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N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30.

Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.

Collaborators (776)

Fellström B, Zannad F, Schmieder R, Holdaas H, Jardine A, Johnsson E, Gottlow M, Bannister K, Beutler J, Chae D, Cobbe S, Grönhagen-Riska C, De Lima J, Lins R, McMahon A, Mayer G, Parving HH, Chevaile A, Remuzzi G, Samuelsson O, Sonkodi S, Süleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wüthrich R, Dargie H, Ritz E, Wedel H, Zwinderman AH, Brady A, Cobbe S, Deighan C, Macfarlane P, Stott D, Gillies A, Carney S, Bannister K, Faull R, Surany M, Saltissi D, Fraenkel M, Mount P, Irish A, Chan D, Dogra S, Wei S, Roger S, Pollock C, Cooper B, Brown F, Healy H, Hutchinson B, Boudville N, Senaratne S, Luxton J, Disney A, Russ G, Isbel N, Johnson D, Wong J, Herzig K, Walker R, Leikis M, Masterson R, Perkovic V, Kramar R, Robl B, Stummvoll HK, Holzer H, Prager R, Graf H, Neyer U, Mayer G, Kovarik J, Balcke P, Lins R, Muyshondt I, Claes K, Maes B, Jadoul M, Dupont P, Marchal M, Pirson Y, Cambier P, Robin M, Warling X, Tielemans C, Dupont P, Marchal M, Van Der Niepen P, Van Vlem B, Billiouw JM, De Meester J, Krzesinski JM, Dubois B, Delanaye P, De Lima J, Gowdak L, Barbosa A, Abreu P, Balda C, Canziani ME, Watanabe R, Barata R, Lisboa N, Vilarinho R, Pecoits R, Teixeira P, Fortes P, Kraev Z, Koteva A, Georgiev M, Krivoshiev S, Popov A, Baldev T, Terziiska G, Rangelov R, Ekova D, Vitanova L, Mitova V, Videnova N, Todorov V, Dimitrova B, Dosev D, Vasileva V, Dimitrakov D, Blagov B, Nikolov D, Tilkijan E, Kapon E, Stavrev P, Guncheva N, Paunova P, Tashkov B, Bojadziev D, Popova G, Delibaltov I, Markov M, Koleva N, Petrova M, Berall M, Pierratos A, Mendelssohn D, Hercz G, Burgess E, Cournoyer S, Giroux C, Soltys G, Savoie L, Brunet S, Begin V, Duncan J, Yeung C, Cameron E, Jastrzebski J, Shapiro J, Copland M, Keown P, Singh R, Jolly S, Mustata S, Kates D, Jung B, Jamal A, Levin A, Chiu A, Chan-Yan C, Landsberg D, Macrae JM, Gill J, De Luca L, Kiaii M, Taylor P, Lambert F, Berrard J, Youmbissi J, Bessette M, Turcot R, Moreau V, Davidman M, Bencovitch D, Frisch G, Lipman M, McMahon A, Pannu N, Davison S, Gourishankar S, Rehman F, Muirhead N, House A, Rehman F, Boudville N, Pichette V, Leblanc M, Prud'Homme L, Marcotte J, Desjardins MH, Raymond M, Tremblay R, Richardson R, Chan C, Sohi P, Pippy C, Gogan N, Handa S, Soroka S, Hirsh D, Panek R, Keough-Ryan T, Ting R, Fung J, Ng P, Tam P, Chow S, Zacharias J, Wu G, Kim D, Wong G, Wadgymar J, Wong M, Schuld R, Bitterova Z, Hanek T, Dvorak K, Pavlikova Z, Fixa P, Zahradnik J, Suchanova J, Krizova E, Tesar V, Zavada J, Lachmanova J, Mokrejsova M, Viklicky O, Lyerova L, Urbanova M, Syrovatka P, Kukura S, Svara F, Sagova M, Sulkova S, Polakovic V, Ryba M, Koci P, Ladefoged S, Jensen H, Ladefoged S, Jensen H, Rasmussen K, Nielsen G, Østergaard O, Nielsen A, Lynggaard F, Otte K, Steffensen G, Otte K, Steffensen G, Løkkegaard NJ, Løkkegaard NJ, Danielsen H, Hasling C, Hansen S, Freese P, Hansen J, Rasmussen E, Nielsen F, Egfjord M, Szpirt W, Mustonen J, Saha H, Ala-Houhala I, Grönhagen-Riska C, Ekstrand A, Honkanen E, Ylinen K, Malmström R, Rauta V, Tertti R, Metsärinne K, Heiro M, Koivuviita N, Kananen K, Salmela A, Lepistö P, Ikäheimo R, Pikkujämsä S, Karhapää P, Lumiaho A, Pulkkinen A, Ikäheimo