Vol 16, No 1 (2010)
Research paper
Published online: 2010-04-19
Comparative evaluation of pentoxyphylline and sulodexide effectiveness in the treatment of symptomatic arteriosclerosis obliterans
Acta Angiologica 2010;16(1):18-29.
Abstract
Background. Although the description of arteriosclerosis obliterans dates back to the middle of the nineteenth
century, no efficient pharmacological agent reducing symptoms of lower limb ischaemia has yet been
discovered. As well as pentoxyphylline, which has been used for many years, sulodexide - a glycosaminoglycan
with heparin-like activity - is also being employed.
Material and methods. In a multidirectional ongoing trial, the effectiveness of both agents was preliminarily assessed following 8 weeks of treatment, including 7 days of intravenous injections, 42 days of oral administration, and subsequent 7-day re-administration of intravenous drips. Both drugs were dosed in accordance with the manufacturer's indications: intravenous pentoxyphylline 2 x 300 mg in 250 ml 0.9% NaCl, and orally: 2 x 600 mg in retard form; intravenous sulodexide 1 x 1 amp. (600 LSU) in 250 ml 0.9% NaCl, and orally 2 x 1 caps. (250 LSU). Forty patients with the early stage of the disease (IIB according to the Fontaine classification) were evaluated (mean age 54.3 years old - 17 study subjects in the pentoxyphylline group and 23 in the sulodexide group). Lower limb arterial sufficiency was assessed by means of treadmill test, with ankle-brachial index evaluation and plethysmography conducted before and after the treadmill test.
Results and conclusions. In the conducted project, the non-significant influence of pentoxyphylline over both pain-free and total claudication distance was determined. In the case of sulodexide, significant lengthening of pain-free (by 20.13 m) and total claudication distance (by 25.71 m) were established, and statistical significance was reached for claudication distance increase by sulodexide in comparison with pentoxyphylline (16%; p < 0.05). No significant influence of the two agents over plethysmographic parameters of arterial sufficiency both pre- and post-treadmill tests was demonstrated, although comparative analysis showed a clinically irrelevant difference in the affection of lower-limb pressure values before and after treatment. A 5-year evaluation period of both drugs' effectiveness has been planned, with the intention of enlarging the study population.
Material and methods. In a multidirectional ongoing trial, the effectiveness of both agents was preliminarily assessed following 8 weeks of treatment, including 7 days of intravenous injections, 42 days of oral administration, and subsequent 7-day re-administration of intravenous drips. Both drugs were dosed in accordance with the manufacturer's indications: intravenous pentoxyphylline 2 x 300 mg in 250 ml 0.9% NaCl, and orally: 2 x 600 mg in retard form; intravenous sulodexide 1 x 1 amp. (600 LSU) in 250 ml 0.9% NaCl, and orally 2 x 1 caps. (250 LSU). Forty patients with the early stage of the disease (IIB according to the Fontaine classification) were evaluated (mean age 54.3 years old - 17 study subjects in the pentoxyphylline group and 23 in the sulodexide group). Lower limb arterial sufficiency was assessed by means of treadmill test, with ankle-brachial index evaluation and plethysmography conducted before and after the treadmill test.
Results and conclusions. In the conducted project, the non-significant influence of pentoxyphylline over both pain-free and total claudication distance was determined. In the case of sulodexide, significant lengthening of pain-free (by 20.13 m) and total claudication distance (by 25.71 m) were established, and statistical significance was reached for claudication distance increase by sulodexide in comparison with pentoxyphylline (16%; p < 0.05). No significant influence of the two agents over plethysmographic parameters of arterial sufficiency both pre- and post-treadmill tests was demonstrated, although comparative analysis showed a clinically irrelevant difference in the affection of lower-limb pressure values before and after treatment. A 5-year evaluation period of both drugs' effectiveness has been planned, with the intention of enlarging the study population.
Keywords: arteriosclerosis obliteranschronic lower limb ischaemiapentoxyphyllinesulodexide