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The effects of acebutolol and metoprolol on walking distances and distal blood pressure in hypertensive patients with intermittent claudication.

The effects of acebutolol (with intrinsic sympathomimetic activity (ISA] and metoprolol (without ISA) on arm blood pressure, ankle systolic blood pressure, claudication distances (CD) and maximal walking distances (MWD) were compared in patients with essential hypertension and intermittent claudication. Fourteen patients participated in a long-term, open, randomized cross-over study. After randomization the patients received either acebutolol, 200 mg b.i.d., or metoprolol, 100 mg b.i.d. After eight weeks the drugs were shifted and after another eight weeks they were withdrawn. Arm and ankle blood pressure, CD and MWD were determined before randomization and after 4, 8, 12 and 16 weeks, and again 4-6 weeks after withdrawal of the drugs. The arm blood pressure was reduced by 20/13 mmHg after acebutolol and by 22/21 mmHg after metoprolol. In spite of a significant decrease in arm blood pressure there were no significant changes in ankle blood pressure, CD or MWD after the two drugs. After withdrawal of the drugs and after the arm blood pressure had returned to the control value no significant changes were seen in CD, MWD or ankle blood pressure. It is concluded that beta-blockers have no deleterious effect on CD, MWD or ankle blood pressure in patients with hypertension and intermittent claudication. No effect of ISA was demonstrated.

Acebutolol↗

Treatment of intermittent claudication. Lumbar paravertebral somatic block with phenol.

Our experience of twenty-eight patients with intermittent claudication treated by means of paravertebral lumbar somatic nerve block is presented. There was immediate demonstrable improvement in 92-5% of the twenty-six patients included in this follow up. At the end of 6 months the improvement was maintained in 72-7% of the patients and in about 70-0% of patients at 6 months and at 9 months. Six of the seven patients followed up for 1 year had a claudication distance at least twice that prior to the block. The results of this indicate that lumbar somatic nerve block is less disturbing and more effective than other forms of conservative treatment for intermittent claudication.

Aged↗

Drug treatment of intermittent claudication: a critical analysis of the methods and findings of published clinical trials, 1965-1985.

1. All trials of drug therapy for intermittent claudication published in English during the period 1965-1985 were reviewed. A total of 75 trials had studied 33 different pharmacological agents. Treadmill exercise, the most reproducible method of evaluating symptoms in this condition, was used in 49% of trials. 2. Oxpentifylline was the drug that had been most frequently studied. In seven placebo-controlled trials the average response to oxpentifylline, compared with placebo and weighted for sample-size, was 65% improvement in claudication distance. There was, however, a significant negative relation between sample-size and response (rs = -0.79, P less than 0.05), suggesting that this estimate was likely to have been biased by non-publication of negative results. 3. One third of all trials were uncontrolled; 84% of these reported benefit from drug treatment, compared with 32% of placebo-controlled trials (P less than 0.001). Sample-sizes varied from seven to 227 patients; 31% of trials reported data from less than 20 patients and these were likely to have had insufficient statistical power. 4. Overall, 57 of the 75 trials (76%) had at least one of the following deficiencies: an uncontrolled design; not double-blind; failure to use treadmill exercise; less than 20 patients included in the analysis. Thus, a priori three-quarters of all trials were unlikely to have made a satisfactory assessment of drug efficacy. 5. The information available does not establish convincingly that any drug consistently improves exercise performance in intermittent claudication. In view of the deficiencies in previous trials, we propose guidelines for future studies with regard to trial design, sample-size and methods of exercise testing.

Clinical Trials as Topic↗

Hyperhomocyst(e)inaemia: an independent risk factor for intermittent claudication.

