Abstract | OBJECTIVES: BACKGROUND: The optimal dose of enoxaparin in patients with arterial disorders has not been established. METHODS: Patients with unstable angina/NQMI were treated over a 14-day period in an open label dose-ranging trial. During the in-hospital phase, patients received either 1.25 mg/kg body weight (dose tier 1) or 1.0 mg/kg (dose tier 2) of enoxaparin subcutaneously every 12 h. A fixed dose of either 60 mg ( body weight > or = 65 kg) or 40 mg ( body weight < 65 kg) was administered subcutaneously every 12 h after hospital discharge. RESULTS: In an initial cohort of 321 patients (dose tier 1), the rate of major bleeding through 14 days was 6.5% and occurred predominantly at instrumented sites. In a second cohort of 309 patients (dose tier 2), the rate of major hemorrhage was reduced to 1.9%. In both dose tiers, only 3% to 5% of patients withdrew consent for subcutaneous injections during the home treatment phase. Through 14 days, the incidence of death, recurrent myocardial infarction or recurrent ischemia requiring revascularization was 5.6% in dose tier 1 and 5.2% in dose tier 2. CONCLUSIONS: An acute phase regimen of enoxaparin (1.0 mg/kg every 12 h) is associated with an acceptable rate of major hemorrhage during the in-hospital phase. There is a high rate of patient compliance during the home treatment phase. A Phase III trial is now underway to test the benefits of uninterrupted treatment with enoxaparin during both the in-hospital and outpatient treatment phases.
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Authors | |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 29
Issue 7
Pg. 1474-82
(Jun 1997)
ISSN: 0735-1097 [Print] United States |
PMID | 9180107
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticoagulants
- Enoxaparin
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Topics |
- Aged
- Angina, Unstable
(drug therapy)
- Anticoagulants
(administration & dosage, adverse effects)
- Enoxaparin
(administration & dosage, adverse effects)
- Female
- Hemorrhage
(chemically induced)
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(drug therapy)
- Patient Compliance
- Thrombolytic Therapy
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