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N Engl J Med. 2010 Apr 29;362(17):1563-74. doi: 10.1056/NEJMoa1001282. Epub 2010 Mar 14.

Effects of combination lipid therapy in type 2 diabetes mellitus.

Collaborators (1238)

Gotto AM Jr, Bailey K, Gohdes D, Haffner S, Hiss R, Jamerson K, Lee K, Nathan D, Sowers J, Walters L, Friedewald WT, Buse JB, Bigger JT, Byington RP, Cushman WC, Ismail-Beigi F, Gerstein HC, Ginsberg HN, Goff DC Jr, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Gerstein HC, Yusuf S, Punthakee Z, Russo R, Anand S, Chrysler K, Cracknell B, Cukierman-Yaffe T, Gafni A, Guyatt G, Hall S, Kaszyca J, Lonn E, Mackie P, Reiding V, Shehadeh N, Tadeson B, Thompson K, Vallis M, Vasudeva V, Wilderman I, Wright D, Punthakee Z, Smith A, Stanton I, Capes S, Manjoo P, Valla T, Danby S, Harper W, Harvey P, Hunt D, Moroso A, Otto R, Prebtani A, Punthakee Z, Davis A, Capes S, Hill KL, McCarthy V, Edwards AL, Mitchell DJ, Clearwaters MA, Dielissen C, Gillam M, Hammond B, Jensen H, Kherani A, Lau D, Pringle V, Rabi D, Sigal R, Smith C, Walker M, Williams G, Joyce C, Parsons M, Rowe B, Burton J, Chandurkar V, Coady-McDonald S, Gibbons D, Kovacs C, Murphy B, Smart R, Varghese S, Mereu L, Ryan E, Senior P, Kirkland P, Abe J, Dalton K, Gendall W, Germsheid J, Hartmann D, Jeffrys A, Kumar U, MacDonald C, Makhani N, Mawani S, Morales F, Paty B, Pick M, Schwanke B, Stark A, Tennant M, Varma S, Weiss-Aburto D, Werbiski-Wood P, Woloschuk B, Zimmerman W, Bélanger A, Gauthier S, Bahsali G, Barbeau C, Caponi E, Duchesne R, Dumas R, Gauthier P, Girouard J, Kandalaft N, Labbé M, Palardy J, Pilon M, Raymond J, Schiffrin A, Hramiak I, Tereschyn S, Driscoll M, Gehring M, Gonder J, Lincoln C, McBeth W, McDonald C, McDonald T, Pauli P, Paul T, Powers S, Ronald N, Trinh V, Vancer L, Walsh G, Lochnan H, Ooi TC, Maranger J, Bradley L, Buhrmann R, Cyr M, Gilchrist C, Hanlon B, Harley M, Jay K, Leech T, Malcolm J, McLean M, Parker E, Sigal R, Sullivan K, Yale JF, Segal SA, Al Ansari G, Renouf N, Allaire N, Alawadhi MA, Belfer B, Blank DW, Bouchard F, Buoy-Phang S, Carter J, Coppin L, Dalpe D, Delpech I, Doran PM, Emmian F, Fortin S, Garfield N, Gosselin M, Horan S, Kalergis M, Koutelias S, Légaré C, Lombardo A, Morais JA, Quigley M, Renouf N, Riopel C, Riopel S, Rivera JA, Rochon G, Roy M, Salera M, Sherman MH, Shingler M, Staples HE, Ulyatt L, Yared Z, Leiter LA, Booth G, Sparrow L, Choi H, Bedard DC, Berger A, Berndl LA, Cheng A, Evalmplev V, Goguen J, Hanna A, Josse RG, Kalas JA, Perry S, Pike M, Elliott T, Dawson K, Kong J, Albiani D, Inducil M, Al Amoudi R, Broughton T, Hall L, Harrison B, Hirvi N, Lee R, Merkur A, Norman E, Paty B, Potter M, Stevenson D, Vafadaran A, Woo V, Berard L, Anderlic T, Austman K, Bernard A, Catte D, Darvill P, Hak D, Hutchison K, Janzen L, Klopak T, Mandock C, Mathen M, Mawani S, Mawani A, Murphy L, Nyomba G, Penner B, Pockett S, Russell S, Stockl F, Studney J, Sukkau R, Abbott C, Ur E, Yuille M, Archibald M, Clayton D, Cruess A, Davis N, Fong H, Frizzell S, Hanway B, Hoskin-Mott A, Imran A, Ingraham C, McCarthy G, Murdock H, Palmer T, Patterson AM, Ransom T, Shu D, Tuttle J, Probstfield JL, Kingry C, Line AS, Corson MA, Knopp R, Lipkin E, Sullivan MD, Johnson J, Griswold C, Liebert K, Brown A, Juliano D, Kurashige EM, Moberg S, Leader J, Ariani K, Karunaratne K, Azizad M, Chow C, Gutierrez H, Partamian J, Toven J, Toven J, Mular J, Sanders