부산대학교 도서관

Byline: Erin A Bohula, MD [ebohula11@bwh.harvard.edu] (a,*,*), Benjamin M Scirica, MD (a,*), Prof Silvio E Inzucchi, MD (b), Prof Darren K McGuire, MD (c), Prof Anthony C Keech, MD (d), Steven R Smith, MD (e), Estella Kanevsky, MS (a), Sabina A Murphy, MPH (a), Prof Lawrence A Leiter, MD (f), Prof Jamie P Dwyer, MD (g), Ramon Corbalan, MD (h), Prof Christian Hamm, MD (i), Lee Kaplan, MD (j), Prof Jose Carlos Nicolau, MD (k), Ton Oude Ophuis, MD (l), Prof Kausik K Ray, FRCP (m), Prof Mikhail Ruda, MD (n), Jindrich Spinar, MD (o), Tushar Patel, PhD (p), Wenfeng Miao, MD (p), Carlos Perdomo, MS (p), Bruce Francis, MD (p), Shobha Dhadda, PhD (p), Marc P Bonaca, MD (a), Christian T Ruff, MD (a), Prof Marc S Sabatine, MD (a,[Dagger]), Stephen D Wiviott, MD (a,[Dagger]), Marc S Sabatine, Stephen D Wiviott, Benjamin M Scirica, Silvio Inzucchi, Anthony Keech, Darren K McGuire, Steven R Smith, Andrew Satlin, Conville Brown, Andrzej Budaj, Ramon Corbalan, Jamie Dwyer, Armando Garcia-Castillo, Milan Gupta, Christian Hamm, Lee Kaplan, Anthony Keech, Lawrence A Leiter, Jose Carlos Nicolau, Ton Oude Ophuis, Kauski Ray, Mikhail Ruda, Benjamin M Scirica, Jindrich Spinar, Neil Weissman, Harvey D White, Stephen D Wiviott, J Amerena, M Arstall, D Colquhoun, R Jayasinghe, A Lee, R Lehman, R Moses, J Proietto, P Purnell, J Waites, P Blombery, D Cross, M Worthley, M d'Emden, J Selvanayagam, RE Oqueli, A Whelan, P Garrahy, F de Looze, D Ninio, J Horowitz, M William, M Suranyi, G Wittert, M Le May, AS Pandey, S Vizel, R Labonte, Y Beaudry, C Fortin, A Bell, S Kouz, E St-Amour, I Bata, F St Maurice, R Chehayeb, C Constance, G Wong, A Hess, J Liutkus, P Poirier, I Teitelbaum, J Berlingieri, J Cha, M Hartleib, M Heffernan, D Twum-Barima, V Pandith, R Aronson, R Goldenberg, B Ajala, A Jain, S Ross, H Bajaj, H Khandwala, Z Yared, N Gupta, J Bedard, S Wharton, F Blouin, D Savard, D Shukla, J Cobos, G Godoy, L Perez, C Pincetti, V Saavedra Guajardo, P Varleta, C Conejeros, F Lanas, E Bayram Llamas, E Cardona Munoz, R Garcia, J Garza Ruiz, G Llamas Esperon, E Lopez Rosas, G Melendez Mier, G Ramos, H Hart, D Scott, I Ternouth, J Benatar, J Elliott, R Cutfield, P Manning, M Williams, K Ferrier, R Scott, S Wilson, R Leikis, BK Nirmalaraj, E Krzyzagorska, P Miekus, M Bronisz, E Mirek-Bryniarska, K Landa, A Stasiewski, T Zechowicz, D Zytkiewicz-Jaruga, J Korecki, M Ogorek, L Pawlowicz, M Piepiorka, J Skierkowska, A Stankiewicz, E Szyprowska, R Witek, A Bochenek, P Konczakowski, L Wojnowski, M Wujkowski, K Cymerman, R Korzeniak, P Mader, B Miklaszewicz, P Stachlewski, A Goch, W Pomiecko, M Skorski, L Romanowski, K Jusiak, E Laskowska-Derlaga, R Bijata-Bronisz, J Kazmierczak, R Goldberg, D Henderson, E Korban, K Rohr, E Claxton, R Weiss, D Angiolillo, F Boccalandro, K Chu, E Thorn, P Randhawa, N Singh, G Bittar, T Guarnieri, S Saeed, S Sharma, M Shepard, W French, P Desai, R Bernstein, W Rogers, R Singal, R Schneider, J Shanes, S Ong, J Condit, S Donahoe, D Brill, D Einhorn, R Ebrahimi, A Labroo, R Graf, J Scott, J Hoekstra, P Jetty, G Luckasen, P O'Donnell, W Gonte, D Pomposini, M Quadrel, M Koren, D Schlager, E Schramm, D Singal, S Lupovitch, A Soni, P Seigel, J Roberts, J Soufer, S Reza, E Quinlan, T Moretto, B First, M Khan, S Chilka, H Colfer, A Teklinski, K Wallace-Wilding, H Ellison, D Muse, S Aronoff, A Higgins, S Patel, V Elinoff, A Karim, V Awasty, R Chuang, H Roseman, P Dugano-Daphnis, M Albert, K Sheikh, H Bays, S Kaster, M Goldstein, D Rubino, G Calatayud, H Snyder, T Williams, K Hershon, M Hagan, S Isserman, B Kahn, J Anderson, MP Gimness, A Raisinghani, M