But What Does it Mean for The Patient in the Real Clinical Arena?

Implications: 1. The results are intriguing, but the clinical relevance for the large number of patients who could be exposed in the real-life clinical situation is uncertain. 2. The hypotheses for thsi program early-on seem to be supported by the phase 3 data to date, i.e., the nitro-comopounds may have actions that are different than their parent compounds. 3. It will be inteesting to see across finished studies what the actual effects on blood pressure may be.

Analysis: These results are intriguing from both a hypothetical and practical point of view for patient health and welfare. It remains to be seen whether the hypotensive effect is conssitent across finished phase 3 studies and, eventually, in the post-marketing environment. It must be remembered that a decrease in DBP or SBP is to be generally considered a positive effect (as long as a precipitous hypotensive effect is not seen); however, statistical significance is not the same as clinical relevance for the average patient with osteoarthritis being treated with an NSAID. Thus, the actual data from the completed studies will need to be evaluated to ascertain if a statistically significant result in lowering of SBP and/or DBP for Naprocinod vs. e.g., Napoxen is really clinically meaningful to the majority of patients under treatment for osteoarthritis. The FDA wilil be the final arbiter of any labeling claim that the Sponsor wishes to make for the product and it is likely that an FDA Advisory Committee will be asked to comment on such a claim.