S, Haywood LJ, Kamdar V, DeQuattro DL, Wang L, Song Z, Becerra L, Cai AQ, Pruitt C, DeQuattro V, Failor R, Ellsworth A, Jackson N, Miller C, Britt D, Dobie S, Hirsch I, Khakpour D, Quaempts R, Stoffel W, Neighbor W, Cappocia K, Hawkins V, Tapp L, Force R, Macdonald M, Pettingill K, Liday C, Koester S, Pettinger T, Solbrig R, Waldron C, Woodhouse W, Hoover B, Lusk S, Wilcox T, Hachey D, Linz PE, Pepper PV, Kozlowski J, Chase C, Griffin C, Samuelson D, Gutierrez P, Gonzales C, Engle M, Coopersmith J, Griffin S, Lammers R, Leon J, Zirkle D, Hollingsworth S, Riddle MC, Hanavan KA, McDaniel PA, Swift R, Ahmann AJ, Gammell-Matthews SC, Karl DM, Burden V, MacNeil B, MacMurray M, Weiss J, Carlson C, DesRochers SK, Negreanu D, Stephens EA, Gale D, Wysham C, Weeks D, Kuntsmann L, Maxwell L, Yedinak S, Pena H, Kistler J, White J, Dudl J, Lyons L, House B, Murray M, Stevenson R, Wu P, Palma A, Briere S, Wilson T, Becker D, Harden K, Hawley C, Dailey G, Baron M, Gianella A, Jacobson M, Farro E, Philis-Tsimikas A, Banares A, Bravo-Medina A, Horne J, Esquer E, Morrissey R, Grimm RH Jr, Kirpach BR, Bartkoske MM, Boyce CM, Druckman N, Gillett AM, Levin JA, Livingston GJ, Murray AM, Wood H, Margolis KL, Kempainen S, Madden M, Fareed MT, Hall K, Moor R, Wood K, Bergenstal R, Cuddihy R, Davick B, Hokanson J, Johnson M, Lausch M, List S, Monk A, Robinson R, Smith K, Whipple D, Damberg G, Hahn R, Koenig V, Magadan M, Sabin-Smith S, Stewart P, Strock E, Peremislov D, Gunyou K, Passi R, Ashanti C, Thomas L, Stoffels D, Seaquist ER, Mech MV, Benedict LE, Demmon DJ, Kendall D, Kumar AF, Martinson SM, Miller SA, Pease C, Rao JP, Redmon JB, Swanson JE, Wimmer JK, Okorocha Y, Stiles M, Kodl C, Chadha C, Peterson KA, Seaquist LA, Boese C, Cruciani M, Dodds E, Ek FP, Feldman JL, Fontaine P, Lange CJ, Mendenhall TJ, Peterson AM, Rudelt A, Schrock TM, Spielman DP, Velasco S, Weinhand JC, Sperl-Hillen JM, O'Connor PJ, Busch ME, Chung A, Klein BK, Krugen N, Bunkers-Lawson T, Ekstrom HL, Gunderson HS, Johnson BM, MacIndoe JH, Prewedo DJ, Rawl JL, Roethke CM, Quinlan M, Fox CR, Bate BM, Cao QT, Ohnstad MM, Meyers PJ, Sivitz WI, Wayson SM, Lower TA, Larson L, Ahrens LA, Bayless M, Beck SE, Chahal J, Chenard C, Doelle GC, Guzman VM, Kabadi UM, Ochs KA, Rahhal A, Spanheimer RG, Snetselaar L, Smith K, Wells D, Genuth S, Ismail-Beigi F, Thibonnier M, Vargo L, Kelly C, Bongorno T, Dolish A, Pavlik L, Tiktin M, Isteitieh S, Bartlett A, Kulow T, Ismail-Beigi F, Krikorian A, Moore L, Richardson L, Coles-Herman E, Yee K, Frankino J, Jing M, Sood A, Hustak L, Julius M, Pavlik L, Ross T, Long L, Schwing W, Tiktin M, Sullivan MK, Strauss L, Behm K, Eskandari F, Hall C, Hayes D, Horowitz K, Isteitieh S, Madhun Z, Seeholzer E, Shina J, Taylor H, Schnall A, Huang S, Heeg M, Tang J, Belkin J, Lee MS, Joly T, Sadler LS, Griffith M, Hornsby A, Klyn K, Ospelt E, Long L, DeSmit M, McCann P, Schmidt NP, Gottfried C, Kulow T, Zaletal J, Kapadia MS, Smith L, Schnall AM, Dragmen L, Ellert R, Smith J, Leksan J, Sussman T, Huang S, Heeg M, Tang J, Belkin J, Lee MS, Joly T, Ismail-Beigi F, Hustak L, Julius M, Schwing W, Tiktin M, Anselmo J, Eskandari F, Daymeyer S, Hall C, Hayes D, Horowitz K, Isteitieh S, Johnson C, Kern E, Richmond MA, Richardson L, Roberts K, Shina J, Sood A, Suhan P, Taylor H, Watts S, Martin J, Moor L, Burtch B, Ober S, Strauss GJ, Leone A, Belkin J, Huang S, Frank K, Stephens D, Lee MS, Joly