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N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.

Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes.

Collaborators (1307)

Chalmers J, MacMahon S, Patel A, Cooper M, Ferrannini E, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu LS, Mancia G, Marre M, Mogensen CE, Neal B, Pan CY, Poulter N, Rodgers A, Williams B, Woodward M, Collins R, Holman R, Sandercock P, Sleight P, Fulcher G, Adams M, Branley M, Jenkins B, Louis D, Lowe H, Luo W, McCormack A, Mitchell P, Ong S, Pollock C, Watson J, Wong T, Billot L, Bompoint S, Colman S, Francis L, Heritier S, Li Q, Ninomiya T, Pillai A, Woodward M, Travert F, Baksi A, Bao YQ, Cutfield R, de Galan B, Dumas R, Fovenyi J, Fu HJ, Fulcher G, Huang H, Jia PH, Khir A, Krahulec B, Li CL, Li J, Litonjua A, MacIsaac R, Placzkiewicz-Jankowska E, Quirk S, Southern S, Tack C, Tandon N, Xu ZR, Zhang JC, Zhang Z, Zou XM, Heller S, Del Prato S, Fulcher G, Hamet P, Pan CY, Flynn S, Monaghan H, Allen S, Bi YF, Carreras A, Cass A, Chen T, Currie R, Davies P, de Galan B, Du X, Fathers J, Gibb S, Girgis S, Graziano A, Heritier S, Hibbard J, Hough S, Huynh A, Jan S, Jardine M, Jayne K, Joshi R, Kengne AP, Li N, Liu X, Mallows A, Morrison A, Mullane B, Ng R, Orpilla E, Pandey S, Parkinson M, Perkins N, Perkovic V, Regaglia J, Rodeghiero C, Ryan S, Schmidt M, Singleton J, Starzec G, Travert F, Turnbull F, Vijayan B, Yabsley P, Bormans A, Faatui J, Gray B, Holloway T, Mills C, Milne A, Ng C, Ng M, Pink S, Van Rooyen J, Waghulde S, Han D, Liu B, Wang XP, Harrap S, Reid J, Subramaniam R, Williams F, Chan B, Chan S, Chaturvedi V, Flett S, Hynd D, Jeemon P, Leahy A, McGrath E, Noske S, Prabhakaran D, Reddy KS, Shah S, Tandon N, Hamet P, De Guise D, Guertin MR, Chretien P, Daneau C, Martineau D, St-Onge M, Liu LS, Ma LY, Wang W, Chen JL, Chen JW, Deng Q, Ge Y, Sui H, Tang RK, Yu XJ, Zhao XM, Zou XM, Grobbee DE, Bak A, Bobbink W, Gilsing M, Williamson K, Blizanowska A, Derne C, Descusse G, Fafejtova M, Haars G, Hafkamp M, Jongebreur G, Kladivova M, Leveque S, Noury M, Paddenburg D, Peterfai E, Powidel M, Puzej V, Raczova, Ruda V, Soedamah-Muthu S, Stolk R, Suiker A, van Bemmelen KP, van Everdingen C, Weber C, Wisse H, Poulter N, Adderkin A, Cheeseman L, Cullen T, Currie E, Ekeroth M, Field J, Glaser N, Heffernan S, Massie E, Michitiuc I, Mirza S, Ngai Y, Owers A, Petchey E, Rask A, Sasikaran T, Small L, Spanidis E, Wilson A, Doughty R, Baker J, Gamble G, Jerums G, Walsh H, Whalley G, Grobbee DE, Stolk R, Cruickshank K, Aldington S, Beulens J, Hughes A, Lu J, Meijers T, Nijsssen K, Stanton A, Tandon N, Thom S, van Schooneveld M, Vingerling J, Wisse H, Glasziou P, Alexander J, Beller E, Clarke P, Hamet P, Chalmers J, Harrap S, MacMahon S, Tremblay J, Woodward M, Nugent P, Topliss D, Warner J, Jacklin C, Jerums