The aim of this study was to test the question of hyperhomocyst(e)inaemia as a risk factor for intermittent claudication (IC) independent of other important risk factors for peripheral atherosclerotic disease, such as smoking, hypertension, diabetes mellitus, hypercholesterolaemia, hypertriglyceridaemia, low levels of high-density-lipoprotein (HLD) cholesterol and age. The study population was recruited from an epidemiological study in Linköping County, Sweden, where all middle-aged men (n = 15,253, 45-69 years of age) were screened for IC. Seventy-eight subjects with verified IC and 98 healthy sex- and age-matched controls were randomly selected. Plasma levels of homocyst(e)ine (including the sum of free and bound forms of homocysteine and their disulphide oxidation products, homocystine, and homocysteine-cysteine mixed disulphide) were significantly higher (16.74 +/- 5.45 mumol l-1, mean value +/- SD, P = 0.0002) in IC subjects than in controls (13.80 +/- 3.21 mumol l-1), with 23% of the claudicants above the 95th percentile for controls. Stepwise logistic regression analysis revealed that the difference in plasma homocyst(e)ine was independent of the other above-mentioned risk factors. Moreover, the elevation of plasma homocyst(e)ine in claudicants was mainly confined to subjects with serum folate levels of less than or equal to 11.0 nmol l-1. The results suggest that folic acid supplementation should be tried in IC subjects with hyperhomocyst(e)inaemia.

Aged↗

Colour duplex ultrasound: a screening modality for femoropopliteal disease in patients with intermittent claudication.

In patients presenting with intermittent claudication, Colour Duplex Ultrasound (CDU) examination of the femoro-popliteal segment has been proposed as a screening modality. Those patients with atheromatous lesions suitable for percutaneous transluminal angioplasty (PTA) could proceed to diagnostic angiography. Patients with long segment occlusive disease demonstrated by CDU, who were not considered suitable candidates for surgery, would not require angiographic examination. This prospective study was performed on 46 limbs in 25 consecutive patients who presented for investigation of claudication. There was close correlation between the two methods in the demonstration of high-grade stenoses and occluded segments. Using angiography as the 'gold standard' this study indicated a diagnostic accuracy for CDU of 93% with a sensitivity of 89% and a specificity of 95%. Angiography tended to show longer occluded segments than CDU. Colour Duplex Ultrasound shows promise as a screening investigation in patients with intermittent claudication to detect lesions that may be suitable for PTA.

Aged↗

Intermittent claudication: a double-blind crossover trial of pentoxifylline.

The influence of the xanthine derivative pentoxifylline ('Trental' or BL191; Hoechst-Roussel) on exercise tolerance was measured in 38 subjects with stable, severe to moderately severe, intermittent claudication who completed a randomised, double-blind, placebo controlled, cross-over clinical trial. Patients received placebo tablets or 400 mg slow-release pentoxifylline tablets ('Trental 400') twice a day for one week, followed by three times daily for seven weeks, and then crossed over to receive the alternate preparation for another eight weeks. Claudication distance and walking distance were measured on a treadmill before starting treatment and again at four-week intervals during the trial. At the same times, red blood cell filterability, plasma fibrinogen concentration and blood viscosity, resting and post-ischemic calf muscle blood flow, and the resting and post-exercise ankle/brachial systolic pressure ratio were also measured. In this study, the observed effects of pentoxifylline treatment were no greater than those of placebo, even though serum levels of pentoxifylline and its hydroxy-metabolite were within the anticipated range. This was shown by a 'therapeutic effect ratio' of 0.98 for treadmill claudication distance and 0.96 for treadmill walking distance after within-patient analysis at the end of the cross-over (where a ratio of 1.0 means the test drug and placebo effects are identical). These ratios have 95% confidence limits of 0.72-1.34 and 0.74-1.25, respectively.

Aged↗

Effect of the oral hypoglycaemic sulphonylurea glibenclamide, a blocker of ATP-sensitive potassium channels, on walking distance in patients with intermittent claudication.

