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1. The effect of frequent hemodialysis on self-reported sleep quality: Frequent Hemodialysis Network Trials

Author

Unruh, Mark L., Larive, Brett, Eggers, Paul W., Garg, Amit X., Gassman, Jennifer J., Finkelstein, Fredric O., Kimmel, Paul L., Chertow, Glenn M., Achinger, S., Anderson, S., Appel, L., Apruzzes, R., Atwal, J., Augustine, B., Ayus, J., Bardsley, J., Bay, W., Beach, S., Beck, G., Bharti, B., Briggs, J., Bullas, R., Burkart, J., Burrowes, J., Cabezon, E., Callegari, J., Carter, M., Champagne, J., Chan, C., Chan, W., Chang, J., Chertow, G., Cheung, A., Copland, M., Coplon, N., Coppley, A., Daugirdas, J., Dellagrottaglie, S., Depner, T., Derse, A., Dominguez, A., Doss, S., Eggers, P., Eknoyan, G., Escalada, R., Fensterer, A., Finkelstein, F., Fofie, Y., Franzwa, B., Frome, R., Fu, Z., Garg, A., Gassman, J., Gayda, P., Geller, N., Geronemus, R., Goodman, W., Gorodetskaya, I., Gotch, F., Greene, T., Greenwood, R., Grimm, R., Gutierrez, M., Hall, Y., Handelman, G., Henderson, L., Hernandez, A., Higgins, H., Hilkin, A., Hostetter, T., Hoy, C., Humphreys, M., Hunsicker, L., James, S., Kariisa, M., Kaufman, A., Kaufman, T., Kaysen, G., Ke, S., Keene, R., Kimmel, P., Kliger, A., Kotanko, P., Kramer, C., Kuhlmann, M., Kwan, S., Kwok, S., Lacson, E., Larive, B., Leavell, E., Lemus, D., Levin, A., Levin, N., Li, M., Lilli, K., Lindsay, R., Lockridge, R., Luan, J., MacKrell, J., Manaster, R., Mandaci, O., Mathew, R., Mauck, V., Mazzorato, A., McCulloch, C., McGrath-Chong, M., McLeroy, S., Mehta, R., Meisels, I., Miller, B., Mohr, P., Moossavi, S., Nabali, A., Narva, A., Nissenson, A., Ornt, D., Painter, P., Pepas, J., Peterson, C., Pierratos, A., Pipkin, M., Prichard, S., Rajagopalan, S., Ramos, R., Rashid, M., Rastogi, A., Regozo, K., Riley, J., Rivas, M., Rocco, M., Rodriquez, R., Roecker, E., Roger, D., Rogers, J., Salusky, I., Sanz, G., Sanz, J., Schiller-Moran, B., Schlarb, J., Schuessler, R., Schulman, G., Schweitzer, S., Sergeyeva, O., Shah, S., Sherer, S., Sika, M., Sioson, L., Skelton, R., Smith, M., Snell, C., Somers, D., Sonico, J., Spanner, E., Star, R., Steigerwald, D., Stokes, J., Suri, R., Suter, M., Tamura, M., Tarallo, M., Tichy, M., Ting, G., Tran, T., Ulloa, D., Unruh, M., Vassalotti, J., Wallace, W., Waterman, E., Wei, J., Weiss, B., West, J., Wiggins, K., and Winchester, J.

Published
2016
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7. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis

Author

Chertow GM, Block GA, Correa-Rotter R, Drüeke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS., Evolve Team, Chertow G, Parfrey P, Block G, Drüeke T, Goodman W, Herzog C, London G, Mahaffey K, Moe S, Wheeler D, Hennekens C, Baigent C, Brown W, O'Brien P, Anderson S, Hoel J, Szczech L, Patel U, Wampole J, Pun P, Felker M, Inrig J, Shah S, Hernandez A, Patel C, Brennan M, Albizem M, Capper E, Cauchi L, Cheng S, Dehmel B, Dhami K, Durham C, Francioni M, Gadd S, Goodman B, Guimaraes L, Grey N, Hamlin R, Harris C, Harris E, Heavey S, Heiges T, Heiser D, Jaeger P, James M, James P, Karimi S, Kewalramani R, Kraszewski A, Liang J, Maguire J, McCormick K, McFarlane K, Mix C, Modafferi D, Prathikanti R, Ryan C, Santiago N, Schumacher J, Seder C, Shahinfar S, Soares B, Stolman D, Tisher C, Trotman M, Tseng S, Ulias G, Unger P, Vyshenskaya A, Walsh L, White C, Wilde K, Santos J, Zarazaga C, Marin I, Garrote N, Cusumano A, Penalba N, Del Valle E, Juncos L, Saye J, Lef L, Altobelli V, Petraglia G, Rosa-Diez G, Douthat W, Lobo J, Gallart C, Lafalla A, Diez G, Linares B, Lopez N, Ramirez N, Gonzalez R, Valtuille R, Beresan H, Hermida O, Rudolf G, Marchetta N, Rano M, Ramirez M, Garcia N, Gillies A, Jones B, Pedagogos E, Walker R, Talaulikar G, Bannister K, Suranyi M, Kark A, Roger S, Kerr P, Disney A, Mount P, Fraenkel M, Mathew M, Fassett R, Jose M, Hawley C, Lonergan M, Mackie J, Ferrari P, Menahem S, Sabto J, Hutchison B, Langham R, Pollock C, Holzer H, Oberbauer R, Arias I, Graf H, Mayer G, Lhotta K, Neyer U, Klauser-Braun R, Hoerl W, Horn S, Kovarik J, Kramar R, Eigner M, Dhaene M, Billiouw J, De Meester J, Warling X, Cambier-Dwelschauwers P, Evenepoel P, Daelemans R, Dratwa M, Maes B, Stolear J, Dejagere T, Vanwalleghem J, Bouman K, Jadoul M, Peeters J, Vanholder R, Tielemans C, Donck J, Almeida F, de Oliveira J, Burdmann E, Garcia V, Thome F, Deboni L, Bregman R, Lugon J, Araújo S, Ferreira Filho S, Daher Ede F, Baptista M, Carvalho A, d'Avila D, Moyses Neto M, Yu L, Bastos M, Lacativa P, Jorgetti V, Romão Ede A, da Costa JC, Pecoits Filho R, Gordan P, Salgado N, Araújo M, Coelho S, Oliveira I, Moysés R, Vasconcellos L, Batista P, Gross J, Pedrosa A, Cournoyer S, LeBlanc M, Chow S, Karunakaran S, Wong G, Tobe S, Desmeules S, Zimmerman D, Murphy S, Montambault P, Donnelly S, MacRae J, Culleton B, Soroka S, Rabbat C, Jindal K, Vasilevsky M, Michaud M, Wijeyesinghe E, Zacharias J, Lok C, Muirhead N, Verrelli M, Da Roza G, Sapir D, Olgaard K, Daugaard H, Brandi L, Jensen P, Boulechfar H, Ang K, Simon P, Rieu P, Brunet P, Touchard G, Torres P, Combe C, Durrbach A, Ortiz J, Hannedouche T, Vela C, Lionet A, Ryckelynck P, Zaoui P, Choukroun G, Fessi H, Lang P, Stroumza P, Joly D, Mousson C, Laville M, Dellanna F, Erley C, Braun J, Rambausek M, Riegel W, Klingberg M, Schwertfeger E, Wizemann V, Eckardt K, Reichel H, Passauer J, Hübel E, Frischmuth N, Liebl R, Fiedler R, Schwenger V, Voßkühler A, Kunzendorf U, Renders L, Rattensberger D, Rump L, Ketteler M, Neumayer H, Zantvoort F, Stahl R, Ladanyi E, Braun B, Kulcsar I, Mezei I, Csiky B, Rikker C, Arkossy O, Berta K, Szegedi J, Major L, Ferenczi S, Fekete A, Szabo T, Zakar G, Wagner G, Erdelyine S, Borbas B, Eustace J, Reddan D, Capasso G, Locatelli F, Villa G, Cozzolino M, Brancaccio D, Messa P, Bolasco P, Ricciardi B, Malberti F, Moriero E, Cannella G, Ortalda V, Stefoni S, Frascà G, Cappelli G, Albertazzi A, Zoccali C, Farina M, Elli A, Avella F, Ondei P, Mingardi G, Errico R, Losito A, Di Giulio S, Pertosa G, Schena F, Grandaliano G, Gesualdo L, Auricchio M, Bochicchio-Ricardelli T, Correa-Rotter J, Verástegui F, Peña J, Wong A, Cruz-Valdez J, Zamora M, Solis M, Diaz M, Flores M, Sandoval E, van den Dorpel M, Brink H, Van Kuijk W, Vermeij C, Gregoor P, Hagen E, van der Sande F, Klinger M, Nowicki M, Muszytowski M, Bidas K, Bentkowski W, Wiecek A, Ksiazek A, Marczewski K, Ostrowski M, Switalski M, Sulowicz W, Matuszkiewicz-Rowinska J, Mysliwiec M, Durlik M, Rutkowski B, Macario F, Carvalho B, Frazao J, Machado D, Weigert A, Andrusev A, Khrustalev O, Zemtchenkov A, Gurevich K, Staroselsky K, Khadikova N, Rozhinskaya L, Timokhovskaya G, Strokov A, Balkarova O, Ermolenko V, Kolmakova E, Komandenko M, Timofeev M, Shilo V, Shostka G, Smirnov A, Anashkin V, Volgina G, Domashenko O, Gurevich A, Perlin D, García J, Ribes E, Piera E, Lucas M, Galicia M, Prados M, González M, Romero R, de Francisco ÁM, Montenegro J, Santiago C, García F, de La Ossa J, Arrieta J, Pons J, Martín-Malo A, Amigó J, Cases A, Sterner G, Jensen G, Wikström B, Jacobson S, Lund U, Weiss L, Ståhl A, von Albertini B, Burnier M, Meier P, Martin P, Uehlinger D, Dickenmann M, Yaqoob M, Zehnder D, Kalra P, Padmanabhan N, Roe S, Eadington D, Pritchard N, Hutchison A, Davies S, Wilkie M, Davies M, Pai P, Swift P, Kwan J, Goldsmith D, Tomson C, Stratton J, Dasgupta I, Sarkar S, Moustafa M, Gandhi K, Jamal A, Galindo-Ramos E, Tuazon J, Batlle D, Tucker K, Schiller-Moran B, Assefi A, Martinez C, Samuels L, Goldman J, Cangiano-Rivera J, Darwish R, Lee M, Topf J, Kapatkin K, Baer H, Kopelman R, Acharya M, Tharpe D, Bernardo M, Nader P, Guzman-Rivera J, Pergola P, Sekkarie M, Alas E, Zager P, Liss K, Navarro J, Roppolo M, Denu-Ciocca C, Kshirsagar A, El Khatib M, Kant K, Scott D, Murthyr B, Finkelstein F, Keightley G, McCrary R, Pitone J, Cavalieri T, Tsang A, Pellegrino B, Schmidt R, Ahmad S, Brown C, Friedman E, Mittman N, Fadem S, Shapiro W, Reddy M, Goldberger S, Woredekal Y, Agarwal A, Anger M, Haque M, Chidester P, Kohli R, Rubinstein S, Newman G, Gladish R, Ayodeji O, Soman S, Sprague S, Hunt N, Gehr T, Rizk D, Warnock D, Polack D, Pahl M, Fischer D, Dreyer P, James G, Husserl F, Rogers T, Raff A, Sedor J, Silver M, Smith M, Steinberg S, DelGiorno T, Jones E, Cunha P, Cheng J, Pogue V, Blumenthal S, Brown E, Charytan C, Buerkert J, Cook M, Felsenfeld A, Tareen N, Gupta A, Herman T, Diamond S, Hura C, Laski M, MacLaurin J, Plumb T, Brosnahan G, Kumar J, Henriquez M, Poole C, Osanloo E, Matalon A, Sholer C, Arfeen S, Azer M, Belledonne M, Gross M, Dunnigan E, McConnell K, Becker B, Rigolosi R, Spiegel D, Stegman M, Patak R, Streja D, Ranjit U, Youell T, Wooldridge T, Stafford C, Cottiero R, Weinberg M, Schonefeld M, Shahmir E, Hazzan A, Ashfaq A, Bhandari K, Cleveland W, Culpepper M, Golden J, Lai L, Lien Y, Lorica V, Robertson J, Malireddi K, Morse S, Thakur V, Israelit A, Raguram P, Alfred H, Weise W, Al-Saghir F, El Shahawy M, Rastogi A, Nissenson A, Kopyt N, Lynn R, Lea J, McClellan W, Teredesai P, Ong S, Tolkan S, Sugihara J, Minga T, Mehrotra R, Minasian R, Bhatia D, Specter R, Capelli J, Sidhu P, Dalal S, Dykes P, Khan M, Rahim F, Saklayen M, Thomas A, Michael B, Torres M, Al-Bander H, Murray B, Abukurah A, Gupta B, Nosrati S, Raja R, Zeig S, Braun M, Amatya A, Endsley J, Sharon Z, Dolson G, Dumler F, Ntoso K, Rosansky S, Kumar N, Gura V, Thompson N, Goldfarb D, Halligan R, Middleton J, Widerhorn A, Arbeit L, Arruda J, Crouch T, Friedman L, Khokhar S, Mittleman J, Light P, Taparia B, West C, Cotton J, Dhingra R, Kleinman L, Arif F, Lew S, Nammour T, Sterrett J, Williams M, Ramirez J, Rubin J, McCarthy J, Noble S, Chaffin M, Rekhi A., Chertow, Gm, Block, Ga, Correa-Rotter, R, Drüeke, Tb, Floege, J, Goodman, Wg, Herzog, Ca, Kubo, Y, London, Gm, Mahaffey, Kw, Mix, Tc, Moe, Sm, Trotman, Ml, Wheeler, Dc, Parfrey, Ps., Evolve, Team, Chertow, G, Parfrey, P, Block, G, Drüeke, T, Goodman, W, Herzog, C, London, G, Mahaffey, K, Moe, S, Wheeler, D, Hennekens, C, Baigent, C, Brown, W, O'Brien, P, Anderson, S, Hoel, J, Szczech, L, Patel, U, Wampole, J, Pun, P, Felker, M, Inrig, J, Shah, S, Hernandez, A, Patel, C, Brennan, M, Albizem, M, Capper, E, Cauchi, L, Cheng, S, Dehmel, B, Dhami, K, Durham, C, Francioni, M, Gadd, S, Goodman, B, Guimaraes, L, Grey, N, Hamlin, R, Harris, C, Harris, E, Heavey, S, Heiges, T, Heiser, D, Jaeger, P, James, M, James, P, Karimi, S, Kewalramani, R, Kraszewski, A, Liang, J, Maguire, J, Mccormick, K, Mcfarlane, K, Mix, C, Modafferi, D, Prathikanti, R, Ryan, C, Santiago, N, Schumacher, J, Seder, C, Shahinfar, S, Soares, B, Stolman, D, Tisher, C, Trotman, M, Tseng, S, Ulias, G, Unger, P, Vyshenskaya, A, Walsh, L, White, C, Wilde, K, Santos, J, Zarazaga, C, Marin, I, Garrote, N, Cusumano, A, Penalba, N, Del Valle, E, Juncos, L, Saye, J, Lef, L, Altobelli, V, Petraglia, G, Rosa-Diez, G, Douthat, W, Lobo, J, Gallart, C, Lafalla, A, Diez, G, Linares, B, Lopez, N, Ramirez, N, Gonzalez, R, Valtuille, R, Beresan, H, Hermida, O, Rudolf, G, Marchetta, N, Rano, M, Ramirez, M, Garcia, N, Gillies, A, Jones, B, Pedagogos, E, Walker, R, Talaulikar, G, Bannister, K, Suranyi, M, Kark, A, Roger, S, Kerr, P, Disney, A, Mount, P, Fraenkel, M, Mathew, M, Fassett, R, Jose, M, Hawley, C, Lonergan, M, Mackie, J, Ferrari, P, Menahem, S, Sabto, J, Hutchison, B, Langham, R, Pollock, C, Holzer, H, Oberbauer, R, Arias, I, Graf, H, Mayer, G, Lhotta, K, Neyer, U, Klauser-Braun, R, Hoerl, W, Horn, S, Kovarik, J, Kramar, R, Eigner, M, Dhaene, M, Billiouw, J, De Meester, J, Warling, X, Cambier-Dwelschauwers, P, Evenepoel, P, Daelemans, R, Dratwa, M, Maes, B, Stolear, J, Dejagere, T, Vanwalleghem, J, Bouman, K, Jadoul, M, Peeters, J, Vanholder, R, Tielemans, C, Donck, J, Almeida, F, de Oliveira, J, Burdmann, E, Garcia, V, Thome, F, Deboni, L, Bregman, R, Lugon, J, Araújo, S, Ferreira Filho, S, Daher Ede, F, Baptista, M, Carvalho, A, D'Avila, D, Moyses Neto, M, Yu, L, Bastos, M, Lacativa, P, Jorgetti, V, Romão Ede, A, da Costa, Jc, Pecoits Filho, R, Gordan, P, Salgado, N, Araújo, M, Coelho, S, Oliveira, I, Moysés, R, Vasconcellos, L, Batista, P, Gross, J, Pedrosa, A, Cournoyer, S, Leblanc, M, Chow, S, Karunakaran, S, Wong, G, Tobe, S, Desmeules, S, Zimmerman, D, Murphy, S, Montambault, P, Donnelly, S, Macrae, J, Culleton, B, Soroka, S, Rabbat, C, Jindal, K, Vasilevsky, M, Michaud, M, Wijeyesinghe, E, Zacharias, J, Lok, C, Muirhead, N, Verrelli, M, Da Roza, G, Sapir, D, Olgaard, K, Daugaard, H, Brandi, L, Jensen, P, Boulechfar, H, Ang, K, Simon, P, Rieu, P, Brunet, P, Touchard, G, Torres, P, Combe, C, Durrbach, A, Ortiz, J, Hannedouche, T, Vela, C, Lionet, A, Ryckelynck, P, Zaoui, P, Choukroun, G, Fessi, H, Lang, P, Stroumza, P, Joly, D, Mousson, C, Laville, M, Dellanna, F, Erley, C, Braun, J, Rambausek, M, Riegel, W, Klingberg, M, Schwertfeger, E, Wizemann, V, Eckardt, K, Reichel, H, Passauer, J, Hübel, E, Frischmuth, N, Liebl, R, Fiedler, R, Schwenger, V, Voßkühler, A, Kunzendorf, U, Renders, L, Rattensberger, D, Rump, L, Ketteler, M, Neumayer, H, Zantvoort, F, Stahl, R, Ladanyi, E, Braun, B, Kulcsar, I, Mezei, I, Csiky, B, Rikker, C, Arkossy, O, Berta, K, Szegedi, J, Major, L, Ferenczi, S, Fekete, A, Szabo, T, Zakar, G, Wagner, G, Erdelyine, S, Borbas, B, Eustace, J, Reddan, D, Capasso, G, Locatelli, F, Villa, G, Cozzolino, M, Brancaccio, D, Messa, P, Bolasco, P, Ricciardi, B, Malberti, F, Moriero, E, Cannella, G, Ortalda, V, Stefoni, S, Frascà, G, Cappelli, G, Albertazzi, A, Zoccali, C, Farina, M, Elli, A, Avella, F, Ondei, P, Mingardi, G, Errico, R, Losito, A, Di Giulio, S, Pertosa, G, Schena, F, Grandaliano, G, Gesualdo, L, Auricchio, M, Bochicchio-Ricardelli, T, Correa-Rotter, J, Verástegui, F, Peña, J, Wong, A, Cruz-Valdez, J, Zamora, M, Solis, M, Diaz, M, Flores, M, Sandoval, E, van den Dorpel, M, Brink, H, Van Kuijk, W, Vermeij, C, Gregoor, P, Hagen, E, van der Sande, F, Klinger, M, Nowicki, M, Muszytowski, M, Bidas, K, Bentkowski, W, Wiecek, A, Ksiazek, A, Marczewski, K, Ostrowski, M, Switalski, M, Sulowicz, W, Matuszkiewicz-Rowinska, J, Mysliwiec, M, Durlik, M, Rutkowski, B, Macario, F, Carvalho, B, Frazao, J, Machado, D, Weigert, A, Andrusev, A, Khrustalev, O, Zemtchenkov, A, Gurevich, K, Staroselsky, K, Khadikova, N, Rozhinskaya, L, Timokhovskaya, G, Strokov, A, Balkarova, O, Ermolenko, V, Kolmakova, E, Komandenko, M, Timofeev, M, Shilo, V, Shostka, G, Smirnov, A, Anashkin, V, Volgina, G, Domashenko, O, Gurevich, A, Perlin, D, García, J, Ribes, E, Piera, E, Lucas, M, Galicia, M, Prados, M, González, M, Romero, R, de Francisco, Ám, Montenegro, J, Santiago, C, García, F, de La Ossa, J, Arrieta, J, Pons, J, Martín-Malo, A, Amigó, J, Cases, A, Sterner, G, Jensen, G, Wikström, B, Jacobson, S, Lund, U, Weiss, L, Ståhl, A, von Albertini, B, Burnier, M, Meier, P, Martin, P, Uehlinger, D, Dickenmann, M, Yaqoob, M, Zehnder, D, Kalra, P, Padmanabhan, N, Roe, S, Eadington, D, Pritchard, N, Hutchison, A, Davies, S, Wilkie, M, Davies, M, Pai, P, Swift, P, Kwan, J, Goldsmith, D, Tomson, C, Stratton, J, Dasgupta, I, Sarkar, S, Moustafa, M, Gandhi, K, Jamal, A, Galindo-Ramos, E, Tuazon, J, Batlle, D, Tucker, K, Schiller-Moran, B, Assefi, A, Martinez, C, Samuels, L, Goldman, J, Cangiano-Rivera, J, Darwish, R, Lee, M, Topf, J, Kapatkin, K, Baer, H, Kopelman, R, Acharya, M, Tharpe, D, Bernardo, M, Nader, P, Guzman-Rivera, J, Pergola, P, Sekkarie, M, Alas, E, Zager, P, Liss, K, Navarro, J, Roppolo, M, Denu-Ciocca, C, Kshirsagar, A, El Khatib, M, Kant, K, Scott, D, Murthyr, B, Finkelstein, F, Keightley, G, Mccrary, R, Pitone, J, Cavalieri, T, Tsang, A, Pellegrino, B, Schmidt, R, Ahmad, S, Brown, C, Friedman, E, Mittman, N, Fadem, S, Shapiro, W, Reddy, M, Goldberger, S, Woredekal, Y, Agarwal, A, Anger, M, Haque, M, Chidester, P, Kohli, R, Rubinstein, S, Newman, G, Gladish, R, Ayodeji, O, Soman, S, Sprague, S, Hunt, N, Gehr, T, Rizk, D, Warnock, D, Polack, D, Pahl, M, Fischer, D, Dreyer, P, James, G, Husserl, F, Rogers, T, Raff, A, Sedor, J, Silver, M, Smith, M, Steinberg, S, Delgiorno, T, Jones, E, Cunha, P, Cheng, J, Pogue, V, Blumenthal, S, Brown, E, Charytan, C, Buerkert, J, Cook, M, Felsenfeld, A, Tareen, N, Gupta, A, Herman, T, Diamond, S, Hura, C, Laski, M, Maclaurin, J, Plumb, T, Brosnahan, G, Kumar, J, Henriquez, M, Poole, C, Osanloo, E, Matalon, A, Sholer, C, Arfeen, S, Azer, M, Belledonne, M, Gross, M, Dunnigan, E, Mcconnell, K, Becker, B, Rigolosi, R, Spiegel, D, Stegman, M, Patak, R, Streja, D, Ranjit, U, Youell, T, Wooldridge, T, Stafford, C, Cottiero, R, Weinberg, M, Schonefeld, M, Shahmir, E, Hazzan, A, Ashfaq, A, Bhandari, K, Cleveland, W, Culpepper, M, Golden, J, Lai, L, Lien, Y, Lorica, V, Robertson, J, Malireddi, K, Morse, S, Thakur, V, Israelit, A, Raguram, P, Alfred, H, Weise, W, Al-Saghir, F, El Shahawy, M, Rastogi, A, Nissenson, A, Kopyt, N, Lynn, R, Lea, J, Mcclellan, W, Teredesai, P, Ong, S, Tolkan, S, Sugihara, J, Minga, T, Mehrotra, R, Minasian, R, Bhatia, D, Specter, R, Capelli, J, Sidhu, P, Dalal, S, Dykes, P, Khan, M, Rahim, F, Saklayen, M, Thomas, A, Michael, B, Torres, M, Al-Bander, H, Murray, B, Abukurah, A, Gupta, B, Nosrati, S, Raja, R, Zeig, S, Braun, M, Amatya, A, Endsley, J, Sharon, Z, Dolson, G, Dumler, F, Ntoso, K, Rosansky, S, Kumar, N, Gura, V, Thompson, N, Goldfarb, D, Halligan, R, Middleton, J, Widerhorn, A, Arbeit, L, Arruda, J, Crouch, T, Friedman, L, Khokhar, S, Mittleman, J, Light, P, Taparia, B, West, C, Cotton, J, Dhingra, R, Kleinman, L, Arif, F, Lew, S, Nammour, T, Sterrett, J, Williams, M, Ramirez, J, Rubin, J, Mccarthy, J, Noble, S, Chaffin, M, and Rekhi, A.