G, McNeil K, Correcha M, Hines M, Margrie F, Nolan C, Petrovsky N, Silva D, Socha L, Sunderland J, Todor A, Darnell D, Fernandez M, Forbes P, Harvey A, Littlefield S, McGrath B, Meyer C, Singh R, Teede H, Wong J, Yeap A, Zoungas S, Bohra S, Clowes V, Simmons D, Davis T, England M, Gillett M, Jackson D, Kamber N, Panicker V, Rakic V, Schimke KE, van Nguyen H, Beggs J, Davoren P, Kamp M, Turner F, Cooke D, Fassett R, Shepherd J, Smith S, Chow J, Curtale M, Malkus B, Rayment G, Spicer T, Suranyi M, Wong M, Anderson C, Bradshaw J, Hoh A, Jeffries W, Turner J, Gledhill A, Hannay T, Haworth K, Hendrich E, McIntyre H, McIntyre M, Morton A, Pennisi J, Borger R, Chan Y, Chan K, Colagiuri S, Hoang J, Naidu V, Perampalam S, Por E, Sourjina T, Tejani N, Bendall C, Budgeon J, Carey D, De Looze F, Lepre F, Stephensen J, Carroll P, Duroux M, Larter C, Ratcliffe M, Miller C, Phillips PA, Stranks S, Taylor P, Bune A, Fulcher G, Fuller A, Pollock C, Stack P, Kean M, Wong J, Yue D, Baker S, Bittinger L, Cotton R, Eccleston D, Harvey P, Jackson B, Lawlor V, Liaw ST, Neil C, Park M, Premaratne E, Pyrlis F, Rudge G, Beattie D, Tan Y, Brozowska G, Das D, Gan M, Goss B, Park K, Perampalam S, Shirkhedkar D, Sullivan C, Ting A, Calvert G, Lucas E, Moses R, Nattrass N, Slobodniuk R, Webb A, Binder B, Jetha S, Ross S, Visvanatha L, Bélanger A, Dumas R, Gauthier S, Labbé M, Raymond J, Godin C, Lachance C, St-Pierre B, Langlois MF, Maheux P, Poulin F, Thibodeau CL, Chiasson JL, Ciuria N, Gossard F, Hamet P, Julien L, Potvin S, Van Nguyen P, Vigneault I, Blais J, Gosselin G, Harvey N, Masson C, Robitaille Y, Savard C, Durand C, Fleury C, Kouz S, Proulx M, Roy M, Bradley J, Marcoux M, Parmar M, Séguin T, Blanchet M, Dubé F, Garceau D, Garceau C, Kelly L, Kirouac I, Mercier L, Pleau M, Plourde E, Raby K, Trudel D, Al-Beiruti B, Ingraham C, McGibbon A, Patterson A, Reidy S, Tuttle J, Ur E, Cauchi L, Furtado N, McManus R, Rodger N, Ali M, Dion C, Forestell L, Godden K, McJannet S, Nawaz S, Poirier R, Dawson K, Lewis J, Thompson D, Bédard D, Josse R, Leiter L, Chen CX, Wang ZX, Wu KG, Yang F, Shi YM, Yan XF, Ding YC, Sun G, Wang F, Liu FY, Yang HS, Zhu KS, Liu CM, Yin JM, Li MY, Liu LF, Liu B, Shi JS, Liu JY, Liu HB, Wu YS, Liu YH, Zhang PQ, Zhang LM, Liu WS, Wang RY, Zhang SY, Hu L, Jiang FF, Wu Y, Chen MW, He Y, Pan TR, Yang MG, Zhang Q, Gong MX, Shi LX, Wu DR, Zhuang HJ, Bi YF, Chen YH, Gu LQ, Ning G, Zhang LZ, Fu HJ, Li HB, Yuan SY, Jia FY, Shi FY, Tian GS, Liu SQ, Zhang J, Tang JL, Wang SY, Wang YX, Zhu JX, Cui JY, Geng J, Jia RB, Qin L, Wang HY, Jin JG, Li XM, Lu XP, Wang WB, Zhang LY, Bai MY, Hu BL, Shen RC, Wu XM, Zhang LQ, Wang CZ, Zheng ZR, Li CL, Tian H, Yan ST, Lin YY, Liu ZM, Shi YQ, Tang W, Zhang ST, Zhu SJ, Ge H, Guo BX, Qie SG, Ni CH, Wang AH, Xu ZR, Zhao DM, Gao Y, Guo XH, Jia PH, Li XJ, Wu YH, Yu