PARIS & PRINCETON, N.J.--()--Today, the OASIS study group will present initial results of the CURRENT-OASIS 7 clinical trial at the European Society of Cardiology congress in Barcelona. Sanofi-aventis (EURONEXT:SAN) and (NYSE:SNY) and Bristol-Myers Squibb (NYSE:BMY), co-commercialization and co-development partners for PLAVIX® (clopidogrel bisulfate), were sponsors of the study.
CURRENT-OASIS 7 is the largest clinical trial (25,087 patients) to evaluate different dosing regimens of PLAVIX® plus aspirin in a broad range of acute coronary syndrome (ACS) patients (UA/NSTEMI/STEMI). The study was designed to assess the efficacy and safety of an intensified clopidogrel regimen (600 mg loading dose day 1 / 150 mg days 2-7 / 75 mg days 8-30) versus the approved PLAVIX® dosage (300 mg loading dose day 1 / 75 mg days 2-30) for patients managed with an early invasive strategy with an intent for percutaneous coronary intervention (PCI).
The primary end-point (cardiovascular death, heart attack, or stroke at thirty days) for the entire study population (including subpopulations of patients that underwent PCI (70%) or not (30%) examining the difference between the high-dose and standard-dose PLAVIX® (clopidogrel bisulfate) regimens did not reach statistical significance (4.2% vs. 4.4%, HR 0.95, p=0.37).
For clinically relevant subgroups that were pre-specified for preliminary analyses, such as the PCI subgroup (70% of the trial population, 17,232 patients), potentially medically relevant differences in patient outcomes were observed. In this subgroup, analysis showed an improvement in outcome for patients taking the higher dose regimen (600 mg loading / 150 mg for days 2-7 / 75 mg days 8-30) over the standard dose regimen (300 mg loading / 75 mg for days 2-30), as shown by the reduction of the same composite end-point of cardiovascular death, myocardial infarction and stroke by 15% (4.5% vs 3.9%, p=0.037). In addition, analysis showed an important 42% relative risk reduction in definite stent thrombosis (1.2% vs 0.7%, p=0.001) with the higher dose regimen of clopidogrel over the standard loading dose.
“An artery opening procedure with stent placement exposes a patient to an increased risk of stent occlusion and subsequent heart attack,” said Doctor Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. “CURRENT-OASIS 7 provides important new information about a high-dose regimen of PLAVIX® in ACS patients planned for PCI. We are pleased to contribute to furthering the understanding of patient care during the acute phase of coronary intervention.”
The primary safety end-point was assessed by the stringent bleeding definition of OASIS and while a significant increase in the primary safety end-point of major bleeding with the high-dose compared to the standard-dose PLAVIX® regimen was observed in the overall trial population (2.5% vs 2.0%, HR 1.25, p=0.01) and the PCI population (1.6% vs 1.1%, HR 1.44, p=0.006), there was no statistically significant difference in intracranial bleeding or fatal hemorrhage in the overall population and the PCI population.
Sanofi-aventis and Bristol-Myers Squibb believe that the CURRENT-OASIS 7 data add to the broad clinical experience with PLAVIX®, which has been used in over 90 million patients during the 11 years it has been on the market.
About PLAVIX® (clopidogrel bisulfate)
PLAVIX® is recommended daily for patients who have had a recent heart attack or stroke, or poor circulation in the legs that may cause pain during exercise, such as walking, and may be relieved by rest (known as peripheral artery disease, or P.A.D.). PLAVIX® is also recommended in addition to aspirin for patients who have been hospitalized with heart-related chest pain (unstable angina) or had a heart attack.
Important Risk Information
- PLAVIX® is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX® should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin. (See CONTRAINDICATIONS and PRECAUTIONS.*)
- The rates of major and minor bleeding were higher in patients treated with PLAVIX® plus aspirin compared with placebo plus aspirin in clinical trials. (See ADVERSE REACTIONS.*)
- As part of the worldwide post marketing experience with PLAVIX®, there have been cases of reported thrombotic thrombocytopenic purpura (TTP), some with fatal outcome. TTP has been reported rarely following use of PLAVIX®, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange). (See WARNINGS.*)
- In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See ADVERSE REACTIONS.*)
*Please see full prescribing information for the United States by visiting www.PLAVIX.com. For the most updated PLAVIX® labelling information in Europe please refer to: http://www.emea.europa.eu/humandocs/PDFs/EPAR/PLAVIX/H-174-PI-en.pdf.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY). For more information, please visit: www.sanofi-aventis.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com.
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