References

PLAVIX References

  1. Albers GW, Amarenco P, Easton JD, et al. Antithrombotic and thrombolytic therapy for ischemic stroke: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004;126(suppl):483S-512S.
  2. Albers GW, Amarenco P, Easton JD, et al. Antithrombotic and thrombolytic therapy for stroke. Chest 2001;119:300S-320S.
  3. American Heart Association. Heart Attack, Stroke and Cardiac Arrest Warning signs.
    http://www.americanheart.org/presenter.jhtml?identifier=3053. Accessed October 13, 2006.
  4. American Heart Association. Heart Disease and Stroke Statistics?2006 Update. Dallas, Tex: American Heart Association; 2006.
  5. American Heart Association. Peripheral Vascular Disease.
    http://www.americanheart.org/presenter.jhtml?identifier=4692. Accessed October 13, 2006.
  6. American Heart Association. Risk Factors and Coronary Heart Disease.
    http://www.americanheart.org/presenter.jhtml?identifier=4726. Accessed October 13, 2006.
  7. American Heart Association. Stroke Statistics.
    http://www.americanheart.org/presenter.jhtml?identifier=4725. Accessed October 13, 2006.
  8. American Stroke Association. Stroke Risk Factors.
    http://www.strokeassociation.org/presenter.jhtml?identifier=4716. Accessed October 13, 2006.
  9. American Heart Association. What is a heart attack?
    http://www.americanheart.org. Accessed October 3, 2006. (see pdf)
  10. Braunwald E, Antman EM, Beasley JW, et al. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non ST segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). 2002. Available at: http://www.acc.org.
  11. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet. 1996;348:1329-1339.
  12. Caro J, Migliaccio-Walle K, Ishak KJ, Proskorovsky I. The morbidity and mortality following a diagnosis of peripheral arterial disease: long-term follow-up of a large database. BMC Cardiovasc Disord. 2005;5:14.
  13. Criqui MH, Langer RD, Fronek A, et al. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992;326: 381-386.
  14. CURE Study Investigators. The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: rationale, design and baseline characteristics incuding a meta-analysis of the effects of thienopyridines in vascular disease. European Heart Journal 2000;21: 2033-2041.
  15. PCP visual aid. USA.CLO 06.04.215/ B1-A0714-06-06.
  16. Plavix (clopidogrel bisulfate) web site.
    http://www.plavix.com/plavix/home/index.jsp. Accessed October 13, 2006.
  17. Plavix? (clopidogrel bisulfate) Prescribing Information. Sanofi-aventis U.S. LLC. Revised February 2007.
  18. Specialty visual aid. USA.CLO.06.04.216/ B1-A0713-06-06.
  19. Submission visual aid. US.CLO.06.08.086/ B1-A0758-09-06.
  20. Weitz JI, Byrne J, Clagett GP, et al. Diagnosis and treatment of chronic arterial insufficiency of the lower extremities: A critical review. Circulation. 1996;94:3026-3049.
  21. Yeghiazarians Y, Braunstein JB, Askari A, Stone PH. Unstable angina pectoris. N Engl J Med. 2000;342:101-114.
  22. Creager MA, Dzau VJ. Vascular diseases of the extremities. In Harrison?s Principles of Internal Medicine. 15th ed. New York: McGraw-Hill, 2001. 1434-1442.
  23. Data on file, sanofi-aventis U.S. LLC.
  24. PCP visual aid. US.CLO.08.04.148.
Indications
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Use PLAVIX plus aspirin for patients with non–ST–segment elevation acute coronary syndrome (UA/non–Q–wave MI), including patients to be managed medically and those to be managed with percutaneous coronary intervention (with or without stent) or CABG, to decrease the rate of a combined end point of CV death, MI, or stroke as well as the rate of a combined end point of CV death, MI, stroke, or refractory ischemia.

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Use PLAVIX plus aspirin for patients with ST–segment elevation acute myocardial infarction to reduce the rate of death from any cause and the rate of a combined end point of death, reinfarction, or stroke. This benefit is not known to pertain to patients who receive primary angioplasty.

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Use PLAVIX alone for patients with a history of recent stroke, recent MI, or established PAD 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.
Important Risk Information 18
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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.*)

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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.*)

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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.*)

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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.*)