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PubMed1986

Changes in peripheral blood pressures after five years of follow-up in non-operated patients with intermittent claudication.

Changes in the segmental blood pressures (BP) in the legs after five years of follow-up and factors related to the changes were studied in 93 non-operated non-diabetic patients with intermittent claudication. Independent variables affecting the ankle/arm BP index (ABI) in the more affected leg were the initial ABI, smoking, duration of claudication and location of the stenoses (whether single or multiple). ABI was stable in non-smokers but decreased in smokers. It also decreased in patients with multiple stenoses at the initial examination but not in those with single stenoses. The correlation between subjective changes in claudication and changes in the ankle BP was poor. In the less affected leg, ABI decreased both in smokers and non-smokers but stenoses in legs without signs of stenoses initially developed to a greater extent in smokers than in non-smokers. Smoking is an important risk factor for progression of the occlusive atherosclerotic disease in intermittent claudication. Patients with multiple stenoses seem to have a more progressive occlusive disease.

Blood Pressure↗
PubMed2003

Xanthine oxidase and activated neutrophils cause oxidative damage to skeletal muscle after contractile claudication.

We previously showed oxidative damage and edema within skeletal muscle after contractile claudication. To investigate the sources of this oxidative damage in the gastrocnemius muscle, we administered allopurinol (Allo, to inhibit xanthine oxidase) and cyclophosphamide (Cyclo, to deplete neutrophils) before inducing contractile claudication in male Sprague Dawley rats. Contractile claudication (ligated stimulated, LS) caused a significant increase in xanthine oxidase activity [sham ligated stimulated (SS) = 2.57 +/- 0.07; LS = 3.22 +/- 0.07] and neutrophil infiltration (SS = 0.47 +/- 0.03; LS = 0.91 +/- 0.10) compared with controls (SS), and this was associated with increased lipid peroxidation, protein oxidation, muscle damage, and edema. Pretreatment with Allo attenuated the increase in xanthine oxidase activity and attenuated lipid hydroperoxides (control LS = 12.85 +/- 0.50; Allo LS = 9.96 +/- 0.71), muscle damage, and neutrophil infiltration (control LS = 0.91 +/- 0.10; Allo LS = 0.61 +/- 0.07). This latter finding suggests that xanthine oxidase-derived oxidants are chemotactic to neutrophils. Pretreatment with Cyclo reduced neutrophil infiltration (control LS = 0.91 +/- 0.10; Cyclo LS = 0.55 +/- 0.02) and attenuated lipid peroxidation (control LS = 12.85 +/- 0.50; Cyclo LS = 6.462 +/- 0.62), protein oxidation (control LS = 2.59 +/- 0.47; Cyclo LS = 1.77 +/- 0.60), muscle damage, and edema. Together, these data indicate that contractile claudication causes an increase in xanthine oxidase activity and neutrophils in muscle and that inhibition of these oxidant sources protects against oxidative stress, muscle damage, and edema.

Animals↗
PubMed1993

Serum lipoproteins and hemostatic function in intermittent claudication.

Normoglucemic men with intermittent claudication (n = 41), mean age of 63 years, and sex-, age-, body mass index-, and smoking habit-matched controls (n = 75) were compared for plasma lipoprotein and hemostatic variables. The patients had significantly lower levels of large high-density lipoprotein (HDL) particles (HDL2b, HDL2a, and HDL3a) and elevated lipoprotein(a) [Lp(a)] concentrations than the control subjects. Of the hemostatic variables, plasminogen activator inhibitor-1 (PAI-1), plasma antiplasmin, plasma fibrinogen, and urine beta-thromboglobulin concentrations were significantly elevated in patients. In intermittent claudication patients Lp(a) correlated significantly with activation of the coagulation system, ie, with the levels of plasma fibrinogen and urine fibrinopeptide A. No correlations between the values for Lp(a) and PAI-1 or plasma alpha 2-antiplasmin were seen. The PAI-1 activity showed significant univariate correlations to the levels of HDL3b, HDL2b (inverse), and very-low-density lipoprotein triglycerides, of which the positive correlation to HDL3b persisted in multivariate analysis (r = .48, P < .001). Independent characteristics for intermittent claudication estimated by multiple regression analysis were PAI-1, plasma fibrinogen, and HDL3a, with a combined R2 of .36. The intermittent claudication subgroup that was being treated with beta-blockers/thiazides had a higher frequency of coronary heart disease compared with the other patients. In addition, the patients taking beta-blockers/thiazides had elevated triglyceride concentrations, lower HDL cholesterol with a size shift toward smaller particles, and a tendency toward raised PAI-1 and plasma alpha 2-antiplasmin levels compared with the patient group that did not take these medications.

