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PubMedDate not supplied

Medical management of intermittent claudication.

The symptoms of intermittent claudication (IC) lead sufferers to seek medical attention, potentially leading to substantial workup and invasive testing. However, only a minority of people with IC develop limb-threatening ischemia or symptoms of significant lifestyle-limiting claudication. Patients with IC have a substantial risk of concomitant cardiovascular and cerebrovascular disease. Assessment of co-morbidities and control of risk factors reduce the cardiovascular risk of these patients. A multitude of drugs have been developed and tested in numerous trials for the symptoms of IC. Although no drug alone offers a "cure" to IC, some are used as adjuvant therapy to reduce claudication symptoms.

Cardiovascular Agents↗
PubMed1984

Does oxpentifylline ('Trental') have a place in the treatment of intermittent claudication?

In a randomized double-blind study, the clinical and haemorrheological responses of 40 patients receiving oxpentifylline (200 mg 3-times daily) were compared with those of 40 patients receiving placebo. The treatment period in both groups was 2 months. The parameters measured before and after treatment were: subjective response; claudication and maximum walking distances; ankle systolic indices; maximum blood flow in the lower limb by gravimetric plethysmography; plasma fibrinogen; erythrocyte deformability and whole blood viscosity. There was a significant increase (p less than 0.05) in mean erythrocyte deformability in the oxpentifylline group but not in the placebo group; this apparent difference between the groups, however, was not significant. The placebo group showed a significant improvement (p less than 0.05) in claudication distance and mean plasma fibrinogen concentration, but no such improvements were observed in the oxpentifylline group. There were no significant differences in either of the two groups with regard to the subjective response, ankle systolic indices, maximum limb blood flow or whole blood viscosity. It is concluded that oxpentifylline , when taken in oral form at the dose used in this study, increased erythrocyte deformability without conferring any clinical or haemorrheological benefit to patients with intermittent claudication.

Adult↗
PubMed2004

Randomized trial of AT-1015 for treatment of intermittent claudication. A novel 5-hydroxytryptamine antagonist with no evidence of efficacy.

AT-1015 is a novel selective 5-HT2A serotonin receptor antagonist that is known to impair platelet aggregation and vasoconstriction. Serotonin has been hypothesized to contribute to claudication symptoms in individuals with peripheral arterial disease (PAD) via microvascular vasoconstrictor and thrombotic effects. AT-1015 was thus evaluated in 439 patients with claudication who were randomized in a double-blind, placebo-controlled trial comparing 10 mg, 20 mg, and 40 mg BID versus placebo for 24 weeks. Treadmill walking performance was assessed by peak walking time (PWT) and pain-free walking time (PFWT). Quality of life (QoL) was measured by the Walking Impairment Questionnaire (WIQ) and the Health Status Survey SF-36. Limb hemodynamics was assessed with the ankle-brachial index (ABI). The 40 mg arm was terminated prematurely by recommendation of the Data Safety Monitoring Committee due to an excess number of non-fatal myocardial infarctions. At study conclusion, there were no statistically significant differences in the mean change of PWT, PFWT, ABI and QoL between the 10 mg and 20 mg BID treatment groups compared with placebo. The proportion of patients who experienced an adverse event (AE) was similar across all treatment groups. Antimuscarinic and gastrointestinal AEs were more common in the AT-1015 treatment groups. Two deaths occurred: one in the placebo group and the other in the AT-1015 20 mg group. Although a prolongation of the QTc interval was observed in all groups, this was not clinically significant (QTc > 500 ms). Mean supine pulse rates were significantly increased in all AT-1015 treatment groups, consistent with predicted antimuscarinic effects. Population pharmacokinetic analysis fit a one-compartment model with first-order absorption and elimination. These data indicate that selective serotonin receptor blockade does not improve exercise tolerance or quality of life in individuals with claudication.

Aged↗
PubMed2005

Quality of the assessment of primary and secondary endpoints in claudication and critical leg ischemia trials.

