
Boaz MendzelevskiIndependent Researcher · Cardiac Safety
Boaz Mendzelevski
Doctor of Medicine
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28
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Publications (28)
In clinical trials, traditionally only a limited number of 12‐lead resting electrocardiograms (ECGs) can be recorded and, thus, long intervals may elapse between assessment timepoints and valuable information may be missed during times when patients' cardiac electrical activity is not being monitored. These limitations have led to the increasing us...
Purpose:
The aim of this analysis was to investigate the potential for ulixertinib (BVD-523) to prolong cardiac repolarization. The mean prolongation of the corrected QT (QTc) interval was predicted at the mean maximum drug concentrations of the recommended phase 2 dose (RP2D; 600 mg BID) and of higher concentrations. In addition, the effect of ul...
Ozanimod is a novel, selective, oral sphingosine-1-phosphate (1 and 5) receptor modulator in development for multiple sclerosis and inflammatory bowel disease. This randomized, double-blind, placebo-controlled, positive-controlled, parallel-group thorough QT study characterized the effects of ozanimod on cardiac repolarization in healthy subjects....
Purpose:
The goal of this study was to evaluate the moxifloxacin-induced QT interval prolongation in healthy male and female Korean and Japanese volunteers to investigate interethnic differences.
Methods:
This multicenter, randomized, double-blind, placebo-controlled, 2-way crossover study was conducted in healthy male and female Korean and Japa...
TV-1106 (Teva Pharmaceuticals) is a genetically fused recombinant protein of human growth hormone and human serum albumin, in development for treatment of growth hormone deficiency (GHD). TV-1106 is expected to have an extended duration of action compared to daily GH treatment and may enable the reduction in frequency of injections, and improve com...
To investigate the QT/QTc effects of orally administered moxifloxacin in healthy Chinese volunteers.
This was a single-blinded, randomized, single-dose, placebo-controlled, two-period cross-over study. A total of 24 healthy Chinese volunteers were enrolled, randomly assigned to two groups: one group received moxifloxacin (400 mg, po) followed by pl...
Human plasma butyrylcholinesterase (BChE) contributes to cocaine metabolism and has been considered for use in treating cocaine addiction and cocaine overdose. TV-1380 is a recombinant protein composed of the mature form of human serum albumin fused at its amino terminus to the carboxy-terminus of a truncated and mutated BChE. In preclinical studie...
Aims:
Rasagiline is a selective, irreversible monoamine oxidase type B inhibitor, developed for the treatment of Parkinson's disease. In compliance with current regulatory requirements, rasagiline underwent a thorough QT/QTc (TQT) study to assess its potential to prolong cardiac repolarization. The primary aim of this study was to evaluate the eff...
In December 2008, the US Food and Drug Administration (FDA) issued a guidance for industry requiring sponsors to demonstrate that a new antidiabetic therapy being developed to treat type 2 diabetes does not increase cardiovascular (CV) risk to an unacceptable extent. CV events reported during phase 2 and phase 3 trials should be prospectively and i...
Introduction:
Development of new drugs in oncology may have implications for cardiovascular risk. This report describes some aspects of our growing knowledge in the area of evaluating benefit-risk and may be of direct importance to scientists working in drug discovery and development.
Areas covered:
This report of webinar highlights entitled "Tr...
This White Paper, prepared by members of the Cardiac Safety Research Consortium, discusses several important issues regarding the evaluation of blood pressure (BP) responses to drugs being developed for indications not of a direct cardiovascular (CV) nature. A wide range of drugs are associated with off-target BP increases, and both scientific atte...
To assess steady-state effects of therapeutic and supra-therapeutic doses of prucalopride on the QT interval using a novel design involving a parallel placebo group with nested crossover for positive control.
A double-blind, double-dummy, placebo- and active-controlled study was conducted in 120 healthy male and female volunteers (NCT00903747). Vol...
Cardiac safety is a relatively new field in drug development clinical research. It first emerged as a regulatory focus after the high-profile withdrawals of drugs such as terfenadine and cisapride in the 1990s, and became synonymous with drug-induced QT prolongation and its associated cardiac arrhythmia - torsades de pointes (TdP). Recent regulator...
Reference ranges for electrocardiogram (ECG) intervals, heart rate, and QRS axis in general use by medical personnel and ECG readers are unrepresentative of true age- and sex-related values in large populations and are not based on modern electrocardiographic and ECG reading technology.
The results of ECG interpretation by cardiologists using digit...
Background:
Oral dopamine agonists are effective for treating early Parkinson's disease (PD). Rotigotine is a dopamine agonist delivered through a silicone-based transdermal patch that is replaced every 24 hours.
Objectives:
To assess the efficacy and safety of rotigotine in patients with PD not receiving dopaminergic medications.
Design:
Rand...
A so-far undescribed complication of Wallstent deployment occurred in a 68-yr-old patient with symptomatic coronary artery disease. The patient had coronary angioplasty to the right coronary artery, complicated by a dissection which necessitated stent implantation. After insertion of one Wallstent, further significant distal disease was observed. A...
Spontaneous coronary artery dissection is an extremely rare cause of myocardial infarction. It has been reported mainly in young women during or after pregnancy. The prognosis and treatment of coronary dissection are not clear. We report three cases of spontaneous coronary artery dissection in young women. One of them was pregnant and one was 2 wee...
Spontaneous coronary artery dissection is an extremely rare cause of myocardial infarction. It has been reported mainly in young women during or after pregnancy. The prognosis and treatment of coronary dissection are not clear. We report three cases of spontaneous coronary artery dissection in young women. One of them was pregnant and one was 2 wee...
EDITOR,—Darwood Darbar and colleagues showed the predictive value of QTc dispersion (>/=60 ms) in patients with peripheral vascular disease,1 but we think that three parts of this paper need attention.The first is the patient population. This small, retrospective study was not controlled for risk factors, which introduces significant selection bias...
A 32-year-old woman, in the 22nd week of pregnancy, underwent emergency coronary artery bypass grafting to the left anterior descending artery (LAD). She had suffered an acute myocardial infarction 10 days previously, and continued to suffer from intractable angina pectoris afterwards. Cardiac catheterization revealed spontaneous dissection of the...