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1. Anticoagulation and clinical outcomes in heart failure patients with atrial fibrillation: Findings from the ADHERE registry

Author

Eapen, ZJ, Mi, X, Fonarow, GC, Setoguchi, S, Piccini, JP, Mills, RM, Klaskala, W, Curtis, LH, and Hernandez, AF

Abstract

The risks and benefits of anticoagulation for patients with both heart failure and atrial fibrillation are unclear. We hypothesized that anticoagulation was associated with improved clinical outcomes of heart failure patients with atrial fibrillation independent of other risk factors. We conducted a retrospective cohort study of clinical registry data linked to Medicare claims for new users of oral anticoagulation (warfarin) without contraindications, discharged home alive, and stratified by CHADS2 score. Outcomes of interest were propensity score-adjusted estimates of the effects of warfarin at discharge on all-cause mortality, thromboembolic events, major adverse cardiovascular events, and bleeding events. Among 10,494 patients with heart failure and atrial fibrillation, the 2249 patients newly treated with warfarin had lower 1-year mortality (27.7% vs 39.3% for CHADS2 score ≤ 3 [P < .001]; 31.6% vs 41.8% for CHADS2 score > 3 [P < .001]) than patients not treated with warfarin. There was no significant difference in thromboembolic events, major adverse cardiovascular events, or bleeding events at 1 year. After multivariate adjustment, exposed individuals in both CHADS2 subgroups had lower adjusted 1-year mortality (CHADS2 ≤ 3: hazard ratio, 0.78 [95% confidence interval, 0.69-0.89]; CHADS 2 > 3: 0.78 [0.66-0.93]). In conclusion, warfarin use in heart failure patients with atrial fibrillation was associated with improved survival at 1 year independent of baseline CHADS2 score. However, there was no significant reduction in clinical events, such as thromboembolic or major adverse cardiovascular events at 1 year that might simply explain the survival benefit associated with warfarin.

Published
2013

3. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction

Author

Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM, and VICTORIA Study Group

Subjects
animal structures
Abstract

The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.

Published
2020

4. Assessment of analgesia, sedation, physical restraint and delirium in patients admitted to Spanish intensive care units. Proyecto ASCyD

Author

Arias-Rivera, S, Lopez-Lopez, C, Frade-Mera, MJ, Via-Clavero, G, Rodriguez-Mondejar, JJ, Sanchez-Sanchez, MM, Acevedo-Nuevo, M, Gil-Castillejos, D, Robleda, G, Cachon-Perez, M, Latorre-Marco, I, Mera, MJF, Rivera, SA, Vega, VB, Lavela, JE, Basurto, FP, Monzo, VM, Sanchez, MDS, Olivares, JCQ, Mancera, AIN, Jaen, SH, Diaz, NR, Rodriguez-Rey, LFC, Garcia, MDH, Lopez, CL, Sanz, TRV, de la Ventana, ABS, Martinez, MG, Olivera, MJT, Sanchez, LG, Gozalo, MJ, Pena, JAT, Dominguez, SR, Cobo, MCM, Fernandez, OH, Mora, MA, Gonzalez, MDB, Lopez, JM, Ayala, AC, Blanco, RG, Rodriguez-Palmero, LMM, Nuevo, MA, Marco, IL, Gonzalez, SG, Fernandez, AC, Santos, CF, Garcia, SD, Sevillano, MCA, Mondejar, JJR, Molina, AR, Celdran, DL, Lopez, NDE, Garcia, ABG, Sanz, LN, Rojo, FJM, Hernandez, AF, Gonzalez, SA, Viguria, RG, Oroz, AM, Berardo, BMM, Roig, MAZ, Ortiz, MDG, Orue, PA, Gallano, JB, Gomez, YG, Salazar, MLM, Nunez, CR, Martinez, MM, Aguado, GL, Hervas, PP, Marmaneu, MM, Artola, MMA, Cisternas, ES, Gimeno, YM, Calvo, AR, Tato, JLT, Carbonell, JI, Talavera, DV, Jara, MS, Martinez, JM, Sanchez, BM, Ceron, MY, and Pagan, MCP

Subjects
Critical care, Sedation, Pain, Delirium, Physical restraint, Nursing assessment
Abstract

