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N Engl J Med. 2008 Nov 20;359(21):2195-207. doi: 10.1056/NEJMoa0807646. Epub 2008 Nov 9.

Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein.

Collaborators (1332)

Ridker PM, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Nordestgaard BG, Shepherd J, Willerson JT, Ridker PM, Danielson E, Glynn RJ, MacFadyen JG, Mora S, Glynn RJ, Collins R, Bailey K, Gersh B, Lamas G, Smith S, Vaughan D, Mahaffey K, Brown P, Montgomery D, Wilson M, Wood F, Altamirano J, Boskis P, Colombo H, Cuneo C, Diaz M, Esper R, Fernandez A, Foye R, Hershson A, Kuschnir E, La Greca R, Lorenzatti A, Lozada A, Luciardi H, Luquez H, Maffei L, Majul C, Marin M, Muntaner J, Nul D, Paolasso E, Rey R, Rodenas P, Rodriguez P, Rojas C, Telsolin P, Vita N, Adrianes G, Argento O, Bacart P, Baeck L, Baguet J, Balthazar Y, Battello G, Behets J, Beke P, Berwouts P, Boermans P, Bolly F, Borms J, Boulad M, Boulanger L, Bous J, Van Boxstael R, Brands Y, Buyse L, Calozet Y, Camps K, Capiau L, Celis H, Coucke F, D'Argent F, Op de Beeck G, De Meulemeester M, De Praeter K, De Rouck S, Delcourt A, Delvaux J, Demanet E, Dendale P, Derijcke M, Deruyck C, Devaux J, Dupont C, Van Duyse J, Erpicum L, Gilio C, Gillet A, Grosjean J, Heeren J, Henry G, Heyvaert F, Hollanders G, Hutsebaut A, Janssens P, Lannoy H, Ledoux C, Legros P, Leliaert R, Martens R, Maury O, Mehuys G, Michaux J, Migeotte A, Mortelmans J, Van Mulders N, Van Parijs P, Van Peer W, Pieters E, Reynders P, Van Riet D, Robert P, Van Stee J, Teheux J, Teuwen J, Thoeng J, Timmermans B, Tshinkulu M, Vanden Bemden S, Vantroyen D, Veevaete M, Vercruysse K, Vereecken G, Vermeersch L, Vernijns J, Verspecht E, Vinck G, Vrancken F, Watté G, Weymans J, Windmolders S, Albuquerque DC, Barbosa EC, Bertolami MC, Blacher C, Brasileiro AL, Costa e Forti A, Eliaschewitz FG, Esteves JP, Feitosa GS, Fonseca FA, Francischetti EA, Franco RJ, Gomes MA, Gross JL, Jardim PC, Kohlmann O Jr, Loures-Vale AA, Magalhães ME, Maia LN, Moriguchi EH, Nogueira PR, Oigman W, Repetto G, Santos RD, Saraiva JF, Xavier HT, Benov H, Chompalova B, Donova T, Gocheva N, Goudev A, Grigorov M, Gruev T, Hergeldjieva V, Marchev S, Mihov A, Pasheva V, Penev A, Popov A, Raev D, Sirakova V, Slavcheva A, Stoikov A, Stoilov R, Tisheva S, Todorov G, Torbova S, Uzunangelov J, Achyuthan G, Akhras R, Barriere G, Bartlett J, Behiels S, Bell A, Bergeron J, Berlingieri J, Bhamjee H, Bodok-Nutzati R, Booth W, Boyd C, Brault S, Bruckswaiger D, Bukovy B, Campbell G, Carlson B, Cha J, Chehayeb R, Cheng W, Chilvers M, Chouinard G, Chow W, Conter H, Conway J, Craig B, Craig D, Dattani I, Del Grande R, Dharamshi S, Dickson M, Dion D, Dowell A, Drexler J, Dube S, Dupont A, Dworkin B, Fields L, Filteau P, Gardiner E, Gervais B, Gillis G, Girard R, Goldman H, Gorfinkel I, Goulet S, Greenspoon A, Gritter R, Gupta A, Gupta M, Habib N, Harding R, Hart R, Henein S, Henry D, Hirsch A, Ho K, Hoag G, Houde D, Howlett E, Ing G, Jadd J, Janes J, Jardine F, Johnston T, Kanani S, Kazimirski M, Kelly A, Klajner F, Kooy J, Lalani A, Lam S, Laranjeiro J, LaRose D, Leiter L, Leung W, Li J, Lowe D, Luces K, Ma P, MacKinnon R, Martinho V, Matangi M, McCrossin M, McIsaac H, McMullen W, Mehta P, Meunier M, Misik K, Nayar A, Ng A, Nigro F, Noronha L, O'Mahony W, Pandey S, Papp E, Patel V, Patrick L, Peddle C, Pinsky N, Poirier P, Powell C, Price J, Rolfe A, Saliba N, Sawkiw R, Senior R, Shu D, Smith R, Somani R, Soowamber M, Stakiw K, Talbot P, Taliano J, Tan K, Teitelbaum