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2. 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
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3. 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., 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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

5. NSAIDS In The Postoperative Period

Author

Appadurai, Ian R., Power, Ian, Worsley, Mark H., O'Callaghan, C. A., Andrews, P. A., Ogg, C. S., Gibson, P., Eadington, D. W., Winney, R. J., and Penn, G. C.

Published
1993

6. Vaccination against hepatitis B infection in patients with end stage renal disease. (Original Article)

Author

Bel'eed, K., Wright, M., Eadington, D., Farr, M., and Sellars, L.

Subjects
Chronic kidney failure -- Care and treatment -- Prevention, Hepatitis B -- Prevention -- Care and treatment, Hepatitis B vaccine -- Dosage and administration, Health
Abstract

Background: Experience of hepatitis B vaccination in a contemporary renal replacement programme is reported. Methods: A total of 406 patients were involved: 214 on haemodialysis, 97 on continuous ambulatory peritoneal [...]

Published
2002

22. Renal tubular responses to low-dose infusion of angiotensin II in type 1 diabetes mellitus; relation to chronic glycaemic control.

Author

Eadington, D. W., Frier, B. M., and Swainson, C. P.

Abstract

Renal responses to low-dose infusion of angiotensin II (ANGII, 1.25 and 2.5 ng.kg min) were examined in 15 patients with type 1 diabetes and in 10 control subjects after pretreatment with lithium carbonate (750 mg, 20 mmol). Mean arterial pressure rose during ANGII infusion in both groups. The renal haemodynamic response to angiotensin II was not abnormal in the diabetic patients. Absolute proximal reabsorption of sodium was increased at baseline in the diabetic group, and fell during ANGII. Fractional lithium excretion was reduced in the diabetic patients at baseline (<0.05), and the fall in fractional lithium excretion during ANGII was less than in the control group (=0.012). In the diabetic group correlations existed between glycated haemoglobin and baseline glomerular filtration rate (<0.05), baseline fractional lithium excretion (=0.03), and the fall in fractional lithium excretion during angiotensin II infusion (=0.013). There was no correlation between glycated haemoglobin and absolute lithium clearance. Some indices of sodium reabsorption by the proximal renal tubule in diabetic patients correlate with prevailing chronic glycaemic control, largely reflecting changes in glomerular filtration rate. Reduced fractional proximal tubular responsiveness to exogenous angiotensin II is consistent with a role for endogenous angiotensin II as one mediator of increased tubular reabsorption of sodium in type I diabetes, but the data does not exclude alternative mechanisms. [ABSTRACT FROM PUBLISHER]

Published
1994

26. Vasopressin Secretion in Diabetic Subjects with and without Autonomic Neuropathy: Responses to Osmotic and Postural Stimulation

Author

Reid, W., Ewing, D. J., Lightman, S. L., Eadington, D., Williams, T. D. M., Roulston, J. E., and Clarke, B. F.

Abstract

1. The release of arginine vasopressin (AVP) after an osmotic stimulus and head-up tilt was assessed in diabetic subjects with and without autonomic neuropathy 2. Six diabetic subjects with (DAN +ve) and five without (DAN − ve) evidence of autonomic neuropathy and five normal subjects were infused with 5% (w/v) NaCl at a rate of 0.05 ml min−1 kg−1 body weight for 120 min. Blood pressure, heart rate and plasma AVP were measured over this period 3. Seven DAN +ve, six DAN −ve and six normal subjects were tilted head-up to 45° for 120 min. Blood pressure, heart rate and plasma AVP were measured during the study 4. Infusion of 5% (w/v) NaCl produced appropriate rises in plasma osmolality and plasma AVP levels which did not differ between the three groups, confirming the normal osmotic release of AVP in the diabetic subjects 5. During head-up tilt, there were no differences in AVP responses between the three groups, despite a major hypotensive stimulus in the DAN + ve group 6. We conclude that osmotic release of AVP is normal in diabetes, but that cardiovascular release of AVP is impaired in diabetic subjects with cardiovascular reflex evidence of autonomic neuropathy, reflecting an afferent defect.

Published
1989
Full Text
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30. An unusual rash and end-stage renal failure

Author

Tan, Huck J and Eadington, D

Abstract

A 55-year-old man was admitted to hospital with a 2-week history of increasing dyspnoea and peripheral oedema. He gave a 5-year history of intermittent purpuric rash on both legs, with recurrent ulceration at the right lateral malleolus, and arthralgia.