Clinical trials in peripheral arterial disease (PAD) require an accurate definition of the disease for inclusion; they typically use treadmill testing, questionnaires and hemodynamic measures as primary and secondary endpoints. Trials of new pharmacologic therapies for PAD often employ multiple clinical sites with presumed expertise in the diagnosis and management of PAD as well as in clinical trials. However, considerable variability has been observed in the assessment of endpoints used in PAD trials, as well as a marked placebo response with treadmill testing. This variability and placebo response impact adversely on overall trial integrity, necessitate an inflated sample size, and may contribute to the large number of recently negative claudication trials. We hypothesized that site monitoring visits for evaluating testing methods would identify and characterize several critical issues that would contribute to poor testing quality. One hundred sites participating in three claudication trials for which peak walking time on the treadmill was the primary endpoint, and 16 sites participating in a critical leg ischemia study for which transcutaneous oxygen tension (TcPO2) was the primary endpoint were evaluated. Each site was visited one or more times by a clinical monitor trained in conducting a 'site endpoint evaluation visit' focusing on equipment, physical set-up of the room in which testing was to be conducted, and the site staff's ability to conduct each of the specific measurements. Full reports were generated that covered a number of technical issues for each measurement and data were extracted from these reports to summarize the testing problems encountered at each site. Problems with treadmill testing were common. For example, 92% of sites had problems with their treadmill equipment, 58% did not perform proper treadmill familiarization, 24% did not start the treadmill test appropriately, 24% did not conduct the test properly, and 15% did not properly conclude the test to determine the peak walking time of the participant. Similar problems were encountered with the ankle-brachial index test, the administration of questionnaires and measurement of the TcPO2. Major deficiencies were identified at the majority of sites in the assessment of primary and secondary endpoints in PAD trials. These errors and improper testing provide a potential explanation for the wide variability and placebo responses observed in claudication and critical leg ischemia trials. Site interventions need to address these deficiencies in measurement to improve the quality of PAD trials.

Blood Gas Monitoring, Transcutaneous↗
PubMed2004

Beta-adrenergic blocking agents and intermittent claudication: systematic review.

To clarify contradictions in past reports and the package inserts for beta-adrenergic blocking agents (beta-blockers) for patients with intermittent claudication (IC), we investigated the effects of beta-blockers in patients with IC using the systematic review technique. Data sources were randomized, controlled trials that investigated the effects of beta-blockers compared with the placebo or untreated group (controls) in patients with IC. Primary endpoints were walking distance and walking time, and secondary endpoints were ankle-brachial index (ABI) and calf blood flow. Nine trials were included in the analysis. Meta-analysis showed that there was a significant worsening in maximal walking distance and initial claudication distance in patients receiving beta-blockers, with standardized mean differences of -0.31 and -0.39 (95% confidence interval -0.58 to -0.04 and -0.73 to -0.06, P=0.03 and 0.02, respectively) compared with controls. There were no significant differences in maximal walking time (0.07, -0.24 to 0.37), time to onset of claudication (0.12, -0.23 to 0.47), ABI at rest (0.24, -0.30 to 0.78), calf blood flow at rest (0.00, -0.26 to 0.25), and calf blood flow after exercise (-0.23, -0.69 to 0.22). However, only one trial evaluated ABI, and the number of cases is increasing, suggesting that beta-blockers do not worsen ABI. There was no evidence that beta-blockers prescribed for patients with IC have unsuitable "precautions" in the package inserts. However, reluctance to administer beta-blockers to patients because they have IC is not appropriate.

Adrenergic beta-Antagonists↗
PubMed2004

Treadmill versus shuttle walk tests of walking ability in intermittent claudication.

