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Orbofiban in unstable angina (OPUS-TIMI 16 trial)
Current Controlled Trials in Cardiovascular Medicinevolume 2, Article number: 71901 (2001)
This paper describes the effects of prolonged glycoprotein IIb/IIIa inhibition with oral orbofiban on the composite end point of death, myocardial infarction, recurrent ischaemia requiring hospitalisation, urgent revascularisation or stroke in patients with acute coronary syndromes (ACS). This research was undertaken because whilst intravenous glycoprotein IIb/IIIa inhibitors have been shown to be beneficial in patients with ACS, the effects of prolonged oral inhibition of this receptor have not been previously described.
In patients with ACS, orbofiban had no effect on the primary composite end point and was associated with increased mortality; the trial was terminated prematurely. Subgroup analysis suggested that patients who underwent percutaneous coronary intervention had a lower mortality rate and a significant reduction in the composite end point.
I found this article interesting because it provides important data regarding the potential role of oral glycoprotein IIb/IIIa inhibitor in the management of patients with ACS.
Possible implications of these findings are that prolonged oral inhibition of glycoprotein IIb/IIIa for all patients with ACS is inappropriate. Those patients requiring percutaneous coronary intervention may benefit, as has been shown in the trials of intravenous glycoprotein IIb/IIIa receptor antagonists.
ACS is defined as ischaemic pain at rest within 72 h of randomisation, associated with positive cardiac markers, electrocardiographic changes, or prior cardiovascular disease. In total, 10,288 patients in 29 countries were randomised into three groups to receive either 50 mg orbofiban twice daily, 50mg of orbofiban twice daily for 30 days followed by 30 mg of orbofiban twice daily, or a placebo. All patients received aspirin.
Cannon CP, McCabe CH, Wilcox RG, Langer A, Caspi A, Berink P, Lopez-Sendon J, Toman J, Charlesworth A, Anders RJ, Alexander RJ, Skene A, Braunwald E: Oral glycoprotein IIb/IIIa inhibition with orbofiban in patients with unstable coronary syndromes (OPUS-TIMI 16) trial. Circulation. 2000, 102: 149-156.