Aims: Main aim: To determine the Spanish intensive care units (ICU) that assess and record pain levels, sedation/agitation, delirium and the use of physical restraint (PR) as standard practice. Secondary aims: To determine the use of validated assessment tools and to explore patients' levels of pain and sedation/agitation, the prevalence of delirium, and the use of PR. Method: An observational, descriptive, cross-sectional, prospective and multicentre study using an ad hoc survey with online access that consisted of 2 blocks. Block I: with questions on the unit's characteristics and routine practice; Block II: aspects of direct care and direct assessments of patients admitted to participating units. Results: One hundred and fifty-eight units and 1574 patients participated. The pain of communicative patients (CP) was assessed and recorded as standard in 109 units (69%), the pain of non-communicative patients (NCP) in 84 (53%), sedation/agitation in 111 (70%), and delirium in 39 units (25%). There was recorded use of PR in 39 units (25%). Validated scales were used to assess the pain of CP in 139 units (88%), of NCP in 102 (65%), sedation/agitation in 145 (92%), delirium in 53 units (34%). In 33 units (21%) pain, sedation/agitation and delirium of PC and NPC was assessed, and in 8 of these units there was a specific PR protocol and register. Among the patients who could be assessed, an absence of pain was reported in 57%, moderate pain in 27%; 48% were calm and collaborative, and 10% agitated; 21% had PR, and 12.6% of the patients had delirium. Conclusions: The assessment of pain, sedation and delirium is demonstrated, and low percentages of agitation and delirium achieved. We observed a high percentage of patients with pain, and moderate use of PC. We should generalise the use of protocols to assess, prevent and treat pain and delirium by appropriately managing analgesia, sedation, and individual and well-considered use of PC. (C) 2019 Sociedad Espanola de Enfermeria Intensiva y Unidades Coronarias (SEEIUC). Published by Elsevier Espana, S.L.U. All rights reserved.

Published
2020

5. Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial

Author

Voors, A, Bax, J, Hernandez, A, Wirtz, A, Pap, A, Ferreira, A, Senni, M, van der Laan, M, Butler, J, Voors AA, Bax JJ, Hernandez AF, Wirtz AB, Pap AF, Ferreira AC, Senni M, van der Laan M, Butler J, Voors, A, Bax, J, Hernandez, A, Wirtz, A, Pap, A, Ferreira, A, Senni, M, van der Laan, M, Butler, J, Voors AA, Bax JJ, Hernandez AF, Wirtz AB, Pap AF, Ferreira AC, Senni M, van der Laan M, and Butler J

Abstract

Aims: Neladenoson bialanate is a partial adenosine A1 receptor agonist with demonstrated beneficial effects on cardiac function in animal models. We aimed to assess the dose–response effect of neladenoson bialanate on cardiac structure and function, clinical outcome, and safety in patients with heart failure (HF) with reduced ejection fraction (HFrEF). Methods and results: PANTHEON was a dose-finding, phase IIb, randomized, double-blind, placebo-controlled trial conducted in 92 centres in 11 countries including 462 patients with chronic HFrEF, randomized to once daily oral dose of neladenoson bialanate (5, 10, 20, 30, and 40 mg) or placebo. The primary endpoints were change from baseline to 20 weeks in left ventricular ejection fraction (LVEF) (echocardiography) and in N-terminal pro-B-type natriuretic peptide (NT-proBNP). Mean age of the patients was 67 years, 17% were female, mean LVEF was 28%, mean NT-proBNP was 2085 ng/L. After 20 weeks of treatment, there was no dose–effect of neladenoson bialanate on changes in NT-proBNP or LVEF (primary endpoints). No effect of neladenoson bialanate was found on left ventricular volumes, high-sensitivity troponin T, or cardiovascular mortality, HF hospitalization, and urgent visits for HF (secondary endpoints). There was a dose-dependent increase in creatinine and cystatin C, and a dose-dependent decrease in estimated glomerular filtration rate and heart rate. Conclusions: In patients with chronic HFrEF, treatment with neladenoson bialanate was not associated with dose-dependent favourable effects on cardiac structure and function, cardiac risk markers, or clinical outcome but was associated with a dose-dependent decrease in renal function. Clinical Trial Registration: ClinicalTrials.gov Identifier NCT02992288.