Christina, M Raikhel, E Gillespie, E Portnay, M Heiman, M Qureshi, J Lee, R Blonder, F Cucher, G Miller, D Kotlaba, G Cornett, J Beavins, C Augenbraun, S Reinhardt, A Bartkowiak Jr, A Salacata, T Blevins, S Benjamin, J Diener, W George, B Barker, R Richwine, D Baldari, A Alfieri, A Barreto, L Zhang, R Shah, E Hendrix, V Subramaniyam, S Hurley, M Lillestol, M O'Donoghue, S Shayani, E Ryan, R Call, L Zemel, A Chang, A Kivitz, B Freyne, V Bland, K Shore, E Mostel, E Uzoaga, N Andrawis, N Gabra, A Ghitis, K Sabatino, D Browder, S Varma, S Smith, R Fink, GR Aycock Jr, WD Doty, T Alfonso, S Eshaghian, R Karlsberg, S Zarich, C Landau, M McKenzie, R Krause, W Davis, T Haddad, S Voyce, C Alford, J LeDoux, D O'Dea, M McKenzie, J Park, V Aroda, A Getaneh, B Graham, R Bhagwat, D Korn, G Ruoff, A Wiseman, I Lieber, J Fialkow, JM Gonzalez-Campoy, C Bayron, B Bertolet, J Lash, C Gerrish, D Robertson, J Rosenfeld, M Seidner, J Agaiby, J Silverfield, D Sugimoto, B Lubin, M Alhaddad, H Lui, G Lakin, S Chokshi, D Donovan, W Felten, S Minton, C Kimmelstiel, J Kuvin, C Still, W Byars, J Talano, V Desai, AJ Bradley III, S Baker, M Chane, A Mercado, S Baron, B Harris, N Mayer, M Concha, K Carr, L Chaykin, J Willis, A Clay, E Fenstad, J Furda, P Peterson, M Chang, L Aronne, D Jones, R Prashad, M Benson, R Stegemoller, K Longshaw, J Saleh, W Jennings, R Detweiler, D Viswanath, R Patel, G Miller, S Lederman, D Weinstein, R Korabathina, V Singh, J Rosen, R Estevez, P Levin, R McNeill, V Kalen, J Reed, R Ashley, L Herman, Y Tsai, D Kayne, A White, I Hussain, L Tami, K Cohen, J Robinson, S Sharma, D Fuchs-Ertman, G Platt, L Belardo, R Reddy, C Rosendorff, F Saba, S Powell, K Anderson, M Abidi, S Rezkalla, A Paraschos, J Wilson, M Moursi, A Shah, R Patel, V Nadar, L Stonesifer, M Bialow, K Cannon, W Ellison, M Stedman, J Brown, W Harper, KJ Lucas, M DiGiovanna, H Rodbard, M Biscoveanu, C Davis, J Hall, R Littlefield, T Gorman, D Kereiakes, FM Chang, H Tatu, D Cheung, J Kaine, T Knutson, T Logemann, G Pueblitz, J Bianco, B Henson, M Neustel, M Gelernt, W Nelson, K Moriarty, G Lefebvre, K Maw, L Rink, P Behn, H Studdard, G Argoud, T O'Connor, P Krichmar, G Raad, J Pereles-Ortiz, C Sorli, A Cohen, K Pettis, B Cavanaugh, C Phillips, J Wahlen, D Radin, J Rider, E Kosinski, W Leimbach, A Odhav, J Hakas, A Tan, M Howell, D Wombolt, N Fishman, P Shah, P Wylie, C Arauz-Pacheco, A Cavale, A George, R Kroll, J Krantzler, N Tahirkheli, M Jabro, M Newell, P Mullen, N Gencheff, J Meli, K Vora, L Kotek, K Pyzdrowski, H Paez, J Moran, A Tannenbaum, K Deck, R Busch, L Levinson, M Azizad, J Whitaker, B Fox, C Huffman, M Ashraf, J Diogo, R Kushner, J Tallet, V Channamsetty, D Suh, M Atieh, J Navas, V Young, S Shaw, I Dor, B Duffy, P Rubin, D Lewis, W Kaye, R Benton, J Burbano, D Hotchkiss, A Magno, A Alberton, J Collins, O Alvarado, M Stich, S Mahal, J Liu, M Hong, J Dy, B Block, J Lamantia, J Pritchard, M Davis, S Srivastava, S Bilazarian, R Rosario, M McCartney, V Blumberg, R Rajan, E Martin, S Wright, A White, L Levinson, C Brinson, J Johnston, S Wilson, M Graves, M Dominguez, W McKenzie, R Abadier, C Tran, R Castello, E Morawski, J White, F Morris, A Perez, P Trueba, M Sanchez, J Andersen, R Kastelic, J Khan, H Rodriguez, W Izquierdo, A Matias, L Essandoh, C Ince Summary Background There is a direct relationship between bodyweight and risk of diabetes. Lorcaserin, a selective serotonin 2C receptor agonist that suppresses appetite, has been shown to facilitate sustained weight loss in obese or overweight patients. We aimed to evaluate the long-term effects of lorcaserin on diabetes