AIMS: The oral hypoglycaemic sulphonylurea glibenclamide stimulates endogenous insulin secretion through blockade of ATP-sensitive potassium (KATP) channels on pancreatic beta cells, but also blocks cardiovascular KATP channels, leading to increased peripheral vascular resistance and reduced peripheral blood flow in non-diabetic subjects. Therefore, this study examined whether a single oral dose of glibenclamide adversely affected the pain-free or maximal walking distance in patients with intermittent claudication. METHODS: In a double-blind, randomized crossover study, 12 non-diabetic patients with intermittent claudication were given a single oral dose of glibenclamide (5.25 mg) or placebo separated by a washout period of 1 week. A treadmill test was carried out 180 min after glibenclamide/placebo intake for determination of pain-free and maximal walking distance. Plasma glucose concentrations were kept constant by an euglycemic clamp. Changes in ankle/brachial blood pressure index (ABI), serum insulin, and serum glibenclamide were also assessed. RESULTS: The pain-free walking distance was 62.8 +/- 9.8 metres (mean +/- sem) after glibenclamide and 52.6 +/- 5.9 metres after placebo (P = 0.52). The maximal walking distance was 142.7 +/- 18.7 metres after glibenclamide and 132.6 +/- 16.6 metres after placebo (P = 0.23). The ABI was not significantly changed by glibenclamide compared with placebo. Serum glibenclamide was 0.51 +/- 0.08 microm 180 min after administration of the drug. Glibenclamide produced an 8-fold increase in circulating insulin compared with placebo (P < 0.001). CONCLUSIONS: Glibenclamide given as a single oral dose commonly used in glucose-lowering drug therapy does not reduce pain-free or maximal walking distance in non-diabetic patients with intermittent claudication.

Adenosine Triphosphate↗

Neurogenic intermittent claudication in association with spondylolisthesis.

In the last three decades, more attention has been put upon neurogenic intermittent claudication, also called pseudoclaudication. The syndrome usually develops in patients with congenital narrow spinal canal and secondary additional narrowing. Two cases of spondylolisthesis with neurogenic intermittent claudication are presented. The pathogenesis, symptoms and findings of neurogenic intermittent claudication are discussed.

Female↗

Transcutaneous oxygen tension during exercise in patients with claudication.

Transcutaneous oxygen tension (TcPO2) was monitored during maximal exercise in 10 patients with stable moderate to severe claudication. The TcPO2 fell by 16% at the onset of claudication and 32% at the maximum walking distance. On resting this decrease reached a maximum of 66% roughly four minutes after exercise. This was followed by a steady recovery. The percentage changes were reproducible in each patient and were appreciably different from the TcPO2 exercise profiles of normal healthy volunteers. TcPO2 monitoring during exercise is a simple, reproducible, cheap, and useful technique for assessing claudication and compares favourably with other techniques used to quantify this condition.

Aged↗

Fibrinogen in relation to personal history of prevalent hypertension, diabetes, stroke, intermittent claudication, coronary heart disease, and family history: the Scottish Heart Health Study.

OBJECTIVE: To determine the relations of plasma fibrinogen to family history of premature heart disease, personal history of hypertension, diabetes, stroke, coronary heart disease, and to presence of intermittent claudication. DESIGN: Random population survey across 22 local government districts in Scotland. PARTICIPANTS: 10,359 men and women aged 40 to 59 years. Plasma fibrinogen was measured in 8824. MAIN OUTCOME MEASURE: Plasma fibrinogen concentration. RESULTS: Persons with a family history of heart disease or a personal history of high blood pressure, diabetes, stroke, or presence of intermittent claudication all had higher plasma fibrinogen concentrations than those without. When compared with participants without cardiovascular or related disease (men: 2.27 (SE = 0.01) g/l, n = 3367; women 2.34 (0.01) g/l, n = 3096), predefined cases of either myocardial infarction (men: 2.51 (0.02) g/l, n = 248; women: 2.63 (0.04) g/l, n = 72) or angina (men: 2.45 (0.02) g/l, n = 394; women: 2.50 (0.02) g/l, n = 398) had significantly higher plasma fibrinogen concentrations (p < 0.001). After adjustment for 10 other coronary risk factors, there was a noticeable linear trend in the odds ratios for myocardial infarction across all quartiles (quarters) of plasma fibrinogen concentrations in both sexes. Similarly, the risk of angina increased linearly with increasing fibrinogen concentrations, although the test for a linear trend was NS among women. CONCLUSIONS: This large population study confirms that plasma fibrinogen is not only a risk factor for coronary heart disease and stroke, but it is also raised with family history of premature heart disease and with personal history of hypertension, diabetes, and presence of intermittent claudication.

