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2. Liraglutide and Renal Outcomes in Type 2 Diabetes
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Mann JFE, Ørsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornøe K, Zinman B, Buse JB, LEADER Steering Committee and Investigators. Bergenstal R, Daniels G, Moses AC, Nauck M, Nissen S, Pocock S, Steinberg W, Stockner M, Kristensen P, Ravn LS, Zychma M, Flyvbjerg A, Ford I, Kloos RT, Schactman MJ, Sleight P, Swedberg K, Tenner SM, Akalın S, Arechavaleta R, Bain S, Babkowski MC, Benroubi M, Berard L, Comlekci A, Czupryniak L, Eliasson B, Eriksson M, Fonseca V, Franek E, Gross J, Hafidh K, Haluzik M, Hayes F, Huang YY, Jacob S, Kaddaha G, Khalil A, Kilhovd B, Laakso M, Leiter L, Lalic N, Ji L, Luedemann J, Mannucci E, Marre M, Masmiquel L, Mota M, Omar M, O’Shea D, Pan C, Petrie J, Pieber T, Pratley R, Raz I, Rea R, Rutten G, Satman I, Shestakova M, Simpson R, Smith D, Tack C, Tarnow L, Thomas N, Van Gaal L, Travert F, Vidal J, Warren M, Yoon KH, Tuttle RM, Sheerman SI, Hegedüs L, Baerwald H, Bergenstal M, Celik S, Dias C, Eder M, Fitzgibbons S, Irvhage L, Kloluckova J, Kriulianski R, McDuffie R, Moen S, Paster A, Saalfeld RM, Sankar K, Shehaj E, Swierzewska P, Tiktin M, Tovey S, Gibson CM, Chakrabarti AK, Dashe JF, Hinchey J, Leary MC, Pride Y, Wiviott S, Allen S, Mehr AP, Mutter WP, Parikh S, Ray S, Cheifetz A, Leffler D, Sheth S, Alexander E, Gaglia JL, Goessling W, Mitzner LD, Rosenberg C, Snow KJ, Wagner A, Piazza G, Abell S, Davis T, D'Emden M, Ding SA, Gilfillan C, Greenaway T, Gunawan F, Ho J, Jackson R, Kalra B, Lau SL, Lin J, MacIsaac R, Makepeace A, Malabu U, Marjason J, McCallum R, McLean M, Moin N, Petersons C, Price S, Roberts A, Roberts D, Sangla K, Stranks S, Tan Y, Thynne T, Walters J, Ward G, Wen W, Zhang J, Brix J, Feder A, Höbaus C, Höllerl F, Höller V, Kotter T, Kratz E, Krzizek EC, Leb-Stoeger U, Mader J, Mras N, Novak E, Obendorf F, Peric S, Pesau G, Prager R, Ribitsch A, Schnack C, Schernthaner G, Wascher T, Batens AH, Benhalima K, De Block C, Ernest P, Fouckova A, Jandrain B, Lapauw B, Letiexhe M, Mathieu C, Neven S, Peiffer F, Ruige J, Scheen A, Taes Y, Van Boxelaer I, Vandistel G, Van Durme Y, Verhaegen A, Alencar E, Alencar R, Almeida AC, Alves B, Alves E, Alves G, Alves J, Araujo L, Arruda V, Augusto GA, Baggentoss R, Balestrassi L, Barbosa M, Barcelos I, Belem L, de Bem A, Betti RT, Bona R, Bosco A, Branda J, Bronstein M, Bueno T, Bulcão T, Caiado F, Camazzola F, Cambréa MF, Campos S, Canani L, Carra MK, Caruso S, Carvalho N, Casillo A, Castro D, Cavalcanti T, Cavichioli V, Cercato C, Chacra A, Challela W, Charchar HS, Chaves C, Chrisman C, Correia-Deur J, da Costa A Jr, Costa M, Costi B, Coutinho P, Coutinho W, Cunha MR, Daher J Jr, Davini E, Democh D Jr, Eliaschewitz F, Esmanhoto Facin G, Farias F, Felício J, Fernandes V, Filho CS, Filho FF, Filho M, Fontan D, Fontenele AP, Forti A, Franco D, Freire K, Fusaro A, Genestreti P, Gerchman F, Godi A, Gomes KF, Gonçalves P, Gonçalves R, Griz L, Grossman M, Gurgel MH, Vasconcellos Haddad AW, Halpern A, Hissa M, Inuy A, Jaime J, Jonasson T, Jorge JC, Malucelli FJ, Kohara S, Kramer C, Lacerda C, Ladeira S, Lana J, Lastebasse F, Leitão A, Leite S, Lerário AC, Lima D, Lima M, Lippi V, Lunardi M, Machado E, Maia F, Maia J, Maia KP, Mañas N, Marchisotti F, Marinho C, Martins C, Figueiredo de Medeiros F, Melo A, Melo F, Mendonca E, Mendonça P, Filho RM, Miguel M, Miléo K, Miyahara M, Montenegro AP, Moraes A, Moreira A, Ítalo Mota J, Mothe FS, Murro A, Nakatani V, Napoli TF, Neto BG, Neto OQ, Niclewicz E, Ohe LN, Oliveira F, Oliveira M, Panarotto D, Parente E, Parolin S, Pechmann L, Costa da Penha P, Perlamagna L, Perotta B, Pimentel L, Pinto M, Poço C, Ponte C, Prazeres P, Quintao E, Raduan R, Rassi DT, Rassi N, Reck L, Montenegro R Jr, Ribeiro R, Rodovalho S, Silveira Rodrigues G, Rollin G, Rossi S, Sabino C, Sales AP, Salles J, Sampaio CR, Santana L, Sato V, da Silva Santos M, Santos NL, Santos R, Saraiva J, Sartori C, Sena R, Sevilha M, Sgarbi J, Silva D, D'albuquerque Silva L, Silva ME, Siqueira K, Soares S, Sobreira W, Sousa B, Souza AC, Souza B, Tambascia M, Tarantino R, Tenor F, Tomarchio M, Triches C, Tristão LJ, Valenti A, Vasques E, Vencio S, Vianna A, Munhoz Vidotto T, Vieira S, Villar H, Visconti G, Volaco A, Wajchenberg B, Zanatta L, Zimmerman L, Abbott EC, Abu-Bakare A, Advani A, Allison R, Bishara P, Bowering CK, Cheng A, Chouinard S, Clayton D, Conway J, D'Amours M, de Tugwell B, DeYoung P, D'Ignazio G, Dube F, Ekoe JM, Fagan S, Garceau C, Gottesman I, Hanna A, Harris S, Hramiak IM, Hurd C, Imran S, Josse R, Joyce C, Kaiser S, Khan F, Kirouac I, Kovacs C, Labonte I, Langlois WJ, Levac MF, Liutkus J, McDonald C, Milosevic V, Nyomba BL, Paul T, Raby K, Ransom T, Reichert SM, Retnakaran R, Rabasa-Lhoret R, Raff E, Shaikholeslami R, Sigalas J, Yip CE, Weisnagel SJ, Woo V, Bao Y, Cai X, Chen J, Chen K, Chen M, Chen X, Chen Y, Ji Y, Lei J, Li H, Liu P, Mu Y, Ren M, Ren Y, Shi Y, Wang D, Wang F, Wang J, Wang Y, Yan L, Yang G, Yang J, Yu X, Yuan G, Xu M, Zhao X, Zheng J, Zhou L, Anderlová K, Brožová J, Haluzík M, Hanušová V, Kosák M, Křížová J, Mráz M, Owen K, Rušavý Z, Tomešová J, Trachta P, Žourek M, Andersen PH, Boesgaard T, Christensen S, Gram J, Gregersen S, Henriksen JE, Hermansen K, Jakobsen PE, Jensen J, Krogsaa A, Larsen M, Lervang HH, Madsbad S, Mortensen L, Olesen T, Pietraszek A, Ridderstråle M, Safai N, Schioldan AG, Schmidt C, Snorgaard O, Stidsen J, Cederberg H, Haapamäki H, Hukkanen J, Jauhiainen R, Kujari ML, Lahtela J, Laine M, Mäkelä J, Miilunpohja M, Savolainen M, Taurio J, Vänttinen M, Creton C, Cosma NV, Dillinger J, Jacques JL, Guedj AM, Moulla M, Petit C, Ratsianoharana V, Richter D, Rodier M, Roussel R, Hinz A, Politz E, Esser M, Deuse U, Mittag D, Hagenow A, Jacob F, Jordan R, Gantke D, Venschott-Jordan U, Löhr C, Klausmann G, Eschenbrücher K, Karakas M, Jahrsdörfer B, Kunze MR, Wöhrle J, König W, Spielhagen H, Kilimnik A, Lüdemann HP, Lüdemann J, Mölle A, Mölle M, Müller J, Appelt S, Sauter A, Sauter J, Hartmann U, Löw A, Krötz F, Sohn HY, von Schacky C, Klauss V, Braun D, Segner A, Degtyareva E, Kreutzmann K, Paschmionka R, Hauck N, Sihal O, Busch AK, Maus O, Stübler P, Füllgraf-Horst S, Vietzke A, Müller C, Tosch-Sisting R, Lengsfeld B, Thaler J, Schaum T, Steindorf J, Steindorf S, König A, Reitschuster S, Schlott D, Clever HU, Witzel P, Kempe HP, Stemler L, Benis A, Diakoumopoulou E, Kazakos K, Kypraios N, Liatis S, Pagkalos E, Siami E, Tentolouris N, Alur VC, Agrawal M, Ali M, Asirvatham A, Asirvatham E, Bandgar TR, Balaji M, Bardoloi N, Baruah M, Bekur R, Bhansali A, Bhatia S, Bhonsley S, Bhuyan S, Borah B, Bright N, Ambrish C, Chaudhury T, Choudhury S, Chellan G, Das M, Dharmalingam M, Dutta P, Erugu A, Vinutha