Subjects
Adult, Male, Dialysis, Cinacalcet, Cardiovascular Disease, medicine.medical_specialty, Calcimimetic, medicine.medical_treatment, Naphthalenes, Coronary artery disease, Renal Dialysis, Internal medicine, Odds Ratio, medicine, Humans, Intensive care medicine, Aged, Etelcalcetide, Hyperparathyroidism, Hypocalcemia, business.industry, General Medicine, Middle Aged, medicine.disease, Intention to Treat Analysis, Cardiovascular Diseases, Parathyroid Hormone, Cinacalcet Hydrochloride, Kidney Failure, Chronic, Female, Hyperparathyroidism, Secondary, Secondary hyperparathyroidism, business, medicine.drug
Abstract

Disorders of mineral metabolism, including secondary hyperparathyroidism, are thought to contribute to extraskeletal (including vascular) calcification among patients with chronic kidney disease. It has been hypothesized that treatment with the calcimimetic agent cinacalcet might reduce the risk of death or nonfatal cardiovascular events in such patients.In this clinical trial, we randomly assigned 3883 patients with moderate-to-severe secondary hyperparathyroidism (median level of intact parathyroid hormone, 693 pg per milliliter [10th to 90th percentile, 363 to 1694]) who were undergoing hemodialysis to receive either cinacalcet or placebo. All patients were eligible to receive conventional therapy, including phosphate binders, vitamin D sterols, or both. The patients were followed for up to 64 months. The primary composite end point was the time until death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event. The primary analysis was performed on the basis of the intention-to-treat principle.The median duration of study-drug exposure was 21.2 months in the cinacalcet group, versus 17.5 months in the placebo group. The primary composite end point was reached in 938 of 1948 patients (48.2%) in the cinacalcet group and 952 of 1935 patients (49.2%) in the placebo group (relative hazard in the cinacalcet group vs. the placebo group, 0.93; 95% confidence interval, 0.85 to 1.02; P=0.11). Hypocalcemia and gastrointestinal adverse events were significantly more frequent in patients receiving cinacalcet.In an unadjusted intention-to-treat analysis, cinacalcet did not significantly reduce the risk of death or major cardiovascular events in patients with moderate-to-severe secondary hyperparathyroidism who were undergoing dialysis. (Funded by Amgen; EVOLVE ClinicalTrials.gov number, NCT00345839.).

Published
2012

8. Cinacalcet, fibroblast growth factor-23, and cardiovascular disease in hemodialysis: The evaluation of cinacalcet HCl therapy to lower cardiovascular events (EVOLVE) trial