I, Threoux P, Tremblay G, Turcotte C, Tytus R, Walsh P, Webb G, Willoughby P, Woo V, Woodland R, Yee G, Acevedo M, Caorsi C, Cardenas N, Gonzalez B, Gutierrez M, Prieto J, Stockins B, Valerta P, Vejar M, Ardila W, Aschner P, Botero J, Botero R, Calderon C, Casas L, Castellanos R, Cure C, Escobar I, Fortich A, Garcia L, Hernandez E, Isaza D, Jaramillo N, Jiménez C, Kattah W, Luengas C, Marin M, Matiz C, Perez M, Quintero A, Rizcala A, Ruiz A, Urina M, Valenzuela A, Cob-Sanchez A, Gutreiman-Golberg M, Lainez-Ventosilla A, Ramirez-Zamora L, Slon-Hitti C, Speranza-Sánchez M, Vinocour-Fornieri M, Hansen H, Nordestgaard B, Steffensen R, Stender S, Alvarado-Renderos J, Rivera-Ochoa L, Villarroel-Abrego H, Eha J, Jaanson E, Kaasik U, Keba E, Mäeots E, Petersen M, Reinmets S, Roostalu U, Vahula V, Veidrik K, Bellmann R, Hanefeld M, Horacek T, Klein C, Knels R, Koenig W, Laus S, Meissner G, Mondrof C, Schell E, Schuster H, Sehnert W, Stahl H, Szelazek G, Winkelmann B, Witczak E, Elis A, Gavish A, Grossman E, Harats D, Keidar S, Levy Y, Osamah H, Shapiro I, Shveydel E, Wolfovitz E, Yogev R, Zeltser D, Arenas JL, Cardona-Muñoz E, Cervantes JL, Flores-Lozano F, Gonzalez C, Gonzalez-Galvez G, Gonzalez JG, Gutierrez-Fajardo P, Morales E, de los Rios M, Romero-Zazueta A, Talavera JO, Velasco-Sanchez R, Vergara-Takahashi H, Zúñiga-Guajardo S, Agous I, Bak A, Bartels G, Basart D, Cornel J, De Schipper L, Holwerda N, Jonker J, Köse V, Lok D, Lokhorst B, Mosterd A, Nierop P, Oude Ophuis A, Somer S, Tiebesl J, Trip M, Van Hessen M, Van Kempen W, Andersen M, Berz A, Bjurstrom M, Bo P, Brunstad O, Daae-Johansen T, Elle S, Fauske J, Fossdal B, Gjefsen O, Hallaraker A, Haugen J, Helberg S, Holm-Johnsen S, Istad H, Jacobsen T, Johansen R, Jorstad T, Jorum I, Kjorlaug K, Kontny F, Langaker K, Larsen B, Lonning S, Loraas A, Mansilla-Tinoco R, Medhus R, Meyer I, Nasrala S, Ofjord E, Ose L, Palmas J, Risberg K, Sandberg A, Sirnes P, Skjegstad E, Skjelvan G, Solnor L, Storm-Larsen A, Tandberg A, Tomala T, Torkelsen A, Ursin A, Valnes K, Walaas K, Binns-Halman R, Delgado-Paredes A, Lombana-Vasquez B, Noriega-Aguirre L, Trujillo-Sagel R, Kowalczyk-Kram M, Artemiuk E, Asankowicz-Bargiel B, Banas I, Baranska E, Baranski M, Bijata-Bronisz R, Sikorska A, Blaszczyk B, Bolanowski J, Brokl-Stolarczyk B, Brzecki K, Buczkowski K, Chmielewski T, Chojnowska-Jezierska J, Chwist-Novak A, Cygan W, Czajkowska-Kaczmarek E, Dargiewicz A, Dluzniewski M, Dudka C, Fares I, Flasinska J, Gadzinski W, Gaszczyk G, Golebiowski G, Gozdur W, Grudzien K, Sobieska E, Kalamarz J, Kalinowska A, Kornacewicz-Jach Z, Korol M, Korycka W, Kostka T, Kostrzewska A, Kot A, Kowalska-Werbowy B, Krupinska G, Lotocka E, Luberda-Heynar Z, Lukas W, Lysek R, Machyna-Dybala A, Mlynarczyk-Jeremicz K, Mocarska-Gorna B, Niedbal-Yahfouf I, Pasternak D, Potakowska I, Ramian U, Roleder M, Rosinska-Migda J, Sidorowicz-Bialynicka A, Skierkowska J, Skorinko I, Slaboszewska J, Sleziak-Barglik K, Stachlewski P, Superson-Byra E, Tissler-Nahorska G, Turbak R, Uzunow A, Wasowicz D, Wodniecki J, Wojnowski L, Wrzol A, Zdrojewska J, Zurakowska-Krzywonos A, Zurowska-Gebala M, Ablachim T, Abobului M, Balanescu S, Bobescu E, Bojinca M, Cristea M, Gaita D, Stoicovici R, Tataru R, Tudose A, Ardashev V, Arutyunov G, Azarin O, Barbarash O, Bondarev S, Borisov M, Boyarkin M, Burova N, Chazova I, Dovgalevsky P, Duplyakov D, Egorova L, Goloshchekin B, Gratsianskiy N, Ivleva A, Karpov R, Karpov YA, Karpov YB, Khokhlov A, Khokhlov R, Khrustalev O, Konyakhin A, Kostenko