Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women.
OBJECTIVE
Bisphosphonates are effective treatment for osteoporosis, but upper gastrointestinal injury associated with some compounds has caused concern. This study compared the incidence of gastric ulcers after treatment with risedronate, a pyridinyl bisphosphonate, and alendronate, a primary amino bisphosphonate. Esophageal and gastroduodenal injury assessed by endoscopy scores was a secondary endpoint.


METHODS
Healthy, postmenopausal women (n = 515) received 5 mg risedronate (n = 255) or 10 mg alendronate (n = 260) for 2 weeks. At baseline and on days 8 and 15, subjects underwent endoscopy and evaluator-blinded assessment of the esophageal, gastric, and duodenal mucosa.


RESULTS
Gastric ulcers were observed during the treatment period in 9 of 221 (4.1%) evaluable subjects in the risedronate group compared with 30 of 227 (13.2%) in the alendronate group (P < 0.001). Mean gastric endoscopy scores for the risedronate group were lower than those for the alendronate group at days 8 and 15 (P </= 0.001). Mean esophageal and duodenal endoscopy scores were similar in the 2 groups at days 8 and 15. Esophageal ulcers were noted in 3 evaluable subjects in the alendronate group, compared with none in the risedronate group, and duodenal ulcers were noted in 1 evaluable subject in the alendronate group and 2 in the risedronate group.


CONCLUSIONS
At doses used for the treatment of osteoporosis, risedronate was associated with a significantly lower incidence of gastric ulcers than alendronate. These findings confirm that bisphosphonates differ in their potential to damage the gastroesophageal mucosa.
Lanza
F L
FL
Houston Institute for Clinical Research, Houston, Texas 77074, USA. dr.lanza@pdq.net
Hunt
R H
RH
Thomson
A B
AB
Provenza
J M
JM
Blank
M A
MA
D000328:Adult; D019386:Alendronate / Q000009:adverse effects*; D004384:Duodenoscopy; D004386:Duodenum / Q000187:drug effects* / Q000473:pathology; D004724:Endoscopy; D004945:Esophagoscopy; D004947:Esophagus / Q000187:drug effects* / Q000473:pathology; D012968:Etidronic Acid / Q000009:adverse effects* / Q000031:analogs & derivatives*; D005260:Female; D005773:Gastroscopy; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D000068296:Risedronic Acid; D016037:Single-Blind Method; D013270:Stomach / Q000187:drug effects* / Q000473:pathology; D013276:Stomach Ulcer / Q000139:chemically induced / Q000453:epidemiology
D000068296:Risedronic Acid; D012968:Etidronic Acid; D019386:Alendronate