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QTc prolongation

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April 2018: Postgraduate Medical Journal
Jingtao Lu, Jianguo Li, Gabriel Helmlinger, Nidal Al-Huniti
Modeling the relationship between drug concentrations and heart rate corrected QT interval (QTc) change from baseline (C-∆QTc), based on Phase I single ascending dose (SAD) or multiple ascending dose (MAD) studies, has been proposed as an alternative to thorough QT studies (TQT), in assessing drug-induced QT prolongation risk. The present analysis used clinical SAD, MAD and TQT study data of an experimental compound, AZD5672, to evaluate the performance of: (i) three computational platforms (linear mixed-effects modeling implemented via PROC MIXED in SAS, as well as in R using LME4 package and linear quantile mixed models (LQMM) implemented via LQMM package; (ii) different model structures with and without treatment- or time-specific intercepts; and (iii) three methods for calculating the confidence interval (CI) of QTc prolongation (analytical and bootstrap methods with fixed or varied geometric mean concentrations)...
March 19, 2018: Journal of Pharmacokinetics and Pharmacodynamics
Rada M Savic, Prasanna Jagannathan, Richard Kajubi, Liusheng Huang, Nan Zhang, Moses Were, Abel Kakuru, Mary K Muhindo, Norah Mwebaza, Erika Wallender, Tamara D Clark, Bishop Opira, Moses Kamya, Diane V Havlir, Philip J Rosenthal, Grant Dorsey, Francesca T Aweeka
Background: Dihydroartemsinin-piperaquine is highly efficacious as intermittent preventive therapy for malaria during pregnancy (IPTp). Determining associations between piperaquine exposure, malaria risk, and adverse birth outcomes informs optimal dosing strategies. Methods: HIV-uninfected pregnant women were enrolled in a placebo-controlled trial of IPTp at 12-20 weeks gestation and randomized to: sulfadoxine-pyrimethamine every 8 weeks (n=106), dihydroartemsinin-piperaquine every 8 weeks (n=94), or dihydroartemsinin-piperaquine every 4 weeks (n=100) during pregnancy...
March 14, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Barbara Wiśniowska, Sebastian Polak
The current study is an example of drug-disease interaction modeling where a drug induces a condition which can affect the pharmacodynamics of other concomitantly taken drugs. The electrophysiological effects of hypokaliemia and heart rate changes induced by the antiasthmatic drugs were simulated with the use of the cardiac safety simulator. Biophysically detailed model of the human cardiac physiology-ten Tusscher ventricular cardiomyocyte cell model-was employed to generate pseudo-ECG signals and QTc intervals for 44 patients from four clinical studies...
March 15, 2018: Journal of Pharmacokinetics and Pharmacodynamics
Hitesh Raheja, Vinod Namana, Kirti Chopra, Ankur Sinha, Sushilkumar Satish Gupta, Stephan Kamholz, Norbert Moskovits, Jacob Shani, Gerald Hollander
Background: Acute alcohol intoxication has been associated with cardiac arrhythmias but the electrocardiogram (ECG) changes associated with acute alcohol intoxication are not well defined in the literature. Objective: Highlight the best evidence regarding the ECG changes associated with acute alcohol intoxication in otherwise healthy patients and the pathophysiology of the changes. Methods: A literature search was carried out; 4 studies relating to ECG changes with acute alcohol intoxication were included in this review...
2018: Open Cardiovascular Medicine Journal
Ying-Zi Shen, Ke Peng, Juan Zhang, Xiao-Wen Meng, Fuhai Ji
OBJECTIVE: The aim of this systematic review and meta-analysis was to investigate whether or not the use of haloperidol could reduce the incidence of delirium in adult patients. SUBJECTS AND METHODS: PubMed, Embase, the Cochrane Library, Elsevier, Wiley, and Ovid were searched for randomized controlled trials and prospective interventional cohort studies that compared haloperidol with placebo for delirium prophylaxis or with second generation antipsychotics for delirium treatment...
March 8, 2018: Medical Principles and Practice: International Journal of the Kuwait University, Health Science Centre
Salma I Patel, Michael J Ackerman, Fadi E Shamoun, Jeffrey B Geske, Steve R Ommen, William T Love, Stephen S Cha, Johan M Bos, Steven J Lester
INTRODUCTION: Risk assessment for sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM) remains complex. The goal of this study was to assess electrocardiogram (ECG)-derived risk factors on SCD in a large HCM population Methods: Retrospective review of adults with HCM evaluated at Mayo Clinic, Rochester, MN from 1 December 2002 to 31 December 2012 was performed. Data inclusive of ECG and 24-hour ambulatory Holter monitor were assessed. SCD events were documented by ventricular fibrillation (VF) noted on implantable cardioverter defibrillator (ICD), or appropriate VT or VF-terminating ICD shock...
