Document Detail


Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis.
MedLine Citation:
PMID:  23121374     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.).
Authors:
; Glenn M Chertow; Geoffrey A Block; Ricardo Correa-Rotter; Tilman B Drüeke; Jürgen Floege; William G Goodman; Charles A Herzog; Yumi Kubo; Gerard M London; Kenneth W Mahaffey; T Christian H Mix; Sharon M Moe; Marie-Louise Trotman; David C Wheeler; Patrick S Parfrey
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-03
Journal Detail:
Title:  The New England journal of medicine     Volume:  367     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-27     Completed Date:  2013-01-07     Revised Date:  2013-05-30    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2482-94     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00345839
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Cardiovascular Diseases / etiology,  mortality,  prevention & control*
Female
Humans
Hyperparathyroidism, Secondary / drug therapy*,  etiology
Hypocalcemia / chemically induced
Intention to Treat Analysis
Kidney Failure, Chronic / complications,  drug therapy*,  therapy
Male
Middle Aged
Naphthalenes / adverse effects,  therapeutic use*
Odds Ratio
Parathyroid Hormone / blood
Renal Dialysis* / adverse effects
Chemical
Reg. No./Substance:
0/Naphthalenes; 0/Parathyroid Hormone; UAZ6V7728S/cinacalcet
Investigator
Investigator/Affiliation:
G Chertow / ; P Parfrey / ; G Block / ; R Correa-Rotter / ; T Drüeke / ; J Floege / ; W Goodman / ; C Herzog / ; G London / ; K Mahaffey / ; S Moe / ; D Wheeler / ; C Hennekens / ; C Baigent / ; W Brown / ; P O'Brien / ; S Anderson / ; J Hoel / ; K Mahaffey / ; L Szczech / ; U Patel / ; J Wampole / ; P Pun / ; M Felker / ; J Inrig / ; S Shah / ; A Hernandez / ; C Patel / ; M Brennan / ; M Albizem / ; E Capper / ; L Cauchi / ; S Cheng / ; B Dehmel / ; K Dhami / ; C Durham / ; M Francioni / ; S Gadd / ; B Goodman / ; L Guimaraes / ; N Grey / ; R Hamlin / ; C Harris / ; E Harris / ; S Heavey / ; T Heiges / ; D Heiser / ; P Jaeger / ; M James / ; P James / ; S Karimi / ; R Kewalramani / ; A Kraszewski / ; Y Kubo / ; J Liang / ; J Maguire / ; K McCormick / ; K McFarlane / ; C Mix / ; D Modafferi / ; R Prathikanti / ; C Ryan / ; N Santiago / ; J Schumacher / ; C Seder / ; S Shahinfar / ; B Soares / ; D Stolman / ; C Tisher / ; M Trotman / ; S Tseng / ; G Ulias / ; P Unger / ; A Vyshenskaya / ; L Walsh / ; C White / ; K Wilde / ; J Santos / ; C Najun Zarazaga / ; I Marin / ; N Garrote / ; A Cusumano / ; N Penalba / ; E Del Valle / ; L Juncos / ; J Martinez Saye / ; L Lef / ; V Altobelli / ; G Petraglia / ; G Rosa-Diez / ; W Douthat / ; J Lobo / ; C Gallart / ; A Lafalla / ; G Diez / ; B Linares / ; N Lopez / ; N Ramirez / ; R Gonzalez / ; R Valtuille / ; H Beresan / ; O