Cardiac imaging approaches to evaluate drug-induced myocardial dysfunction

被引:15
作者
Christian, Jennifer B. [1 ]
Finkle, John K. [2 ]
Ky, Bonnie [3 ]
Douglas, Pamela S. [4 ]
Gutstein, David E. [5 ]
Hockings, Paul D. [6 ]
Lainee, Pierre
Lenihan, Daniel J. [7 ]
Mason, Jay W. [8 ]
Sager, Philip T. [9 ]
Todaro, Thomas G. [10 ]
Hicks, Karen A. [11 ]
Kane, Robert C. [12 ]
Ko, Hon-Sum [13 ]
Lindenfeld, JoAnn [14 ]
Michelson, Eric L. [15 ]
Milligan, James
Munley, Jiefen Y. [15 ]
Raichlen, Joel S. [15 ]
Shahlaee, Amir [16 ]
Strnadova, Colette [17 ]
Ye, Brenda [18 ]
Turner, J. Rick [19 ]
机构
[1] GlaxoSmithKline, Clin Effectiveness & Safety, Durham, NC 27709 USA
[2] GlaxoSmithKline, Upper Providence, PA USA
[3] Univ Penn, Sch Med, Div Cardiovasc Med, Philadelphia, PA 19104 USA
[4] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA
[5] Merck Sharp & Dohme Corp, Rahway, NJ USA
[6] AstraZeneca AB, Molndal, Sweden
[7] Vanderbilt Univ, Div Cardiovasc Med, Nashville, TN USA
[8] Univ Utah, Salt Lake City, UT USA
[9] Sager Consulting Partners, San Francisco, CA USA
[10] Medpace, Cincinnati, OH USA
[11] US FDA, Div Cardiovasc & Renal Prod, Off Drug Evaluat 1, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[12] US FDA, Div Hematol Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[13] US FDA, Div Dermatol & Dent Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[14] Univ Colorado, Dept Med, Aurora, CO USA
[15] AstraZeneca LP, Wilmington, DE USA
[16] US FDA, Off Hematol & Oncol Prod, Silver Spring, MD USA
[17] Hlth Canada, Ottawa, ON K1A 0L2, Canada
[18] US FDA, Div Med Imaging Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[19] Quintiles, Durham, NC USA
关键词
CARDIOVASCULAR MAGNETIC-RESONANCE; OF-ECHOCARDIOGRAPHYS GUIDELINES; VENTRICULAR EJECTION FRACTION; DOXORUBICIN CARDIOTOXICITY; 3-DIMENSIONAL ECHOCARDIOGRAPHY; HEART-FAILURE; ANTHRACYCLINE CARDIOTOXICITY; AMERICAN-SOCIETY; CLINICAL-TRIALS; VOLUMETRIC CT;
D O I
10.1016/j.ahj.2012.09.001
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
The ability to make informed benefit-risk assessments for potentially cardiotoxic new compounds is of considerable interest and importance at the public health, drug development, and individual patient levels. Cardiac imaging approaches in the evaluation of drug-induced myocardial dysfunction will likely play an increasing role. However, the optimal choice of myocardial imaging modality and the recommended frequency of monitoring are undefined. These decisions are complicated by the array of imaging techniques, which have varying sensitivities, specificities, availabilities, local expertise, safety, and costs, and by the variable time-course of tissue damage, functional myocardial depression, or recovery of function. This White Paper summarizes scientific discussions of members of the Cardiac Safety Research Consortium on the main factors to consider when selecting nonclinical and clinical cardiac function imaging techniques in drug development. We focus on 3 commonly used imaging modalities in the evaluation of cardiac function: echocardiography, magnetic resonance imaging, and radionuclide (nuclear) imaging and highlight areas for future research. (Am Heart J 2012;164:846-55.)
引用
收藏
页码:846 / 855
页数:10
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