March 7, 2018: Acta Cardiologica
Peter Manu, Yevgeniya Lapitskaya, Atef Shaikh, Jimmi Nielsen
BACKGROUND: Clozapine is widely prescribed for treatment-refractory schizophrenia, but its use is limited by many potentially life-threatening adverse effects. The risk of rechallenge after these complications has never been comprehensively assessed in controlled studies. Thus, clinical guidelines must rely on the published case reports. The number of such reports is likely to increase over time, and updated analyses of larger samples are needed, as they may lead to changes in clinical guidelines...
March 2018: American Journal of Therapeutics
Maarten Timmers, Vikash Sinha, Borje Darpo, Brian Smith, Randy Brown, Hongqi Xue, Georg Ferber, Johannes Streffer, Alberto Russu, Luc Tritsmans, Bhavna Solanki, Jennifer Bogert, Luc Van Nueten, Giacomo Salvadore, Partha Nandy
Nonclinical assays with JNJ-54861911, a β-secretase 1 inhibitor have indicated that at high concentrations, it may delay cardiac repolarization. A 4-way crossover thorough QT (TQT) study was performed in 64 healthy subjects with 50 and 150 mg JNJ-54861911 once daily for 7 days, placebo, and 400 mg moxifloxacin. Retrospective high-precision QT (HPQT) analysis was performed on serial elecrocardiograms extracted from first-in-human single-ascending dose (SAD) and multiple-ascending dose (MAD) studies to evaluate if early studies could detect and predict QT effect...
March 5, 2018: Journal of Clinical Pharmacology
(no author information available yet)
OBJECTIVE: Multicenter studies have shown that cardiovascular risks of ADHD medication are extremely low. However, QTc length has been shown to be increased in smaller samples of patients or case reports after stimulant and atomoxetine medication. Based on recent studies of genetic polymorphisms associated with drug-induced QTc prolongation and polymorphisms linkage to regional populations, we hypothesized that the drug-induced QTc prolongation could be a factor of particular polymorphisms linked to specific regional populations undistinguished in multicenter studies...
February 5, 2018: Neuro Endocrinology Letters
Valentina Kutyifa, Usama Daimee, Scott McNitt, Bronislava Polonsky, Charles Lowenstein, Kris Cutter, Coeli Lopes, Wojciech Zareba, Arthur J Moss
BACKGROUND: A comprehensive report on the clinical course of the three major genotypes of the long QT syndrome (LQTS) in a large U.S. patient cohort is lacking. METHODS: Our study consisted of 1,923 U.S. subjects from the Rochester-based LQTS Registry with genotype-positive LQT1 (n = 879), LQT2 (n = 807), and LQT3 (n = 237). We evaluated the risk of a first cardiac event (syncope, aborted cardiac arrest, or sudden cardiac death, whichever occurred first) from birth through age 50 years...
March 5, 2018: Annals of Noninvasive Electrocardiology
Nam Nhut Phan, Kuan-Lun Li, Yen-Chang Lin
BACKGROUND: Arsenic has been shown to cause various diseases (such as blackfoot disease, cardiovascular diseases, bladder cancer and skin cancer) in many areas of the world. However, the effects of arsenic on cardiac rhythm functions still lack investigation. METHODS: In this study, different concentrations of arsenic were orally applied to Sprague Dawley rats in order to examine the relationship between arsenic and cardiovascular rhythm (i.e. long QT) via electrocardiography measurement...
March 2, 2018: Toxicology Mechanisms and Methods
Semi Ozturk, Ahmet Seyfeddin Gurbuz, Suleyman Cagan Efe, Raim Iliaz, Mutse Banzragch, Kadir Demir
Background Neurologic and liver involvement in Wilson's disease (WD) is well-documented, however, few reports demonstrated cardiac involvement. Tpe and Tpe/QT are new measures of ventricular repolarization which were recently suggested as predictor of arrythmogenesis. We aimed to evaluate ventricular depolarization and repolarization parameters including QT, QTc, Tpe intervals, Tpe/QT, Tpe/QTc ratios, and QT dispersion (QTd) in patients with WD. Materials and methods Thirty-five patients with WD and 30 healthy controls were included in the study...
March 1, 2018: Acta Clinica Belgica
Jörg Täubel, Ulrike Lorch, Simon Coates, Sara Fernandes, Paul Foley, Georg Ferber, Jean-Pierre Gotteland, Oliver Pohl
OBE022, a new orally active prostaglandin F2α  receptor antagonist (OBE022) with myometrial selectivity is being developed to reduce uterine contractions during preterm labor. This first-in-human study evaluated the effect of OBE022 following multiple doses on the QT interval in 23 healthy postmenopausal women, using the effect of a meal on QTc to demonstrate assay sensitivity. We report the cardiac safety outcome performed during the multiple ascending part of this trial. OBE022 was administered after a standardized breakfast on day 1 and in the fasted state from day 3 to day 9 wth a standardized lunch 4 hours after administration...
