nach oben

Drug Safety

Erschienen in:

01.06.2008 | Review Article

Safety of Clopidogrel and Aspirin for Stroke Prevention

Implications of the CHARISMA trial

verfasst von: Dr Sean Ruland

Erschienen in: Drug Safety | Ausgabe 6/2008

Einloggen, um Zugang zu erhalten

Abstract

Antiplatelet therapy is universally recommended for the prevention of recurrent events in patients with noncardioembolic ischaemic stroke or transient ischaemic attack (TIA), acute and chronic coronary artery disease, or peripheral arterial disease. However, choosing which antiplatelet agents to use in these situations remains controversial. The use of aspirin, aspirin plus extended-release dipyridamole, or clopidogrel is recommended as initial therapy in patients with noncardioembolic ischaemic stroke or TIA to reduce the risk of recurrent stroke and other cardiovascular events. Based on the results of the MATCH trial, combination therapy with aspirin plus clopidogrel is not recommended for patients with ischaemic stroke or TIA due to the increased risk of haemorrhage.

The results of the CHARISMA trial support this recommendation; despite previous data demonstrating a favourable benefit-risk profile of aspirin plus clopidogrel in patients with acute coronary syndrome, this combination should not be used in patients at high risk for atherothrombosis and those with previous stroke or TIA. In these patients, the CHARISMA trial demonstrated a lack of significant clinical efficacy and an increased risk of bleeding with clopidogrel plus aspirin compared with aspirin alone.

Further research is needed to assess the benefit-risk ratio of clopidogrel plus aspirin in specific subpopulations of patients at high risk for atherothrombotic events, and to determine the role of clopidogrel plus aspirin in preventing cardioembolic stroke or early recurrent stroke after symptomatic large-vessel atherostenosis. Recent and ongoing studies are seeking to better define the roles of different antiplatelet regimens in preventing recurrent stroke.

World Health Organization. The World Health Report 2004: changing history. Geneva: World Health Organization, 2004

Neal B, Chapman N, Patel A. Managing the global burden of cardiovascular disease. Eur Heart J 2002; 4 Suppl.: F2–6CrossRef

World Health Organization. The World Health Report 2003: shaping the future. Geneva: World Health Organization, 2003

Thom T, Haase N, Rosamond W, et al. Heart disease and stroke statistics -2006 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee [erratum appears in Circulation 2006; 113: e696]. Circulation 2006; 113: e85–151PubMedCrossRef

Vickrey BG, Rector TS, Wickstrom SL, et al. Occurrence of secondary ischemic events among persons with atherosclerotic vascular disease. Stroke 2002; 33: 901–6PubMedCrossRef

Sacco RL, Adams R, Albers G, et al. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: a statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke -co-sponsored by the Council on Cardiovascular Radiology and Intervention: The American Academy of Neurology affirms the value of this guidelines. Stroke 2006; 37: 577–617PubMedCrossRef

Harrington RA, Becker RC, Ezekowitz M, et al. Antithrombotic therapy for coronary artery disease. Chest 2004; 126: 513–48SCrossRef

Menon V, Harrington RA, Hochman JS, et al. Thrombolysis and adjunctive therapy in acute myocardial infarction. Chest 2004; 126: 549–75SCrossRef

Braunwald E, Antman EM, Beasley JW, et al. ACC/AHA 2002 guidelines update for the management of patient with unstable angina and non-ST-segment elevation myocardial infarction [summary article]: 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). Circulation 2002; 106: 1893–900PubMedCrossRef

10.

Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult [summary article]: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update 2001 Guidelines for the Evaluation and Management of Heart Failure). Circulation 2005; 112: 1825–52CrossRef

11.

Smith Jr SC, Feldman TE, Hirshfeld Jr JW, et al. ACC/AHA/ SCAI 2005 guideline update for percutaneous coronary intervention [summary article]: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). Circulation 2006; 113: 156–75PubMedCrossRef

12.

Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction [executive summary]: a report of the ACC/ AHA Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines on the Management of Patients With Acute Myocardial Infarction). Circulation 2004; 110: 588–636PubMedCrossRef

13.

Popma JJ, Berger P, Ohman EM, et al. Antithrombotic therapy during percutaneous coronary intervention. Chest 2004; 126: 576–99SCrossRef

14.

Salem DN, Stein PD, Al-Ahmad A, et al. Antithrombotic therapy in valvular heart disease: native and prosthetic. Chest 2004; 126: 457–82SCrossRef

15.

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: 483S–512SPubMedCrossRef

16.

Hirsch AT, Kaskal ZJ, Hertzer NR, et al. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic) [executive summary]: a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients with Peripheral Arterial Disease). Circulation 2006; 113: 1474–547 458CrossRef

17.

Clagett GP, Sobel M, Jackson MR, et al. Antithrombotic therapy in peripheral arterial occlusive disease. Chest 2004; 126: 609–26SCrossRef

18.

The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation [erratum appears in N Engl J Med 2001; 345: 1506]. N Engl J Med 2001; 345: 494–502CrossRef

19.