FP, Gunasekaran P, Das Gupta R, Iqbal A, Jagadish P, Jain S, Jebasingh H, John A, John M, Kalra S, Kasaragod P, Kesavadev J, Kumar H, Kumar P, Lakshmanan V, Lila AR, Mathew T, Miyen H, Mohan T, Motha A, Murthy C, Shivashankara N, Nanaiah A, Ommen T, Pani K, Pandey K, Paramesh S, Paramesh V, Pillai B, Prabhu M, Kalki RC, Ramachandran S, Ramu M, Rao Y, Reddy S, Saikia P, Saravu K, Selvam K, Sethi B, Shankar A, Sharma A, Shah N, Shankar P, Shetty R, Shivane V, Srivalli S, Thaseen S, Sarada S, Shirisha A, Subramani M, Balaji V, Mohan V, Padmanaban V, Verma M, Vidyasagar S, Walinjkar V, Walia R, Davenport C, Forde H, Gadintshware G, Gan KJ, Khattak A, O'Connell J, O'Shea D, Beilin V, Cahn A, Cohen O, Cukierman-Yaffe T, Daoud D, Darawsha M, Dicker D, Gavish A, Hochberg I, Ilany J, Inbal U, Itzhak B, Karasik A, Karnieli E, Khader N, Khamaisi M, Lender D, Lieberman GS, Mahamid R, Marcoviciu D, Michael L, Minuchin O, Mosenzon O, Narevichius F, Percik R, Potekhin M, Sabbah M, Sawaed S, Schurr D, Segal E, Slezak L, Vollach I, Zaina A, Zloczower M, Zolotov S, Antenore A, Arnone M, Arturi F, Barbaro V, Barone M, Di Biagio R, Buscemi C, Buscemi S, Buzzetti R, Di Carlo A, Carlone A, Caruso V, Casadidio I, Cerrelli F, Ciavarella A, Cipolloni L, Colella A, Colotto M, Consoli A, Crippa VG, Cuccuru I, Cufone S, Desideri C, Fallarino M, Febo F, Filetti S, Foffi C, Formoso G, Frosio L, Di Fulvio P, Gambineri A, Ginestra F, Grimaldi MS, Lamanna C, Leto G, Lucotti P, Lugarà M, Lumera G, Magistro A, Maranghi M, Martelli D, Mattina A, Monti LD, Parise M, Pedace E, Perticone F, Piatti P, Pompea Antonia Baldassarre M, Ragghianti B, Repaci A, Ribichini D, Da Ros S, Rossi M, Santilli M, Sesti G, Setola E, Succurro E, Sussolano E, Tarquini G, Verga S, Vitale V, Alanis RR, del Rosario Arechavaleta-Granell M, de Jesús Beltran Jaramillo T, de Jesús Rodríguez Berrones DA, Rodríguez Briones I, Rodríguez Briones R, Acevedo Castañeda ES, Chapa Grimaldo JB, Flores-Moreno CA, Garza Felix S, Nieto Flores J, Morales Franco G, Garza Morán RA, Hernández González SO, González-Gálvez G, González González JG, Hernández Salazar E, García Hernández PA, Campos Hurtado S, López-Velázco ML, Cardona Muñóz EG, Nuñez Márquez R, Campos Moreno OV, Cavazos Oliveros FJ, Haro Ortiz JA, Pelayo-Orozco ES, Sida Perez P, Vazquez Ramírez R, Uribe Rios MA, López Rodríguez JC, Rodríguez Rosales M, Robledo Durón I, Alvarado Ruíz R, González Saldivar G, Reyes Sánchez R, Sánchez-Michel BL, Contreras Sandoval AY, Velasco Gutiérrez A, Perez Verdín AE, Ramos Zavala MG, Abbink-Zandbergen E, Ahdi M, Bugter A, van Dijk M, Eisma G, Erdtsieck R, Gerards M, Gerdes V, Haak H, Harbers V, Hoogenberg K, Huvers F, Janssen W, Kars M, Kooy A, Lafeber M, Landewé-Cleuren S, Lieverse A, Meesters E, Moerman S, van Moorsel D, Nijhuis J, Smit CJ, Thevissen K, Timmerman Thijssen DM, Willemsen A, Birkeland K, Cooper J, Gulseth H, Hjelmesæth J, Jørgensen P, Kilhovd BK, Kulseng B, Nicolaisen B, Skadberg Ø, Wium C, Antkowiak-Piatyszek K, Arciszewska M, Bajkowska-Fiedziukiewicz A, Bogdanski P, Czubek U, Cypryk K, Dabrowski J, Dabrowska M, Dziedzic S, Dziewit T, Faligowska M, Fedor-Plenkowska G, Gajos G, Galicka-Latala D, Galuszka-Bilinska A, Gladysz I, Grycewicz J, Hachula G, Janas I, Jazwinska-Tarnawska E, Jedynasty K, Jozefowska M, Kaminska A, Katra B, Kitowska-Koterla J, Klupa T, Koblik T, Konduracka E, Konieczny J, Konieczny M, Kosinski M, Kulkowski G, Kunecki M, Kurmaniak M, Lesniewski R, Lominska T, Losa B, Majkowska D, Malecki M, Mirocka J, Misztal M, Mruk K, Musialik K, Olejniczak H, Opadczuk P, Peczynska J, Plinta M, Polaszewska-Muszynska M, Przech E, Pupek-Musialik D, Ruzga Z, Scibor Z, Sidorowicz-Bialynicka A, Siegel A, Stankiewicz A, Strzelecka-Sosik A, Swierszcz T, Szulinska M, Szymkowiak K, Trybul I, Witek P, Wozniak I, Zambrzycki J, Zarzycka-Lindner G, Zuradzka-Wajda D, Zurawska-Klis M, Ahn HY, Chin SO, Choi SH, Chon S, Han KA, Jang HC, Jeong KC, Kang SM, Kim JW, Kim HS, Kim SJ, Kim SW, Kim YS, Lee EY, Lim S, Min KW, Nam JY, Oh SJ, Park SY, Rhee SY, Shin JA, Son JI, Song YD, Woo JT, Yang HK, Yoo JS, Yoon JW, Avram R, Braicu MD, Carlan L, Catrinoiu D, Ciomos D, Ciorba A, Ghise G, Girgavu S, Guja C, Mihai D, Nicodim S, Nistor L, Pintilei DR, Pintilei E, Pletea N, Pop A, Rosu M, Savu O, Serban V, Sima A, Sitterli-Natea C, Suciu G, Szabo M, Szilagyi I, Timar B, Vlad A, Vladu IM, Alfaraj A, Dubova V, Dvoryashina I, Gaysina L, Gromova S, Gudkova K, Ivanova S, Ivashkina I, Kalashnikova M, Kazankova T, Khaykina E, Khaykina O, Kiseleva T, Komissarova E, Kononenko I, Koreneva V, Koshcheeva O, Koshel L, Kozachuk D, Kufelkina T, Kunitsyna M, Likhodey N, Lysenko T, Makarova O, Malceva A, Mikhailova S, Ogorodnikova E, Pavlikova I, Pekareva E, Postoeva A, Reshedko D, Reshedko G, Reshedko L, Rogaleva A, Rogova L, Rozanov D, Runov G, Samylina I, Semikina T, Sergeeva-Kondrachenko M, Shatskaya O, Shimokhina O, Smetanina S, Startseva M, Strelkova A, Suplotova L, Suvorova L, Sych Y, Valeeva A, Valeeva F, Venjkova T, Vinokurova V, Voychik E, Yanovskaya E, Yanovskaya M, Yarkova N, Yarygina E, Yuzhakova N, Zakharova T, Zanozina O, Zenovko A, Zhuk S, Zhukova E, Aleksic S, Bulatovic A, Buric B, Cvijovic G, Jelic MA, Jojic B, Jotic A, Kendereski A, Lalic K, Lukic L, Macesic M, Petkovic MM, Micic D, Milicic T, Popovic L, Prostran M, Rajkovic N, Seferovic J, Singh S, Stojanovic R, Stosic L, Vuksanovic M, Zamaklar M, Zivkovic TB, Zoric S, Aboo N, Albertse HW, Badat A, Basson M, Bawa E, Bester F, Blignaut S, Booysen S, Bosch FJ, Burgess L, Cassimjee S, Coetzee K, Du Bois J, Engelbrecht J, Finegan K, Gibson GJ, Hansa S, Hemus A, Immink IP, Jacovides A, Joshi P, Joshi S, Kapp C, KhoeleMachobane S, Uys Knox HJ, Kok J, Komati S, Lai E, Lakha D, Lehloenyane K, Mahomed AG, Meeding R, Moodley R, Moosa N, Nel J, Nell H, Van Niekerk FJ, Pillay N, Pretorius M, Prozesky H, Ramduth S, Roos J, Sarvan M, Seeber M, Siebert M, Somasundram P, Stavrides A, Venter N, Wadvalla S, Alcolea JO, Álvarez de Arcaya Vicente A, Pérez Arroyo MB, Romero Bobillo E, Buño MM, Carreira Arias JN, Cepero García D, Masmiquel Comas L, Coves Figueras MJ, de la Cuesta Mayor C, Feria-Carot MD, Frade Fernández AM, Ferreiro Gómez M, García García C, García Delgado E, Durán García S, Gómez Gómez LA, Soto González A, Hernán García C, Ángeles Tapia Herrero M, Jodar Gimeno E, Quevedo Juanals J, López Jiménez M, Masanes F, Marco Mur ÁL, Navarro López M, Ramis JN, Palmer AG, Calle Pascual A, Romero Pérez LG, Morales Portillo C, Prieto González S, Mezquita Raya P, Reyes García R, Vera TR, Rodríguez Castro C, Rodríguez Rodríguez I, Sacanella Meseguer E, Serrano Olmedo I, Lopez Soto A, Toba Alonso F, Aliaga Verdugo A, Vidal Cortada J, Vigil Medina L, Ackefelt-Frick E, Alfredsson H, Beling E, Benedek P, Crisby M, Dorkhan M, Drescik T, Eeg-Olofsson