T, Hoogwerf BJ, Brakeman J, Matzinger M, Newsome J, Becker J, Bizjack S, Clingman B, Curtas-Thomas S, Depietro G, Ellert R, Horner C, Bunae G, Hamrahian A, Hawkins A, Head T, Iannica S, Jones L, Kaiser P, McCoy R, Mehta A, Olansky L, Orasko A, Reddy S, Ross D, Shockley L, Siraj E, Williams M, Zimmerman R, Hamaty M, Weiss D, Fagan KA, Hanslik TM, Farrell J, Brys P, Oligny M, Prokop K, Lenardic K, Karapanzcik T, Huang S, Heeg M, Tang J, Belkin J, Lee MS, Joly T, Akpunonu B, Franco-Saenz R, Gilmore J, Gilmore M, Godfrey L, Ross P, Bauer B, Chrisstie M, Lopez A, Mulrow P, Peters C, Pop-Busui R, Roman J, Smith C, Bick J, Blust Z, Nelsen PT, Marcus D, Osei K, Dziengelewski EA, Breedlove H, Boland D, Boyer CC, Cataland S, Kearns PA, Irwin JE, Schuster DP, Varga-Spangler JL, Bowles T, Weiland K, Arnold K, Evans T, Bouttamy J, Letson A, Craig E, Davidorf F, Cohen RM, Burton K, Craig J, Carter B, Harrer J, Hurd R, Lopez-Stickney D, Pritchard C, Pfefferman A, Ramlo-Halsted BA, McCormick C, Riley C, Strominger M, Knittel A, Groff G, Bailey C, Howald A, Anderson N, Bierschbach JL, Tyzinski M, Smith B, Krug S, Hershberger V, Hutchins RK, Raymond LA, Thomas A, Kahkonen DM, Cushman T, Roman M, Stys AM, White K, Austin M, Chatterton C, Francis JK, Jones C, Kruger D, McLellan A, Whitehouse F, Higgins E, Levy S, Schoenherr A, Edwards P, Grunberger G, Aman LC, Bandagi AH, Russell KM, Tucker C, Abidova Y, Amirikia A, Narduccio M, Billingsly B, Bigger JT, Lopez-Jimenez CR, Bornholdt R, Busaca L, Ginsberg HN, Gonzales P, Gosh D, Love P, Kosok A, Robinson E, Steinman R, Watson C, Reyes G, Schubart UK, Mendoza M, Goswami G, Laufer A, Russo J, Vincenty N, Alderman MH, Carroll L, Sanguily MJ, Gorkin JU, Mayer AC, Ramos L, Sessoms V, Stewart AF, Brillon D, Cordero J, Richardson MA, Wei E, Ganz F, Meyer BR, Paley J, Anderson S, Charles C, Dwoskin A, Chiong R, Hyams K, Lorber DL, Arenstein T, Depree P, Elmorsy AA, Wendel JM, Zintl LL, August P, Beck M, Goldberg MD, Hofacker MJ, Marotta-Kollarus M, Ocampo EJ, Resta CA, Tibaldi JM, Bastien A, Grudzinski S, Niblack P, Abreu L, Brobyn T, Brown K, Casale M, Dougherty D, Haddad G, Heintz K, Kelly M, Linneman D, Olivia C, Salvador MA, Zee P, Hyman D, Brautigam DF, Fischer R, Chiarot JM, Scharf DM, Nunn B, Carlson J, Flanders C, Hagen MR, Newman S, Gordon TA, Goland R, Tuck CH, Kringas P, Hey-Hadavi J, Montes J, Vargas-Jerez J, Salas-Spiegel J, Getaneh A, Ramirez J, Vasquez EF, Kranwinkel G, Durant SA, Donovan DS, Febres G, Hernandez C, Jonaitis MA, Mesa L, Banerji MA, Norton M, Patel P, Daly V, Hirsch S, Jazmin C, Khillan R, Mendonca D, Relingado A, Sandoval E, Tiewala M, Banerji MA, Norton M, Patel P, Daly V, Hirsch S, Jazmin C, Khillan R, Mendonca D, Relingado A, Sandoval E, Tiewala M, Goff DC Jr, Summerson JH, Crago L, Blackwell CS, Bertoni A, Blaine RL, Kirk JK, Spach RL, Williamson J, Calles J, Katula J, Wishnietsky DB, Feinglos MN, Jones J, Mason MB, Furst MA, Bean WJ, Gedon-Lipscomb G, Green JB, Parham T, Satterwhite BM, Thacker CR, Padhiar D, Noel R, Padhiar N, West S, Braden J, Francis A, Atkinson HH, Dibari M, Allen J, Stanfield J, Delvalle-Fagan T, Gordineer LJ, Gordon L, Gordon M, Smith SL, Yates H, Pedley CF, Zurek G, Baird M, Dunn B, Kinder W, Mauney S, Buse JB, Duclos MD, Kirby RE, Largay JF, McDermott NM, Goley A, Braithwaite SS, Dostou JM, Fasy EA, Kelly DC, Metz CE, Jeffries J, Rubin D, Vukojicik K, Miller JL, Besterman W, Norton