in patients with acute coronary syndromes
- Author
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Roe, MT, Mahaffey, KW, Kilaru, R, Alexander, JH, Akkerhuis, Martijn, Simoons, Maarten, Harrington, RA, Tardiff, BE, Granger, CB, Ohman, EM, Moliterno, DJ, Lincoff, AM, Armstrong, PW, van der Werf, F, Califf, RM, Topol, EJ, Roe, MT, Mahaffey, KW, Kilaru, R, Alexander, JH, Akkerhuis, Martijn, Simoons, Maarten, Harrington, RA, Tardiff, BE, Granger, CB, Ohman, EM, Moliterno, DJ, Lincoff, AM, Armstrong, PW, van der Werf, F, Califf, RM, and Topol, EJ
- Published
- 2004
47. Platelet glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: ameta-analysis of all major randomised clinical trials.
- Author
-
Boersma, E, Harrington, RA, Moliterno, DJ, White, H, Theroux, P, Van de Werf, F, de Torbal, A, Armstrong, PW, Wallentin, LC, Wilcox, RG, Simes, J, Califf, RM, Topol, EJ, Simoons, ML, Boersma, E, Harrington, RA, Moliterno, DJ, White, H, Theroux, P, Van de Werf, F, de Torbal, A, Armstrong, PW, Wallentin, LC, Wilcox, RG, Simes, J, Califf, RM, Topol, EJ, and Simoons, ML
- Published
- 2002
48. Patients with acute coronary syndromes without persistent ST elevation undergoing percutaneous coronary intervention benefit most from early intervention with protection by a glycoprotein IIb/IIIa receptor blocker
- Author
-
Ronner, E, Boersma, Eric, Akkerhuis, Martijn, Harrington, RA, Lincoff, AM, Deckers, Jaap, Karsch, KR, Kleiman, NS, Vahanian, A, Topol, EJ, Califf, RM, Simoons, Maarten, Ronner, E, Boersma, Eric, Akkerhuis, Martijn, Harrington, RA, Lincoff, AM, Deckers, Jaap, Karsch, KR, Kleiman, NS, Vahanian, A, Topol, EJ, Califf, RM, and Simoons, Maarten
- Published
- 2002
49. Sustained ventricular arrhythmias among patients with acute coronary syndromes with no ST-segment elevation - Incidence, predictors, and outcomes
- Author
-
Al-Khatib, SM, Granger, CB, Huang, Y, Lee, KL, Califf, RM, Simoons, Maarten, Armstrong, PW, van der Werf, F, White, HD, Simes, RJ, Moliterno, DJ, Topol, EJ, Harrington, RA, Al-Khatib, SM, Granger, CB, Huang, Y, Lee, KL, Califf, RM, Simoons, Maarten, Armstrong, PW, van der Werf, F, White, HD, Simes, RJ, Moliterno, DJ, Topol, EJ, and Harrington, RA
- Published
- 2002
50. Introduction
- Author
-
O'Shea Jc and Califf Rm
- Subjects
Clinical trial ,medicine.medical_specialty ,business.industry ,Medicine ,Cardiology and Cardiovascular Medicine ,business ,Intensive care medicine - Published
- 2001
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