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First-dose effects of fingolimod: Pooled safety data from three phase 3 studies.

Author: CohenJeffrey A, CollinsWilliam, DiMarcoJohn P, KapposLudwig, O'ConnorPaul, RederAnthony T, TangDejun, Zhang-AubersonLixin

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Overview

This report presents the first-dose fingolimod effects on cardiac parameters, using pooled data from phase 3 FREEDOMS, FREEDOMS II and TRANSFORMS studies. Fingolimod treatment initiation induced a transient slowing of heart rate and AV conduction, but symptomatic bradycardia and second-degree AV block were uncommon.
Paper Details　
Original Abstract of the Article :
Fingolimod treatment initiation is associated with a transient slowing of heart rate and atrioventricular conduction. This report presents first-dose fingolimod effects (0.5mg or 1.25mg) on cardiac parameters using phase 3 FREEDOMS, FREEDOMS II and TRANSFORMS pooled study data (n=3635 patients). Vit...See full text at original site
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引用元：
https://doi.org/10.1016/j.msard.2014.05.005

データ提供：米国国立医学図書館（NLM）

Fingolimod: First-Dose Effects on Heart Rate and Conduction

Fingolimod, an immunomodulatory drug used to treat multiple sclerosis, is known to have transient effects on heart rate and atrioventricular conduction. This report analyzes pooled data from three phase 3 clinical trials investigating the first-dose effects of fingolimod on cardiac parameters. The authors observed a transient decrease in heart rate after the first dose, with a maximum reduction of 8 beats per minute for the 0.5mg dose and 11 beats per minute for the 1.25mg dose. They also noted that symptomatic bradycardia and second-degree atrioventricular block were uncommon and typically well tolerated. The study provides valuable insights into the cardiac safety profile of fingolimod and the importance of careful monitoring during treatment initiation.

Understanding the Cardiac Effects of Fingolimod

This analysis highlights the transient effects of fingolimod on heart rate and atrioventricular conduction. The authors' findings emphasize the importance of careful monitoring during treatment initiation to minimize the risk of bradycardia and other cardiac complications. The study underscores the importance of individualized care and close collaboration between patients and healthcare professionals to ensure safe and effective treatment with fingolimod.

Living with Multiple Sclerosis: Navigating Treatment Options

Individuals diagnosed with multiple sclerosis should discuss treatment options with their healthcare providers, including the potential benefits and risks of fingolimod. It is important to understand the potential cardiac effects of fingolimod and the importance of monitoring during treatment initiation. Regular check-ups with a healthcare professional are crucial for ensuring safe and effective management of multiple sclerosis.

Dr.Camel's Conclusion

Just as a camel's heart rate adapts to the challenges of desert life, the body responds to fingolimod with transient changes in heart rate and conduction. This research provides a deeper understanding of these cardiac effects, highlighting the importance of close monitoring during treatment initiation. By working closely with healthcare professionals, patients can navigate the complexities of multiple sclerosis treatment and strive for a healthier future.

Date :
  1. Date Completed 2016-02-22
  2. Date Revised 2015-08-12
Further Info :

Pubmed ID

26265275

DOI: Digital Object Identifier

10.1016/j.msard.2014.05.005

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Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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