K, Eliasson K, Fardelin P, Fredholm A, Frid A, Gerok-Andersson K, Hjelmaeus L, Hufnagl A, Jasinska E, Kowalska E, Lafolie P, Lindquist O, Lundvall M, Melander E, Nicander C, Moris L, Tengmark BO, Saphir U, Skagerberg P, Steczkó-Nilsson C, Strandell B, Tomson Y, Chen JY, Chen YC, Chiang CY, Chou CW, Ho CW, Hsiao PJ, Hsieh MC, Hsu RS, Hsu SR, Huang CH, Hung WW, Lee MY, Lee YM, Lin CW, Lin CH, Lin KD, Lin SD, Lin SF, Liou MJ, Lu WT, Shin SJ, Sia HK, Su MH, Su SL, Sun JH, Tien KJ, Tsai DH, Tsai SS, Tu ST, Wang CC, Wang SY, Yang CY, Yen FC, Acikgoz A, Akalin S, Akin S, Akinci B, Akkurt A, Akturk M, Alkis N, Altun I, Altunbas HA, Altuntas Y, Araz M, Aribas S, Arslan E, Arslan G, Arslan M, Ataoglu EH, Ayan F, Aydin K, Aydogan BI, Ayvaz G, Bahadir MA, Balci MK, Basaran MN, Baskal N, Bugra MZ, Calan M, Cavdar U, Cetin F, Cinar N, Colbay M, Dagdelen S, Damci T, Davutoglu V, Demir M, Demir T, Deyneli O, Dincer I, Dogan B, Kanipek Doker KY, Engin I, Eraydin A, Erbas T, Erdogan MF, Ersoy C, Gedik A, Gokay F, Gul OO, Guler S, Gumus T, Gunes E, Gurler MY, Hatipoglu E, Ilkova H, Iyidir OT, Kabakci G, Karadag B, Karatemiz G, Karci AC, Kartal E, Kaya EB, Keskin C, Keskin EF, Kocabas G, Kocak F, Kol AK, Korkmaz H, Kucukler FK, Mesci BA, Oguz A, Orbay E, Oz H, Ozcan ND, Ozdem S, Ozisik S, Ozkan C, Ozsan M, Ozyazar M, Parlar H, Sargin H, Sargin M, Saygili F, Selek A, Simsek Y, Sisman P, Solmaz K, Soydas C, Tatliagac S, Tamer I, Temizkan S, Tulunay C, Tuncel E, Turker F, Unluhizarci K, Unluturk U, Uygur MM, Vatansever B, Yazici D, Yavuz DG, Yener S, Yenigun M, Yilmaz M, Abbas S, Alawadi F, Aziz AA, Bashier A, Rashid F, Abraham P, Adamson K, Atkin S, Aye M, Azam M, Barnett AH, Bellary S, Dhatariya K, Eaton M, English P, Ewing J, Furlong N, Gibson M, Green D, Herring R, Hordern V, Jaap A, Javed Z, Johnson A, Konya J, Kumar S, Lindsay R, Mackie A, McGlynn S, McKenzie J, Millward A, Murthy N, Paisey R, Pearson E, Piya M, Ramell M, Robertson D, Russell-Jones D, Saravanan P, Sathyapalan T, Shakher J, Shiels H, Sivaraman S, Smith J, Srinivas-Shankar U, Stokes J, Tracey I, Vaidya B, Yee M, Yemparala P, Walker J, Wiggins P, Williams J, Wright J, Mackinnon C, Inkster J, Zeeshan J, Bejnariu C, Malipatil N, Giritharan S, Lonnen K, Kyrou I, Aamir S, Ababa M, Abreu M, Adams D, Adams P, Aden J, Aguilar D, Aguillon A, Ahmed A, Ahmed B, Ahmed I, Akhtar A, Akright B, Akright L, Albarracin C, Albert S, Ali S, Aliuddin B, Almasmary A, Al-Maweri A, Alzohaili O, Amador W, Amine M, Amini S, Anderson M, Anderson L, Anderson R, Andrews M, Angel J, Anteer W, Anthony V, Antillon A, Anzures P, Arcon-Rios S, Arkin D, Arodak B, Aronne L, Aronoff S, Arreola G, Arroyo S, Asnani S, Astudillo-Tee G, Ault S, Austin B, Avila V, Avitabile N, Awasty V, Azar M, Aziz A, Bahrami P, Baig M, Bailey K, Bailey T, Baker M, Bala NS, Balbes-Reyes I, Baldwin D, Baldwin E, Balentine T, Ballard T, Baloch K, Banarer S, Baney C, Banka A, Barber L, Barber M, Barker T, Barnes K, Barnum O, Barra J, Bartkowiak A, Baula G, Bautista A, Bayliss R, Beaman M, Beatty K, Becker J, Bedolla L, Begum G, Belejchak P, Bell A, Beltran M, Belucher C, Bensfield E, Benton J, Bergamo K, Bergman B, Berry M, Bettino K, Beyea M, Bhargava A, Bhattacharya A, Bilas A, Bischoff L, Bixler L, Bizjack S, Blank R, Blankfield R, Block L, Bloodworth J, Bloomberg K, Bloomberg R, Blustin J, Boban I, Bolden A, Boncu O, Bookless P, Brassie C, Brautigam D, Bressler P, Brewster R, Brown C, Brown D, Brown F, Bruskewitz M, Bryant D, Buchanan C, Buchanan N, Buck G, Buckley S, Bueno J, Burke D, Burton K, Buske S, Byars W, Bye R, Caldwell R, Calvin K, Camacho R, Campbell E, Cannon D, Cantrell J, Caplan J, Cardenas C, Carlton J, Carpio G, Carrol A, Cartwright L, Casanova G, Castaneda L, Castle M, Castro L, Catangay J, Chaidarun S, Chambers J, Chambliss T, Chandra L, Chang A, Chang S, Chappel J, Chappel C, Chappell T, Charles C, Chavira A, Chaykin L, Check E, Chee L, Cherry A, Chestnut A, Chiarot J, Chiniwala N, Chionh K, Choe J, Christiansen M, Chrzanowski S, Chuang E, Chuck L, Clyatt J, Cohan B, Cohen R, Comi R, Comulada-Rivera A, Conner K, Connor G, Contreras R, Cook K, Cook R, Corder C, Cornejo B Sr, Cornette L, Cortes G, Cortez L, Cox C, Cox G, Craig W, Cramer B, Cromer C, Cromer M, Cuddihy R, Culmer D, Curran H, Curran M, Dadis C, Dagogo-Jack S, Dairywala I, D'Alessio D, Damberg G, Dang A, Daniel K, Davidson M, Dean J, DeBold R, Deitz P, Del M, Delaney D, Delgado E, DeMicco M, DeMuro MA, DeSalle D, Desouza C, Devireddy K, DeVries B, Dezube M, Diab I, Diesburg-Stanwood A, Dilliard J, Dilling J, Diner J, Dishongh K, Dodis R, Doing C, Doll W, Donoho A, Donovan D, Doremus N, Dorfman S, Doshi P, Dostou J, Douglas D, Douglass S, Dowell M, Drazich E, Driver E, Du H, DuBose R III, Duclos M, Dunn K, Dunnam T, Durham N, Dye L, Eagerton D, Ebenibo S, Edeoga C, Edwards G, Ekwensi J, El Asmar I, El Sayad N, Eliopoulos C, Elkosseifi M, Elmer R, Elmore M, Elson D, ElZein L, Emmert L, Erbe L, Estes S, Estrada L, Estrada A, Eveleigh T, Everhart B, Faas F, Faircloth C, Farmer M, Fehr K, Ferguson T, Fernandes J, Ferree K, Ferrington B, Fitzhugh M, Fitzsimmons R, Flanders D, Flores M, Flores E, Flores J, Florida C, Flynn J, Folmar P, Forbes R, Ford W, Fowler M, Fraker A, Francis S, Franco-Cotto E, Fratila C, Fuentes M, Galagan R, Galloway A, Garcia M, Garcia R, Garriott M, Garza J, Gass N, Gates S, Geary M, Geiger K, Geishauser J, Giglio A, Gilbert M, Godwin S, Goetter B, Goley A, Golici L, Gomori E, Gonzales J, Gore A, Gorman T, Gosmanova A, Goswami K, Gotham A, Govoni J, Graddick S, Grant T, Greca A, Green C, Greenbaum K, Greenwald J, Grover D, Grunberger G, Guice M, Guirao D, 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E, Martinez G, Martinez-Miss S, Marx P, Massara L, Mastoor M, Matfin G, Maturu A, Maurides P, May M, Mayfield R, Maynard B, Mazza A, McCann K, McCoy J, McCoy T, McCullen MK, McDaniel C, McDaniel AM, McDermott M, McDonald A, McMasters B, McMurray C, Medlin T, Meinel M, Mendez I, Menefee J, Meredith M, Merriweather M, Mersey J, Messino C, Meyer S, Meyers L, Michael D, Midyett C, Miklius A, Milford E, Miller B, Miller H, Milligan M, Minor A, Miranda-Palma B, Mirarchi N, Mittadodla S, Mittle J, Moffat A, Mohaupt S, Mohiuddin K, Mokshagundam S, Monaco S, Monsaert R, Montano-Pereira C, Montgomery A, Moody K, Moon M, Moore D, Moore L, Morawski E, Moreau C, Morin D, Moscoa C, Motzkin C, Mueller R, Munoz C, Munoz M, Myneni A, Naderi B, Nagireddy P, Naidu J, Naidu R, Naik S, Naimark R, Nardicchi M, Ndukwu I, Neller C, Netten-Foster L, Neumiller J, New T, Newman S, Newton T, Nguyen B, Nicol B, Nicol P, Ninivaggi L, Niswender K, Norman L, Noworatzky G, Nyenwe E, O'Brien H, O'Connell T, Oden W, Odugbesan A, Oliver M, Oliver T, Olmeda C, O'Neil C, Oremus R, Ortega T, Ortiz-Santos S, Osborn T, Padmanabhan