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Purpose

ESTEEM: Efficacy and safety of the oral direct thrombin inhibitor ximelagatran in patients with recent myocardial infarction. Purpose

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Purpose

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  1. ESTEEM: Efficacy and safety of the oral direct thrombin inhibitor ximelagatran in patients with recent myocardial infarction Purpose To compare the efficacy and safety of four doses of oral ximelagatran with placebo in patients given acetylsalicylic acid with recent ST-elevation or non-ST-elevation myocardial infarction, and to investigate any dose–effect relation Reference Wallentin L, Wilcox RG, Weaver WD et al. for the ESTEEM Investigators. Oral ximelagatran for secondary prophylaxis after myocardial infarction: the ESTEEM randomised controlled trial. Lancet 2003;362:789–97.

  2. ESTEEM: Efficacy and safety of the oral direct thrombin inhibitor ximelagatran in patients with recent myocardial infarction - TRIAL DESIGN - Design Multicenter, multinational, randomized, double-blind, placebo-controlled, dose guiding Patients 1883 patients with ST-elevation or non-ST-elevation MI within the past 14 days Follow up and primary endpoint Primary composite endpoint: all-cause mortality, non-fatal MI and severe recurrent ischemia. 6 months follow up. Treatment Ximelagatran 24, 36, 48 or 60 mg twice daily or placebo for 6 months. All patients received acetylsalicylic acid 160 mg once daily.

  3. ESTEEM: Efficacy and safety of the oral direct thrombin inhibitor ximelagatran in patients with recent myocardial infarction - TRIAL DESIGN continued - Baseline characteristics (%) Ximelagatran Placebo (n=638) 24 mg 36 mg 48 mg 60 mg Combined (n=307) (n=303) (n=311) (n=324) (n=1245) Demographics Mean age (years) 69 69 69 68 68 68 Men 69 68 68 68 69 68 Index event Unstable angina 6 7 7 5 5 6 Non-Q-wave MI 44 45 38 45 43 43 Q-wave MI 49 48 55 50 52 51 Drugs Beta-blockers 88 86 86 86 88 86 ACE inhibitors 66 65 62 68 66 65 Statins 66 64 66 62 69 66 Wallentin et al. Lancet 2003;362:789–97.

  4. Placebo Ximelagatran ESTEEM: Efficacy and safety of the oral direct thrombin inhibitor ximelagatran in patients with recent myocardial infarction - RESULTS - Cumulative risk of death, MI and severe recurrent ischemia 20 Cumulative risk (%) 16 12 8 4 P = 0.036 0 0 30 60 90 120 150 180 Days after randomization Wallentin et al. Lancet 2003; 362 :789 – 97.

  5. Death (%) 2.7 2.6 1.3 1.9 2.5 2.1 MI (%) 5.2 4.6 4.3 3.9 3.4 4.0 Severe recurrent 8.2 4.6 7.9 5.8 6.8 6.3 ischemia (%) ESTEEM: Efficacy and safety of the oral direct thrombin inhibitor ximelagatran in patients with recent myocardial infarction - RESULTS continued - Primary endpoint and its components Ximelagatran Placebo (n=638) 24 mg 36 mg 48 mg 60 mg Combined (n=307) (n=303) (n=311) (n=324) (n=1245) Primary endpoint: all-cause mortality nonfatal MI and 16 12 14 12 13 13 severe recurrent ischemia (%) Hazard ratio 0.72 0.85 0.70 0.78 0.76 95% CI 0.49–1.05 0.59–1.21 0.48–1.02 0.54–1.12 0.59–0.98 Wallentin et al. Lancet 2003; 362 :789 – 97.

  6. 24 mg (n=307) 2 (0.67–6.41) 8 (1.80–7.09) ESTEEM: Efficacy and safety of the oral direct thrombin inhibitor ximelagatran in patients with recent myocardial infarction - RESULTS continued - Bleeding events – % (95% CI) Oral ximelagatran Placebo (n=638) 36 mg 48 mg 60 mg Combined (n=303) (n=311) (n=324) (n=1245) Major bleeding 1 1 3 2 2 (0.14–3.48) (1.24–9.42) (0.51–5.46) (0.80–4.84) Bleeding leading 2 4 9 8 8 to discontinuation (0.71–3.72) (2.25–8.47) (1.94–7.46) (1.87–6.01) of study medication, or major bleeding Wallentin et al. Lancet 2003; 362 :789 – 97.

  7. ESTEEM: Efficacy and safety of the oral direct thrombin inhibitor ximelagatran in patients with recent myocardial infarction - RESULTS AND SUMMARY- • Oral ximelagatran in combination with acetylsalicylic acid was more effective than acetylsalicylic acid alone in reducing the risk for the composite endpoint of death, nonfatal myocardial infarction and severe recurrent ischemia (P=0.0357) • The efficacy did not differ between the individual ximelagatran doses • The frequency of major bleeding did not differ between the treatment groups. However, the cumulative risk of total bleeding (major and minor) was higher in those on ximelagatran than in those on placebo • The number of patients with concentrations of alanine transaminase that were more than three times the upper limit of normal was higher in the ximelagatran groups than in the placebo group (P<0.0001)

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