Mehta SR, Yusuf S, Peters RJG, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet 2001; 358: 527–33PubMedCrossRef

20.

Steinhubl SR, Berger PB, Mann III JT, et al. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial [erratum appears in JAMA 2003; 289: 987]. JAMA 2002; 288: 2411–20PubMedCrossRef

21.

Chen ZM, Jiang LX, Chen YP, et al. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet 2005; 366: 1607–21PubMedCrossRef

22.

Sabatine MS, Cannon CP, Gibson CM, et al. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med 2005; 352: 1179–89PubMedCrossRef

23.

Bhatt DL, Fox KAA, Hacke W, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med 2006; 354: 1706–17PubMedCrossRef

24.

Diener H-C, Bogousslavsky J, Brass LM, et al. Aspirin and clopidogrel compared with clopidogrel alone after recent is-chemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet 2004; 364: 331–7PubMedCrossRef

25.

Vorchheimer DA, Becker R. Platelets in atherothrombosis. Mayo Clin Proc 2006; 81: 59–68PubMedCrossRef

26.

Ruggeri ZM. Platelets in atherothrombosis. Nat Med 2002; 8: 1227–34PubMedCrossRef

27.

Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomized trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002; 324: 71–86CrossRef

28.

Jamieson DG, Parekh A, Ezekowitz MD. Review of antiplatelet therapy in secondary prevention of cerebrovascular events: a need for direct comparisons between antiplatelet agents. J Cardiovasc Pharmacol Ther 2005; 10: 153–61PubMedCrossRef

29.

Quinn MJ, Fitzgerald DJ. Ticlopidine and clopidogrel. Circulation 1999; 100: 1667–72PubMedCrossRef

30.

Majerus PW, Tollefsen DM. Blood coagulation and anticoagulant, thrombolytic, and antiplatelet drugs. In: Brunton LL, Lazo JS, Parker KL, editors. Goodman and Gilman’s the pharmacological basis of therapeutics. 11th ed. New York: McGraw-Hill, 2006: 1467–88

31.

Gent M, Beaumont D, Blanchard J, et al. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet 1996; 348: 1329–39CrossRef

32.

Bhatt DL, Topol EJ for the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, et al. Clopidogrel added to aspirin versus aspirin alone in secondary prevention and high-risk prevention: rationale and design of the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial. Am Heart J 2004; 148: 263–8PubMedCrossRef

33.

Pfeffer MA, Jarcho JA. The charisma of subgroups and the subgroups of CHARISMA. N Engl J Med 2006; 354: 1744–6PubMedCrossRef

34.

Rothwell PM. Subgroup analysis in randomized controlled trials: importance, indications, and interpretation. Lancet 2005; 365: 176–86PubMedCrossRef

35.

Weisberg LA for the Ticlopidine Aspirin Stroke Study Group. The efficacy and safety of ticlopidine and aspirin in non-whites: analysis of a patient subgroup from the Ticlopidine Aspirin Stroke Study. Neurology 1991; 43: 27–31CrossRef

36.

Gorelick PB, Richardson D, Kelley M, et al. Aspirin and ticlopidine for prevention of recurrent stroke in black patients. JAMA 2003; 289: 2947–57PubMedCrossRef

37.

Secondary Prevention of Small Subcortical Strokes (SPS3) Trial [online]. Available from URL: http://www.clinicaltrials.gov/ct/show/NCT00059306?.order=20 [Accessed 2007 Feb 15]

38.

Spagnoli LG, Mauriello A, Sangiorgi G, et al. Extracranial thrombotically active carotid plaque as a risk factor for ischemic stroke. JAMA 2004; 292: 1845–52PubMedCrossRef

39.

Kennedy J, Hill MD, Ryckborst KJ, et al. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomized controlled pilot trial. Lancet Neurol 2007; 6: 961–9PubMedCrossRef

40.

The ESPRIT Study Group. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial. Lancet 2006; 367: 1665–73CrossRef

41.

Diener HC. Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS), baseline results [abstract]. Joint World Congress on Stroke: International Stroke Society, Mediterranean Stroke Society, and Southern African Stroke Foundation; 2006 Oct 26–29; Cape Town, South Africa

Titel: Safety of Clopidogrel and Aspirin for Stroke Prevention
Implications of the CHARISMA trial
verfasst von: Dr Sean Ruland
Publikationsdatum: 01.06.2008
Verlag: Springer International Publishing
Erschienen in: Drug Safety / Ausgabe 6/2008
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.2165/00002018-200831060-00001

Springer Medizin

Abstract

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 6/2008

Safety of Green Tea Extracts

Prevalence, Clinical Features and Avoidability of Adverse Drug Reactions as Cause of Admission to a Geriatric Unit

Adverse Drug Reaction Reporting by Patients in the Netherlands Three Years of Experience

Cardiovascular Safety and Overall Tolerability of Solifenacin in Routine Clinical Use

Cardiotoxicity Profile of Trastuzumab

Safety of the Nonselective NSAID Nabumetone