Endoscopic evaluation of the effects of indobufen and aspirin in healthy volunteers.
This is an outcomes pharmacodynamic study using Nonsteroidal antiinflammatory agents, particularly acetylsalicylic acid (ASA), have been shown useful in various cardiovascular disorders, but they can be a major cause of iatrogenic gastrointestinal injury. Newer NSAIDs such as indobufen, an inhibitor of platelet aggregation that acts by reversibly inhibiting the platelet cyclooxygenase enzyme, have proven to be as effective as the older NSAIDs and appear to have a better gastrointestinal tolerability profile. When the gastroduodenal tolerability of 10 days of oral treatment with indobufen or ASA was assessed in healthy adult volunteers using endoscopic evaluation and the modified score scale of Lanza, only 1 of 18 (6%) volunteers who received indobufen had an increased erosion score at the completion of therapy, compared with 6 of 18 volunteers who received ASA (33%). Overall, both drugs were well tolerated. These results suggest that indobufen has a lower incidence of gastrointestinal effects than other NSAIDs and should be useful in the management of patients with cardiovascular disease.
Institute for Pharmacokinetic and Analytical Studies, Ligornetto, Switzerland.
A
A
Marzo
S
S
Crestani
I
I
Fumagalli
A
A
Giusti
D T
DT
Lowenthal
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005753:Gastric Mucosa / Q000473:pathology*; D006801:Humans; D054833:Isoindoles; D008297:Male; D008875:Middle Aged; D010654:Phenylbutyrates / Q000009:adverse effects*; D016037:Single-Blind Method
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D054833:Isoindoles; D010654:Phenylbutyrates; C020371:indobufen; D001241:Aspirin