Transcript What about VIOXX?

What about VIOXX?
Adenomatous Polyp Prevention
on Vioxx (APPROVe)
Vioxx (rofecoxib) versus Placebo
Basic Clinical Trial
Objective: Assess whether Vioxx may prevent the
recurrence of benign polyps in patients who have a
history of such tumors.
Study Outcome: Stopping rule invoked due to
adverse safety finding: an increased risk of non-fatal
cardiovascular events in those taking Vioxx in 25mg
doses, which only became evident after 18 months.
VIOXX GI Outcomes Research
(VIGOR)
Vioxx versus Naproxen
Comparative Clinical Trial
Objective: Compare gastrointestinal (GI) outcomes in
subjects using NSAIDs.
Study Outcomes: New safety labeling for Vioxx.
Patients taking Vioxx had fewer stomach ulcers and
bleeding than patients taking naproxen, another nonsteroidal anti-inflammatory drug (NSAID).
However, the study also showed a greater number of
heart attacks in patients taking Vioxx.
Notes
Vioxx is a Cox-2 Inhibitor – the state of the
art class anti-inflammatory medication.
Other licensed drugs in this class include
Celebrex and Bextra, which remain on the
market.
Early Stopping Rules
For phase III randomized trials, these issues are typically under the
purview of an independent Data and Safety Monitoring Board
(DSMB), composed of statisticians and clinical investigators not
directly involved with the study.
The DSMB is responsible for reviewing the data, performing interim
analyses when the study reaches its specified number of events, and
deciding whether or not to close the study on the basis of
predetermined early stopping rules that relate to toxicity or outcome.
If excess harm is observed, or if a statistically significant benefit is
observed, the study is stopped early and the patient is informed of the
results.
If treatment is ongoing, the patient is typically offered the opportunity to
receive the regimen that is perceived to be superior.
Thus, the early stopping rule has the potential to minimize harm and to
maximize benefit for those patients enrolled in a randomized trial.