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Intermittent claudication is a common symptom. It is a marker of generalised antherosclerotic disease and may herald other cardiovascular catastrophes. The aim of management is to reduce the total cardiovascular morbidity and mortality. The functional status and quality of life of severely affected patients can be improved by endovascular and surgical interventions.
BACKGROUND: Intermittent claudication is pain, caused by chronic occlusive arterial disease, that develops in a limb during exercise and is relieved with rest. Buflomedil is a vasoactive agent claimed to have beneficial effects on the microcirculation. It is used chiefly to treat peripheral vascular disease and to a lesser extent for cerebrovascular arterial disease. However, its clinical efficacy for intermittent claudication has not yet been critically examined. OBJECTIVES: To evaluate the available evidence on the efficacy of buflomedil for intermittent claudication. SEARCH STRATEGY: We searched Medline, International Pharmaceutical Abstracts (IPA) and the Cochrane Controlled Trials Register. Abbott Laboratories, the distributor of buflomedil, was asked to provide reports of controlled clinical trials. Reference lists of retrieved articles were checked, and enquiries sent to authors of known trials, to identify additional trials. Finally, we conducted a Science Citation Index search. SELECTION CRITERIA: Trial reports had to be double-blinded, randomized, and conformed to our PIO-criteria (Patients, Intervention, Outcome) to be considered for inclusion. Patients were required to have proven intermittent claudication (Fontaine stage II); the intervention was to be oral administration of buflomedil compared to placebo; and outcomes had to include pain-free walking distance (PFWD) and maximum walking distance (MWD) analysed by standardized exercise test. DATA COLLECTION AND ANALYSIS: Searches of bibliographic databases yielded three eligible randomized controlled trials (RCTs) and a meta-analysis referring to nine eligible trials. Two of these nine trials had already been identified; two had been published in journals not referenced in traditional bibliographic indexes; and five were unpublished. Despite multiple requests, only one of the five unpublished trials was provided by the author of the meta-analysis, the other four could not be retrieved. Four of the six eligible trials retrieved were subsequently excluded after quality evaluation. Data on walking distances were extracted from the two remaining trials. Differences in incremental gain between active and placebo groups for PFWD and MWD with their confidence intervals were calculated. MAIN RESULTS: Both RCTs showed moderate improvements in PFWD for patients on buflomedil. In one trial this improvement (75 m, 95% CI 37-114) was statistically significant, but in the other, with a wholly diabetic population, it was non-significant (81m, 95% CI -9-170) compared to placebo. For both RCTs the gains in MWD were statistically significant, but with wide confidence intervals (81 m, 95% CI 30-131; and 171 m, 95% CI 27-316 respectively). Pooling of the data was not attempted. REVIEWER'S CONCLUSIONS: There is little evidence available to evaluate the efficacy of buflomedil for intermittent claudication. Most available trials are of poor quality and were excluded. The two trials included showed moderately positive results but these are undermined by publication bias since we know of another four unpublished, irretrievable, and inconclusive studies. There is a lack evidence for the efficacy of buflomedil in intermittent claudication.
PURPOSE: Intermittent claudication can be regarded as repeated ischemia reperfusion injury, which can induce a generalized increase in vascular permeability, including in intestine. The lactulose mannitol test (L/M test) was performed in patients with intermittent claudication to evaluate the change in intestinal permeability when they were forced to walk. METHODS: The L/M test was performed in 11 patients with intermittent claudication and 11 control subjects without intermittent claudication. The test was performed at rest and after exercise. Patients walked on a treadmill until they stopped because of pain. The control subjects were forced to walk as far as 200 m on a treadmill. The L/M test was repeated in the patients after successful arterial reconstruction. Then the patients were instructed to walk the same distance at the same speed as they had before surgery. RESULTS: In patients, the mean L/M ratio after exercise was significantly higher than the mean L/M ratio when they were at rest (0.068 +/- 0.053 vs 0.022 +/- 0.009, P <.05). In control subjects, however, no significant difference was observed between the mean L/M ratios after exercise and at rest. The mean L/M ratio after exercise, decreased from 0.068 +/- 0.053 to 0.018 +/- 0. 016 after successful arterial reconstruction (P <.05) in patients. CONCLUSION: Intestinal permeability, determined by means of the L/M test, significantly increased in patients with intermittent claudication after exercise, and it diminished after arterial reconstruction. The L/M test is, consequently, a new noninvasive method to reflect ischemia in lower limbs during exercise.
