TOLERANCE TO CALCIUM NADROPARIN FOR THE P REVENTION OF THROMBOEMBOLISM IN THE ELDERLY

Objective: To evaluate the safety of a low molecular weight heparin fo r the prevention of thromboembolic disease in elderly patients. Method s: A multicentre, randomized, open study was conducted in 295 patients : 146 patients (mean age 82.8 +/- 0.5 years) received calcium nadropar in and 149 patients (mean age 83.8 +/- 0.6 years) received calcium hep arin. All medical patients were hospitalized with transcient locomotor disability, requiring prophylaxis for thromboembolism. Patients were randomized to 28-days treatments with either subcutaneous calcium nadr oparin 0.3 ml (3075 anti-Xa IU) daily or subcutaneous calcium heparin twice a day (0.3 ml - 5000 UI - if bodyweight was less than 70 kg or 0 .3 ml - 7500 IU, - if bodyweight was over or equal to 70 kg). Results: The overall objective was to assess tolerability in terms of prematur e discontinuation of treatment for any reason: Discontinuation was mor e frequent in the calcium heparin group (16.1%) than in the calcium na droparin group (11%), but without statistical significance. Premature withdrawal of therapy definitively attributable to drug administration occurred in 10 patients from the calcium heparin group (1 deep vein t hrombus, 1 pulmonary embolus, 4 major bleeding events, 1 thrombopenia, 3 allergic events) and in only 1 from the calcium nadroparin group (1 allergic event). The difference was statistically significant (p = 0. 01). Conclusions: The results of this study offer new evidence to conf irm the safety and simplicity of administration of calcium nadroparin in the prevention of thromboembolism in elderly patients.