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PubMed1985

The effect of hemodilution upon patients with intermittent claudication.

Seventeen patients with stable intermittent claudication and a PCV of more than 0.45 were venesected until a PCV of 0.35 was achieved. Only patients that were not considered candidates for surgical treatment were entered into the study. Each patient acted as their own control and was studied twice before the venesection at a mean PCV of 0.49 then after achieving a PCV of 0.35 or less (mean PCV of 0.33), and finally one month after the last venesection (mean PCV of 0.37). Angina developed in one patient after the third venesection and was withdrawn from the study. In the remaining sixteen patients, blood flow of the calf muscle during exercise increased significantly after venesection from 5.90 to 8.84 milliliters per 100 grams per minute (p = 0.02). This was measured by xenon 133 clearance and a cadmium telluride detector. There was also a substantial decrease (p less than 0.001) in whole blood viscosity at both low and high shear stresses, but there was no change in plasma viscosity or plasma fibrinogen. Treadmill claudication distance improved in only two patients. Ten patients were tired when the PCV decreased to 0.35 and subjective claudication distance deteriorated in four of these patients. Subsequent isovolemic venesection with dextran 70 volume replacement to a PCV of 0.35 did not improve the response in the six patients restudied. We conclude that venesection did not benefit these patients with intermittent claudication and there was an unacceptable incidence of side effects. Therefore, we suggest that reducing the PCV to 0.35 should be avoided in patients with intermittent claudication who have been refused surgical treatment.

Adult↗
PubMed1999

Vascular surgical society of great britain and ireland: systemic effects of exercise in claudicants are associated with neutrophil activation

BACKGROUND: Claudication induces potentially harmful systemic effects which may be mediated through free radicals and neutrophil activation. This study examined the impact of these mechanisms on renal tubular function. METHODS: Flow cytometry was used to determine CD11b expression by neutrophils and monocytes, and expression of P selectin (CD62P) by platelets, in 16 patients with intermittent claudication and eight matched controls before and at intervals after exercise. Total antioxidant capacity (TAC) and von Willebrand factor (vWF) were measured at similar intervals. Renal tubular function was assessed before and 60 min after exercise by assay of retinol binding protein : creatinine ratio (RBP : Cr) in urine. All patients and none of the controls had a significant exercise-induced fall in ankle pressure. Fluorescein isothiocyanate-labelled monoclonal antibodies against CD11b and CD62P were added to blood and analysis was performed on the flow cytometer within 72 h. RESULTS: There were no significant differences in monocytes, platelets or vWF between patients and controls over time. There was a significant change in RBP : Cr following exercise in patients (median 4.2 (95 per cent confidence interval 2.4-85.2); P </= 0.01, Wilcoxon test) but not controls (2.7 (-1 to 7.5); P not significant). See Table above. CONCLUSION: Renal tubular function was adversely affected by acute exercise in claudicants. TAC was higher in claudicants at rest and was increased after exercise suggesting an increased free radical challenge. Neutrophil activation is significantly different between claudicants and controls before and after exercise, and may provide a link between free radical generation and renal tubular injury.

Journal Article↗
PubMed2002

Reversible prolongation of motor conduction time after transcranial magnetic brain stimulation after neurogenic claudication in spinal stenosis.

STUDY DESIGN: A consecutive and controlled cohort study. OBJECTIVES: To assess the value of motor conduction time (MCT) between cortex and symptomatic leg muscles after transcranial magnetic brain stimulation as an indicator of reversible root ischemia in patients with neurogenic claudication in spinal stenosis. SUMMARY OF BACKGROUND DATA: Neurogenic claudication in spinal stenosis is thought to result from transient ischemia of active nerve root fibers. Subgroups of these patients have slowing of sensory or motor nerve root conduction during spinal claudication. MATERIAL AND METHODS: Forty-two patients with spinal claudication and radiologically confirmed signs of spinal stenosis were consecutively recruited. Motor conduction time was measured before and repetitively after challenge of walking on a treadmill (four stimuli per minute) until disappearance of the symptoms. Data of 30 patients (65 +/- 10 years) with a defined onset of motor-evoked potentials were compared with those of 12 control subjects (62 +/- 12 years). RESULTS: One minute after treadmill challenge, MCT increased in all 13 patients with signs of an exercise-dependent neurologic deficit by at least 1 msec (mean increase, 1.6 +/- 0.6 msec; < 0.001). Test-retest comparisons in six of these patients revealed good reproducibility of the MCT increase (coefficient of repeatability, 1.24 msec). In contrast, MCTs were unchanged or decreased in all 17 patients without exercise-dependent neurologic deficit ( < 0.01) and in the control subjects ( < 0.05). CONCLUSIONS: Measurements of MCT before and after treadmill challenge can demonstrate reversible root ischemia in patients with spinal claudication and exercise-dependent deficit of thickly myelinated nerve root fibers.

