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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. [ABSTRACT FROM AUTHOR]

The article discusses the importance of electrocardiogram (ECG) reading on clinical research and practice. It stresses that it is critical in data collection during clinical research with the investigational drug's cardiac safety profile, especially the interval duration measurements of heart activity, emphasizing ECG centralization. It suggests that relevance of the findings should also be associated with one's prior history and current health status.

The article discusses the scientific approach in the centralization of electrocardiogram (ECG) Phase III on cardiac safety risk assessment. It emphasizes the QT wave interval prolongation, or the contraction and repolarization of cardiac muscles, on polymorphic ventricular tachycardia or torsades de pointes during drug interaction. The clinical trial "Thorough QT/QTc (TQT) Study" promotes cardiac safety data collection associated with market drugs and further enhances assessment.

The article discusses the implication of electrocardiography (ECG) in the development of drugs as well as the use of laboratories. According to the article, ECGs are used to gather information as well as assess the effect of investigational drugs on the electrical functions of the heart. In addition, it states that sponsors should consider several factors such as reducing the price they pay for research since it does not give them the assurance that all the results are correct. INSET: Homework for Sponsors.