Preliminary comparison of the clinical efficacy and tolerability of low—molecular-weight dermatan sulfate and calcium heparin in postthrombotic syndrome

Autor: Gaetano Catania, Angelo A. Bignamini, Ernesto Palazzini, Giovanni Romano, Villiam Zamboni, Tommaso Salanitri, Catalano F, Beniamino Tesauro, Alessandro Megha
Rok vydání: 1996
Předmět:
Zdroj: Current Therapeutic Research. 57:969-979
ISSN: 0011-393X
DOI: 10.1016/s0011-393x(96)80115-9
Popis: Fifty-three patients with postthrombotic syndrome (36 women and 17 men; mean age, 52.9 years; age range, 26 to 80 years) took part in this open-label, observer-masked, treatment-controlled, multicenter study comparing low—molecular-weight dermatan sulfate (desmin) and calcium heparin. Patients were distributed among three treatment groups: (1) group A—desmin 200 mg once daily intramuscularly (IM); (2) group B—desmin 200 mg twice daily IM; and (3) group C—calcium heparin 5000 IU twice daily subcutaneously. Treatments lasted 2 months for all three groups. The primary efficacy end point of the study was the reduction of limb edema, assessed by measuring changes in the circumference of the more affected limb. Limb venous pressure, healing of stasis ulcers, and improvement of signs and symptoms of venous stasis were also monitored. Treatment tolerability was monitored throughout the study. After 2 months of therapy, desmin and calcium heparin were found to be similarly effective in relieving the signs and symptoms of venous stasis, particularly limb edema and pain. Statistically significant reductions in venous pressure in the affected limbs were achieved with both drugs; however, no statistically significant between-group difference was seen in the reduction of limb circumference, perhaps because of the small number of patients in the study. Although both drugs were effective in promoting healing of cutaneous ulcers, the difference in the prevalence of ulcers (1 patient in the calcium heparin group vs 12 patients in the desmin groups) in the treatment groups precluded a valid comparison of treatments. The tolerability of desmin therapy was found to be superior to that of calcium heparin both systemically (calcium heparin was associated with statistically and clinically significant alterations in serum transaminases) and locally (hemorrhagic suffusion occurred in several patients after the injection of calcium heparin).
Databáze: OpenAIRE