SM, Weatherly J, Bishop S, Cross B, Nuss K, Surgenor M, Alley D, Farmer A, Foard J, White J, Wood Y, Dulin M, Konen J, Barringer T, Andrews K, Hoffman C, Morris C, Norton S, Tochiki P, Reinblatt G, Bruner P, Peace R, Stuart DO, Strickland J, Cummings L, Craig D, Stanfield J, Morgan J, Peace R, Stuart DO, Strickland J, Cummings L, Craig D, Stanfield J, Williams G, Crouse JR, Menon L, Marion S, Davis D, Cabrera B, Calles J, Chandler T, Ellis J, Kouba E, Riddle P, Myers E, Fonseca V, John-Kalarickal J, McDuffie RH, Asafu-Adjaye NO, Leger SM, Reilly P, Afner G, Arrey F, Asnani S, Borshard E, Boyd D, Cemo A, Chennur S, Dupart P, Garg R, Girindra GP, Gouda B, Itoua-N'Ganongo W, Innocent-Ituah I, Johnson C, Kuhadiya N, Kukreja M, Mangan-Mbondi I, Mason S, McLain C, Naylyanya J, Nazereth K, Nazereth S, Singh S, Thethi T, Varnado K, Williams R, Barzilay JI, Eley M, Bader K, Curry-Ball D, Goodman S, Stevens M, Cushman WC, Geraci TS, Walsh SM, Coley LG, Elam MB, Pickering DI, Huff C, Elam MB, Thompson CW, Lichtermann L, Peeples S, Turner-Bates J, Heimberg M, Childress D, Turner J, Jasper J, Coley J, Hamilton BP, Hamilton J, Kuzbida G, Hatten W Jr, Lancaster A, Haywood J, Luck J, Bannerman-Wood D, Felicetta J, Bourne-Collo M, Svoboda ME, Clothier D, Deitz M, Flaugher C, Hayward P, Scheibe T, Velarde S, Heritage S, Nelson JP, Heritage D, Martinez C, Sweeney ME, Harrelson D, McConnell S, Watson F, Johnson R, Whittington L, Nanes M, Salles M, Rice C, Cowden C, Basile J, Ham DB, North-Lee B, Baig HA, Rehman SU, Mixson J, Nelson D, Kirchner KA, Hinton LA, Mack L, Adair C, James B, Spencer A, Jones A, Katz L, Richardson EA, Goldberg AG, Nieves A, Russo JE, Adams J, Sochalski SA, Coles M, Anderson S, Williams M, Hoffman D, Papademetriou V, Gregory B, Alignay R, Nylen E, Rajendran B, Hodges R, Amodeo S, Ross A, Notargiacomo A, Metcalfe M, Narayan P, Wojackovski D, Giddings S, Clark E, Pittler A, Davis R, Harris P, Waidmann K, Conwill L, Felton S, Chen A, Simmons DL, Cooper JJ, Dishongh K, Bates R, Bhaghayath K, Choksi P, Conley S, Elbein S, Faas F, Hamid Z, Johnson J, Johnson P, Mayo A, Moriarty MS, Nair G, Rani D, Rasouli N, Said S, Rassouli N, Rodriguez M, Thomas K, Watson K, Williams D, Makdissi A, Byington RP, Ambrosius WT, Anderson RT, Barnes J, Beal J, Bell C, Bonds DE, Burton S, Collins C, Cook D, Craven B, Craven T, Dunbar D, Evans GW, Feeney P, Furberg CD, Greven CM, Griffin J, Harvin L, Hepler J, Howard L, Howard-Perdue LT, Hough M, Hwang W, Kimel A, Lefkowitz D, Lopina A, Lovato J, Lovato LC, Miller ME, Reboussin D, Rushing S, Sanders L, Sims L, Stowe C, Walkup M, Wilmoth S, Wilson K, Woolard N, Raisch D, Ringer R, Sather M, DelCurto B, Garnand D, Prineas R, Campbell C, Zhang Z, Kesler L, Hall S, Hensley S, Li Y, Soliman E, Milne D, Marcovina S, Chmielewski J, Gadbois K, Gaur V, Strylewicz G, Ramirez M, Waddell S, Mehan M, Bryan RN, Davatzkios C, Moonis G, Desiderio L, D'Arcy S, Davis M, Danis R, Johnson S, Robinson N, Hubbard L, Esser B, Thayer D, Neider M, Glander K, Burger M, Gama V, Guilfoil G, Schiffman M, Wabers H, Dingledine J, Graham T, Simons-Morton DG, Cooper L, Domanski M, Nwachuku C, Rosenberg Y, Salive M, Savage P, Fleg JL, Cutler JA, Geller N, Follmann D, Proschan M, Jennings C, Schaeffer E, Mills P, Bittner J, Kirby R, Frommer P, Fine L, Chan J, Fradkin J, Malozowski S, Meyers C, Hostetter T, Launer L, Chew EY, Albright A, Narayan KM, Engelgau M, Zhang P.

