Sublingual collagen-cogrinded aspirin (50 mg and 100 mg) significantly reduced or abolished gastric mucosal lesions at 7 days compared to standard aspirin, with similar TXB2 levels.
RCT (n=200)
Double-blind
Randomly assigned
Does a novel sublingual aspirin formulation reduce gastric mucosal injury compared to standard aspirin in healthy volunteers?
A novel sublingual collagen-cogrinded aspirin formulation provides equivalent thromboxane inhibition to standard aspirin but with significantly reduced gastric mucosal injury in healthy volunteers.
Low-dose aspirin represents the best option in the secondary prevention of coronary artery disease, but its extensive use in primary prevention is limited by the occurrence of gastric mucosal lesions and increased risk of bleeding. We investigated the safety profile of a novel sublingual aspirin formulation in 200 healthy volunteers, randomly assigned to ten (n = 20 each) different 7-day once-daily treatment regimens. Gastric mucosal injury based on the modified Lanza score (MLS), the histopathology of gastric mucosa and the serum determination of thromboxane B2 (TXB2) and urinary 11-dehydro-TXB2 levels were evaluated at basal as well as after 7 days of each placebo or aspirin treatment regimen. In Groups A and B (placebo—oral and sublingual, respectively), no changes in MLS and in gastric mucosal micro-vessel diameter were found at day 7. In contrast, in Groups C and D (oral standard aspirin—100 and 50 mg daily, respectively), the median MLS was significantly increased. Very few changes were found in Groups E and F (standard sublingual aspirin—100 and 50 mg, respectively). Groups G and H (oral administration of micronized collagen-cogrinded aspirin) showed gastric protection compared to Groups C and D. Moreover, Groups I and L (sublingual collagen-cogrinded aspirin—100 and 50 mg, respectively) showed a significant reduction (Group I) or total abolition (Group L) of gastric mucosal lesions and no difference compared to the standard one in serum TXB2 and urinary 11-dehydro-TXB2 levels. In conclusion, our data show that the new formulation leads to a better safety profile compared to standard aspirin, representing a better therapeutic option for extended use in primary and secondary prevention of cardiovascular diseases.
Mollace et al. (Thu,) conducted a rct in Healthy volunteers (n=200). Sublingual collagen-cogrinded aspirin vs. Placebo and standard oral/sublingual aspirin was evaluated on Gastric mucosal injury based on the modified Lanza score (MLS), histopathology of gastric mucosa, serum TXB2, and urinary 11-dehydro-TXB2 levels. Sublingual collagen-cogrinded aspirin (50 mg and 100 mg) significantly reduced or abolished gastric mucosal lesions at 7 days compared to standard aspirin, with similar TXB2 levels.