The fate of 257 consecutive patients (100 women) aged 36-85 years (mean 65) first seen with intermittent claudication in 1977 was analysed after a mean of 6-5 (SD 0-5) years. When first seen none of the patients complained of rest pain or had ulcers or gangrenous lesions on the feet.At follow up 113 ofthe patients (44%) had died. Causes of death were no different from those in the general population. Mortality was twice that of the general population matched for age and sex. Mortality among the men was twice that among the women. In men under 60 mortality was four times that expected.The rate of clinical progression of the arteriosclerotic disease (that is, rest pain or gangrene) of the worst affected leg was 7-5% in the first year after referral. Thereafter the rate was 2 2% a year. An ankle systolic blood pressure below 70 mm Hg, a toe systolic blood pressure below 40 mm Hg, or an ankle/arm pressure index below 50% were individually significantly associated with progression of the arteriosclerotic disease.These findings show the importance of peripheral blood pressure measurements in the management of patients with intermittent claudication due to arteriosclerotic disease.
The development of the GLOBIAD is a major step towards a better systematic assessment of IAD in clinical practice and research worldwide. However, further validation is needed.
A double-blind, randomized multicentre study was undertaken to evaluate the possible effect of chelation treatment with ethylenediamine-tetraacetic acid (EDTA) in patients with severe intermittent claudication. A total of 153 patients received 20 intravenous infusions of either 3 g Na2EDTA or placebo during a period of 5-9 weeks. Vitamin, mineral and trace element supplements were administered orally. The changes observed in the pain-free and maximal walking distances, measured on a treadmill, were similar in the two groups. During the 3-month (n = 149) and 6-month (n = 123) follow-up period, no long-term therapeutic effect of EDTA could be demonstrated. The ankle-brachial blood pressure index remained unchanged throughout the study period. This study failed to demonstrate any effect of EDTA chelation treatment in intermittent claudication.
A double-blind, parallel group, multicenter clinical trial of pentoxifylline compared with placebo enrolled 150 patients with moderately severe chronic occlusive arterial disease (COAD) at three centers in Scandinavia. The study consisted of a 4-6 week single-blind, placebocontrolled run-in phase, during which the stabilization of the initial claudication distance of all patients was assessed before randomization to a 6-month double-blind observation period. The diagnosis of COAD was established by clinical findings, conventional angiography, and noninvasive peripheral Doppler pressure assessment at rest and after exercise. The results of the overall intention-to-treat analysis of the study population show statistically significant superiority of pentoxifylline over placebo for all absolute claudication distance summary and end point measures. By using two clinically relevant parameters, which are a resting ankle/arm pressure ratio 0.8 or less and a duration of COAD for greater than 1 year, a target population could be defined in whom trial results became highly significant. For nontarget patients with mild COAD, we conclude that basic therapeutic measures should include the treatment of risk factors and the initiation of physical training. For target patients, however, a multifactorial therapeutic approach, including the use of pentoxifylline, is justified. (Circulation 1989(Circulation :80:1549(Circulation -1556 B asic measures for the treatment of chronic occlusive arterial disease (COAD) are the avoidance of risk factors and the institution of physical training.'1-" However, the decision of whether or not to use vasoactive drugs is controversial, and recommendations differ widely among different schools of medicine mainly because of the difficulty in predicting treatment outcome.The drug used in this trial, pentoxifylline, is a compound that improves blood fluidity by reducing red cell rigidity and blood viscosity.12-15 Furthermore, it inhibits platelet aggregation16 and, as recently published, diminishes the state of neutrophile granulocyte activation.17The purpose of this Scandinavian study was to compare pentoxifylline and placebo as treatment for COAD. Furthermore, those patients were to be identified in whom treatment with pentoxifylline
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