Ketanserin in intermittent claudication. A double-blind placebo-controlled study

Twenty patients with intermittent claudication and having an ankle/arm blood pressure ratio less than or equal to 0.75 were randomized to receive ketanserin 40 mg b.i.d. or placebo for three months under double-blind conditions following a six-week run-in period. A placebo was administered for an additional six weeks at the end of the double-blind phase. Results indicated that ketanserin significantly increased (p less than 0.04) the pain-free walking distance by 36% versus a non-significant 10% rise with placebo. During the run-out period, this parameter remained significantly increased (p less than 0.04) with ketanserin. Changes in the total walking distance during the double-blind period were 15% and 11% for ketanserin and placebo, respectively, with a significant (p less than 0.05) increase to 30% occurring in the ketanserin group during the run-out phase. There was a decrease in the ankle/arm blood pressure ratio in the worst leg in both groups. The rise of systemic blood pressure after exercise was attenuated with ketanserin. Side-effects were reported in only one patient in the placebo group. These data indicate that ketanserin may be of value in patients suffering from intermittent claudication. Other studies are, however, warranted to determine whether this beneficial effect is general or restricted to a subgroup of patients.