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PubMed2002

Measuring treatment effects of cilostazol on clinical trial endpoints in patients with intermittent claudication.

Intermittent claudication (IC) comprises the most common presenting symptoms of peripheral arterial disease (PAD), which itself is a manifestation of systemic atherosclerosis. Typical symptoms of IC are aching pain, numbness, and fatigue in the lower extremities. Symptoms are induced by walking or exercise and usually resolve with rest. The cornerstone of treating IC is risk-factor reduction and a supervised exercise regimen. Pharmacotherapy specifically indicated for the treatment of IC includes a new drug, cilostazol, and the traditional drug, pentoxifylline. Cilostazol also has antiplatelet, antithrombotic, and vasodilatory activity, as well as a positive effect on serum lipids. Eight multicenter clinical trials, seven in the U.S. and one in the U.K., used objective and subjective clinical endpoints to assess the treatment efficacy of cilostazol. Objective endpoints included maximal and pain-free walking distance (MWD and PFWD, respectively), the ankle-brachial index, peripheral hemodynamic measurements, and serum lipid levels. Subjective endpoints, assessed by patient questionnaires, included perceived functional status and health-related quality of life. Cilostazol treatment showed statistically significant increases in MWD and PFWD within 4 weeks, as well as improvements in physical functional status at 24 weeks, compared with placebo and pentoxifylline. Increases in high-density lipoprotein cholesterol and decreases in plasma triglycerides were also noted. Subjective assessments appeared to match objective parameters.

Aged↗
PubMed2000

The "galloping" history of intermittent claudication.

Intermittent claudication (IC) due to arterial occlusive disease was first diagnosed by the French veterinary surgeon Jean-François Bouley jeune in a horse drawing a cabriolet in the streets of Paris as early as 1831. The animal was repeatedly exercised and always started to limp with the hind legs at similar work loads. Autopsy revealed partially thrombosed aneurysm of the abdominal aorta and occlusions of both femoral arteries which were correctly identified as the cause of IC. In 1858 the famous neurologist Jean-Martin Charcot working at the Salpêtrière in Paris first discovered the condition in a patient, who was wounded by a bullet during the conquest of Algery and developed iliac artery aneurysm obliterated by a thrombus. He was aware of the first description in veterinary medicine. In Germany IC was also first mentioned in horses (Rademacher, 1838). 13 reports of patients were contributed by the neurologist Heinrich Erb in 1898 and 1904. Some interesting features of the phenomenon of IC like the amount of exercise necessary to provoke it, localization, social relevance, prolongation of the Achilles tendon reflex, decrease of maximal plantar flexion force of the foot and production of "Lewis factor p" are summarized. In human patients arteriosclerosis is the well recognized principal cause of arterial obstructions, in horses, however, the lesions are due to infection by the roundworm Strongylus vulgaris. In the fascinating life cycle the larvae migrate into the intima of small and large arteries and provoke aneurysms and intravascular thrombosis.

Animals↗
PubMed2001

Intermittent Claudication.

Intermittent claudication is the most common symptom in patients with peripheral arterial disease (PAD). As such, it is mandatory for clinicians to treat both the PAD-specific symptoms (to decrease functional impairment and thereby improve quality- of-life, as well as to decrease rates of amputation) and the underlying systemic atherosclerosis (and thereby reduce cardiovascular ischemic events, especially myocardial infarction and stroke). Most patients with claudication can successfully decrease their exertional limb symptoms via a combination of exercise (preferably supervised) and pharmacotherapeutic interventions (eg, cilostazol). Endovascular revascularization currently serves as an effective therapy for patients with high-grade stenoses of the proximal limb arterial segments, (eg, the distal aorta, common iliac artery, or external iliac artery, and occasionally the proximal common femoral artery). Surgical revascularization usually is reserved for patients who present with severe aortoiliac disease in whom long-term patency is likely to be achieved (eg, aortobifemoral or femoral-femoral bypass) and who have a low cardiovascular perioperative ischemic risk. Patients who undergo successful revascularization also are likely to benefit from exercise rehabilitation programs. All patients with PAD, of any severity, must successfully normalize atherosclerosis risk factors and use antiplatelet therapies. Such interventions include complete smoking cessation, glycemic control, normalization of blood pressure (less than 130/90 mm Hg), and lowering of low-density lipoprotein (LDL) cholesterol to less than 100 mg/dL. Antiplatelet agents (eg, clopidogrel, aspirin) should be prescribed to decrease rates of cardiovascular ischemic events in all patients with PAD, unless otherwise contraindicated.

