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N Engl J Med. 2012 Dec 6;367(23):2204-13. doi: 10.1056/NEJMoa1208799. Epub 2012 Nov 3.

Cardiorenal end points in a trial of aliskiren for type 2 diabetes.

Collaborators (817)

Viberti G, Lachin JM, Zinman B, Pedersen TR, Villamil AS, Juncos L, Prager R, Verpooten G, Zanella MT, Leiter L, Pan C, Wang H, Botero R, Cifkova R, Christiansen JS, Groop PH, Marre M, Haller H, Nickenig G, Siamopoulos K, Gero L, Maggioni A, Remuzzi G, Katayama SS, Kim SG, Petrulioniene Z, Lok D, Kooy A, Jorde R, Medina F, Polonia J, Wong KS, Dukat A, Rayner BL, Ruilope L, Weiss L, Wuethrich R, Sheu W, Sritara P, Comlekci A, Bilous R, Toto R, Jamerson K, Carillo E, Juncos L, Orias M, Kuschnir E, Rusculleda M, Garcia S, Farias E, Lema L, Hominal M, Montaña O, Sala J, Diaz M, Piskorz D, Vita N, Litwak L, Sinay I, Marin M, Massari P, Majul C, Aizemberg D, Azize GM, Bartolacci I, Reboredo A, Vico M, Milesi R, Sessa H, Wassermann A, Margulis F, Zangroniz P, Watschinger B, Prager R, Toplak H, Paulweber B, Drexel H, Francesconi C, Foeger B, Mayer G, Braun RK, Brath H, Gaal LV, Niepen PV, Persu A, Vercammen C, Vriese AD, Coucke F, Mathieu C, Fery F, Treille S, Meeus G, Acker KV, Scheen A, Tits J, Ruige J, Krzesinski JM, Hollanders G, Liénart F, Dendale P, Quinonez M, Arnouts P, Vanuytsel J, Zanella M, Mion D Jr, Forti A, Almeida F, Cunha R, de Paula RB, Brandao A, Rocha J, Krieger E, Feitosa G, Saraiva J, Martin J, Hissa MN, Schmid H, Felicio J, Sgarbi J, Oigman W, Bowering K, Garceau C, Berlingieri JC, Weisnagel SJ, Hardin P, Powell C, Turcot R, Muirhead N, Aronson R, Barima YT, Steele AW, Pandey S, Woo V, Cha J, Dattani D, Godin C, Gupta M, Leiter L, Saunders K, Tellier G, Ting R, Tobe S, Chouinard G, Schlosser R, Khandwala H, Ekoe JM, Harris SB, Pichette V, Lachance P, Ooi TC, Tildesley H, Barrett B, Cournoyer S, Lu J, Zhang H, Liu X, Yan S, Qi X, Li Q, Li H, Lv X, Yang J, Sun N, Xia W, Wang N, Tong N, Mei C, Gu S, Zhang J, Chen X, Li L, Su B, Wang L, Qiu M, Wu X, Liu Z, Jia W, Xu G, Dong J, Zhu D, Zhang M, Yan J, Liu B, Chen J, Fu J, Yan L, Zhan X, Zhong L, Yang T, Ma J, Xu M, Xu X, Shi B, Ji Q, Zhong H, He R, Yuan Z, Zhou Z, Lin H, Yang W, Ke Y, Li Q, Hong T, Franco C, Casas L, Triana A, Botero R, Jaramillo C, Hernandez E, Barrera C, Blanco D, Stipal R, Widimsky P, Dohnalova L, Komroskova M, Kvapil M, Belobradkova J, Tesar V, Cifkova R, Vodnansky P, Kocourkova B, Christiansen JS, Lervang HH, Perrild H, Rossing P, Oestergaard O, Juhl H, Thorsteinsson B, Snorgaard O, Urhammer S, Egstrup K, Tikkanen T, Helin K, Rinne J, Lahtela J, Strand J, Valtonen E, Saari M, Kananen K, Savela K, Marre M, Blacher J, Aldigier JC, Zaoui P, Fauvel JP, Gouet D, Valensi PE, Charpentier G, Marechaud R, Penfornis A, Ovize M, Kovalchuck AA, Haller H, Dellanna F, Schoen N, Groeschel W, Eickhoff F, Hanefeld M, Merke J, Rambausek M, Zimmermann U, Stuetz W, Vosskuehler A, Hevendehl G, Schax U, Lehmann G, Haack A, Hilgenberg J, Klausmann