BACKGROUND: Intermittent claudication is pain in the legs due to muscle ischaemia associated with arterial stenosis or occlusion. Angioplasty is a technique that involves dilatation and recanalisation of a stenosed or occluded artery. OBJECTIVES: The objective of this review was to determine the effects of angioplasty of arteries in the leg when compared with non surgical therapy, or no therapy, for patients with mild to moderate intermittent claudication. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group trials register and reference lists of relevant articles. The reviewers also contacted investigators in the field and hand searched recent conference proceedings. SELECTION CRITERIA: Randomised trials of angioplasty for mild or moderate intermittent claudication. DATA COLLECTION AND ANALYSIS: One reviewer extracted data and both reviewers assessed trial quality independently. MAIN RESULTS: Two trials with a total of 98 participants were included. The average age was 62 years old with 20 women and 789 men. Patients were followed for 15 months in one trial and six years in another. At six months of follow up, mean ankle brachial pressure indices were higher in the angioplasty groups than control groups (weighted mean difference 0.17, 95% confidence interval 0.11 to 0.24). In one trial, walking distances were greater in the angioplasty group, but in the other trial, in which controls underwent an exercise programme, walking distances did not show a greater improvement in the angioplasty group. At two years of follow up in one trial, the angioplasty group were more likely to have a patent artery (odds ratio 5.5, 95% confidence interval 1.8 to 17.0) but not a significantly better walking distance or quality of life. In the other trial, long term follow up at six years demonstrated no significant differences in outcome between the angioplasty and control groups. REVIEWER'S CONCLUSIONS: These limited results suggest that angioplasty may have had a short term benefit, but this may not have been sustained.
BACKGROUND: Intermittent claudication due to peripheral arterial occlusive disease (PAOD) is a common cause of pain and disability in the middle-aged. Clinical trials of the potent vasodilator prostaglandin E1 have been disappointing. This is the first report of a controlled clinical trial of AS-0:3, a novel prodrug of prostaglandin E1 incorporated into lipid microspheres that has been developed to improve delivery of the active compound to blood vessel walls. METHODS AND RESULTS: Eighty patients with stenosis or occlusion, symptoms of intermittent claudication, and maximum walking distance of > or = 30 and < or = 300 m on a standard treadmill test were randomized to placebo or one of three dosage regimens of AS-013. Drug was administered by intravenous injection 5 d/wk for 4 weeks. Treadmill tests and other assessments were completed at weeks 0, 4, and 8. A statistically significant increase in maximum walking distance was observed at 4 weeks (for placebo: median, 4.5 m; interquartile range [IQR], 20; for active treatment: median, 28.0 m; IQR, 81; P < .01, Mann-Whitney test). A similar response was seen at 8 weeks (for placebo; median, -11.2 m; IQR, 35; for active treatment: median, 35 m; IQR, 68; P < .01, Mann-Whitney test). Dose-related improvements in pain-free walking distance and quality of life were observed. No serious safety issues were noted. CONCLUSIONS: These promising clinical data indicate that AS-013, a new prodrug of prostaglandin E1, could provide an effective and acceptable treatment for patients with intermittent claudication. Studies to investigate the optimal dosing regimen, duration of clinical benefit, and effects in more severe forms of peripheral arterial disease are warranted.
