Efficacy, safety, tolerability, and pharmacokinetic profile of evacetrapib administered as monotherapy or in combination with atorvastatin in japanese patients with dyslipidemia

American Journal of Cardiology

Volumn 113, Issue 12, 2014, Pages 2021-2029

  Teramoto, Tamio ^a   Takeuchi, Masakazu ^b   Morisaki, Yoji ^b   Ruotolo, Giacomo ^b   Krueger, Kathryn A ^b  

^a TEIKYO UNIVERSITY   (Japan)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALDOSTERONE; ASPARTATE AMINOTRANSFERASE; ATORVASTATIN; BICARBONATE; BILE ACID SEQUESTRANT; BIOLOGICAL MARKER; CHOLESTEROL ESTER TRANSFER PROTEIN; EVACETRAPIB; EZETIMIBE; GLUCOCORTICOID; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROCORTISONE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; ICOSAPENTAENOIC ACID ETHYL ESTER; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MINERALOCORTICOID; PLACEBO; POTASSIUM; SODIUM;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALDOSTERONE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BICARBONATE BLOOD LEVEL; BLOOD PRESSURE; BLOOD SAMPLING; CHOLESTEROL BLOOD LEVEL; CONTROLLED STUDY; DIET THERAPY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DYSLIPIDEMIA; ENZYME ACTIVITY; FEMALE; FEVER; FRACTURE; GASTROENTERITIS; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYPERCHOLESTEROLEMIA; JAPANESE (PEOPLE); LIVER DYSFUNCTION; LUNG INJURY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MONOTHERAPY; MULTICENTER STUDY; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SKIN DISEASE; SODIUM BLOOD LEVEL; SPINE FRACTURE; TREATMENT DURATION;

ADULT; ANTICHOLESTEREMIC AGENTS; BENZODIAZEPINES; CHOLESTEROL ESTER TRANSFER PROTEINS; CHOLESTEROL, HDL; CHOLESTEROL, LDL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; FEMALE; FOLLOW-UP STUDIES; HEPTANOIC ACIDS; HUMANS; JAPAN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PYRROLES; REFERENCE VALUES; RISK ASSESSMENT; TREATMENT OUTCOME;

EID: 84901434197     PISSN: 00029149     EISSN: 18791913     Source Type: Journal    
DOI: 10.1016/j.amjcard.2014.03.045     Document Type: Article

References (18)