Adult↗

Long-term outcome of patients with claudication after balloon angioplasty of the femoropopliteal arteries.

PURPOSE: To report the long-term outcome of patients with lifestyle-limiting claudication after percutaneous transluminal angioplasty (PTA) of the femoropopliteal arteries. MATERIALS AND METHODS: Between 1989 and 1992, 173 consecutive claudicant patients (mean age, 65 years; age range, 41-90 years) underwent PTA in 218 limbs; all interventions included femoral and/or popliteal arterial segments, and additional iliac (n = 27) and infrapopliteal (n = 11) arterial lesions were also treated. Patients were followed up for 7-10 years. Altogether, 37 (17%) limbs were classified as Fontaine class 2A, and 181 (83%) were class 2B. Average length of the primary lesion was 5.2 cm. Reinterventions were analyzed. Patency rates and patient survival were assessed by means of life table analysis. Cox-Mantel tests and Cox proportional hazards models were used to define associated independent determinants. Development of chronic critical ischemia (CCI) and its determinants was assessed by using the Pearson chi(2) test and multiple logistic regression analysis. RESULTS: The primary and secondary patencies (+/- standard error of the estimate), respectively, were 46% +/- 3 and 63% +/- 3 at 1 year, 25% +/- 3 and 41% +/- 4 at 5 years, and 14% +/- 3 and 22% +/- 4 at 10 years. One-third (71 of 218) of the limbs required repeat interventions, including surgical revascularization in 35 limbs. Fourteen (6.4%) limbs developed CCI, resulting in a 0.8% incidence per year. In multivariate analysis, poor postinterventional peripheral runoff was an indicator of increased risk of CCI development (P =.03). CONCLUSION: Although the long-term patency rates of PTA of the femoropopliteal arteries in claudicant patients were poor, the acceptable number of reinterventions and the low frequency of development of CCI imply the long-term benefits achievable with this treatment.

Adult↗

Cost-effectiveness targets for multi-detector row CT angiography in the work-up of patients with intermittent claudication.

PURPOSE: To determine the costs, sensitivity for detection of significant stenoses, and proportion of equivocal multi-detector row computed tomographic (CT) angiography results in the work-up of patients with intermittent claudication that would make this imaging examination cost-effective compared with gadolinium-enhanced magnetic resonance (MR) angiography. MATERIALS AND METHODS: A decision model was used to compare the societal cost-effectiveness of a new imaging modality with that of gadolinium-enhanced MR angiography. Main outcome measures were quality-adjusted life years (QALYs) and lifetime costs. By using threshold analysis of a given willingness to pay per QALY, target values for costs, sensitivity for detection of significant stenoses, and proportion of cases requiring additional work-up with intraarterial digital subtraction angiography owing to equivocal results of the new modality were determined. The base case evaluated was that of 60-year-old men with severe intermittent claudication and assumed an incremental cost-effectiveness threshold of 100,000 US dollars per QALY. RESULTS: If treatment were limited to angioplasty, a new imaging modality would be cost-effective if the costs were 300 US dollars and the sensitivity was 85%, even if up to 35% of patients needed additional work-up. When both angioplasty and bypass surgery were considered as treatment options, a new imaging modality was cost-effective if the costs were 300 US dollars, the sensitivity was higher than 94%, and 20% of patients required additional work-up. CONCLUSION: Multi-detector row CT angiography, as compared with currently used imaging modalities such as MR angiography, has the potential to be cost-effective in the evaluation of patients with intermittent claudication.

Angiography, Digital Subtraction↗

Femoropopliteal angioplasty in patients with claudication: primary and secondary patency in 140 limbs with 1-3-year follow-up.

