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PubMed1987

Influence of pentoxifylline on muscle tissue oxygen tension (pO2) of patients with intermittent claudication before and after pedal ergometer exercise.

Ten patients with Stage II chronic arterial occlusive disease (intermittent claudication) took part in a randomized, intraindividual crossover study involving acute intravenous administration of 200 mg pentoxifylline or physiological saline solution (placebo). The tissue oxygen tension (pO2) response (pO2 kinetics) following treatment with placebo revealed a nominal but statistically nonsignificant increase in arithmetic mean and median pO2 immediately after the end of exercise. Values thereafter reverted approximately to the initial values recorded at rest. Comparison of the pooled pO2 histograms during the individual periods before and after the end of exercise, however, revealed a broadening of the histogram base, reflecting both higher pO2 values and, more particularly, increased numbers of hypoxic and anoxic pO2 values. This is interpreted as an expression of nonhomogeneous capillary perfusion (maldistribution). Following administration of pentoxifylline to the same patients, there was a statistically significant increase in mean and median pO2 at ten and twenty minutes after the end of exercise. Even after thirty and sixty minutes, these values were in some cases still clearly higher than the initial preexercise values. Study of the pooled pO2 histograms discloses a right shift compared with the initial preexercise histograms. This suggests that pentoxifylline exerts a positive effect on maldistribution by making capillary perfusion more homogeneous. The results support the conclusion that, in the context of reactive hyperemia after muscular exercise, tissue oxygen supply is markedly improved by pentoxifylline in comparison with saline solution. The measurement of tissue pO2 before and at intervals after pedal ergometer exercise is a new objective technique for assessing the efficacy of blood flow-promoting therapy, permitting close simulation of the pathophysiological situation in the muscles of the lower leg in intermittent claudication.

Arterial Occlusive Diseases↗
PubMed1988

Multicenter double-blind study of ticlopidine in the treatment of intermittent claudication and the prevention of its complications.

In this multicenter trial 169 patients with chronic intermittent claudication due to obstructive peripheral vascular disease were randomized in a double-blind fashion into two parallel groups receiving either 250 mg ticlopidine or placebo, twice daily. At entry, the two groups (83 ticlopidine, 86 placebo) were well matched for the major clinical features apart from an excess of women in the ticlopidine group. At six months, 167 patients were alive, 2 having died of malignant disease (1 from each group). At this stage, 39 patients from the ticlopidine group and 29 from the placebo group (p = 0.04) had increased their walking distance by more than 50% of baseline values. For the groups as a whole pain-free and total walking distance were greater in the ticlopidine group than in the placebo group (194 vs 124 meters, p = 0.03 and 236 vs 170 meters, p = 0.04, respectively). Two patients from the ticlopidine group vs 9 patients from the placebo group (p = 0.03) developed significant cardiovascular events during the study. These results indicate that ticlopidine has a beneficial effect both in the treatment of the symptoms and the prevention of vascular complications in patients with intermittent claudication.

Clinical Trials as Topic↗
PubMed1989

Efficacy and safety of pentoxifylline in geriatric patients with intermittent claudication.

The effects of pentoxifylline on intermittent claudication were evaluated at a dose of 1200 mg/day in an open-label twelve-week study on geriatric patients with chronic occlusive arterial disease (COAD). Standardized treadmill testing and clinical signs and symptoms of COAD were followed up before and during drug administration. Twenty-four subjects with a mean age of 73.5 years, capable of walking between 20 and 200 meters on the treadmill, were entered into the trial; 22 participated for eight weeks and 19 completed the study in terms of treadmill walking distance measurements at 12 weeks. The mean walking distance for all patients was increased 111% over baseline at week 12. Thirteen subjects were considered drug responders (greater than or equal to 50% increase in treadmill walking distance) and 9 were considered nonresponders (less than 50% increase). Improvements in clinical signs and symptoms of COAD were noted. Decreases in elevated systemic systolic pressures (but not diastolic) were unexpectedly observed in many drug responders. Seven of 19 males reported sexual function improvements while receiving pentoxifylline. Fourteen (58%) of the 24 subjects reported mild side effects of dyspepsia, nausea, vomiting, dizziness, headache, or insomnia; no subjects were withdrawn from the study because of side effects. In summary, pentoxifylline improved function and symptoms in 13 of 22 geriatric patients with intermittent claudication; the drug was safe and well tolerated at the usual dosage in this geriatric patient population.

Aged↗
PubMed1989

Clinical efficacy of picotamide in long-term treatment of intermittent claudication.