Aged↗
PubMed1999

A new pharmacological treatment for intermittent claudication: results of a randomized, multicenter trial.

BACKGROUND: Effective medication is limited for the relief of intermittent claudication, a common manifestation of arterial occlusive disease. Cilostazol is a potent inhibitor of platelet aggregation with vasodilation effects. OBJECTIVE: To evaluate the safety and efficacy of cilostazol for the treatment of intermittent claudication. METHODS: Thirty-seven outpatient vascular medicine clinics at regional tertiary and university hospitals in the United States participated in this multicenter, randomized, double-blind, placebo-controlled, parallel trial. Of the 663 screened volunteer patients with leg discomfort, a total of 516 men and women 40 years or older with a diagnosis of moderately severe chronic, stable, symptomatic intermittent claudication were randomized to receive cilostazol, 100 mg, cilostazol, 50 mg, or placebo twice a day orally for 24 weeks. Outcome measures included pain-free and maximal walking distances via treadmill testing, patient-based quality-of-life measures, global assessments by patient and physician, and cardiovascular morbidity and all-cause mortality survival analysis. RESULTS: The clinical and statistical superiority of active treatment over placebo was evident as early as week 4, with continued improvement at all subsequent time points. After 24 weeks, patients who received cilostazol, 100 mg, twice a day had a 51% geometric mean improvement in maximal walking distance (P<.001 vs placebo); those who received cilostazol, 50 mg, twice a day had a 38% geometric mean improvement in maximal walking distance (P<.001 vs placebo). These percentages translate into an arithmetic mean increase in distance walked, from 129.7 m at baseline to 258.8 m at week 24 for the cilostazol, 100 mg, group, and from 131.5 to 198.8 m for the cilostazol, 50 mg, group. Geometric mean change for pain-free walking distance increased by 59% (P<.001) and 48% (P<.001), respectively, in the cilostazol, 100 mg, and cilostazol, 50 mg, groups. These results were corroborated by the results of subjective quality-of-life assessments, functional status, and global evaluations. Headache, abnormal stool samples or diarrhea, dizziness, and palpitations were the most commonly reported potentially drug-related adverse events and were self-limited. A total of 75 patients (14.5%) withdrew because of any adverse event, which was equally distributed between all 3 treatment groups. Similarly, there were no differences between groups in the incidence of combined cardiovascular morbidity or all-cause mortality. CONCLUSION: Compared with placebo, long-term use of cilostazol, 100 mg or 50 mg, twice a day significantly improves walking distances in patients with intermittent claudication.

Adult↗
PubMed1984

Intermittent claudication. Current results of nonoperative management.

We reviewed the clinical course of 91 men with mild intermittent claudication who had been followed up for at least six months without operation. During 2.5 years' mean follow-up, 60% of the patients had more severe claudication. Actuarial analysis revealed an annual mortality of 4.5% and an annual operation rate of 9%. Historical factors, including age, race, smoking, exercise, diabetes, hypertension, and the ankle-brachial index (ABI), were analyzed to determine if these variables could predict clinical outcome. Only cigarette smoking, exercise, and the ABI were significant in this regard. Patients who had smoked at least 40 pack-years had an operation rate 3.3 times higher than those who smoked less. Major daily exercise was associated with stable claudication. The initial ABI did not correlate with clinical outcome. A subsequent decrease in the ABI of at least 0.15, however, was associated with an operation rate 2.5 times higher and a symptom progression rate 1.8 times higher than patients without this change in the ABI. When regression analysis was used, the preceding variables were only 63% to 79% accurate in predicting the clinical outcome of individual patients. Careful follow-up of patients with intermittent claudication is therefore recommended to allow timely operative intervention when required.

Adult↗
PubMed2000

Vitamin E for intermittent claudication.