S, Papacostea O, Park I, Parker A, Parker K, Parker R, Patel C, Patel M, Patel R, Patino M, Patterson S, Paulson K, Paz A, Pemba R, Pepe C, Perez J, Perez T, Perry D, Phillips B, Phillips J, Pickett A, Pinson M, Pitzer R, Poduri M, Poehls J, Poteat T, Powell L, Prasad S, Prevost J, Price E, Priest D, Prieto L, Purewal T, Purighalla R, Purighalla U, Quadrel M, Qureshi A, Radhamma R, Rafla E, Rajab H, Ramalingam R, Ramirez A, Ramirez J, Ramirez K, Ramirez M, Randall M, Rangaraj U, Rao V, Rasmussen P, Rasouli N, Ray A, Reed J, Rems L, Renaud K, Reno M, Resnick M, Reusch J, Reynolds L, Rhoton K, Rhudy J, Ricci C, Rice L, Richardson A, Richardson L, Rickard H, Rickels M, Riff D, Rightenour N, Risser J, Rizvi A, Robertson J, Robinson A, Robinson R, Rockwell M, Rodriguez JP, Rodriguez M, Rojas M, Rojas W, Rooker-Morris L, Root C, Rose M, Rosenberg R, Rosenstock J, Roth M, Ruby R, Sachson R, Sack P, Sadler RK, Sahai S, Salazar J, Salgam M, Samal A, Samson A, Sanagorski R, Sanchez A, Sandberg J, Sanderson M, Sandoval J, Santiago E, Sapp T, Saunders J, Schill J, Schott C, Schreiman R, Schu D, Schuh K, Schutta M, Schwartz J, Schweppe L, Scofield H, Scribner A, Seal J, Sealock J, Seaton B, Sedlak-Hanslik T, Seekins K, Segal M, Seggelke S, Semenza S, Sentman P, Serra M, Seshadri P, Sevilla E, Shah S, Shaheen K, Shanik M, Shaw J, Sheets M, Shellabarger C, Sher J, Shippey J, Shivaswamy V, Shomali M, Shore D, Shroff P, Siddiqui T, Siegwald A, Silver R, Simmons D, Simons R, Sinan A, Singh M, Sirinvaravong S, Skero J, Slover-Zipf J, Small S, Smith B, Smith K, Smith M, Sohl J, Solarz SH, Soler D, Sood A, Sora N, Souchet A, Soule J, Sparks J, Spector L, Speicher R, Spillers L, Spivey T, Springer N, Sprouse H, St John J, Stacey A, Stacey H, Stafford M, Stagner E, Staples K, Steadman E, Steed R, Steeves G, Steinberg H, Stell C, Stirman E, Straub K, Strock E, Sue M, Suris O, Sutton T, Tabbah I, Talsania M, Tang R, Tapia J, Taylor K, Taylor-Hancher R, Teator R, Tekateka M, Temple B, Temple K, Teodori M, Tharp P, Thethi T, Theuma P, Thomas S, Thottan A, Thrasher J, Thrasher L, Tiemeyer M, Tinney I, Tobin T, Toma S, Tovar M, Townsend J, Trantow C, Traylor H, Trevino M, Troy M, Trumper D, Tryggestad J, Tucker C, Turner J, Turney R, Tuten C, Tyzack J, Ullo L, Underkofler C, Unger J, Urdanetta R, Valdivia V, Valenti S, Vanderheiden A, Vanderlinde-Wood M, Varma C, Vasquez E, Vazquez M, Vickery D, Villafuerte B, Villegas C, Vivar J, Vivekananthan K, Vo G, Vukojicic K, Wachter A, Wahl D, Waitmann J, Walker D, Walsh J, Walsh K, Walton A, Wang A, Wardell K, Watkins S, Watkinson J, Watts M, Watwe V, Weaver N, Weber R, Wedick C, Weeks D, Weeks L, Weindorff K, Weinstein R, Weiss S, Wenger K, Wentworth M, Werner A, West M, Whelan S, White B, White J, Whitmire M, Whittington R, Wical J, Wigley C, Wilkins F, Will K, Williams A, Wilson LE, Wince M, Wine S, Winkle P, Winner C, Wise J, Witte M, Wittenmyer J, Wood C, Wood R, Woodruff C, Worthington B, Wynn D, Wysham C, Xavier P, Yela S, Yenoby L, Young L, Younus N, Yourell V, Zaid M, Zubair I., Mann, Jfe, Ørsted, Dd, Brown-Frandsen, K, Marso, Sp, Poulter, Nr, Rasmussen, S, Tornøe, K, Zinman, B, Buse, Jb, Bergenstal R, LEADER Steering Committee and Investigators., Daniels, G, Moses, Ac, Nauck, M, Nissen, S, Pocock, S, Steinberg, W, Stockner, M, Kristensen, P, Ravn, L, Zychma, M, Flyvbjerg, A, Ford, I, Kloos, Rt, Schactman, Mj, Sleight, P, Swedberg, K, Tenner, Sm, Akalın, S, Arechavaleta, R, Bain, S, Babkowski, Mc, Benroubi, M, Berard, L, Comlekci, A, Czupryniak, L, Eliasson, B, Eriksson, M, Fonseca, V, Franek, E, Gross, J, Hafidh, K, Haluzik, M, Hayes, F, Huang, Yy, Jacob, S, Kaddaha, G, Khalil, A, Kilhovd, B, Laakso, M, Leiter, L, Lalic, N, Ji, L, Luedemann, J, Mannucci, E, Marre, M, Masmiquel, L, Mota, M, Omar, M, O’Shea, D, Pan, C, Petrie, J, Pieber, T, Pratley, R, Raz, I, Rea, R, Rutten, G, Satman, I, 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Resnick, M, Reusch, J, Reynolds, L, Rhoton, K, Rhudy, J, Ricci, C, Rice, L, Richardson, A, Richardson, L, Rickard, H, Rickels, M, Riff, D, Rightenour, N, Risser, J, Rizvi, A, Robertson, J, Robinson, A, Robinson, R, Rockwell, M, Rodriguez, Jp, Rodriguez, M, Rojas, M, Rojas, W, Rooker-Morris, L, Root, C, Rose, M, Rosenberg, R, Rosenstock, J, Roth, M, Ruby, R, Sachson, R, Sack, P, Sadler, Rk, Sahai, S, J, Salazar, Salgam, M, Samal, A, Samson, A, Sanagorski, R, Sanchez, A, Sandberg, J, Sanderson, M, Sandoval, J, Santiago, E, Sapp, T, Saunders, J, Schill, J, Schott, C, Schreiman, R, Schu, D, Schuh, K, Schutta, M, Schwartz, J, Schweppe, L, Scofield, H, Scribner, A, Seal, J, Sealock, J, Seaton, B, Sedlak-Hanslik, T, Seekins, K, Segal, M, Seggelke, S, Semenza, S, Sentman, P, Serra, M, Seshadri, P, Sevilla, E, Shah, S, Shaheen, K, Shanik, M, Shaw, J, Sheets, M, Shellabarger, C, Sher, J, Shippey, J, Shivaswamy, V, Shomali, M, Shore, D, Shroff, P, Siddiqui, T, Siegwald, A, Silver, R, Simmons, D, Simons, R, Sinan, A, Singh, M, Sirinvaravong, S, Skero, J, Slover-Zipf, J, Small, S, Smith, B, Smith, K, Smith, M, Sohl, J, Solarz, Sh, Soler, D, Sood, A, Sora, N, Souchet, A, Soule, J, Sparks, J, Spector, L, Speicher, R, Spillers, L, Spivey, T, Springer, N, Sprouse, H, St John, J, Stacey, A, Stacey, H, Stafford, M, Stagner, E, Staples, K, Steadman, E, Steed, R, Steeves, G, Steinberg, H, Stell, C, Stirman, E, Straub, K, Strock, E, Sue, M, Suris, O, Sutton, T, Tabbah, I, Talsania, M, Tang, R, Tapia, J, Taylor, K, Taylor-Hancher, R, Teator, R, Tekateka, M, Temple, B, Temple, K, Teodori, M, Tharp, P, Thethi, T, Theuma, P, Thomas, S, Thottan, A, Thrasher, J, Thrasher, L, Tiemeyer, M, Tinney, I, Tobin, T, Toma, S, Tovar, M, Townsend, J, Trantow, C, Traylor, H, Trevino, M, Troy, M, Trumper, D, Tryggestad, J, Tucker, C, Turner, J, Turney, R, Tuten, C, Tyzack, J, Ullo, L, Underkofler, C, Unger, J, Urdanetta, R, Valdivia, V, Valenti, S, Vanderheiden, A, Vanderlinde-Wood, M, Varma, C, Vasquez, E, Vazquez, M, Vickery, D, Villafuerte, B, Villegas, C, Vivar, J, Vivekananthan, K, Vo, G, Vukojicic, K, Wachter, A, Wahl, D, Waitmann, J, Walker, D, Walsh, J, Walsh, K, Walton, A, Wang, A, Wardell, K, Watkins, S, Watkinson, J, Watts, M, Watwe, V, Weaver, N, Weber, R, Wedick, C, Weeks, D, Weeks, L, Weindorff, K, Weinstein, R, Weiss, S, Wenger, K, Wentworth, M, Werner, A, West, M, Whelan, S, White, B, White, J, Whitmire, M, Whittington, R, Wical, J, Wigley, C, Wilkins, F, Will, K, Williams, A, Wilson, Le, Wince, M, Wine, S, Winkle, P, Winner, C, Wise, J, Witte, M, Wittenmyer, J, Wood, C, Wood, R, Woodruff, C, Worthington, B, Wynn, D, Wysham, C, Xavier, P, Yela, S, Yenoby, L, Young, L, Younus, N, Yourell, V, Zaid, M, Zubair, I., Mann J.F.E., Orsted D.D., Brown-Frandsen K., Marso S.P., Poulter N.R., Rasmussen S., Tornoe K., Zinman B., Buse J.B., and Buscemi S.
