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Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency.
Anker SD, Schroeder S, Atar D, Bax JJ, Ceconi C, Cowie MR, Crisp A, Dominjon F, Ford I, Ghofrani HA, Gropper S, Hindricks G, Hlatky MA, Holcomb R, Honarpour N, Jukema JW, Kim AM, Kunz M, Lefkowitz M, Le Floch C, Landmesser U, McDonagh TA, McMurray JJ, Merkely B, Packer M, Prasad K, Revkin J, Rosano GM, Somaratne R, Stough WG, Voors AA, Ruschitzka F. Anker SD, et al. Among authors: somaratne r. Eur J Heart Fail. 2016 May;18(5):482-9. doi: 10.1002/ejhf.516. Epub 2016 Apr 12. Eur J Heart Fail. 2016. PMID: 27071916 Free article. Review.
Erratum to "Traditional and new composite endpoints in heart failure clinical trials: facilitating comprehensive efficacy assessments and improving trial efficiency" [Eur J Heart Fail 2016;18:482-489].
Anker SD, Schroeder S, Atar D, Bax JJ, Ceconi C, Cowie MR, Crisp A, Dominjon F, Ford I, Ghofrani HA, Gropper S, Hindricks G, Hlatky MA, Holcomb R, Honarpour N, Jukema JW, Kim AM, Kunz M, Lefkowitz M, Floch CL, Landmesser U, McDonagh TA, McMurray JJ, Merkely B, Packer M, Prasad K, Revkin J, Rosano GM, Somaratne R, Stough WG, Voors AA, Ruschitzka F. Anker SD, et al. Among authors: somaratne r. Eur J Heart Fail. 2016 Jun;18(6):727. doi: 10.1002/ejhf.591. Eur J Heart Fail. 2016. PMID: 27324688 Free article. No abstract available.
Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk).
Bonaca MP, Nault P, Giugliano RP, Keech AC, Pineda AL, Kanevsky E, Kuder J, Murphy SA, Jukema JW, Lewis BS, Tokgozoglu L, Somaratne R, Sever PS, Pedersen TR, Sabatine MS. Bonaca MP, et al. Among authors: somaratne r. Circulation. 2018 Jan 23;137(4):338-350. doi: 10.1161/CIRCULATIONAHA.117.032235. Epub 2017 Nov 13. Circulation. 2018. PMID: 29133605 Free article. Clinical Trial.
PCSK9 inhibition-mediated reduction in Lp(a) with evolocumab: an analysis of 10 clinical trials and the LDL receptor's role.
Raal FJ, Giugliano RP, Sabatine MS, Koren MJ, Blom D, Seidah NG, Honarpour N, Lira A, Xue A, Chiruvolu P, Jackson S, Di M, Peach M, Somaratne R, Wasserman SM, Scott R, Stein EA. Raal FJ, et al. Among authors: somaratne r. J Lipid Res. 2016 Jun;57(6):1086-96. doi: 10.1194/jlr.P065334. Epub 2016 Apr 21. J Lipid Res. 2016. PMID: 27102113 Free PMC article.
Efficacy and safety of evolocumab (AMG 145), a fully human monoclonal antibody to PCSK9, in hyperlipidaemic patients on various background lipid therapies: pooled analysis of 1359 patients in four phase 2 trials.
Stein EA, Giugliano RP, Koren MJ, Raal FJ, Roth EM, Weiss R, Sullivan D, Wasserman SM, Somaratne R, Kim JB, Yang J, Liu T, Albizem M, Scott R, Sabatine MS; PROFICIO Investigators. Stein EA, et al. Among authors: somaratne r. Eur Heart J. 2014 Sep 1;35(33):2249-59. doi: 10.1093/eurheartj/ehu085. Epub 2014 Mar 4. Eur Heart J. 2014. PMID: 24598985
Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial.
Giugliano RP, Pedersen TR, Park JG, De Ferrari GM, Gaciong ZA, Ceska R, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Ott BR, Kanevsky E, Pineda AL, Somaratne R, Wasserman SM, Keech AC, Sever PS, Sabatine MS; FOURIER Investigators. Giugliano RP, et al. Among authors: somaratne r. Lancet. 2017 Oct 28;390(10106):1962-1971. doi: 10.1016/S0140-6736(17)32290-0. Epub 2017 Aug 28. Lancet. 2017. PMID: 28859947 Free article. Clinical Trial.
Clinical Efficacy and Safety of Evolocumab in High-Risk Patients Receiving a Statin: Secondary Analysis of Patients With Low LDL Cholesterol Levels and in Those Already Receiving a Maximal-Potency Statin in a Randomized Clinical Trial.
Giugliano RP, Keech A, Murphy SA, Huber K, Tokgozoglu SL, Lewis BS, Ferreira J, Pineda AL, Somaratne R, Sever PS, Pedersen TR, Sabatine MS. Giugliano RP, et al. Among authors: somaratne r. JAMA Cardiol. 2017 Dec 1;2(12):1385-1391. doi: 10.1001/jamacardio.2017.3944. JAMA Cardiol. 2017. PMID: 29117276 Free PMC article. Clinical Trial.
Impact of PCSK9 inhibition on coronary atheroma progression: Rationale and design of Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV).
Puri R, Nissen SE, Somaratne R, Cho L, Kastelein JJ, Ballantyne CM, Koenig W, Anderson TJ, Yang J, Kassahun H, Wasserman SM, Scott R, Borgman M, Nicholls SJ. Puri R, et al. Among authors: somaratne r. Am Heart J. 2016 Jun;176:83-92. doi: 10.1016/j.ahj.2016.01.019. Epub 2016 Feb 17. Am Heart J. 2016. PMID: 27264224 Clinical Trial.
59 results