Published
2019

7. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes

Author

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

Subjects
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

Published
2017
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8. Comparison of fatal or irreversible events with extended-duration betrixaban versus standard dose enoxaparin in acutely Ill medical patients: An APEX trial substudy

Author

Gibson, CM, Korjian, S, Chi, G, Daaboul, Y, Jain, P, Arbetter, D, Goldhaber, SZ, Hull, R, Hernandez, AF, Lopes, RD, Gold, A, Cohen, AT, Harrington, RA, Bello, F, Ferrari, AE, Jure, H, Macin, S, Oliva, M, Parody, M, Poy, C, Baker, R, Colquhoun, D, Coughlin, P, Finfer, S, Hammerschlag, G, Rubinfeld, A, Huber, K, König, J, Mathies, R, Pilger, E, Schoenerr, H, Adzerikho, I, Koryk, V, Mikhailova, E, Mitkovskaya, N, Pimanov, S, Polonetsy, L, Soroka, N, Blockmans, D, Delforge, M, Dive, A, Lienart, F, Motte, S, Annichino Bizzacchi, J, Fiss, E, Freire, A, Manenti, E, Ramacciotti, E, Raymuno, S, Rocha, A, Saraiva, JF, Dimov, B, Grigorov, M, Kalpachki, R, Kamenova, Z, Kostadinova, M, Milanova, M, Mincheva, V, Pencheva, G, Raev, D, Runev, N, Stoeva, N, Stoyanov, M, Syulemzova, S, Todorov, G, Tokmakova, M, Dhar, A, Douketis, J, Kahn, S, Le Gal, G, Pearce, M, Provencher, S, Verreault, S, Arias Alarcon, M, Olivares Cañon, C, Opazo Lazcano, M, Potthoff Cardenas, S, Butkovic-Soldo, S, Car, S, Ciglenecki, N, Francetic, I, Jakopovic, M, Kalinic-Grgorinic, H, Knezevic, A, Malojcic, B, Marusic, S, Sikic Vagic, J, Skerk, V, Cermak, O, Cervinka, P, Chlumsky, J, Chochola, J, Cizek, V, Dunaj, M, Dusek, J, Francek, L, Havelka, J, Herold, M, Holaj, R, Horny, I, Gibson, CM, Korjian, S, Chi, G, Daaboul, Y, Jain, P, Arbetter, D, Goldhaber, SZ, Hull, R, Hernandez, AF, Lopes, RD, Gold, A, Cohen, AT, Harrington, RA, Bello, F, Ferrari, AE, Jure, H, Macin, S, Oliva, M, Parody, M, Poy, C, Baker, R, Colquhoun, D, Coughlin, P, Finfer, S, Hammerschlag, G, Rubinfeld, A, Huber, K, König, J, Mathies, R, Pilger, E, Schoenerr, H, Adzerikho, I, Koryk, V, Mikhailova, E, Mitkovskaya, N, Pimanov, S, Polonetsy, L, Soroka, N, Blockmans, D, Delforge, M, Dive, A, Lienart, F, Motte, S, Annichino Bizzacchi, J, Fiss, E, Freire, A, Manenti, E, Ramacciotti, E, Raymuno, S, Rocha, A, Saraiva, JF, Dimov, B, Grigorov, M, Kalpachki, R, Kamenova, Z, Kostadinova, M, Milanova, M, Mincheva, V, Pencheva, G, Raev, D, Runev, N, Stoeva, N, Stoyanov, M, Syulemzova, S, Todorov, G, Tokmakova, M, Dhar, A, Douketis, J, Kahn, S, Le Gal, G, Pearce, M, Provencher, S, Verreault, S, Arias Alarcon, M, Olivares Cañon, C, Opazo Lazcano, M, Potthoff Cardenas, S, Butkovic-Soldo, S, Car, S, Ciglenecki, N, Francetic, I, Jakopovic, M, Kalinic-Grgorinic, H, Knezevic, A, Malojcic, B, Marusic, S, Sikic Vagic, J, Skerk, V, Cermak, O, Cervinka, P, Chlumsky, J, Chochola, J, Cizek, V, Dunaj, M, Dusek, J, Francek, L, Havelka, J, Herold, M, Holaj, R, and Horny, I

Abstract

Background-Extended-duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results-This was a post hoc analysis of the APEX trial-a multicenter, double-blind, randomized controlled trial comparing extended-duration betrixaban versus standard-of-care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time-to-first event analysis. In patients with positive D-dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [P=0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [P=0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [P=0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [P=0.002]). Conclusions-Among hospitalized medically ill patients, extended-duration betrixaban demonstrated an ≈ 30% reduction in fatal or irreversible ischemic or bleeding events compared with standard-duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin.