BACKGROUND: Intermittent claudication is both frequent and disabling. Conservative treatment consists of the elimination of risk factors, particularly smoking, drug treatment, and physical exercises. This review represents an attempt to define how effectively exercise prolongs the walking ability of claudicants. METHODS: A computerized literature search was done to identify all controlled trials on the subject. In addition, other studies were admitted if they were in accordance with certain quality criteria. RESULTS: Without exception, these studies showed that exercise can prolong the pain-free walking distance of claudicants. Even though this message seems uniform and convincing, one should point out that all trials are burdened with methodological flaws. The variability of increase in walking ability demonstrated in these studies is impressive and cannot be fully explained. A multitude of possible mechanisms could be involved in bringing about the clinical effect; at present it is impossible to define their relative importance. CONCLUSIONS: The optimal exercise program should be supervised, performed regularly for at least 2 months, and of high intensity. Appropriate steps to guarantee patients' compliance must be taken. Even though many fundamental questions remain unanswered, it is justified to prescribe exercise therapy for intermittent claudication more generally than is realized in today's practice.
Defibrotide is an antithrombotic drug which enhances prostacyclin production and activates fibrinolytic system. The aim of this study was to investigate the improvement of walking distance in patients with intermittent claudication treated with defibrotide. DICLIS was a double blind, placebo-controlled study which included patients with walking distance autonomy at a standardized treadmill test < or =350 > or =100 meters. A total of 310 patients were randomly allocated to placebo (n = 101), defibrotide 800 mg/day (n = 104) or defibrotide 1200 mg/day (n = 105). During a one year follow-up, the Absolute Walking Distance (AWD) was measured six times (0, 30, 60, 90, 180, 360 days). Similar improvement in walking distance was found in the three groups until the 90th day; thereafter placebo group showed no further increase, while AWD continued to increase in the defibrotide groups. Between the 180th and 360th day visits, AWD was significantly higher (P <0.01) in patients given defibrotide than in patients given placebo. No difference in efficacy was observed between the two dosages of defibrotide. No differences in side effects were observed among the three groups. The results of the present trial suggest that long-term administration of defibrotide improves walking distance in patients with intermittent claudication.
BACKGROUND: Intermittent claudication (IC) occurs in patients with peripheral occlusive arterial disease and results in leg pain after walking a certain distance - the claudication distance. Until recently, no specific questionnaire has been available to measure quality of life in patients with IC. OBJECTIVES: To validate the Claudication Scale (CLAU-S) questionnaire in patients in France, the UK, Germany and Belgium. METHODS: Patients completed the CLAU-S questionnaire and provided demographic and clinical data. Pooled data were examined for psychometric and structural validity and test-retest reliability. Structural equation modelling (SEM) was used to confirm that the questionnaire was measuring the causal relationships involved in IC in each of the language groups studied. RESULTS: Cross-sectional and factor analysis confirmed the validity of the questionnaire in the pooled patient population. Item convergent and discriminant coefficients and internal consistency reliability coefficients met or exceeded standard criteria. Principal component analysis confirmed the factorial structure. The underlying causal relationships in IC were identified using SEM and were consistent in all language groups studied. CONCLUSIONS: The CLAU-S questionnaire has undergone validation in English, French, German and Flemish and has a very satisfactory validity in these languages.
It has been suggested that, by reducing the viscosity of blood, flow through capillaries is increased with consequent improvement in the symptoms of patients with peripheral vascular disease. We examined the effects of treatment with drugs purported to reduce blood viscosity to test the validity of this claim. Measurements of viscosity and the rate of blood flow to the leg were made in a group of patients before and after treatment with three different drugs--tetranicotinoylfructose (Bradilan), oxypentifylline (Trental) and cinnarizine (Stugeron). All patients had intermittent claudication in one leg and the distribution of arteriosclerosis was similar in each patient. After treatment there was little or no change in blood viscosity and no change in the rate of flow recorded in the symptomatic legs. We did not find any objective evidence to support the use of these drugs in patients with intermittent claudication.
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Two cases of neural muscular atrophy of the Charcot-Marie-Tooth-Hoffmann type with strain-dependent pain in the leg similar to intermittent claudication are reported. While the pathogenesis of a neurogenic intermittent claudication appears to be reasonably explained by a pathological narrowness of the lumbar spinal duct, this question must remain open in the cases of neurospinal systemic disease described.
