The Suspension of Treatments in ADAPT: Concerns beyond the Cardiovascular Safety of Celecoxib or Naproxen
2006

Concerns about Stopping Treatments in the ADAPT Trial

publication

Author Information

Author(s): John C. S. Breitner, Barbara K. Martin, Curtis L. Meinert

Primary Institution: University of Washington, Johns Hopkins Bloomberg School of Public Health

Conclusion

The decision to suspend treatments in the ADAPT trial was influenced by safety concerns, despite the data suggesting little cardiovascular risk.

Supporting Evidence

  • The ADAPT Steering Committee was responsible for the decision to suspend treatments.
  • The suspension of celecoxib was due to safety concerns raised by Pfizer.
  • The decision to suspend naproxen was complicated by operational issues.

Takeaway

The researchers had to stop giving certain medications in a study because they were worried about safety, even though the data didn't clearly show they were dangerous.

Potential Biases

There may be bias in how the safety data were interpreted and reported.

Limitations

The safety data were not definitive and were not collected to test specific hypotheses.

Digital Object Identifier (DOI)

10.1371/journal.pctr.0010041

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