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Valdecoxib, a COX-2-specific inhibitor, does not affect cardiac repolarization.
Nenad Sarapa1, Margaret R Britto, Barbara Cotton
1Department of Clinical Pharmacology, Pharmacia Corporation, 5200 Old Orchard Road, Skokie, IL 60077, USA.
Journal of Clinical Pharmacology
|September 16, 2003
Summary
Valdecoxib, a COX-2 inhibitor, did not prolong the QTc interval in healthy adults, even at supratherapeutic doses. This suggests valdecoxib does not increase the risk of cardiac arrhythmia associated with QT prolongation.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- QTc interval prolongation is a potential safety concern for some medications.
- Valdecoxib is a selective COX-2 inhibitor used for pain management.
Purpose of the Study:
- To evaluate the effect of valdecoxib on cardiac repolarization as measured by the QTc interval.
- To assess the safety of valdecoxib at therapeutic and supratherapeutic doses regarding cardiac electrical activity.
Main Methods:
- Double-blind, four-way crossover study in 34 healthy adults.
- Administration of placebo, 40 mg, 80 mg, or 120 mg valdecoxib daily for 5 days.
- Serial electrocardiograms (ECGs) collected to measure QTc interval duration.
Main Results:
- No statistically significant QTc prolongation was observed compared to placebo across all valdecoxib doses.
- Pharmacokinetic analysis showed a greater than proportional increase in drug exposure with increasing doses.
- The study was powered to detect small but clinically relevant changes in QTc interval.
Conclusions:
- Repeated administration of valdecoxib up to 120 mg had no effect on cardiac repolarization in healthy volunteers.
- These findings suggest that valdecoxib is unlikely to increase the risk of cardiac arrhythmia related to QT prolongation in patients.