Published
2017

9. Simulating real-life exposures to uncover possible risks to human health: A proposed consensus for a novel methodological approach

Author

Tsatsakis, AM, primary, Kouretas, D, additional, Tzatzarakis, MN, additional, Stivaktakis, P, additional, Tsarouhas, K, additional, Golokhvast, KS, additional, Rakitskii, VN, additional, Tutelyan, VA, additional, Hernandez, AF, additional, Rezaee, R, additional, Chung, G, additional, Fenga, C, additional, Engin, AB, additional, Neagu, M, additional, Arsene, AL, additional, Docea, AO, additional, Gofita, E, additional, Calina, D, additional, Taitzoglou, I, additional, Liesivuori, J, additional, Hayes, AW, additional, Gutnikov, S, additional, and Tsitsimpikou, C, additional

Published
2016
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22. Trends in use of implantable cardioverter-defibrillator therapy among patients hospitalized for heart failure: have the previously observed sex and racial disparities changed over time?

Author

Al-Khatib SM, Hellkamp AS, Hernandez AF, Fonarow GC, Thomas KL, Al-Khalidi HR, Heidenreich PA, Hammill S, Yancy C, Peterson ED, Get With the Guidelines Steering Committee and Hospitals, Al-Khatib, Sana M, Hellkamp, Anne S, Hernandez, Adrian F, Fonarow, Gregg C, Thomas, Kevin L, Al-Khalidi, Hussein R, Heidenreich, Paul A, Hammill, Stephen, and Yancy, Clyde

Published
2012
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23. Indications for cardiac resynchronization therapy: 2011 update from the heart failure society of america guideline committee.

Author

Stevenson WG, Hernandez AF, Carson PE, Fang JC, Katz SD, Spertus JA, Sweitzer NK, Tang WH, Albert NM, Butler J, Westlake Canary CA, Collins SP, Colvin-Adams M, Ezekowitz JA, Givertz MM, Hershberger RE, Rogers JG, Teerlink JR, Walsh MN, and Stough WG

Abstract

Cardiac resynchronization therapy (CRT) improves survival, symptoms, quality of life, exercise capacity, and cardiac structure and function in patients with New York Heart Association (NYHA) functional class II or ambulatory class IV heart failure (HF) with wide QRS complex. The totality of evidence supports the use of CRT in patients with less severe HF symptoms. CRT is recommended for patients in sinus rhythm with a widened QRS interval (>=150 ms) not due to right bundle branch block (RBBB) who have severe left ventricular (LV) systolic dysfunction and persistent NYHA functional class II-III symptoms despite optimal medical therapy (strength of evidence A). CRT may be considered for several other patient groups for whom evidence of benefit is clinically significant but less substantial, including patients with a QRS interval of >=120 to <150 ms and severe LV systolic dysfunction who have persistent mild to severe HF despite optimal medical therapy (strength of evidence B), some patients with atrial fibrillation, and some with ambulatory class IV HF. Several evidence gaps remain that need to be addressed, including the ideal threshold for QRS duration, QRS morphology, lead placement, degree of myocardial scarring, and the modality for evaluating dyssynchrony. Recommendations will evolve over time as additional data emerge from completed and ongoing clinical trials. [ABSTRACT FROM AUTHOR]

Published
2012

27. Patient Characteristics From a Regional Multicenter Database of Acute Decompensated Heart Failure in Asia Pacific (ADHERE International-Asia Pacific)

Author

Atherton JJ, Hayward CS, Wan Ahmad WA, Kwok B, Jorge J, Hernandez AF, Liang L, Kociol RD, Krum H, and ADHERE International-Asia Pacific Scientific Advisory Committee

Abstract

BACKGROUND: Heart failure (HF) is a leading cause of hospitalization. Although a number of multicenter international HF hospital registries have been published, there are limited data for the Asia Pacific region. METHODS: ADHERE (ie, Acute Decompensated Heart Failure Registry) International-Asia Pacific is an electronic web-based observational database of 10,171 patients hospitalized with a principal diagnosis of HF from 8 Asia-Pacific countries between January 2006 and December 2008. RESULTS: The median age (67 years) varied by more than 2 decades across the region. Fifty-seven percent of patients were male. Ninety percent of patients were Asian and 8.4% were white. Dyspnea was the presenting symptom in 95%, with 80% having documented rales. During the index hospitalization, left ventricular function was assessed in 50%, and intravenous therapies included diuretics (85%), vasodilators (14%), and positive inotropes (15%). In-hospital mortality was 4.8%. Discharge medications included angiotensin-converting enzyme inhibitors and/or angiotensin receptor blockers (63%), [beta]-blockers (41%), and aldosterone antagonists (31%). CONCLUSIONS: Compared with other multicenter registries, patients hospitalized with acute HF in the Asia Pacific region tend to present with more severe clinical symptoms and signs and are younger, especially in countries at an earlier stage in their epidemiological transition. Echocardiography and disease-modifying medications are used less often, highlighting potential opportunities to improve outcomes. [ABSTRACT FROM AUTHOR]

