Jantoven (Page 7 of 8)

14.3 Myocardial Infarction

WARIS (The Warfarin Re-Infarction Study) was a double-blind, randomized study of 1214 patients 2 to 4 weeks post-infarction treated with warfarin to a target INR of 2.8 to 4.8. The primary endpoint was a composite of total mortality and recurrent infarction. A secondary endpoint of cerebrovascular events was assessed. Mean follow-up of the patients was 37 months. The results for each endpoint separately, including an analysis of vascular death, are provided in Table 7:

Table 7: WARIS — Endpoint Analysis of Separate Events
Event Warfarin(N=607) Placebo(N=607) RR (95% CI) % Risk Reduction(p -value)
RR=Relative risk; Risk reduction=(1 — RR); CI=Confidence interval; MI=Myocardial infarction; py=patient years
Total Patient Years of Follow-up 2018 1944
Total Mortality 94 (4.7/100 py) 123 (6.3/100 py) 0.76 (0.60, 0.97) 24 (p=0.030)
Vascular Death 82 (4.1/100 py) 105 (5.4/100 py) 0.78 (0.60, 1.02) 22 (p=0.068)
Recurrent MI 82 (4.1/100 py) 124 (6.4/100 py) 0.66 (0.51, 0.85) 34 (p=0.001)
Cerebrovascular Event 20 (1.0/100 py) 44 (2.3/100 py) 0.46 (0.28, 0.75) 54 (p=0.002)

WARIS II (The Warfarin, Aspirin, Re-Infarction Study) was an open-label, randomized study of 3630 patients hospitalized for acute myocardial infarction treated with warfarin to a target INR 2.8 to 4.2, aspirin 160 mg per day, or warfarin to a target INR 2.0 to 2.5 plus aspirin 75 mg per day prior to hospital discharge. The primary endpoint was a composite of death, nonfatal reinfarction, or thromboembolic stroke. The mean duration of observation was approximately 4 years. The results for WARIS II are provided in the Table 8.

Table 8: WARIS II — Distribution of Events According to Treatment Group
Event Aspirin(N=1206) Warfarin(N=1216) Aspirin plusWarfarin(N=1208) Rate Ratio(95% CI) p -value
CI=confidence interval
ND=not determined
*
The rate ratio is for aspirin plus warfarin as compared with aspirin.
The rate ratio is for warfarin as compared with aspirin.
Includes death, nonfatal reinfarction, and thromboembolic cerebral stroke.
No. of Events
Major Bleeding 8 33 28 3.35* (ND)4.00 (ND) NDND
Minor Bleeding 39 103 133 3.21* (ND)2.55 (ND) NDND
Composite Endpoints 241 203 181 0.81 (0.69-0.95)*0.71 (0.60-0.83) 0.030.001
Reinfarction 117 90 69 0.56 (0.41-0.78)*0.74 (0.55-0.98) <0.0010.03
Thromboembolic Stroke 32 17 17 0.52 (0.28-0.98)*0.52 (0.28-0.97) 0.030.03
Death 92 96 95 0.82

There were approximately four times as many major bleeding episodes in the two groups receiving warfarin than in the group receiving aspirin alone. Major bleeding episodes were not more frequent among patients receiving aspirin plus warfarin than among those receiving warfarin alone, but the incidence of minor bleeding episodes was higher in the combined therapy group.

15. REFERENCES

  • Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:160S-198S.
  • Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:454S-545S.
  • Singer DE, Albers GW, Dalen JE, et al. Antithrombotic therapy in atrial fibrillation. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:546S-592S.
  • Becker RC, Meade TW, Berger PB, et al. The primary and secondary prevention of coronary artery disease. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:776S-814S.
  • Salem DN, O’Gara PT, Madias C, Pauker SG. Valvular and structural heart disease. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:593S-629S.
  • Monagle P, Chalmers E, Chan A, et al. Antithrombotic therapy in neonates and children. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th Ed. Chest. 2008;133:887S-968S.

16. HOW SUPPLIED/STORAGE AND HANDLING

Tablets

JANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit-dose blister packages with potencies and colors as follows:

2 mg — Compressed tablet, lavender, round; in

Bottles of 30 NDC 54868-0822-0

3 mg — Compressed tablet, tan, round; in

Bottles of 30 NDC 54868-5425-0

4 mg — Compressed tablet, blue, round; in

Bottles of 30 NDC 54868-0825-0

5 mg — Compressed tablet, peach, round; in

Bottles of 30 NDC 54868-5207-0
Bottles of 100 NDC 54868-5207-1

6 mg — Compressed tablet, teal, round; in

Bottles of 30 NDC 54868-1216-0

Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.

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