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54. Tissue and Animal Models of Sudden Cardiac Death

Author

Sallam, Karim, Li, Yingxin, Sager, Philip T., Houser, Steven R., and Wu, Joseph C.

Subjects
Clinical Trials as Topic, Patch-Clamp Techniques, Heart Diseases, Induced Pluripotent Stem Cells, Drug Evaluation, Preclinical, Models, Cardiovascular, Cardiovascular Agents, Cell Differentiation, Article, Ion Channels, Electrophysiology, Disease Models, Animal, Long QT Syndrome, Death, Sudden, Cardiac, Organ Culture Techniques, Tachycardia, Ventricular, Animals, Humans, Computer Simulation, Myocytes, Cardiac, Cells, Cultured, Forecasting
Abstract

Sudden cardiac death is a common cause of death in patients with structural heart disease, genetic mutations, or acquired disorders affecting cardiac ion channels. A wide range of platforms exist to model and study disorders associated with sudden cardiac death. Human clinical studies are cumbersome and are thwarted by the extent of investigation that can be performed on human subjects. Animal models are limited by their degree of homology to human cardiac electrophysiology, including ion channel expression. Most commonly used cellular models are cellular transfection models, which are able to mimic the expression of a single-ion channel offering incomplete insight into changes of the action potential profile. Induced pluripotent stem cell-derived cardiomyocytes resemble, but are not identical, adult human cardiomyocytes and provide a new platform for studying arrhythmic disorders leading to sudden cardiac death. A variety of platforms exist to phenotype cellular models, including conventional and automated patch clamp, multielectrode array, and computational modeling. Induced pluripotent stem cell-derived cardiomyocytes have been used to study long QT syndrome, catecholaminergic polymorphic ventricular tachycardia, hypertrophic cardiomyopathy, and other hereditary cardiac disorders. Although induced pluripotent stem cell-derived cardiomyocytes are distinct from adult cardiomyocytes, they provide a robust platform to advance the science and clinical care of sudden cardiac death.

Published
2015

55. The Potential Role of the J‐Tpeak Interval in Proarrhythmic Cardiac Safety: Current State of the Science From the American College of Clinical Pharmacology and the Cardiac Safety Research Consortium.

Author

Vicente, Jose, Strauss, David G., Upreti, Vijay V., Fossler, Michael J., Sager, Philip T., and Noveck, Robert

Subjects
HEART conduction system, BIOMARKERS, CARRIER proteins, DRUG side effects, CLINICAL drug trials, ELECTROCARDIOGRAPHY, MEDICAL protocols, MEDICAL research, PHARMACOLOGY, VENTRICULAR tachycardia, LONG QT syndrome, PROARRHYTHMIA, PHYSIOLOGY
Abstract

The article highlights the role of the J-Tpeak Interval in Proarrhythmic Cardiac Safety. Topics discussed the J-Tpeak interval is the time from the end of the QRS complex to the peak of the T-wave; mentions the assessment for unanticipated electrocardiogram (ECG) effects and highlights the use of Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative to impact drug discovery, development, and therapeutic use.

Published
2019
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56. The Cardiac Safety Research Consortium enters its second decade: An invitation to participate

Author

Turner, J. Rick, primary, Kowey, Peter R., additional, Rodriguez, Ignacio, additional, Cabell, Christopher H., additional, Gintant, Gary, additional, Green, Cynthia L., additional, Kunz, Barbara Lopez, additional, Mortara, Justin, additional, Sager, Philip T., additional, Stockbridge, Norman, additional, Wright, Theressa J., additional, Finkle, John, additional, and Krucoff, Mitchell W., additional

Published
2016
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60. Drug‐induced Proarrhythmia and Torsade de Pointes: A Primer for Students and Practitioners of Medicine and Pharmacy.