Published
2012

31. The need for multiple measures of hospital quality: results from the get with the guidelines-heart failure registry of the american heart association.

Author

Hernandez AF, Fonarow GC, Liang L, Heidenreich PA, Yancy C, and Peterson ED

Subjects
*HEART failure treatment, *HOSPITAL statistics, *CARDIOVASCULAR system physiology, *CLINICAL medicine, *DIAGNOSIS related groups, *HEART failure, *HOSPITAL patients, *HOSPITALS, *EVALUATION of medical care, *MEDICAL protocols, *MEDICARE, *QUALITY assurance, *COMORBIDITY, *KEY performance indicators (Management), *RELATIVE medical risk, *ACQUISITION of data, *PATIENT readmissions
Abstract

Background- Process and outcome measures are often used to quantify quality of care in hospitals. Whether these quality measures correlate with one another and the degree to which hospital provider rankings shift on the basis of the performance metric is uncertain. Methods and Results- Heart failure patients >=65 years of age hospitalized in the Get With the Guidelines-Heart Failure registry of the American Heart Association were linked to Medicare claims from 2005 to 2006. Hospitals were ranked by (1) composite adherence scores for 5 heart failure process measures, (2) composite adherence scores for emerging quality measures, (3) risk-adjusted 30-day death after admission, and (4) risk-adjusted 30-day readmission after discharge. Hierarchical models using shrinkage estimates were performed to adjust for case mix and hospital volume. There were 19 483 patients hospitalized from 2005 to 2006 from 153 hospitals. The overall median composite adherence rate to heart process measures was 85.8% (25th, 75th percentiles 77.5, 91.4). Median 30-day risk-adjusted mortality was 9.0% (7.9, 10.4). Median risk-adjusted 30-day readmission was 22.9% (22.1, 23.5). The weighted [kappa] for remaining within the top 20th percentile or bottom 20th percentile was <=0.15 and the Spearman correlation overall was <=0.21 between the different measures of quality of care. The average shift in ranks was 33 positions (13, 68) when criteria were changed from 30-day mortality to readmission and 51 positions (22, 76) when ranking metric changed from 30-day mortality to composite process adherence. Conclusions- Agreement between different methods of ranking hospital-based quality of care and 30-day mortality or readmission rankings was poor. Profiling quality of care will require multidimensional ranking methods and/or additional measures. [ABSTRACT FROM AUTHOR]

Published
2011
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32. Predictors of hospital length of stay in heart failure: findings from get with the guidelines.

Author

Whellan DJ, Zhao X, Hernandez AF, Liang L, Peterson ED, Bhatt DL, Heidenreich PA, Schwamm LH, and Fonarow GC

Abstract

BACKGROUND: This study was undertaken to identify predictors of hospital length of stay (LOS) for heart failure (HF) patients using clinical variables available at the time of admission and hospital characteristics. METHODS AND RESULTS: A cohort of 70,094 HF patients discharged to home from 246 hospitals participating in the Get With The Guidelines-Heart Failure was analyzed for admission predictors for LOS. The analysis incorporated patient characteristics (PC) first, then added hospital characteristics (HC) followed by standard laboratory evaluations (SL), including troponin and brain natriuretic peptide (BNP). There were 31,995 patients (45.6%) with LOS < 4 days, 26,750 (38.2%) with LOS 4 to 7 days, and 11,349 (16.2%) with LOS > 7 days. Patients with longer LOS had more comorbidities and a higher severity of disease on admission. Overall models explained a modest amount of LOS variation, with an r(2) of 4.8%, with PC responsible for 1.3% of variation and together with SL explained 2.2% of variation. HC did not change the variation. CONCLUSIONS: Based on admission vital signs and BNP levels, patients with longer LOS have more comorbidities and a higher disease severity. The ability to risk stratify for LOS based on patient admission and hospital characteristics is limited. [ABSTRACT FROM AUTHOR]

Published
2011

33. Use and predictors of heart failure disease management referral in patients hospitalized with heart failure: insights from the get with the guidelines program.