Erratum in

  • N Engl J Med. 2010 May 6;362(18):1748.

Abstract

BACKGROUND:

We investigated whether combination therapy with a statin plus a fibrate, as compared with statin monotherapy, would reduce the risk of cardiovascular disease in patients with type 2 diabetes mellitus who were at high risk for cardiovascular disease.

METHODS:

We randomly assigned 5518 patients with type 2 diabetes who were being treated with open-label simvastatin to receive either masked fenofibrate or placebo. The primary outcome was the first occurrence of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years.

RESULTS:

The annual rate of the primary outcome was 2.2% in the fenofibrate group and 2.4% in the placebo group (hazard ratio in the fenofibrate group, 0.92; 95% confidence interval [CI], 0.79 to 1.08; P=0.32). There were also no significant differences between the two study groups with respect to any secondary outcome. Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group (hazard ratio, 0.91; 95% CI, 0.75 to 1.10; P=0.33). Prespecified subgroup analyses suggested heterogeneity in treatment effect according to sex, with a benefit for men and possible harm for women (P=0.01 for interaction), and a possible interaction according to lipid subgroup, with a possible benefit for patients with both a high baseline triglyceride level and a low baseline level of high-density lipoprotein cholesterol (P=0.057 for interaction).

CONCLUSIONS:

The combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke, as compared with simvastatin alone. These results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620.)

2010 Massachusetts Medical Society

Comment in

PMID:
20228404
[PubMed - indexed for MEDLINE]
PMCID:
PMC2879499
Free PMC Article

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