PURPOSE: To compare treadmill and shuttle walk tests for assessing functional capacity in patients with intermittent claudication, with respect to test-retest reliability, cardiovascular responses, and patient preferences. METHODS: Patients with stable intermittent claudication (N = 55, ages 52-85 yr, median age 68 yr) were recruited from the Sheffield Vascular Institute at the Northern General Hospital, Sheffield, UK. Each patient performed an incremental shuttle walk test, a constant-pace shuttle walk test, and a standardized treadmill test (3.2 km x h(-1), 12% gradient), each on three occasions. The incremental shuttle walk began at 3 km x h(-1) and increased by 0.5 km x h(-1) every minute, whereas the constant-pace shuttle walk was performed at the fixed pace of 4 km x h(-1). Claudication distance (CD), maximum walking distance (MWD), heart rate (HR), and blood pressure were assessed in each testing session. The patients also completed a test preference questionnaire. RESULTS: CD and MWD for both shuttle walks were greater than the corresponding walking distances achieved in the treadmill test (P < 0.001). Average coefficients of variation for repeated incremental shuttle walk, constant-pace shuttle walk, and treadmill tests were 15.9%, 21.1%, and 18.7%, respectively, for MWD, corresponding to average intraclass correlation coefficients of 0.87, 0.82, and 0.87. Treadmill walking evoked greater increases in HR and blood pressure (P < 0.001), and fewer patients expressed a preference for it (24 vs 43% for shuttle walking). CONCLUSION: These findings indicated that shuttle walk testing exhibits similar test-retest reliability as treadmill testing, but that it evoked a lower level of cardiovascular stress and is preferred to treadmill testing by a large proportion of patients.

Aged↗
PubMed2002

An incremental test to identify the pain threshold speed in patients with intermittent claudication.

The purpose of this study was to develop a test for identifying the speed of onset of claudication, or pain threshold speed (PTS), in 16 patients affected by intermittent claudication. An echo-Doppler examination and the ankle-brachial index (ABI) determination were also performed. Test repeatability was evaluated in 10 patients retested within a few days. All 16 patients underwent the incremental walking test 3 times during a 6-month rehabilitation training program to verify the test's sensitivity in detecting the expected functional modifications. PTS was identified in all patients examined and the test-retest correlation coefficient (R) for PTS was 0.98. During the 6-month rehabilitation period, the ABI rose from 0.43 +/-0.16 to 0.72+/-0.15 for the worst limb and PTS also rose significantly from 3.9+/-1.4 km/h to 6.1+/-1.1 km/h. The average increments of ABI and PTS were significantly correlated. An incremental walking test for the identification of the walking speed at which claudication occurs has been developed. The PTS is a reproducible parameter that can be combined with other test results to establish the severity of the disease and to check any modifications that occur during rehabilitation.

Adult↗
PubMed1976

Intermittent claudication of the foot in view of foot muscle blood flow measured by 133Xe clearance technique and arteriographic findings.

In 20 limbs of 10 healthy subjects and 55 limbs of 41 patients with occlusive areterial diseases of the legs, muscle blood flow was measured in the flexor hallucis brevis muscle by 133Xe clearance technique. The clearance curves after the ischemic exercise differenciated limbs with intermittent claudication of the foot from normals and limbs without claudication. An attempt was also made with arteriographic findings in 102 limbs of 84 patients with occlusions of the leg and/or foot arteries only. From results obtained, it is concluded that 133Xe clearance technique applied in the flexor hallucis brevis muscle can be used for diagnosis of foot pain during walking of uncertain origin and intermittent claudication of the foot is caused by severe circulatory insufficiencies of the plantar muscles during walking in the patients with involvements of the posterior tibial and/or plantar arteries.

Adult↗
PubMed2001

Pharmacotherapy of intermittent claudication.

Intermittent claudication (IC) is leg muscle pain, cramping and fatigue brought on by exercise and is the primary symptom of peripheral arterial disease. The goals of pharmacotherapy for IC are to increase the walking capacity/quality of life and to decrease rates of amputation. In 1988, pentoxifylline was the only drug that had reasonable supportive clinical trial evidence for being beneficial in IC. Since then a number of drugs have shown benefit or potential in IC. Cilostazol, a specific inhibitor of phosphodiesterase 3 and activator of lipoprotein lipase, clearly increases pain-free and absolute walking distances in claudicants. However, cilostazol does cause minor side effects including headache, diarrhoea, loose stools and flatulence. Naftidrofuryl, a serotonin (5-HT2) receptor antagonist and antiplatelet drug, is beneficial in claudicants. Inhibitors of platelet aggregation (including nitric oxide from L -arginine or glyceryl trinitrate) and anticoagulants (low molecular weight heparin, defibrotide) probably have both short and long-term benefits in IC. In addition, intravenous infusions of prostaglandins (PGs) PGE1 and PGI2 have an established role in severe peripheral arterial disease and the recent introduction of longer lasting and/or oral forms of the PGs makes them more likely to be useful in the IC associated with less severe forms of the disease. There are some exciting new approaches to the treatment of IC, including propionyl-L-carnitine and basic fibroblast growth factor (bFGF).

