Comparison of low-molecular-weight heparin with unfractionated heparin acutely and with placebo for 6 weeks in the management of unstable coronary artery disease fragmin in unstable coronary artery disease study (FRIC)

Low-molecular-weight heparin has a number of pharmacological and pharmacokinetic advantages over unfractionated heparin that make it potentially suitable, when used in combination with aspirin, for the treatment of unstable coronary artery disease. Patients with unstable angina or non-Q-wave myocard...

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Bibliographic Details
Published in:Circulation (New York, N.Y.) N.Y.), 1997-07, Vol.96 (1), p.61-68
Main Authors: KLEIN, W, BUCHWALD, A, HILLIS, S. E, MONRAD, S, SANZ, G, TURPIE, A. G. G, VAN DER MEER, J, OLAISSON, E, UNDELAND, S, LUDWIG, K
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Angina, Unstable - drug therapy
Anticoagulants - therapeutic use
Aspirin - administration & dosage
Biological and medical sciences
Blood Coagulation Tests
Blood. Blood coagulation. Reticuloendothelial system
Dalteparin - therapeutic use
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Female
Heparin - therapeutic use
Humans
Injections, Intravenous
Injections, Subcutaneous
Male
Medical sciences
Middle Aged
Myocardial Infarction - drug therapy
Patient Compliance
Pharmacology. Drug treatments
Prospective Studies
Treatment Outcome
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Summary:Low-molecular-weight heparin has a number of pharmacological and pharmacokinetic advantages over unfractionated heparin that make it potentially suitable, when used in combination with aspirin, for the treatment of unstable coronary artery disease. Patients with unstable angina or non-Q-wave myocardial infarction (1482) were included in the study, which had two phases. In an open, acute phase (days 1 to 6), patients were assigned either twice-daily weight-adjusted subcutaneous injections of dalteparin (120 i.u./kg) or dose-adjusted intravenous infusion of unfractionated heparin. In the double-blind, prolonged treatment phase (days 6 to 45), patients received subcutaneously either dalteparin (7500 i.u. once daily) or placebo. During the first 6 days, the rate of death, myocardial infarction, or recurrence of angina was 7.6% in the unfractionated heparin-treated patients and 9.3% in the dalteparin-treated patients (relative risk, 1.18; 95% confidence interval [CI], 0.84 to 1.66). The corresponding rates in the two treatment groups for the composite end point of death or myocardial infarction were 3.6% and 3.9%, respectively (relative risk, 1.07; 95% CI, 0.63 to 1.80). Revascularization procedures were undertaken in 5.3% and 4.8% of patients in unfractionated heparin and dalteparin groups, respectively (relative risk, 0.88; 95% CI, 0.57 to 1.35). Between days 6 and 45, the rate of death, myocardial infarction, or recurrence of angina was 12.3% in both the placebo and dalteparin groups (relative risk, 1.01; 95% CI, 0.74 to 1.38). The corresponding rates for death or myocardial infarction were 4.7% and 4.3% (relative risk, 0.92; 95% CI, 0.54 to 1.57). Revascularization procedures were undertaken in 14.2% and 14.3% of patients in the placebo and dalteparin groups, respectively. Our results add to previous evidence suggesting that the low-molecular-weight heparin dalteparin administered by twice-daily subcutaneous injection may be an alternative to unfractionated heparin in the acute treatment of unstable angina or non-Q-wave myocardial infarction. Prolonged treatment with dalteparin at a lower once-daily dose in our study did not confer any additional benefit over aspirin (75 to 165 mg) alone.
ISSN:0009-7322
1524-4539
DOI:10.1161/01.CIR.96.1.61