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N Engl J Med. 2016 May 26;374(21):2021-31. doi: 10.1056/NEJMoa1600176. Epub 2016 Apr 2.

Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease.

Collaborators (440)

Alzogaray M, Aparici M, Berli M, Bevacqua M, Bustamante Labarta M, Bustos B, Caccavo A, Candiello A, Carignano M, Carrillo N, Carro N, Cartasegna L, Casali W, Cassettari A, Centeno M, Cuello J, Cusimano S, Cuneo C, Duran R, Damonte C, De Landaluc M, De Martino E, Diez R, Duran R, Fernandez A, Ferrari A, Forti L, Galello M, Garcia C, Giachello F, Garrido M, Gonzalez M, Guerlloy F, Guerrero R, Hrabar A, Imposti H, Hominal M, Liniado G, Lanchiotti P, Laugle C, Liniado G, Litvak MR, Longhi A, Luciardi H, Mackinnon I, Marino J, Manzano R, Merlo B, Milesi R, Molina de Salazar DI, Mulazzi C, Nemi S, Orio S, Pelaggage M, Raimondi S, Rodino L, Rodriguez A, Rodriguez C, Rodriguez D, Sago L, Sala J, Sanchez A, Sanchez R, Santos D, Schygiel P, Sernia V, Smith T, Sokn F, Soso L, Trivi M, Vico M, Vilamajo O, Villamil A, Vogel D, Zaidman C, Abhayaratna W, Canalese J, Krum H, Patel A, Alves AR Jr, Alves CB, Ayoub JC, Bergoli LC, Blacher MG, Bodanese LC, Braga JC, Brasil CK, Costa MK, Costa OM, de Faria DG, Del Monaco MI, Fabian Restelatto L, Filho F, Franco RJ, Furtado MV, Leaes PE, Maia LN, MarinNeto JA, Martins AP, Mattar ET, Melo CM, Mothe FS, Oliveira GB, Oliveira LF, Pelloso E, Polanczyk CA, Rosa PR, Sales SO, Saraiva JF, Schmidt A, Silva VS, Sousa AC, Valle A, Wiehe M, Abramson B, Anand S, Aw J, Baxter W, Berlingieri J, Cha J, Chaulk R, Chetty T, Dagenais G, Dattani D, Delage F, Dion D, Dominguez M, Gallo R, Glendinning K, Goldman H, Gosselin G, Greenspoon A, Hungly Q, Juneau M, Keegan P, Kelly A, Kilby D, Lavoie M, Leiter LA, Lonn E, Magloire P, Mehta P, Mercante N, Miscescu H, Moran G, Nawaz S, Nigam A, Pang P, Papp E, Petrella R, Poirier C, Rabasa-Lhoret R, Rizvi Q, Saulnier D, Sharma M, Sohal P, Stern S, Tobe S, Walsh P, Ward R, Weeks A, Woo V, Yellin J, Zuliani P, Bai XJ, Dong LG, Feng JZ, Fu P, Gao P, Gao MM, Ge H, Hu SP, Hua Q, Li DJ, Liu ZD, Liu YJ, Liu XL, Liu LH, Liu FY, Lu FH, Lv T, Ma H, Ma SP, Man RH, Shen Y, Shi JF, Sun XD, Wang B, Wang SY, Wang YN, Wang YQ, Wei YJ, Yang HS, Yang XC, Yu JH, Yu K, Yu LT, Zhang B, Zhang F, Zhang HY, Zhang L, Zhang W, Zhao JG, Zhao Y, Zhong BX, Accini J, Aroca G, Arcos E, Accini-Valencia M, Casanova M, Celemin C, Coronel BJ, Cotes C, Cure C, Duarte A, Escobar D, Figueredo M, Garcia H, Garcia L, Grisales M, Hernandez Z, Molina de Salazar D, Martinez K, Nino Castellanos B, Diego-Olite M, Ospina Rendon N, Posada I, Quintero A, Quiros F, Sanchez G, Sotomayor A, Suarez M, Urina M, Adamkova V, Cifkova R, Ferkl R, Galovcova M, Hartman J, Jozifova M, Linhart K, Linhart T, Moravcikova D, Nussbaumerova B, Plachy M, Rosolova H, Seifert B, Soucek M, Duarte Vera Y, Espinel M, Lopez-Jaramillo M, McDermont J, Penaherrera E, Plascencia F, Pow-Chon-Long F, Tettamanti D, Bajnok L, Baranyi E, Bartfai E, Bod E, Bodis B, Czuriga I, Huber E, Mezosi E, Poor F, Somos E, Tarjanyi Z, Tatrai T, Tomcsanyi J, Vertes A, Zsary A, Aggarwal DK, Alexander KG, Aman S, Arun, Ayyar V, Balaji Y, Balasubramanian E, Bantwal G, Bhalvishiya Y, Bosco B, Chidambaram N, Dabra A, Daniel S, Deshpande N, Devendra HR, Ghoshroy D, Gnanasekaran S, Gupta R, Gutti MZ, Jayakumar P, Joshi G, Joshi S, Kalantri SP, Kapoor A, Khan A, Khedar R, Kishore J, Kumar A, Kumar S, Kumaravel, Manjunath AR, Mehta K, Mohan V, Murthy S, Nambiar A, Narendra J, Paul SK, Qureshi MA, Rajasekaran S, Ramu M, Ranka RL, Rangadham K, Roy S, Sathyanarayan MR, Selvam K, Sethuraman JP, Shabhasane D, Shivaraj K, Shunmugvavelu M, Sidhu G, Singh B, Singh R, Srinivas A, Srinivas J, Srinivasulu B, Thomas N, Umarani R, Varghese K, Varma S, Yelvatkar S, Biton A, Goldhaber A, Ivri S, Shapiro I, Shveydel E, Shveydel N, Tsalihin D, Vinker S, Yosefy H, Kim S, Choe KH, Ambigga D, Aris MA, Ghapar KA, Krishnan C, Mahadasa P, Maizatullifah M, Mazapuspavina Y, Ramanathan L, Shah A, Yusoff K, Bonarius JH, De Jong A, DeRuiter Z, DeVos R, Dirkse HA, Drenth E, Ferguson H, Jansen R, Mevissen H, Rol H, Schilder A, Spelt I, VanLeeuwen P, Abola M, Co H, Loyola A, Mercado J, Morales D, Padua L, Palileo L, Patanao A, Rogelio G, Roxas A, Sulit D, Tang-Manga A, Tumanan-Mendoza B, Boytsov S, Chukaeva I, Karpov Y, Kisliak O, Kobalava Z, Ledyacva A, Lopatin Y, Nedogoda S, Solovieva M, Tsoma V, Tyurina T, Hranai M, Badat A, Gerntholtz T, Sliwa K, Al-Khalili F, Carlberg B, Dotevall A, Nilsson P, Olsson A, Rosengren A, Soderberg S, Khunti K, Loke I, Toff WD, Artomov D, Babanina T, Bagriy A, Chobotko G, Danyliuk S, Doretska N, Dorovska O, Dovgan N, Dzyak G, Glushko L, Gorbas I, Ilashchuk T, Karapetyan K, Karavanska I, Khimion L, Khorsun A, Kononenko L, Kuryata O, Kvasha O, Lazareva S, Loktyev D, Lysenko G, Martynyuk V, Miroshnchenko N, Onyschenko O, Petryk N, Pivovarova S, Rakytskay I, Sapozhnychenko L, Smymova I, Soya O, Tashchuk V, Turubarova-Leunova N, Vasilyeva L, Velichko N, Yagensky A, Zborovskyy S, Zhurba S.

