This multicentre, randomised, open trial compared the efficacy and safety/acceptability of
calcium nadroparin, a non-steroidal anti-inflammatory
drug,
naproxen, in the treatment of superficial
venous thrombosis of the lower limbs, in 117 patients.
Calcium nadroparin was given at two dosage regimens: a fixed dose (daily
subcutaneous injection of 0.6 ml, i.e. 6150 anti-Xa IU, n = 38) or a dose adjusted for
body weight (31.5 anti-Xa IU/kg, n = 40). The
naproxen was given orally (500 mg as a single daily dose, n = 39).
Treatment duration was 6 days in both groups. A very marked difference was found to the advantage of
calcium nadroparin, although this difference did not reach the threshold of statistical significance with regard to repermeabilisation of the thrombosed superficial vein at the end of treatment. The most striking result concerned the regression of symptoms and signs. At the end of treatment (D7), there was a significant difference to the advantage of the
calcium nadroparin groups, particularly regarding feelings of heat and redness (p < 0.001 in both cases). The persistence of symptoms and signs at 8 weeks was statistically less frequent (p = 0.007) in the
calcium nadroparin groups than in the
naproxen group. Efficacy did not differ between the
calcium nadroparin fixed dose and
calcium nadroparin weight-adjusted dose groups. No adverse events nor clinically significant laboratory abnormalities were encountered. Antithrombotic treatment of superficial
venous thromboses with
calcium nadroparin is well tolerated and appears to be associated with a greater improvement in symptoms and signs, in the short and mid-terms, than that obtained with an oral non-steroidal anti-inflammatory.