IMPORTANCE It remains unclear whether dabigatran etexilate mesylate is associated with higher risk of bleeding than warfarin sodium in real-world clinical practice. OBJECTIVE To compare the risk of bleeding associated with dabigatran and warfarin using Medicare data. DESIGN, SETTING, AND PARTICIPANTS In this retrospective cohort study, we used pharmacy and medical claims in 2010 to 2011 from a 5% random sample of Medicare beneficiaries. We identified participants as those newly diagnosed as having atrial fibrillation from October 1, 2010, through October 31, 2011, and who initiated dabigatran or warfarin treatment within 60 days of initial diagnosis. We followed up patients until discontinued use or switch of anticoagulants, death, or December 31, 2011. EXPOSURES Dabigatran users (n = 1302) and warfarin users (n = 8102). MAIN OUTCOMES AND MEASURES We identified any bleeding events and categorized them as major and minor bleeding by anatomical site. Major bleeding events included intracranial hemorrhage, hemoperitoneum, and inpatient or emergency department stays for hematuria, gastrointestinal, or other hemorrhage. We used a propensity score weighting mechanism to balance patient characteristics between 2 groups and Cox proportional hazards regression models to evaluate the risk of bleeding. We further examined the risk of bleeding for 4 subgroups of high-risk patients: those 75 years or older, African Americans, those with chronic kidney disease, and those with more than 7 concomitant comorbidities. RESULTS Dabigatran was associated with a higher risk of bleeding relative to warfarin, with hazard ratios of 1.30 (95% CI, 1.20-1.41) for any bleeding event, 1.58 (95% CI, 1.36-1.83) for major bleeding, and 1.85 (95% CI, 1.64-2.07) for gastrointestinal bleeding. The risk of intracranial hemorrhage was higher among warfarin users, with a hazard ratio of 0.32 (95% CI, 0.20-0.50) for dabigatran compared with warfarin. Dabigatran was consistently associated with an increased risk of major bleeding and gastrointestinal hemorrhage for all subgroups analyzed. The risk of major bleeding among dabigatran users was especially high for African Americans and patients with chronic kidney disease. CONCLUSIONS AND RELEVANCE Dabigatran was associated with a higher incidence of major bleeding (regardless of the anatomical site), a higher risk of gastrointestinal bleeding, but a lower risk of intracranial hemorrhage. Thus, dabigatran should be prescribed with caution, especially among high-risk patients.
BACKGROUND It is not known what effect the increased use of prescription drugs by enrollees in Medicare Part D has had on spending for other medical care. METHODS We compared spending for prescription drugs and other medical care 2 years before the implementation of Part D in January 2006 with such expenditures 2 years after the program’s implementation in four groups of elderly beneficiaries: Medicare Advantage enrollees with stable, uncapped, employer-based drug coverage throughout the study period (no-cap group), those who had no previous drug coverage, and those who had previous limited benefits (with either a $150 or a $350 quarterly cap) before they were covered by Part D in 2006. RESULTS Between December 2005 and December 2007, as compared with the increase in the no-cap group, the increase in total monthly drug spending was $41 higher (95% confidence interval [CI], $33 to $50) (74%) among enrollees with no previous drug coverage, $27 higher (95% CI, $20 to $34) (27%) among those with a previous $150 quarterly cap, and $13 higher (95% CI, $8 to $18) (11%) among those with a previous $350 cap. The use of both lipid-lowering and antidiabetic medications rose in the groups with no or minimal previous drug coverage. As compared with expenditures in the no-cap group, monthly medical expenditures (excluding drugs) were $33 lower (95% CI, $29 to $37) in the group with no previous coverage and $46 lower (95% CI, $29 to $63) in the group with a previous $150 quarterly cap, whereas medical spending was $30 higher (95% CI, $25 to $36) in the group with a previous $350 cap. CONCLUSIONS Enrollment in Medicare Part D was associated with increased spending on prescription drugs. Groups that had no or minimal drug coverage before the implementation of Part D had reductions in other medical spending that approximately offset the increased spending on drugs, but medical spending increased in the group that had more generous previous coverage.
Key Points Question How does the risk of overdose change with the number of days with concurrent opioid and benzodiazepine use? Findings In this cohort study of US Medicare data, the overdose risk associated with concurrent benzodiazepine use changed over time. Concurrent benzodiazepine use was associated with a 5-fold increase in the risk of opioid-related overdose during the initial 90 days and an increase of 1.87 times on days 91 to 180. Meaning Policy interventions should focus on preventing concurrent opioid and benzodiazepine use in the first place instead of reducing the length of concurrent use. Patients using both medications should be closely monitored, particularly during the first days of concurrent use.
ABSTRACT:We calculated prescription drug usage in two groups of Medicare beneficiaries: employer group with no coverage gap, and individual Part D group with no coverage or some generic drug coverage in the coverage gap. Among those with employer coverage, 40 percent reached the doughnut hole, compared with 25 percent of those without such coverage. Overall, 5 percent went through the doughnut hole to reach the catastrophic coverage level. Those lacking coverage in the doughnut hole reduced their drug use by 14 percent; those with generic coverage reduced their use by 3 percent. Coverage of generic drugs with a $0-$10 copayment in the doughnut hole could be financed by, at most, a six-to-ninepercentage-point increase in initial coinsurance. [Health Affairs 28, no. 2 (2009): w317-w325
Part D increased adherence to medications that reduce the risk of cardiovascular events for patients with hypertension, diabetes, and hyperlipidemia. This should improve the health of the elderly people in the long run.
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