PURPOSE: To determine the usefulness of percutaneous transluminal angioplasty in the femoropopliteal arteries in patients with claudication. MATERIALS AND METHODS: In a prospective study of 106 claudicants (71 men and 35 women, aged 41-90 years [mean, 67 years]), a total of 208 lesions in 140 limbs were treated. The patients were followed up for 12-36 months. The patency rates were based on determination of the ankle-brachial index. RESULTS: The hemodynamic success rate for all the treated limbs was 89%, 99% for femoropopliteal stenoses (n = 71) and 80% for femoropopliteal occlusions (n = 69). In multiple logistic regression analysis, a smaller number of diseased vessels (one to two vs three to seven) and milder lesion severity (stenosis vs occlusion) correlated favorably with early success. Survival analysis with the Kaplan-Meier method according to established criteria revealed 1-, 2-, and 3-year primary patency rates of 47% (27 of 57 limbs), 41% (14 of 34 limbs), and 43% (three of seven limbs), respectively. CONCLUSION: In selected cases, good primary success and acceptable long-term results can be achieved with femoropopliteal angioplasty in claudicants.

Adult↗

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↗

Comparison of results in endovascular interventions for infrainguinal lesions: claudication versus critical limb ischemia.

This study analyzed clinical success, patency, and limb salvage after endovascular repair in patients treated for chronic limb ischemia presenting with claudication versus critical limb ischemia. Between October 2001 and August 2004, 115 patients (mean age 71) underwent endovascular treatment for infrainguinal arterial disease. Techniques included subintimal angioplasty and transluminal angioplasty with or without stents. Lesions were classified according to Transatlantic InterSociety Consensus. Follow-up (mean 11 months) included physical exam, ankle-brachial index, and duplex ultrasound. Patency rates were determined using Kaplan-Meier and compared by log-rank analysis. One hundred ninety-nine lesions were treated in 121 limbs using percutaneous techniques. Comorbidities were similar except higher rates of diabetes mellitus (67% vs 41%, P < 0.001) and chronic renal insufficiency (22% vs 7%, P < 0.05) were found in critical limb ischemia patients. Primary patency for claudicants was 100 per cent, 98 per cent, and 85 per cent at 3, 6, and 12 months and 89 per cent, 80 per cent, and 72 per cent for critical limb ischemia, respectively (P = 0.06). Limb salvage was 91 per cent at 12 months for critical limb ischemia patients. Morbidity was similar between groups, and there was no perioperative mortality. Percutaneous intervention for both claudication and critical limb ischemia provides acceptable 12 month patency with limited morbidity.

Adult↗

Nomograms used to define the short-term treatment with PGE(1) in patients with intermittent claudication and critical ischemia. The ORACL.E (Occlusion Revascularization in the Atherosclerotic Critical Limb) Study Group. The European Study.

Infusional, cyclic PGE1 treatment is effective in patients with intermittent claudication and critical limb ischemia (CLI). One of the problems related to chronic PGE1 treatment in vascular diseases due to atherosclerosis is to evaluate the variations of clinical conditions due to treatment in order to establish the number of cycles per year or per period (in severe vascular disease reevaluation of patients should be more frequent) needed to achieve clinical improvement. In a preliminary pilot study a group of 150 patients (mean age 67+/-12 years) with intermittent claudication (walking range from 0 to 500 m) and a group of 100 patients with CLI (45% with rest pain, and 55% gangrene; mean age 68 +/-11 years) the number of PGE1 cycles according to the short-term protocol (STP) needed to produce significant clinical improvement was preliminarily evaluated. Considering these preliminary observations, the investigators established a research plan useful to produce nomograms indicating the number of cycles of PGE1-STP per year needed to improve the clinical condition (both in intermittent claudication and CLI). A significant clinical improvement was arbitrarily defined as the increase of at least 35% in walking distance (on treadmill) and/or the disappearance of signs and symptoms of critical ischemia in 6 months of treatment in at least 75% of the treated patients. With consideration of the results obtained with the preliminary nomograms a larger validation of the nomograms is now advisable. A cost-effectiveness analysis is also useful to define the efficacy of treatment on the basis of its costs. The publication of this report in two angiological journals (Angeiologie and Angiology) will open the research on nomograms to all centers willing to collaborate to the study. The data are being collected in the ORACL.E database and will be analyzed within 12 months after the publication of this report.

Aged↗

Failure of pentoxifylline or cilostazol to improve blood and plasma viscosity, fibrinogen, and erythrocyte deformability in claudication.