February 28, 2018: Clinical Pharmacology in Drug Development
Elias Tsiompanidis, Spyros I Siakavellas, Anastasios Tentolouris, Ioanna Eleftheriadou, Stamatia Chorepsima, Anastasios Manolakis, Konstantinos Oikonomou, Nikolaos Tentolouris
AIM: To examine the impact of liver cirrhosis on QT interval and cardiac autonomic neuropathy (CAN). METHODS: A total of 51 patients with cirrhosis and 51 controls were examined. Standard 12-lead electrocardiogram recordings were obtained and QT as well as corrected QT interval (QTc) and their dispersions (dQT, dQTc) were measured and calculated using a computer-based program. The diagnosis of CAN was based upon the battery of the tests proposed by Ewing and Clarke and the consensus statements of the American Diabetes Association...
February 15, 2018: World Journal of Gastrointestinal Pathophysiology
Bharath Yarlagadda, Venkat Vuddanda, Tawseef Dar, Mohammad-Ali Jazayeri, Valay Parikh, Mohit K Turagam, Madhav Lavu, Sindhu Reddy Avula, Donita Atkins, Sudharani Bommana, Rakesh Gopinathannair, Madhu Reddy Yeruva, Dhanunjaya Lakkireddy
Background: We sought to investigate and compare the safety and efficacy of two commonly used antiarrhythmic drugs, Dofetilide (DF) and Sotalol (SL), during inpatient drug initiation in patients with symptomatic atrial fibrillation (AF). Methods: We performed a single center retrospective study of consecutive patients, admitted for initiation of either DF or SL, for AF between 2012 and 2015. Rates of successful cardioversion, QT interval prolongation, adverse events and drug discontinuations were calculated and compared...
December 2017: Journal of Atrial Fibrillation
James Ogunmodede, Philip Kolo, Ibraheem Katibi, Ayodele Omotoso
Background: HAART has improved survival of HIV patients. Its contribution to the development of new cardiovascular abnormalities has generated much interest. This study aimed at determining the prevalence of QTc prolongation among HIV patients and determining the influence if any of the use of HAART on the QTc and on the risk of having QTc prolongation. Materials and Methods: One hundred and fifty HIV positive subjects comprising 76 HIV positive subjects on HAART (Group A), 74 who were HAART- naïve (Group B), and 150 age and sex-matched healthy controls (Group C) were studied...
November 2017: Ethiopian Journal of Health Sciences
Mirjam Simoons, Adrie Seldenrijk, Hans Mulder, Tom Birkenhäger, Mascha Groothedde-Kuyvenhoven, Rob Kok, Cornelis Kramers, Wim Verbeeck, Mirjam Westra, Eric van Roon, Roberto Bakker, Henricus Ruhé
Currently, there is a lack of international and national guidelines or consensus documents with specific recommendations for electrocardiogram (ECG) screening and monitoring during antidepressant treatment. To make a proper estimation of the risk of cardiac arrhythmias and sudden (cardiac) death during antidepressant use, both the drug and patient-specific factors should be taken into account; however, solid evidence on how this should be done in clinical practice is lacking. Available recommendations on the management of QT(c) prolongation (with antidepressant treatment) emphasize that special attention should be given to high-risk patients; however, clinicians are in need of more concrete suggestions about how to select patients for ECG screening and monitoring...
February 26, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Deniz Aygün, Fatih Aygün, Kemal Nişli, Firdevs Baş, Agop Çıtak
Aim: We aimed to study electrocardiographic changes in children with diabetic ketoacidosis and ketosis and to evaluate the relation of the changes with serum electrolyte levels and ketosis. Material and Methods: This study was performed in Istanbul Medical Faculty, Pediatric Emergency and Intensive Care Department between May 2008 and May 2009. The electrocardiographic parameters and QT length of children with diabetic ketoacidosis and ketosis were evaluated at diagnosis and after the treatment...
December 2017: Türk Pediatri Arşivi
Adnan Yamanoglu, Nalan Gokce Celebi Yamanoglu, Tugba Evran, Ozgur Sogut
New substances are constantly being added to the content of synthetic cannabinoids (SCs). SCs can affect the cardiovascular system and cause hypotension and bradycardia, myocardial infarction, atrial fibrillation, prolonged QTc, and Mobitz type II atrioventricular block. However, no cases associated with ventricular fibrillation (VF) have been reported to date. We report a case of a 26-year-old male patient admitted to the emergency department due to altered consciousness after SC use and requiring prolonged cardiopulmonary resuscitation due to resistant VF and cardiogenic shock...
February 26, 2018: Journal of Clinical Ultrasound: JCU
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