Animals↗
PubMed2006

Intravascular ultrasound-guided creation of re-entry sites to improve intermittent claudication in patients with aortic dissection.

PURPOSE: To report percutaneous fenestration of aortic dissection flaps to relieve distal ischemia using a novel intravascular ultrasound (IVUS)-guided fenestration device. CASE REPORTS: Two men (47 and 62 years of age) with aortic dissection and intermittent claudication had percutaneous ultrasound-guided fenestration performed under local anesthesia. Using an ipsilateral transfemoral approach, the intimal flap was punctured under real-time IVUS guidance using a needle-catheter combination through which a guidewire was placed across the dissection flap into the false lumen. The fenestration was achieved using balloon catheters of increasing diameter introduced over the guidewire. Stenting of the re-entry was performed in 1 patient to equalize pressure across the dissection membrane in both lumens. The procedures were performed successfully and without complications. In both patients, ankle-brachial indexes improved from 0.76 to 1.07 and from 0.8 to 1.1, respectively. Both patients were without claudication at the 3- and 6-month follow-up examination. CONCLUSION: Percutaneous intravascular ultrasound-guided fenestration and stenting at the level of the iliac artery in aortic dissection patients with claudication is a technically feasible and safe procedure and relieves symptoms.

Aortic Dissection↗
PubMed2006

Absence of buttock claudication following stent-graft coverage of the hypogastric artery without coil embolization in endovascular aneurysm repair.

PURPOSE: To evaluate the safety and efficacy of stent-graft coverage of the hypogastric artery origin without coil embolization during endovascular treatment of aortoiliac or iliac aneurysms. METHODS: A retrospective study was conducted of patients who underwent endovascular aneurysm repair with endograft coverage of the hypogastric artery between September 2001 and September 2005. Among the 88 patients who underwent EVAR during the study period, 21 patients (19 men; mean age 77+/-6 years, range 67-86) had unilateral hypogastric artery coverage without coil embolization. Aneurysmal arteries included 11 aortoiliac, 8 isolated common iliac arteries (CIA), and 2 isolated hypogastric arteries. Preoperative AAA size was a mean 57 mm (range 46-73), and mean CIA aneurysm diameter was 36 mm (range 17-50). All covered hypogastric arteries were patent prior to the procedure. The stent-grafts implanted were 10 Excluder, 10 AneuRx, and 1 Zenith. Clinical outcome focused on mortality and morbidity, including the occurrence and duration of new-onset buttock claudication, which was further correlated with superior gluteal and profunda femoris artery patency. RESULTS: Immediate seal was achieved in all patients. Mean follow-up was 16 months (range 1-54). No type I endoleaks developed from the aortic or external iliac artery, and no type II endoleaks were found from the origin of the hypogastric artery. New-onset buttock claudication occurred in 2 (9.5%) patients, but resolved in both within 4 months. No additional secondary procedures, aneurysm rupture, or aneurysm-related death occurred. CONCLUSION: Stent-graft coverage of the orifice of the hypogastric artery without coil embolization is a safe and effective adjunct during the treatment of aortoiliac or iliac aneurysm, with a low incidence of buttock claudication.

Aged↗
PubMed2000

Pharmacological management of intermittent claudication: a meta-analysis of randomised trials.

