Bencyclane - a new aspect of the mechanism of action in patients with peripheral arterial occlusive disease. Open-label, prospective, randomized trial

Abstract

Background. Bencyclane provides a favourable therapeutic effect in patients with peripheral vascular disease; however, its mechanism of action has not been completely explained. We have attempted to clarify bencyclane’s mechanism of action in patients with peripheral arterial occlusive disease (PAOD), taking into particular consideration antiplatelet and fibrinolytic activity of the drug, on the basis of particular clinical and laboratory parameters.
Materials and methods. The study was performed on 36 patients with PAOD according to Fontaine stage II, aged 43-69 years (mean 56 years). We used patients receiving pentoxifylline as a control group. Patients were randomised into two groups of 18 subjects each, based on date of birth. All patients in group A (bencyclane) received 200 mg of bencyclane in 250 ml of normal saline as an i.v. infusion in the morning and 200 mg of the drug orally in the evening for 14 days. In a control group B (pentoxifylline) patients were given 300 mg of pentoxifylline in 250 ml of normal saline as an i.v. infusion in the morning and 400 mg of pentoxifylline orally in the evening for 14 days. Clinical examinations were performed before the start and at the end of the therapy and laboratory estimations were made before the start of the therapy and after finishing a 2-hour drug infusion on the first and last days of treatment.
Results. In comparison with pentoxifylline, bencyclane is characterized by stronger antiplatelet, fibrinolytic and antiaggregatory activity, with comparable vasodilating effects and to a lesser extent it influences erythrocyte deformability.
Conclusion. Antiplatelet and fibrinolytic activity, as well as lowering the PAI-1 level and rising concentrations of t-PA and 6-keto PGF_1α, may suggest that bencyclane’s mechanism of action is endothelial-derived.