Published
2001
Full Text
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33. 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. D. Torres, P. Sampaio Lacativa, L. Major, U. Lund, A. Lafalla, S. Sarkar, Jennifer M. MacRae, J. Lobo, Liudmila Rozhinskaya, Johann Braun, H. Daugaard, S. Khokhar, S. Rubinstein, D. Bhatia, G. Timokhovskaya, T. Wooldridge, A. Voßkühler, Nelson Kopyt, Pablo E. Pergola, Michel Burnier, L. Samuels, J. Alcázar de La Ossa, J. Billiouw, R. Liebl, P. Sidhu, S. Menahem, P. Montambault, E. Schwertfeger, K. Staroselsky, J. Kovarik, S. Horn, N. Tareen, Simon D. Roger, Francesco Locatelli, Kenneth W. Mahaffey, J Vanwalleghem, Robert I. Lynn, M. Prados, K. Kapatkin, N. Peñalba, Kailash Jindal, M. Stegman, R. Stahl, Joseph A. Eustace, S. Desmeules, A. Hazzan, D. Scott, B. Taparia, G. Keightley, P. Jensen, V. Ortalda, K. McConnell, Alejandro Martin-Malo, Margaret M. Williams, Stuart M. Sprague, S. Chow, Diego Brancaccio, Yumi Kubo, P. Dykes, E. de Francesco Daher, C. Erley, Joanna Matuszkiewicz-Rowińska, T. Minga, I. Dasgupta, Galen S. Wagner, N. Marchetta, R. Rigolosi, P. Raguram, P. Lang, P. Cambier-Dwelschauwers, A. Tsang, M. Schonefeld, W. Bentkowski, Z. Sharon, Daniel Batlle, James T. McCarthy, M. Vital Flores, M. Rambausek, A. Zemtchenkov, Fabio Malberti, V. Thakur, O. Domashenko, D. Wheeler, J. Capelli, Bernard Jones, D. Uehlinger, K. Olgaard, K. Lhotta, M. Bernardo, S. Goldberger, Alison Thomas, E. Dunnigan, A. Ksiazek, A. Assefi, C. Poole, G. Rosa Diez, G. Newman, J. Cotton, C. Combe, B. Murthyr, Sharon M. Moe, H. Neumayer, J. Mittleman, Robert G. Fassett, W. Cleveland, F. van der Sande, C. Vela, H. Fessi, J. Robertson, Giuseppe Cannella, Bryan N. Becker, João M. Frazão, V. Shilo, M. Rano, J. De Meester, R. Fiedler, J. Floege, B. Murray, Giovambattista Capasso, F. Dellanna, J. Luiz Gross, K. Tucker, C. Santiago, Paul J. Martin, M. Nowicki, L. Friedman, William G. Goodman, G. Diez, Markus Ketteler, S. Arfeen, I. Mezei, J. Ortiz, Elizabeth E. Brown, Deborah Zimmerman, Aleix Cases, M. El Khatib, Martine Leblanc, R. Daelemans, K. Malireddi, C. Rikker, R. Gladish, F. Aranda Verástegui, R. Kopelman, B. Borbas, J. Buerkert, K. Ntoso, J. Peña, V. Garcia, C. West, M. Azer, J. Kwan, J. Sterrett, P. Swift, A. Raff, R. Kohli, S. Lew, Steven J. Rosansky, H. Graf, K. Bouman, F. Skinner, C. Tielemans, S. Ferreira Filho, Jocemir Ronaldo Lugon, M. Weinberg, Parfrey, P. S., Drueke, T. B., Block, G. A., Correa-Rotter, R., Floege, J., Herzog, C. A., London, G. M., Mahaffey, K. W., Moe, S. M., Wheeler, D. C., Kubo, Y., Dehmel, B., Goodman, W. G., Chertow, G. M., 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., London, 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., and Rekhi, A.