HL, Zhang HX, Zhou YH, Li AQ, Shi LP, Lu FH, Tian Q, Zhao YX, Chen T, Shu D, Bian RW, Chen L, Li J, Lu H, Zhang SH, Li J, Yu DM, Zhang Z, Zhang QM, Shen LL, Wang WG, Zhang TJ, Zhu S, Bao YQ, Jia WP, Zhang H, Jing YL, Yang J, Li YJ, Zhang F, Chu SL, Wang XY, Gao FR, Gao XW, Zhou JC, Li Q, Wang SW, Xiang Y, Zhang JC, Li WP, Sun M, Zhou HY, Ren LJ, Ma HB, Zhang HR, Kraml P, Rybka J, Svestka L, Kucharova L, Komrskova M, Bartikova J, Benesova R, Honka M, Balabanova H, Girman P, Jirsova E, Kobrova D, Kriz J, Sechser T, Slepickova J, Brezina J, Kulic F, Patek F, Pozivilova P, Tupa M, Cerna J, Dohnalova L, Podiukova I, Tiser P, Zackova R, Kaasiku R, Podar T, Sulkovskaja I, Vinogradova T, Jurgenson T, Kaasik U, Vork A, Bedos-Chevalier N, Benamo E, Latil-Plat F, Rubin P, Boch C, Chagnoux M, Khodabandehlou T, Le Devehat C, Pinel J, Vanhoutte C, Vimeux M, Bouhanick B, Marty I, Pelle C, Bekherraz A, Cochereau O, Kouadio P, Marre M, Vukusic I, Bedos-Chevalier N, Maubon A, Rodier M, Blickle JF, Koch P, Loeb G, Paris-Bockel D, Bohme P, Popieul M, Ziegler O, Demer C, Gendre D, Hadjadj S, Laneuze V, Marechaud R, Hespel JP, Robert AM, Matschke B, Hanefeld M, Henkel E, Kohler C, Lehmann D, Ott P, Pahner A, Stier U, Temelkova-Kurktschiev T, Andratschke-Gentsch B, Bueschges G, Markhof P, Meier G, Nischwitz M, Schmid S, Von Schacky C, Koranyi L, Jermendy G, Nadas J, Csongradi C, Kasa G, Kozma T, Matyus Z, Tarko M, Koranyi L, Kovacs B, Kulcsar E, Deak L, Kovacs Z, Rumi G, Dudas M, Gyimesi A, Varga R, Csapo I, Fovenyi J, Hermanyi I, Kolev G, Hidvegi T, Mate C, Nemeth I, Szeri B, Herold M, Sarman B, Somogyi A, Balsay M, Bencsik Z, Eory E, Korodi T, Sereg M, Hohmann Z, Lengyel Z, Voros P, Domotor E, Fuleki T, Munster Z, Bujtor Z, Oroszlan T, Tarnok F, Anand R, Das S, Karthikeyan G, Lakshmy R, Naik N, Prabhakaran D, Reddy KS, Sen S, Tandon N, Ahmed M, Ali M, Anjaneyulu A, Naidu K, Raju K, Rao L, Reddy N, Reddy P, Sethi B, Joshi P, Kumbhalmar S, Lokhande K, Rathod P, Sable S, Karkuzhali K, Mariyam S, Mohan V, Poongothai S, Premalatha G, Salomi J, Selvi V, Srinivasan R, Visalatchi R, Ashraf M, Barton J, Chong J, Courcy M, Elfadil M, Kelly C, Aloul B, Collier C, Dolan E, Foley C, Gallagher B, Gusau B, Hacke L, Ho E, Maguire B, Stanton A, Thompson C, Twohill M, Firth R, Gribben A, Hoashi S, Joyce M, O'Loughlin H, Rizvi S, Wade B, Brennan A, Byrne D, Cullen M, Khamis A, Murphy M, Ryan M, Bell M, Bramhill C, Campbell C, Corredia N, Cullen L, Gibney J, Kyaw Tun T, Mullan K, Owens D, Phelan N, Tan C, Tomkin G, Galli P, Mancia G, Paleari F, Vilei V, Whisstock C, Babarskienie R, Milvidaite I, Gintautaite A, Sirvyte R, Varoneckas G, Grizas V, Marcinkeviciene J, Tumyniene V, Vasiliauskas D, Vytautas G, Hla K, Kalairajah A, Nayar S, Ramanathan L, Abdullah R, Bakar W, Ismail T, Kamaruddin N, Loganathan A, Majid F, Mansor