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Anticoagulants: Evidence-Based Medicine, Not Always Ethical.

Francesco Marongiu1,2, Antonella Mameli3, Silvia Marongiu3

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Evidence-based medicine (EBM) trials for anticoagulants in venous thromboembolism (VTE) and atrial fibrillation (AF) sometimes lacked ethical considerations. Placebo controls and non-inferiority margins in randomized clinical trials (RCTs) may have caused harm.

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Area of Science:

  • Medical Ethics
  • Clinical Trial Methodology
  • Evidence-Based Medicine

Background:

  • Evidence-based medicine (EBM) disseminates scientific methods but has faced ethical challenges.
  • Early EBM lacked ethical consideration in managing venous thromboembolism (VTE) and atrial fibrillation (AF).
  • The convergence of EBM and ethical principles in anticoagulant development requires critical review.

Purpose of the Study:

  • To critically review the ethical considerations in EBM for anticoagulant use in VTE and AF.
  • To analyze whether methodological rigor in trials has overshadowed clinical ethics.
  • To explore the justification and ethical implications of placebo-controlled trials and non-inferiority margins.

Main Methods:

  • Critical review of key randomized clinical trials (RCTs) for anticoagulant treatment and prevention in VTE and AF.
  • Analysis of the ethical justification for using placebo controls versus observational data.
  • Evaluation of non-inferiority margin methodology in anticoagulant trials.

Main Results:

  • Several RCTs using placebo controls for anticoagulants were ethically questionable, given existing evidence from observational studies.
  • The use of placebos in certain trials led to unjustified mortality and morbidity.
  • Non-inferiority margin methodology may be too generous, potentially leading to a 'biocreep' phenomenon.

Conclusions:

  • Over-reliance on RCTs, sometimes with flawed methodology (e.g., unethical placebos), can disadvantage patient care.
  • Methodological rigor in EBM must be balanced with ethical principles, especially in anticoagulant research.
  • A re-evaluation of trial design and ethical oversight is crucial for advancing patient care and clinical investigation.