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Information on how to access Fragmin® (dalteparin sodium) prescribing information and adverse event reporting can be found at the bottom of the page.

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.


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.


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

Click below to learn how to use a Fragmin Needle-Trap

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PP-PFE-GBR-3863. November 2021



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