Intermittent claudication, a symptom of atherosclerosis in the large vessels of the lower limbs, greatly affects patient mobility and quality of life. Medical therapy for a moderate form of this condition includes vasodilators, antiplatelet agents and alternative treatments such as ginkgo biloba.A meta-analysis of results from 52 trials (including 5088 patients) was conducted for all current medical therapies for intermittent claudication. After 24 weeks, some of the medical therapies were found to be more effective than placebo for the primary end-points of either pain-free walking distance or maximum walking distance. Vasodilators presented the best results in walking distance. Pentoxifylline offered better results than naftidrofuryl, although the treatment benefit, measured in additional metres walked with treatment than without, was modest. Antiplatelets, ginkgo biloba and levocarnitine were slightly more effective than placebo, although the treatment benefit was of limited clinical importance. On average, patients walked 60m further with therapy than without, and only about half of that added distance was pain-free. Very little consistent information was available for other clinical end-points, such as overall mortality and adverse effects. These data suggest that some of the medical therapy, pentoxifylline in particular, can only modestly increase functional status in patients with moderate intermittent claudication. There is a need for uniformity in research design and reporting of trials. A future trial comparing medical therapy with physical therapy is indicated.

Humans↗
PubMed2004

Drug treatment of intermittent claudication.

The US FDA has approved two drugs for the management of intermittent claudication: pentoxifylline and cilostazol. The mechanism of action that provides symptom relief with pentoxifylline is poorly understood but is thought to involve red blood cell deformability as well as a reduction in fibrinogen concentration, platelet adhesiveness and whole blood viscosity. The recommended dose of pentoxifylline is 400 mg three times daily with meals. Cilostazol is a potent, reversible, phosphodiesterase III inhibitor. The inhibition of phosphodiesterase allows for the increased availability of cyclic adenosine monophosphate (cAMP). cAMP mediates many agonist-induced platelet inhibitory, vasodilatory and vascular antiproliferative responses. Cilostazol, at a dose of 100 mg twice daily, is recommended to be taken 30 minutes before or 2 hours after breakfast and dinner. In addition to pentoxifylline and cilostazol, clinical trials indicate many other drugs may relieve the symptoms of intermittent claudication. Ginkgo biloba, available as an over-the-counter extract, provides symptom relief comparable to pentoxifylline. Two European agents, naftidrofuryl and buflomedil, also have efficacy that is reported to be similar to pentoxifylline. Policosanol is a mixture of fatty alcohols derived from honeybee wax which, according to very limited data, reduces symptoms of claudication. Amino acids, certain peptides and prostaglandins may have a therapeutic role. Finally, novel approaches including angiogenesis mediated by growth factors, are currently under investigation.

Animals↗
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↗
PubMed2004

Exercise rehabilitation for the patient with intermittent claudication: a highly effective yet underutilized treatment.

Peripheral arterial disease (PAD), when accompanied by claudication, is a disabling disease that affects 12 percent of the population of the United States (US). PAD is associated with increased mortality as well as decreased functional status and quality of life. Smoking cessation and treatment of diabetes are key aspects of risk factor modification for the PAD patient as well as controlling other cardiovascular risk factors. Typically, only the most severely diseased patients with PAD receive surgery for the indication of claudication and other therapeutic options are being sought. Exciting developments are taking place in the area of drug development for instance. The benefits of a supervised walking exercise program have been consistently demonstrated in persons with PAD and therefore, exercise rehabilitation constitutes an important form of therapy for these persons. Unfortunately, in the US, exercise rehabilitation is not always reimbursed which may lessen its utility presently. All therapies which are used to treat claudication should incorporate measures of functional status and quality of life in addition to treadmill walking in order to ascertain the benefit of a given treatment for patients with PAD.

Clinical Trials as Topic↗
PubMed2005

Pharmacotherapeutical approaches to decreasing hematocrit and increasing claudication distance in diabetic patients with peripheral vascular disease.