G, Adelberger V, Gessner S, Fiesselmann A, Oerter E, Hohenstatt T, Groeschel A, Behnke T, Sisting RT, Schoch D, Bieler T, Schleyer S, Altes U, Klepzig C, Rudofsky G, Mueller G, Burkhardt F, Reschke K, Senftleber I, Wiesweg CK, Herrmann HJ, Brandstetter R, Segner A, Nickenig G, Schmitt H, Rippert R, Goebel R, Schreibmueller F, Pencz I, Ott P, Siamopoulos K, Migdalis I, Pappas S, Pagkalos E, Yalouris A, Tsapas A, Maltezos E, Tentolouris N, Papadakis I, Ioannidis G, Goumenos D, Corona V, Gonzalez R, Haase F, Monterroso V, Sánchez V, Turcios E, Wyss F, Arango JL, Bako B, Deak L, Dömötör E, Dudas M, Fulop T, Kiss I, Koranyi L, Lengyel Z, Nyirati G, Oroszlan T, Aniko S, Vörös P, Kapocsi J, Wittmann I, Paragh G, Abraham G, Tandon N, Thomas N, Mohan V, Sahay R, Sethi B, Rao V, Kumar S, Chowdhury S, Dharmalingam M, Seshiah V, Bantwal G, Viswanathan V, Yajnik C, Adhikari P, Krishnan U, Varthakavi P, Hiremath J, Bhattacharyya A, Dani S, Modi KK, Glorioso N, Morosetti M, Veglio F, Perticone F, Dotta F, Quarello F, Sesti G, Aiello A, D'Ospina A, Giordano C, Novo S, Santoro A, Ferri C, Capuano V, Trimarco B, Tonolo G, Villa G, De Pellegrin A, Zanette G, Federici M, Aucello G, Piatti P, Vinciguerra A, Mannarino E, Taddei S, Filetti S, Grandaliano G, Marchionni N, Lambiase C, Locatelli F, Scanferla F, Lembo G, Leotta S, Mos L, Calatola P, Fogari R, David S, Pedrinelli R, Pignone AM, Cozzolino D, Bevilacqua MT, Catena C, Del Prato S, Cerasola G, Frontoni S, Falcone C, Porta A, Bonora E, Cocchi R, Fucili A, Frisinghelli A, Volpe M, Carugo S, Gambardella S, Spagnuolo V, Maglia G, D'Angelo AR, Corsi A, Limone PP, Guarnieri A, Ghigo E, Ronchi E, Ravera M, Scioli GA, Sekiguchi M, Aoki S, Ogawa Y, Seino H, Onishi Y, Tojo A, Narimiya M, Iwaita Y, Takeda H, Shimizu H, Yamada T, Kojima S, Zushi S, Kaneko S, Matsumoto A, Kajiyama S, Fujita H, Shikata K, Tone A, Matsubayashi S, Tanaka S, Sekigami T, Tatsukawa Y, Abe N, Kawahara K, Kasahara H, Maeda Y, Suzuki Y, Okamoto H, Tachi K, Yamada K, Uzu T, Itou T, Fukui T, Kim S, Kim Y, Cho W, Kwak I, Chae D, Oh H, Ha S, Shin Y, Cha D, Kim Y, Kim S, Kang S, Lim C, Song J, Kwon Y, Badariene J, Labutiniene IP, Zabuliene L, Poteliuniene V, Miglinas M, Kooy A, van den Meiracker AH, Gregoor PJ, Luik AJ, van Loon BJ, Feenstra HJ, Kaasjager HA, Viergever PP, Woittiez AJ, van Bemmel T, Lieverse AG, Simsek S, Gaillard CA, van der Zwaan C, Lok DJ, Spiering W, Nierop PR, Baggen MG, Leendert RJ, de Jong A, Leurs PB, Vincent HH, Wins EH, Voors AA, Ronner E, Heeg JE, van Hal JM, Boermans T, Feis WL, Mostard G, Bakker RC, Dunselman PH, Jorde R, Skeie S, Istad H, Skjelvan G, Gronert J, Tomala T, Gudnason S, Torvik DT, Risberg K, Abedini S, Cabrera W, Medina B, Medina F, Herrada B, Saavedra A, Polonia DJ, Providencia DL, Carvalho D, Vasconcelos MP, da Silva GF, Branco P, Gil DV, da Costa AG, da Silva PM, Arez L, Martins L, Birne R, Dzuponova J, Surovcikova M, Culak J, Dukat A, Filipova S, Andre I, Stevlik J, Uhliar R, Fabryova