N, Mohamed Z, Mustafa N, Nawawi H, Nor N, Subramaniam K, Yusoff K, Aziz N, Eng Leong G, Gaik Kin C, Jeremiah H, Khir A, Lim S, Mumtaz M, Abdul Rashid A, Alias R, Bahari Ismail S, bt Wan Mohamad W, bt Zainal-Abidin R, Daud K, Doud R, Ismail AA, Masandid H, Mohamed M, Mumtaz M, Wahab S, Wan Bebakar W, Chan SP, Hew FL, Lim MH, Rokiah P, Yeoh KH, Alhakim M, Amin A, Asten K, vd Berg Putten J, Bierman B, Boer H, Bredemeijer R, Durian F, Jansen A, Muilwijk P, Muilwijk-Vermeer P, Opstelten W, Ponteyn-Rose S, Sluijters C, Sumajow C, Swart J, Tavenier D, van Oort L, van Vliet J, van Welson I, Blokzyl-Mol P, Bulk H, Faber-Mollema D, Leutscher T, Mulder D, Ottema R, Prins C, Soer E, Tiebesl J, Fierkens M, Jaspers P, Koster Y, Bell T, Geerts C, Gieskes C, Jalloh-Vos H, Pegt G, Ramautarsing D, Schenk W, van Kempen W, van Kempen A, van Meurs J, Vink C, Venekamp W, Bie L, Hollander-Bosboom D, Keyzer J, Lieverse A, Lokhorst B, Rompen A, Sanders S, ten Berge-Lammens G, van Foreest-Bruggink A, Vrugt M, Boerema-Zikkenheiner I, de Haan-Zwart S, Timmerman R, Viergever P, Bossen W, Elzinga B, Janssen W, Knot M, Prins A, Boonman-de Winter L, Bosser-van Rijckevorsel J, de Zwaan-Herfst M, Erdtsieck-Ernste E, Froger-Nuyten M, Jonk-Smulders E, Offringa A, van der Smissen-van Meel A, van Veen M, Arendhorst J, Bonekamp C, Jans N, Meeuwese P, Scholten M, Tjaden B, van der Meer S, van Kuppevelt R, Florkowski C, McEwan R, McGregor P, Scott R, Strey C, Brown S, Kenyon J, Leikis R, Luke R, Baker J, Chiu W, Clarke R, Dissanayake A, Elston M, Gunatilaka S, Kerr G, Leary J, Moffat J, Rosen I, Te Whiu M, Austin S, Singh J, Ward G, Carswell G, Cruz S, Dixon P, Nesdale D, Snell H, Barker C, Burton A, Doran J, Gale F, Hammond M, Hills M, Bartley F, Dunn P, Johnstone A, McLeod D, Reda E, Waterman A, Clarke T, Cresswell P, Eagleton C, Ferguson A, Gallen AM, Kent L, Krebs J, Rosemergy I, Ross C, Smith R, Capulong G, de la Pena P, Fabros C, Galan M, Pascual S, Que M, Agra J, Alcantara C, Avila G, Delos Santos L, Guzman L, Licaros M, Panelo A, Solfelix C, Aragon J, Capuli-Isidro M, Daria A, Del Rosario L, Derpo C, Gonzales C, Lim E, Litonjua A, Narvacan-Montano C, Obrero T, Oreal J, Pallera R, Pipo E, Pollisco C, Trinidad S, Jimeno C, Lim-Abrahan M, Manansala A, Nicodemus N, Januszewicz A, Sieradzki J, Kawecka-Jaszcz K, Klocek M, Mazur A, Blaszczyk M, Bloch C, Jedrzejczak P, Ziolkowska-Trzcinka E, Frolow M, Kopczynska J, Makowski M, Nizankowski R, Petriczek T, Szczeklik A, Klupa T, Sieradzki J, Trznadel-Morawska I, Grodzicki T, Gryglewska B, Wizner B, Orlowska-Kunikowska E, Przezdziak M, Wyrzykowski B, Chudek J, Czerwienska B, Ficek R, Nieszporek T, Wiecek A, Czubek U, Latacz P, Nessler B, Piwowarska W, Czupryniak L, Loba J, Pawlowski M, Saryusz-Wolska M, Kadziela J, Norwa-Otto B, Ruzyllo W, Boruczkowska A, Gluszek J, Kosicka T, Krasinska