Does Plavix cause ulcers; what patients should know

The NEJM published a study suggesting that Plavix (clopidogrel) had a higher-than-previously-thought risk of ulcers:

Results

We enrolled 320 patients (161 patients assigned to receive clopidogrel and 159 to receive aspirin plus esomeprazole). Recurrent ulcer bleeding occurred in 13 patients receiving clopidogrel and 1 receiving aspirin plus esomeprazole. The cumulative incidence of recurrent bleeding during the 12-month period was 8.6 percent (95 percent confidence interval, 4.1 to 13.1 percent) among patients who received clopidogrel and 0.7 percent (95 percent confidence interval, 0 to 2.0 percent) among those who received aspirin plus esomeprazole (difference, 7.9 percentage points; 95 percent confidence interval for the difference, 3.4 to 12.4; P=0.001).

Conclusions

Among patients with a history of aspirin-induced ulcer bleeding whose ulcers had healed before they received the study treatment, aspirin plus esomeprazole was superior to clopidogrel in the prevention of recurrent ulcer bleeding. Our finding does not support the current recommendation that patients with major gastrointestinal intolerance of aspirin be given clopidogrel.

The NY Times picked up on this with their story, Study Raises Questions on Plavix Safety.

This study compared the incidence of ulcers in patients on Plavix as compared with aspirin (81mg) and Nexium (20mg). The aspirin/Nexium combination had a significantly lower incidence of ulcers.

Plavix is an antiplatelet medication used to prevent heart attacks and strokes, as well as in stent placement after angioplasty. It is currently recommended that those who have had a prior ulcer or other GI complications while on aspirin on NSAID be placed on Plavix instead. This study contradicts this recommendation, and the editorial suggests that a PPI be added the aspirin instead.

Studies have shown that Plavix only had a marginally lower risk of GI bleeding than aspirin (0.5 percent compared to 0.7 percent in 325mg of aspirin), so the results are not completely surprising.

With the current climate of adverse drug reactions, the NY Times headline is misleading. Plavix is an excellent and effective medication. There should be no concerns about its safety, like the COX-2 inhibitors. Instead, the take-home point should be that Plavix is no safer than over-the-counter aspirin.

Update:

JournalClub with an opinion.