With a number of drugs entering the market, cardiac safety remains a cause of major concern for the regulatory authorities, before approval. The incidence of drug induced arrhythmia with non-cardiovascular drugs is low, however the result is fatal, hence much focus is being given to assess the pro-arrhythmic potential of a drug. The arrhythmogenic risk of the drug is higher if the patient is on polypharmacy or has other risk factors such as an electrolyte imbalance or an underlying structural heart disease. QT prolongation can be either due to congenital causes such as Long QT syndromes (LQTS) which include Romano-Ward syndrome, Jervell and Lange-Nielson syndrome or can be acquired, which is mainly due to drugs. Several drugs such as terfenadine, astemizole, cisapride and grepafloxacin have been withdrawn from the market due to QT prolongation and development of a fatal ventricular arrythmia - torsades de pointes (TdP). This has led to implementation of guidelines to assess cardiac safety. The pro-arrhythmic risk can be assessed using thorough QT/QTc studies or exposure response modelling of intensive ECGs. This article will give an overall view of the use of QT/QTc interval as a biomarker for cardiac safety and the current guidelines for thorough QT/QTc studies which are mainly done to assess the pro-arrhythmic potential of a non-anti-arrhythmic drug.
Background: The presence of comorbidities and relative immunosuppression in chronic kidney disease patients on hemodialysis raises concerns that these patients may have an increased risk of severe COVID-19. We aimed to examine the presentation and in-hospital outcomes of COVID-19 patients with end stage renal disease requiring hemodialysis. Methods:To examine presentation and in-hospital outcomes of COVID-19 in patients with end stage renal disease requiring hemodialysis. The study was conducted in a tertiary care centre from June 2020 to December 2020. We collected clinical & laboratory data of 126 COVID-19 positive in-patients requiring hemodialysis. CKD patients referred to our centre for hemodialysis patients were also included. Patients requiring invasive ventilation and management in intensive care units were excluded. Patients were categorised into two groups based on their outcomes; survivors and non-survivors. Detailed history & biochemistry results were recorded and analysed using SPSS 20.0. Results: A total of 126 patients were included in our study, with male predominance, n=91(72.2%). The median age of our study population was 53 years. The main presenting complaints were fever, n=78(61.9%); cough, n=69(54.8%), dyspnea, n= 62(49.2%), fatigue, n=102(81%) and myalgia, n=51(40.5%). Eighty nine(70.6%) patients were hypertensives, 48 (38.1%) known diabetics and 13 (10.3%) had pre-existing chronic obstructive pulmonary disease. Lung involvement in CT imaging at the time of admission, were found in 93(85.5%) patients. On comparison between survivor and non-survivors, there was no statistical difference in the biochemical prole, however there was signicant chest imaging ndings (p<0.001) and requirement of ventilator (p<0.001) in the non-survivor group. Conclusion: In our study, mortality was high in patients showing chest imaging ndings and also in those requiring non-invasive ventilation even in non-intensive care setting, at admission. The high mortality in CKD patients on hemodialysis emphasizes the need of dedicated COVID hemodialysis units,to prevent interruption in routine outpatient stable dialysis patients.
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