prevention and remission. Methods In this randomised, double-blind, placebo-controlled trial done in eight countries, we recruited overweight or obese patients (body-mass index [greater than or equal to]27 kg/m.sup.2) with or at high risk for atherosclerotic vascular disease. Eligible patients were aged 40 years or older; patients at high risk for atherosclerotic vascular disease had to be aged 50 years or older with diabetes and at least one other risk factor. Patients were randomly assigned to receive either lorcaserin (10 mg twice daily) or matching placebo. Additionally, all patients had access to a standardised weight management programme based on lifestyle modification. The prespecified primary metabolic efficacy endpoint of time to incident diabetes was assessed in patients with prediabetes at baseline. The prespecified secondary outcomes for efficacy were incident diabetes in all patients without diabetes, achievement of normoglycaemia in patients with prediabetes, and change in glycated haemoglobin (HbA.sub.1c) in patients with diabetes. Hypoglycaemia was a prespecified safety outcome. Analysis was by intention to treat, using Cox proportional hazard models for time-to-event analyses. This trial is registered with ClinicalTrials.gov, number NCT02019264. Findings Between Feb 7, 2014, and Nov 20, 2015, 12,000 patients were randomly assigned to lorcaserin or placebo (6000 patients in each group) and followed up for a median of 3*3 years (IQR 3*0--3*5). At baseline, 6816 patients (56*8%) had diabetes, 3991 (33*3%) prediabetes, and 1193 (9*9%) normoglycaemia. At 1 year, patients treated with lorcaserin had a net weight loss beyond placebo of 2*6 kg (95% CI 2*3--2*9) for those with diabetes, 2*8 kg (2*5--3*2) for those with prediabetes, and 3*3 kg (2*6--4*0) for those with normoglycaemia (p Interpretation Lorcaserin decreases risk for incident diabetes, induces remission of hyperglycaemia, and reduces the risk of microvascular complications in obese and overweight patients, supporting the role of lorcaserin as an adjunct to lifestyle modification for chronic management of weight and metabolic health. Funding Eisai. Author Affiliation: (a) TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA, USA (b) Section of Endocrinology, Yale School of Medicine, New Haven, CT, USA (c) Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX, USA (d) NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia (e) Translational Research Institute for Metabolism and Diabetes, Florida Hospital, Orlando, FL, USA (f) Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada (g) Division of Nephrology/Hypertension, Vanderbilt University Medical Center, Nashville, TN, USA (h) Department of Cardiovascular Diseases, Catholic University School of Medicine, Santiago, Chile (i) The Kerchoff Heart Center, Bad Bauheim, Germany (j) Obesity, Metabolism and Nutrition Institute, Massachusetts General Hospital, Boston, MA, USA (k) Heart Institute, University of Sao Paulo, Sao Paulo, Brazil (l) CWZ Hospital, Nijmegen, Netherlands (m) Imperial Centre for Cardiovascular Disease Prevention, School of Public Health, Imperial College London, London, UK (n) Russian Cardiologic Research and Production Complex of Rosmedtechnology, Moscow, Russia (o) Internal Cardiology Department, University Hospital Brno, Brno, Czech Republic (p) Eisai, Woodcliff Lake, NJ, USA * Correspondence to: Dr Erin A Bohula, TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA 02115, USA (footnote)* Contributed equally (footnote)[Dagger] Contributed equally (footnote)[double dagger] Members listed in the appendix