V, Libov I, Lukyanov Y, Mezentseva N, Panov A, Repin M, Shabalin A, Shalaev S, Shilkina N, Shulman V, Sidorenko B, Smolenskaya O, Starodubtsev A, Talibov O, Titkov Y, Tsyba L, Uspenskiy Y, Vishnevsky A, Yarokhno N, Ahmed S, Ashtiker H, Bester A, Bhorat Q, Biermann E, Boyd W, Burgess L, Dindar F, Dulabh R, Engelbrecht I, Erasmus E, Fouche L, Furman S, Govind U, Herbst L, Jacovides A, Kahanovitz C, Kruger C, Lakha D, Lombaard J, MacLeod A, Makan H, Manuel E, McDonald M, Mitha E, Mitha I, Moola S, Nell H, Nieuwoudt G, Olivier P, Padayachee T, Pillai P, Pillay S, Ranjith N, Reyneke S, Sandell R, Sandell P, Sebastian P, Skriker M, Smit J, van Rensburg D, van Zyl L, Vawda Z, Wellman H, Miserez A, Adbulhakim E, Angus M, Balmer F, Balmer J, Barrat R, Blair D, Blyth A, Brodie R, Brydie D, Campbell C, Campbell I, Church M, Clark C, Clements R, Donnachie, Fitpatrick P, Godley C, Hill J, Jarvie F, Kieran W, Langridge S, Leslie R, Liddell A, MacKenzie J, MacKintosh C, Mair R, Marshall G, Martin R, McCann C, McKibbin C, McLachlan B, McLean F, Murray S, Norris A, Pawa R, Pexton N, Ramage A, Reid S, Robertson A, Rourke E, Sarmiento R, Shaw H, Shaw R, Sheil L, Spence G, Stewart E, Thomas H, Thomson J, Thomson W, Travers J, Ward R, Williams L, Wooff D, Young W, Belzarena C, Huarte A, Kuster F, Lluberas R, Abarikwu C, Abate L, Abbott R, Ackley C, Adams G, Adkins S, Albakri E, Albarracin C, Allison J, Alvarado O, Alwine L, Amin K, Amin M, Anderson J, Anderson M, Anderson W, Andrawis N, Andrews C, Angles L, Aquino N, Ariani M, Armstrong C, Aronoff S, Arora N, Atri P, Baker J, Baker K, Balli E, Banish D, Bardenheier J, Barnett G, Bartkowiak A, Basista M, Beliveau W, Bell G, Benchimol G, Bennett B, Bennett N, Bermudez Y, Bernstein J, Berroya A, Bhargava M, Biaggioni I, Bimson S, Bittar N, Bleser S, Blumberg M, Bobson C, Boeren J, Bogan R, Boling E, Booras C, Borge A, Bradlau C, Brady J, Brandon D, Brideau D, Brobyn T, Brodowski M, Broker R, Broussard C, Brown C, Browning D, Brusco O, Bryant J, Buchanan P, Bueso G, Burgess G, Burke B, Buynak R, Byrd L, Camilo-Vazquez E, Campbell J, Cannon L, Capo J, Carmouche D, Castaldo R, Castilleja J, Caudill T, Caulin-Glaser T, Champlin J, Chardon-Feliciano D, Cheng T, Cherlin R, Cheung D, Chodock A, Christensen J, Christian D, Christiansen L, Ciemiega R, Clark J, Coble S, Cohen K, Colan D, Cole F, Cole R, Colleran K, Collins G, Conard S, Cook J, Cooperman M, Cooze D, Copeland T, Corder C, Courtney D, Cox W, Crump W, Cruz L, Cuellar J, Cunningham T, Daboul N, Dailey R, Dallas A, Dansinger M, Dao L, Darwin C, Dauber I, Davidson M, Davis P, Degarmo R, Degoma R, Dempsey M, Denny D, Denyer G, Desai V, Despot J, Dewan M, Dickert J, Diederich C, Doben S, Dobratz D, Douglas B, Drehobl M, Dresner J, Dreyfus J, Drummond W, Dunbar W, Dunlap J, Dunmyer S, Eaton C, Ecker A, Edris M, Egbujiobi L, Elkind A, Ellis J, Ellison H, Engeron E, Erdy G, Ervin W, Eshowsky S, Estock D, Fang C, Fanning J, Feinberg B, Feld L, Fenton I, Fernandez E, Ferrera R, Fiacco P, Fierer R, Finneran M, Fintel D, Fischer M, Flippo G, Flores A, Folkherth S, Forbes R, Fowler R, Francis P, Franco M, Frank A, Fraser N, Fuchs R, Gabriel J, Gaddam S, Gaffney M, Gamponia M, Gandhi D, Ganzman H, Gaona R, Gaona R Jr, Garibian G, Garofalo J, Gatewood R, Gazda S, Geiger R, Geller M, Germino W, Gibbs R, Gifford C, Gilhooley N, Gill S, Gillespie E, Godwin D, Goldberg M, Goldberg R, Goldstein M, Gonzalez-Ortiz E, Goodman D, Gordon G, Gordon M, Goswami A, Gottlieb D, Gottschlich G, Graham D, Gray