BACKGROUND: It is thought that vitamin E may improve tolerance to intermittent claudication (i.e. pain caused by ischaemia in the muscles of the leg during exercise), thereby relieving the pain, through a variety of mechanisms. OBJECTIVES: The objective of this review was to determine the effects of vitamin E on people with intermittent claudication. SEARCH STRATEGY: The reviewers searched the Cochrane Peripheral Vascular Diseases Group trials register, reference lists of relevant articles and a library specialising in literature on vitamins. SELECTION CRITERIA: Controlled trials comparing vitamin E with placebo, or other interventions, in patients with intermittent claudication. DATA COLLECTION AND ANALYSIS: Both reviewers extracted data and assessed study quality independently. MAIN RESULTS: Five eligible studies were found with a total of 265, predominantly male, participants. The average age was 57 years. The follow-up varied from 12 weeks to 18 months. The trials were small and generally of poor quality. The people studied were reasonably homogeneous but five different doses of vitamin E were used and four different physical outcomes were measured. No trials were identified that compared vitamin E with treatments other than placebo. All trials showed positive effects on one of their main outcomes. No serious adverse effects of vitamin E were reported. Two trials that lasted approximately eight months and used similar doses reported patients' subjective evaluation of the treatment. The relative risk for the combined results of these two trials using a random effects model was 0.57 with a 95% confidence interval of 0.28 to 1.15. REVIEWER'S CONCLUSIONS: While vitamin E - which is inexpensive and has had no serious side effects reported with its use - may have beneficial effects, there is insufficient evidence to determine whether it is an effective treatment for intermittent claudication.

Humans↗
PubMed2003

Endovascular stents for intermittent claudication.

BACKGROUND: Endovascular stents have been suggested as a means to improve the patency of arteries after angioplasty in patients with intermittent claudication. OBJECTIVES: The null hypothesis to be tested by this review is that for individuals with claudication, the use of an endovascular stent in addition to percutaneous transluminal angioplasty, does not improve symptoms of life-style limiting claudication, when compared to percutaneous angioplasty alone. SEARCH STRATEGY: We searched the Specialised Register of the Cochrane Peripheral Vascular Disease Group, (last searched October 2002), and the Cochrane Central Register of Controlled Trials (CENTRAL), (last searched Issue 3, 2002). We also searched MEDLINE and EMBASE (up to and including January 2001); bibliographies of published data, and hand searched the Journal of Vascular Interventional Radiology (1990-2001). Enquiries were made to stent manufacturers for unpublished trial data. SELECTION CRITERIA: Randomised trials comparing angioplasty alone, versus angioplasty with endovascular stents, in subjects with intermittent claudication. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted the data. Only published trial data were used. Effectiveness was measured by pre-defined primary outcome measures: restenosis / reocclusion rates and maximum walking distance. MAIN RESULTS: Two trials were included with a total sample size of 104 subjects. Both trials included only individuals with femoro-popliteal disease and compared angioplasty and stenting with the Palmaz stent against angioplasty alone. Although one study showed a slight statistical advantage in arterial patency after angioplasty alone, this was not found when the two studies were combined. No differences in the secondary outcomes in either study were detected. REVIEWER'S CONCLUSIONS: The small number of relevant trials identified, together with the small sample sizes and methodological weaknesses, severely limit the usefulness of this review in guiding practice. Larger multicentre trials are needed.

Adult↗
PubMed1995

Antioxidant consumption during exercise in intermittent claudication.

Twenty male claudicant patients and nine age-matched controls were exercised on a treadmill. Blood and urine samples were taken before and after exercise. Total antioxidant concentration was measured using an enhanced chemiluminescent assay and microalbuminuria determined by radioimmunoassay. Claudicants had increased microalbuminuria after exercise. Mean (s.e.m.) antioxidant concentrations were similar for patients and controls at rest: 479(28) and 438(23) mumol/l respectively. Claudicants showed a significant decrease in antioxidant concentration 1 min after exercise to 428(27) mumol/l; this returned to 470(30) mumol/l by 10 min. A correlation was found between the decrease in antioxidant concentration and the increase in microalbuminuria (rs = -0.496, P < 0.05). This study supports the concept of ischaemia-reperfusion injury in claudicant patients and has implications for treatment.

Adult↗
PubMed1978

Neurogenic and vascular claudication.

Intermittent claudication from peripheral vascular disease is sometimes difficult to distinguish from similar claudication due to degenerative disease of the lumbar spine. In the present study 26 patients with vascular disease were compared with 23 patients with lumbar degenerative disease. Assessment was by clinical and radiological examination. In the vascular group characteristic distinguishing features were: abnormal foot pulses, arterial bruits, relief of symptoms by standing, a constant claudicating distance and stocking sensory loss. In the lumbar group typical findings were: discomfort on lifting, bending, coughing or sneezing, pain on standing, history of back injury, variable claudicating distance and segmental sensory loss.

