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N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.

A Randomized Trial of Intensive versus Standard Blood-Pressure Control.

Collaborators (844)

Wright JT Jr, Cushman W, Oparil S, Cheung AK, Rocco M, Reboussin DM, Fine L, Kimmel P, Ryan L, Launer L, Moy C, Whelton P, Johnson KC, Bild D, Bonds D, Cook N, Cutler J, Fine L, Kaufmann P, Kimmel P, Launer L, Moy C, Riley W, Ryan L, Snyder J, Tolunay E, Yang S, Wright JT Jr, Rahman M, Lerner AJ, Rahman M, Still C, Wiggers A, Zamanian S, Bee A, Dancie R, Cushman W, Wall B, Nichols L, Burns R, Martindale-Adams J, Berlowitz D, Clark E, Walsh S, Geraci T, Huff C, Shaw L, Oparil S, Lewis CE, Bradley V, Calhoun D, Glasser S, Jenkins K, Ramsey T, Cheung AK, Beddhu S, Chelune G, Childs J, Gren L, Randall A, Rocco M, Goff D, Rodriguez C, Coker L, Hawfield A, Yeboah J, Crago L, Summerson J, Hege A, Reboussin D, Williamson J, Ambrosius W, Applegate W, Evans G, Foy C, Freedman B, Kitzman D, Legault C, Lyles M, Pajewski N, Rapp S, Rushing S, Shah N, Sink KM, Vitolins M, Wagenknecht L, Wilson V, Perdue L, Woolard N, Craven T, Garcia K, Gaussoin S, Lovato L, Newman J, Amoroso B, Davis P, Griffin J, Harris D, King M, Lane K, Roberson W, Steinberg D, Ashford D, Babcock P, Chamberlain D, Christensen V, Cloud L, Collins C, Cook D, Currie K, Felton D, Harpe S, Howard M, Lewis M, Nance P, Perdue L, Puccinelli-Ortega N, Russell L, Walker J, Craven B, Goode C, Troxler M, Davis J, Hutchens S, Killeen AA, Lukkari AM, Ringer R, Dillard B, Archibeque N, Warren S, Sather M, Pontzer J, Taylor Z, Soliman EZ, Zhang ZM, Li Y, Campbell C, Hensley S, Hu J, Keasler L, Barr M, Taylor T, Bryan R, Davatzikos C, Nasarallah I, Desiderio L, Elliott M, Borthakur A, Battapady H, Erus G, Smith A, Wang Z, Doshi J, Townsend R, Cohen D, Huan Y, Duckworth M, Ford V, Sexton K, Wright JT Jr, Lerner A, Rahman M, Still C, Bee A, Stokes DL, Smith S, Sunshine J, Clampitt M, Smith S, Welch B, Donahue M, Dagley A, Pennell D, Cannistraci C, Merkle K, Lewis J, Sika M, Wright C, Sabati M, Campuzano E, Martin H, Roman A, Cruz J, Nagornaya N, Coker L, Hege A, Maldjian J, Kaminsky S, Fuller D, Jung Y, Oparil S, Lewis B, Wadley V, Jenkins K, Ramsey T, Evanochko W, Roberson G, Corbitt T, Fisher W, Clements C, Weiner D, Wells A, Civiletto A, Aurigemma GP, Bodkin N, Norbash A, Lavoye M, Ellison A, Killiany R, Sakai O, Cheung A, Ambrosius W, Berlowitz D, Cushman W, Lewis B, Oparil S, Wright JT Jr, Goff D, Sink K, Williamson J, Oparil S, Lewis CB, Glasser S, Bhatt U, Horwitz E, Navaneethan S, Rocco M, Hawfield A, Rodriguez C, Diamond M, Contreras G, Yeboah J, Muhlestein JB, Dwyer J, Weiner D, Simmons D, Chonchol M, Kramer H, Bates J, Servilla K, Slinin Y, Kirchner K, Fanti P, Wright C, Auchus A, Lerner A, Malik A, Asdaghi N, Kitzman D, Freedman B, Papademetriou V, Rehman S, Chapman A, Thomas G, Schreiber M Jr, Navaneethan SD, Hickner J, Lioudis M, Lard M, Marczewski S, Maraschky J, Colman M, Aaby A, Payne S, Ramos M, Horner C, Rahman M, Drawz P, Raghavendra PP, Ober S, Mourad R, Pallaki M, Russo P, Raghavendra P, Fantauzzo P, Tucker L, Schwing B, Sedor JR, Horwitz EJ, Schellling JR, O'Toole JF, Humbert L, Tutolo W, White S, Gay A, Clark W Jr, Hughes