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Male ,Settore MED/09 - Medicina Interna ,Acute Kidney Injury ,Aged ,Albuminuria ,Creatinine ,Diabetes Mellitus, Type 2 ,Diabetic Nephropathies ,Double-Blind Method ,Female ,Follow-Up Studies ,Glomerular Filtration Rate ,Glucagon-Like Peptide 1 ,Humans ,Hypoglycemic Agents ,Intention to Treat Analysis ,Kidney Failure, Chronic ,Liraglutide ,Middle Aged ,Type 2 diabetes ,030204 cardiovascular system & hematology ,urologic and male genital diseases ,GLOMERULAR-FILTRATION-RATE ,KIDNEY-FUNCTION ,DISEASE ,law.invention ,Kidney Failure ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine ,Settore MED/49 - Scienze Tecniche Dietetiche Applicate ,Chronic ,RISK ,Kidney ,Acute kidney injury ,11 Medical And Health Sciences ,General Medicine ,medicine.anatomical_structure ,TRIAL ,liraglutide, randomized controlled trial, type 2 diabetes, renal outcomes ,Life Sciences & Biomedicine ,Type 2 ,medicine.drug ,medicine.medical_specialty ,Renal function ,030209 endocrinology & metabolism ,CARDIOVASCULAR OUTCOMES ,Follow-Up Studie ,03 medical and health sciences ,Medicine, General & Internal ,General & Internal Medicine ,Diabetes mellitus ,Internal medicine ,Diabetes Mellitus ,Intensive care medicine ,Science & Technology ,business.industry ,MORTALITY ,medicine.disease ,INTENSIVE GLUCOSE CONTROL ,INDIVIDUALS ,chemistry ,Diabetic Nephropathie ,LEADER Steering Committee and Investigators ,business - Abstract
BACKGROUND: In a randomized, controlled trial that compared liraglutide, a glucagon-like peptide 1 analogue, with placebo in patients with type 2 diabetes and high cardiovascular risk who were receiving usual care, we found that liraglutide resulted in lower risks of the primary end point (nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes) and death. However, the long-term effects of liraglutide on renal outcomes in patients with type 2 diabetes are unknown. METHODS: We report the prespecified secondary renal outcomes of that randomized, controlled trial in which patients were assigned to receive liraglutide or placebo. The secondary renal outcome was a composite of new-onset persistent macroalbuminuria, persistent doubling of the serum creatinine level, end-stage renal disease, or death due to renal disease. The risk of renal outcomes was determined with the use of time-to-event analyses with an intention-to-treat approach. Changes in the estimated glomerular filtration rate and albuminuria were also analyzed. RESULTS: A total of 9340 patients underwent randomization, and the median follow-up of the patients was 3.84 years. The renal outcome occurred in fewer participants in the liraglutide group than in the placebo group (268 of 4668 patients vs. 337 of 4672; hazard ratio, 0.78; 95% confidence interval [CI], 0.67 to 0.92; P=0.003). This result was driven primarily by the new onset of persistent macroalbuminuria, which occurred in fewer participants in the liraglutide group than in the placebo group (161 vs. 215 patients; hazard ratio, 0.74; 95% CI, 0.60 to 0.91; P=0.004). The rates of renal adverse events were similar in the liraglutide group and the placebo group (15.1 events and 16.5 events per 1000 patient-years), including the rate of acute kidney injury (7.1 and 6.2 events per 1000 patient-years, respectively). CONCLUSIONS: This prespecified secondary analysis shows that, when added to usual care, liraglutide resulted in lower rates of the development and progression of diabetic kidney disease than placebo. (Funded by Novo Nordisk and the National Institutes of Health; LEADER ClinicalTrials.gov number, NCT01179048 .).
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- 2017
3. BNFL 3013 Containers for Radioactive material Transportation
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Fischer, L., primary, DeMicco, M., additional, Russell, E., additional, and Anderson, B., additional
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- 2010
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4. On The Application of Flow Forming to the Fabrication of Type B Radioactive Material Package Containment Vessels, Rev. 1
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Mok, G., primary, DeMicco, M., additional, Fischer, L., additional, Hagler, L., additional, Russell, E., additional, Wen, J., additional, Hafner, R., additional, and Anderson, B., additional
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- 2010
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5. Packaging Review Guide for Reviewing Safety Analysis Reports for Packagings
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DiSabatino, A, primary, Biswas, D, additional, DeMicco, M, additional, Fisher, L, additional, Hafner, R, additional, Haslam, J, additional, Mok, G, additional, Patel, C, additional, and Russell, E, additional
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- 2007
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6. Assessment of Drug-Drug Interactions between Daclatasvir and Methadone or Buprenorphine-Naloxone
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Garimella, T., primary, Wang, R., additional, Luo, W.-L., additional, Wastall, P., additional, Kandoussi, H., additional, DeMicco, M., additional, Bruce, R. D., additional, Hwang, C., additional, Bertz, R., additional, and Bifano, M., additional
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- 2015
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7. A randomized, placebo‐controlled study of theNS5B inhibitor beclabuvir with peginterferon/ribavirin forHCVgenotype 1
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Tatum, H., primary, Thuluvath, P. J., additional, Lawitz, E., additional, Martorell, C., additional, DeMicco, M., additional, Cohen, S., additional, Rustgi, V., additional, Ravendhran, N., additional, Ghalib, R., additional, Hanson, J., additional, Zamparo, J., additional, Zhao, J., additional, Cooney, E., additional, Treitel, M., additional, and Hughes, E., additional
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- 2014
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8. Pharmacokinetics (PK) of the Pan-Her Inhibitor Dacomitinib (D) in Subjects with Mild or Moderate Hepatic Impairment
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O'Connell, J., primary, Plotka, A., additional, Liang, Y., additional, Boutros, T., additional, Ni, G., additional, Masters, J., additional, DeMicco, M., additional, Pardo, P., additional, Bello, C., additional, and Giri, N., additional
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- 2013
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9. 847 ACH-2684 DEMONSTRATES POTENT VIRAL SUPPRESSION IN GENOTYPE 1 HEPATITIS C PATIENTS WITH AND WITHOUT CIRRHOSIS: SAFETY, PHARMACOKINETIC, AND VIRAL KINETIC ANALYSIS
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Lawitz, E., primary, Hill, J., additional, Vince, B., additional, Murillo, A., additional, Gruener, D., additional, Marbury, T., additional, Demicco, M., additional, Agarwal, A., additional, Robison, H., additional, Huang, M., additional, Robarge, L., additional, Hui, J., additional, Olek, E., additional, Deshpande, M., additional, and Kocinsky, H., additional
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- 2013
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10. Annealing Requirements for Flow-Formed Containment Vessels for Type B Radioactive Materials
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Mok, G. C., primary, Anderson, B. L., additional, DeMicco, M. F., additional, Hafner, R. S., additional, Hagler, L. B., additional, Russell, E. W., additional, and Syn, C. K., additional
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- 2012
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11. 1120 PSI-7977 400 MG QD SAFETY AND TOLERABILITY IN THE FIRST 450 PATIENTS TREATED FOR 12 WEEKS
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Jacobson, I., primary, Lawitz, E., additional, Lalezari, J., additional, Crespo, I., additional, Davis, M., additional, Hassanein, T., additional, DeMicco, M., additional, Arora, S., additional, Gitlin, N., additional, Herring, R., additional, Nelson, D.R., additional, Anderson, J.K., additional, Hyland, R.H., additional, Mader, M., additional, Hindes, R., additional, Albanis, E., additional, Symonds, W.T., additional, and Berrey, M.M., additional
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- 2012
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12. 1163 A PHASE 2A STUDY OF BMS-791325, AN NS5B POLYMERASE INHIBITOR, WITH PEGINTERFERON ALFA-2A AND RIBAVIRIN IN TREATMENT-NAIVE PATIENTS WITH GENOTYPE 1 CHRONIC HEPATITIS C INFECTION
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Tatum, H., primary, Thuluvath, P., additional, Lawitz, E., additional, Martorell, C.T., additional, Demicco, M., additional, Cohen, S., additional, Rustgi, V., additional, Ravendhran, N., additional, Ghalib, R., additional, Hanson, J., additional, Zamparo, J., additional, Yang, R., additional, Hughes, E., additional, and Cooney, E., additional
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- 2012
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13. 1 ATOMIC: 97% RVR FOR PSI-7977 + PEG/RBV × 12 WEEK REGIMEN IN HCV GT1: AN END TO RESPONSE-GUIDED THERAPY?
