Incidence of lactic acidosis in metformin users
Incidence of lactic acidosis in metformin users
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DOI：
10.2337/diacare.22.6.925
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发表时间：
1999-06-01
期刊：
影响因子：
16.2
通讯作者：
Butler-Jones, D
中科院分区：
文献类型：
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作者：
Stang, M;Wysowski, DK;Butler-Jones, D
目的-本研究的目的是确定二甲双胍users.RESEARCH设计和方法的地理定义的人口乳酸酸中毒的发病率-这项研究是基于萨斯喀彻温省卫生行政数据库的历史队列。在1980年至1995年（含）期间开过二甲双胍处方的个人有资格进入该队列。病例定义为出院时诊断为酸中毒（国际疾病分类，第九次修订代码：276.2），并通过病历审查确认血乳酸水平大于或等于5 mmol/l。二甲双胍处方后120天内死亡的个人死亡登记也进行了审查。结果-在研究期间，11,797名居民接受了一个或多个二甲双胍处方，导致22,296人-年的暴露。有10例受试者出院时诊断为酸中毒。然而，主要记录审查显示，仅2例病例的实验室检查结果为血乳酸水平升高，发生率为9例/100，000二甲双胍暴露人年。在这两种情况下，除二甲双胍外的其他因素可能导致乳酸酸中毒。结论-从1980年至1995年，乳酸酸中毒的发病率为9每100,000人年（95%CI 0-21）在加拿大萨斯喀彻温省的二甲双胍患者分发。该发生率来源于完全确定二甲双胍使用者中与乳酸酸中毒相关的住院和死亡的人群。这与先前发表的基于病例被动报告的发生率相似，并且远低于开药患者中40-64/100，000患者-年的乳酸酸中毒发生率。
OBJECTIVE - The purpose of this study was to determine the incidence of lactic acidosis in a geographically defined population of metformin users.RESEARCH DESIGN AND METHODS - The study was based on a historical cohort from the Saskatchewan Health administrative databases. Individuals with a metformin prescription dispensed between 1980 and 1995 inclusive were eligible for the cohort. Person-years of exposure were calculated Cases were defined by hospital discharge with a diagnosis of acidosis (International Classification of Diseases, Ninth Revision code: 276.2) and confirmation by chart review of a blood lactate level greater than or equal to 5 mmol/l. Death registrations of individuals dying within 120 days of a metformin prescription were also reviewed.RESULTS - During the study period, 11,797 residents received one or more metformin prescriptions, resulting in 22,296 person-years of exposure. There were 10 subjects who had hospital discharges with a diagnosis of acidosis. However, primary record review revealed only two cases with laboratory findings of elevated blood lactate levels, for an incidence rate of 9 cases per 100,000 person-years of metformin exposure. In both cases, other factors besides metformin could have contributed to the lactic acidosis. No additional cases were found on review of death registrations.CONCLUSIONS - From 1980 through 1995, the incidence rate of lactic acidosis was 9 per 100,000 person-years (95% CI 0-21) in patients dispensed metformin in Saskatchewan, Canada. This incidence rate was derived from a population with complete ascertainment of hospitalizations and deaths associated with lactic acidosis in metformin users. It is similar to previously published rates based on passive reporting of cases, and it is well below the lactic acidosis rate of 40-64 per 100,000 patient-years in patients prescribed phenformin.