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

34. The utility of myocardial perfusion imaging before renal transplantation: a retrospective analysis.

Author

Callan PD, Bhandari S, Clark AL, Eadington D, Papadopoulos E, and Tweddel AC

Subjects
Female, Humans, Male, Middle Aged, Retrospective Studies, Stress, Physiological, Kidney Transplantation, Myocardial Perfusion Imaging
Abstract

Background: Renal transplantation (RT) reduces morbidity and mortality in patients with end-stage renal failure. Myocardial perfusion imaging provides prognostic information in patients with renal failure, but its role before transplantation remains unclear. We performed a retrospective review assessing the prognostic value of technetium-99m sestamibi myocardial perfusion imaging at a tertiary UK centre., Patients and Methods: We included scans performed between 2005 and 2012. Available scans were reanalysed to calculate the semiquantitative summed scores: sum rest score (SRS), sum stress score (SSS), sum difference score and sum motion score (SMS). Kaplan-Meier survival estimates assessed all-cause mortality and cardiac events according to scan findings, transplant decision and SSS. Cox-proportional hazards tested for an association between clinical/scan variables and all-cause mortality, and combined all-cause mortality/cardiovascular (CV) events., Results: One hundred and thirty-eight scans were identified with complete follow-up. During a median 40.4-month follow-up, 21 patients died, with 11 nonfatal CV events. There was no significant difference between groups according to scan findings for mortality (log-rank P=0.17) or mortality/CV events (P=0.06). An SSS greater than 8 was associated with higher mortality and CV events combined (P=0.028). An abnormal baseline ECG [hazard ratio (HR): 16.1] and higher SRS (HR: 2.3) were associated independently with higher mortality; an abnormal ECG (HR: 3.4) also predicted higher cardiac events/mortality., Conclusion: Moderate to severe perfusion defects by SSS were associated with higher mortality and CV events. Higher SRS was associated independently with increased mortality on multivariable analysis, highlighting a key role for semiquantitative analysis methods for risk stratification. An abnormal ECG was associated strongly with both endpoints, and may be a useful screening tool to select patients for further investigation.

Published
2018
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35. Effect of renal artery revascularization upon cardiac structure and function in atherosclerotic renal artery stenosis: cardiac magnetic resonance sub-study of the ASTRAL trial.

Author

Ritchie J, Green D, Chrysochou T, Hegarty J, Handley K, Ives N, Wheatley K, Houston G, Wright J, Neyses L, Chalmers N, Mark P, Patel R, Moss J, Roditi G, Eadington D, Lukaschuk E, Cleland J, and Kalra PA

Subjects
Aged, Aged, 80 and over, Angioplasty, Atherosclerosis physiopathology, Blood Pressure, Female, Glomerular Filtration Rate, Heart Ventricles diagnostic imaging, Heart Ventricles physiopathology, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Myocardium pathology, Renal Artery surgery, Renal Artery Obstruction physiopathology, Treatment Outcome, Atherosclerosis surgery, Heart Ventricles pathology, Renal Artery Obstruction surgery
Abstract

Background: Cardiac abnormalities are frequent in patients with atherosclerotic renovascular disease (ARVD). The Angioplasty and Stenting for Renal Artery Lesions (ASTRAL) trial studied the effect of percutaneous renal revascularization combined with medical therapy compared with medical therapy alone in 806 patients with ARVD., Methods: This was a pre-specified sub-study of ASTRAL (clinical trials registration, current controlled trials number: ISRCTN59586944), designed to consider the effect of percutaneous renal artery angioplasty and stenting on change in cardiac structure and function, measured using cardiac magnetic resonance (CMR) imaging. Fifty-one patients were recruited from six selected ASTRAL centres. Forty-four completed the study (medical therapy n = 21; revascularization n = 23). Full analysis of CMR was possible in 40 patients (18 medical therapy and 22 revascularization). CMR measurements of left and right ventricular end systolic (LV and RVESV) and diastolic volume (LV and RVEDV), ejection fraction (LVEF) and mass (LVM) were made shortly after recruitment and before revascularization in the interventional group, and again after 12 months. Reporting was performed by CMR analysts blinded to randomization arm., Results: Groups were well matched for mean age (70 versus 72 years), blood pressure (148/71 versus 143/74 mmHg), degree of renal artery stenosis (75 versus 75%) and comorbid conditions. In both randomized groups, improvements in cardiac structural parameters were seen at 12 months, but there were no significant differences between treatment groups. Median left ventricular changes between baseline and 12 months (medical versus revascularization) were LVEDV -1.9 versus -5.8 mL, P = 0.4; LVESV -2.1 versus 0.3 mL, P = 0.7; LVM -5.4 versus -6.3 g, P = 0.8; and LVEF -1.5 versus -0.8%, P = 0.7. Multivariate regression also found that randomized treatment assignment was not associated with degree of change in any of the CMR measurements., Conclusions: In this sub-study of the ASTRAL trial, renal revascularization did not offer additional benefit to cardiac structure or function in unselected patients with ARVD., (© The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.)