The clinical efficacy of picotamide was investigated in a randomized, double-blind, placebo-controlled study in patients with peripheral occlusive arterial disease of the lower limbs at functional stage II of the Fontaine classification. Forty patients with a history of claudication for at least six months were admitted to the study and were given either 3 x 300 mg tablets of picotamide (20 subjects) or three identical placebo tablets (20 subjects) for six months. The two groups of patients were similar in regard to clinical features and potential risk factors. At the end of treatment painfree walking distance and systolic ankle-arm pressure ratio improved more in the picotamide than in the placebo group (p = 0.05). Systolic ankle pressure curves, determined before and after the six-month treatment, showed a positive trend to a higher postexercise ankle pressure and a faster return to the preexercise levels in the picotamide group; however, the difference was not statistically significant. Laboratory monitoring revealed a slight prolongation of bleeding time, a significant decrease in arachidonic acid-induced platelet aggregation, and an enhanced fibrinolysis with absence of interference with hemostasis in the picotamide group. One patient in the placebo group developed a major cardiovascular event (angina pectoris) during the study. These results indicate that picotamide is an effective drug that may modify the natural course of intermittent claudication and associated vascular problems.

Adult↗
PubMed1992

Does pentoxifylline prolong the walking distance in exercised claudicants? A placebo-controlled double-blind trial.

The aim of this study was to test whether in claudicants oral pentoxifylline, given for twelve weeks in addition to physical exercise, prolongs the walking distance more than placebo plus exercise. Forty outpatients were randomized into group A (2 x 600 mg oral pentoxifylline per day) or group B (placebo). Both groups received the same exercise program in addition. The maximal and painfree walking distances and blood viscosity were measured. Intergroup differences in terms of blood viscosity reached the level of significance only after twelve weeks (p = 0.006 at shear rate of 94.5 s-1), but values of group A continuously decreased and those of group B continuously increased. After one and eight weeks, but not after twelve weeks, the maximal walking distances were significantly longer in group A than in group B. At no point were there significant intergroup differences in terms of painfree walking distance. The data suggest that pentoxifylline is clinically effective in claudicants even when given in addition to exercise. The benefit of drug plus physical therapy compared with exercise alone could be observed mainly in the first weeks of treatment and may wear off during long-term therapy.

Administration, Oral↗
PubMed1993

A botanical compound, Padma 28, increases walking distance in stable intermittent claudication.

Thirty-six patients with a median age of sixty-seven years and a median duration of intermittent claudication of five years were randomized to either active treatment with Padma 28 or placebo. The effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures and by measurements of the pain-free and the maximal walking distance on a treadmill. The ankle pressure index (ankle systolic pressure/arm systolic pressure) was calculated. The group randomized to active treatment received two tablets bid containing 340 mg of a dried herbal mixture composed according to an ancient lamaistic preparation (Padma 28). After active treatments, administered over a period of four months in a double-blinded, randomized design, the patients allocated to this group attained a significant increase in the pain-free walking distance from 52 m (20-106) to 86 m (24-164; P < 0.05) and in the maximal walking distance from 115 m (72-218) to 227 m (73- > 1,000; P < 0.05). The patient-group receiving placebo treatments did not show any significant changes in either the painfree or the maximal walking distance. The authors could not demonstrate any significant changes in the ankle pressure index either during active or during placebo treatment. In conclusion, this study has shown that treatment with Padma 28 over a period of four months significantly increased the walking distance in patients with stable, intermittent claudication of long duration.

Aged↗
PubMed1994

Clinical and hemodynamic effects of stepwise lowering of hemoglobin concentration in patients with intermittent claudication.

This study evaluates the effect of stepwise lowering of the hemoglobin (Hb) concentration on maximal walking distance (MWD) and hemodynamics in patients with intermittent claudication. The results in a study group (n = 6) were compared with those of a control group (n = 6) whose members were not subjected to venesections. An average decrease of Hb concentration from 151 +/- 4 to 121 +/- 3 g/L did not significantly influence MWD, the result being 282 +/- 62 meters before venesections and 255 +/- 54 meters after three to five (mean four) repeated venesections. Transcutaneous oxygen pressure was measured at the dorsum of the foot before and after exercise and did not change with a gradual decrease of the Hb concentration. Maximal heart rate, painfree walking distance, ankle pressure, and blood lactate concentration were also unchanged. An average venesection volume of about 1.4 liters whole blood within fourteen days, without isovolemic replacement, did not change the blood volume, which was 5.1 +/- 0.4 liters before and 5.0 +/- 0.5 liters after venesections. In conclusion, hemodilution accomplished by venesections did not have a clinically or physiologically beneficial effect in patients with severe intermittent claudication. However, hemodynamics and clinical symptoms were not affected by a considerable decrease in the arterial oxygen content within the normal Hb concentration range.

