GLFD Guilford Pharmaceuticals (MM)

AGGRASTAT(R) Injection Strategy Trial Data Published in JAMA BALTIMORE, May 11 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (NASDAQ:GLFD) today announced the publication of results from the STRATEGY trial of AGGRASTAT(R) Injection (tirofiban hydrochloride) in the Journal of the American Medical Association, (May 2005 - Vol. 293, No. 17 pgs. 2109 - 2117). The study found that a combination of AGGRASTAT(R) and a drug-eluting stent (DES; sirolimus eluting stent) resulted in a significantly lower rate of death, myocardial infarction, stroke, and binary restenosis at eight months for patients with ST-elevation myocardial infarction (STEMI), while also providing a similar cost of care when compared to abciximab used in combination with a bare metal stent. Marco Valgimigli, M.D., Chair of Cardiology, University of Ferrara, and principal investigator for the STRATEGY trial, commented, "Our results demonstrate that tirofiban in combination with a drug-eluting stent (sirolimus eluting stent (SES)) during primary percutaneous coronary intervention resulted in improved clinical and angiographic outcomes relative to a strategy of abciximab in combination with a bare metal stent. Moreover, there was a statistically significant reduction in the incidence of thrombocytopenia for patients receiving tirofiban and sirolimus eluting stent versus abciximab plus bare metal stent and a trend toward lower bleeding rates for patients treated with tirofiban and DES. Additional large scale trials, like TENACITY and MULTI-STRATEGY, will be needed to further evaluate the new single high-dose bolus (SHDB) regimen of tirofiban for these patients." Dr. Valgimigli continued, "In addition to clinical and angiographic data, we have confirmed that the SHDB regimen of tirofiban yields similar levels of platelet inhibition to that achieved with abciximab even in particularly high- risk patients such as those presenting with STEMI." STRATEGY Trial: Single High-Dose BoluS TiRofibAn and Sirolimus Eluting STEnt versus Abiciximab and Bare Metal Stent in Acute MYocardial Infarction (STRATEGY) Study The eight-month study included 175 patients with persistent ST segment elevation myocardial infarction (STEMI) who were randomized to receive either the single high-dose bolus (SHDB) tirofiban regimen (N=87; bolus of 25 mcg/Kg/3-min, followed by an infusion of 0.15 mcg/Kg/min for 18-24 h) plus SES, or abciximab (N=88; bolus of 0.25 mg/kg/3-min, followed by a 12-hour infusion of 0.125 mcg/Kg per minute) and bare metal stent (BMS). At eight months, clinical and angiographic follow-up was conducted in 175 patients. The primary end-point, a composite of death, myocardial infarction (MI), stroke and binary restenosis rate at eight months, occurred in 18% of patients receiving SHDB tirofiban-DES and 32% of patients receiving abciximab-BMS (HR, 0.53; 95% CI, 0.28 - 0.92; p=0.04). Overall, the composite of death or reinfarction was similar in the tirofiban plus sirolimus eluting stent group (13%) versus the abciximab plus bare metal stent group (17%) (HR, 0.71; 95% CI, 0.34-1.5; p=0.39), while there was a significant reduction in the need for TVR (7% versus 20% respectively; HR, 0.30; 95% CI, 0.12-0.77; p=0.01) in the tirofiban plus SES group. There was also a trend towards reduction in all bleeding events for patients treated with SHDB tirofiban-SES compared to abciximab-BMS. Moreover, there was a statistically significant reduction in thrombocytopenia in patients treated with SHDB tirofiban-SES versus abciximab-BMS (1 patient versus 9 patients, p=0.03). About GP IIb/IIIa Antagonists Platelets are blood cells that provide an early defense from the potential complications of vascular injury. When a blood vessel is damaged, platelets adhere to the site and promote blood clot formation. Clot formation prevents bleeding and recruits other cells to help heal the damage. While usually a beneficial process, these effects can be harmful when a clot forms on a ruptured lipid plaque within the coronary vasculature. GP IIb/IIIa antagonists block the ability of platelets to aggregate, inhibiting clot formation and reducing the potential for cardiac ischemia. Over the last 8-10 years, several large-scale, placebo-controlled clinical trials have established the efficacy of intravenous GP IIb/IIIa inhibitors for patients with acute coronary syndrome who are medically managed or go to the cath lab. Important Information About AGGRASTAT(R) Injection AGGRASTAT(R) was approved by the Food and Drug Administration (FDA) on May 14, 1998. AGGRASTAT(R), in combination with heparin, and aspirin, if not contraindicated, is indicated for the treatment of ACS including patients who are to be managed medically and those undergoing PTCA or atherectomy. In this setting, AGGRASTAT(R) has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction or refractory ischemia/repeat cardiac procedure. In most patients, AGGRASTAT(R) should be administered intravenously, at an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min. For complete information, please refer to the product's prescribing information. AGGRASTAT(R) (tirofiban hydrochloride) is contraindicated in patients with known hypersensitivity to any component of the product; active internal bleeding or a history of bleeding diathesis within the previous 30 days; or a history of intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm. Other contraindications to AGGRASTAT(R) include: a history of thrombocytopenia following prior exposure to AGGRASTAT(R); history of stroke within 30 days or any history of hemorrhagic stroke; major surgical procedure or severe physical trauma within the previous month; or history, symptoms, or findings suggestive of aortic dissection. AGGRASTAT(R) is also contraindicated in patients with: severe hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg); concomitant use of another parenteral GP IIb/IIIa inhibitor; or acute pericarditis. Bleeding is the most common complication encountered during therapy with AGGRASTAT(R). Administration of AGGRASTAT(R) is associated with an increase in bleeding events classified as both major and minor bleeding events, by criteria developed by the Thrombolysis in Myocardial Infarction Study group (TIMI). Most major bleeding associated with AGGRASTAT(R) occurs at the arterial access site for cardiac catheterization. Fatal bleedings have been reported. AGGRASTAT(R) should be used with caution in patients with platelet count