L, Benacka J, Koleny D, Szentivanyi M, Spisak V, Pella D, Pastrnakova E, Martinka E, Chua T, Wong KS, Lau T, Ng TG, Yeoh LY, Bhana SA, Rayner B, Wellmann H, Amod A, Ranjith N, Ahmed F, Rheeder P, Makan H, Naicker P, Podgorski G, De Teresa E, Olivan J, Fernandez VL, Povedano ST, Terns M, Ricart W, Gonzalez JM, Fernandez P, Parreño Lde T, Redon J, Parra J, Calvo C, Lopez I, Puig JG, Calle A, Garcia JC, Lopez JM, Jimenez ML, Fraile B, Perez JS, Nadal JJ, Guija E, Calviño J, Barrios V, Iglesias JN, Armario P, Garcia M, Aranda P, Brotons C, Ruilope L, Gomez P, Catelao AM, Cusachs AR, Sarro M, Martinez V, dell Valle MH, Trias F, Comas A, Salvador N, Martinez F, Hernandez F, Martinez J, Mateos C, Peral JL, Tolosana J, Sobrino J, Isart J, Vizcaino J, Vega FF, Zamorano JL, Bacariza M, Soubriet A, Fernández-Cruz A, Querejeta R, Leira VM, Iglesias FE, Ibrik O, Martin D, Nanclares MS, Mediavilla JD, Galceran JM, Lopez A, Muros T, Pascual J, Casalla F, Tornero F, Fernandez G, Weiss L, Pettersson P, Olsen H, Franke F, Stroembom U, Furuland H, Larnefelt H, Allemann Y, Krapf R, Wuethrich R, Gerber P, Munger R, Hayoz D, Graf HJ, Burnier M, Petrillo A, Batt R, Constam EN, Moccetti T, Bianda T, Rickli H, Bulliard C, Wu KD, Lin SH, Wu CJ, Sheu WH, Su SL, Chen SC, Chou CW, Lee CT, Yang TC, Chen HC, Sritara P, Sukonthasarn A, Sriratanasathavorn C, Eiam-Ong S, Supasyndh O, Chanchairujira T, Kitiyakara C, Comlekci A, Arici M, Usalan C, Guneri S, Koc M, Kalender B, Ates K, Gurgun C, Araz M, Demirbas B, Biernacki W, Calvert J, Eavis P, Kerrane J, Litchfield J, Middleton A, Roberts J, Simpson H, Charles H, Jardine A, Fisher M, Banerjee D, Gallen I, Gnudi L, Harvey J, O'Hare P, Vora J, Winocour P, Soran H, Browne D, Darko D, Mancebo JG, de Roa ER, Antepara N, Carrillo E, Berrizbeitia M, Guevara L, Pernalete N, Ontiveros C, Zigrang W, Blakney E, Rosenblit P, Weinstein R, Klaff L, Lipetz R, Busick E, Tung P, Cooperman M, Michael S, Sun CH, Hart T, Maddux A, Bowden R, East C, Arakaki R, Villafuerte B, Mamish Z, Mendez R, Connery L, Nour K, Wynne A, Busch R, Zamora B, Sachson R, Prasad J, Lasala G, Smith M, Fitz-Patrick D, Ruiz-Rivera L, Barranco E, Solomon R, Woolley A, Brown C, Freedman Z, Schmidt S, Pollock J, Ruddy M, Toto R, Kopyt NP, Bazzi A, Horowitz B, Feng W, Wahl T, Duprez D, Gilbert J, Steigerwalt S, Jacqmein J, Gorton S, Allison J 3rd, Pino J, Lock J, Leimbach W, Anderson J, Beacom M, Craig W, Gorson D, Kerstein H, Segal S, Downey H, Ledger G, McGill J, Gabriel J, Nolen T, Levinson L, Williams T, Levenson D, Lerman S, Minehart C, Agarwal N, Verma S, Valitutto M, Demetry K, Mersey J, Koeper D, Fanti P, Eng G, Jamerson K, Grimm R, Fagan T, Bajaj M, Katz L, Portnay G, Altschuller A, Desai V, Bilazarian S, Ipp E, Rodelas R, Burstein D, Berg J, Velez J, Lund R, Rekhi A, Martin E, Martin J, Robertson D, Singh N, Narayan P, Moustafa M, Lanier D, Seidner M, Phillips A, Vaughters B, Sprague A, Swartz S, Lopez R, Kumar J, Bressler P, Sadler L, Wise J, Kilbane A.

