Abstract：
OBJECTIVE:The objectives of this study were to observe a commercially insured sample diagnosed with a venous thromboembolism (VTE) event and treated postevent with warfarin and to detail the thromboembolic and bleeding outcomes in the time periods during warfarin therapy and after discontinuation of such therapy. METHODS:This retrospective, observational cohort study used medical, pharmacy, and eligibility data from 2 US health plans. Study inclusion required an inpatient diagnosis of deep venous thrombosis (DVT) or pulmonary embolism (PE) between January 1, 1998, and December 31, 2000; warfarin, heparin, or low-molecular-weight heparin within 30 days after diagnosis; no VTE diagnosis; and no anticoagulant use for 3 months preceding diagnosis. A random sample of medical charts was abstracted to validate VTE events and collect prothrombin time/international normalized ratio (INR) result data. Recurrent VTE events, bleeding events, and proportion of time within INR range were captured in the postindex VTE event time period. Univariate and multivariate statistical techniques were used to assess outcomes. RESULTS:A total of 2,090 patients were identified with a newly diagnosed VTE event (DVT only, 1450; PE with or without DVT, 640). Mean (SD) age was 61.7 (16) years; mean (SD) follow-up time after the index diagnosis was 21.3 (10) months. Overall mean (SD) length of warfarin therapy was 6.6 (6) months. During the follow-up period, 224 patients (10.7%) experienced a recurrent VTE event and 122 patients (5.8%) experienced a bleeding event requiring hospitalization. The cumulative incidence of recurrent VTE events over 3 and 6 months was 9.0% and 10.9%, respectively. Using the chart abstraction subset, patients were within the appropriate INR range 37.7% of the time while receiving warfarin. CONCLUSIONS:Negative outcomes associated with warfarin therapy-recurrent VTE events and bleeding requiring hospitalization-were experienced by 10.7% and 5.8% of patients, respectively. These data suggest that negative outcomes may be more prevalent in usual community medical practice compared with rates observed in the controlled environment of the clinical trial or specialized anticoagulation clinic.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Willey VJ,Bullano MF,Hauch O,Reynolds M,Wygant G,Hoffman L,Mayzell G,Spyropoulos ACdoi
10.1016/s0149-2918(04)90187-7subject
Has Abstractpub_date
2004-07-01 00:00:00pages
1149-59issue
7eissn
0149-2918issn
1879-114Xpii
S0149291804901877journal_volume
26pub_type
杂志文章abstract：BACKGROUND:The median time to approval of new drugs in Canada decreased considerably in the mid-1990s, although it continued to be longer than in such countries as Australia, Sweden, the United Kingdom, and the United States. Ongoing concern about approval times pointed to a need for a further international comparison....
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pub_type： 临床试验,杂志文章
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journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
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journal_title：Clinical therapeutics
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journal_title：Clinical therapeutics
pub_type： 临床试验,杂志文章,随机对照试验
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更新日期：1990-05-01 00:00:00
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更新日期：2019-12-01 00:00:00
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journal_title：Clinical therapeutics
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journal_title：Clinical therapeutics
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journal_title：Clinical therapeutics
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