Improvement of Walking Distance in Patients with Intermittent Claudication by Chronic Local Therapy with Isosorbide Dinitrate Ointment

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Abstract
Isosorbide dinitrate ointment (100 mg tid) was directly applied to 30 male patients with stable, documented intermittent claudication on the areas where ischemic pain was experienced. The symptom-free distance walked (DWA) and the maximum distance reached (MDR) basally, after one, three, six, and twelve months were evaluated by means of treadmill stress tests (TSTs) (angle 0°-velocity constant/patient). After the basal TST, patients were randomly divided into two groups: placebo group and therapy group (double blind), and a further TST was administered one month later. DWA results were 74±8 m vs 297 ±83 m and MDR results were 163 ±22 m vs 506 ±86 m in the therapy group (basal vs one month TST: p < .01) and 94±24 m vs 96±15 m and 232±53 m vs 183±26 m in the placebo group, respectively (basal vs one month TST: NS). Being confident that a significant placebo effect was absent, the authors opened the trial and treated all patients, repeating further TSTs at three, six, and twelve months. The following results were obtained: DWA was 84±13 m, 316±63 m, 374±55 m, and 452±61 m; and MDR was 197 ±29 m, 431 ±59 m, 514 ±57 m, and 547 ±59 m, respectively, in basal conditions and after three, six, and twelve months of treatment (p < .01 for all the values for both DWA and MDR vs basal values). These results suggest the effectiveness of this treatment, independently from a placebo effect, in improving walking tolerance in patients with intermittent claudication.