Author

Turner, J. Rick, Rodriguez, Ignacio, Mantovani, Emily, Gintant, Gary, Kowey, Peter R., Klotzbaugh, Ralph J., Prasad, Krishna, Sager, Philip T., Stockbridge, Norman, Strnadova, Colette, and the Cardiac Safety Research Consortium

Subjects
PREVENTION of drug side effects, VENTRICULAR arrhythmia, ATTITUDE (Psychology), DRUG interactions, DOSE-effect relationship in pharmacology, ELECTROCARDIOGRAPHY, HEALTH occupations students, MEDICAL personnel, MEDICAL protocols, MEDICAL prescriptions, PATIENT safety, PROFESSIONS, VENTRICULAR tachycardia, DRUG development, HUMAN services programs, CONTINUING education units, PROARRHYTHMIA, GENETICS
Abstract

Abstract: Multiple marketing withdrawals due to proarrhythmic concerns occurred in the United States, Canada, and the United Kingdom in the late 1980s to early 2000s. This primer reviews the clinical implications of a drug's identified proarrhythmic liability, the issues associated with these safety‐related withdrawals, and the actions taken by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and by regulatory agencies in terms of changing drug development practices and introducing new nonclinical and clinical tests to asses proarrhythmic liability. ICH Guidelines S7B and E14 were released in 2005. Since then, they have been adopted by many regional regulatory authorities and have guided nonclinical and clinical proarrhythmic cardiac safety assessments during drug development. While this regulatory paradigm has been successful in preventing drugs with unanticipated potential for inducing the rare but potentially fatal polymorphic ventricular arrhythmia torsade de pointes from entering the market, it has led to the termination of drug development programs for other potentially useful medicines because of isolated results from studies with limited predictive value. Research efforts are now exploring alternative approaches to better predict potential proarrhythmic liabilities. For example, in the domain of human electrocardiographic assessments, concentration‐response modeling conducted during phase 1 clinical development has recently become an accepted alternate primary methodology to the ICH E14 “thorough QT/QTc” study for defining a drug's corrected QT interval prolongation liability under certain conditions. When a drug's therapeutic benefit is considered important at a public health level but there is also an identified proarrhythmic liability that may result from administration of the single drug in certain individuals and/or drug‐drug interactions, marketing approval will be accompanied by appropriate directions in the drug's prescribing information. Health‐care professionals in the fields of medicine and pharmacy need to consider the prescribing information in conjunction with individual patients’ clinical characteristics and concomitant medications when prescribing and dispensing such drugs. [ABSTRACT FROM AUTHOR]

Published
2018
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61. Cardiovascular Safety During and After Use of Phentermine and Topiramate.

Author

Ritchey, Mary E, Harding, Abenah, Hunter, Shannon, Peterson, Craig, Sager, Philip T, Kowey, Peter R, Nguyen, Lan, Thomas, Steven, Cainzos-Achirica, Miguel, Rothman, Kenneth J, Andrews, Elizabeth B, and Anthony, Mary S

Abstract

Increases in heart rate were seen during the clinical program for fixed-dose combination phentermine (PHEN) and topiramate (TPM), an oral medication indicated for weight management; however, the effect on cardiovascular (CV) outcomes is uncertain.

Published
2019
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64. Effects of the Once-Weekly Glucagon-Like Peptide-1 Receptor Agonist Dulaglutide on Ambulatory Blood Pressure and Heart Rate in Patients With Type 2 Diabetes Mellitus

Author

Ferdinand, Keith C., primary, White, William B., additional, Calhoun, David A., additional, Lonn, Eva M., additional, Sager, Philip T., additional, Brunelle, Rocco, additional, Jiang, Honghua H., additional, Threlkeld, Rebecca J., additional, Robertson, Kenneth E., additional, and Geiger, Mary Jane, additional

Published
2014
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70. Clinical Cardiac Electrophysiology Fellowship Teaching Objectives for the New Millennium

Author

LINK, MARK S., primary, ANTZELEVITCH, CHARLES, additional, WALDO, ALBERT L., additional, GRANT, AUGUSTUS O., additional, DIMARCO, JOHN P., additional, JOSEPHSON, MARK E., additional, MARCHLINSKI, FRANCIS E., additional, GARAN, HASAN, additional, SAGER, PHILIP T., additional, REYNOLDS, DWIGHT W., additional, DENES, PABLO, additional, SCHEINMAN, MELVIN M., additional, and ESTES, N.A. MARK, additional

Published
2001
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91. Different Effects of Amiodarone and Quinidine on the Homogeneity of Myocardial Refractoriness in Patients With Intraventricular Conduction Delay.

