TY - JOUR
T1 - Primary amino-bisphosphonates
T2 - A new class of gastrotoxic drugs - Comparison of alendronate and aspirin
AU - Graham, David Y.
AU - Malaty, H. M.
AU - Goodgame, Richard
PY - 1997
Y1 - 1997
N2 - Background: Alendronate and pamidronate are primary amino-bisphosphonates used in the treatment of metabolic bone disease. Both drugs have been associated with reversible erosive esophagitis and as a result pamidronate is approved in the United States only for parenteral use. In rats, alendronate causes acute gastric mucosal damage similar to that seen with aspirin or nonsteroidal anti-inflammatory drugs. Methods: We performed a blinded, crossover, randomized, single-center, placebo-controlled, endoscopie comparison of alendronate (40 mg/day), aspirin (1, 300 mg/day), and placebo to evaluate the presence and degree of mucosal damage to the esophagus, stomach, and duodenal bulb. Results: Twelve normal healthy volunteers were studied both before and after 4 days of drug therapy. Placebo caused no visible endoscopie damage. In contrast, both aspirin and alendronate were associated with visible gastric mucosal injury in the majority of those studied (75 and 58%, respectively) and both were significantly greater than placebo (p < 0.001). The gastric mucosal injury was deemed severe in 50% of those receiving alendronate or aspirin; one alendronate-associated gastric ulcer was seen. Esophageal and duodenal bulb injury was seen once each, and both were associated with alendronate. Conclusions: The primary amino-bisphosphonate alendronate causes mucosal injury to the upper gastrointestinal tract similar to aspirin. Even when used according to manufacturer's dosing instructions alendronate should probably be used with caution.
AB - Background: Alendronate and pamidronate are primary amino-bisphosphonates used in the treatment of metabolic bone disease. Both drugs have been associated with reversible erosive esophagitis and as a result pamidronate is approved in the United States only for parenteral use. In rats, alendronate causes acute gastric mucosal damage similar to that seen with aspirin or nonsteroidal anti-inflammatory drugs. Methods: We performed a blinded, crossover, randomized, single-center, placebo-controlled, endoscopie comparison of alendronate (40 mg/day), aspirin (1, 300 mg/day), and placebo to evaluate the presence and degree of mucosal damage to the esophagus, stomach, and duodenal bulb. Results: Twelve normal healthy volunteers were studied both before and after 4 days of drug therapy. Placebo caused no visible endoscopie damage. In contrast, both aspirin and alendronate were associated with visible gastric mucosal injury in the majority of those studied (75 and 58%, respectively) and both were significantly greater than placebo (p < 0.001). The gastric mucosal injury was deemed severe in 50% of those receiving alendronate or aspirin; one alendronate-associated gastric ulcer was seen. Esophageal and duodenal bulb injury was seen once each, and both were associated with alendronate. Conclusions: The primary amino-bisphosphonate alendronate causes mucosal injury to the upper gastrointestinal tract similar to aspirin. Even when used according to manufacturer's dosing instructions alendronate should probably be used with caution.
UR - http://www.scopus.com/inward/record.url?scp=0030802835&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0030802835&partnerID=8YFLogxK
M3 - Article
C2 - 9260798
AN - SCOPUS:0030802835
SN - 0002-9270
VL - 92
SP - 1322
EP - 1325
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 8
ER -