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Kowdlev, K.V., primary, Läwitz, E., additional, Crespo, I., additional, Hassanein, T., additional, Davis, M., additional, DeMicco, M., additional, Nelson, D.R., additional, Bernstein, D., additional, Afdhal, N.H., additional, Jacobson, I., additional, Vierling, J., additional, Gordon, S., additional, Anderson, J.K., additional, Hyland, R.H., additional, Hindes, R.G., additional, Baker, C., additional, Sorensen, R., additional, Albanis, E., additional, Symonds, W.T., additional, and Berrey, M.M., additional
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- 2012
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14. 1219 THREE-DAY, DOSE-RANGING STUDY OF THE HCV NS5A INHIBITOR GS-5885
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Lawitz, E., primary, Gruener, D., additional, Hill, J., additional, Marbury, T., additional, Komjathy, S., additional, DeMicco, M., additional, Murillo, A., additional, Jenkin, F., additional, Kim, K., additional, Simpson, J., additional, Aycock, M., additional, Mathias, A., additional, Yang, C., additional, Dowdy, E., additional, Liles, M., additional, Cheng, G., additional, Mondou, E., additional, Link, J., additional, Brainard, D., additional, McHutchison, J., additional, Ohmstede, C., additional, and Bannister, R., additional
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- 2011
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15. 1372 ONCE DAILY PSI-7977 PLUS PEG-IFN/RBV IN HCV GT1: 98% RAPID VIROLOGIC RESPONSE, COMPLETE EARLY VIROLOGIC RESPONSE: THE PROTON STUDY
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Nelson, D.R., primary, Lalezari, J., additional, Lawitz, E., additional, Hassanein, T., additional, Kowdley, K., additional, Poordad, F., additional, Sheikh, A., additional, Afdhal, N., additional, Bernstein, D., additional, Dejesus, E., additional, Freilich, B., additional, Dieterich, D., additional, Jacobson, I., additional, Jensen, D., additional, Abrams, G.A., additional, Darling, J., additional, Rodriguez-Torres, M., additional, Reddy, R., additional, Sulkowski, M., additional, Bzowej, N., additional, Demicco, M., additional, Strohecker, J., additional, Hyland, R., additional, Mader, M., additional, Albanis, E., additional, Symonds, W.T., additional, and Berrey, M.M., additional
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- 2011
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16. 1055 ANTIVIRAL ACTIVITY OF ANA598, A POTENT NON- NUCLEOSIDE POLYMERASE INHIBITOR, IN CHRONIC HEPATITIS C PATIENTS
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Lawitz, E., primary, Rodriguez-Torres, M., additional, DeMicco, M., additional, Nguyen, T., additional, Godofsky, E., additional, Appleman, J., additional, Rahimy, M., additional, Crowley, C., additional, and Freddo, J., additional
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- 2009
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17. Dose-Ranging Trial Comparing 6 Regimens of a New Microcrystalline Cellulose (MCC)-Free Formulation of Sodium Phosphate (NaP) Tablets (INKP-102) to Visicol® Tablets for Colon Cleansing
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DeMicco, M., primary, Wruble, L., additional, Medoff, J., additional, Rose, M., additional, Karlstadt, R., additional, Ettinger, N., additional, Carnal, R., additional, and Zang, B., additional
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- 2005
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18. P1–055PHARMACOKINETICS (PK) OF THE PAN-HER INHIBITOR DACOMITINIB (D) IN SUBJECTS WITH MILD OR MODERATE HEPATIC IMPAIRMENT.
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O'Connell, J., Plotka, A., Liang, Y., Boutros, T., Ni, G., Masters, J., DeMicco, M., Pardo, P., Bello, C., and Giri, N.
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- *
LIVER cancer , *PROTEIN-tyrosine kinase inhibitors , *PHARMACOKINETICS , *ELECTROCARDIOGRAPHY , *PROTEIN binding , *PERIODIC health examinations - Published
- 2013
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19. Metabolic heterogeneity in cancer.
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Demicco M, Liu XZ, Leithner K, and Fendt SM
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- Humans, Neoplasms metabolism
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Cancer cells rewire their metabolism to survive during cancer progression. In this context, tumour metabolic heterogeneity arises and develops in response to diverse environmental factors. This metabolic heterogeneity contributes to cancer aggressiveness and impacts therapeutic opportunities. In recent years, technical advances allowed direct characterisation of metabolic heterogeneity in tumours. In addition to the metabolic heterogeneity observed in primary tumours, metabolic heterogeneity temporally evolves along with tumour progression. In this Review, we summarize the mechanisms of environment-induced metabolic heterogeneity. In addition, we discuss how cancer metabolism and the key metabolites and enzymes temporally and functionally evolve during the metastatic cascade and treatment., (© 2024. Springer Nature Limited.)
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- 2024
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20. A palmitate-rich metastatic niche enables metastasis growth via p65 acetylation resulting in pro-metastatic NF-κB signaling.
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Altea-Manzano P, Doglioni G, Liu Y, Cuadros AM, Nolan E, Fernández-García J, Wu Q, Planque M, Laue KJ, Cidre-Aranaz F, Liu XZ, Marin-Bejar O, Van Elsen J, Vermeire I, Broekaert D, Demeyer S, Spotbeen X, Idkowiak J, Montagne A, Demicco M, Alkan HF, Rabas N, Riera-Domingo C, Richard F, Geukens T, De Schepper M, Leduc S, Hatse S, Lambrechts Y, Kay EJ, Lilla S, Alekseenko A, Geldhof V, Boeckx B, de la Calle Arregui C, Floris G, Swinnen JV, Marine JC, Lambrechts D, Pelechano V, Mazzone M, Zanivan S, Cools J, Wildiers H, Baud V, Grünewald TGP, Ben-David U, Desmedt C, Malanchi I, and Fendt SM
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- Mice, Animals, Carnitine O-Palmitoyltransferase metabolism, Acetylation, Acetyl Coenzyme A metabolism, Palmitates, NF-kappa B metabolism, Lysine Acetyltransferases metabolism
- Abstract
Metabolic rewiring is often considered an adaptive pressure limiting metastasis formation; however, some nutrients available at distant organs may inherently promote metastatic growth. We find that the lung and liver are lipid-rich environments. Moreover, we observe that pre-metastatic niche formation increases palmitate availability only in the lung, whereas a high-fat diet increases it in both organs. In line with this, targeting palmitate processing inhibits breast cancer-derived lung metastasis formation. Mechanistically, breast cancer cells use palmitate to synthesize acetyl-CoA in a carnitine palmitoyltransferase 1a-dependent manner. Concomitantly, lysine acetyltransferase 2a expression is promoted by palmitate, linking the available acetyl-CoA to the acetylation of the nuclear factor-kappaB subunit p65. Deletion of lysine acetyltransferase 2a or carnitine palmitoyltransferase 1a reduces metastasis formation in lean and high-fat diet mice, and lung and liver metastases from patients with breast cancer show coexpression of both proteins. In conclusion, palmitate-rich environments foster metastases growth by increasing p65 acetylation, resulting in a pro-metastatic nuclear factor-kappaB signaling., (© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.)
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- 2023
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21. Author Correction: PHGDH heterogeneity potentiates cancer cell dissemination and metastasis.
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Rossi M, Altea-Manzano P, Demicco M, Doglioni G, Bornes L, Fukano M, Vandekeere A, Cuadros AM, Fernández-García J, Riera-Domingo C, Jauset C, Planque M, Alkan HF, Nittner D, Zuo D, Broadfield LA, Parik S, Pane AA, Rizzollo F, Rinaldi G, Zhang T, Teoh ST, Aurora AB, Karras P, Vermeire I, Broekaert D, Elsen JV, Knott MML, Orth MF, Demeyer S, Eelen G, Dobrolecki LE, Bassez A, Brussel TV, Sotlar K, Lewis MT, Bartsch H, Wuhrer M, Veelen PV, Carmeliet P, Cools J, Morrison SJ, Marine JC, Lambrechts D, Mazzone M, Hannon GJ, Lunt SY, Grünewald TGP, Park M, Rheenen JV, and Fendt SM
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- 2022
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22. PHGDH heterogeneity potentiates cancer cell dissemination and metastasis.