Author

Guanggen Cui, Sager, Philip T., Singh, Bramah N., and Luyi Sen

Subjects
AMIODARONE, QUINIDINE, ARRHYTHMIA, HEART beat, PHARMACODYNAMICS
Abstract

The article focuses on a study which examined the effects of amiodarone and quinidine on myocardial refractoriness in patients diagnosed with intraventricular conduction delay. The study included patients who are undergoing treatment for ventricular arrhythmia. It found that the administration of amiodarone increased the QT interval of the patients and reduced heart rate. Meanwhile, quinidine increased QRS interval more than amiodarone.

Published
1998
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92. Ventricular Arrhythmias: Medical Therapy, Device Treatment, and Indications for Electrophysiologic Study

Author

Sager, Philip T. and Batsford, William P.

Abstract

Sustained ventricular arrhythmias commonly occur in post-myocardial infarction patients. Electrophysiology studies have greatly contributed to understanding the mechanisms of these arrhythmias and in guiding therapy. In addition to pharmacologic therapy, new treatment modalities-which include arrhythmia surgery, device therapy, and percutaneous catheter ablation-have resulted in a significantly improved outcome in patients with malignant ventricular arrhythmias

Published
1988
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93. Electrophysiologic effects of thrombolytic therapy in patients with a transmural anterior myocardial infarction complicated by left ventricular aneurysm formation

Author

Sager, Philip T., Perlmutter, Robin A., Rosenfeld, Lynda E., McPherson, Craig A., Wackers, Frans J.Th., and Batsford, William P.

Abstract

To assess the effects of early thrombolytic therapy on the incidence of clinical and induced ventricular arrhythmias in high risk postmyocardial infarction patients, 32 patients with a transmural anterior myocardial infarction complicated by left ventricular aneurysm formation were prospectively evaluated. Sixteen patients (Group A) received routine care because of contraindication to thrombolytic therapy or other factors and 16 (Group B) received either tissue plasminogen activator or streptokinase within 6 h of the onset of chest pain. The two groups were similar in left ventricular ejection fraction (mean ± SD, 28 ± 9% [Group A] versus 30 ± 8% [Group B]) and occurrence of spontaneous nonsustained ventricular tachycardia, new bundle branch block and congestive heart failure. Group B patients had higher peak creatine kinase MB levels (446 ± 336 versus 205 ± 120 IU; p = 0.017) and earlier time to peak creatine kinase values (13.4 ± 6.6 versus 19.1 ± 6.1 h; p = 0.006).

Published
1988
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94. Rapid self-terminating ventricular tachycardia induced during electrophysiologic study: A prospective evaluation

Author

Sager, Philip T., Perlmutter, Robin A., Rosenfeld, Lynda E., McPherson, Craig A., and Batsford, William P.

Abstract

The clinical significance of rapid self-terminating ventricular tachycardia induced during electrophysiologic study was prospectively evaluated in three patient groups with clinical ventricular arrhythmias. Group A (11 patients) had inducible rapid self-terminating ventricular tachycardia only (mean cycle length ≤250 ms and ≥10 beats in duration). In Group B (22 patients) induction of this arrhythmia was followed by the induction of sustained ventricular tachycardia. In Group C (82 patients) sustained ventricular tachycardia was induced without preceding rapid self-terminating ventricular tachycardia.

Published
1989
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95. Efficacy of intravenous ibutilide for rapid termination of atrial fibrillation and atrial flutter: A dose-response study

Author

Ellenbogen, Kenneth A., Stambler, Bruce S., Wood, Mark A., Sager, Philip T., Wesley, Robert C., Meissner, Marc D., Zoble, Robert G., Wakefield, Linda K., Perry, Kimberly T., Vanderlugtt, James T., and Investigators, Ibutilide

Abstract

Objectives. Currently available antiarrhythmic drugs have limited efficacy for short-term, rapid termination of atrial fibrillation and atrial flutter.

Published
1996
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