Why the study?
Does ranitidine prevent aspirin-induced gastric mucosal damage in healthy male volunteers, and does the time of administration affect the severity of damage?
Does ranitidine prevent aspirin-induced gastric mucosal damage in healthy male volunteers, and does the time of administration affect the severity of damage?
Ranitidine protects against aspirin-induced gastric mucosal damage, which exhibits circadian variation with greater severity in the morning.
Supports ranitidine and evening aspirin dosing to limit gastric injury; confirms circadian variation in mucosal damage susceptibility.
The severity of gastric mucosal injury produced by aspirin (ASA) was endoscopically assessed during morning and evening studies in 10 healthy, male volunteers. In a randomized, double-blind design, subjects received either ASA (1300 mg) alone or ASA (1300 mg) plus Ranitidine (150 mg) or placebo tablets during morning and evening studies. Each subject had 3 morning and 3 evening studies. The severity of damage produced by ASA was assessed by counting the number of punctate mucosal hemorrhages observed in the gastric antrum and low-body. This study demonstrated (1) wide intersubject variability in the severity of damage produced by ASA (range of 47-1030 lesions/subject in morning studies), (2) significant protection against ASA-induced damage by Ranitidine and (3) significantly greater damage produced by ASA in the morning compared to the evening studies. Because evening acid secretory rates are higher and because ASA-induced damage is believed to be acid-dependent, this last observation was unexpected. It suggests mucosal resistance is higher in the evening and raises the possibility that there may be circadian variation in gastric mucosal resistance.
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Moore et al. (1987) studied this question.
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