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13 results on '"Litwin, Jeffrey S."'

1. Acquired (Drug-Induced) Long QT Syndrome

Author

Litwin, Jeffrey S., Kleiman, Robert B., Gussak, Ihor, Gussak, Ihor, editor, Antzelevitch, Charles, editor, Wilde, Arthur A. M., editor, Friedman, Paul A., editor, Ackerman, Michael J., editor, and Shen, Win-Kuang, editor

Published
2008
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4. Cardiac safety: beyond QT: how does ECG reading in clinical research compare to a healthcare interpretation?

Author

Litwin, Jeffrey S.

Subjects
United States. Food and Drug Administration -- Powers and duties, Electrocardiography -- Safety and security measures, Clinical trials -- Safety and security measures, Electrocardiogram -- Safety and security measures, General interest, Health
Abstract

If you talk to a clinical cardiologist about cardiac safety, it is highly unlikely that the letters 'QT' will ever be uttered. On the other hand, if you speak to [...]

Published
2010

5. The science of cardiac safety: centralized approach for Phase III studies enhances the quality and integrity of collected data

Author

Turner, J. Rick, Satin, Lawrence Z., Callahan, Timothy S., and Litwin, Jeffrey S.

Subjects
United States. Food and Drug Administration -- Powers and duties, Clinical trials -- Safety and security measures, Health risk assessment -- Methods, Pharmaceutical industry -- Product development -- Quality management, General interest, Health
Abstract

There is considerable interest in drug safety among multiple stakeholders in the United States, including the Food and Drug Administration (FDA), the National Institutes of Health, the Institute of Medicine [...]

Published
2010

7. Effects of cladribine tablets on heart rate, atrio-ventricular conduction and cardiac repolarization in patients with relapsing multiple sclerosis

Author

Hermann, Robert, Litwin, Jeffrey S., Friberg, Lena E., Dangond, Fernando, Munafo, Alain, Hermann, Robert, Litwin, Jeffrey S., Friberg, Lena E., Dangond, Fernando, and Munafo, Alain

Abstract

Aims Cladribine tablets have shown significant efficacy for the treatment of relapsing multiple sclerosis, a chronic and debilitating immune-mediated disorder. This study was conducted to examine acute and/or cumulative effects of cladribine tablets 10 mg (3.5 or 5.25 mg/kg cumulative dose over 2 years) on heart rate, AV conduction and cardiac repolarization in patients with relapsing-remitting multiple sclerosis (RRMS). Methods CLARITY was a 96-week, double-blind, placebo-controlled, multicentre trial which evaluated the safety and efficacy of cladribine tablets 3.5 and 5.25 mg/kg body weight in patients with RRMS. A total of 135 patients were included in the ECG substudy, providing a total of 1534 post-dose ECGs. ECG data were collected 15 minutes pre-dose and between 0.5 and 3 hours post-dose at pre-study evaluation, study Day 1 and Weeks 5, 9, 13, 48 and 52. Results For cladribine tablets 3.5 mg/kg, the maximum change in placebo-adjusted post-dose QTcF vs. visit-baseline (BL) was -0.42 ms (90% CI: -3.61-4.44) at Week 1 (acute effects), and 3.20 ms (90% CI: -0.08-6.33) for cladribine tablets 5.25 mg/kg. The greatest observed differences in post-dose QTcF vs. study BL occurred at Week 48 for both the 3.5 and 5.25 mg/kg doses of cladribine tablets with 5.99 ms (90% CI: 0.53-11.44) and 8.74 ms (90% CI: 3.18-14.31), respectively. No significant changes were observed in T-wave morphology in either treatment group. Conclusions Cladribine tablets 3.5 mg/kg (approved dose in Europe/other regions) did not confer clinically meaningful effects on heart rate, AV conduction and ventricular repolarization.

Published
2019
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9. The merits of ECG centralization: a call to sponsors to rethink the role of ECGs in drug development and the use of central core labs

Author

Litwin, Jeffrey S.

Subjects
Management, Analysis, Usage, Safety and security measures, Company business management, Biomedical laboratories -- Safety and security measures -- Management -- Analysis -- Usage, Electrocardiography -- Usage -- Analysis -- Safety and security measures, Pharmaceutical industry -- Safety and security measures -- Management -- Usage -- Analysis, Electrocardiogram -- Usage -- Analysis -- Safety and security measures, Medical laboratories -- Safety and security measures -- Management -- Analysis -- Usage
Abstract

Cardiac safety has become the number one reason for drug withdrawals and labeling changes during the past several years. This has resulted in greater regulatory scrutiny for all new compounds [...]

Published
2008

13. Fundamentals of ECG Interpretation in Clinical Research and Cardiac Safety Assessment.

Author

Morganroth, Joel, Gussak, Ihor, Kleiman, Robert, and Litwin, Jeffrey S.

Abstract

The interpretation of ECGs recorded during clinical drug trials shares many similarities with the clinical interpretation of ECGs, but also differs in several significant ways. The fundamental rules for measurement of ECG intervals and overall ECG interpretation (cardiac rhythm, conduction, etc.) are identical whether an ECG is recorded from a patient having chest pain in an emergency room, or from a healthy subject involved in a clinical drug trial. But, the overall purpose of the evaluation of two such ECGs differs greatly. [ABSTRACT FROM AUTHOR]

Published
2005
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