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Rossi M, Altea-Manzano P, Demicco M, Doglioni G, Bornes L, Fukano M, Vandekeere A, Cuadros AM, Fernández-García J, Riera-Domingo C, Jauset C, Planque M, Alkan HF, Nittner D, Zuo D, Broadfield LA, Parik S, Pane AA, Rizzollo F, Rinaldi G, Zhang T, Teoh ST, Aurora AB, Karras P, Vermeire I, Broekaert D, Elsen JV, Knott MML, Orth MF, Demeyer S, Eelen G, Dobrolecki LE, Bassez A, Brussel TV, Sotlar K, Lewis MT, Bartsch H, Wuhrer M, Veelen PV, Carmeliet P, Cools J, Morrison SJ, Marine JC, Lambrechts D, Mazzone M, Hannon GJ, Lunt SY, Grünewald TGP, Park M, Rheenen JV, and Fendt SM
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- Animals, Cell Line, Tumor, Cell Movement, Cell Proliferation, Disease Progression, Female, Gene Silencing, Humans, Mice, Serine metabolism, Breast Neoplasms pathology, Neoplasm Metastasis, Phosphoglycerate Dehydrogenase genetics
- Abstract
Cancer metastasis requires the transient activation of cellular programs enabling dissemination and seeding in distant organs
1 . Genetic, transcriptional and translational heterogeneity contributes to this dynamic process2,3 . Metabolic heterogeneity has also been observed4 , yet its role in cancer progression is less explored. Here we find that the loss of phosphoglycerate dehydrogenase (PHGDH) potentiates metastatic dissemination. Specifically, we find that heterogeneous or low PHGDH expression in primary tumours of patients with breast cancer is associated with decreased metastasis-free survival time. In mice, circulating tumour cells and early metastatic lesions are enriched with Phgdhlow cancer cells, and silencing Phgdh in primary tumours increases metastasis formation. Mechanistically, Phgdh interacts with the glycolytic enzyme phosphofructokinase, and the loss of this interaction activates the hexosamine-sialic acid pathway, which provides precursors for protein glycosylation. As a consequence, aberrant protein glycosylation occurs, including increased sialylation of integrin αv β3 , which potentiates cell migration and invasion. Inhibition of sialylation counteracts the metastatic ability of Phgdhlow cancer cells. In conclusion, although the catalytic activity of PHGDH supports cancer cell proliferation, low PHGDH protein expression non-catalytically potentiates cancer dissemination and metastasis formation. Thus, the presence of PHDGH heterogeneity in primary tumours could be considered a sign of tumour aggressiveness., (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)- Published
- 2022
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23. Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation.
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DeMicco M, Barrow L, Hickey B, Shailubhai K, and Griffin P
- Abstract
Background: Plecanatide, with the exception of a single amino acid replacement, is identical to human uroguanylin and is approved in the United States for adults with chronic idiopathic constipation (CIC). This double-blind, placebo-controlled, phase III study evaluated the efficacy and safety of plecanatide versus placebo in CIC., Methods: Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg ( n = 443), 6 mg ( n = 449), or placebo ( n = 445). Patients recorded bowel movement (BM) characteristics [including spontaneous BMs (SBMs) and complete SBMs (CSBMs)] and rated CIC symptoms in daily electronic diaries. The primary endpoint was the percentage of durable overall CSBM responders (weekly responders for ⩾9 of 12 treatment weeks, including ⩾3 of the last 4 weeks). Weekly responders had ⩾3 CSBMs/week and an increase of ⩾1 CSBM from baseline for the same week., Results: A significantly greater percentage of durable overall CSBM responders resulted with each plecanatide dose compared with placebo (3 mg = 20.1%; 6 mg = 20.0%; placebo = 12.8%; p = 0.004 each dose). Over the 12 weeks, plecanatide significantly improved stool consistency and stool frequency. Significant increases in mean weekly SBMs and CSBMs began in week 1 and were maintained through week 12 in plecanatide-treated patients. Adverse events were mostly mild/moderate, with diarrhea being the most common (3 mg = 3.2%; 6 mg = 4.5%; placebo = 1.3%)., Conclusions: Plecanatide resulted in a significantly greater percentage of durable overall CSBM responders and improved stool frequency and secondary endpoints. Plecanatide was well tolerated; the most common AE, diarrhea, occurred in a small number of patients.[ClinicalTrials.gov identifier: NCT02122471]., Competing Interests: Conflict of interest statement: KS and PG are employees and stockholders of Synergy Pharmaceuticals Inc. At the time of the study and of manuscript preparation, LB and BK were employees and stockholders of Synergy Pharmaceuticals Inc. MD states no potential conflict of interest.
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- 2017
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24. Evaluation of drug-drug interaction between daclatasvir and methadone or buprenorphine/naloxone.
- Author
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Garimella T, Wang R, Luo WL, Wastall P, Kandoussi H, Demicco M, Bruce D, Hwang C, Bertz R, and Bifano M
- Abstract
Introduction: Daclatasvir (DCV) is a potent hepatitis C virus (HCV) NS5A replication complex inhibitor with pangenotypic (1-6) activity in vitro. Methadone (MET) and buprenorphine (BUP) are opioid medications used to treat opioid addiction; patients on HCV therapy may require MET or BUP treatment. The effect of DCV on the pharmacokinetics (PK) of MET or BUP/naloxone (NLX) was assessed in subjects on stable MET or BUP., Materials and Methods: An open-label, two-part study assessed the effect of steady-state oral administration of DCV on the PK of MET (Part 1, P1) or BUP/NAL (Part 2, P2). Safety/tolerability and pharmacodynamics (PD, opioid withdrawal scales/overdose assessment) were also assessed. Subjects (P1, N=14; P2, N=11) received daily single-dose oral MET (40-120mg) or BUP/NLX (8/2-24/6mg) based on their prescribed stable dose throughout, in addition to DCV (60mg QD) on Days 2-9. Serial PK sampling occurred predose and postdose till 24 hours on Day 1 (MET/BUP) and Day 10 (MET/BUP/DCV). Noncompartmental PK were derived. Geometric mean ratios (GMR) and 90% confidence intervals (90% CI) for MET/BUP/norBUP Cmax and AUCTAU were derived from linear mixed effects models., Results: Subjects were aged 19-39 years, mostly white (P1, 93%; P2, 100%) and male (P1, 71%; P2, 91%). All subjects completed the study. No clinically meaningful effect was demonstrated as the GMR and 90% CIs fell within the prespecified interval (P1, 0.7-1.4; P2, 0.5-2.0: see Table 1). DCV coadministration was well-tolerated: overall, six (43%) subjects had adverse events (AEs) (all mild and resolved without treatment). DCV had no clinically significant effect on the PD of MET or BUP/NLX., Conclusions: Steady-state administration of DCV 60mg QD had no clinically meaningful effect on the PK of MET or BUP/NLX and was generally well-tolerated, suggesting that no dose adjustments will be required.
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- 2014
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25. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial.
- Author
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Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, DeMicco M, Bernstein DE, Afdhal N, Vierling JM, Gordon SC, Anderson JK, Hyland RH, Dvory-Sobol H, An D, Hindes RG, Albanis E, Symonds WT, Berrey MM, Nelson DR, and Jacobson IM
- Subjects
- Drug Therapy, Combination, Female, Hepacivirus genetics, Hepatitis C, Chronic genetics, Hepatitis C, Chronic virology, Humans, Male, Middle Aged, Puerto Rico, Recombinant Proteins administration & dosage, Sofosbuvir, Treatment Outcome, United States, Uridine Monophosphate administration & dosage, Antiviral Agents administration & dosage, Hepatitis C, Chronic drug therapy, Interferon-alpha administration & dosage, Polyethylene Glycols administration & dosage, Ribavirin administration & dosage, Uridine Monophosphate analogs & derivatives
- Abstract
Background: The uridine nucleotide analogue sofosbuvir is a selective inhibitor of hepatitis C virus (HCV) NS5B polymerase. We assessed the safety and efficacy of sofosbuvir in combination with pegylated interferon alfa-2a (peginterferon) and ribavirin in non-cirrhotic treatment-naive, patients with HCV., Methods: For this open-label, randomised phase 2 trial, we recruited patients from 42 centres in the USA and Puerto Rico between March 23, 2011, and Sept 21, 2011. Patients were eligible for inclusion if they had chronic HCV infection (genotypes 1, 4, 5, or 6), were aged 18 years or older, and had not previously received treatment for HCV infection. Using a computer-generated randomisation sequence, we randomly assigned patients with HCV genotype-1 to one of three cohorts (A, B, and C; in a 1:2:3 ratio), with randomisation stratified by IL28B (CC vs non-CC allele) and HCV RNA (<800,000 IU/mL vs ≥800,000 IU/mL). Patients received sofosbuvir 400 mg plus peginterferon and ribavirin for 12 weeks (cohort A) or for 24 weeks (cohort B), or 12 weeks of sofosbuvir plus peginterferon and ribavirin followed by 12 weeks of either sofosbuvir monotherapy or sofosbuvir plus ribavirin (cohort C). We enrolled patients with all other eligible genotypes in cohort B. The primary efficacy endpoint was sustained virological response at post-treatment week 24 (SVR24) by intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT01329978., Results: We enrolled 316 patients with HCV genotype-1: 52 to cohort A, 109 to cohort B, and 155 to cohort C. We assigned 11 patients with HCV genotype-4 and five patients with genotype-6 to cohort B (we detected no patients with genotype 5). In patients with HCVgenotype-1, SVR24 was achieved by 46 patients (89%, 95% CI 77-96) in cohort A, 97 patients (89%, 82-94) in cohort B, and by 135 (87%, 81-92) in cohort C. We detected no difference in the proportion of patients achieving SVR24 in cohort A compared with cohort B (p=0·94), or in cohort C (p=0·78). Nine (82%) of 11 patients with genotype-4 and all five with genotype-6 achieved SVR24. Seven patients, all with genotype-1 infection, relapsed after completion of assigned treatment. The most common adverse events that led to the discontinuation of any study drug--anaemia and neutropenia--were associated with peginterferon and ribavirin treatment. Three (6%) patients in cohort A, 18 (14%) patients in cohort B, and three (2%) patients in cohort C discontinued treatment because of an adverse event., Interpretation: Our findings suggest that sofosbuvir is well tolerated and that there is no additional benefit of extending treatment beyond 12 weeks, but these finding will have to be substantiated in phase 3 trials. These results lend support to the further assessment of a 12 week sofosbuvir regimen in a broader population of patients with chronic HCV genotype-1 infection, including those with cirrhosis., Funding: Gilead Sciences., (Copyright © 2013 Elsevier Ltd. All rights reserved.)