Journal Article↗
PubMed1997

The management of intermittent claudication.

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.

Journal Article↗
PubMed2001

Buflomedil for intermittent claudication.

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.

Administration, Oral↗
PubMed2000

Intestinal permeability is increased in patients with 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.

Aged↗
PubMed2000

Angioplasty (versus non surgical management) for intermittent claudication.

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.

Angioplasty, Balloon↗
PubMed1997

Randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of AS-013, a prostaglandin E1 prodrug, in patients with intermittent claudication.

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.

Aged↗
PubMed1993

A review of the clinical effectiveness of exercise therapy for intermittent claudication.

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.

Clinical Trials as Topic↗
PubMed2004

Outcome of conservative therapy of patients with severe intermittent claudication.

BACKGROUND: Intermittent claudication due to peripheral artery disease (PAD) can be treated conservatively, or by revascularization. OBJECTIVES: To assess the short-term outcome of conservatively-treated claudicants, and determine predictors for clinical improvement. Design. A retrospective cohort study. METHODS: We evaluated Fontaine stage, walking distance and ankle brachial index (ABI) at baseline and after median 9 months (interquartile range (IQR) 6-24) in 181 patients with severe claudication. RESULTS: We found clinical improvement by at least one Fontaine stage in 38 patients (21%) with an increased walking distance from baseline median 100 m (IQR 50-150) to follow-up median 650 m (IQR 300 to unlimited; p<0.001), but without changes in ABI (median 0.57, IQR 0.48-0.73 vs. median 0.54, IQR 0.45-0.81; p=0.10). One hundred and thirty-eight patients (76%) remained clinically and hemodynamically stable. A worsening of the clinical stage but without amputation was recorded in five patients (3%). Female gender (hazard ratio (HR) 0.51, p=0.052), diabetes (HR 0.35, p=0.020), and baseline ABI below 0.44 (HR 0.31, p=0.019) were associated with a reduced probability of clinical improvement. CONCLUSION: Certain patients with intermittent claudication show substantial clinical improvement with conservative medical therapy, despite any lack of hemodynamic improvement. Given the low number of patients with clinical deterioration in the short term, primarily conservative therapy should be the preferred initial option for most claudicants.

Aged↗
PubMed2004

Treatment of intermittent claudication: cilostazol.

Intermittent claudication is a potentially disabling disorder that impairs quality of life and is a marker of underlying cardiovascular disease. Treatment involves secondary prevention and measures to improve walking. Cilostazol significantly increases walking distance and quality of life in claudicants.

Cilostazol↗
PubMed2000

Improvement of walking distance by defibrotide in patients with intermittent claudication--results of a randomized, placebo-controlled study (the DICLIS study). Defibrotide Intermittent CLaudication Italian Study.

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.

Adult↗
PubMed2001

International validation of the CLAU-S quality-of-life questionnaire for use 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.

Aged↗
PubMed1978

Drug therapy in intermittent claudication: an objective assessment of the effects of three drugs on patients with intermittent claudication.

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.

Aged↗
PubMed1975

[The concept of neurogenic intermittent claudication. A rare form of intermittent limping in neurologic system disease].

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.

Arterial Occlusive Diseases↗
PubMed2003

Disease-specific quality of life assessment in intermittent claudication: review.

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.

Activities of Daily Living↗