Author

Gharacholou SM, Hellkamp AS, Hernandez AF, Peterson ED, Bhatt DL, Yancy CW, and Fonarow GC

Abstract

BACKGROUND: Heart failure disease management (HFDM) may be beneficial in heart failure (HF) patients at risk for readmission or post-discharge mortality. However, characteristics of hospitalized HF patients referred to HFDM are not known. METHODS AND RESULTS: Get With the Guidelines (GWTG) program data was used to analyze 57,969 patients hospitalized with HF from January 2005 through January 2010 from 235 sites. Factors associated with referral to HFDM and rates of HF quality measures by referral status were studied. Mean age of patients was 69.7 ± 14.5 years, 52% were men, and 65% were white. HFDM referral occurred in 11,150 (19.2%) patients. The median rate of HFDM referral among all hospitals was 3.5% (25th-75th percentiles 0%-16.7%) and 8.7% (2.8%-27.7%) among hospitals with at least one previous HFDM referral. Quality and performance measures were higher in patients referred to HFDM. HFDM referral was associated with atrial fibrillation, implanted cardiac device, depression, and treatment at larger hospitals. Patients at higher 90-day mortality risk were paradoxically less likely to receive HFDM referral. CONCLUSIONS: HFDM referral occurred in less than one-fifth of hospitalized HF patients and was more frequently recommended to lower-risk patients. Increasing use and optimizing selection of patients for HFDM referral is a potential target for quality improvement. [ABSTRACT FROM AUTHOR]

Published
2011

41. Linking inpatient clinical registry data to Medicare claims data using indirect identifiers.

Author

Hammill BG, Hernandez AF, Peterson ED, Fonarow GC, Schulman KA, Curtis LH, Hammill, Bradley G, Hernandez, Adrian F, Peterson, Eric D, Fonarow, Gregg C, Schulman, Kevin A, and Curtis, Lesley H

Abstract

Background: Inpatient clinical registries generally have limited ability to provide a longitudinal perspective on care beyond the acute episode. We present a method to link hospitalization records from registries with Medicare inpatient claims data, without using direct identifiers, to create a unique data source that pairs rich clinical data with long-term outcome data.Methods and Results: The method takes advantage of the hospital clustering observed in each database by demonstrating that different combinations of indirect identifiers within hospitals yield a large proportion of unique patient records. This high level of uniqueness also allows linking without advance knowledge of the Medicare provider number of each registry hospital. We applied this method to 2 inpatient databases and were able to identify 81% of 39,178 records in a large clinical registry of patients with heart failure and 91% of 6,581 heart failure records from a hospital inpatient database. The quality of the link is high, and reasons for incomplete linkage are explored. Finally, we discuss the unique opportunities afforded by combining claims and clinical data for specific analyses.Conclusions: In the absence of direct identifiers, it is possible to create a high-quality link between inpatient clinical registry data and Medicare claims data. The method will allow researchers to use existing data to create a linked claims-clinical database that capitalizes on the strengths of both types of data sources. [ABSTRACT FROM AUTHOR]

Published
2009
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49. Fatal Moclobemide Overdose or Death Caused by Serotonin Syndrome?

Author

Hernandez, AF, Montero, MN, Pla, A, and Villanueva, E

Abstract

A 41-year-old man was found dead in a hotel room. He was previously diagnosed with depression. Multiple containers of medication and paraphenalia were found at the scene. Autopsy findings included fully developed rigor mortis and pulmonary edema with hemorrhage. Toxicologic analysis of different body fluids was performed and the following drugs were identified in the blood (mg/L): moclobemide (59.76), clomipramine (1.69), tramadol (10.89), diazepam (2.08), nordiazepam (0.82) and caffeine (9.64). A fatal serotonin syndrome was presumably developed as a result of moclobemide-clomipramine interaction as has been recently reported. Tramadol could have a synergistic effect on that syndrome. The forensic pathologists ruled that the cause of death was multiple drug intoxication resulting in serotonin syndrome and that the manner of death was suicide. However, an accidental death from drug abuse could be an alternative diagnosis.

Published
1995
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