Aged↗
PubMed1992

The Edinburgh Claudication Questionnaire: an improved version of the WHO/Rose Questionnaire for use in epidemiological surveys.

The WHO/Rose Questionnaire on intermittent claudication was developed in 1962 for use in epidemiological surveys, and has been widely used. Several population studies have shown, however, that it is only moderately sensitive (60-68%), although highly specific (90-100%). In this study, reasons for the poor sensitivity and good specificity were determined following its application to 586 claudicants and to 61 subjects with other causes of leg pain. The results showed two important findings: firstly, that over half of the false negatives were produced by one question alone; and secondly that only three questions were required to maintain the specificity of the questionnaire. This knowledge, in conjunction with the pre-testing of additional questions, enabled a new questionnaire to be constructed: the "Edinburgh Claudication Questionnaire". This questionnaire was tested on 300 subjects aged over 55 years attending their general practitioner, and found to be 91.3% (95% CI 88.1-94.5%) sensitive and 99.3% (95% CI 98.9-100%) specific in comparison to the diagnosis of intermittent claudication made by a physician. The repeatability of the questionnaire after 6 months was excellent (kappa = 0.76, p < 0.001). These results suggest that this revised version of the WHO/Rose Questionnaire should be adopted for use in future epidemiological surveys of peripheral vascular disease.

Aged↗
PubMed2005

The US experience with cilostazol in treating intermittent claudication.

The management of peripheral arterial disease (PAD) patients with intermittent claudication (IC) requires both aggressive risk management and targeted symptomatic therapies. The phosphodiesterase inhibitor cilostazol is the only US Food and Drug Administration (FDA) approved medication to demonstrate consistent benefits on both objective measures of exercise capacity and subjective measures of everyday functioning and quality of life. Pentoxifylline is also approved by the FDA for the treatment of claudication, but with less clinical benefit than cilostazol. This report will provide an overview of cilostazol's role in the treatment of patients with IC. Data will be presented regarding the safety and efficacy demonstrated by cilostazol in clinical trials, as well as the effects of risk-factor control, exercise therapy, revascularization, and experimental drugs on the treatment of claudication in the PAD population. Based on the available evidence, a comprehensive approach to claudication management is recommended.

Cilostazol↗
PubMed2005

Intermittent claudication: exercise-increased walking distance is not related to improved cardiopulmonary fitness.

OBJECTIVES: To assess if exercise training improves the symptoms of intermittent claudication by improvement in cardiopulmonary fitness. METHODS: Claudication distance (CD), maximum walking distance (MWD), calf endurance (repetitive heel raises), cardiovascular fitness (VO2 peak), and ankle-brachial pressure index (ABPI) were measured in 16 subjects with intermittent claudication before, and following an 8-week treadmill training programme. RESULTS: Training resulted in a median increase in CD of 65.5 m (p<0.01), MWD of 339.5 m (p<0.001) and HR of 19 (p<0.03). Notably, improvements in MWD correlated with those in HR (p=0.001; R=0.75). There was no training-associated change in VO2 peak (median increase of only 0.35 ml/kg/min; p=0.60) or ABPI (median increase of only 0.01; p=0.64). CONCLUSION: In this study, overall improvement in claudication was not related to an improvement in cardiopulmonary fitness.

Aged↗
PubMed2006

Variability in responsiveness to clopidogrel in patients with intermittent claudication.

