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N Engl J Med. 2008 Sep 25;359(13):1343-56. doi: 10.1056/NEJMoa0804602. Epub 2008 Sep 2.

Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis.

Collaborators (445)

Pedersen TR, Rossebø AB, Gerdts E, Skjaerpe T, Holme I, Willenheimer R, Boman K, Wachtell K, Egstrup K, Kesäniemi YA, Gohlke-Bärwolf C, Nienaber C, Chambers J, Ray S, Brudi P, Malbecq W, Hassager C, Gundersen T, Julian D, Pocock SJ, Kjekshus J, Karlsen G, McPeters G, Andersen GS, Koskinen P, Puhakainen I, Ketter A, Esfahani HA, Meergans M, Farrelly N, Parish C, Larsen V, Boström H, Bergvall L, Wincott K, Abdulla J, Akrawi F, Berning J, Christensen KL, Clemmensen P, Dalsgaard D, Davidsen FJ, Dixen U, Dorph-Petersen A, Dodt KK, Egstrup K, Elming H, Engby B, Espersen G, Franow HK, Frederiksen M, Friis E, Glud TK, Grande P, Gøtzsche O, Haar D, Hansen D, Hansen JF, Hansen MG, Hassager C, Høfsten DE, Høst N, Iemming L, Jensen G, Jensen J, Jeppesen J, Kjaergaard J, Kjøller-Hansen L, Klausen IC, Korup E, Kristensen JE, Kristensen K, Larsen J, Lindvig K, May O, Melchior T, McNair A, Nielsen ES, Nielsen H, Nielsen JE, Niemann T, Olsen JF, Olsen ME, Ottesen M, Pedersen AT, Poulsen SH, Ralskiaer N, Rasmussen B, Rasmussen H, Rasmussen J, Rasmussen SL, Rosenberg J, Roseva-Nielsen N, Scheibel M, Schmidt EB, Schou M, Schultz K, Seibaek M, Sortsøe H, Stentebjerg SE, Svendsen TL, Sykulski R, Sørensen EV, Thomsen KK, Thorsen J, Tuxen C, Tveskov C, Ulriksen H, Ahonen J, Engblom E, Groundstroem K, Haapanen J, Jerkkola T, Jääskeläinen T, Kanniainen E, Kervinen H, Kervinen K, Kesäniemi AY, Kettunen P, Kettunen R, Kiilavuori K, Kuusisto J, Lilleberg J, Seppälä-Lindroos A, Melin J, Mustonen JN, Nikkilä M, Nurminen J, Pajari R, Peuhkurinen K, Raasakka P, Terho T, Tiensuu T, Turpeinen A, Utriainen SO, Uusimaa P, Vihinen T, Ylitalo A, Arenz J, Bahlmann E, Bangert M, Bauknecht C, Bea F, Berchem L, Berhardt P, Blessing E, Boldt LH, Borges AC, Boscher D, Brandt R, Breithardt G, Böhmeke T, Baar M, Diefenbach C, Doliva R, Drawert S, Droese K, Düngen HD, Edelmann F, Franzen O, Freyland M, Gadow J, Gehlhar S, Gerk U, Giokoglu K, Gohlke H, Gohlke-Bärwolf C, Guha M, Görnand L, Hafer A, Hamm C, Hartmann F, Hegeler C, Heitzer T, Horstkotte D, Jander N, Kaden F, Keweloh B, Kilkowski A, Knebel F, Kober G, Kokott N, Krekel NO, Kreuzer J, Kruck I, Kuhls S, Lange R, Lange SA, Lorenz HM, Lüdecke J, Mathey D, Mayer B, Mellwig KP, Moebes R, Münzel T, Nienaber C, Omran H, Osterziel KJ, Park JW, Petzsch M, Pinick P, Pomykaj T, Preusch M, Proskynitopoulos N, Rauch B, Rehders T, Reichert U, Reichl S, Reinicke H, Richter I, Sachs H, Salzer F, Sanad W, Schmidt A, Schmidt H, Schnabel A, Schneider C, Schofer J, Schramm A, Schreckenberg A, Schumacher A, Schunkert H, Schäfer J, Stangl K, Steven D, Strasser R, Tack C, Thuneke F, Troatz C, Tsogias G, Tübler T, von Olshausen K, Vahlhaus C, Viedt C, Weiler C, Werle M, Wichter T, Winkler R, Worth H, Wunderlich J, Zagoric Z, Colwell N, Crean PA, Crowley J, Foley DP, Moore DP, Vaughan CJ, Al-Ani A, Andersen K, Arntzen KH, Bjørnerheim R, Bonarjee VV, Bøhmer E, Davidsen ES, Eveborn GD, Falang JE, Fausa D, Frøland G, Gerdts E, Gradek G, Graven T, Grundtvig M, Grønvold T, Gundersen T, Halvorsen BA, Haug BK, Heskestad A, Hofsøy KA, Hole T, Høgalmen G, Ihlen H, Klemsdal TO, Klykken B, Knutsen KM, Koss A, Lem P, Lied A, Myhre ES, Nerdrum T, Ose A, Pedersen TR, Rossebø AB, Rød R, Samstad S, Semb AG, Sirnes PA, Skjelvan GK, Skjaerpe T, Snaprud TR, Stakkevold TI, Steine K, Tjønndal HA, Torvik D, Ugelstad TP, Undheim B, Vegsundvåg JA, von der Lippe A, von Rosen M, Vaage E, Walde N, Woie L, Waage K, Aakhus S, Aaser E, Agert G, Ahlberg G, Ahlström P, Andersson K, Andersson L, Aronsson T, Atmer B, Axelsson U, Backman C, Bandh S, Bartfay SE, Bastani H, Bech-Hanssen O, Berglund S, Bergström A, Bjuhr O, Blomgren J, Boman K, Broqvist M, Carlsson R, Cherfan P, deSilva K, Diderholm E, Digerfeldt C, Dilan A, Ebrahimi A, Ellström J, Ercegovac V, Eskilsson J, Falk L, Fredholm O, Fredlund BO, Fredriksson B, Frisk M, Gustafsson G, Gustafsson PE, Hammar C, Henriksson A, Henriksson P, Herlitz J, Hjelmaeus L, Höglund C, Illés L, Jansson JH, Jensen-Urstad M, Johansson J, Johansson L, Jonson T, Juhlin T, Juhlin-Dannfelt A, Juntti-Larsson L, Karlsson F, Klintberg L, Kronvall T, Kvidal P, Kåregren A, Larsson AC, Liljedahl S, Lindberg R, Linde B, Lycksell M, Löfdahl P, Lönnberg I, Martinsson A, Modica A, Mooe T, Moström PA, Nielsen NE, Nilsson O, Noberius F, Näslund U, Nyman P, Ohlsson-Onerud A, Olsson SE, Pedersen K, Persson B, Randers F, Risenfors M, Rodmar K, Roijer A, Rydberg E, Rüter G, Sandgren S, Schaufelberger M, Serban D, Shams B, Svennberg L, Svensson K, Svensson O, Szecsödy P, Thollander J, Ticic D, Tolagen K, Trivic Z, Tygesen H, Ulvenstam G, Viklund J, Wedén U, Wiberg S, Willenheimer R, Wodlin P, Zethson-Halldén ML, Zlatewa R, Ohlin H, Aberg J, Adams P, Anantharam B, Behan M, Boon N, Brookes C, Campbell N, Capps N, Chalal N, Chambers J, Clesham G, Davidson C, Dutka D, Findlay I, Fraser AG, Glover J, Goodfield N, Grapsa J, Haq I, Hildick-Smith D, Howarth B, Howarth P, Kadr H, Kneale B, Kumar P, Lewis PS, Liodakis M, Lloyd G, McKeown P, McLeod A, McMurray J, Nihoyannopoulos P, Ray S, Senior R, Taggu W, Veasey R, Walker D.

