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The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Dataset for amiodarone adverse events compared to placebo using data from randomized controlled trials.

Morgan K Moroi1, Mohammed Ruzieh2, Nader M Aboujamous3

  • 1Penn State College of Medicine, Hershey, PA, USA.

Data in Brief
|December 25, 2019
PubMed
Summary

This study analyzed adverse events from 43 trials comparing amiodarone to placebo. Amiodarone use was associated with increased risks across multiple organ systems, detailed in this comprehensive dataset.

Keywords:
Adverse eventsAmiodaroneToxicity

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Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Research

Background:

  • Amiodarone is an effective antiarrhythmic drug.
  • However, amiodarone is associated with a high incidence of adverse events.
  • A comprehensive understanding of these risks is crucial for patient management.

Purpose of the Study:

  • To systematically analyze and present the adverse events associated with amiodarone compared to placebo.
  • To provide a detailed dataset for assessing the relative risk (RR) of specific adverse events.
  • To explore the relationship between amiodarone dosage (loading and maintenance) and adverse event occurrence.

Main Methods:

  • Data extracted from 43 randomized controlled trials.
  • Independent data extraction by two authors (M.M., M.R.).
  • Mantel-Haenszel random effects model used to calculate relative risk (RR).

Main Results:

  • Detailed forest plots illustrating the RR of adverse events across pulmonary, thyroid, hepatic, cardiac, skin, gastrointestinal, neurological, and ocular systems.
  • Dataset includes baseline patient characteristics and amiodarone dosing information.
  • Comparative analysis of amiodarone versus placebo for various adverse events.

Conclusions:

  • The dataset provides a robust resource for evaluating amiodarone-induced adverse events.
  • Facilitates further research into risk stratification and management strategies.
  • Supports informed clinical decision-making regarding amiodarone therapy.