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N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.

Effects of intensive blood-pressure control in type 2 diabetes mellitus.

Collaborators (1238)

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, Rehman SU, Ham DB, North-Lee B, Baig HA, 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, Solomon 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, Gotto AM Jr, Bailey K, Gohdes D, Haffner S, Hiss R, Jamerson K, Lee K, Nathan D, Sowers J, Walters L.

Abstract

BACKGROUND:

There is no evidence from randomized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus. We investigated whether therapy targeting normal systolic pressure (i.e., <120 mm Hg) reduces major cardiovascular events in participants with type 2 diabetes at high risk for cardiovascular events.

METHODS:

A total of 4733 participants with type 2 diabetes were randomly assigned to intensive therapy, targeting a systolic pressure of less than 120 mm Hg, or standard therapy, targeting a systolic pressure of less than 140 mm Hg. The primary composite outcome was nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years.

RESULTS:

After 1 year, the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the standard-therapy group. The annual rate of the primary outcome was 1.87% in the intensive-therapy group and 2.09% in the standard-therapy group (hazard ratio with intensive therapy, 0.88; 95% confidence interval [CI], 0.73 to 1.06; P=0.20). The annual rates of death from any cause were 1.28% and 1.19% in the two groups, respectively (hazard ratio, 1.07; 95% CI, 0.85 to 1.35; P=0.55). The annual rates of stroke, a prespecified secondary outcome, were 0.32% and 0.53% in the two groups, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P=0.01). Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group (3.3%) and 30 of the 2371 participants in the standard-therapy group (1.3%) (P<0.001).

CONCLUSIONS:

In patients with type 2 diabetes at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events. (ClinicalTrials.gov number, NCT00000620.)

PMID:
20228401
PMCID:
PMC4123215
DOI:
10.1056/NEJMoa1001286
[Indexed for MEDLINE]
Free PMC Article

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