PERIPHERAL VASODILATORS - HEMODYNAMIC-EFF ECT AND CLINICAL BENEFIT

Patients with Chronic occlusive arterial disease of lower limbs have a n excess mortality due to associated cardiovascular diseases or cancer . They also have an important morbidity, with a high prevalence of cor onary artery diseases and strokes. In this context, the only benefit o f peripheral vasodilators devoid of any effect on morbidity and mortal ity, could be only on quality of life. Haemodynamic effects of these d rugs have been evaluated by several reproducible techniques in order t o measure the peripheral blood flow (plethysmography, Xe-133 clearance , transcutaneous oxygen-pressure, electromagnetic debimetry). An incre ase in blood flow has been demonstrated in patients receiving pentoxif ylline, naftidrofuryl, or blufomedil in phase II clinical trials using these different methods. No general haemodynamic effect has been obse rved with these drugs which were better denominated vaso-active drugs. However the most relevant criteria remained to confirm a clinical ben efit, particularly on intermittent claudication. Number of positive cl inical trials in patients with intermittent claudication have been pub lished, but from a methodological point of view few of them were suita ble and demonstrated a statistically significant benefit Criticisms we re mainly related to the type of trial (cross-over is not recommended because of the drug-period effect), the lack of 'intention to treat' a nalysis, the inhomogeneity of the compared groups (for example differe nt percentages of diabetics and excess of drop-outs). In spite of an e stablished haemodynamic effect and of a demonstrated benefit in claudi cants, peripheral vasodilators appear to have a slight interest in the global care of patients with occlusive arterial disease of lower limb s mainly on functional symptoms.