R, Helanterä A, Wallin M, Kolunen M, Asola M, Huhti J, Jääskeläinen K, Nuortimo J, Stenborg M, Erkinheimo J, Huuskonen M, Paldanius R, Helin K, Norvio L, Haapala M, Lindström CJ, Monkam R, Bataille P, Nour D, Bouzerjnidj M, Wheatley P, Billion S, Brignon P, Maaz M, Charpentier B, Durrbach A, Djeffal R, Snanoudj R, El Esper N, Choukroun G, Dahmane D, Fessi H, Kessler M, Bellou-Zerrouki M, Cao-Huu T, Lamotte C, Lebleu J, Luong CN, Bouali B, Reach I, Mac-Namara E, Bourdon F, Majdanali G, Bouffandeau A, Chaghouri B, Hugot V, Torres PA, Binaut R, Fleury D, Bacri JL, Maisonneuve N, Vanhille P, Lemaitre V, Lambrey G, Zaoui P, Kuentz F, Palancin P, Milongo R, Hachache T, Dehais F, Dupuy P, Wehbe B, Benarbia S, Yver L, Pujo M, Fourcade J, Philit JB, Ballé C, Bambauer R, Bittner K, Dragoun GP, Matzkies F, Hartmann H, Hoffmann HD, Kliem V, Kraatz U, Kraatz G, Krämer H, Krämer W, Krämer-Guth A, Kühn R, Kulzer P, Kurth C, Liebl R, Merker L, Meyer T, Mohler C, Neumann K, Nikolay J, Reiter E, Schannen G, Scherberich J, Schmieder R, Sperschneider H, Wagner J, Bast I, Anding-Rost K, Passauer J, Scheuermann E, Krause RD, Pommer W, Bhandari S, Webb A, Lewis D, Eadington D, Collinson H, Sellars L, Svreck P, Brown A, Bow A, Ahmed S, Severn A, Henderson I, Jardine A, Junor B, Nolan C, Geddes C, McGregor E, Mark P, Patel R, Rodger S, Main J, Reaich D, Paterson A, Maxwell P, Brown H, Finn M, O'Donoghue D, Wood G, Espinosa O, Middleton R, Woodrow G, Wright M, Rowe P, Cramp H, Tse W, Fox J, Macteir R, Isles C, Streather C, Semple D, Banerjee D, Mitra S, Gokal R, Bubtana A, Asari A, Jeffrey R, Mumtaz R, El Nahas M, Kwan J, Kumwenda M, Douglas A, Harron C, Courtney A, Brown H, Sunil J, Garrett P, Maddekar N, Bergin E, Harty J, Conway B, Hollywood M, Macgregor M, Mackenzie P, Papagalanis N, Biblaki D, Ntatsis G, Kaperonis N, Siapera V, Iatrou C, Kontouli T, Spanou E, Kalocheretis P, Zerbala S, Sofroniadou S, Tsakiris D, Kelesidis A, Xanthopoulou K, Tsouchnikas I, Papakonstantinou S, Sobolos K, Bamichas G, Siamopoulos K, Gouva C, Kitsos A, Katopodis K, Nikolopoulos P, Vargemezis V, Thodis E, Yannatos E, Katartzi K, Panagoutsos S, Sonkodi S, Kiss E, Zsom M, Kiss I, Lakatos A, Fodor E, Nádori E, Arkossy O, Koroknai L, Mázik R, Vezekényi Z, Kovács A, Samir N, Akócsi K, Varga G, Ferenczi S, Villányi B, Schneider K, Vinkovits S, Czégány Z, Onody Z, Szegedi J, Valikovics F, Angyal S, Zilahi Z, Ladányi E, Széll J, Berta K, Szamosfalvi B, Ambrus C, Deák G, Faludi M, Molnár M, Zakar G, Varga D, Kovács L, Tüsér Z, Bodvarsson M, Arnadottir M, Redden D, Mutwali A, Griffin B, Lenihan C, O'Seaghda C, Lappin D, Gafney M, Akram M, Remuzzi G, Marchesi D, Mingardi G, Allaria P, Giangrande A, Lucatello A, Caligara F, Angelo L, Deferrari G, Robaudo C, Lauria F, Imbasciati E, Barbisoni F, Farina M, Maggio M, Borlandelli S, Badalamenti S, Finazzi S, Angelini C, Bianchi G, Spotti D, Quartagno R, Malberti F, La Russa A, Pecchini P, Ghiringhelli P, Zoccali C, Delfino D, Mallamaci F, Marino F, Curatola G, Caridi G, Ciccarelli M, Borghi M, Tagliaferri M, Massazza M, Espinoza B, Torres M, López E, Montañez JL, Bochicchio T, Cruz J, Chevaile A, Cordero L, Beutler J, Hollander A, Hoogeveen E, Koolen M, Bos W, Endeman H, Vincent H, Geers T, Rensma P, Apperloo A, Haest R, Van de Ven P, Alphen R, Van Buren M, Essen G, Woittiez A, Ouwehand A, Vleming L, Krol-Van Stratten M, Janssen