Unstable Angina and NSTEMI: Efficacy and Safety Profile

Efficacy and Safety Profile

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

Reference

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

*Including, but not limited to: congestive cardiac failure (NYHA class III or IV), acute respiratory failure or acute infection, who also have a predisposing risk factor for VTE such as age over 75 years, obesity, cancer or previous history of VTE.~
†In patients with chronic renal insufficiency or acute renal failure.

PP-FRA-GBR-0161.  June 2019