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Purpose Bleeding complications are a serious adverse effect of medications that prevent abnormal blood clotting. To facilitate epidemiologic investigations of bleeding complications, we developed and validated an automated database case definition for bleeding-related hospitalizations. Methods The case definition utilized information from an in-progress retrospective cohort study of warfarin-related bleeding in Tennessee Medicaid enrollees 30 years of age or older. It identified inpatient stays during the study period of January 1990 through December 2005 with diagnoses and/or procedures that indicated a current episode of bleeding. The definition was validated by medical record review for a sample of 236 hospitalizations. Results We reviewed 186 hospitalizations that had medical records with sufficient information for adjudication. Of these, 165 (89% [95% CI, 83%-92%]) were clinically confirmed bleeding-related hospitalizations. An additional 19 hospitalizations (10% [7%-15%]) were adjudicated as possibly bleeding-related. Of the 165 clinically confirmed bleeding-related hospitalizations, the automated database and clinical definitions had concordant anatomical sites (gastrointestinal, cerebral, genitourinary, other) for 163 (99% [96%-100%]). For those hospitalizations with sufficient information to distinguish between upper/lower gastrointestinal bleeding, the concordance was 89%(76%-96%) for upper gastrointestinal sites and 91%(77%-97%) for lower gastrointestinal sites. Conclusion A case definition for bleeding-related hospitalizations suitable for automated databases had a positive predictive value of between 89% and 99% and could distinguish specific bleeding sites.

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Background Proton-pump inhibitors (PPIs) and clopidogrel are frequently co-prescribed though the benefits and harms of their concurrent use are unclear. Objective To examine the association between concurrent PPI and clopidogrel use and the risks for gastroduodenal bleeding hospitalizations and serious cardiovascular disease. Design Retrospective cohort study that used automated data to identify patients who received clopidogrel between 1999 through 2005 following hospitalization for coronary heart disease. Setting Tennessee Medicaid Program Patients 20,596 patients (including 7593 concurrent users of clopidogrel and PPIs) hospitalized for myocardial infarction, coronary artery revascularization, or unstable angina pectoris. Measurements Baseline and followup drug use assessed from automated records of dispensed prescriptions. Primary outcomes were hospitalizations for gastroduodenal bleeding and serious cardiovascular disease (fatal or nonfatal myocardial infarction/sudden cardiac death, stroke, or other cardiovascular death). Results Pantoprazole and omeprazole accounted for 62% and 9% of the concurrent PPI use. Adjusted gastroduodenal bleeding hospitalization incidence in concurrent PPI users was 50% lower than that in nonusers (HR, 0.50 [95% CI, 0.39 to 0.65]). For patients at highest risk of bleeding, PPI use was associated with an absolute reduction of 28 (12 to 37) gastroduodenal bleeding hospitalizations per 1000 person years. The hazard ratio associated with concurrent PPI use for risk of serious cardiovascular disease was 0.99 (CI, 0.82 to 1.19) and was 1.01 (CI, 0.77 to 1.30) among patients who had percutaneous coronary interventions with stenting. Limitations There was possible unmeasured confounding and misclassification of exposure (no information on adherence or over-the-counter use of drugs) and endpoints (not confirmed by medical record review). Because many patients entered the cohort from hospitals with relatively few cohort members, the analysis relied on the assumption that after adjusting for observed covariates, PPI users from one such hospital could be compared with nonusers from a different hospital. Conclusion Among patients with serious coronary heart disease treated with clopidogrel, concurrent PPI use was associated with reduced incidence of gastroduodenal bleeding hospitalizations. The corresponding point estimate for serious cardiovascular disease was not increased; however, the 95% confidence interval included a clinically important increased risk. Funding Agency for Healthcare Quality and Research, National Heart Lung and Blood Institute.

These findings, if confirmed, may provide a new avenue for the personalized prevention of magnesium deficiency and, thus, colorectal cancer.

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