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Adverse outcomes from blood clot therapy may be due to patient characteristics, not dosing errors

Even though incorrect dosing occurs in about 5 percent of patients with heart attack who receive a certain blood clot dissolving therapy, patient-related factors appear to be more responsible for adverse outcomes, not dosing errors, according to a study in the April 13 issue of JAMA.

Several studies have reported higher death, stroke, and major hemorrhagic event rates in patients who received incorrect doses of fibrinolytic (clot-busting) agents, according to background information in the article. However, several patient factors identified as related to risk of incorrect dosing are also markers of higher risk of death, thereby limiting inference about the cause and effect relationship of incorrect dosing and adverse outcomes. It has been assumed that the adverse outcomes are caused by incorrect dosing. However, it is also possible that the adverse outcomes may be due to confounding factors, such that sicker patients with an unstable early clinical course could be more likely to receive incorrect doses.

Rajendra H. Mehta, M.D., M.S., of Duke Clinical Research Institute and Duke University Medical Center, Durham, N.C., and colleagues conducted a study to determine how much of the association between incorrect dosing and adverse outcomes is cause and effect. Because every patient received both an active fibrinolytic and a placebo, the researchers were able to hypothesize that if the incorrect dose was causing adverse outcomes, the association between incorrect dosing of active fibrinolytic and adverse outcome would be much stronger than the association between incorrect dosing of placebo.

The study included 16,949 patients with heart attacks who were enrolled in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) trial. Patients were assigned to one of two clot-dissolving fibrinolytic treatments: either tenecteplase (given as a five second bolus; with alteplase placebo) or alteplase (given as a bolus plus infusion, wit
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Contact: Richard Merritt
919-660-1309
JAMA and Archives Journals
12-Apr-2005


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