J, Gray W, Green S, Greenberg R, Greenspan M, Greenwald M, Grover D, Gupta R, Gupta-Bala S, Guthrie R, Gutmann J, Gvora T, Habib G, Hack T, Haidar A, Hamdy O, Hansen M, Hanshaw C, Hargrove J, Harris H, Harris H, Harrison B, Hart T, Heacock J, Head D, Headley D, Henderson D, Herman L, Herrera C, Hershberger V, Hershon K, Heym H, Hill G, Hippert R, Hirsch A, Hnatiuk G, Hoekstra J, Holt W, Homan J, Honsinger R, Howard J, Howard V, Howard W, Huling R, Imburgia M, Isajiw G, Ison R, Iverson W, Jacks R, Jackson B, Jackson K, Jacobs J, Jacobson E, James A, Jayanty V, Johary A, Johnson G, Jones P, Jones T, Joseph J, 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J, McIvor M, Mcneff J, Mendolla M, Mercado A, Mersey J, Milam J, Milko T, Miller M, Miller R, Miller S, Mobley D, Modi T, Modiano M, Mollen M, Montgomery R, Moran J, Morelli J, Morin D, Moskow H, Moursi M, Mueller N, Mullins M, Myers E, Nadar V, Naiser J, Nash S, Natarajan S, Neft M, Neuman D, Nevins B, Newman J, Newman R, Newman S, Nolen T, Nwasuruba C, Oberoi M, Odom A, Ong Y, Oppy J, Owen S, Pampe E, Pangtay D, Parker R, Patel B, Patel J, Patel M, Patel R, Paul A, Pearlstein R, Penepent P, Peniston J, Perlman M, Persson D, Peters P, Peterson G, Peterson J, Pettyjohn F, Phillips A, Phillips D, Piel M, Pillai T, Pi-Sunyer F, Pollack A, Pond M, Pongonis J, Porras C, Portnoy E, Potos W, Powers J, Prasad J, Pritchett K, Pudi K, Pullman J, Purdy A, Quinones Y, Raad G, Radbill M, Radin D, Rai K, Raikhel M, Raine C, Ramanujan R, Ramirez G, Ramos-Santana Z, Rapo S, Ravin S, Rawtani P, Reeves R, Reeves W, Reiter W, Rendell M, Resnick H, Reynolds W, Rhudy J, Rice L, Rictor K, Ringrose R, Riser J, Rizvi M, Rizzo W, Robinson J, Robison W, Rogers W, Rohlf J, Rosen R, Ross E, Roth E, Rovner S, Rucki P, Runde M, Ryan W, Rybicki J, Saleem T, Salvato P, Santram D, Scharf B, Schear M, Schectman G, Schmidt J, Schneider A, Schneider P, Schneider R, Schoenfelder S, Schussheim A, Schwartz R, Schwartz S, Schwarze M, Scott C, Segal S, Settipane R, Shah M, Shamim T, Shanes J, Shapero P, Shapiro J, Shealy N, Shepard M, Shepherd A, Sheta M, Shrivastava R, Shusman R, Siddiqui M, Sidney A, Silvers D, Simek C, Simpson C, Sinatra L, Singh S, Singson D, Slabic S, Smith D, Smith K, Smith S, Smith T, Snell P, Specter J, Speer J, Spees R, Sperling M, Spuhler W, Staab P, Stafford J, Stanton D, Stein E, Stern S, Stocks T, Stone A, Strader W, Strout C, Strzinek R, Subich D, Suen J, Sugimoto D, Sulman S, Suresh D, Sweeney G, Szatkowski A, Szeto J, Szewczak S, Szulawski I, Taber L, Taghizadeh B, Tague R, Tambunan D, Tannoury G, Tavaez Valle J, Thieneman A, Thigpen D, Thompson P, Tidman R, Tilton G, Tokatlian E, Topkis R, Torelli M, Tortorice F, Toth P, Touger M, Treat S, Trevino M, Trupin S, Turner A, Turner M, Tweel C, Ugarte J, Ulmer E, Urbach D, Vacker M, Vallecillo J, van de Beek M, Vargas L, Vazquez Tanus J, Verma A, Vijayaraghavan K, Wade P, Wade T, Wagner S, Wahle J, Walker J, Walker M, Weinstein R, Weisbrot A, Weiss R, West P, White A, Wickemeyer W, Wieskopf B, Wiggins M, Williams H, Wilson M, Wiseman J, Yataco A, Yates S, Zamarra J, Zamora B, Zawada E, Zemel L, Zigrang W, Zusman R, Aguiton M, Arroyo-Parejo M, Beaujon Sierralta J, Berrizbeitia M, Carrizales de Marlin Y, Colan Parraga J, Fernandez C, Fuenmayor N, Giesen G, Gonzalez Gomez C, Guaipo A, Herrera Rivera C, Jaua L, Lopez N, Lopez Nouel R, Marulanda M, Morr I, Nass A, Palmucci G, Perez L, Ponte C, Rivas I, de Roa E, Figarella Salazar G, Sanchez F, Siriti U, Viloria A.