Published
2017
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36. Revascularization versus medical therapy for renal-artery stenosis.

Author

Wheatley K, Ives N, Gray R, Kalra PA, Moss JG, Baigent C, Carr S, Chalmers N, Eadington D, Hamilton G, Lipkin G, Nicholson A, and Scoble J

Subjects
Adult, Aged, Aged, 80 and over, Blood Pressure, Combined Modality Therapy, Drug Therapy, Combination, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Kaplan-Meier Estimate, Male, Middle Aged, Platelet Aggregation Inhibitors therapeutic use, Renal Artery Obstruction drug therapy, Renal Artery Obstruction mortality, Renal Artery Obstruction physiopathology, Stents, Treatment Outcome, Angioplasty, Balloon adverse effects, Antihypertensive Agents therapeutic use, Renal Artery Obstruction therapy
Abstract

Background: Percutaneous revascularization of the renal arteries improves patency in atherosclerotic renovascular disease, yet evidence of a clinical benefit is limited., Methods: In a randomized, unblinded trial, we assigned 806 patients with atherosclerotic renovascular disease either to undergo revascularization in addition to receiving medical therapy or to receive medical therapy alone. The primary outcome was renal function, as measured by the reciprocal of the serum creatinine level (a measure that has a linear relationship with creatinine clearance). Secondary outcomes were blood pressure, the time to renal and major cardiovascular events, and mortality. The median follow-up was 34 months., Results: During a 5-year period, the rate of progression of renal impairment (as shown by the slope of the reciprocal of the serum creatinine level) was -0.07x10(-3) liters per micromole per year in the revascularization group, as compared with -0.13x10(-3) liters per micromole per year in the medical-therapy group, a difference favoring revascularization of 0.06x10(-3) liters per micromole per year (95% confidence interval [CI], -0.002 to 0.13; P=0.06). Over the same time, the mean serum creatinine level was 1.6 micromol per liter (95% CI, -8.4 to 5.2 [0.02 mg per deciliter; 95% CI, -0.10 to 0.06]) lower in the revascularization group than in the medical-therapy group. There was no significant between-group difference in systolic blood pressure; the decrease in diastolic blood pressure was smaller in the revascularization group than in the medical-therapy group. The two study groups had similar rates of renal events (hazard ratio in the revascularization group, 0.97; 95% CI, 0.67 to 1.40; P=0.88), major cardiovascular events (hazard ratio, 0.94; 95% CI, 0.75 to 1.19; P=0.61), and death (hazard ratio, 0.90; 95% CI, 0.69 to 1.18; P=0.46). Serious complications associated with revascularization occurred in 23 patients, including 2 deaths and 3 amputations of toes or limbs., Conclusions: We found substantial risks but no evidence of a worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease. (Current Controlled Trials number, ISRCTN59586944.), (2009 Massachusetts Medical Society)

Published
2009
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37. Randomized prospective comparison of laparoscopic and open peritoneal dialysis catheter insertion.

Author

Wright MJ, Bel'eed K, Johnson BF, Eadington DW, Sellars L, and Farr MJ

Subjects
Catheterization adverse effects, Device Removal, Female, Humans, Length of Stay, Male, Middle Aged, Prospective Studies, Survival Analysis, Catheterization methods, Catheters, Indwelling adverse effects, Laparoscopy, Peritoneal Dialysis methods
Abstract

Objective: To compare laparoscopic and conventional peritoneal dialysis catheter insertion with respect to post operative discomfort, complication rates, and catheter survival., Design: Randomized prospective study., Setting: Tertiary referral renal unit., Patients: Fifty patients commencing peritoneal dialysis., Intervention: Catheters were implanted laparoscopically or by a conventional surgical technique., Main Outcome Measures: The duration of surgery, hospital stay, pain scores, and analgesic requirements were recorded. Complications (early/late) and catheter survival were compared., Results: The conventional procedure was faster than the laparoscopic (14.3 vs 21.9 minutes, p < 0.0001). There was no difference in any other parameter assessed., Conclusions: The data suggest that the insertion techniques are equivalent, and that laparoscopic insertion does not reduce early complication rates.