OBJECTIVES: intermittent claudication (IC) is a common condition that has a major impact on the patients' quality of life (QoL). Generic QoL instruments often lack sensitivity to detect small but clinically significant variation in QoL. Disease-specific instruments may overcome this problem. This study aims to review various disease-specific QoL instruments available for use in IC and make recommendations for clinical utilization based on validity, reliability and responsiveness. METHODS: a detailed literature search and extensive bibliography review of all papers relating to disease-specific QoL and IC. RESULTS: several disease-specific QoL instruments are available for use in patients with IC. The most notable of these are the Claudication Scale (CLAU-S), Sickness Impact Profile - Intermittent Claudication (SIP(IC)) and the VascuQoL. The Walking Impairment Questionnaire (WIQ) is an objective measure of the patient's walking ability and not a QoL instrument. CONCLUSION: many of the questionnaires are new and have undergone only a limited validation process. More work is required in this field before any one disease-specific QoL instrument can be recommended for use in patients with IC.
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Normoglucemic men with intermittent claudication (n = 41), mean age of 63 years, and sex-, age-, body mass index-, and smoking habit-matched controls (n = 75) were compared for plasma lipoprotein and hemostatic variables. The patients had significantly lower levels of large high-density lipoprotein (HDL) particles (HDL2b, HDL2a, and HDL3a) and elevated lipoprotein(a) [Lp(a)] concentrations than the control subjects. Of the hemostatic variables, plasminogen activator inhibitor-1 (PAI-1), plasma antiplasmin, plasma fibrinogen, and urine beta-thromboglobulin concentrations were significantly elevated in patients. In intermittent claudication patients Lp(a) correlated significantly with activation of the coagulation system, ie, with the levels of plasma fibrinogen and urine fibrinopeptide A. No correlations between the values for Lp(a) and PAI-1 or plasma alpha 2-antiplasmin were seen. The PAI-1 activity showed significant univariate correlations to the levels of HDL3b, HDL2b (inverse), and very-low-density lipoprotein triglycerides, of which the positive correlation to HDL3b persisted in multivariate analysis (r = .48, P < .001). Independent characteristics for intermittent claudication estimated by multiple regression analysis were PAI-1, plasma fibrinogen, and HDL3a, with a combined R2 of .36. The intermittent claudication subgroup that was being treated with beta-blockers/thiazides had a higher frequency of coronary heart disease compared with the other patients. In addition, the patients taking beta-blockers/thiazides had elevated triglyceride concentrations, lower HDL cholesterol with a size shift toward smaller particles, and a tendency toward raised PAI-1 and plasma alpha 2-antiplasmin levels compared with the patient group that did not take these medications.
BACKGROUND: Anticoagulant treatment for intermittent claudication might improve functional capacity, and prevent acute cardiovascular complications caused by peripheral obstructive arterial disease. OBJECTIVES: To assess the effects of anticoagulant drugs (heparin, low molecular weight heparin (LMWH) and oral anticoagulants) in patients with intermittent claudication (Fontaine stage II) in terms of improving walking capacity (pain-free walking distance or absolute walking distance), mortality, cardiovascular events, ankle/brachial pressure index, progression to surgery, amputation-free survival and side effects of these drugs. SEARCH STRATEGY: Randomised trials of anticoagulants for intermittent claudication were sought using the search strategy described by the Cochrane Peripheral Vascular Diseases Review Group. Additional trials were sought through: reference lists resulting from this search; recent conference proceedings; contact with authors of published trials and pharmaceutical companies producing anticoagulants. SELECTION CRITERIA: All randomised trials of anticoagulants used to treat patients with intermittent claudication. DATA COLLECTION AND ANALYSIS: Thirteen trials were initially considered eligible for inclusion in the review. Two studies evaluated oral anticoagulants, five evaluated standard heparin, and six evaluated LMWHs. Only three studies (two evaluating oral anticoagulants, one evaluating heparin) met the high quality methodological inclusion criteria and were included in the primary analysis. Four other studies were included in the sensitivity analysis. The reviewers extracted the data independently. MAIN RESULTS: No significant difference was observed between heparin treatment and control groups for pain-free walking distance or maximum walking distance at the end of treatment. There were no data to indicate that LMWHs benefit walking distance. Revascularisation or amputation-free survival rates were reported in one study only with a five year follow-up. No study reported a significant effect on overall mortality or cardiovascular events and the pooled odds ratios were not significant for these outcomes either. Major and minor bleeding events were significantly more frequent in the group treated with oral anticoagulants compared to control, with a non-significant increase in fatal bleeding events. No major bleeding events were reported in the study evaluating heparin, while a non-significant increase in minor bleeding events was reported. REVIEWER'S CONCLUSIONS: No benefit of heparin, LMWHs or oral anticoagulants has been established for intermittent claudication. An increased risk of major bleeding events has been observed especially with oral anticoagulants. The use of anticoagulants for intermittent claudication cannot be recommended at this stage.