B, Tykarski A, Wichrowska A, Czekalski S, Simachowicz A, Wasik-Olejnik A, Brzezicki B, Ciesielska M, Ganska A, Gornikiewicz-Brzezicka B, Bandurska-Stankiewicz E, Tarasiewicz U, Chlebus M, Najwa A, Trzepla E, Zapecka-Dubno B, Steuer M, Steuer E, Dworzanski W, Michalczyk K, Pikula J, Tylec E, Bogieva R, Chazova I, Duishvili D, Gornostaev V, Mamyrbaeva K, Moiseev V, Mychka V, Aleksandrov A, Kravchenko T, Martyanova I, Vilkov V, Galitsyna N, Shestakova M, Zaytseva N, Babenko A, Volkova A, Zalevskaya A, Kaverzina Z, Martyanova I, Nebieridze D, Oganov R, Tolpygina S, Dorofeikov V, Gugova F, Konrady A, Kurbanovna A, Shlyakhto E, Zvartau N, Dmitrova T, Fremovceva A, Kobalava I, Sirotkina A, Balazovjech I, Horvathova H, Krahulec B, Lahitova R, Lamitova R, Strbova L, Sukeova J, Mokan M, Pridavkova D, Smatanova S, Sutarik L, Simkova E, Spisak V, Stranankova D, Morsky J, Ruffini L, Tataiova E, Krcmery S, Mikes Z, Hricova L, Jurcina A, Marcinova M, Sedlakova M, Sefara P, Spurny P, Szokeova E, Snincak M, Banikova A, Gaziova M, Micko K, Nociar J, Pivkova M, Rajtukova B, Ambrovicova V, Antolik J, Cibulkova A, Ondrusova L, Sojka G, Hranai M, Korpasova M, Minarik P, Moravcikova O, Porubska M, Sirotiakova J, Rac M, Mazur J, Moravcova M, Sulej P, Beles L, Belesova K, Jakabova G, Zelinska M, Bruce M, De Vries A, Furnace J, Jamieson C, Macleod M, McDonald P, Ross S, Bright J, Darko D, Hopkins D, Beevers G, Haynes R, Karthikeyan V, Lim HS, Lip GY, Partridge J, Appleby M, Donnelly R, Dwyer AM, Gibson T, Scott A, Fisher B, Gray J, McKenzie J, Paice G, Baksi A, Bartlett J, Hogan D, Moody S, Thomas Z, Whittingstall E, Wilson P, Jackson S, Meakin L, Walwyn L, Chandran S, Heslop S, Joshi A, Vora J, Westwell F, White H, Banerjee M, Collins J, Cruickshank K, Dunkerley J, Harrison C, Hart K, Holland M, Luckson M, Shaw S, Wood T, Forbes F, Gallagher K, Harrower A, Matthews D, McIntyre E, McKay G, McMahon J, Dudgeon L, Fox C, Hall K, Hollway M, James L, Marsh S, Morgan D, Nayani G, Richards V, Staff C, Stockman J, James D, Patel V, Randall C, Begg A, Grogan R, Hinnie J, McIntyre M, Coates F, Davies P, George A, Golding-Cook S, Hamon C, Jefferies M, Kolinsky E, Meachin C, Millward A, Neeves K, Soler-Lopez M, Stokes J, Cunningham B, Ghosh D, Mukhtar M, Simpson E, Simpson H, Howard R, Inglis J, Mukhtar R, Reckless J, Robinson A, Shute C, Stirling C, Ward A, Day J, Green C, Jackson P, Roberts A, Wallis E, Cunningham M, Heller S, Hudson S, Ariff B, Bunker J, Callister W, Coghlan C, Elkeles R, Fernandez R, Gordon V, Harman J, Jugnee N, Knisley L, Macduff J, Mackay J, McFadden-Lewis K, McKerracher A, Mistry P, Mitchell S, Murphy S, Strain A, Thom S, Trainor O, Whitehouse S, Zambanni A, Boardman S, Reid C, Reid V, Coddington C, Ellis A, Holliday C, Slater C, Brown D, Dawson V, Gibson H, Jennings P, Thow J, Whitwell S.

