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.
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References
1.
Hugson WC, Mann JI, Garrod A.: Intermittent Claudication: prevalence and risk factors. Br Med J1:1397, 1978.
2.
Noon GP, Dietrich EB, Richardson WP et al: Distal tibial arterial bypass: analysis of 91 cases. Arch Surg99:770, 1969.
3.
Stoney RJ, James DR, Wylie EJ: Surgery for femoropopliteal atherosclerosis. Arch Surg103:548, 1971.
4.
Sinzinger H. , Fitscha P., Peskar AB: Platelet half life, tromboxane B2 and circulating endothelial cells in peripheral vascular disease . Angiology37:112, 1986.
5.
Reid HL, Dormandy JA, Earnes AJ et al: Impaired red cell deformability in peripheral vascular disease . Lancet1:666, 1976.
6.
Accetto B.: Beneficial hemoreologic therapy of chronic peripheral arterial disorders with pentoxifylline: results of double-blind study versus vasodilator nydrilin . Am Heart J103:864, 1982.
7.
Porter JM, Cutler BS, Lee BY et al: Pentoxifylline efficacy in the treatment of intermittent claudication: multicenter controlled double-blind trial with objective assessment of chronic occlusive arterial disease patients. Am Heart J104:66, 1982.
8.
Poggesi L., Scarti L., Boddi M. et al: Pentoxifylline treatment in patients with occlusive peripheral arterial disease. Circulatory changes and effects on prostaglandin synthesis . Angiology36:628, 1985.
9.
Perhoniemi V. ,. Salmenkivi K., Sundberg S. et al: Effects of flunarizine and pentoxifylline on walking distance and blood rheology in claudication . Angiology35:366, 1984.
10.
Coffman JO, Mannick JA: Failure of vasodilator drugs in arteriosclerosis obliterans. Ann Intern Med76:35, 1972.
11.
Hansteen V. , Lorentseen E.: Vasodilator drugs in the treatment of peripheral arterial insufficiency. Acta Med Scand, Suppl . 556:9, 1974.
12.
Vyden JK, Nagasawa K., Kanazawa M. et al: Lack of effect of cyclandelate in peripheral arterial disease . Angiology35:1, 1984.
13.
Trubestein G., Balzer K., Bisler H. et al: Buflomedil in arterial occlusive disease: results of a controlled multicenter study. Angiology35:500, 1984.
14.
Belch Jjf, McArdle B., Pollock JG et al: Epoprostenol (prostacyclin) and severe arterial disease. A double-blind trial. Lancet1:111, 1983.
15.
Szczeklik A. , Skawinsky S., Gluszko P.: Successful therapy of advanced arteriosclerosis obliterans with prostacyclin. Lancet1:111, 1979.
16.
De Cree J., Geukens SH, Leempoels J. et al: Placebo-controlled double-blind trial of ketanserin in treatment of intermittent claudication. Lancet2:775, 1984.
17.
Biagini A., Carpeggiani C., Testa R. et al: Claudicatio intermittens: trattamento topico con isosorbide dinitrato in pasta. Risultati preliminari. G It Cardiol11:983, 1981.
18.
Winer BJ: Statistical principles in experimental design. New York1971, McGraw-Hill Book Co., Inc.
19.
Biagini A., Testa R., Carpeggiani C. et al: Lokalbehandlung der Claudicatio Intermittens mit Isosorbiddinitrat . Herz-Kreislauf9:514, 1982.
20.
Lund F.: Percutaneous nytroglicerin treatment in cases of peripheral circulatory disorders. Especially Raynaud's disease. Acta Med Scand Supp . 206, 130:196, 1948.
