[Calcium nadroparin in the prevention of thromboembolic disease in elderly subjects. Study of tolerance].
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.
Forette
B
B
Hôpital Sainte-Périne, Paris.
Wolmark
Y
Y
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006470:Hemorrhage / Q000209:etiology; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D017762:Nadroparin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012307:Risk Factors; D013921:Thrombocytopenia / Q000139:chemically induced; D013923:Thromboembolism / Q000517:prevention & control*
D017762:Nadroparin; D006493:Heparin
Nadroparine calcique dans la prévention de la maladie thrombo-embolique chez le sujet âgé. Etude de la tolérance.