Author

Moe S. M., Chertow G. M., Parfrey P. S., Kubo Y., Block G. A., Correa-Rotter R., Drueke T. B., Herzog C. A., London G. M., Mahaffey K. W., Wheeler D. C., Stolina M., Dehmel B., Goodman W. G., Floege J., Santos J., Najun Zarazaga C., Marin I., Garrote N., Cusumano A., Penalba N., Del Valle E., Juncos L., Martinez Saye J., Lef L., Altobelli V., Petraglia G., Rosa Diez G., Douthat W., Lobo J., Gallart C., Lafalla A., Diez G., Linares B., Lopez N., Ramirez N., Gonzalez R., Valtuille R., Beresan H., Hermida O., Rudolf G., Marchetta N., Rano M., Ramirez M., Garcia N., Gillies A., Jones B., Pedagogos E., Walker R., Talaulikar G., Bannister K., Suranyi M., Kark A., Roger S., Kerr P., Disney A., Mount P., Fraenkel M., Mathew M., Fassett R., Jose M., Hawley C., Lonergan M., Mackie J., Ferrari P., Menahem S., Sabto J., Hutchison B., Langham R., Pollock C., Holzer H., Oberbauer R., Arias I., Graf H., Mayer G., Lhotta K., Neyer U., Klauser R., Hoerl W., Horn S., Kovarik J., Kramar R., Eigner M., Dhaene M., Billiouw J., De Meester J., Warling X., Cambier-Dwelschauwers P., Evenepoel P., Daelemans R., Dratwa M., Maes B., Stolear J., Dejagere T., Vanwalleghem J., Bouman K., Jadoul M., Peeters J., Vanholder R., Tielemans C., Donck J., Almeida F., Picollo De Oliveira J., Burdmann E., Garcia V., Saldanha Thome F., Deboni L., Bregman R., Lugon J., Araujo S., Ferreira Filho S., De Francesco Daher E., Sperto Baptista M., Carvalho A., D'Avila D., Moyses Neto M., Yu L., Bastos M., Sampaio Lacativa P., Jorgetti V., De Almeida Romao E., Cardeal Da Costa J., Pecoits Filho R., Gordan P., Salgado N., Teixeira Araujo M., Neiva Coelho S., Oliveira I., Moyses R., Vasconcellos L., Batista P., Luiz Gross J., Pedrosa A., Cournoyer S., LeBlanc M., Chow S., Karunakaran S., Wong G., Tobe S., Desmeules S., Zimmerman D., Murphy S., Montambault P., Donnelly S., MacRae J., Culleton B., Soroka S., Rabbat C., Jindal K., Vasilevsky M., Michaud M., Wijeyesinghe E., Zacharias J., Lok C., Muirhead N., Verrelli M., Da Roza G., Sapir D., Olgaard K., Daugaard H., Brandi L., Jensen P., Boulechfar H., Ang K., Simon P., Rieu P., Brunet P., Touchard G., Urena Torres P., Combe C., Durrbach A., Ortiz J., Hannedouche T., Vela C., Lionet A., Ryckelynck P., Zaoui P., Choukroun G., Fessi H., Lang P., Stroumza P., Joly D., Mousson C., Laville M., Dellanna F., Erley C., Braun J., Rambausek M., Riegel W., Klingberg M., Schwertfeger E., Wizemann V., Eckardt K., Reichel H., Passauer J., Hubel E., Frischmuth N., Liebl R., Fiedler R., Schwenger V., Vosskuhler A., Kunzendorf U., Renders L., Rattensberger D., Rump L., Ketteler M., Neumayer H., Zantvoort F., Stahl R., Ladanyi E., Kulcsar I., Mezei I., Csiky B., Rikker C., Arkossy O., Berta K., Szegedi J., Major L., Ferenczi S., Fekete A., Szabo T., Zakar G., Wagner G., Kazup Erdelyine S., Borbas B., Eustace J., Reddan D., Capasso G., Locatelli F., Villa G., Cozzolino M., Brancaccio D., Messa P., Bolasco P., Ricciardi B., Malberti F., Moriero E., Cannella G., Ortalda V., Stefoni S., Frasca G., Cappelli G., Albertazzi A., Zoccali C., Farina M., Elli A., Avella F., Ondei P., Mingardi G., Errico R., Losito A., Di Giulio S., Pertosa G., Schena F., Grandaliano G., Gesualdo L., Auricchio M., Bochicchio-Ricardelli T., Aranda Verastegui F., Pena J., Chew Wong A., Cruz-Valdez J., Torres Zamora M., Solis M., Sebastian Diaz M., Vital Flores M., Alvarez Sandoval E., Van Den Dorpel M., Brink H., Van Kuijk W., Vermeij C., Smak Gregoor P., Hagen E., Van Der Sande F., Klinger M., Nowicki M., Muszytowski M., Bidas K., Bentkowski W., Wiecek A., Ksiazek A., Marczewski K., Ostrowski M., Switalski M., Sulowicz W., Matuszkiewicz-Rowinska J., Mysliwiec M., Durlik M., Rutkowski B., Macario F., Carvalho B., Frazao J., Machado D., Weigert A., Andrusev A., Khrustalev O., Zemtchenkov A., Gurevich K., Staroselsky K., Khadikova N., Rozhinskaya L., Timokhovskaya G., Strokov A., Balkarova O., Ermolenko V., Kolmakova E., Komandenko M., Timofeev M., Shilo V., Shostka G., Smirnov A., Anashkin V., Volgina G., Domashenko O., Gurevich A., Perlin D., Martinez Garcia J., Andres Ribes E., Coll Piera E., Fernandez Lucas M., Galicia M., Prados M., Gonzalez M., Romero R., Martin de Francisco A., Montenegro J., Santiago C., Garcia F., Alcazar De La Ossa J., Arrieta J., Pons J., Martin-Malo A., Soler Amigo J., Cases A., Sterner G., Jensen G., Wikstrom B., Jacobson S., Lund U., Weiss L., Stahl A., Von Albertini B., Burnier M., Meier P., Martin P., Uehlinger D., Dickenmann M., Yaqoob M., Zehnder D., Kalra P., Padmanabhan N., Roe S., Eadington D., Pritchard N., Hutchison A., Davies S., Wilkie M., Davies M., Pai P., Swift P., Kwan J., Goldsmith D., Tomson C., Stratton J., Dasgupta I., Sarkar S., Moustafa M., Gandhi K., Jamal A., Galindo-Ramos E., Tuazon J., Batlle D., Tucker K., Schiller-Moran B., Assefi A., Martinez C., Samuels L., Goldman J., Cangiano-Rivera J., Darwish R., Lee M., Topf J., Kapatkin K., Baer H., Kopelman R., Acharya M., Tharpe D., Bernardo M., Nader P., Guzman-Rivera J., Pergola P., Sekkarie M., Alas E., Zager P., Liss K., Navarro J., Roppolo M., Denu-Ciocca C., Kshirsagar A., El Khatib M., Kant K., Scott D., Murthyr B., Finkelstein F., Keightley G., McCrary R., Pitone J., Cavalieri T., Tsang A., Pellegrino B., Schmidt R., Ahmad S., Brown C., Friedman E., Mittman N., Fadem S., Shapiro W., Reddy M., Goldberger S., Woredekal Y., Agarwal A., Anger M., Haque M., Chidester P., Kohli R., Rubinstein S., Newman G., Gladish R., Ayodeji O., Soman S., Sprague S., Hunt N., Gehr T., Rizk D., Warnock D., Polack D., Pahl M., Fischer D., Dreyer P., James G., Husserl F., Rogers T., Raff A., Sedor J., Silver M., Smith M., Steinberg S., DelGiorno T., Jones E., Cunha P. D., Cheng J., Pogue V., Blumenthal S., Brown E., Charytan C., Buerkert J., Cook M., Felsenfeld A., Tareen N., Gupta A., Herman T., Diamond S., Hura C., Laski M., MacLaurin J., Plumb T., Brosnahan G., Kumar J., Henriquez M., Poole C., Osanloo E., Matalon A., Sholer C., Arfeen S., Azer M., Belledonne M., Gross M., Dunnigan E., McConnell K., Becker B., Skinner F., Rigolosi R., Spiegel D., Stegman M., Patak R., Streja D., Ranjit U., Youell T., Wooldridge T., Stafford C., Cottiero R., Weinberg M., Schonefeld M., Shahmir E., Hazzan A., Ashfaq A., Bhandari K., Cleveland W., Culpepper M., Golden J., Lai L., Lien Y., Lorica V., Robertson J., Malireddi K., Morse S., Thakur V., Israelit A., Raguram P., Alfred H., Weise W., Al-Saghir F., El Shahawy M., Rastogi A., Nissenson A., Kopyt N., Lynn R., Lea J., McClellan W., Teredesai P., Ong S., Tolkan S., Sugihara J., Minga T., Mehrotra R., Minasian R., Bhatia D., Specter R., Capelli J., Sidhu P., Dalal S., Dykes P., Khan M., Rahim F., Saklayen M., Thomas A., Michael B., Torres M., Al-Bander H., Murray B., Abukurah A., Gupta B., Nosrati S., Raja R., Zeig S., Braun M., Amatya A., Endsley J., Sharon Z., Dolson G., Dumler F., Ntoso K., Rosansky S., Kumar N., Gura V., Thompson N., Goldfarb D., Halligan R., Middleton J., Widerhorn A., Arbeit L., Arruda J., Crouch T., Friedman L., Khokhar S., Mittleman J., Light P., Taparia B., West C., Cotton J., Dhingra R., Kleinman L., Arif F., Lew S., Nammour T., Sterrett J., Williams M., Ramirez J., Rubin J., McCarthy J., Noble S., Chaffin M., Rekhi A., Moe, S. M., Chertow, G. M., Parfrey, P. S., Kubo, Y., Block, G. A., Correa-Rotter, R., Drueke, T. B., Herzog, C. A., London, G. M., Mahaffey, K. W., Wheeler, D. C., Stolina, M., Dehmel, B., Goodman, W. G., Floege, J., Santos, J., Najun Zarazaga, C., Marin, I., Garrote, N., Cusumano, A., Penalba, N., Del Valle, E., Juncos, L., Martinez Saye, J., Lef, L., Altobelli, V., Petraglia, G., Rosa Diez, G., Douthat, W., Lobo, J., Gallart, C., Lafalla, A., Diez, G., Linares, B., Lopez, N., Ramirez, N., Gonzalez, R., Valtuille, R., Beresan, H., Hermida, O., Rudolf, G., Marchetta, N., Rano, M., Ramirez, M., Garcia, N., Gillies, A., Jones, B., Pedagogos, E., Walker, R., Talaulikar, G., Bannister, K., Suranyi, M., Kark, A., Roger, S., Kerr, P., Disney, A., Mount, P., Fraenkel, M., Mathew, M., Fassett, R., Jose, M., Hawley, C., Lonergan, M., Mackie, J., Ferrari, P., Menahem, S., Sabto, J., Hutchison, B., Langham, R., Pollock, C., Holzer, H., Oberbauer, R., Arias, I., Graf, H., Mayer, G., Lhotta, K., Neyer, U., Klauser, R., Hoerl, W., Horn, S., Kovarik, J., Kramar, R., Eigner, M., Dhaene, M., Billiouw, J., De Meester, J., Warling, X., Cambier-Dwelschauwers, P., Evenepoel, P., Daelemans, R., Dratwa, M., Maes, B., Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo De Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., De Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., De Almeida Romao, E., Cardeal Da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., Malberti, F., Moriero, E., Cannella, G., Ortalda, V., Stefoni, S., Frasca, G., Cappelli, G., Albertazzi, A., Zoccali, C., Farina, M., Elli, A., Avella, F., Ondei, P., Mingardi, G., Errico, R., Losito, A., Di Giulio, S., Pertosa, G., Schena, F., Grandaliano, G., Gesualdo, L., Auricchio, M., Bochicchio-Ricardelli, T., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., Van Den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak Gregoor, P., Hagen, E., Van Der Sande, F., Klinger, M., Nowicki, M., Muszytowski, M., Bidas, K., Bentkowski, W., Wiecek, A., Ksiazek, A., Marczewski, K., Ostrowski, M., Switalski, M., Sulowicz, W., Matuszkiewicz-Rowinska, J., Mysliwiec, M., Durlik, M., Rutkowski, B., Macario, F., Carvalho, B., Frazao, J., Machado, D., Weigert, A., Andrusev, A., Khrustalev, O., Zemtchenkov, A., Gurevich, K., Staroselsky, K., Khadikova, N., Rozhinskaya, L., Timokhovskaya, G., Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar De La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., Von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, B., Assefi, A., Martinez, C., Samuels, L., Goldman, J., Cangiano-Rivera, J., Darwish, R., Lee, M., Topf, J., Kapatkin, K., Baer, H., Kopelman, R., Acharya, M., Tharpe, D., Bernardo, M., Nader, P., Guzman-Rivera, J., Pergola, P., Sekkarie, M., Alas, E., Zager, P., Liss, K., Navarro, J., Roppolo, M., Denu-Ciocca, C., Kshirsagar, A., El Khatib, M., Kant, K., Scott, D., Murthyr, B., Finkelstein, F., Keightley, G., Mccrary, R., Pitone, J., Cavalieri, T., Tsang, A., Pellegrino, B., Schmidt, R., Ahmad, S., Brown, C., Friedman, E., Mittman, N., Fadem, S., Shapiro, W., Reddy, M., Goldberger, S., Woredekal, Y., Agarwal, A., Anger, M., Haque, M., Chidester, P., Kohli, R., Rubinstein, S., Newman, G., Gladish, R., Ayodeji, O., Soman, S., Sprague, S., Hunt, N., Gehr, T., Rizk, D., Warnock, D., Polack, D., Pahl, M., Fischer, D., Dreyer, P., James, G., Husserl, F., Rogers, T., Raff, A., Sedor, J., Silver, M., Smith, M., Steinberg, S., Delgiorno, T., Jones, E., Cunha, P. D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., Rekhi, A., and Clinical sciences