1. P.J. Barter, M. Caulfield, M. Eriksson, S.M. Grundy, J.J. Kastelein, M. Komajda, J. Lopez-Sendon, L. Mosca, J.C. Tardif, D.D. Waters, C.L. Shear, J.H. Revkin, K.A. Buhr, M.R. Fisher, A.R. Tall, and B. Brewer Effects of torcetrapib in patients at high risk for coronary events N Engl J Med 357 2007 2109 2122
2. A.M. Gotto Jr., C.P. Cannon, X.S. Li, S. Vaidya, U. Kher, E.A. Brinton, M. Davidson, J.E. Moon, S. Shah, H.M. Dansky, Y. Mitchel, and P. Barter Evaluation of lipids, drug concentration, and safety parameters following cessation of treatment with the cholesteryl ester transfer protein inhibitor anacetrapib in patients with or at high risk for coronary heart disease Am J Cardiol 113 2014 76 83
3. T. Teramoto, M. Shirakawa, M. Kikuchi, M. Nakagomi, S. Tamura, H.K. Surks, S.C. McCrary, and H. Numaguchi Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with dyslipidemia Atherosclerosis 230 2013 52 60
4. G. Cao, T.P. Beyer, Y. Zhang, R.J. Schmidt, Y.Q. Chen, S.L. Cockerham, K.M. Zimmerman, S.K. Karathanasis, E.A. Cannady, T. Fields, and N.B. Mantlo Evacetrapib is a novel, potent, and selective inhibitor of cholesteryl ester transfer protein that elevates HDL cholesterol without inducing aldosterone or increasing blood pressure J Lipid Res 52 2011 2169 2176
5. Nakano M, Morisaki Y, Friedrich S, James D, Nasu R, Takeuchi M, and Suico J.G. Safety, tolerability, and pharmacodynamics of evacetrapib in healthy Japanese. The 44th Annual Scientific Meeting of the Japan Atherosclerosis Society HS-30 p 206. 2012.
6. S.J. Nicholls, H.B. Brewer, J.J. Kastelein, K.A. Krueger, M.D. Wang, M. Shao, B. Hu, E. McErlean, and S.E. Nissen Effects of the CETP inhibitor evacetrapib administered as monotherapy or in combination with statins on HDL and LDL cholesterol: a randomized controlled trial JAMA 306 2011 2099 2109
7. T. Teramoto, J. Sasaki, H. Ueshima, G. Egusa, M. Kinoshita, K. Shimamoto, H. Daida, S. Biro, K. Hirobe, T. Funahashi, K. Yokote, and M. Yokode Risk factors of atherosclerotic diseases. Executive summary of Japan Atherosclerosis Society (JAS) guideline for diagnosis and prevention of atherosclerosis cardiovascular diseases for Japanese J Atheroscler Thromb 14 2007 267 277
8. C.P. Cannon High-density lipoprotein cholesterol as the Holy Grail JAMA 306 2011 2153 2155
9. S.J. Nicholls, E.M. Tuzcu, D.M. Brennan, J.C. Tardif, and S.E. Nissen Cholesteryl ester transfer protein inhibition, high-density lipoprotein raising, and progression of coronary atherosclerosis: insights from ILLUSTRATE (Investigation of Lipid Level Management Using Coronary Ultrasound to Assess Reduction of Atherosclerosis by CETP Inhibition and HDL Elevation) Circulation 118 2008 2506 2514
10. S.E. Nissen, J.C. Tardif, S.J. Nicholls, J.H. Revkin, C.L. Shear, W.T. Duggan, W. Ruzyllo, W.B. Bachinsky, G.P. Lasala, and E.M. Tuzcu Effect of torcetrapib on the progression of coronary atherosclerosis N Engl J Med 356 2007 1304 1316
11. L. Yvan-Charvet, F. Matsuura, N. Wang, M.J. Bamberger, T. Nguyen, F. Rinninger, X.C. Jiang, C.L. Shear, and A.R. Tall Inhibition of cholesteryl ester transfer protein by torcetrapib modestly increases macrophage cholesterol efflux to HDL Arterioscler Thromb Vasc Biol 27 2007 1132 1138
12. L. Yvan-Charvet, J. Kling, T. Pagler, H. Li, B. Hubbard, T. Fisher, C.P. Sparrow, A.K. Taggart, and A.R. Tall Cholesterol efflux potential and antiinflammatory properties of high-density lipoprotein after treatment with niacin or anacetrapib Arterioscler Thromb Vasc Biol 30 2010 1430 1438
13. S. Han, L. Levoci, P. Fischer, S.P. Wang, K. Gagen, Y. Chen, D. Xie, T. Fisher, A.G. Ehrhardt, A.M. Peier, and D.G. Johns Inhibition of cholesteryl ester transfer protein by anacetrapib does not impair the anti-inflammatory properties of high density lipoprotein Biochim Biophys Acta 1831 2013 825 833
14. F. Briand, Q. Thieblemont, A. Andre, K. Ouguerram, and T. Sulpice CETP inhibitor torcetrapib promotes reverse cholesterol transport in obese insulin-resistant CETP-ApoB100 transgenic mice Clin Transl Sci 4 2011 414 420
15. J. Castro-Perez, F. Briand, K. Gagen, S.P. Wang, Y. Chen, D.G. McLaren, V. Shah, R.J. Vreeken, T. Hankemeier, T. Sulpice, T.P. Roddy, B.K. Hubbard, and D.G. Johns Anacetrapib promotes reverse cholesterol transport and bulk cholesterol excretion in Syrian golden hamsters J Lipid Res 52 2011 1965 1973
16. S. Friedrich, J.J. Kastelein, D. James, T. Waterhouse, S.E. Nissen, S.J. Nicholls, and K.A. Krueger The pharmacokinetics and pharmacokinetic/ pharmacodynamic relationships of evacetrapib administered as monotherapy or in combination with statins CPT Pharmacometrics Syst Pharmacol 3 2014 e94 10.1038/psp.2013.70
17. C.P. Cannon, S. Shah, H.M. Dansky, M. Davidson, E.A. Brinton, A.M. Gotto, M. Stepanavage, S.X. Liu, P. Gibbons, T.B. Ashraf, J. Zafarino, Y. Mitchel, and P. Barter Safety of anacetrapib in patients with or at high risk for coronary heart disease N Engl J Med 363 2010 2406 2415
18. G.G. Schwartz, A.G. Olsson, M. Abt, C.M. Ballantyne, P.J. Barter, J. Brumm, B.R. Chaitman, I.M. Holme, D. Kallend, L.A. Leiter, E. Leitersdorf, J.J. McMurray, H. Mundl, S.J. Nicholls, P.K. Shah, J.C. Tardif, and R.S. Wright Effects of dalcetrapib in patients with a recent acute coronary syndrome N Engl J Med 367 2012 2089 2099