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Aggrenox

Aggrenox. Is it as good as the ads?. Multicentre, randomized, double-blind, placebo-controlled trial 6,602 patients randomized within 3 months of qualifying event (TIA or stroke) Treatment and follow-up time: 2 years Visits at 1 month and 3 months, then at 3-month intervals.

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Aggrenox

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  1. Aggrenox Is it as good as the ads?

  2. Multicentre, randomized, double-blind, placebo-controlled trial 6,602 patients randomized within 3 months of qualifying event (TIA or stroke) Treatment and follow-up time: 2 years Visits at 1 month and 3 months, then at 3-month intervals ESPS-2: European Stroke Prevention Study Diener et al. J Neurol Sci 1997;151:S1-S77 Diener et al. J Neurol Sci 1996;143:1-13

  3. n=6,602 ESPS-2: Treatment Arms ASA/ER DP 25 mg ASA/ 200 mg ER DP bid (n=1,650) ASA 25 mg bid (n=1,649) ER DP 200 mg bid (n=1,654) Placebo (n=1,649)

  4. Dipyridamole Extended Release Pellets Dipyridamole HP cellulose protective coating: water soluble polymers ASA Tartaric acid: dipyridamole solubiliser Sustained release coating: water insoluble polymers Aggrenox® Capsule

  5. Mechanisms of Actionof Aggrenox® Dipyridamole ASA Increases plasma adenosine Inhibits platelet phosphodiesterase Irreversibly inhibits cyclooxygenase and thromboxane A2 Inhibition of platelet activation and aggregation

  6. ESPS-2 Results: Stroke Rates at 24 Months 16 15.2% 12.8%* 12.5%* 12 9.5%* Incidence (%) 8 4 0 Placebo ASA ER DP ASA/ER DP *p<0.001 vs. placebo

  7. 100 95 ASA 90 85 80 6 12 18 24 ESPS-2 Results:Stroke-Free Survival ER DP ASA/ER DP Patients without stroke (%) Placebo Time (months) Kaplan-Meier stroke-free survival curves

  8. ESPS-2: Secondary Endpoint Vascular Events* (MI, Stroke, Vascular Death After Two Years) Number of events % vascular events / N ER DP + ASA ER DP ASA Placebo 246 / 1650 324 / 1654 314 / 1649 361 / 1649 14.9 19.6 19.0 21.9 ER DP = Extended release dipyridamole ASA = Acetylsalicylic acid *Antiplatelet Trialists’ Collaboration (APT) definition Diener et al. J Neurol Sci 1997;151:S1-S77

  9. ESPS-2: Effects on Stroke – RRR (Pairwise Comparisons) 40 37.0%* 30 23.1%** 18.1%† 20 16.3%† RRR (%) 10 0 ASA/ ER DP vs. Placebo ER DP vs.Placebo ASA vs.Placebo ASA/ER DP vs. ASA ER DP = Extended release dipyridamole ASA = Acetylsalicylic acid RRR = Relative Risk Reduction * p<0.001, **p<0.006, †p<0.05 Diener et al. J Neurol Sci 1997;151:S1-S77 Diener et al. J Neurol Sci 1996;143:1-13

  10. ESPS-2: Effects on Stroke – Events Prevented (Pairwise Comparisons) Events prevented NNT ER DP + ASA vs. Placebo ER DP vs. Placebo ASA vs. Placebo ER DP + ASA vs. ASA 58‰ 26‰ 29‰ 30‰ 18 39 35 34 ER DP = Extended release dipyridamole ASA = Acetylsalicylic acid NNT = Number Needed to Treat Diener et al. J Neurol Sci 1997;151:S1-S77

  11. Number Needed to Treat (NNT) To prevent one stroke in Antiplatelet therapy a. ESPS-2 (ER DP + ASA vs. ASA) b. CAPRIE (Clopidogrel vs. ASA) (patients with inclusion criterion stroke) Antihypertensive therapy vs. placebo in the elderly (MRC) Lipid-lowering therapy Simvastatin vs. placebo (4S) Intervention NNT 34 143 70 101 2 years 1.91 years 5 years 5 years ER DP = Extended release dipyridamole ASA = Acetylsalicylic acid

  12. ESPS-2: Adverse Events 100 Placebo ASA 80 ER DP 60 ASA/ER DP Patients reporting (%) * * * * 40 20 * * 0 Headache GI Events Dizziness Bleeding events * Significantly associated with treatment according to factorial analysis

  13. Aggrenox® Precautions • Use caution in patients with severe coronary artery disease (e.g. unstable angina or recently sustained myocardial infarction) as DP may aggravate chest pain • The dose of ASA in Aggrenox® has not been proven to provide adequate treatment for recurrent MI or angina pectoris • Avoid use in patients with severe renal failure and in patients with severe hepatic insufficiency • Use caution in patients with inherited or acquired bleeding disorders • Patients should be alerted to signs and symptoms of GI side effects due to ASA component

  14. with ASA, you prevent 29 strokes with clopidogrel, you prevent 39 strokes with Aggrenox you prevent 58 strokes If you take 1000 patients and follow them for 2 years...

  15. Risk factor modification in asymptomatic patients (all of the usual culprits and sins) additionally, tailor treatment to the cause of symptomatic patients endarterectomy warfarin antiplatelet drugs Conclusions

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