Postphlebitic syndrome: clinical activity and tolerability of desmin, new LMW dermatan sulfate

Abstract

One hundred patients suffering from postphlebitic syndrome of the lower limbs were enrolled in an open, randomized, and multicenter (six centers) trial for a period of eighteen months. Patients were randomly assigned to three treatment groups to receive (for ninety consecutive days) Desmin, a new low-molecular-weight dermatan sulfate, at the dose, respectively, of 100 mg once daily by subcutaneous (SC) route (36 patients), 100 mg twice a day by SC route (33 patients), and 200 mg once daily by intramuscular (IM) route (31 patients). The general and local tolerability and the clinical efficacy of the drug were evaluated by means of clinical, instrumental, and laboratory parameters. Desmin is effective in the decompensation stage of postphlebitic syndrome; this was demonstrated by a significant reduction in the severity of a number of typical symptoms as well as by the drug's positive effect on venous tone as confirmed by phlebotensiometric examination. The daily dose of 200 mg (either SC or IM) was more effective than the 100 mg dose. The results obtained at the end of the trial (ninety days) were statistically better than those obtained after thirty days of treatment. This trial demonstrated that both the systemic and the local (at the site of injection) tolerability of the drug, administered for three months, were good and without significant variations in the laboratory parameters monitored.