Blood Coagulation↗
PubMed1990

Activation and decreased deformability of neutrophils after intermittent claudication.

This study investigated local alterations in neutrophil activation and deformability after intermittent claudication. In 17 patients with one-sided peripheral arterial occlusive disease, neutrophil count, proportion of activated neutrophils (by nitro blue tetrazolium test), and neutrophil filterability as a measure of passive deformability were assessed in the femoral arterial and venous blood of the diseased leg and in the femoral venous blood of the healthy leg (n = 10). The values were obtained at rest, immediately after claudication, and 10 minutes after claudication induced by repetitive toe stands. Immediately after exercise, the arterial and venous blood differences in the diseased leg were 1) neutrophil count, 9% (95% confidence interval [CI], 5-14%; relative increase in the venous blood compared with arterial blood); 2) the proportion of activated neutrophils, 26% (CI, 10-42%); and 3) the neutrophil filterability, -10% (CI, -4% to -15%). At rest and 10 minutes after exercise, neutrophil parameters did not differ significantly between the femoral arterial and venous blood. Furthermore, no arterial and venous blood differences in the neutrophil parameters were found in the healthy leg. In addition to local changes, systemic changes occurred immediately after exercise. In the femoral arterial blood, the total neutrophil count had risen by 13% (CI, 8-18%), the proportion of activated neutrophils had risen by 41% (CI, 25-58%), and average neutrophil rigidity had risen 17% (CI, 11-22%) compared with the values obtained before exercise. At 10 minutes after exercise, all neutrophil parameters were still elevated. We conclude that even short periods of ischemia, as in intermittent claudication, cause local alterations in neutrophil function and distribution.

Arteries↗
PubMed1994

Chelation therapy for intermittent claudication. A double-blind, randomized, controlled trial.

BACKGROUND: The use of repeated intravenous infusions of EDTA, which has become known as "chelation therapy," has been promoted for treating intermittent claudication as well as a wide range of other disorders. Multiple reports of excellent results in large numbers of patients have encouraged the use of this regimen. The lack of well-controlled studies substantiating the benefits of this treatment has limited its use mainly to private clinics. The aim of the study was to assess the benefits of chelation therapy in patients with intermittent claudication. METHODS AND RESULTS: A double-blind, randomized, controlled trial included 32 patients with intermittent claudication who were randomized to a treatment group (15) and a control group (17). Main outcome measures were subjective and measured walking distances and ankle/brachial pulse indices. Other outcome measures included lifestyle and subjective parameters of improvement, cardiac function, ECG, renal function, hematology, blood glucose, and lipid biochemistry. No clinically significant differences in main outcome measures between chelation therapy and placebo groups were detected up to 3 months after treatment. Measures of mood state, activities of daily living, and quality of life factors were not consistently affected by chelation therapy. An equal proportion (13%) of each group thought that they had received the active agent. The proportion of patients showing an improvement in walking distance was not significantly different between the chelation group (60%) and the control group (59%). CONCLUSIONS: Chelation therapy has no significant beneficial effects over placebo in patients with intermittent claudication.

Activities of Daily Living↗
PubMed1998

Cilostazol has beneficial effects in treatment of intermittent claudication: results from a multicenter, randomized, prospective, double-blind trial.