R, Wright JT Jr, Dobre M, Still CH, Bee A, Williams M, Bhatt U, Hebert L, Agarwal A, Murphy MB, Ford N, Stratton C, Baxter J, Lykins AA, Neal AM, Hirmath L, Kwame O, Soe K, Miser WF, Sagrilla C, Johnston J, Anaya A, Mintos A, Howell AA, Rogers K, Taylor S, Ebersbacher D, Long L, Bednarchik B, Wiggers A, Long L, Schnall A, Smith J, Peysha L, Peysha L, Bednarchik B, Leach L, Tribout M, Harwell C, Ellington P, Banerji MA, Ghody P, Rambaud MV, Townsend R, Cohen D, Huan Y, Duckworth M, Ford V, Leshner J, Davison A, Vander Veen S, Gadegbeku CA, Gillespie A, Paranjape A, Amoroso S, Pfeffer Z, Quinn SB, He J, Chen J, Lustigova E, Malone E, Krousel-Wood M, Deichmann R, Ronney P, Muery S, Trapani D, Diamond M, Mulloy L, Hodges M, Collins M, Weathers C, Anderson H, Stone E, Walker W, McWilliams A, Dulin M, Kuhn L, Standridge S, Lowe L, Everett K, Preston K, Norton S, Gaines S, Rizvi AA, Sides AW, Herbert D, Hix MM, Whitmire M, Arnold B, Hutchinson P, Espiritu J, Feinglos M, Kovalik E, Gedon-Lipscomb G, Evans K, Thacker C, Zimmer R, Furst M, Mason M, Powell J, Bolin P, Zhang J, Pinion M, Davis G, Bryant W, Phelps P, Garris-Sutton C, Atkinson B, Contreras G, Suarez M, Schulman I, Koggan D, Vassallo J, Peruyera G, Rocco M, Hawfield A, Bethea C, Mayer S, Gilliam L, Pedley C, Zurek G, Baird M, Smoak MM, Williams J, Rogers S, Gordon L, Kennedy E, Belle B, McCorkle-Doomy J, Adams J, Chamberlain D, Lopez R, Janavs J, Rahbari-Oskoui F, Chapman A, Dollar A, Williams O, Han Y, Haley W, Fitzpatrick P, Blackshear J, Shapiro B, Harrell A, Palaj A, Henderson K, Johnson A, Gonzalez H, Robinson J, Tamariz L, Schulman I, Denizard J, Barakat R, Krishnamoorthy D, Greenway F, Monce R, Church T, Hendrick C, Yoches A, Sones L, Baltazar M, Pemu P, Jones C, Akpalu D, Dember L, Soares D, Yee J, Umanath K, Ogletree N, Thaxton S, Campana K, Sheldon D, MacArthur K, Muhlestein J, Allred N, Clements B, Dhar R, Meredith K, Le V, Miner E, Orford J, Riessen ER, Ballantyne B, Chisum B, Johnson K, Peeler D, Chertow G, Tamura M, Chang T, Erickson K, Shen J, Stafford RS, Zaharchuk G, Del Cid M, Dentinger M, Sabino J, Sahay R, Telminova EK, Weiner DE, Sarnak M, Chan L, Civiletto A, Heath A, Kantor A, Jain P, Kirkpatrick B, Well A, Yuen B, Chonchol M, Farmer B, Farmer H, Greenwald C, Malaczewski M, Lash J, Porter A, Ricardo A, Rosman RT, Cohan J, Barrera NL, Meslar D, Meslar P, Conroy MM, Unruh M, Hess R, Jhamb M, Thomas H, Fazio P, Klixbull E, Komlos-Weimer M, Mandich L, Vita T, Toto R, Van Buren P, Inrig J, Cruz M, Lightfoot T, Wang N, Webster L, Beddhu S, Raphael K, Stults B, Zaman T, Simmons D, Lavasani T, Filipowicz R, Wei G, Miller GM, Harerra J, Christensen J, Giri A, Chen X, Anderton N, Jensen A, Lewis J, Burgner A, Dwyer JP, Schulman G, Herrud T, Leavell E, McCray T, McNeil-Simaan E, Poudel M, Reed M, Sika M, Woods D, Zirkenbach JL, Raj DS, Cohen S, Patel S, Velasquez M, Bastian RS, Wing M, Roy-Chaudhury A, Depner T, Dalyrymple L, Kaysen G, Anderson S, Beddhu S, Nord J, Simmons D, Miller GM, Harerra J, Giri A, Ix JH, Goldenstein L, Miracle CM, Forbang N, Mircic M, Thomas B, Tran T, Rastogi A, Kim M, Rashid M, Lizarraga B, Hocza A, Sarmosyan K, Norris J, Sharma T, Chioy A, Bernard E, Cabrera E, Lopez C, Nunez S, Riad