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N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.

Effects of intensive glucose lowering in type 2 diabetes.

Collaborators (1174)

Gotto AM, 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, Gerstein HC, Ginsberg HN, Goff DC Jr, Grimm RH Jr, Ismail-Beigi F, Probstfield JL, Simons-Morton DG, Gerstein HC, Yusuf S, Punthakee Z, Russo R, Anand S, Cracknell B, Cukierman-Yaffe T, Gafni A, Guyatt G, Hall S, Kaszyca J, Lonn E, McLeod D, Read K, Reiding V, Shehadeh N, Tadeson B, Thompson K, Vallis M, Vasudeva V, Wilderman I, Punthakee Z, Smith A, Stanton I, Capes S, Danby S, Harper W, Harvey P, Hunt D, Manjoo P, Moroso A, Otto R, Prebtani A, Valla T, 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, Hartman D, Jeffrys A, MacDonald C, Makhani N, Mawani S, Morales F, Paty B, Pick M, Schwanke B, Stark A, Tennant M, Varma S, 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, Bate R, 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, 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, Inducil M, Al Amoudi R, Broughton T, Hall L, Harrison B, Hirvi N, Lee R, 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, 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, Ariani K, Karunaratne K, Azizad M, Chow C, Gutierrez H, Partamian J, Toven J, Mular J, Sanders S, Haywood LJ, Kamdar V, DeQuattro DL, Wang L, Song Z, Miller C, Becerra L, Qi Cai A, Pruitt C, DeQuattro V, Failor R, Ellsworth A, Jackson N, Miller C, Britt D, Dobie S, Hirsch I, Khakpour D, Quaempts R, Stoffel W, Wilcox T, Neighbor W, Cappocia K, Force R, Macdonald M, Lusk S, Liday C, Borzadek E, Koester S, Pettinger T, Solbrig R, Waldron C, Pettingill K, Woodhouse W, Hoover B, Linz PE, Pepper PV, Kozlowski J, Chase C, Samuelson D, Gutierrez P, Gonzales C, Engle M, Coopersmith J, Griffin S, Lammers R, Leon J, 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, Wysham C, Weeks D, Kuntsmann L, Maxwell L, Yedinak S, Pena H, White J, Dudl J, Lyons L, House B, Murray M, Wu P, Palma A, Briere S, Wilson T, Becker D, Harden K, Hawley C, Stevenson R, 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, Tariq Fareed M, Hall K, Moor R, Wood K, Bergenstal R, Cuddihy R, Davick B, Hokanson J, Johnson M, Kendall D, 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, Seaquist ER, Mech MV, Benedict LE, Demmon DJ, Kumar AF, Martinson SM, Miller SA, Pease C, Rao JP, Redmon JB, Swanson JE, Wimmer JK, Peterson K, Seaquist LA, Boese C, Cruciani M, Dodds E, Parenteau Ek F, Feldman JL, Fontaine P, Lange CJ, Mendenhall TJ, Peterson AM, Rudelt A, Schrock TM, Spielman DP, Velasco S, Weinhandl 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, Spencer M, 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, Ismail-Beigi F, Genuth S, Thibonnier M, Vargo L, Kelly C, Bongorno T, Dolish A, Pavlik L, Tiktin M, Isteitieh S, 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, 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, Daeumeyer 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, Moore 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 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, 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, Casey Boyer C, Cataland S, Green 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, Laver Bierschbach J, Tyzinski M, Smith B, Krug S, Hershberger V, Hutchins RK, Raymond LA, Kahkonen DM, Cushman T, Roman M, Stys AM, Thomas A, 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, Bigger JT, Lopez-Jimenez CR, Bornholdt R, Busacca 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, Fritts Stewart A, 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, 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, Busby M, Dostou JM, Fasy EA, Kelly DC, MacIntosh B, Metz CE, Jeffries J, Rubin D, Miller JL, Norton SM, Weatherly J, Bishop S, Cross B, Nuss K, Surgenor M, Wood Y, Andrews K, Barringer T, Hoffman C, Konen J, Morris C, Tochiki P, Reinblatt G, Bruner P, Peace R, Stuart DO, Strickland J, Cummings L, Craig D, Stanfield J, Peace R, Stuart DO, Strickland J, Cummings L, Craig D, Stanfield J, Crouse JR, Menon L, Marion S, Davis D, Cabrera B, Calles J, Chandler T, Ellis J, Kouba E, Riddle P, Myers E, Fonseca V, 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, Huff CM, Pickering DI, Massimino P, Elam MB, Thompson CW, Lichtermann L, Peeples S, Turner-Bates J, Heimberg M, Childress D, Solomon S, Turner J, Jasper J, Pfeifer R, Coley J, Hamilton BP, Hamilton J, Kuzbida G, Bannerman-Wood D, Hatten W Jr, Lancaster A, Jang H, Felicetta J, Bourne-Collo M, Svoboda ME, Clothier D, Deitz M, Flaugher C, Hayward P, Scheibe T, Heritage D, Velarde S, Heritage S, Nelson JP, Sweeney ME, Harrelson D, McConnell S, Rice CR, Watson F, Johnson R, Whittington L, Nanes M, Salles M, Basile J, Ham DB, North-Lee B, Baig HA, Rehman SU, Mixson J, Nelson D, Kirchner KA, Ross BS, Kazi M, Subauste J, Hinton LA, Mack L, James B, Spencer A, Henegar L, Jones A, Katz L, Richardson EA, Goldberg AG, Nieves A, Russo JE, Sochalski SA, Hoffman D, Papademetriou V, Narayan P, Wojciechowski D, Gregory B, Alignay R, Nylen E, Rajendran B, Hodges R, Ross A, Notargiacomo A, Giddings S, Clark E, Pittler A, Davis R, Harris P, Hofmeister T, Simmons DL, Cooper JJ, Dishongh K, Choksi P, Elbein S, Faas F, Hamid Z, Johnson J, Mayo A, Moriarty MS, Rani D, Rasouli N, Watson K, Makdissi A, Friedewald WT, 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, Selph L, Hall S, Hensley S, Li Y, Mills M, 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, Glader K, Burger M, 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.

Abstract

BACKGROUND:

Epidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors.

METHODS:

In this randomized study, 10,251 patients (mean age, 62.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 38% were women, and 35% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up.

RESULTS:

At 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001).

CONCLUSIONS:

As compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620.)

2008 Massachusetts Medical Society

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PMID:
18539917
[PubMed - indexed for MEDLINE]
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