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Efficacy and Safety Profile: Unstable Angina and NSTEMI

Wallentin L et al. Lancet 1996;347:561–568 (FRISC).1

Study Design:

Prospective, multicentre, double-blind, randomised, placebo-controlled, parallel group trial in patients with unstable angina or NSTEMI (N=1,506). Patients were given subcutaneous Fragmin (120 IU/kg [maximum 10,000 IU] twice daily for 6 days then 7,500 IU once daily for the next 35–45 days) or placebo injections.

Primary endpoints:

Rate of death and new MI in the first 6 days.

Secondary endpoints:

Rates of death and new MI after 40 and 150 days, frequency of revascularisation procedures and need for heparin infusion, and a composite endpoint.

Results:

Acute phase: Patients treated with Fragmin had a lower rate of death and new MI compared with placebo (1.8% vs. 4.8%). Treatment with Fragmin resulted in 63% relative risk reduction of death and/or MI versus placebo (P=0.001, ARR=3%). There was a significant difference in the composite endpoint (death, MI, revascularisation, i.v. heparin) in favour of Fragmin (5.4% vs. 10.3%).

Extended phase: At 40 days the differences in rates of death and MI between patients treated with Fragmin or placebo persisted, although sub-group analysis showed that the effect was confined to non-smokers (80% of sample). 4–5 months after the end of treatment, there were no significant differences in the rates of death, new myocardial infarction or revascularisation.

Conclusion:

Acute treatment with Fragmin lowered the risk of death, MI and revascularisation in patients with coronary artery disease.

MI = Myocardial Infarction

Unstable Angina and NSTEMI

Fragmin Tolerability

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Using Fragmin Needle-Trap

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PP-PFE-GBR-2688. December 2020

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