OBJECTIVE: The concept of clopidogrel resistance is frequently evoked in the cardiac literature. The variability of antiplatelet response in patients with intermittent claudication has not been investigated. The aim of this study was to describe the effect of the addition of clopidogrel to aspirin using ex vivo measures of platelet activation in patients with life-style limiting intermittent claudication. DESIGN OF STUDY: Data from randomised controlled trial. MATERIALS: Data from 67 patients with intermittent claudication taking part in a randomised controlled trial and who received clopidogrel in addition to aspirin was analysed. METHODS: Platelet activation was measured using whole-blood flow cytometric measurement of ADP-stimulated fibrinogen binding at baseline and 12h after administration of a loading dose of 300 mg clopidogrel. Patients continued to receive 75 mg clopidogrel daily for 30 days and platelet activation was again measured at day 30. Compliance with treatment was assessed by counting returned tablets. RESULTS: Six patients were excluded from analysis because of incomplete compliance with treatment. Six of the sixty-one patients (9.8%) showed no reduction in platelet activation 12h after administration of the loading dose of clopidogrel. At 30 days these six patients still showed no response to clopidogrel. Amongst the remaining 55 patients, the mean reduction in fibrinogen binding after clopidogrel administration was 51.5% (95% CI: 43.8-59.2). Amongst responders there was a wide variability in reduction of fibrinogen binding in response to clopidogrel (range 8.11-97.7%). Four of these patients (6.6%) showed a reduction of more than 95% in fibrinogen binding. CONCLUSIONS: Patients with intermittent claudication show a wide variability in their response to clopidogrel. While a small proportion of these patients shows no response at all, another small group appears to respond excessively to clopidogrel. Clinical studies are required to identify whether hyper-responders are at increased risk of bleeding complications and whether hyporesponders are at a higher risk of thrombotic events.

Adult↗
PubMed2006

The PADHOC device is a better guide to the actual incapacity suffered by claudicants than the gold standard constant load treadmill test.

BACKGROUND: The Constant Load Treadmill Test (CLTT) is currently the primary method used to measure walking impairment in patients with peripheral vascular disease. The aim of this study was to compare the CLTT and PADHOC device as assessments of walking impairment. METHODS: 55 patients with intermittent claudication underwent a CLTT and a Double Physiological Walking Test (DPWT) using the PADHOC device. Health-related quality of life was measured using the Short Form 36 and the Claudication Scale. RESULTS: The initial claudication and maximum walking distance from the first part of the DPWT showed the best correlation with domains of pain and physical function. CONCLUSIONS: The DPWT is more representative of the functional incapacity experienced by patients with intermittent claudication. We believe that the PADHOC is a suitable alternative to the CLTT in the assessment of this patient group.

Aged↗
PubMed2006

The novel phosphodiesterase inhibitor NM-702 improves claudication-limited exercise performance in patients with peripheral arterial disease.

OBJECTIVES: The current study tested the hypothesis that NM-702 improves treadmill exercise performance in peripheral arterial disease patients with claudication-limited exercise performance. BACKGROUND: Patients with claudication experience significant disability, owing to their exercise limitation. Therapeutic options to improve exercise performance in these patients are limited. NM-702 is a novel drug that inhibits phosphodiesterase as well as thromboxane A2 synthase. METHODS: This study was a randomized, multi-center, placebo-controlled, double-blind trial. Patients were randomized to receive 24 weeks of twice-daily treatment with either placebo (intent to treat population, n = 130), 4 mg NM-702 (n = 126), or 8 mg NM-702 (n = 130). RESULTS: After 24 weeks of treatment, 8 mg NM-702 was associated with a statistically significant increased peak walking time on a graded treadmill as compared with placebo (p = 0.004). Peak walking time after 24 weeks was increased by 17.1 +/- 49.0% in the placebo arm, 22.1 +/- 60.1% in the 4-mg NM-702 arm, and 28.1 +/- 50.5% in the 8-mg NM-702 arm. NM-702 at the 8-mg dose for 24 weeks was associated with statistically significant improvements in the treadmill claudication onset time as compared with placebo. In addition, as compared with placebo, NM-702 improved the physical component and physical functioning scores of the Medical Outcomes Study 36-Item Short Form and the walking distance and stair climbing domains of the Walking Impairment Questionnaire. NM-702 was generally well tolerated, but adverse events typical of vasodilators were common. CONCLUSIONS: NM-702 used for 24 weeks by patients with claudication was associated with improvements in laboratory- and ambulatory-based exercise performance.

Aged↗
PubMed2004

Helicobacter pylori seropositivity is associated with enhanced platelet activation in patients with intermittent claudication.

