Gastric and duodenal safety of daily alendronate
Gastric and duodenal safety of daily alendronate
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DOI：
10.1001/archinte.162.8.936
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发表时间：
2002-04-22
影响因子：
--
通讯作者：
Platt, R
中科院分区：
文献类型：
--
作者：
Donahue, JG;Chan, KA;Platt, R
背景：使用阿仑膦酸钠后胃溃疡的孤立病例报告引起了对每日阿仑膦酸钠胃十二指肠安全性的关注。这项研究进行估计的过度风险住院治疗胃或十二指肠穿孔，溃疡，出血与阿仑膦酸钠use.Participants和方法：研究对象是6432名男性和女性，35岁或以上。受试者是8个健康维护组织的成员，他们在1995年10月至1997年9月期间服用了阿仑膦酸钠。还有一组33176年龄，性别和健康维护组织匹配的未暴露的人。由于担心骨质疏松症可能混淆阿仑膦酸钠使用与穿孔、溃疡或出血之间的关系，第二个对照组由9776名60岁或以上的骨质疏松性骨折妇女组成。胃十二指肠事件的住院治疗由自动索赔记录中的出院诊断代码确定，并通过手动记录review.Results确认：基于阿仑膦酸钠组和未暴露组中的14例确认事件，阿仑膦酸钠队列的胃十二指肠穿孔，溃疡或出血的粗发病率比为3.0。在控制了既往住院、合并症和近期暴露于处方非甾体类药物和口服皮质类固醇后，发病率比为1.8（95%置信区间为0.83.9）。年龄、性别和健康维护组织限制的阿仑膦酸钠使用者队列相对于骨折队列的粗发病率比为1.1，校正后的发病率比为1.1（95%置信区间，0.6-2.2）。骨质疏松症和相关因素似乎在阿仑膦酸钠使用与确诊的胃十二指肠穿孔、溃疡、或出血;在未校正的分析中，我们观察到阿仑膦酸钠使用者风险增加的很大一部分是混杂的结果。
Background: Isolated case reports of gastric ulcers after alendronate sodium use raised concern about the gastroduodenal safety of daily alendronate. This study was conducted to estimate the excess risk of hospitalizations for gastric or duodenal perforations, ulcers, and bleeding associated with alendronate use.Participants and Methods: Study subjects were 6432 men and women, 35 years or older. The subjects were members of 8 health maintenance organizations who were dispensed alendronate from October 1995 through September 1997. There was also a group of 33176 age-, sex-, and health maintenance organization-matched unexposed persons. Because of concerns that osteoporosis might confound the association between alendronate use and perforation, ulcer, or bleeding, a second comparison group of 9776 women, 60 years or older, who had osteoporotic fractures was assembled. Hospitalizations for gastroduodenal events were identified by discharge diagnosis codes in automated claims records, and confirmed by manual record review.Results: Based on the 14 confirmed events in the alendronate group and 35 in the unexposed group, the crude incidence rate ratio of gastroduodenal perforation, ulcer, or bleeding for the alendronate cohort was 3.0. The incidence rate ratio was 1.8 (95% confidence interval, 0.83.9) after control for prior hospitalizations, comorbidity, and recent exposure to prescription nonsteroidal antiinflammatory drugs and oral corticosteroids. The crude incidence ratio rate for the age, sex, and health maintenance organizations-restricted cohort of alendronate users relative to the fracture cohort was 1.1 and the adjusted incidence rate ratio was 1.1 (95% confidence interval, 0.6-2.2).Conclusions: Osteoporosis and related factors appear to play an important role in the relationship between alendronate use and confirmed gastroduodenal perforation, ulcer, or bleeding; a substantial fraction of the increased risk we observed for alendronate users in the unadjusted analysis was the result of confounding.