gt; 1% of treated patients: acute infection (excluding septic shock), acute rheumatic disorder, acute lumbar or sciatic pain, vertebral compression, or acute arthritis of the lower extremities. Risk factors include > 75 years of age, cancer, previous DVT/PE, obesity and chronic venous insufficiency. A total of 3681 patients were enrolled and treated: 1848 received FRAGMIN and 1833 received placebo. The mean age of the study population was 69 years (range 26 to 99 years), 92.1% were white and 51.9% were female. The primary efficacy endpoint was eva luated at Day 21 and was defined as at least one of the following within Days 1 to 21 of the study: asymptomatic DVT (diagnosed by compression ultrasound), a confirmed symptomatic DVT, a confirmed pulmonary embolism or sudden death. The follow-up extended through Day 90.
When given at a dose of 5000 IU once a day subcutaneously, FRAGMIN significantly reduced the incidence of thromboembolic reactions including verified DVT by Day 21 (see Table 15). The prophylactic effect was sustained through Day 90.
Table 15
Efficacy of FRAGMIN in the Prophylaxis of Deep Vein Thrombosis in Medical Patients with Severely Restricted Mobility During Acute Illness
Indication Dosing Regimen
FRAGMIN
5000 IU once daily subcutaneous
n (%) Placebo
once daily subcutaneous
n (%)
All Treated Medical Patients
During Acute Illness 1848 1833
Treatment failure in eva luable patients (Day 21)1
DVT, PE, or sudden death 42/1518 (2.8)2 73/1473 (5.0)
Total Thromboembolic Reactions (Day 21) 37/1513 (2.5) 70/1470 (4.8)
Total DVT 32/1508 (2.1) 64/1464 (4.4)
Proximal DVT 29/1518 (1.9) 60/1474 (4.1)
Symptomatic VTE 10/1759 (0.6) 17/1740 (1.0)
PE 5/1759 (0.3) 6/1740 (0.3)
Sudden Death 5/1829 (0.3) 3/1807 (0.2)
1 Defined as DVT (diagnosed by compression ultrasound at Day 21 + 3), confirmed symptomatic DVT, confirmed PE or sudden death.
2 p-value = 0.0015
14.5 Patients with Cancer and Acute Symptomatic Venous ThromboembolismIn a prospective, multi-center, open-label, clinical trial, 676 patients with cancer and newly diagnosed, objectively confirmed acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) were studied. Patients were randomized to either FRAGMIN 200 IU/kg subcutaneous (max 18,000 IU subcutaneous daily for one month) then 150 IU/kg subcutaneous (max 18,000 IU subcutaneous daily for five months (FRAGMIN arm) or FRAGMIN 200 IU/kg subcutaneous (max 18,000 IU subcutaneous daily for five to seven days and oral anticoagulant for six months (OAC arm). In the OAC arm, oral anticoagulation was adjusted to maintain an INR of 2 to 3. Patients were eva luated for recurrence of symptomatic venous thromboembolism (VTE) every two weeks for six months.
The median age of patients was 64 years (range: 22 to 89 years); 51.5% of patients were females; 95.3% of patients were Caucasians. Types of tumors were: gastrointestinal tract (23.7%), genito-urin |