Abstract

BACKGROUND:

In patients with type 2 diabetes, the effects of intensive glucose control on vascular outcomes remain uncertain.

METHODS:

We randomly assigned 11,140 patients with type 2 diabetes to undergo either standard glucose control or intensive glucose control, defined as the use of gliclazide (modified release) plus other drugs as required to achieve a glycated hemoglobin value of 6.5% or less. Primary end points were composites of major macrovascular events (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) and major microvascular events (new or worsening nephropathy or retinopathy), assessed both jointly and separately.

RESULTS:

After a median of 5 years of follow-up, the mean glycated hemoglobin level was lower in the intensive-control group (6.5%) than in the standard-control group (7.3%). Intensive control reduced the incidence of combined major macrovascular and microvascular events (18.1%, vs. 20.0% with standard control; hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P=0.01), as well as that of major microvascular events (9.4% vs. 10.9%; hazard ratio, 0.86; 95% CI, 0.77 to 0.97; P=0.01), primarily because of a reduction in the incidence of nephropathy (4.1% vs. 5.2%; hazard ratio, 0.79; 95% CI, 0.66 to 0.93; P=0.006), with no significant effect on retinopathy (P=0.50). There were no significant effects of the type of glucose control on major macrovascular events (hazard ratio with intensive control, 0.94; 95% CI, 0.84 to 1.06; P=0.32), death from cardiovascular causes (hazard ratio with intensive control, 0.88; 95% CI, 0.74 to 1.04; P=0.12), or death from any cause (hazard ratio with intensive control, 0.93; 95% CI, 0.83 to 1.06; P=0.28). Severe hypoglycemia, although uncommon, was more common in the intensive-control group (2.7%, vs. 1.5% in the standard-control group; hazard ratio, 1.86; 95% CI, 1.42 to 2.40; P<0.001).

CONCLUSIONS:

A strategy of intensive glucose control, involving gliclazide (modified release) and other drugs as required, that lowered the glycated hemoglobin value to 6.5% yielded a 10% relative reduction in the combined outcome of major macrovascular and microvascular events, primarily as a consequence of a 21% relative reduction in nephropathy. (ClinicalTrials.gov number, NCT00145925.)

2008 Massachusetts Medical Society

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