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| __NOTOC__
| | #REDIRECT [[Eptifibatide#Clinical Studies]] |
| {{Eptifibatide}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Clinical Studies==
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| INTEGRILIN was studied in 3 placebo-controlled, randomized studies. PURSUIT evaluated patients with acute coronary syndromes: UA or [[NSTEMI]]. Two other studies, ESPRIT and IMPACT II, evaluated patients about to undergo a [[PCI]]. Patients underwent primarily balloon [[angioplasty]] in IMPACT II and intracoronary stent placement, with or without [[angioplasty]], in ESPRIT.
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| ===Non-ST-Segment Elevation Acute Coronary Syndrome===
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| Non-ST-segment elevation acute coronary syndrome is defined as prolonged (≥10 minutes) symptoms of cardiac ischemia within the previous 24 hours associated with either ST-segment changes (elevations between 0.6 mm and 1 mm or depression >0.5 mm), T-wave inversion (>1 mm), or positive CK-MB. This definition includes "[[unstable angina]]" and "[[NSTEMI]]" but excludes MI that is associated with Q waves or greater degrees of ST-segment elevation.
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| PURSUIT (Platelet Glycoprotein IIb/IIIa in [[unstable angina]]: Receptor Suppression Using INTEGRILIN Therapy)
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| PURSUIT was a 726-center, 27-country, double-blind, randomized, placebo-controlled study in 10,948 patients presenting with UA or [[NSTEMI]]. Patients could be enrolled only if they had experienced cardiac ischemia at rest (≥10 minutes) within the previous 24 hours and had either ST-segment changes (elevations between 0.6 mm and 1 mm or depression >0.5 mm), T-wave inversion (>1 mm), or increased CK-MB. Important exclusion criteria included a history of bleeding diathesis, evidence of abnormal bleeding within the previous 30 days, uncontrolled hypertension, major surgery within the previous 6 weeks, stroke within the previous 30 days, any history of hemorrhagic stroke, serum creatinine >2 mg/dL, dependency on renal dialysis, or platelet count <100,000/mm3.
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| Patients were randomized to placebo, to INTEGRILIN 180-mcg/kg bolus followed by a 2-mcg/kg/min infusion (180/2), or to INTEGRILIN 180-mcg/kg bolus followed by a 1.3-mcg/kg/min infusion (180/1.3). The infusion was continued for 72 hours, until hospital discharge, or until the time of CABG, whichever occurred first, except that if [[PCI]] was performed, the INTEGRILIN infusion was continued for 24 hours after the procedure, allowing for a duration of infusion up to 96 hours.
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| The lower-infusion-rate arm was stopped after the first interim analysis when the 2 active-treatment arms appeared to have the same incidence of bleeding.
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| Patient age ranged from 20 to 94 (mean 63) years, and 65% were male. The patients were 89% Caucasian, 6% Hispanic, and 5% Black, recruited in the United States and Canada (40%), Western Europe (39%), Eastern Europe (16%), and Latin America (5%).
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| This was a "real world" study; each patient was managed according to the usual standards of the investigational site; frequencies of [[angiography]], [[PCI]], and CABG therefore differed widely from site to site and from country to country. Of the patients in PURSUIT, 13% were managed with [[PCI]] during drug infusion, of whom 50% received intracoronary stents; 87% were managed medically (without [[PCI]] during drug infusion).
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| The majority of patients received [[aspirin]] (75-325 mg once daily). [[Heparin]] was administered intravenously or subcutaneously, at the physician's discretion, most commonly as an intravenous bolus of 5000 units followed by a continuous infusion of 1000 units/h. For patients weighing less than 70 kg, the recommended [[Heparin]] bolus dose was 60 units/kg followed by a continuous infusion of 12 units/kg/h. A target aPTT of 50 to 70 seconds was recommended. A total of 1250 patients underwent [[PCI]] within 72 hours after randomization, in which case they received intravenous [[Heparin]] to maintain an ACT of 300 to 350 seconds.
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| The primary endpoint of the study was the occurrence of death from any cause or new MI (evaluated by a blinded Clinical Endpoints Committee) within 30 days of randomization.
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| Compared to placebo, INTEGRILIN administered as a 180-mcg/kg bolus followed by a 2-mcg/kg/min infusion significantly (p=0.042) reduced the incidence of endpoint events (see Table 6). The reduction in the incidence of endpoint events in patients receiving INTEGRILIN was evident early during treatment, and this reduction was maintained through at least 30 days (see Figure 1). Table 5 also shows the incidence of the components of the primary endpoint, death (whether or not preceded by an MI) and new MI in surviving patients at 30 days. <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = INTEGRILIN (EPTIFIBATIDE) INJECTION, SOLUTION [MERCK SHARP & DOHME CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ad82e30-50d8-450c-8a2a-b4b507ed1ce2 | publisher = | date = | accessdate = 5 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| [[Category:Antiplatelet drugs]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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