Randomized, double-blind, pilot study of geranylgeranylacetone versus placebo in patients taking low-dose enteric-coated aspirin. Low-dose aspirin-induced small bowel damage

Abstract

Objective. Low-dose enteric-coated aspirin is increasingly being used for prevention of cardiovascular disease. The aim of this study was to evaluate whether geranylgeranylacetone (GGA) could prevent aspirin-induced small bowel injury. Material and methods. This was a prospective, randomized, double-blind, pilot study of GGA versus placebo in subjects taking low-dose enteric-coated aspirin. Young healthy volunteers were enrolled and each received 100 mg of enteric-coated aspirin per day plus either GGA (150 mg/day) or matching placebo for 7 days. Video capsule endoscopy of the small bowel and the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire were performed before and after the administration of aspirin. Results. Twenty volunteers were evaluated. There was no significant difference in the number of lesions in any category between those receiving or not receiving GGA. Large erosions or ulcers were observed in 12 (60%; 95% confidence interval 36%-80%) aspirin users. Mucosal breaks were most frequently found in the latter half of the proximal small bowel. Conclusions. Short-term administration of low-dose enteric-coated aspirin was associated with visible small bowel damage in the majority of users. We could not prove that aspirin-induced small bowel mucosal injury was prevented by GGA.

Small bowel ulcerative lesions are common in elderly NSAIDs users with peptic ulcer bleeding

“…Nevertheless data on peptic ulcer patients are limited [12] . In our study, prevalence of small bowel ulcerative lesions in NSAID users with non-bleeding peptic ulcer equals the mean of medical literature for non-ulcer NSAIDs consumers [1,23,[25][26][27] , even that reported by our group for NSAID consumers with iron deficiency anemia [13] . On the contrary, prevalence of small bowel ulcerative lesions was much higher among NSAID consumers with peptic ulcer bleeding.…”

“…Nevertheless recent reports suggest that proton pump inhibitors could exacerbate small bowel ulcerative lesions [22] . Small bowel ulcerative lesions are more frequent in reports including chronic NSAID consumers [1,23] than those including healthy volunteers who received NSAIDs short-term [8,[23][24][25][26] . A head to head comparison in our study revealed no difference between short and long-term NSAID consumers with concurrent peptic ulcer.…”

“…Thus, some kind of mucosal adaptation, such as heme oxygenase-1 up regulation [27] , could have balanced NSAIDs deleterious effect over time [1] . Small bowel injury and clinically relevant complications associated with the use of NSAIDs, even small dose aspirin, are well recognized [23,[25][26][27] . Nevertheless data on peptic ulcer patients are limited [12] .…”

Antiplatelet therapy with acetylsalicylic acid: Approaches to reducing the frequency of gastrointenstinal adverse reactions

“…Прием мизопростола 200 мкг 4 раза в день в течение 8 нед оказался эффективен при лечении индуцированной АСК энтеропатии [48]. Помимо аналогов про-стагландинов разрабатываются и апробируются другие химиче-ские соединения с цитопротективной активностью в тонкой киш-ке (Rebamipide, Teprenone, Polaprezinc, Irsogladine maleate), но по-ка они доступны только в нескольких азиатских странах [49][50][51].…”

Associations between drugs and small‐bowel mucosal bleeding: Multicenter capsule‐endoscopy study

“…3,4,[6][7][8][9][10][11]15,[18][19][20][21][22][23][24][25][26] However, in most studies, the primary endpoint was smallbowel mucosal injury, and the outcomes did not include smallbowel overt bleeding. In addition, these studies had small sample sizes, and half of them included healthy subjects and nonhospital-based patients.…”