COX-2: where are we in 2003?--distinction from NSAIDs becoming blurred.

The distinction between cyclooxygenase-2-selective inhibitors (CSIs) and nonsteroidal anti-inflammatory drugs ultimately must be clinical and must be clinically and economically relevant. This distinction needs to be demonstrated in a substantial and clinically relevant difference in the respective rates of serious adverse reactions of the upper gastrointestinal tract. Event-driven, randomized, blinded, controlled trials with sufficient power are required to resolve uncertainties concerning the relative risk of thrombotic cardiovascular events in patients taking CSIs who have risk factors for these events. Patients and situations more representative of those in primary-care practice - elderly, comorbidities, comedication - need to be included in larger studies to provide a better understanding of the risks and benefits of CSIs.