The paper deals with pharmacotherapeutical approaches to decreasing hematocrit in order to improve macro and microcirculation in arteries of lower limbs of type 2 diabetes patients. The study included 37 patients with diabetic angiopathy, all of whom had inoperable changes to arteries. In order to decrease hematocrit and cause haemodilution, we used 10 % solution of hydroxyethyl starch. Indications for inclusion in the study were carried out in close cooperation with a vascular surgeon. We applied hydroxyethyl starch according to a predetermined scheme. Using normovolemic and hypervolemic haemodilution, we decreased hematocrit to 0.41-0.42. Patients underwent a treadmill examination at the beginning of the study and then repeatedly during the course of study, when we measured the claudication distance to quantify, the effects of decreased hematocrit. The results show that the effect is most pronounced after 6 weeks, when hematocrit fell from a baseline of 0.435 to 0.421 (p < 0.01) and claudication distance increased to 51% (also significant). On average the claudication distance rose from 55.7 m to 84.6 m (p < 0.01). In the following weeks (after the sixth week of the study), the studied parameters changed only insignificantly (p > 0.05).

Diabetic Angiopathies↗
PubMed1999

Antithrombotic drugs in the primary medical management of intermittent claudication: a meta-analysis.

BACKGROUND: There is no consensus on the efficacy of the antithrombotic drugs available for patients with intermittent claudication. METHODS: A Medline and manual search was used to identify relevant publications. Uncontrolled or retrospective studies, double reports or trials without clinical outcomes were excluded. Included studies were graded as level 1 (randomised and double- or assessor-blind), level 2 (open randomised), or level 3 (non-randomised comparative). Mortality, cerebro- or cardiovascular events, amputations, arterial occlusions or number of revascularization procedures performed in the lower limbs, pain-free and total walking distance, ankle brachial index and calf blood flow, were the main outcomes considered. When feasible, end of treatment results, either continuous or binary, were combined with appropriate statistical methods. RESULTS: Mortality was significantly decreased by ticlopidine compared to placebo (common odds ratio 0.68, 95% C.I., 0.49 - 0.95); clopidogrel decreased vascular events in comparison to aspirin (odds ratio 0.76, 95% C.I., 0.63 - 0.92) in level 1 studies. Arterial occlusions and the number of revascularization procedures performed were statistically significantly decreased by aspirin and ticlopidine, respectively. A small but statistically significant improvement in pain-free walking distance was determined by picotamide, indobufen, low molecular weight heparins, sulodexide and defibrotide, in small studies. CONCLUSIONS: Clopidogrel and ticlopidine do reduce clinically important events in patients with intermittent claudication and could be added to the primary medical treatment of these patients. The use of aspirin in these patients cannot be based on direct evidence, but only on analogy with coronary and cerebral atherosclerosis, where it has documented efficacy. Other antithrombotic drugs were not properly evaluated in patients with intermittent claudication.

Fibrinolytic Agents↗
PubMed1999

Prospective controlled study of polytetrafluoroethylene versus saphenous vein in claudicant patients with bilateral above knee femoropopliteal bypasses.

BACKGROUND: Although several studies have compared the patency rates of polytetrafluoroethylene (PTFE) and saphenous vein grafts (SVG) for the above knee location, none have compared the 2 grafts when implanted in the same patient with claudication who needs bilateral above knee femoropopliteal bypasses. METHODS: Forty-three patients (86 limbs) with bilateral disabling claudication who had superficial femoral artery occlusion and above knee reconstitution with 2- to 3-vessel runoff were analyzed. Patients were treated on one side with PTFE and on the other side with SVG. They were sequentially assigned to PTFE-SVG alternating with SVG-PTFE. All patients were followed using duplex ultrasound and ankle/brachial indexes at 1 month and every 6 months thereafer. RESULTS: The perioperative complication rates were 5% for PTFE and 12% for SVG. There was no operative death or perioperative amputation for either procedure. The Kaplan-Meier estimate of primary, assisted primary, and secondary patency rates at 72 months were 68%, 68%, and 77% for PTFE and 76%, 83%, and 85% for SVG. There were no statistically significant differences between primary and secondary patency rates for both grafts; however; the assisted primary patency rates were higher for SVG (P < .05). The crude limb salvage rate at 72 months was 98% for PTFE and 98% for SVG. There were no risk factors identified that had an impact on graft patency. CONCLUSIONS: PTFE and SVG for above knee bypasses have comparable patency and limb salvage rates in claudicant patients with bilateral superficial femoral artery occlusion and 2- to 3-vessel runoff This may justify the use of PTFE for above knee locations in these selected patients.

Aged↗