Enoxaparin Sodium (Page 9 of 12)
14.5 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction
In a multicenter, double-blind, parallel group study, patients who recently experienced unstable angina or non-Q-wave myocardial infarction were randomized to either enoxaparin sodium injection, 1 mg/kg every 12 hours subcutaneously or heparin intravenous bolus (5000 U) followed by a continuous infusion (adjusted to achieve an aPTT of 55 to 85 seconds). A total of 3171 patients were enrolled in the study, and 3107 patients were treated. Patients ranged in age from 25 to 94 years (median age 64 years), with 33.4% of patients female and 66.6% male. Race was distributed as follows: 89.8% Caucasian, 4.8% Black, 2.0% Asian, and 3.5% other. All patients were also treated with aspirin 100 to 325 mg per day. Treatment was initiated within 24 hours of the event and continued until clinical stabilization, revascularization procedures, or hospital discharge, with a maximal duration of 8 days of therapy. The combined incidence of the triple endpoint of death, myocardial infarction, or recurrent angina was lower for enoxaparin sodium injection compared with heparin therapy at 14 days after initiation of treatment. The lower incidence of the triple endpoint was sustained up to 30 days after initiation of treatment. These results were observed in an analysis of both all-randomized and all-treated patients. The efficacy data are provided below (see Table 23).
| Indication | Dosing Regimen* | |||
| Enoxaparin Sodium Injection | Heparin | Reduction | p Value | |
| 1 mg/kg q12h subcutaneous | aPTT Adjusted Intravenous Therapy | |||
| n (%) | n (%) | (%) | ||
| All Treated Unstable Angina and Non-Q-Wave MI Patients | 1578 (100) | 1529 (100) | ||
| Time point† | ||||
| 48 Hours | 96 (6.1) | 112 (7.3) | 1.2 | 0.120 |
| 14 Days | 261 (16.5) | 303 (19.8) | 3.3 | 0.017 |
| 30 Days | 313 (19.8) | 358 (23.4) | 3.6 | 0.014 |
| * All patients were also treated with aspirin 100 to 325 mg per day. | ||||
| † Evaluation time points are after initiation of treatment. Therapy continued for up to 8 days (median duration of 2.6 days). | ||||
The combined incidence of death or myocardial infarction at all time points was lower for enoxaparin sodium injection compared to standard heparin therapy, but did not achieve statistical significance. The efficacy data are provided below (see Table 24).
| Dosing Regimen* | ||||
| Enoxaparin Sodium Injection | Heparin | Reduction | p Value | |
| 1 mg/kg q12h subcutaneously | aPTT Adjusted Intravenous Therapy | (%) | ||
| Indication | n (%) | n (%) | ||
| All Treated Unstable Angina and Non-Q-Wave MI Patients | 1578 (100) | 1529 (100) | ||
| Time point† | ||||
| 48 Hours | 16 (1.0) | 20 (1.3) | 0.3 | 0.126 |
| 14 Days | 76 (4.8) | 93 (6.1) | 1.3 | 0.115 |
| 30 Days | 96 (6.1) | 118 (7.7) | 1.6 | 0.069 |
| * All patients were also treated with aspirin 100 to 325 mg per day. | ||||
| † Evaluation time points are after initiation of treatment. Therapy continued for up to 8 days (median duration of 2.6 days). | ||||
In a survey one year following treatment, with information available for 92% of enrolled patients, the combined incidence of death, myocardial infarction, or recurrent angina remained lower for enoxaparin sodium injection versus heparin (32.0% vs 35.7%).
Urgent revascularization procedures were performed less frequently in the enoxaparin sodium injection group as compared to the heparin group, 6.3% compared to 8.2% at 30 days (p=0.047).
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