Author information

  • 1Division of Cardiology, Aker University Hospital, Trondheimsveien 235, N-0514 Oslo, Norway. anne@rossebo.net

Abstract

BACKGROUND:

Hyperlipidemia has been suggested as a risk factor for stenosis of the aortic valve, but lipid-lowering studies have had conflicting results.

METHODS:

We conducted a randomized, double-blind trial involving 1873 patients with mild-to-moderate, asymptomatic aortic stenosis. The patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily. The primary outcome was a composite of major cardiovascular events, including death from cardiovascular causes, aortic-valve replacement, nonfatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary-artery bypass grafting, percutaneous coronary intervention, and nonhemorrhagic stroke. Secondary outcomes were events related to aortic-valve stenosis and ischemic cardiovascular events.

RESULTS:

During a median follow-up of 52.2 months, the primary outcome occurred in 333 patients (35.3%) in the simvastatin-ezetimibe group and in 355 patients (38.2%) in the placebo group (hazard ratio in the simvastatin-ezetimibe group, 0.96; 95% confidence interval [CI], 0.83 to 1.12; P=0.59). Aortic-valve replacement was performed in 267 patients (28.3%) in the simvastatin-ezetimibe group and in 278 patients (29.9%) in the placebo group (hazard ratio, 1.00; 95% CI, 0.84 to 1.18; P=0.97). Fewer patients had ischemic cardiovascular events in the simvastatin-ezetimibe group (148 patients) than in the placebo group (187 patients) (hazard ratio, 0.78; 95% CI, 0.63 to 0.97; P=0.02), mainly because of the smaller number of patients who underwent coronary-artery bypass grafting. Cancer occurred more frequently in the simvastatin-ezetimibe group (105 vs. 70, P=0.01).

CONCLUSIONS:

Simvastatin and ezetimibe did not reduce the composite outcome of combined aortic-valve events and ischemic events in patients with aortic stenosis. Such therapy reduced the incidence of ischemic cardiovascular events but not events related to aortic-valve stenosis. (ClinicalTrials.gov number, NCT00092677.)

2008 Massachusetts Medical Society

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