BACKGROUND: Cilostazol is a new phosphodiesterase inhibitor that suppresses platelet aggregation and also acts as a direct arterial vasodilator. This prospective, randomized, placebo-controlled, parallel-group clinical trial evaluated the efficacy of cilostazol for treatment of stable, moderately severe intermittent claudication. METHODS AND RESULTS: Study inclusion criteria included age > or =40 years, initial claudication distance (ICD) on treadmill (12.5% incline, 3.2 km/h) between 30 and 200 m, and confirmation of diagnosis of chronic lower-extremity arterial occlusive disease. After stabilization and single-blind placebo lead-in, 81 subjects (62 male, 19 female) from 3 centers were randomized unequally (2:1) to 12 weeks of treatment with cilostazol 100 mg PO BID or placebo. Primary outcome measures included ICD and maximum distance walked (absolute claudication distance, or ACD). Secondary outcome measures included ankle pressures, subjective assessments of benefit by patients and physicians, and safety. Treatment and control groups were similar with respect to age, severity of symptoms, ankle pressures, and smoking status. Statistical analyses used intention-to-treat analyses for each of 77 subjects who had > or =1 treadmill test after initiation of therapy. Comparisons between groups were based on logarithms of ratios of ICD and ACD changes from baseline using ANOVA test at last treatment visit. The estimated treatment effect showed a 35% increase in ICD (P<0.01) and a 41% increase in ACD (P<0.01). There was no significant change in resting or postexercise ankle/brachial indexes. Patients' and physicians' subjective assessments corroborated the measured improvements in walking performance observed in the cilostazol-treated group. CONCLUSIONS: Cilostazol improved walking distances, significantly increasing ICD and ACD. The data suggest cilostazol is safe and well tolerated for the treatment of intermittent claudication.

Adult↗
PubMed2000

Impact of a 4-week treatment with prostaglandin E1 on health-related quality of life of patients with intermittent claudication.

Intermittent claudication impairs functional status and quality of life in many patients by limiting walking capacity. The aim of this study was to evaluate the effects of a 4-week treatment with prostaglandin E1 (PGE1), a drug inducing vasodilation and inhibiting platelet aggregation, on improving functional status and health-related quality of life in patients with disabling intermittent claudication. Forty-two untrained outpatients (37 men and five women, mean age 64 +/- 8 years) with intermittent claudication,and maximum walking distance (MWD) of at least 50 and no more than 200 m on treadmill test (5% slope, 3 km/hr) were randomized to 4 weeks of double-blind treatment either with 60 mcg PGE1 daily given IV in 250 mL saline over a period of 2 hours (21 patients) or placebo (250 mL saline, 21 patients). Treatment-free follow-up was completed 8 weeks after the final infusion. Pain free walking distance (PFWD), MWD, and questionnaire evaluation were determined at baseline, after the 4-week treatment period, and at the end of the 8 weeks of the treatment-free follow-up period. After 4 weeks of treatment with PGE1 PFWD and MWD increased from 72 +/- 16 m to 135 +/- 33 m (+87%, p<0.001)and from 140 +/- 30 m to 266 +/- 62 m (+90%, p<0.001), respectively. Analysis of the Walking Impairment Questionnaire responses in the PGE1 group at 4 weeks demonstrated significant improvements in the walking impairment score (+19 percentage points, p<0.001), in the distance score (+25 percentage points, p<0.001), in the speed score (+24 percentage points, p<0.001), in the stair climbing score (+20 percentage points, p<0.001). The RAND survey responses showed improvements in physical function and bodily pain scores (+14 percentage points, p<0.001, and +15 percentage points, p<0.01, respectively). After the treatment-free follow-up period of 8 weeks, increases in PFWD and MWD were maintained (113 +/- 26 m, +57%, p<0.001, and 229 +/- 55 m, +63%, p<0.001, respectively). Similarly, at the end of the treatment-free follow-up, the walking impairment score (+16 percentage points, p<0.001), the distance score (+23 percentage points, p<0.001), the speed score (+22 percentage points, p<0.001), the stair climbing score (+18 percentage points, p<0.001) as well as the RAND physical function and bodily pain scores (+10 percentage points, p<0.001, and +13 percentage points, p<0.01, respectively) were still increased compared with baseline. No change from baseline was found in all the target parameters in the placebo group after 4 weeks of treatment and at the end of the treatment-free follow-up period. These data show that a 4-week treatment with PGE1 improves functional status and quality of life as well as treadmill performance in patients with disabling intermittent claudication as compared with placebo-treated patients. The improvements are also maintained for a period of 8 weeks beyond the end of the treatment. Additional studies are needed to determine the duration of functional benefits after the end of treatment.

Aged↗
PubMed2003

Effects of policosanol and lovastatin in patients with intermittent claudication: a double-blind comparative pilot study.

Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of policosanol and lovastatin on patients with moderately severe intermittent claudication. The study had a 4-week baseline step, followed by a 20-week double blinded, randomized treatment period. Twenty-eight patients who met study entry criteria were randomized to policosanol 10 mg or lovastatin 20 mg tablets once daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10 degrees, temperature 25 degrees C) were assessed before and after 20 weeks of treatment. Both groups were similar at randomization. Compared with baseline, policosanol increased significantly (p < 0.01) the initial claudication distance (ICD) from 160.39 +/- 15.82 m to 211.31 +/- 21.48 m (+33.7%) and the absolute claudication distance (ACD) (p < 0.001) from 236.39 +/- 25.44 m to 288.09 +/- 28.47 m (+24.3%); meanwhile both variables remained unchanged after lovastatin therapy. Changes in ICD and ACD were significantly larger in the policosanol than in the lovastatin group (p < 0.01). Policosanol, but not lovastatin, significantly increased (p < 0.05) the ankle/arm index, although between-group differences were not significant. The frequency of patients reporting improvement on quality of life domains was greater in the policosanol than in the lovastatin group. Policosanol significantly (p < 0.001) lowered total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) by 17.5% and 31.0%, respectively, and meanwhile increased (p < 0.01) high-density lipoprotein-cholesterol (HDL-C) levels by 31.5%. Lovastatin reduced (p < 0.01) TC (18.0%), LDL-C (22.6%), and (p < 0.05) triglycerides (9.8%). In addition, policosanol, but not lovastatin, moderately, but significantly, reduced (p < 0.05) fibrinogen levels, so that final values and percent changes in both groups were different (p < 0.01). Treatments were well tolerated. Only 1 lovastatin patient withdrew from the study because of a nonfatal myocardial infarction. Five lovastatin patients, but none from the policosanol group, experienced 6 adverse events (AE) (p < 0.01). The present results indicate that policosanol, but not lovastatin, is a suitable alternative to manage patients with intermittent claudication because of pleiotropic properties beyond its cholesterol-lowering effects.

Adult↗
PubMedDate not supplied

Classic intermittent claudication is an uncommon manifestation of lower extremity peripheral arterial disease in hospitalized patients with coronary artery disease.

Synchronous peripheral arterial disease (PAD) and coronary artery disease (CAD) is common. Standardized questionnaires such as the Rose/WHO questionnaire and later the Edinburgh modification of this questionnaire were developed to screen for PAD. Little data are available on the sensitivity of these questionnaires in hospitalized patients with CAD. The aim of this study was to determine the accuracy of these questionnaires and the prevalence of classic intermittent claudication in hospitalized patients with CAD. Medically stable patients with CAD were invited to participate before hospital discharge. The patients answered both the Rose/WHO and Edinburgh modification claudication questionnaires and had an ankle-brachial index (ABI) measured. An ABI less than or equal to 0.9 was considered to be indicative of significant PAD. Patients who had undergone previous lower extremity revascularization for PAD and had a corrected ABI greater than 0.9 were excluded. Ninety-five patients (66 men) were recruited. By measuring the ABI, 35 patients (25 men) were found to have significant PAD. An additional 3 patients who had an ABI corrected by lower extremity revascularization were excluded from the analysis. The Rose/WHO questionnaire had a sensitivity, specificity, and overall accuracy (95% CI) of 14.3% (2.7-25.9%), 96.7% (92.1-100%), and 66.3% (56.8-75.8%), respectively. The Edinburgh modification of the Rose/WHO questionnaire had a sensitivity, specificity, and overall accuracy (95% CI) of 28.6% (13.6-43.5%), 90.0% (82.4-97.6%), 67.4% (57.9-76.8%), respectively. Despite the high incidence of synchronous PAD in hospitalized patients with CAD, traditional claudication questionnaires are insensitive to PAD detection. Classic claudication is an uncommon manifestation of PAD in hospitalized patients with CAD.

Coronary Artery Disease↗
PubMedDate not supplied

The relationship between ankle-brachial index and leisure-time physical activity in patients with intermittent claudication.