Peripheral artery disease is associated with altered blood rheologic properties, including increased viscosity and decreased red blood cell (RBC) deformability. Pentoxifylline and cilostazol are available therapies for intermittent claudication. Improvement of blood viscosity and erythrocyte deformability have been cited as potential mechanisms of action for pentoxifylline. Cilostazol is a new drug with antiplatelet and vasodilating activity, but the mechanism by which it promotes an improvement in walking is not known. This study was performed to evaluate and compare the hemorheologic effects of pentoxifylline and cilostazol on viscosity, fibrinogen levels, and erythrocyte deformability when administered to adults with moderate to severe claudication. A double-blind, controlled study was conducted and included 59 patients (46 male, 13 female; mean age 65 yr) randomized to pentoxifylline 400 mg orally thrice daily (n=20), cilostazol 100 mg orally twice daily (n=19), or placebo (n=20); all subjects were observed for 24 weeks. Walking ability was assessed before, during, and at the conclusion of treatment by standard constant speed, variable grade treadmill testing. Erythrocyte deformability was measured by passage of washed RBCs, 10% hematocrit in phosphate buffered saline (PBS), through a polycarbonate membrane with 4.7 to 5.0 microm pores. Whole blood and plasma viscosity were measured using a cone/plate viscometer at variable shear rates (from 4.5 to 450 sec(-1)). Erythrocyte sedimentation rate was measured by a modified Westergren technique. Fibrinogen was assayed by a commercial reference laboratory. Plasma viscosities did not change significantly in any treatment group. Within-group comparisons demonstrated a significant (p<0.01) drop in whole blood viscosity (week 24 compared with week 0) for cilostazol-treated subjects (at shear rates of 45, 90, 225, and 450 sec(-1)), but these changes were not significantly different from those in the placebo group. There were no significant changes in whole blood viscosity for subjects treated with pentoxifylline or placebo. There were no significant changes in erythrocyte deformability, fibrinogen, or erythrocyte sedimentation rate. A trend toward improved walking distances was noted for both pentoxifylline and cilostazol in comparison with placebo. This trend was not correlated with changes in any underlying rheologic parameter. Ex vivo rheologic characteristics of blood from patients with intermittent claudication are not significantly affected by long-term administration of pentoxifylline or cilostazol. Pentoxifylline did not modulate viscosity or red cell deformability, a finding at variance with its putative mechanism of action. Pentoxifylline cannot be differentiated from cilostazol based on specific hemorheologic effects evaluated in this study. Different mechanisms of action for these medications should be considered.

Adult↗

Anticardiolipin antibodies as a risk factor of atherosclerosis in intermittent claudication.

Anticardiolipin antibodies have been associated as a risk factor of atherosclerosis. The aim of this study was to evaluate the association between anticardiolipin antibodies and intermittent claudication. Forty consecutive patients (33 men, 7 women; age range: 45-84 years, mean 65.5) who were seen in the angiology and vascular surgery department with intermittent claudication were evaluated. Exclusion criteria included prior revascularization, angioplasty, or a history of thrombosis of a lower limb. Forty individuals (23 men, 17 women; age range: 58-82 years, mean 67.1) who attended a support group for senior citizens and who were apparently healthy formed the control group. Anticardiolipin antibodies were evaluated by means of enzyme-linked immunosorbent assay (ELISA) for quantitative measurement of immunoglobulin G (IgG) and IgM antibodies against cardiolipins in serum. IgG levels were considered normal when < 7, borderline from 7 to 10, and elevated at > 10 GPL units/mL; IgM levels were normal when < 4, borderline from 4 to 7, and elevated at > 7 MPL, as recommended by the test manufacturers. Statistical analysis used the relative risk test with a confidence interval of 95%. Twenty-three patients from the study group and 6 individuals from the control group were found to have elevated levels of anticardiolipin antibodies giving a relative risk of 3.833 (ranging from 1.749 to 8.4; p value < 0.0001). In conclusion, patients who have elevated levels of anticardiolipin antibodies present a 3.8 times greater risk of developing intermittent claudication.

Aged↗