Subjects
Adult, Male, Fibroblast growth factor 23, medicine.medical_specialty, Cinacalcet, Calcimimetic, medicine.medical_treatment, Naphthalenes, Hyperthyroidism, Gastroenterology, ventricular remodeling, Renal Dialysis, Cinacalcet Hydrochloride, Physiology (medical), Internal medicine, medicine, Humans, renal insufficiency, chronic, Aged, Etelcalcetide, calcium, business.industry, Research Support, Non-U.S. Gov't, death, sudden, cardiac, Middle Aged, arrhythmias, cardiac, Cardiovascular Diseases, Female, Fibroblast Growth Factors, Cardiology and Cardiovascular Medicine, medicine.disease, Fibroblast Growth Factor-23, Endocrinology, Randomized Controlled Trial, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug, Kidney disease
Abstract

Background— Patients with kidney disease have disordered bone and mineral metabolism, including elevated serum concentrations of fibroblast growth factor-23 (FGF23). These elevated concentrations are associated with cardiovascular and all-cause mortality. The objective was to determine the effects of the calcimimetic cinacalcet (versus placebo) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events. Methods and Results— This was a secondary analysis of a randomized clinical trial comparing cinacalcet to placebo in addition to conventional therapy (phosphate binders/vitamin D) in patients receiving hemodialysis with secondary hyperparathyroidism (intact parathyroid hormone ≥300 pg/mL). The primary study end point was time to death or a first nonfatal cardiovascular event (myocardial infarction, hospitalization for angina, heart failure, or a peripheral vascular event). This analysis included 2985 patients (77% of randomized) with serum samples at baseline and 2602 patients (67%) with samples at both baseline and week 20. The results demonstrated that a significantly larger proportion of patients randomized to cinacalcet had ≥30% (68% versus 28%) reductions in FGF23. Among patients randomized to cinacalcet, a ≥30% reduction in FGF23 between baseline and week 20 was associated with a nominally significant reduction in the primary composite end point (relative hazard, 0.82; 95% confidence interval, 0.69–0.98), cardiovascular mortality (relative hazard, 0.66; 95% confidence interval, 0.50–0.87), sudden cardiac death (relative hazard, 0.57; 95% confidence interval, 0.37–0.86), and heart failure (relative hazard, 0.69; 95% confidence interval, 0.48–0.99). Conclusions— Treatment with cinacalcet significantly lowers serum FGF23. Treatment-induced reductions in serum FGF23 are associated with lower rates of cardiovascular death and major cardiovascular events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00345839.

Published
2015

12. Extracorporeal dialysis: techniques and adequacy

Author

Passalacqua, S., primary, Staffolani, E., additional, Brescia, P., additional, Loschiavo, C., additional, Mancini, E., additional, Monaci, G., additional, Russo, G. E., additional, Ramunni, A., additional, Granger Vallee, A., additional, Chenine, L., additional, Leray-Moragues, H., additional, Gontier-Picard, A., additional, Rodriguez, A., additional, Chalabi, L., additional, Canaud, B., additional, Lantz, B., additional, Kapke, A., additional, Pearson, J., additional, Vanholder, R., additional, Tomo, T., additional, Robinson, B., additional, Port, F., additional, Daugirdas, J., additional, Ramirez, S., additional, Akonur, A., additional, Agar, B. U., additional, Culleton, B. F., additional, Gellens, M. E., additional, Leypoldt, J. K., additional, Troidle, L., additional, Finkelstein, F. O., additional, Kohn, O. F., additional, Basile, C., additional, Libutti, P., additional, Di Turo, A. L., additional, Casucci, F., additional, Losurdo, N., additional, Teutonico, A., additional, Vernaglione, L., additional, Lomonte, C., additional, Umimoto, K., additional, Nata, Y., additional, Shimamoto, Y., additional, Miyata, M., additional, Krisp, C., additional, Gmerek, A., additional, Wagner, J., additional, Wolters, D., additional, Pedrini, L. A., additional, Kopec, J., additional, Sulowicz, W., additional, Falkenhagen, D., additional, Thijssen, S., additional, Brandl, M., additional, Hartmann, J., additional, Strobl, K., additional, Wallner, M., additional, Mahieu, E., additional, Verhamme, P., additional, Op De Beeck, K., additional, Kuypers, D., additional, Claes, K., additional, Vitale, C., additional, Bagnis, C., additional, Berutti, S., additional, Soragna, G., additional, Gabella, P., additional, Fruttero, C., additional, Marangella, M., additional, Khadzhynov, D., additional, Baumann, C., additional, Lieker, I., additional, Slowinski, T., additional, Neumayer, H.-H., additional, Peters, H., additional, Bibiano, L., additional, Freddi, P., additional, Ricciatti, A., additional, Sagripanti, S., additional, Manarini, G., additional, Frasca, G. M., additional, Hwang, K. S., additional, Park, J.-S., additional, Lee, C. H., additional, Kang, C. M., additional, Kim, G.-H., additional, Urabe, S., additional, Kokubo, K., additional, Tsukao, H., additional, Shimbo, T., additional, Hirose, M., additional, Kobayashi, H., additional, Itoh, Y., additional, Kikuchi, K., additional, Murakami, K., additional, Tsuruta, Y., additional, Niwa, T., additional, Masakane, I., additional, Esashi, S., additional, Igarashi, H., additional, Djogan, M., additional, Boltina, I., additional, Dudar, I., additional, Pastori, G., additional, Favaro, E., additional, Ferraro, A., additional, Marcon, R., additional, Guizzo, M., additional, Lazzarin, R., additional, Conte, F., additional, Nichelatti, M., additional, Limido, A., additional, Zhu, F., additional, Liu, L., additional, Kaysen, G. A., additional, Abbas, S. R., additional, Kotanko, P., additional, Levin, N. W., additional, Debska-Slizien, A., additional, Malgorzewicz, S., additional, Dudziak, M., additional, Rutkowski, B., additional, Svojanovsky, J., additional, Dob ak, P., additional, Nedbalkova, M., additional, Reichertova, A., additional, Soucek, M., additional, Kirmizis, D., additional, Kougioumtzidou, O., additional, Vakianis, P., additional, Papagianni, A., additional, Sestigiani, E., additional, Gissara, Z., additional, Palladino, G., additional, Santoro, A., additional, Schneditz, D., additional, Stockinger, J., additional, Ribitsch, W., additional, Branco, P., additional, Figueiredo, S., additional, Santana, S., additional, Rocha, C., additional, Carvalho, L., additional, Borges, S., additional, Marques, D., additional, Barata, D., additional, Matsuyama, M., additional, Matsuyama, K., additional, Matsuyama, I., additional, Minakuchi, J., additional, Schiffl, H., additional, Fischer, R., additional, Lang, S., additional, de los Santos, C. A., additional, Antonello, I. C., additional, Poli-de-Figueiredo, C. E., additional, d'Avila, D., additional, Rosales, L., additional, Ulloa, D., additional, Carter, M., additional, Umehara, S., additional, Sakai, K., additional, Krieter, D. H., additional, Seidel, S., additional, Merget, K., additional, Lemke, H.-D., additional, Morgenroth, A., additional, Wanner, C., additional, Onogi, T., additional, Nishida, Y., additional, Ueno, J., additional, Taoka, M., additional, Sato, T., additional, Sakurai, K., additional, Saito, T., additional, Yamauchi, F., additional, Asahi, D., additional, Hosoya, H., additional, Maruyama, N., additional, Suzuki, A., additional, Alain, R., additional, Christian, D., additional, Romano, J.-M., additional, Printz, J., additional, Philippe, B., additional, Micha, T., additional, Hadjiyannakos, D., additional, Pani, I., additional, Sonikian, M., additional, Karatzas, I., additional, Vlassopoulos, D., additional, Kanaki, A., additional, Caprioli, R., additional, Lippi, A., additional, Donadio, C., additional, Malliekal, S., additional, Kubey, W., additional, Bernardo, A. A., additional, Katzarski, K., additional, Galach, M., additional, Waniewski, J., additional, Sambale, S., additional, Reising, A., additional, Donnerstag, F., additional, Hafer, C., additional, Schmidt, B., additional, Kielstein, J. T., additional, Ervo, R., additional, Angeletti, S., additional, Turrini Dertenois, L., additional, Cavatorta, F., additional, Gondouin, B., additional, Bevins, A., additional, Cockwell, P., additional, Hutchison, C. A., additional, Doria, M., additional, Genovesi, S., additional, Biagi, F., additional, Grandi, F., additional, Frontini, A., additional, Stella, A., additional, Cases, A., additional, Fort, J., additional, Maduell, F., additional, Comas, J., additional, Arcos, E., additional, Deulofeu, R., additional, Rroji (Molla), M., additional, Seferi, S., additional, Barbullushi, M., additional, Spahia, N., additional, Likaj, E., additional, Thereska, N., additional, Morena, M., additional, Jaussent, I., additional, Bargnoux, A.-S., additional, Dupuy, A.-M., additional, Cristol, J.-P., additional, Hammer, F., additional, Scherberich, J. E., additional, Pizzarelli, F., additional, Ferro, G., additional, Amidone, M., additional, Dattolo, P., additional, Gauly, A., additional, Golla, P., additional, Clajus, C., additional, Beutel, G., additional, Haller, H., additional, Schmidt, B. M. W., additional, Kielstein, J., additional, Nakazawa, R., additional, Shimizu, Y., additional, Uemura, Y., additional, Kashiwabara, H., additional, Watanabe, D., additional, Kato, T., additional, Fuse, M., additional, Azuma, N., additional, Nakanishi, N., additional, Kabayama, S., additional, Alquist Hegbrant, M., additional, Bosch, J. P., additional, Righetti, M., additional, Ferrario, G., additional, Serbelloni, P., additional, Milani, S., additional, Lisi, L., additional, Tommasi, A., additional, Mambelli, E., additional, Bolasco, P. G., additional, Scotto, P., additional, Savoldi, S., additional, Serra, A., additional, Corazza, L., additional, Tomisawa, N., additional, Jinbo, Y., additional, Kobayashi, Y., additional, Kawakubo, Y., additional, and Sakurasawa, T., additional

Published
2011
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13. Association between markers of collagen turnover, arterial stiffness and left ventricular hypertrophy in chronic kidney disease (CKD): the Renal Research Institute (RRI)-CKD Study

Author

Dellegrottaglie, S., primary, Sands, R. L., additional, Gillespie, B. W., additional, Gnanasekaran, G., additional, Zannad, F., additional, Sengstock, D., additional, Finkelstein, F., additional, Kiser, M., additional, Eisele, G., additional, Hinderliter, A. L., additional, Levin, N. W., additional, Cattan, V., additional, Saran, R., additional, and Rajagopalan, S., additional

Published
2011
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26. Association of kt/v and creatinine clearance with outcomes in anuric peritoneal dialysis patients.

