A cohort study of the incidence of serious @entity99 in XXXX @entity1 treated with hypoglycemic agents.

@entity1 @entity6 @entity4506 @entity879 @entity648 @entity409 @entity492 @entity4136 @entity99 @entity493 @entity2449
BACKGROUND: The incidence of @entity879 or serious @entity99 in @entity6 @entity1 is needed to evaluate the safety of hypoglycemic drug therapy. METHODS: We conducted a retrospective cohort study of 5 health maintenance organizations. Study @entity1 were 171,264 health plan members 19 years or older when they received oral hypoglycemic drugs or insulin between April 1, 1997, and June 30, 1999. We searched for hospital discharge diagnoses and procedures potentially indicative of @entity99 and reviewed the full-text medical records. @entity879 was defined as acute @entity409 and (1) @entity99 , (2) prothrombin time prolongation greater than 3 seconds or international normalized ratio greater than 1.5, and (3) a total @entity648 level greater than 3.0 mg/dL (>51 micro mol/L). @entity99 was diagnosed in individuals who did not meet 1 or more of the criteria for @entity879 but had @entity493 transaminase or @entity492 transaminase levels greater than 500 U/L. RESULTS: We identified 35 cases of @entity879 or injury not clearly attributable to a known cause other than use of hypoglycemic agents. The age- and sex-standardized incidence per 1000 @entity1 -years was 0.15 for insulin users, 0.08 for @entity4136 users, 0.12 for @entity2449 users, and 0.10 for @entity4506 users. The incidence was higher (on the order of 0.3 per 1000) during the first 6 months of exposure to all hypoglycemic agents. CONCLUSIONS: @entity879 or injury not clearly attributable to other known causes occurred on the order of 1 per 10,000 @entity1 -years among @entity6 @entity1 treated with oral hypoglycemic drugs or insulin.