W, Kremer Horinga T, Kloppenburg W, Doorenbos C, Sluiter H, Smak-Gregoor P, Van Bommel E, Jongh J, Verseput G, Hagen E, Stork A, Gaillard C, Pondman M, Bax W, Van Geelen J, Schrama Y, Rietveld A, Op de Hoek C, Diderich P, Kaasjager H, Bosch F, Reichert L, Hemmelder M, Halma C, Broekroelofs J, Haanstra W, Vastenburg G, De Fijter C, Groeneveld J, Bergrem H, Thorud L, Holdaas H, Hagen E, Viko H, Eggesbø J, Halvorsen C, Hunderi O, Abedini S, Broch L, Heldal K, Lyngdal P, Iversen B, Øien C, Selvig K, Wiecek A, Witkowicz J, Spiechowicz-Zatoń U, Marcinkowski W, Ksiazek A, Baranowicz-Gaszczyk I, Jóźwiak L, Kuczera M, Szweblik J, Bieńkowski J, Wajda J, Bogdanowicz G, Jaworska-Wieczorek J, Myśliwiec M, Barczyk M, Kalinowski M, Mazerska M, Trusewicz W, Ostrowski J, Błaszczyk E, Majczyńska I, Kazimierczak J, Kacki J, Kochman P, Rutkowski B, Białobrzeska B, Jankowska M, Chmielewski M, Zdrojewski Z, Debska-Slizień A, Switalski M, Kepka A, Szewczyk D, Fusik J, Kuriga M, Ostrowski M, Myszta T, Sułowicz W, Radziszewski A, Walatek B, Kaczmarczyk I, Drozdz M, Piotrowska M, Kraśnicka M, Koźmiński P, Pawłowska S, Zygadło H, Zalasińska I, Chae DW, Jin H, Kim S, Song Y, Na KY, Oh JE, Oh KH, Oh JE, Kim YG, Kim B, Baek HJ, Kim JA, Song Y, Lee YJ, Chang YS, Park CW, Chung HW, Han S, Kim YS, Park JA, Choi BS, Yoon HE, Hwang H, Yoon JM, Kim JY, Han SW, Kim S, Kang CM, Lee CW, Kim GH, Choi NW, Ihm CG, Jeong KH, Kim MJ, Lee SH, Lee TW, Wikström B, Fellström B, Linde T, Nisbeth U, Mulec H, Kronvall M, Frisenette-Fich C, Ståhl Nilsson A, Mauritz NJ, Schirdewan S, Samuelsson O, Stelin G, Ottosson P, Stefansson B, Ramsauer B, Hultström D, Hadimeri H, Andersson PO, Al Magdasi H, Weiss L, Welander G, Gröntoft KC, Zezina L, Hadimeri H, Svensson L, Fagerström A, Lund U, Tidman M, Lundin C, Sjöström P, Wessén P, Halvarsson P, Wrege U, Linder M, Ekspong A, Jensen G, Stelin G, Alfredsson A, Löfberg E, Almroth G, Haarhaus M, Gisslén K, Mathillas O, Bock A, Burnier M, Binet I, Tsinalis D, Wüthrich R, Basci A, Süleymanlar G, Turgan C, Duranay M, Nergizoglu G, Gullulu M, Turkmen F.

Author information

  • 1Department of Medical Science, Renal Unit, University Hospital, SE-751 85, Uppsala, Sweden. bengt.fellstrom@medsci.uu.se

Erratum in

  • N Engl J Med. 2010 Apr 15;362(15):1450.

Abstract

BACKGROUND:

Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved.

METHODS:

We conducted an international, multicenter, randomized, double-blind, prospective trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary end points included death from all causes and individual cardiac and vascular events.

RESULTS:

After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter). During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P=0.59). Rosuvastatin had no effect on individual components of the primary end point. There was also no significant effect on all-cause mortality (13.5 vs. 14.0 events per 100 patient-years; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P=0.51).

CONCLUSIONS:

In patients undergoing hemodialysis, the initiation of treatment with rosuvastatin lowered the LDL cholesterol level but had no significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. (ClinicalTrials.gov number, NCT00240331.)

2009 Massachusetts Medical Society

Comment in

PMID:
19332456
[PubMed - indexed for MEDLINE]
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