In Low-Dose Aspirin Users

Purpose: In NSAID users, two strategies, PPI co-therapy or coxibs, are associated with reducing clinically significant upper GI events. Many osteoarthritis (OA) patients taking NSAIDs require low-dose aspirin (ASA) for cardiovascular prophylaxis. However, ASA use with nonselective (ns)-NSAIDs or coxibs further increases risks of GI events. No prospective study has compared GI risks of coxibs alone compared to ns-NSAID + PPI in patients taking low-dose ASA. This study compared the 12-wk GD ulcer rates among subjects taking low-dose ASA with either the combination of lansoprazole 30mg QD and naproxen 500mg BID (LAN+NAP) or celecoxib 200mg QD (CEL). Methods: 1045 OA subjects requiring chronic NSAIDs and daily ASA (81 mg or 325 mg QD) were enrolled in a randomized, prospective, double-blind, active-control study. H pylori negative subjects with <10 GD erosions at baseline endoscopy, no prior history of ulcer or GI bleed within the past year, and using stable NSAID doses prior to screening were randomized to LAN+NAP or CEL in addition to open-label ASA. 1014 met admission criteria and received ≥1 dose of study drug; 854 completed the end of study endoscopy (35 endoscoped for cause prior; 819 endoscoped as scheduled at wk 12). An ulcer was defined as a GD mucosal break ≥3 mm with depth. Results: Baseline characteristics of the two treatment arms did not significantly differ. Results are shown in the Table. The overall proportion of subjects reporting AEs was not significantly different between the treatment groups. Among the most common AEs were diarrhea (7% vs 4%; p = 0.02) and dyspeptic signs/symptoms (7% vs 10%; p = 0.03), for LAN+NAP compared to CEL, respectively.Table: Gastroduodenal Ulcer RatesConclusions: In patients taking low-dose ASA, the two pain relief strategies, LAN + NAP and CEL have similar GD ulcer rates. However, in ASA patients who have not recently taken NSAIDS nor coxibs, LAN + NAP has significantly lower GD ulcer rates.