The purpose of the study was to examine the relationship between ankle-brachial index (ABI) and leisure-time physical activity (LTPA) in patients with peripheral arterial disease limited by intermittent claudication. Patients included 342 sedentary men and women between the ages of 45 and 85 with intermittent claudication confirmed by a resting ABI of less than 0.90. Patients were categorized into either a low ABI group (ABI <0.50; n=84), a middle ABI group (ABI = 0.50 to 0.69; n=164), or a high ABI group (ABI = 0.70 to 0.89; n=94). The Minnesota LTPA questionnaire was used to estimate physical activity patterns, and a treadmill test, 6- minute walk test, and Walking Impairment Questionnaire were used to measure ambulatory function. A progressive decrease (p=0.030) in the total LTPA was observed among the high ABI (180 +/-131 kcal/day; mean +/- SD), middle ABI (138 +/-127 kcal/day), and low ABI (110 +/-89 kcal/day) groups. Progressive decrements in LTPA spent at moderate intensity (p=0.016) and high intensity (p=0.009), as well as the mean intensity of LTPA (p=0.024) were observed among the three respective ABI groups. Group differences in the LTPA measurements were no longer present (p>0.05) after adjusting for group differences in the absolute claudication distance during a treadmill test, and the 6-minute walk distance. The decline in total daily LTPA with progressively lower ABI in patients with intermittent claudication was due to their decreased participation in physical activities requiring moderate and high intensities. In addition, group differences in the LTPA measurements were explained by differences in ambulatory function.

Ankle↗
PubMed1987

Effects of pentoxifylline on severe intermittent claudication.

Pentoxifylline has been shown to improve treadmill walking distances under blinded, controlled conditions in patients with intermittent claudication. From the pooled data of a blinded, controlled, randomized, multicenter trial, the data from all enrolled patients with severe claudication (less than 70 m on treadmill at baseline) were evaluated. The treadmill data from these more severely ill patients were analyzed separately as a "severe subset" (placebo n = 17; pentoxifylline n = 21). No differences between the two treatment groups were observed in demography, history, or baseline treadmill walking distances. The initial claudication distance (ICD) improved 68% over baseline with pentoxifylline and 12% with placebo (p = .012) after twenty-four weeks of treatment. A new, derived efficacy variable was developed, "minimum distance walked," which tended to minimize psychological effects on treadmill performance. Over sixteen to twenty-four weeks of treatment, the pentoxifylline group improved 49% over baseline and the placebo group 3% (p = .019), when the "minimum distance walked" measurement was used. In this controlled trial the subset of patients with severe intermittent claudication benefited from pentoxifylline therapy.

Aged↗
PubMed1988

Intermittent claudication: predictors and outcome.

The authors reviewed 460 patients with intermittent claudication. With primarily conservative management, these patients were followed for an average of 4.1 years (one to ten years). The mean age was 71.7 years, ranging from thirty-six to eighty-four years; 55.9% were males. The subsequent follow-up study revealed that the status of 44.1% of the patients with underlying arterial insufficiency deteriorated. Eventually, they underwent vascular surgery for limb-threatening ischemia. From this study, the analysis of the parameters could predict the clinical outcome of intermittent claudication at the time of initial and follow-up evaluation. During initial evaluation, when the ankle brachial index (ABI) was higher than 0.7 or when follow-up evaluation did not show a decrease of ABI by 0.15, the chance of favorable outcome was increased by 2.4 and 1.6 times respectively. When the ABI was less than 0.5 at the initial evaluation and decreased 0.15 or more during follow-up studies, the risk of requiring vascular surgery for limb salvage increased by 3.8 and 1.9 times, respectively. The onset of major vascular events in other areas appeared to influence the time of significant deterioration in the lower limb arterial disease, indicating multifactorial and systemic contribution in the natural history of intermittent claudication. In this homogeneous patient population with arterial insufficiency referred to the vascular surgeon, conservative management with strong supervision for smoking cessation, exercise, diet control, body weight reduction, and medical regimen can modify the natural course of intermittent claudication and associated vascular problems.

Adult↗
PubMed1989

The acute effects of cigarette smoking on treadmill exercise distances in patients with stable intermittent claudication.

