Gm. Andreozzi et al., POSTPHLEBITIC-SYNDROME - CLINICAL ACTIVITY AND TOLERABILITY OF DESMIN, NEW LMW DERMATAN SULFATE, Angiology, 47(10), 1996, pp. 1001-1010
One hundred patients suffering from postphlebitic syndrome of the lowe
r limbs were enrolled in an open, randomized, and multicenter (six cen
ters) trial for a period of eighteen months. Patients were randomly as
signed to three treatment groups to receive (for ninety consecutive da
ys) Desmin, a new low-molecular-weight dermatan sulfate, at the dose,
respectively, of 100 mg once daily by subcutaneous (SC) route (36 pati
ents), 100 mg twice a day by SC route (33 patients), and 200 mg once d
aily by intramuscular (IM) route (31 patients). The general and local
tolerability and the clinical efficacy of the drug were evaluated by m
eans of clinical, instrumental, and laboratory parameters. Desmin is e
ffective in the decompensation stage of postphlebitic syndrome; this w
as demonstrated by a significant reduction in the severity of a number
of typical symptoms as well as by the drug's positive. effect on veno
us 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 statis
tically better than those obtained after thirty days of treatment. Thi
s 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 param
eters monitored.