Alendronate gastric ulcers

Abstract

Background : It appears likely that drugs other than NSAIDs may cause ulcers and ulcer complications (e.g. potassium chloride). Alendronate (Fosamax) is used in the treatment and prevention of metabolic bone disease and has also been associated with severe oesophageal damage and stricture. We have previously shown that the dose of alendronate used for Paget's disease (40 mg) causes gastric damage similar to NSAIDs. The usual dose for the treatment of postmenopausal osteoporosis is 10 mg per day. Aim : To investigate whether the 10 mg dose of alendronate causes gastric ulcers. Methods : We performed an endoscopist‐blind, crossover, randomized, single‐centre comparison of 10 mg of alendronate/day and placebo in volunteers aged 40 years or more. Video‐endoscopy was used to evaluate the presence and degree of mucosal damage to the oesophagus, stomach, or duodenal bulb after 7 and 14 days of treatment. Results : Twenty‐four healthy volunteers participated, including 15 women and nine men, ranging in age from 41 to 52 years. Visible gastric mucosal damage was present in nine (38%) who received alendronate compared to three (13%) in the placebo group. There was a marked difference in the severity of mucosal damage; there were no ulcers or large erosions in those receiving placebo. In contrast, potentially clinically significant gastric mucosal injury was seen in six subjects receiving alendronate (two developed antral ulcers and four had large (4–8 mm) superficial antral erosions) compared to none in the placebo group (P = 0.0219). One subject developed oesophageal damage in the form of multiple linear superficial erosions in the mid and distal oesophagus. Duodenal injury was not seen. Conclusion : Alendronate causes gastric ulceration, suggesting that alendronate use may be associated with ulcer complications such as acute upper gastrointestinal bleeding. The results of this study suggest the need for post‐marketing surveillance to clarify the nature, frequency and magnitude of any potential gastrointestinal side‐effects associated with the use of this drug.

Alendronate improves bone mineral density in primary biliary cirrhosis: A randomized placebo-controlled trial

“…Alendronate can be associated with injury of the gastric mucosa. 44 The rate of visible gastric mucosal damage caused by alendronate at therapeutic doses ranges between 24% and 38%, 45,46 much less than that observed with aspirin. The rate of potentially clinically significant mucosal damage is lower, ranging from 3% to 25%.…”

“…The rate of potentially clinically significant mucosal damage is lower, ranging from 3% to 25%. 46,47 A trial including 6,459 postmenopausal women recorded the occurrence of severe adverse events (gastroduodenal perforations, ulcers, and bleeding events) and demonstrated a similar rate in the alendronate and placebo groups (1.6% and 1.9%, respectively). 48 That study included only female patients.…”

Microencapsulation of sodium alendronate reduces drug mucosal damage in rats

“…Like other bisphosphonates, oral sodium alendronate treatment is associated with injuries of the upper gastrointestinal tract, most notably in the esophagus (de Groen et al, 1996;Graham & Malaty, 1999;Lanza et al, 2000). Adverse effects such as gastroesophageal inflammation and ulceration, esophageal erosions, and gastrointestinal bleeding have been associated with the ability of sodium alendronate to damage the epithelium by topical irritant effects (Lanza, 2003;Sener et al, 2005;Marshall et al, 2006).…”

Esofagite ulcerativa associada ao uso de alendronato de sódio: achados histopatológicos e endoscópicos

“…Seu mecanismo de ação consiste na diminuição da reabsorção óssea, através da inibição específica da atividade osteoclástica, sem interferir na formação óssea (8,11) . A presença de alterações nas mucosas do trato gastrointestinal superior e oral tem sido relatada em associação com o AL, desde a sua liberação comercial nos Estados Unidos e Reino Unido em 1995 (6,7,8) . Dentre as regiões acometidas, destaca-se o esôfago.…”