Sixty-three patients suffering from peripheral arterial occlusive disease (PAOD) were treated for a 6-month period with a new low molecular weight heparin, LMWH (Fluxum: 31 patients) or with placebo (32 patients). Both clinical and instrumental evaluations (treadmill test, Winsor index, strain gauge plethysmography) and laboratory parameters (aPTT, Xa, red and white blood cell count, haemoglobin, haematocrit, GOT, GPT, alkaline phosphatase, CPK, total bilirubin and azotaemia) were evaluated 1, 3 and 6 months after therapy began. In patients who received LMWH there was a marked increase of iXa, compared with those who received placebo, whereas the aPTT changes were not different in the two groups; moreover, the Winsor index and pain-free walking distance improved significantly more in the LMWH group compared with the placebo group. Safety was very good in both treatment groups; no haemorrhage episodes were observed in LMWH-receiving patients, and no drug-related drop-outs were registered. The results support the hypothesis of an effect of this drug both on thrombosis prevention and on lower limb blood flow enhancement in PAOD patients, and justify the therapeutic use of LMWH.
|Number of pages||9|
|Journal||Clinical Trials and Meta-analysis/Clinical Trials Journal|
|Publication status||Published - 1993|
- low molecular weight heparin
- peripheral arterial occlusive disease
ASJC Scopus subject areas
- Pharmacology (medical)