The hypothesis that smoking has an acute effect on treadmill exercise performance in patients with peripheral vascular disease was investigated in a crossover trial. Twelve patients with stable intermittent claudication who were regular smokers attended on two occasions within one week and treadmill tests were performed after 1/2, 1, 1 1/2, and 2 hours. Immediately before the second exercise test, two standard cigarettes were smoked or an unlit cigarette was "sham-smoked." Because participants could not be blinded, an attempt to control for patient bias was made. Half were told that we expected smoking to make no difference or possibly cause some improvement, and half were told that we expected it to make no difference or possibly cause some deterioration. These explanations and the order of study days were determined by balanced randomization. Suggestion had a significant influence on claudication distance immediately after smoking (p less than 0.01) but no significant effect on walking distance. Combining data from both groups assumes that no overall bias was introduced by the explanations given. Immediately after smoking, small, nonsignificant increases in claudication distance (+10%, 95% CI-7%, +27%) and walking distance (+9%, 95% CI-2%, +19%) were observed. Smoking caused a mean increase in heart rate of 9 beats per minute, which persisted for one hour, but no consistent change in blood pressure. The results show that suggestion may have a significant influence on treadmill exercise distances. Smoking is unlikely to have an important acute effect on exercise performance in claudicants.

Adult↗
PubMed1993

Beneficial effects of intermittent suction and pressure treatment in intermittent claudication.

The present study reports on the effects of a physical treatment modality in patients with intermittent claudication. During this treatment a major part of the skin surface is subjected to intermittent suction and pressure. In a previous, preliminary study the authors found a beneficial effect of this treatment in intermittent claudication. The study included 34 patients with moderate, stable intermittent claudication. Twenty-two patients participated in a double-blinded, randomized trial comparing the effects of 25 treatments to 25 placebo applications given over a period of two months. Twelve patients participated in an open trial investigating the possible effects of the treatment on platelet aggregation and fibrinolysis. Pain-free and maximal walking distances were measured on a treadmill, and systolic blood pressure was measured on the upper limb, the ankle, and the first toe bilaterally. The threshold for adenosine diphosphate (ADP)-induced platelet aggregation was tested, and the fibrinolytic activity was estimated from the euglobulin clot lysis time. Active treatment resulted in significant improvements in pain-free and maximal walking distances, whereas no changes could be found during placebo administration. The treatment caused significant increments in the ADP thresholds for platelet aggregation, while the effects on fibrinolysis were uncertain. It is concluded that intermittent suction and pressure treatment offers a new approach for conservative treatment of intermittent claudication.

Aged↗
PubMed1997

Reliability of transcutaneous oximeter electrode heating power during exercise in patients with intermittent claudication.

The purposes of this study were to (1) compare the reliability of transcutaneous oximeter electrode power with the reliability of oxygen tension and (2) compare the relationship of the oximetry measures with exercise performance in claudicants. One hundred ten PAOD patients with stable claudication symptoms performed a treadmill test and had the following exercise measures obtained: foot transcutaneous oxygen tension, oximeter electrode heating power, exercise duration, and peak oxygen consumption. A subset of 30 patients were tested once per week over three successive weeks to assess the reliability of the oximetry measures. The coefficient of variation of foot transcutaneous oxygen tension at peak exercise was 32.8%, whereas the variability of the oximeter electrode heating power was only 5.1%. Oximeter electrode heating power at peak exercise was related to maximal claudication pain time (r = 0.44, P < 0.001) and peak oxygen consumption (r = 0.36, P < 0.001), whereas foot transcutaneous oxygen tension was not related to either (r = 0.15, P = 0.119; r = 0.13, P = 0.189; respectively). Thus, transcutaneous oximeter electrode heating power was six to seven times less variable than transcutaneous oxygen tension, and the oximeter electrode power at peak exercise was more closely related to exercise capacity. It is concluded that the measurement of transcutaneous oximeter electrode heating power during exercise is more reliable and better correlated with exercise capacity in PAOD patients with intermittent claudication than the measurement of transcutaneous oxygen tension.

Aged↗
PubMed1997

A comparison between aspirin and pentoxifylline in relieving claudication due to peripheral vascular disease in the elderly.