Published
1999

38. Albumin in the nephrotic syndrome.

Author

Eadington DW, Plant WD, and Winney RJ

Subjects
Furosemide therapeutic use, Humans, Infusions, Intravenous, Albumins administration & dosage, Nephrotic Syndrome drug therapy
Published
1995
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39. Case report: infected false aneurysm at the site of an iliac stent.

Author

Chalmers N, Eadington DW, Gandanhamo D, Gillespie IN, and Ruckley CV

Subjects
Acute Kidney Injury etiology, Aneurysm, False etiology, Aneurysm, Infected etiology, Humans, Male, Middle Aged, Staphylococcal Infections etiology, Tomography, X-Ray Computed, Aneurysm, False diagnostic imaging, Aneurysm, Infected diagnostic imaging, Arterial Occlusive Diseases therapy, Iliac Artery diagnostic imaging, Stents adverse effects
Abstract

False aneurysm formation at the site of iliac artery stent placement is an uncommon but serious complication of the procedure. We report a case of infected false aneurysm at the site of an iliac stent, complicated by renal failure.

Published
1993
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40. Survival on renal-replacement therapy.

Author

Plant WD, Eadington DW, and Winney RJ

Subjects
Comorbidity, Humans, Kidney Failure, Chronic therapy, Quality Assurance, Health Care, Renal Dialysis methods, Kidney Failure, Chronic mortality, Renal Dialysis standards
Published
1993

41. Chronic renal failure.

Author

Eadington D, Plant W, and Winney R

Subjects
Anemia etiology, Humans, Kidney Failure, Chronic complications, Kidney Transplantation, Renal Dialysis, Kidney Failure, Chronic therapy
Published
1993

42. Association between connective tissue changes and smoking habit in type 2 diabetes and in non-diabetic humans.

Author

Eadington DW, Patrick AW, and Frier BM

Subjects
Diabetes Mellitus, Type 2 complications, Dupuytren Contracture complications, Dupuytren Contracture epidemiology, Female, Humans, Joint Diseases complications, Joint Diseases epidemiology, Male, Middle Aged, Prevalence, Connective Tissue physiopathology, Diabetes Mellitus, Type 2 physiopathology, Dupuytren Contracture physiopathology, Joint Diseases physiopathology, Joints physiopathology, Smoking physiopathology
Abstract

Two hundred type 2 (non-insulin-dependent) diabetic patients and 170 non-diabetic age- and sex-matched normotensive controls were examined for limited joint mobility (LJM) and Dupuytren's contracture (DC), and their smoking history was documented. The prevalences of LJM and DC were not significantly different in diabetic and control subjects (LJM: odds ratio 1.58, 95% CI 0.99 to 2.50; DC: odds ratio 1.34, CI 0.81 to 2.23). Cigarette smoking was positively associated with both LJM and DC in the diabetic patients (LJM: relative risk (R) = 1.96, 95% CI 1.10 to 3.49; DC: R = 2.88, CI 1.29 to 6.43) and in the control group (LJM: R = 2.22, CI 1.70 to 5.86; DC: R = 2.71, CI 1.23 to 5.89). Limited joint mobility and Dupuytren's contracture are both associated with cigarette smoking in type 2 diabetic patients and in age-matched non-diabetic subjects. This suggests that type 2 diabetes is only one of a number of factors which promote the development of these connective tissue changes.

Published
1991
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43. Unawareness of hypoglycaemia in insulin-treated diabetic patients: prevalence and relationship to autonomic neuropathy.

Author

Hepburn DA, Patrick AW, Eadington DW, Ewing DJ, and Frier BM

Subjects
Adolescent, Adult, Aged, Cross-Sectional Studies, Diabetic Neuropathies physiopathology, Heart Function Tests, Humans, Hypoglycemia chemically induced, Hypoglycemia physiopathology, Middle Aged, Respiratory Function Tests, Severity of Illness Index, Surveys and Questionnaires, Awareness physiology, Diabetic Neuropathies psychology, Hypoglycemia psychology, Insulin adverse effects
Abstract

