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:
|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.
|Event||Aspirin(N=1206)||Warfarin(N=1216)||Aspirin plusWarfarin(N=1208)||Rate Ratio(95% CI)||p -value|
|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|
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.
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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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