J, Schweitzer S, Sirop S, Thomas S, Wada L, Kramer H, Bansal V, Taylor CE, Segal MS, Hall KL, Kazory A, Gilbert L, Owens L, Poulton D, Whidden E, Blaum C, Wiggins JJ, Gure T, Nyquist L, Robinson E, Qureshi N, Ferguson K, Haider S, James M, Jones C, Renfroe K, Seay A, Weigart C, Thornley-Brown D, Rizik D, Cotton B, Fitz-Gerald M, Grimes T, Johnson C, Kennedy S, Mason C, Rosato-Burson L, Willingham R, Calhoun D, Judd E, Breaux-Shropshire T, Cook F, Medina J, Lewis J, Brantley R, Brouilette J, Glaze J, Hall S, Hiott N, Tharpe D, Boddy S, Mack C, Johnson KC, Womack C, Griffin B, Hendrix C, Johnson K, Jones L, Towers C, Punzi H, Cassidy K, Schumacher K, Irizarry C, Colon I, Colon-Ortiz P, Colon-Hernandez P, Carrasquillo M, Vazquez N, Sosa-Padilla M, Cintron-Pinero A, Ayala M, Pacheco O, Rivera C, Sotomayor-Gonzalez I, Claudio J, Lazaro J, Arce M, Heres L, Perez A, Tavarez-Valle J, Arocho F, Torres M, Vazquez M, Aurigemma GP, Takis-Smith R, Andrieni J, Bodkin N, Chaudhary K, Hu P, Kostis J, Cosgrove N, Bankowski D, Boleyn M, Casazza L, Giresi V, Patel T, Squindo E, Wu Y, Wofford M, Flessner M, Adair C, Asher J, Loope D, Cobb R, Venegas R, Bigger T, Donovan D, Lopez-Jimenez C, Tirado A, Bigger T, Getaneh A, Tang R, Durant S, Bigger T, Maurer M, Teruya S, Helmke S, Alvarez J, Campbell R, Pisoni R, Sturdivant R, Counts C, Hunt V, Spillers L, Brautigam D, Kitchen T, Gorman T, Sayers J, Button S, Chiarot J, Fischer R, Lyon M, Resnick M, Servilla K, Vigil D, Barrett T, Sweeney ME, Johnson R, McConnell S, Salles KS, Watson F, Schenk C, Whittington L, Maher M, Williams J, Swartz S, Conlin P, Alexis G, Lamkin R, Underwood P, Gomes H, Rosendorff C, Atlas S, Kwon L, Matar M, Pisoni R, Basile J, John J, Ham D, Baig H, Saklayen M, Yap J, Neff H, Miller C, Zheng-Phelan L, Gappy S, Rau S, Raman A, Berchou V, Jones E, Olgren E, Yudd M, Sastrasinh S, Michaud J, Fiore J, Kutza M, Shorr R, Mount R, Thoms J, Dunn H, Stinson S, Hunter J, Taylor A, Bates J, Anderson C, Kirchner K, Stubbs J, Hinton A, Spencer AK, Sharma S, Wiegmann T, Mehta S, Krause M, Dishongh K, Wall B, Childress R, Cushman W, Gyamlani G, Niakan A, Thompson C, Moody J, Whittle J, Barnas G, Wolfgram D, Cortese H, Johnson J, Roumie C, Hung A, Wharton J, Niesner K, Katz L, Richardson E, Brock G, Holland J, Dixon T, Zias A, Spiller C, Baker P, Felicetta J, Rehman S, Bingham K, Watnick S, Weiss J, Johnston T, Giddings S, Klein A, Rowe C, Vargo K, Waidmann K, Papademetriou V, Elkhoury JP, Gregory B, Amodeo S, Bloom M, Goldfarb-Waysman D, Treger R, Knibloe K, Ishani A, Slinin Y, Olney C, Rust J, Fanti P, Bansal S, Dunnam M, Dyer C, Hu LL, Zarate-Abbott P, Appel L, Breitner J, Davis B, Dworkin L, Johnston K, Neaton J, Taylor A, Weir M, Yancy C.

Abstract

BACKGROUND:

The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain.

METHODS:

We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.

RESULTS:

At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P=0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group.

CONCLUSIONS:

Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01206062.).

PMID:
26551272
PMCID:
PMC4689591
DOI:
10.1056/NEJMoa1511939
[Indexed for MEDLINE]
Free PMC Article

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