Author

Fried L, Hebah N, Finkelstein F, and Piraino B

Abstract

BACKGROUND: The 2006 Kidney Disease Outcomes Quality Initiative recommended a minimum total Kt/V of 1.7, eliminated creatinine clearance (Ccr) as a target, and recommended the use of ideal body weight to calculate Kt/V. We assessed these recommendations as predictors of outcomes in anuric peritoneal dialysis patients. STUDY DESIGN: Retrospective observational study using administrative data. SETTING & PARTICIPANTS: 1,432 peritoneal dialysis patients with anuria from January 1, 1994, to January 31, 2005, in a national sample (1,428 with Kt/V, 1,416 with Ccr). PREDICTORS: Kt/V and Ccr at anuria; Kt/V based on actual body weight and ideal body weight. OUTCOMES & MEASUREMENTS: Association of dialysis adequacy with mortality and time to first hospitalization after anuria assessed by using accelerated failure time models. RESULTS: 293 anuric patients had Kt/V less than 1.7, 366 had Kt/V of 1.7 to 2.0, and 769 had Kt/V greater than 2.0, using actual body weight for calculation. In unadjusted analyses, Kt/V calculated using actual body weight both less than 1.7 (-41.3%; 95% confidence interval [CI], -55.5 to -22.6) and 1.7 to 2.0 (-26.1%; 95% CI, -42.6 to -4.6) were associated with shorter time to mortality. Kt/V calculated using actual body weight less than 1.7 was associated with shorter time to hospitalization (-38.1%; 95% CI, -50.0 to -23.4), but Kt/V calculated using actual body weight of 1.7 to 2.0 was not a significant predictor (-3.3%; 95% CI, -21.1 to 18.6). After adjustment, Kt/V calculated using actual body weight less than 1.7 remained associated with mortality (-25.3%; 95% CI, -41.1 to -4.8) and hospitalization (-33.4%; 95% CI, -47.1 to -16.0). Ccr did not predict mortality. In unadjusted analysis, Ccr was not associated with hospitalization, but after adjustment, Ccr less than 50 L/wk/1.73 m(2) was significantly associated with shorter time to hospitalization (-19.9%; 95% CI, -35.0 to -1.3). Kt/V using ideal body weight was not a significant predictor in adjusted models. LIMITATIONS: This study was nonrandomized, with few malnourished patients. In addition, there is a potential for informative censoring for transfer to hemodialysis therapy before anuria. CONCLUSIONS: Kt/V calculated using actual body weight less than 1.7 in anuric peritoneal dialysis patients is associated with increased mortality and hospitalization. Use of ideal body weight to calculate Kt/V weakened the associations with outcomes and therefore cannot be recommended. [ABSTRACT FROM AUTHOR]

Published
2008
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29. The effectiveness of low-dose maintenance IV iron therapy: a dialysis facility's experience.

Author

Juergensen P and Finkelstein F

Abstract

Over the past few decades, anemia management in patients with chronic kidney disease and end stage renal disease (ESRD) has advanced significantly. However, these improvements appear to have leveled off, with data from the ESRD Clinical Performance Measures Project showing that, over each of the past 3 years, approximately 80% of patients on hemodialysis were being managed at, or above, the minimum recommended hemoglobin (Hgb) level of 11 g/dL (Centers for Medicare & Medicaid Services, 2005). There are a number of potential reasons for this leveling off. Thus, it is important to carefully evaluate the etiology of the anemia in each patient. One area that needs to be examined involves the use of IV iron therapy. In an effort to improve anemia management, it is important for dialysis facilities to routinely examine their current IV iron protocol to determine its effectiveness in maintaining patients within the recommended target ranges for serum ferritin, transferrin saturation (TSAT), and Hgb levels. Recently the Milford Dialysis Unit took a proactive approach to improving anemia management by assessing the utility of their IV iron maintenance protocol. This review will examine the results of this analysis and provide strategies on how to improve anemia management practices in a dialysis facility. [ABSTRACT FROM AUTHOR]

Published
2006

31. Quality of life in peritoneal dialysis patients.

Author

STEELE, THOMAS E., BALTIMORE, DIANE, FINKELSTEIN, SUSAN H., JUERGENSEN, PETER, KLIGER, ALAN S., FINKELSTEIN, FREDRIC O., Steele, T E, Baltimore, D, Finkelstein, S H, Juergensen, P, Kliger, A S, and Finkelstein, F O

Published
1996

33. Effect of nitroprusside on peritoneal dialysis clearances

Author

Finkelstein, F. O., Yap, P., and Kliger, A. S.

Subjects
Nitroprusside, Vitamin B 12, Humans, Urea, Ferricyanides, Peritoneal Dialysis, Research Article
Abstract

We have studied the effect of intraperitoneal nitroprusside on small (urea) and middle (vitamin B12) molecule dialysis clearances in patients maintained on chronic peritoneal dialysis. Clearances were measured in six patients during the addition of 6 mg of nitroprusside to three and seven consecutive, hourly two-liter exchanges during the course of a routine dialysis treatment. Results indicate that clearances of urea and B12 both increased about 35 percent with the addition of the vasodilator for three exchanges. Clearances immediately returned to baseline values when administration of the vasodilator was discontinued. Addition of the drug to seven consecutive exchanges resulted in a sustained 35 percent increment in clearances. We conclude that addition of 6 mg of nitroprusside to peritoneal dialysis solution can result in a significant increment in both small and middle molecule clearances. Maintenance of the higher clearances requires sustained administration of the drug, which can be tolerated for at least six exchanges with no adverse side effects.

Published
1980

42. Hemodialysis Central Venous Catheter-Related Bacteremia: Time to Onset.

Author

Troidle, L., Juergensen, P., Cantey, L., Eisen, T., and Finkelstein, F. O.

Subjects
BACTEREMIA, BACTERIAL diseases, HEMODIALYSIS, CATHETERS, ANTIBIOTICS
Abstract

Bacteremia (B) is a well-known complication of an indwelling central venous catheter (CVC). Although prophylactic measures such as topical and catheter lock antibiotics have been demonstrated to decrease the risk of B in hemodialysis (HD) in patients with a CVC, there are concerns about the development of resistance to these agents when used for long periods of time. We wondered if we could limit the use of these agents by identifying the period when B was most common after CVC placement. We prospectively noted all patients with a CVC who developed B in any of our 3 units in CT, U.S.A.; 62 episodes of B occurred between 1/1/03 and 9/18/03. 35% of all of the HD patients had a CVC for access during the study period. Staphylococcus aureus accounted for 22 (35.5%) episodes; Gram-negative organisms for 21 (33.8%) and other staphylococcal species for 14 (22.6%). The other 3 episodes were other Gram-positive organisms and 6 patients developed B with more than 1 organism. 3 (4.8%) patients expired while being treated for the B. The average time to onset of B was 96 ± 98 CVC days with a range of 1–365 days. There was no difference in time to onset based on organism. 43.5% of the episodes of B occurred less than 60 days after the CVC was inserted, but 27.4% occurred greater than 100 days after CVC insertion. The time to onset of CVC-related B was variable among the patients developing B in this study. Preventative strategies aimed at reducing the risk of B in patients with a CVC must be used for the life of the CVC. [ABSTRACT FROM AUTHOR]

Published
2004
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43. Why Do So Many Patients Have a Dialysis Catheter and Not Arteriovenous Fistulae or Grafts?

Author

Troidle, L., Eisen, T., and Finkelstein, F. O.

Subjects
HEMODIALYSIS patients, CATHETERIZATION, ARTERIOVENOUS fistula, DIALYSIS (Chemistry), CATHETERS
Abstract

The Dialysis Outcome and Quality Initiative has guidelines for vascular access and states that the dialysis catheter (DC) should be limited to less than 20% of the end-stage renal disease (ESRD) patients. Our center has found this target difficult to achieve. We wondered what the reasons for use of a DC might be. We noted the number of patients with a DC in place and assessed the reasons why the DC was being used on 8/1/03. 73 of the 170 (42.9%) patients had a DC on 8/1/03. 24 (32.9%) of the patients refused to have initial arteriovenous fistulae or grafts (AVF/G) or a secondary AVF/G revision or replacement procedure performed after initial AVF/G failure. 15 (20.5%) patients had a maturing AVF/G, 12 (16.4%) had significant medical and/or surgical contraindications for AVF/G placement, 9 (12.3%) patients were awaiting surgical thrombectomy, revision or placement of AVF/G, 6 patients (8.2%) were awaiting transfer to CPD therapy, 4 (5.5%) patients were undecided about having an AVF/G placed, and 1 (1.4%) had acute renal failure and early ESRD recovery was expected. Only 2 (2.7%) patients had no access plan by the nephrology team. Patients' refusal for an AVF/G placement and patients with a maturing AVF/G or awaiting surgical revision or placement were the most common reasons for the use of a DC in our center. To significantly impact on the high use of the DC, it would be crucial to better understand the reasons for patients’ refusals. [ABSTRACT FROM AUTHOR]

Published
2004
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44. Treatment and outcome of CPD-associated peritonitis

Author

Finkelstein Fred and Troidle Laura

Subjects
Therapeutics. Pharmacology, RM1-950, Infectious and parasitic diseases, RC109-216, Microbiology, QR1-502
Abstract

Abstract CPD-associated peritonitis is a leading cause of morbidity and mortality for ESRD patients maintained on CPD therapy. The percentage of ESRD patients maintained on CPD therapy is declining. The reasons are unclear, but may be due to concerns about CPD-associated peritonitis. The incidence of CPD-associated peritonitis has decreased largely attributed to technical advances and the identification of risk factors including exit-site infection, colonization with Staphylococcus aureus and depression. The typical spectrum of organisms causing peritonitis include gram-positive organisms (67%), gram-negative organisms (28%), fungi (2.5%) or anaerobic organisms (2.5%). Culture-negative episodes do occur: up to 20% of the episodes of peritonitis in some series are culture-negative. The treatment of CPD associated peritonitis is rather standardized with current recommendations by the International Society of Peritoneal Dialysis universally adopted. Approximately 80% of the patients developing peritonitis will respond to antimicrobial therapy and remain on CPD therapy, while 10 to 15% of the patients require catheter removal and transfer to hemodialysis. Approximately 6% of the patients expire as a result of peritonitis. The outcome is different based on organism with gram-negative and fungal episodes having a worse outcome than gram-positive episodes. The development of CPD-associated peritonitis can be linked to traditional risk factors such as exit-site infection and poor technique. Bacterial biofilm has also been suggested as a cause of peritonitis. Our current antimicrobial protocols may not permit adequate dosing to penetrate the biofilm and be a reason for recurrent or repeat episodes of peritonitis. It is important that we improve our understanding of factors responsible for the development and outcome of CPD-associated peritonitis in order for this renal replacement therapy to remain a viable option for patients with ESRD.