Peripheral vascular disease (PVD) commonly presents with leg claudication during walking and eventually limits the walking distance and daily activities. Aspirin or pentoxifylline are commonly prescribed to improve blood flow. Aspirin works through its antiplatelet aggregation mechanism, and pentoxifylline increases the red blood cell flexibility, which leads to increased tissue perfusion. Data on comparative studies of these drugs for improving claudication in the elderly are limited. The objective of this study was to compare pain relief offered by either aspirin or pentoxifylline for walking leg pain in the elderly with PVD. Patients sixty-five years or older with claudication were randomly assigned to receive aspirin or pentoxifylline. Their reported level of walking claudication pain with use of the visual analogue scale (0-5) and the distance walked during exercises were recorded. Six weeks later the same parameters were recorded and results were compared with Student's t test, and a P value less than 0.05 was considered a statistically significant difference. Of the 90 patients who participated, 45 received aspirin (325 mg daily) and 45 were prescribed pentoxifylline (400 mg tid) for six weeks. Both the aspirin and the pentoxifylline groups reported a moderate level of pain (2/5) and remained about the same (2/5 for aspirin and 1/5 for pentoxifylline, P = 0.9, NS) after six weeks. However, the pentoxifylline group reported a farther walking distance of 2 miles compared with the aspirin group of 1.2 miles (P < 0.05). The level of pain did not change significantly with either aspirin or pentoxifylline, but the walking distance was farther with the pentoxifylline group.

Aged↗
PubMed1999

A double-blind, placebo-controlled study of the effects of policosanol in patients with intermittent claudication.

This study was undertaken to evaluate the efficacy and tolerability of policosanol, a new cholesterol-lowering drug with concomitant antiplatelet effects, in patients with intermittent claudication. After a baseline period of 6 weeks, 62 patients were randomized to receive, under double-blind conditions, either placebo (31 patients) or policosanol (31), 10 mg twice daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10 degrees) were assessed before and after 6 months of treatment. Both groups were similar at randomization. Policosanol increased significantly (p < 0.01) the initial claudication distance from 132.5+/-13.5 m (baseline) to 205.7+/-36.3 m (after therapy) and the absolute claudication distance (p<0.0001) from 229.5+/-22.0 m to 365.4+/-46.9 m; meanwhile both variables remained unchanged in the placebo group (p<0.05). The reduction of lower limb symptoms showed a greater benefit in the policosanol group. There was no significant change in either group in the ankle/arm pressure ratio. The treatment was well tolerated. There were 10 discontinuations (seven placebo, three policosanol) from the study. Six withdrawals occurred because of adverse events (AE); all were in placebo patients. There were five serious vascular AEs in the placebo group but none in the policosanol group (p<0.05). Overall, 12/31 (38.7%) placebo patients and 3/31 (9.7%) policosanol patients experienced AEs after randomization, which showed a lesser incidence of AEs in the policosanol group (p<0.01). The present study demonstrates a beneficial effect of policosanol in patients with intermittent claudication.

Adult↗
PubMed2001

Proteinuria in a placebo-controlled study of basic fibroblast growth factor for intermittent claudication.

Intermittent claudication is the most common symptom of peripheral arterial disease (PAD), in part due to an inadequate rise in limb blood flow with exercise. Claudication causes a severe impairment in functional capacity and quality of life in over 3 million Americans. Basic fibroblast growth factor (bFGF) stimulates angiogenesis in vivo and improves limb blood flow in several animal models of hindlimb ischemia. However, the relative safety and efficacy of angiogenic molecules in the treatment of claudication has not been fully evaluated in prospective, blinded clinical trials. In this study, a randomized, double-blind, placebo-controlled, phase II trial of recombinant human bFGF for the treatment of intermittent claudication was performed. bFGF was administered weekly by intravenous infusions of 2 microg/kg for 6 sequential weeks (total dose 12 microg/kg). The primary efficacy endpoint was change in peak walking time (PWT) on a graded exercise treadmill protocol. Secondary efficacy endpoints included changes in functional status as measured by validated questionnaires. The study was stopped prematurely after treatment of the first 24 subjects due to proteinuria in five of the 16 subjects who received systemic bFGF, which exceeded 1000 mg/24 h in four of these five subjects. The small sample size limited evaluation of the predefined efficacy endpoints; however, there was no significant difference between the treatment and control groups for any of the measures of efficacy. In conclusion, intravenous administration of bFGF delivered at low doses weekly for 6 weeks was associated with a high rate of severe proteinuria. It is speculated that bFGF-related proteinuria in this study was primarily related to the systemic route of administration and the frequent dosing schedule. Future clinical trials of bFGF protein should carefully monitor renal function and consider alternative dosing schedules and drug administration routes.

Aged↗