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Clopidogrel Bisulphate Exhibits Favorable Cost Effectiveness Ratio, International Study Says

PARIS and PRINCETON, N.J., April 2 /PRNewswire-FirstCall/ -- Data from two cost-effectiveness analyses of the landmark trial CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events), presented at the 52nd Annual Scientific Session of the American College of Cardiology (ACC 2003), demonstrate that Plavix(R)/Iscover(R) (clopidogrel bisulphate) compares favorably to other cardiovascular therapies in terms of different cost-effectiveness outcomes.

Clopidogrel cost-effectiveness favorable compared to other cardiovascular therapies in patients with ACS (acute coronary syndrome, without ST-segment elevation) (Abstract No. 885-2)

A study conducted by the Stockholm School of Economics in Sweden evaluated the long-term cost-effectiveness of clopidogrel on top of standard therapy including ASA (acetylsalicylic acid) in hospitalized patients with unstable angina.

In the model, patients were assumed to be treated for one year with treatment effects (RR = 0.8) and costs based on the 12,562-patient CURE study. The purpose for this study was to evaluate the cost effectiveness in terms of cost per life year gained (LYG) of the treatment. Survival benefits were projected based on Swedish epidemiological data. When the benefits of clopidogrel on top of standard therapy including ASA (acetylsalicylic acid) were translated to the Swedish ACS population (patients without ST-segment elevation), 120 additional years of life would be gained per 1,000 patients treated.

The authors of this study conclude that based on their pharmacoecomomic model, clopidogrel on top of standard therapy including ASA (acetylsalicylic acid) versus ASA alone in addition to other standard therapy shows a favorable cost-effectiveness ratio compared with other cardiovascular drugs in the ACS (non ST-segment elevation) patient population in Sweden.

At the present time, only direct medical costs are included in most health economic analyses and the trial shows that clopidogrel is cost-effective using only these costs. However, when indirect costs are taken into account, clopidogrel appears to be even more cost-saving.

Clopidogrel highly cost-effective in patients with ACS (unstable angina and non Q-wave MI) undergoing PCI (Abstract No. 1171-112)

An economic analysis of the PCI CURE trial by by Shamir R. Mehta, of McMaster University in Hamilton, Ontario, Canada, examined results in five countries (United States, United Kingdom, France, Sweden and Canada) and calculated the costs of hospitalization, medication and clopidogrel based on healthcare resource utilization for the 2,658 patients who underwent percutaneous coronary intervention (PCI) in the CURE study. Cost effectiveness in this study consisted of analyses of costs and events (heart attack, stroke or death) in the trial and measured as the cost per event avoided.

Data presented at ACC from this analysis indicate that clopidogrel on top of standard therapy including ASA (acetylsalicylic acid) is cost-effective in patients with ACS (unstable angina and non Q-wave MI) undergoing PCI.

"This cost-effectiveness analysis in patients undergoing PCI confirms that clopidogrel on top of standard therapy including ASA (acetylsalicylic acid) compares very well with other treatments in cardiovascular medicine," said Dr. Mehta.

The CURE and PCI-CURE trial, published in The New England Journal of Medicine and The Lancet respectively, demonstrated that initiating therapy early with clopidogrel in addition to ASA and other standard therapy, and continuing their use long-term (up to 1 year), reduces the risk of heart attack, stroke or cardiovascular death in patients with ACS (unstable angina/non-Q-wave MI) compared to patients who received ASA and other standard therapy alone.

Clopidogrel was originally approved for marketing in the United States in November 1997 under the name Plavix(R) and in Europe in July 1998 under the names Plavix(R) and Iscover based on the pivotal 19,185 patient CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) trial. To date, more than 20 million patients worldwide have been treated with clopidogrel.

U.S. INDICATION
Clopidogrel is marketed in the United States by Sanofi-Synthelabo (Euronext: SAN; NYSE: SNY) and Bristol-Myers Squibb (NYSE:BMY) under the name Plavix(R) for the reduction of atherothrombotic events as follows: For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, Plavix(R) has been shown to reduce the rate of a combined end point of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. For patients with acute coronary syndrome (unstable angina/non-Q-wave MI), including patients who are to be managed medically and those who are to be managed with percutaneous coronary intervention (with or without stent) or CABG, Plavix(R) has been shown to decrease the rate of a combined end point of cardiovascular death, MI, or stroke as well as the rate of a combined end point of cardiovascular death, MI, stroke, or refractory ischemia.

IMPORTANT RISK INFORMATION
Clopidogrel (Plavix(R)) is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. As with other antiplatelet agents, Plavix(R) 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(R) plus aspirin compared with placebo plus aspirin in a clinical trial. (See ADVERSE REACTIONS.*)

As part of the worldwide postmarketing experience with Plavix(R)/ Iscover, suspected cases of thrombotic thrombocytopenic purpura (TTP) have been reported at a rate of about 4 cases per million patients exposed. TTP has been reported rarely following use of Plavix(R), sometimes after short exposure ( 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.*)

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