PLAVIX(R) (Clopidogrel Bisulfate) Recommended As Effective Cardiovascular Risk Reduction Treatment for Patients With Established Peripheral Arterial Disease (P.A.D.)
BRIDGEWATER, N.J., and PRINCETON, N.J., Dec. 13 /PRNewswire-FirstCall/ — Recently, the American College of Cardiology (ACC) and the American Heart Association (AHA) announced the first-ever U.S. guidelines for the diagnosis and treatment of peripheral arterial disease (P.A.D.), a serious medical condition that puts up to 12 million Americans at an increased risk for a heart attack or stroke(1). In the guidelines, the antiplatelet therapy Plavix(R) (clopidogrel bisulfate) is recommended for reducing the risk of heart attack, stroke or vascular death in patients with P.A.D. The group of drugs known as antiplatelet agents received a Class 1 recommendation in the guidelines. PLAVIX is the only antiplatelet therapy that has been approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of atherothrombotic events in patients diagnosed with P.A.D.(2).
“These guidelines emphasize the need to properly identify patients at risk for P.A.D. and provide physicians with recommendations for early diagnosis and consistent treatment of this disease and its associated risk of heart attack and stroke,” said Dr. Peter Sheehan, Director, Diabetes Foot and Ankle Center, Hospital for Joint Diseases Orthopaedic Institute, New York, NY*. “An effective treatment recommended in the guidelines is antiplatelet therapy with PLAVIX, which helps to keep blood platelets from sticking together and forming clots, and has been shown to reduce the risk of a heart attack or stroke in patients who have been diagnosed with P.A.D.”
P.A.D. is a chronic condition in which the arteries in the legs become narrowed or clogged due to the formation of plaque, restricting the flow of oxygen-rich blood(3). Poor blood circulation can cause pain in the legs while walking. People with P.A.D. may also have restricted circulation in the arteries of the heart or brain(3,4). If the arteries supplying blood to the heart or brain become blocked, it can result in a heart attack or stroke(5).
P.A.D., like diabetes, is a cardiovascular disease risk equivalent(6). People with P.A.D. run a high risk of suffering atherothrombotic events. In fact, these people are six times more likely to die from cardiovascular disease within 10 years than those without P.A.D.(7).
Some people with P.A.D. may have pain or discomfort in the buttocks, thighs or calves after walking a certain distance. This pain is called intermittent claudication and may be relieved by rest. However, most people with P.A.D. do not experience any symptoms at all — only about one in three people with P.A.D. have leg pain(8).
Those most at risk for the disease include people over 50 with diabetes, smokers over 50, people over 70, people with high blood pressure and/or high cholesterol and those with a family history of heart attack or stroke(3,8). People with diabetes under 50 with one additional cardiovascular risk factor are also at an increased risk for P.A.D.(2).
P.A.D. can be diagnosed by a simple test called the ankle-brachial index (ABI). The ABI is used to determine a patient’s blood pressure at the ankle and the arm. A positive P.A.D. diagnosis is confirmed when the pressure at the ankle is lower than the pressure at the arm(8).
PLAVIX and P.A.D.
Clinical evidence from the landmark CAPRIE study (Clopidogrel vs Aspirin in Patients at Risk of Ischaemic Events) contributed to the inclusion of PLAVIX in the ACC/AHA guidelines. The study compared PLAVIX versus aspirin in reducing the risk of ischaemic stroke, heart attack, or vascular death in 19,185 patients with recent ischaemic stroke, recent heart attack, or established P.A.D. Results demonstrated that PLAVIX (75 mg), compared with aspirin (325 mg), decreased the rate of the combined end point of heart attack, ischaemic stroke, and vascular death(9).
About PLAVIX
PLAVIX is a prescription antiplatelet medicine taken once a day that helps keep platelets in the blood from sticking together and forming clots. Since its initial approval on November 17, 1997, by the U.S. Food and Drug Administration, PLAVIX has been used to treat millions of patients worldwide(10). PLAVIX is marketed worldwide by sanofi-aventis (Paris Bourse: EURONEXT: SAN; New York: NYSE: SNY) and Bristol-Myers Squibb Company as Plavix(R) and Iscover(R).