Published
2006
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46. Risks of salmeterol?

Author

Finkelstein, Frank N. and Finkelstein, F N

Subjects
*LETTERS to the editor, *INHALERS
Abstract

A letter to the editor is presented discussing risks of salmeterol inhaler.

Published
1994
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47. Value of scintigraphy in chronic peritoneal dialysis patients.

Author

JUERGENSEN, PETER H., RIZVI, HASAN, CARIDE, VICENTE J., KLIGER, ALAN S., FINKELSTEIN, FREDRIC O., Finkelstein, Fredric O., Juergensen, P H, Rizvi, H, Caride, V J, Kliger, A S, and Finkelstein, F O

Subjects
*RADIONUCLIDE imaging, *CHRONIC kidney failure, *PERITONEAL dialysis, *DIAGNOSIS
Abstract

Background: A variety of factors can adversely impact chronic peritoneal dialysis (CPD) as an effective renal replacement therapy for patients with end-stage renal disease. These factors include peritonitis, poor clearances, loss of ultrafiltration, and a variety of anatomic problems, such as hernias, peritoneal fluid leaks, loculations, and catheter-related problems caused by omental blockage. This study reviews our experience with peritoneal scintigraphy for the evaluation of some of these difficulties. Methods: From 1991 to 1996, 50 peritoneal scintigraphy scans were obtained in 48 CPD patients. Indications for scintigraphy were evaluated, and the patients were placed into four groups: group I, abdominal wall swelling; group II, inguinal or genital swelling; group III, pleural fluid; and group IV, poor drainage and/or poor ultrafiltration. A peritoneal scintigraphy protocol was established and the radiotracer isotope that was used was 2.0 mCi of 99mtechnetium sulfur colloid placed in two liters of 2.5% dextrose peritoneal dialysis solution. Results: Ten scans were obtained to study abdominal wall swelling, with seven scans demonstrating leaks; six of these episodes improved with low-volume exchanges. Twenty scans were obtained to evaluate inguinal or genital swelling, and 10 of these had scintigraphic evidence for an inguinal hernia leak (9 of these were surgically corrected). One of four scans obtained to evaluate a pleural fluid collection demonstrated a peritoneal-pleural leak that corrected with a temporary discontinuation of CPD. Sixteen scans were obtained to assess poor drainage and/or ultrafiltration. Five of these scans demonstrated peritoneal location, and all of these patients required transfer to hemodialysis. The other 11 scans were normal; four patients underwent omentectomies, allowing three patients to continue with CPD. Conclusion: Peritoneal scintigraphy is useful in the evaluation and assessment of CPD patients who develop anatomical problems (such as anterior abdominal, pleural-peritoneal, inguinal, and genital leaks) and problems with ultrafiltration and/or drainage. [ABSTRACT FROM AUTHOR]

Published
1999
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48. The effects of cinacalcet in older and younger patients on hemodialysis: The evaluation of cinacalcet HCL therapy to lower cardiovascular events (EVOLVE) trial

Author

P. Ryckelynck, Y. Woredekal, T. Gehr, Marian Klinger, J. Passauer, K. Liss, E. Del Valle, B. Linares, Ferdinando Avella, Stolear Jc, S. Tolkan, O. Hermida, V. Wizemann, Ricardo Correa-Rotter, J. Santos, Gert Mayer, Michael Anger, B. Pellegrino, B. Wikström, A. Ståhl, H. Al-Bander, Pedro Alejandro Gordan, Philip A. Kalra, E. Galindo-Ramos, Carmine Zoccali, G. Dolson, M. Eigner, Sanjay Dalal, G. Touchard, J Peeters, G. Da Roza, Shannon Murphy, R. Errico, M. Lonergan, A. Andrusev, H. Boulechfar, P. Zaoui, Michael Suranyi, de Francisco Martín de Francisco, S. Jacobson, B. Gupta, C. Stafford, J. Picollo de Oliveira, Ilka Regina Souza de Oliveira, F. Dumler, J. Martinez Saye, E. de Almeida Romão, Emmanuel A. Burdmann, C. Vermeij, N. Kumar, E. Shahmir, J. Stratton, R. Schmidt, Mario Cozzolino, Lars Christian Rump, Rainer Oberbauer, J. Kumar, M. Saklayen, Brian Hutchison, C. Denu-Ciocca, L. Weiss, E. Friedman, L. Renders, K. Gurevich, L. Brandi, W. Shapiro, Kym M. Bannister, K. Berta, Muhammad M. Yaqoob, C. Lok, A. Pedrosa, Rosa M.A. Moysés, K. Bhandari, J. Arrieta, T. Crouch, Brigitte Maes, G. Wong, Myriam González, Matthew R. P. Davies, R. Gonzalez, Geoffrey A. Block, T. Nammour, T. Youell, J. Ramirez, S. Tobe, N. Ramirez, T. Bochicchio-Ricardelli, J. Cangiano-Rivera, D. Streja, J. Endsley, K. Ang, R. Patak, J. Cheng, T. Rogers, Alberto Albertazzi, H. Holzer, G. Choukroun, Jose A.L. Arruda, Philippe Rieu, P. Simon, Stephen Z. Fadem, Jared G. Sugihara, H. Alfred, Bruce F. Culleton, G. Frascà, Giovanni Pertosa, W. Van Kuijk, H. Beresan, Samuel S. Blumenthal, Piergiorgio Messa, H. Baer, Michael C. Braun, B. Rutkowski, W. Riegel, M. Komandenko, V. Ermolenko, Martin Wilkie, N. Muirhead, Peter G. Kerr, D. Rattensberger, J. Sabto, Anjay Rastogi, L. Lef, M. El Shahawy, D. Tharpe, A. Smirnov, J. Pons, F. García, F. Zantvoort, A. Lionet, J. Topf, Marcia R. Silver, Reinhard Kramar, E. Moriero, A. Rekhi, S. Roe, P. Batista, E. Kolmakova, F. Rahim, M. Ostrowski, Janice P. Lea, Patrizia Ondei, C. Martinez, J. Donck, Nicole Lopez, F. Schena, Allen R. Nissenson, Alex P.S. Disney, R. Valtuille, C. Najun Zarazaga, M. Fraenkel, Pieter Evenepoel, R. Cottiero, S. Di Giulio, V. Gura, S. Karunakaran, P. Nader, F. Saldanha Thome, Walter Douthat, A. Fekete, L. Arbeit, W. Sulowicz, I. Marin, Charles R.V. Tomson, Andrzej Wiecek, Luis A. Juncos, G. Mingardi, P. Light, Max Dratwa, H. Reichel, R. Raja, U. Ranjit, G. Sterner, E. Coll Piera, P. Pai, Robert J. Walker, R. Bregman, E. Hübel, M. Timofeev, T. Szabo, A. Elli, N. Padmanabhan, N. Garrote, M. Mysliwiec, David C. Wheeler, J. Cruz-Valdez, R. Klauser, Maree-Ross Smith, Antonio Carlos Carvalho, A. Losito, M. Durlik, G. Petraglia, Gianni Cappelli, Y. Lien, M. Chaffin, N. García, R. Halligan, Glenn M. Chertow, M. Bastos, P. Smak Gregoor, S. Ong, M. Belledonne, Fredric O. Finkelstein, J. Martínez García, R. Pecoits Filho, M. Klingberg, B. Carvalho, S. Noble, T. Plumb, A. Chew Wong, Michael Roppolo, U. Neyer, S. Ahmad, J. Mackie, R. Minasian, M. Verrelli, A. Abukurah, M. Laski, P. Brunet, Madeleine V. Pahl, Daniel Zehnder, E. Alas, Muralidhar Acharya, G. Rudolf, G. Zakar, M. Reddy, R. Specter, G. Grandaliano, I. Kulcsar, A. Amatya, Eugenie Pedagogos, O. Ayodeji, G. Jensen, S. Diamond, Xavier Warling, P. Teredesai, M. Mathew, M. Haque, M. Solis, E. Andrés Ribes, M.A. van den Dorpel, Akhtar Ashfaq, Christian Rabbat, David G. Warnock, M. Sebastian Diaz, C. Mousson, R. Darwish, M. Sperto Baptista, N. Salgado, E. Alvarez Sandoval, M. Vasilevsky, P. Chidester, D. Polack, Simon J. Davies, G. Brosnahan, A. Agarwal, Chaim Charytan, T. Hannedouche, M. Gross, I. Arias, G. James, Jürgen Floege, Tom Dejagere, Patrick S. Parfrey, S. Cournoyer, T. Cavalieri, Gérard M. London, K. Gandhi, A. Kshirsagar, O. Khrustalev, J. Zacharias, Michel Dhaene, Jennifer Tuazon, W. Weise, J. Guzman-Rivera, HS Brink, Alastair J. Hutchison, P. D. Cunha, Robyn G Langham, S. Soman, J. Goldman, S. Kazup Erdelyine, A. Widerhorn, M. Henriquez, N. Hunt, W. Hoerl, O. Arkossy, J. Szegedi, R. Dhingra, M. Fernandez Lucas, Jesus Navarro, A. Kark, Andrey Gurevich, Cynthia J. Brown, Rajnish Mehrotra, L. Kleinman, S. Ferenczi, Loreto Gesualdo, V. Schwenger, M. Ramirez, N. Mittman, Ana María Cusumano, K. Marczewski, Moustafa Moustafa, Sônia M. H. A. Araújo, E. Ladanyi, M. Auricchio, Maurice Laville, P. Urena Torres, C. Gallart, A. Israelit, V. Altobelli, E. Hagen, S. Nosrati, John P. Middleton, Kant Ks, F. Al-Saghir, S. Steinberg, S. Neiva Coelho, Botond Csiky, Philip G Zager, M. Sekkarie, Vanda Jorgetti, Domingos O. d'Avila, Carol A. Pollock, L. Lai, B. von Albertini, Beckie Michael, U. Kunzendorf, N. Frischmuth, A. Durrbach, L. Vasconcellos, Raymond Vanholder, M. Dickenmann, B. Schiller-Moran, Steven D. Soroka, J. Rubin, O. Balkarova, S. Morse, M. Teixeira Araújo, D. Perlin, M. Khan, C. Hura, Dagmar-C. Fischer, D. Machado, Seamas C. Donnelly, D. Sapir, V. Lorica, L. Deboni, M. Jose, M. Galicia, K. Bidas, David Spiegel, David Goldsmith, Peter F Mount, A. Strokov, L. Yu, J. Pitone, Biagio Ricciardi, Alastair Gillies, M. Moyses Neto, Piergiorgio Bolasco, V. Anashkin, John R. Sedor, M. Lee, E.M. Jones, M. Culpepper, G. London, D. Joly, N. Khadikova, Charles A. Herzog, P. Meier, M. Farina, Dana V. Rizk, William M. McClellan, M. Cook, Bastian Dehmel, Patrizia Ferrari, F. Almeida, V. Pogue, R. McCrary, F. Macario, J. Golden, E. Wijeyesinghe, Tilman B. Drüeke, E. Osanloo, M. Muszytowski, F. Arif, Giuseppe Villa, M. Torres Zamora, Steven Zeig, N. Thompson, A. Jamal, C. Sholer, P. Stroumza, D. Reddan, Arun Gupta, J. Montenegro, T. DelGiorno, D. Eadington, G. Shostka, Michel Jadoul, A. Weigert, Sergio Stefoni, P. Dreyer, Carmel M. Hawley, J. Cardeal da Costa, M. Switalski, G. Talaulikar, A. Felsenfeld, J. MacLaurin, T. Herman, N. Pritchard, M. Michaud, K.-U. Eckardt, R. Romero, G. Volgina, Fred E. Husserl, J. Soler Amigó, David S. Goldfarb, A. Matalon, M. 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Subjects
Parathyroidectomy, Adult, Male, medicine.medical_specialty, Cinacalcet, Epidemiology, medicine.medical_treatment, Calcimimetic Agents, Critical Care and Intensive Care Medicine, Lower risk, Severity of Illness Index, CKD, cardiovascular disease, hemodialysis, hyperparathyroidism, mineral metabolism, Age Factors, Aged, Aged, 80 and over, Cardiovascular Diseases, Cinacalcet Hydrochloride, Female, Humans, Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Kidney Transplantation, Middle Aged, Renal Dialysis, Nephrology, Transplantation, Internal medicine, medicine, Intensive care medicine, Hyperparathyroidism, business.industry, Original Articles, medicine.disease, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug
Abstract