Author information

1
From the Population Health Research Institute, Hamilton Health Sciences (S.Y., J.B., R.M., J.P., H.J., P.G., E.L.), Departments of Medicine (S.Y., R.M., E.L.) and Clinical Epidemiology and Biostatistics (J.P.), and School of Rehabilitation Science (J.B.), McMaster University, Hamilton, ON, Institut Universitaire de Cardiologie et Pneumologie de Québec, Université Laval, Quebec, QC (G.D.), and Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - all in Canada; Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (J.Z., L.L.); St. John's Medical College (D.X.) and St. John's Research Institute (D.X., P.P.), Bangalore, India; Fundacion Oftalmológica de Santander and Instituto Masira, Medical School, Universidad de Santander, Bucaramanga (P.L.-J.), and University of Quindio, Armenia (G.S.-V.) - both in Colombia; College of Medicine, University of the Philippines, Manila (A.D.); Dante Pazzanese Institute of Cardiology (A.A.) and HCor-Heart Hospital (L.S.P.), São Paulo; Institute of Cardiology, Kiev, Ukraine (A.P.); Hungarian Institute of Cardiology, Semmelweis University, Budapest (K. Keltai, M.K.); Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, University of Cape Town, Soweto Cardiovascular Research Group, Cape Town, South Africa (K.S.); Department of Cardiology, Academic Medical Center, Amsterdam (R.J.G.P); Department of Medical Sciences, Cardiology, Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Institute of Clinical Cardiology in the Russian Cardiology Research Complex, Moscow (I.C.); Universiti Teknologi Majlis Amansh Rakyat, Selayang, and University College Sedaya International University, Kuala Lumpur - both in Malaysia (K.Y.); Lady Davis Carmel Medical Center, Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Haifa (B.S.L.); Universi

Abstract

BACKGROUND:

Previous trials have shown that the use of statins to lower cholesterol reduces the risk of cardiovascular events among persons without cardiovascular disease. Those trials have involved persons with elevated lipid levels or inflammatory markers and involved mainly white persons. It is unclear whether the benefits of statins can be extended to an intermediate-risk, ethnically diverse population without cardiovascular disease.

METHODS:

In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants in 21 countries who did not have cardiovascular disease and were at intermediate risk to receive rosuvastatin at a dose of 10 mg per day or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally included revascularization, heart failure, and resuscitated cardiac arrest. The median follow-up was 5.6 years.

RESULTS:

The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the rosuvastatin group than in the placebo group. The first coprimary outcome occurred in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91; P=0.002). The results for the second coprimary outcome were consistent with the results for the first (occurring in 277 participants [4.4%] in the rosuvastatin group and in 363 participants [5.7%] in the placebo group; hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P<0.001). The results were also consistent in subgroups defined according to cardiovascular risk at baseline, lipid level, C-reactive protein level, blood pressure, and race or ethnic group. In the rosuvastatin group, there was no excess of diabetes or cancers, but there was an excess of cataract surgery (in 3.8% of the participants, vs. 3.1% in the placebo group; P=0.02) and muscle symptoms (in 5.8% of the participants, vs. 4.7% in the placebo group; P=0.005).

CONCLUSIONS:

Treatment with rosuvastatin at a dose of 10 mg per day resulted in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically diverse population without cardiovascular disease. (Funded by the Canadian Institutes of Health Research and AstraZeneca; HOPE-3 ClinicalTrials.gov number, NCT00468923.).

PMID:
27040132
DOI:
10.1056/NEJMoa1600176
[Indexed for MEDLINE]

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