Author information

  • 1Department of Medical Endocrinology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. hhparving@dadlnet.dk

Abstract

BACKGROUND:

This study was undertaken to determine whether use of the direct renin inhibitor aliskiren would reduce cardiovascular and renal events in patients with type 2 diabetes and chronic kidney disease, cardiovascular disease, or both.

METHODS:

In a double-blind fashion, we randomly assigned 8561 patients to aliskiren (300 mg daily) or placebo as an adjunct to an angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker. The primary end point was a composite of the time to cardiovascular death or a first occurrence of cardiac arrest with resuscitation; nonfatal myocardial infarction; nonfatal stroke; unplanned hospitalization for heart failure; end-stage renal disease, death attributable to kidney failure, or the need for renal-replacement therapy with no dialysis or transplantation available or initiated; or doubling of the baseline serum creatinine level.

RESULTS:

The trial was stopped prematurely after the second interim efficacy analysis. After a median follow-up of 32.9 months, the primary end point had occurred in 783 patients (18.3%) assigned to aliskiren as compared with 732 (17.1%) assigned to placebo (hazard ratio, 1.08; 95% confidence interval [CI], 0.98 to 1.20; P=0.12). Effects on secondary renal end points were similar. Systolic and diastolic blood pressures were lower with aliskiren (between-group differences, 1.3 and 0.6 mm Hg, respectively) and the mean reduction in the urinary albumin-to-creatinine ratio was greater (between-group difference, 14 percentage points; 95% CI, 11 to 17). The proportion of patients with hyperkalemia (serum potassium level, ≥6 mmol per liter) was significantly higher in the aliskiren group than in the placebo group (11.2% vs. 7.2%), as was the proportion with reported hypotension (12.1% vs. 8.3%) (P<0.001 for both comparisons).

CONCLUSIONS:

The addition of aliskiren to standard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful. (Funded by Novartis; ALTITUDE ClinicalTrials.gov number, NCT00549757.).

Comment in

PMID:
23121378
[PubMed - indexed for MEDLINE]
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