Three-hundred and two insulin-treated diabetic patients were questioned about hypoglycaemia using a structured questionnaire interview. Two-hundred and twenty-six patients (75%) had normal symptomatic awareness, 48 (16%) had partial awareness, 21 (7%) had absent awareness of hypoglycaemia, and 7 (2%) denied ever experiencing hypoglycaemia. Patients with complete loss of awareness of hypoglycaemia had diabetes of longer duration; none had a HbA1 concentration within the non-diabetic range. Loss of awareness of hypoglycaemia was associated with an increased incidence of severe hypoglycaemia, 19 (91%) of the patients with absent awareness, and 33 (69%) with partial awareness of hypoglycaemia experiencing severe hypoglycaemia over 1 year compared with only 41 (18%) of patients with normal awareness of hypoglycaemia (p less than 0.001). Cardiovascular autonomic function tests were performed in 226 (75% of the whole group). Of the patients who had diabetes for more than 15 years, 54% (n = 39) with normal awareness of hypoglycaemia, compared with 59% (n = 10) with absent awareness of hypoglycaemia, had evidence of cardiovascular autonomic impairment (NS). Seven (41%) of the 17 patients with absent awareness of hypoglycaemia and diabetes of greater than 15 years duration had no evidence of autonomic dysfunction. Loss of hypoglycaemia awareness is a common problem in patients with insulin-treated diabetes of long duration, is associated with an increased incidence of severe hypoglycaemia, but is not invariably associated with abnormal cardiovascular autonomic function tests.

Published
1990
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44. Distribution of glycocholate in blood from human fetuses and adults.

Author

Strange RC, Hume R, Eadington DW, and Nimmo IA

Subjects
Adult, Blood Proteins metabolism, Chromatography, Gel, Humans, Infant, Newborn, Protein Binding, Serum Albumin metabolism, Fetal Blood analysis, Glycocholic Acid blood
Abstract

Glycocholate binding by plasma proteins and erythrocytes from fetal and adult blood has been studied, and the results have been used to derive a compartmental model of the distribution of glycocholate in blood. This model assumes that glycocholate is distributed between the aqueous phase, albumin binding sites, binding sites on other plasma proteins, and erythrocytes. Whereas glycocholate binding by albumin was saturable [fetal blood: dissociation constant (0.5 mM), concentration of binding sites (11.3 mumoles/g protein); adult blood: dissociation constant (0.42 mM), concentration of binding sites (20.1 mumoles/g protein)], binding by other plasma proteins was not. The association of glycocholate with erythrocytes appeared to be based on partitioning rather than binding of the bile salt to specific sites. The value of the partition coefficient was 6.0. The compartmental model indicates that, in fetal blood, 46% of the glycocholate is in free solution, and 37% is bound to albumin. In blood from adults, the corresponding values are 31% in free solution and 59% bound to albumin.

Published
1981
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45. Symptomatic awareness of hypoglycaemia: does it change on transfer from animal to human insulin?

Author

Hepburn DA, Eadington DW, Patrick AW, Colledge NR, and Frier BM

Subjects
Adult, Diabetes Mellitus blood, Female, Humans, Hypoglycemia etiology, Insulin therapeutic use, Male, Random Allocation, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Awareness, Cognition, Diabetes Mellitus drug therapy, Hypoglycemia physiopathology, Insulin adverse effects
Abstract

A retrospective survey of symptomatic awareness of hypoglycaemia was performed in 189 randomly selected patients with insulin-treated diabetes who had been transferred from highly purified animal insulins to human insulin in the preceding 24 months. Of the 189 patients 44 (23%) complained of chronic hypoglycaemic unawareness, unrelated to ambient blood glucose control, before change of insulin species. Only 12 of the remaining 145 patients reported a reduction in awareness of hypoglycaemia following transfer to human insulin (6% of the whole group), while 6 (3%) reported an increase in awareness following the transfer. The 12 patients reporting reduced awareness had a mean duration of diabetes of 24 +/ 10 years compared to a duration of 15 +/- 10 years in the patients with normal awareness. The mean glycosylated haemoglobin concentrations were similar in all of the groups of patients. Six patients had developed total loss of awareness of the onset of hypoglycaemia, with all but one patient having suffered multiple episodes of severe hypoglycaemia. This reduced hypoglycaemic awareness on human insulin therapy was not associated with any significant improvement in blood glucose control.

Published
1989
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46. Diagnostic pitfalls in plasma cell neoplasia.

Author

Eadington D, Harrison D, and Winney RJ

Subjects
Adult, Diagnostic Errors, Humans, Male, Middle Aged, Paraproteinemias metabolism, Paraproteinemias diagnosis
Published
1989

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