Hermida / ; G Rudolf / ; N Marchetta / ; M Rano / ; M Ramirez / ; N Garcia / ; A Gillies / ; B Jones / ; E Pedagogos / ; R Walker / ; G Talaulikar / ; K Bannister / ; M Suranyi / ; A Kark / ; S Roger / ; P Kerr / ; A Disney / ; P Mount / ; M Fraenkel / ; M Mathew / ; R Fassett / ; M Jose / ; C Hawley / ; M Lonergan / ; J Mackie / ; P Ferrari / ; S Menahem / ; J Sabto / ; B Hutchison / ; R Langham / ; C Pollock / ; H Holzer / ; R Oberbauer / ; I Arias / ; H Graf / ; G Mayer / ; K Lhotta / ; U Neyer / ; R Klauser-Braun / ; W Hoerl / ; S Horn / ; J Kovarik / ; R Kramar / ; M Eigner / ; M Dhaene / ; J Billiouw / ; J De Meester / ; X Warling / ; P Cambier-Dwelschauwers / ; P Evenepoel / ; R Daelemans / ; M Dratwa / ; B Maes / ; J Stolear / ; T Dejagere / ; J Vanwalleghem / ; K Bouman / ; M Jadoul / ; J Peeters / ; R Vanholder / ; C Tielemans / ; J Donck / ; F Almeida / ; J Picollo de Oliveira / ; E Burdmann / ; V Garcia / ; F Saldanha Thome / ; L Deboni / ; R Bregman / ; J Lugon / ; S Araújo / ; S Ferreira Filho / ; E de Francesco Daher / ; M Sperto Baptista / ; A Carvalho / ; D d'Avila / ; M Moyses Neto / ; L Yu / ; M Bastos / ; P Sampaio Lacativa / ; V Jorgetti / ; E de Almeida Romão / ; J Cardeal da Costa / ; R Pecoits Filho / ; P Gordan / ; N Salgado / ; M Teixeira Araújo / ; S Neiva Coelho / ; I Oliveira / ; R Moysés / ; L Vasconcellos / ; P Batista / ; J Luiz Gross / ; A Pedrosa / ; S Cournoyer / ; M LeBlanc / ; S Chow / ; S Karunakaran / ; G Wong / ; S Tobe / ; S Desmeules / ; D Zimmerman / ; S Murphy / ; P Montambault / ; S Donnelly / ; J MacRae / ; B Culleton / ; S Soroka / ; C Rabbat / ; K Jindal / ; M Vasilevsky / ; M Michaud / ; E Wijeyesinghe / ; J Zacharias / ; C Lok / ; N Muirhead / ; M Verrelli / ; G Da Roza / ; D Sapir / ; K Olgaard / ; H Daugaard / ; L Brandi / ; P Jensen / ; H Boulechfar / ; K Ang / ; P Simon / ; P Rieu / ; P Brunet / ; G Touchard / ; G London / ; P Urena Torres / ; C Combe / ; A Durrbach / ; J Ortiz / ; T Hannedouche / ; C Vela / ; A Lionet / ; P Ryckelynck / ; P Zaoui / ; G Choukroun / ; H Fessi / ; P Lang / ; P Stroumza / ; D Joly / ; C Mousson / ; M Laville / ; F Dellanna / ; C Erley / ; J Braun / ; M Rambausek / ; W Riegel / ; M Klingberg / ; E Schwertfeger / ; V Wizemann / ; K Eckardt / ; H Reichel / ; J Floege / ; J Passauer / ; E Hübel / ; N Frischmuth / ; R Liebl / ; R Fiedler / ; V Schwenger / ; A Voßkühler / ; U Kunzendorf / ; L Renders / ; D Rattensberger / ; L Rump / ; M Ketteler / ; H Neumayer / ; F Zantvoort / ; R Stahl / ; E Ladanyi / ; B Braun / ; I Kulcsar / ; I Mezei / ; B Csiky / ; C Rikker / ; O Arkossy / ; K Berta / ; B Braun / ; J Szegedi / ; L Major / ; S Ferenczi / ; A Fekete / ; T Szabo / ; G Zakar / ; G Wagner / ; S Kazup Erdelyine / ; B Borbas / ; J Eustace / ; D Reddan / ; G Capasso / ; F Locatelli / ; G Villa / ; M Cozzolino / ; D Brancaccio / ; P Messa / ; P Bolasco / ; B Ricciardi / ; F Malberti / ; E Moriero / ; G Cannella / ; V Ortalda / ; S Stefoni / ; G Frascà / ; G Cappelli / ; A Albertazzi / ; C Zoccali / ; M Farina / ; A Elli / ; F Avella / ; P Ondei / ; G Mingardi / ; R Errico / ; A Losito / ; S Di Giulio / ; G Pertosa / ; F Schena / ; G Grandaliano / ; L Gesualdo / ; M Auricchio / ; T Bochicchio-Ricardelli / ; J Correa-Rotter / ; F Aranda Verástegui / ; J Peña / ; A Chew Wong / ; J Cruz-Valdez / ; M Torres Zamora / ; M Solis / ; M Sebastian Diaz / ; M Vital Flores / ; E Alvarez Sandoval / ; M van den Dorpel / ; H Brink / ; W Van Kuijk / ; C Vermeij / ; P Smak Gregoor / ; E Hagen / ; F van der Sande / ; M Klinger / ; M Nowicki / ; M Muszytowski / ; K Bidas / ; W Bentkowski / ; A Wiecek / ; A Ksiazek / ; K Marczewski / ; M Ostrowski / ; M Switalski / ; W Sulowicz / ; J Matuszkiewicz-Rowinska / ; M Mysliwiec / ; M Durlik / ; B Rutkowski / ; F Macario / ; B Carvalho / ; J Frazao / ; D Machado / ; A Weigert / ; A Andrusev / ; O Khrustalev / ; A Zemtchenkov / ; K Gurevich / ; K Staroselsky / ; N Khadikova / ; L Rozhinskaya / ; G Timokhovskaya / ; A Strokov / ; O Balkarova / ; V Ermolenko / ; E Kolmakova / ; M Komandenko / ; M Timofeev / ; V Shilo / ; G Shostka / ; A Smirnov / ; V Anashkin / ; G Volgina / ; O Domashenko / ; A Gurevich / ; D Perlin / ; J Martínez García / ; E Andrés Ribes / ; E Coll Piera / ; M Fernandez Lucas / ; M Galicia / ; M Prados / ; M González / ; R Romero / ; Á Martín de Francisco / ; J Montenegro / ; C Santiago / ; F García / ; J Alcázar de La Ossa / ; J Arrieta / ; J Pons / ; A Martín-Malo / ; J Soler Amigó / ; A Cases / ; G Sterner / ; G Jensen / ; B Wikström / ; S Jacobson / ; U Lund / ; L Weiss / ; A Ståhl / ; B von Albertini / ; M Burnier / ; P Meier / ; P Martin / ; D Uehlinger / ; M Dickenmann / ; M Yaqoob / ; D Zehnder / ; P Kalra / ; D Wheeler / ; N Padmanabhan / ; S Roe / ; D Eadington / ; N Pritchard / ; A Hutchison / ; S Davies / ; M Wilkie / ; M Davies / ; P Pai / ; P Swift / ; J Kwan / ; D Goldsmith / ; C Tomson / ; J Stratton / ; I Dasgupta / ; S Sarkar / ; M Moustafa / ; K Gandhi / ; A Jamal / ; E Galindo-Ramos / ; J Tuazon / ; D Batlle / ; K Tucker / ; B Schiller-Moran / ; A Assefi / ; C Martinez / ; L Samuels / ; J Goldman / ; J Cangiano-Rivera / ; R Darwish / ; M Lee / ; J Topf / ; K Kapatkin / ; H Baer / ; R Kopelman / ; M Acharya / ; D Tharpe / ; M Bernardo / ; P Nader / ; J Guzman-Rivera / ; P Pergola / ; M Sekkarie / ; E Alas / ; P Zager / ; K Liss / ; J Navarro / ; M Roppolo / ; C Denu-Ciocca / ; A Kshirsagar / ; M El Khatib / ; K Kant / ; D Scott / ; B Murthyr / ; F Finkelstein / ; G Keightley / ; R McCrary / ; J Pitone / ; T Cavalieri / ; A Tsang / ; B Pellegrino / ; R Schmidt / ; S Ahmad / ; C Brown / ; E Friedman / ; N Mittman / ; S Fadem / ; W Shapiro / ; M Reddy / ; S Goldberger / ; C Brown / ; Y Woredekal / ; A Agarwal / ; M Anger / ; M Haque / ; P Chidester / ; R Kohli / ; S Rubinstein / ; G Newman / ; R Gladish / ; O Ayodeji / ; S Soman / ; S Sprague / ; N Hunt / ; T Gehr / ; D Rizk / ; D Warnock / ; D Polack / ; M Pahl / ; D Fischer / ; P Dreyer / ; G James / ; F Husserl / ; T Rogers / ; A Raff / ; J Sedor / ; M Silver / ; M Smith / ; S Steinberg / ; T DelGiorno / ; E Jones / ; P D Cunha / ; J Cheng / ; V Pogue / ; G Block / ; S Blumenthal / ; E Brown / ; C Charytan / ; J Buerkert / ; M Cook / ; A Felsenfeld / ; N Tareen / ; A Gupta / ; T Herman / ; S Diamond / ; C Hura / ; M Laski / ; J MacLaurin / ; T Plumb / ; G Brosnahan / ; J Kumar / ; M Henriquez / ; C Poole / ; E Osanloo / ; A Matalon / ; C Sholer / ; S Arfeen / ; M Azer / ; M Belledonne / ; M Gross / ; E Dunnigan / ; K McConnell / ; B Becker / ; R Rigolosi / ; D Spiegel / ; M Stegman / ; R Patak / ; D Streja / ; U Ranjit / ; T Youell / ; T Wooldridge / ; C Stafford / ; R Cottiero / ; M Weinberg / ; M Schonefeld / ; E Shahmir / ; A Hazzan / ; A Ashfaq / ; K Bhandari / ; W Cleveland / ; M Culpepper / ; J Golden / ; L Lai / ; Y Lien / ; V Lorica / ; J Robertson / ; K Malireddi / ; S Morse / ; V Thakur / ; A Israelit / ; P Raguram / ; H Alfred / ; W Weise / ; F Al-Saghir / ; M El Shahawy / ; A Rastogi / ; A Nissenson / ; N Kopyt / ; R Lynn / ; J Lea / ; W McClellan / ; P Teredesai / ; S Ong / ; S Tolkan / ; J Sugihara / ; T Minga / ; R Mehrotra / ; R Minasian / ; D Bhatia / ; R Specter / ; J Capelli / ; P Sidhu / ; S Dalal / ; P Dykes / ; M Khan / ; F Rahim / ; M Saklayen / ; A Thomas / ; B Michael / ; M Torres / ; H Al-Bander / ; B Murray / ; A Abukurah / ; B Gupta / ; S Nosrati / ; R Raja / ; S Zeig / ; M Braun / ; A Amatya / ; J Endsley / ; Z Sharon / ; A Gupta / ; G Dolson / ; F Dumler / ; K Ntoso / ; S Rosansky / ; N Kumar / ; V Gura / ; N Thompson / ; D Goldfarb / ; R Halligan / ; J Middleton / ; A Widerhorn / ; L Arbeit / ; J Arruda / ; T Crouch / ; L Friedman / ; S Khokhar / ; J Mittleman / ; P Light / ; B Taparia / ; C West / ; J Cotton / ; R Dhingra / ; L Kleinman / ; F Arif / ; S Lew / ; T Nammour / ; J Sterrett / ; M Williams / ; J Ramirez / ; J Rubin / ; J McCarthy / ; S Noble / ; M Chaffin / ; A Rekhi /
Comments/Corrections
Comment In:
Nat Rev Nephrol. 2013 Jan;9(1):4   [PMID:  23165298 ]
N Engl J Med. 2012 Dec 27;367(26):2541-2   [PMID:  23121375 ]
N Engl J Med. 2013 May 9;368(19):1844-5   [PMID:  23656653 ]
N Engl J Med. 2013 May 9;368(19):1843   [PMID:  23656655 ]
N Engl J Med. 2013 May 9;368(19):1843   [PMID:  23656656 ]
N Engl J Med. 2013 May 9;368(19):1842-3   [PMID:  23656654 ]
N Engl J Med. 2013 May 9;368(19):1843-4   [PMID:  23656657 ]

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