Background andobjectivesThecalcimimeticcinacalcet reduced therisk of death or cardiovascular (CV) events in older, but not younger, patients with moderate to severe secondary hyperparathyroidism (HPT) who were receiving hemodialysis. To determine whether the lower risk in younger patients might be due to lower baseline CV risk and more frequent use of cointerventions that reduce parathyroid hormone (kidney transplantation, parathyroidectomy, and commercial cinacalcet use), this study examined the effects of cinacalcet in older ($65 years, n=1005) and younger (,65 years, n=2878) patients. Design, setting, participants, & measurements Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) was a global, multicenter, randomized placebo-controlled trial in 3883 prevalent patients on hemodialysis, whose outcomes included death, major CV events, and development of severe unremitting HPT. The age subgroup analysis was prespecified. ResultsOlderpatients hadhigher baselineprevalenceof diabetesmellitusandCV comorbidity. Annualizedrates of kidney transplantation and parathyroidectomy were .3-fold higher in younger relative to older patients and were more frequent in patients randomized to placebo. In older patients, the adjusted relative hazard (95% confidence interval) for the primary composite (CV) end point (cinacalcet versus placebo) was 0.70 (0.60 to 0.81); in younger patients, the relative hazard was 0.97 (0.86 to 1.09). Corresponding adjusted relative hazards for mortality were 0.68 (0.51 to 0.81) and 0.99 (0.86 to 1.13). Reduction in the risk of severe unremitting HPT was similar in both groups. Conclusions In the EVOLVE trial, cinacalcet decreased the risk of death and of major CV events in older, but not younger, patients with moderate to severe HPT who were receiving hemodialysis. Effect modification by age may be partly explained by differences in underlying CV risk and differential application of cointerventions that reduce parathyroid hormone. Clin J Am Soc Nephrol 10: ccc–ccc, 2015. doi: 10.2215/CJN.07730814

Published
2015

49. Serial direct sodium removal in patients with heart failure and diuretic resistance.

Author

Rao VS, Ivey-Miranda JB, Cox ZL, Moreno-Villagomez J, Ramos-Mastache D, Neville D, Balkcom N, Asher JL, Bellumkonda L, Bigvava T, Shaburishvili T, Bartunek J, Wilson FP, Finkelstein F, Maulion C, Turner JM, and Testani JM

Subjects
Aged, Female, Humans, Male, Middle Aged, Cardio-Renal Syndrome drug therapy, Cardio-Renal Syndrome physiopathology, Diuretics therapeutic use, Diuretics administration & dosage, Prospective Studies, Sodium Potassium Chloride Symporter Inhibitors therapeutic use, Sodium Potassium Chloride Symporter Inhibitors administration & dosage, Drug Resistance, Furosemide administration & dosage, Furosemide therapeutic use, Heart Failure drug therapy, Heart Failure physiopathology, Sodium urine
Abstract

Aims: Loop diuretics may exacerbate cardiorenal syndrome (CRS) in heart failure (HF). Direct sodium removal (DSR) using the peritoneal membrane, in conjunction with complete diuretic withdrawal, may improve CRS and diuretic resistance., Methods and Results: Patients with HF requiring high-dose loop diuretics were enrolled in two prospective, single-arm studies: RED DESERT (n = 8 euvolaemic patients), and SAHARA (n = 10 hypervolaemic patients). Loop diuretics were withdrawn, and serial DSR was utilized to achieve and maintain euvolaemia. At baseline, participants required a median 240 mg (interquartile range [IQR] 200-400) oral furosemide equivalents/day, which was withdrawn in all participants during DSR (median time of DSR 4 weeks [IQR 4-6]). Diuretic response (queried by formal 40 mg intravenous furosemide challenge and 6 h urine sodium quantification) increased substantially from baseline (81 ± 37 mmol) to end of DSR (223 ± 71 mmol, p < 0.001). Median time to re-initiate diuretics was 87 days, and the median re-initiation dose was 8% (IQR 6-10%) of baseline. At 1 year, diuretic dose remained substantially below baseline (30 [IQR 7.5-40] mg furosemide equivalents/day). Multiple dimensions of kidney function such as filtration, uraemic toxin excretion, kidney injury, and electrolyte handling improved (p < 0.05 for all). HF-related biomarkers including N-terminal pro-B-type natriuretic peptide, carbohydrate antigen-125, soluble ST2, interleukin-6, and growth differentiation factor-15 (p < 0.003 for all) also improved., Conclusions: In patients with HF and diuretic resistance, serial DSR therapy with loop diuretic withdrawal was feasible and associated with substantial and persistent improvement in diuretic resistance and several cardiorenal parameters. If replicated in randomized controlled studies, DSR may represent a novel therapy for diuretic resistance and CRS., Clinical Trial Registration: RED DESERT (NCT04116034), SAHARA (NCT04882358)., (© 2024 European Society of Cardiology.)

Published
2024
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50. Serum biomarkers of iron stores are associated with worse physical health-related quality of life in nondialysis-dependent chronic kidney disease patients with or without anemia.

Author

Guedes M, Muenz D, Zee J, Lopes MB, Waechter S, Stengel B, Massy ZA, Speyer E, Ayav C, Finkelstein F, Sesso R, Pisoni RL, Robinson BM, and Pecoits-Filho R

Subjects
Biomarkers, Humans, Iron, Quality of Life, Anemia etiology, Anemia, Iron-Deficiency etiology, Renal Insufficiency, Chronic therapy
Abstract

Background: Iron deficiency (ID) is a common condition in nondialysis-dependent chronic kidney disease (NDD-CKD) patients that is associated with poorer clinical outcomes. However, the effect of ID on health-related quality of life (HRQoL) in this population is unknown. We analyzed data from a multinational cohort of NDD-CKD Stages 3-5 patients to test the association between transferrin saturation (TSAT) index and ferritin with HRQoL., Methods: Patients from Brazil (n = 205), France (n = 2015) and the USA (n = 293) in the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps, 2013-2019) were included. We evaluated the association of TSAT and ferritin (and functional and absolute ID, defined as TSAT ≤20% and ferritin ≥300 or <50 ng/mL) on pre-specified HRQoL measures, including the 36-item Kidney Disease Quality of Life physical component summary (PCS) and mental component summary (MCS) as the primary outcomes. Models were adjusted for confounders including hemoglobin (Hb)., Results: TSAT ≤15% and ferritin <50 ng/mL and ≥300 ng/mL were associated with worse PCS scores, but not with MCS. Patients with composite TSAT ≤20% and ferritin <50 or ≥300 ng/mL had lower functional status and worse PCS scores than those with a TSAT of 20-30% and ferritin 50-299 ng/mL. Patients with a lower TSAT were less likely to perform intense physical activity. Adjustment for Hb only slightly attenuated the observed effects., Conclusions: Low TSAT levels, as well as both low TSAT with low ferritin and low TSAT with high ferritin, are associated with worse physical HRQoL in NDD-CKD patients, even after accounting for Hb level. Interventional studies of iron therapy on HRQoL among NDD-CKD individuals are needed to confirm these findings., (© The Author(s) 2021. Published by Oxford University Press on behalf of ERA-EDTA.)

Published
2021
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