[Calcium nadroparin in the prevention of thromboembolic disease in elderly subjects. Study of tolerance]

Abstract

Objective: To evaluate the safety of a low molecular weight heparin for the prevention of thromboembolic disease in elderly patients.

Methods: A multicentre, randomized, open study was conducted in 295 patients: 146 patients (mean age 82.8 +/- 0.5 years) received calcium nadroparin and 149 patients (mean age 83.8 +/- 0.6 years) received calcium heparin. All medical patients were hospitalized with transient locomotor disability, requiring prophylaxis for thromboembolism. Patients were randomized to 28-days treatments with either subcutaneous calcium nadroparin 0.3 ml (3075 anti-Xa IU) daily or subcutaneous calcium heparin twice a day (0.2 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 premature discontinuation of treatment for any reason: Discontinuation was more frequent in the calcium heparin group (16.1%) than in the calcium nadroparin 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 thrombus, 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 confirm the safety and simplicity of administration of calcium nadroparin in the prevention of thromboembolism in elderly patients.