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- 2013
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26. Single- and multiple-ascending-dose studies of the NS3 protease inhibitor asunaprevir in subjects with or without chronic hepatitis C.
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Pasquinelli C, McPhee F, Eley T, Villegas C, Sandy K, Sheridan P, Persson A, Huang SP, Hernandez D, Sheaffer AK, Scola P, Marbury T, Lawitz E, Goldwater R, Rodriguez-Torres M, Demicco M, Wright D, Charlton M, Kraft WK, Lopez-Talavera JC, and Grasela DM
- Subjects
- Adult, Dose-Response Relationship, Drug, Double-Blind Method, Drug Resistance, Viral, Electrocardiography drug effects, Female, Hepacivirus genetics, Hepatitis C, Chronic virology, Humans, Isoquinolines administration & dosage, Isoquinolines adverse effects, Male, RNA, Viral drug effects, Replicon, Sample Size, Sulfonamides administration & dosage, Sulfonamides adverse effects, Hepacivirus drug effects, Hepatitis C, Chronic drug therapy, Isoquinolines therapeutic use, Sulfonamides therapeutic use, Viral Nonstructural Proteins antagonists & inhibitors
- Abstract
Hepatitis C virus (HCV) protease inhibitors combined with pegylated alfa interferon-ribavirin have demonstrated improved efficacy compared with pegylated alfa interferon-ribavirin alone for the treatment of chronic hepatitis C. Asunaprevir (BMS-650032), a novel HCV NS3 protease inhibitor in clinical development, was evaluated for safety, antiviral activity, and resistance in four double-blind, placebo-controlled, sequential-panel, single- and multiple-ascending-dose (SAD and MAD) studies in healthy subjects or subjects with chronic HCV genotype 1 infection. In SAD studies, subjects (healthy or with chronic HCV infection) were randomized to receive asunaprevir in dose groups of 10 to 1,200 mg or a placebo. In MAD studies, healthy subjects were randomized to receive asunaprevir in dose groups of 10 to 600 mg twice daily or a placebo for 14 days; subjects with HCV infection received asunaprevir in dose groups of 200 to 600 mg twice daily, or a placebo, for 3 days. Across all four studies, headache and diarrhea were the most frequent adverse events in asunaprevir recipients. Asunaprevir at doses of 200 to 600 mg resulted in rapid HCV RNA decreases from the baseline; maximal mean changes in HCV RNA over time were 2.7 and 3.5 log(10) IU/ml in the SAD and MAD studies, respectively. No enrichment of signature asunaprevir-resistant viral variants was detected. In conclusion, the novel NS3 protease inhibitor asunaprevir, when administered at single or multiple doses of 200 to 600 mg twice daily, is generally well tolerated, achieving rapid and substantial decreases in HCV RNA levels in subjects chronically infected with genotype 1 HCV.
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- 2012
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27. Residue-free sodium phosphate tablets (OsmoPrep) versus Visicol for colon cleansing: a randomized, investigator-blinded trial.
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Wruble L, Demicco M, Medoff J, Safdi A, Bernstein J, Dalke D, Rose M, Karlstadt RG, Ettinger N, and Zhang B
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- Adolescent, Adult, Aged, Female, Humans, Male, Mass Screening methods, Middle Aged, Phosphates administration & dosage, Preoperative Care methods, Prospective Studies, Tablets, Cathartics therapeutic use, Cellulose, Colonoscopy, Phosphates therapeutic use
- Abstract
Background: The bowel purgative Visicol contains microcrystalline cellulose (MCC) residue, which may impair full visibility during a colonoscopy. An MCC residue-free sodium phosphate (RF-NaP; OsmoPrep) tablet was developed., Objective: To investigate appropriate RF-NaP dosing., Design: Phase 2, randomized, investigator-blinded study., Setting: Six research centers in the United States., Patients and Interventions: Patients undergoing a colonoscopy received Visicol (n = 34) or 1 of 6 RF-NaP regimens administered as either split (S) dosing (the evening before and the day of colonoscopy) or evening-only (E) dosing. Dosing regimens for RF-NaP were 40 tablets S, 3 every 15 minutes (n = 33); 40 tablets S, 4 every 15 minutes (n = 34); 32 tablets E, 4 every 15 minutes (n = 34); 32 tablets S, 4 every 15 minutes (n = 36); 28 tablets E, 4 every 15 minutes (n = 34); 28 tablets S, 4 every 15 minutes (n = 34). Visicol was administered as 40 tablets S, 3 every 15 minutes., Main Outcome Measure: Overall colon cleansing (OCC) was assessed by a physician questionnaire (4-point scale, based on colonic contents). An OCC rating of "excellent" or "good" was considered a response. Safety measures were also monitored., Results: Split dosing with RF-NaP was associated with high OCC and achieved response rates of 90%, 97%, and 100% for 28, 32, and 40 tablets, respectively, compared with 86% for Visicol. In addition, RF-NaP evening-only regimen response rates were 90% (32 tablets) and 72% (28 tablets). Transient shifts in electrolyte levels were reduced, and GI adverse events were less common with lower RF-NaP dose regimens., Conclusions: Administration of RF-NaP retains the benefits of a tablet purgative but eliminates MCC issues. Split dosing and 32-tablet evening-only dosing of RF-NaP tablets were efficacious and well tolerated, and split dosing of RF-NaP tablets is recommended.
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- 2007
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28. A double-blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitis.
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Safdi M, DeMicco M, Sninsky C, Banks P, Wruble L, Deren J, Koval G, Nichols T, Targan S, Fleishman C, and Wiita B
- Subjects
- Administration, Oral, Administration, Rectal, Adult, Double-Blind Method, Enema, Female, Humans, Male, Mesalamine adverse effects, Tablets, Treatment Outcome, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Colitis, Ulcerative drug therapy, Mesalamine administration & dosage
- Abstract
Objectives: The aim of this study was to compare the efficacy of mesalamine rectal suspension enema (Rowasa) alone, oral mesalamine tablets (Asacol) alone, and the combination of mesalamine enema and mesalamine tablets in patients with active mild-to-moderate distal ulcerative colitis., Methods: Sixty outpatients with ulcerative colitis at least 5 cm above the anal verge and not more than 50 cm, inclusive, and a total disease activity index (DAI) score between 4 and 10, inclusive, were randomized to either mesalamine rectal enema (n = 18) once nightly, oral mesalamine 2.4 g/day (n = 22), or a combination of both treatments (n = 20). Placebo capsules and enemas were used to maintain a blind procedure. Total DAI scores and abbreviated DAI scores were evaluated at wk 3 and 6, and wk 1 and 2, respectively. Patients recorded the amount of blood in stools, urgency, straining at stools, and abdominal pain in daily diaries. Physicians and patients rated overall improvement at each visit., Results: At wk 6, combination therapy produced a greater improvement (-5.2) in total DAI scores than did either mesalamine enema (-4.4) or mesalamine tablet (-3.9) therapy alone; similar treatment differences were observed at wk 3. Compared with patients given mesalamine enemas or mesalamine tablets, combination-therapy patients reported an absence of blood in stools significantly sooner and, at all visits, the combination therapy group had the highest percentage of patients who reported no blood in their stools. Physicians' and patients' ratings of improvement indicated that combination therapy significantly improved disease status, compared with mesalamine tablet therapy alone. All treatments were well tolerated., Conclusions: The combination of oral and rectal mesalamine therapy was well tolerated and produced earlier and more complete relief of rectal bleeding than oral or rectal therapy alone.
- Published
- 1997
29. Significance of endoscopically visible blood vessels as an index of atrophic gastritis.
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Meshkinpour H, Orlando RA, Arguello JF, and DeMicco MP
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- Adult, Aged, Atrophy, Female, Gastric Juice metabolism, Gastric Mucosa pathology, Gastritis pathology, Gastroscopy, Humans, Male, Middle Aged, Gastric Mucosa blood supply, Gastritis diagnosis
- Abstract
The endoscopic criteria for atrophic gastritis are. 1. pale mucosa; 2. shiny surface and 3. prominent submucosal vessels. To evaluate the diagnostic accuracy of circumscribed atrophic gastritis based on these findings, we studied 184 consecutive upper gastrointestinal endoscopies. The endoscopic diagnosis of atrophic gastritis was made only if two endoscopists both agreed on the findings and interpretation. The location of the atrophic pattern and whether it was circumscribed or diffuse were recorded. Two biopsy specimens were than obtained. Histologic material was interpreted by a pathologist who had no prior knowledge of the endoscopic findings. Twenty-five patients (13%) had atrophic gastritis endoscopically; in four it was diffuse and in 21 it was circumscribed. Utilizing the criteria of Whitehead, et al, atrophic gastritis was diagnosed histologically in three of four patients with diffuse gastritis but in one of those considered to have circumscribed atrophic gastritis. It is concluded from these preliminary data that a circumscribed atrophic mucosal pattern is a frequent endoscopic finding that does not necessarily represent atrophic gastritis histologically.
- Published
- 1979
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