Author information

  • 1Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02215, USA. pridker@partners.org

Abstract

BACKGROUND:

Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events. Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, we hypothesized that people with elevated high-sensitivity C-reactive protein levels but without hyperlipidemia might benefit from statin treatment.

METHODS:

We randomly assigned 17,802 apparently healthy men and women with low-density lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to rosuvastatin, 20 mg daily, or placebo and followed them for the occurrence of the combined primary end point of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes.

RESULTS:

The trial was stopped after a median follow-up of 1.9 years (maximum, 5.0). Rosuvastatin reduced LDL cholesterol levels by 50% and high-sensitivity C-reactive protein levels by 37%. The rates of the primary end point were 0.77 and 1.36 per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio for rosuvastatin, 0.56; 95% confidence interval [CI], 0.46 to 0.69; P<0.00001), with corresponding rates of 0.17 and 0.37 for myocardial infarction (hazard ratio, 0.46; 95% CI, 0.30 to 0.70; P=0.0002), 0.18 and 0.34 for stroke (hazard ratio, 0.52; 95% CI, 0.34 to 0.79; P=0.002), 0.41 and 0.77 for revascularization or unstable angina (hazard ratio, 0.53; 95% CI, 0.40 to 0.70; P<0.00001), 0.45 and 0.85 for the combined end point of myocardial infarction, stroke, or death from cardiovascular causes (hazard ratio, 0.53; 95% CI, 0.40 to 0.69; P<0.00001), and 1.00 and 1.25 for death from any cause (hazard ratio, 0.80; 95% CI, 0.67 to 0.97; P=0.02). Consistent effects were observed in all subgroups evaluated. The rosuvastatin group did not have a significant increase in myopathy or cancer but did have a higher incidence of physician-reported diabetes.

CONCLUSIONS:

In this trial of apparently healthy persons without hyperlipidemia but with elevated high-sensitivity C-reactive protein levels, rosuvastatin significantly reduced the incidence of major cardiovascular events. (ClinicalTrials.gov number, NCT00239681.)

2008 Massachusetts Medical Society

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