OBJECTIVE: Patients with intermittent claudication have a significantly increased risk of mortality from cardiovascular and cerebrovascular causes. Helicobacter pylori infection and abnormal platelet function have been shown to be associated with atherosclerosis as well as with acute ischemic events. The aim of this study was to assess for the first time the relation between H pylori serology status, platelet activation, and endothelial injury in patients with intermittent claudication. Design of study : A prospective observational study of 125 patients with intermittent claudication suitable for angioplasty was conducted at the Vascular Unit of the Aberdeen Royal Infirmary. Main outcome measures Main outcome measures were (1) H pylori serology using ELISA kit for immunoglobulin G antibody to H pylori and (2) whole blood flow cytometric analysis of resting platelet P-selectin expression and fibrinogen binding as measures of platelet activation. Results are presented as platelet percentage. von Wildebrand factor levels were measured using ELISA as a marker of endothelial injury. Carstair deprivation scores were calculated for all patients. RESULTS: H pylori serology was positive in 62 patients (49.6%), negative in 56 (44.8%) and equivocal in 7 (5.6%). Median P-selectin expression was significantly increased in H pylori-positive patients compared with seronegative patients (0.815 vs 0.65; P =.039). Median platelet fibrinogen binding was higher in seropositive patients, but this failed to reach statistical significance (2.135 vs 1.85%; P =.11). There was no difference in von Wildebrand factor levels between the two groups (P =.51). There was no difference in socioeconomic status between the two groups. CONCLUSION: Patients with intermittent claudication who are H pylori positive show enhanced platelet activation that does not appear to be mediated by means of endothelial cell injury.

Aged↗
PubMed1991

The value of percutaneous transluminal angioplasty of the profunda femoris artery in threatened limb loss and intermittent claudication.

Percutaneous transluminal angioplasty (PTA) has been performed on 29 profunda femoris artery stenoses in 26 limbs of 25 patients. Seventy per cent of the 27 atheromatous stenoses involved the origin or proximal 4 cm of the profunda. One patient had two strictures of a common femoral-profunda femoris vein graft. All had total superficial femoral or femoropopliteal occlusion (median length 29.5 cm, range 4-47 cm). The 13 patients presenting with threatened limb loss were significantly older than the remainder, who had disabling intermittent claudication (P = 0.03), and had twice the incidence of diabetes mellitus. They also had significantly fewer calf vessels patent compared with the claudicants (P = 0.008). The approaches used for profunda PTA included ipsilateral antegrade common femoral (19), ipsilateral retrograde profunda (3), cross-over technique (2), antegrade profunda (1) and brachial cutdown (1). Profunda PTA was technically successful at 26 sites (89.7%), partially successful at one, and failed at two. Concomitant PTA was successful at eight of 10 sites in eight patients. Complications requiring surgery occurred in two (7.7%). The median follow up was 17.5 months (range 1-62 months). Of the 12 limb salvage patients who underwent a technically successful profunda PTA, six required no further intervention, three subsequently underwent bypass grafting and three had an inevitable amputation, the level of amputation having been lowered in one of the patients. Nine claudicants improved symptomatically after technically successful profunda PTA; three underwent an operative procedure. Eight (61.5%) of the limb salvage group have now died, compared with two (15.4%) of the claudicants. Profunda femoris PTA is an effective alternative to profundaplasty in patients with femoropopliteal occlusive disease and may obviate the need for bypass surgery or amputation.

Aged↗
PubMed2003

Treatment of intermittent claudication with beraprost sodium, an orally active prostaglandin I2 analogue: a double-blinded, randomized, controlled trial.

OBJECTIVES: In the current study, we hypothesized that beraprost would: 1) improve treadmill exercise performance and quality of life; and 2) decrease rates of ischemic events in patients with intermittent claudication. BACKGROUND: Previous trials with beraprost sodium, an orally active prostaglandin I(2) analogue, in the treatment of claudication in patients with peripheral arterial disease (PAD) have been inconsistent. METHODS: Patients with intermittent claudication (n = 897) were randomized to receive either 40 microg three times a day of beraprost with meals (n = 385) or placebo (n = 377) in a double-blinded manner for one year. The primary efficacy parameter was treadmill-measured maximum walking distance, as assessed at three and six months after randomization. Secondary efficacy parameters included treadmill-measured pain-free walking distance and change in quality of life. RESULTS: There was no significant improvement in maximum walking distance in the beraprost group (16.7%) as compared with the placebo group (14.6%, p = NS). Administration of beraprost did not improve the pain-free walking distance (p = NS between treatment groups), and there was no improvement in the quality-of-life measures between the treatment groups. The incidence of critical cardiovascular events was 7.3% in the beraprost group and 11.4% in the placebo group (p = NS). There was a significant reduction in the combination of cardiovascular death and myocardial infarction in the beraprost group (p = 0.01). CONCLUSIONS: Despite previous investigations suggesting efficacy, these results indicate that beraprost is not an effective treatment to improve symptoms of intermittent claudication in patients with PAD. The potential benefit of beraprost on critical cardiovascular events would require confirmation in a larger prospective investigation.

Administration, Oral↗