For more information on PLAVIX and P.A.D., visit http://www.plavix.com/.
— Dr. Peter Sheehan is a consultant for the Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership.
WHO SHOULD RECEIVE Plavix(R)(clopidogrel bisulfate)(11)?
PLAVIX is indicated for the reduction of atherothrombotic events as follows:
— Recent Myocardial Infarction (MI), Recent Stroke, or Established Peripheral Arterial Disease (PAD) For patients with a history of recent MI, recent stroke, or established PAD, PLAVIX 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. — Acute Coronary Syndrome (ACS) For patients with ACS (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 coronary artery bypass graft surgery (CABG), PLAVIX 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: — 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 a clinical trial. (See ADVERSE REACTIONS. **) — As part of the worldwide postmarketing experience with PLAVIX, suspected cases of thrombotic thrombocytopenic purpura (TTP), some with fatal outcome, have been reported at a rate of about 4 cases per million patients exposed. TTP has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition and requires urgent referral to a hematologist for prompt treatment. (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 by visiting http://www.plavix.com/. Sanofi-aventis Forward-Looking Statement
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,”"anticipates,”"believes,”"intends,”"estimates,”"plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward- Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2004. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.
Sanofi-aventis Group subsidiaries in the United States include Sanofi- Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.
References: 1. American Heart Association. Heart Disease and Stroke Statistics — 2005 Update. http://www.americanheart.org/presenter.jhtml?identifier=3000090. Accessed June 1, 2005. 2. American College of Cardiology/American Heart Association. ACC/AHA Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic); A Collaborative Report From the AAVS/SVS, SCAI, SIR, SVMB, and the ACC/AHA Task Force on Practice Guidelines – Executive Summary. http://www.acc.org/clinical/guidelines/pad/summary.pdf Accessed December 6, 2005 3. Society of Interventional Radiology. Peripheral arterial disease. Available at http://www.sirweb.org/patPub/pvdPad.shtml. Accessed November 11, 2004. 4. Vascular Disease Foundation. What is peripheral arterial disease, or PAD? Available at http://www.vdf.org/Main_Frame.htm. Accessed November 11, 2004. 5. American Heart Association. What are heart disease and stroke? Dallas, TX, 2004. 6. National Institutes of Health/National Heart, Lung and Blood Institute. Third Report of the Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) – Executive Summary. http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3xsum.pdf Accessed December 7, 2005. 7. Belch JJF, Topol EJ, Agnelli G et al. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Int Med. 2003;163:884-892. 8. Commitment of a Lifetime: Peripheral Artery Disease (P.A.D.). Available at http://216.185.112.5/downloadable/heart/5324_PAD.pdf. Accessed June 1, 2005. 9. Bhatt DL, Chew DP, Hirsch AT, et al. Superiority of clopidogrel versus aspirin in patients with prior cardiac surgery. Circulation. 2001; 103:363-368. 10. Data on file, Sanofi-Synthelablo 11. PLAVIX Prescribing Information. Sanofi-Synthelabo CONTACTS MEDIA INVESTORS Jeff Macdonald John Elicker Bristol-Myers Squibb Bristol-Myers Squibb 212-546-4824 212-546-3775 jeffrey.macdonald@bms.com john.elicker@bms.com Tricia Geoghegan Felix Lauscher sanofi-aventis sanofi-aventis 908-243-2064 212-551-018 tricia.geoghegan@sanofi-aventis.com felix.lauscher@sanofi-aventis.com
sanofi-aventis
CONTACT: Media, Jeff Macdonald, +1-212-546-4824,jeffrey.macdonald@bms.com, or Investor, John Elicker, +1-212-546-3775,john.elicker@bms.com, both of Bristol-Myers Squibb; Media, Tricia Geoghegan,+1-908-243-2064, tricia.geoghegan@sanofi-aventis.com, or Investor, FelixLauscher, +1-212-551-018, felix.lauscher@sanofi-aventis.com, both ofsanofi-aventis
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