BACKGROUND AND OBJECTIVE: intermittent claudication is associated with a significant reduction in quality of life. Treatment of claudicants aims to reduce mortality from cardio- and cerebro-vascular events and to improve quality of life. Quality of life assessment should be used to guide and evaluate treatment in this group of patients. Peripheral percutaneous transluminal angioplasty (PTA) is now widely used in the treatment of intermittent claudication. The aim of this review is to examine the effect of PTA on quality of life (QOL) in patients with intermittent claudication. METHODS: a review was conducted of prospective clinical trials assessing the effect of peripheral PTA on QOL. Publications were retrieved by searching Medline and PreMedline, EMBASE, the Cochrane Central Register of Controlled Trials, the Cochrane Database of systematic reviews, AMED and CINAHL. The reference lists of the relevant publications were also searched. RESULTS: seven prospective studies (10 publications) on the effect of PTA on QOL in claudicants were identified. Several different questionnaires were used to measure quality of life (Nottingham Health Profiile, SF-36, EuroQol) none of which were disease specific. All the studies showed some improvement in QOL after PTA at follow-up periods of between 6 weeks and 24 months, except for one which showed some improvement at 6 months but not at 24 months. CONCLUSIONS: despite the fact that studies on the effect of PTA on QOL in claudicants have used generic QOL questionnaires which are relatively insensitive, the findings suggest that PTA may result in some improvement in QOL in these patients, although level I evidence to support this is lacking. The availability of disease-specific questionnaires should enable a more accurate assessment of PTA on QOL in these patients.
Intermittent claudication, myocardial infarction, and angina pectoris share many epidemiologic and biologic features. Yet few large cohort studies describing the prevalence, incidence, and risk factors for intermittent claudication have been done. The authors evaluated intermittent claudication in 10,059 Israeli men aged 40-65 years, of whom 8,343 were free of coronary heart disease and symptoms of peripheral vascular disease; this latter group was followed for 5 years from 1963 to 1968. Prevalent and incident cases of intermittent claudication were defined by the London School of Hygiene Cardiovascular Disease Questionnaire, and all cardiovascular disease risk factor evaluations were standardized. Baseline prevalence was 27.0/1,000 (211/10,029). A total of 360 previously healthy men developed intermittent claudication for a crude 5-year incidence rate of 43.1/1,000 (360/8,343) or a crude annual incidence of 8.6/1,000. Following univariate analysis with demographic, physiologic, psychosocial, and other cardiovascular disease variables, logistic regression was used to identify risk factors for intermittent claudication. These were the following: > 20 cigarettes per day, odds ratio (OR) = 2.02, 95% confidence interval (CI) 1.54-2.66; serum cholesterol (50-mg/dl difference), OR = 1.35, 95% CI 1.18-1.54; 11-20 cigarettes per day, OR = 1.69, 95% CI 1.24-2.30; anxiety (high vs. low), OR = 1.85, 95% CI 1.29-2.65; socioeconomic status, OR = 1.82, 95% CI 1.26-2.64; and diabetes, OR = 1.85, 95% CI 1.25-2.75. Other significant predictors of smaller magnitude included in the regression were age, psychosocial coping factors, Quetelet's index, and exsmoking. The risk factors for intermittent claudication were a blend of those related to myocardial infarction (smoking, cholesterol, diabetes, but not hypertension) and others related to angina pectoris but not to myocardial infarction (stress and coping variables). There is reason to believe that preventing or modifying these factors will prove effective in altering the natural history and clinical outcomes of peripheral vascular disease as shown in other forms of atherosclerosis.