Aged↗
PubMed1994

Pentoxifylline for intermittent claudication. A critical review.

Pentoxifylline was first introduced in Germany twenty years ago. Today it is the best researched oral drug for intermittent claudication. A total of seventeen placebo-controlled trials could be retrieved from the world literature. The majority of these studies show that pentoxifylline will prolong the walking distance in a statistically significant way. Even though these trials are conducted with considerable scientific rigor, important flaws can be identified. Whether the symptomatic improvement is clinically relevant is difficult to say and may depend on the patient's individual situation. These collective data show that pentoxifylline prolongs the walking distance in patients with intermittent claudication.

Blood Viscosity↗
PubMed1996

Evaluation of the coagulation and fibrinolytic systems in men with intermittent claudication.

The authors evaluated elements of the coagulation and fibrinolytic systems in 18 male patients with intermittent claudication vs 19 men matched for risk factors who served as controls. Prothrombin time and activated partial thromboplastin time did not significantly differ in the patients and the controls. The plasminogen level in the two groups was not significantly different. The level of lipoprotein(a) was significantly higher in the patients than in the controls. The levels of antigen and the activity of protein C did not differ significantly between the two groups. The thrombomodulin level was significantly higher in the patients than in the controls. There were no significant differences between the two groups in the levels of alpha 2-macroglobulin, C1-inactivator, or antithrombin III. The levels of fibrinogen and alpha 1-antitrypsin were significantly higher in the patients vs the controls. Significantly lower levels of alpha 2-plasmin inhibitor and higher levels of alpha 2-plasmin inhibitor/plasmin complex and thrombin/antithrombin III complex were found in the patients vs the controls. These findings suggest that the levels of thrombin/antithrombin III complex, alpha 2-plasmin inhibitor/plasmin complex, and thrombomodulin may perhaps serve as indicators for injury to the peripheral endothelium and that the coagulation and fibrinolytic systems may be activated in patients with intermittent claudication.

Aged↗
PubMed1997

The effect of cigarette smoking on free-living daily physical activity in older claudication patients.

The purposes of this study were (1) to determine whether peripheral arterial occlusive disease (PAOD) patients who smoke have a lower free-living daily physical activity than nonsmoking patients and (2) to determine whether the difference in physical activity persisted after controlling for potential confounders such as PAOD severity, age, body composition, and peripheral circulation. Thirty-four smokers (45.5 +/-9.8 years of smoking) and 43 nonsmokers (former smokers who had a smoking history of 35.0 +/- 13.1 years who quit 12.2 +/- 10.5 years prior to investigation) were studied. Patients wore a Caltrac accelerometer and a pedometer on each hip over two consecutive weekdays to assess free-living daily physical activity. Patients were also characterized on age, weight, body mass index (BMI), percent body fat, ankle/brachial index (ABI), calf blood flow, and exercise capacity. The smoking and nonsmoking claudication patients had a similar level of PAOD severity, for no group differences were noted in ABI (P=0.287) and treadmill time to maximal claudication pain (P=0.201). However, the smokers were 35% less physically active than the nonsmokers (264 +/- 123 vs 407 +/- 272 kcal/day; P<0.006), and they took 23% fewer steps (4,116 +/- 2,199 vs 5,329 +/- 2,924 steps/day; P<0.034). After adjustment for group differences in age, weight, BMI, percent body fat, and calf blood flow, the lower activity level of the smokers persisted. The adjusted daily energy expenditure was 27% lower (292 +/- 105 vs 400 +/- 214 kcal/day; P=0.021), and the adjusted amount of daily walking was 29% lower (4,039 +/- 1,760 vs 5,684 +/- 2,235 steps/day; P=0.003). Smoking PAOD patients had a less physically active lifestyle than nonsmoking patients, and the lower activity level of the smokers was independent of PAOD severity, age, body composition, and peripheral circulation.

Activities of Daily Living↗
PubMed1999

Randomized reliability study evaluating constant-load and graded-exercise treadmill test for intermittent claudication.

The aim of this randomized study was to compare the reliability of the treadmill test at constant-load (C-test, 3 km/hr; fixed grade of 12%) recommended in Germany with that of the graded-exercise test (G-test, 3 km/hr; increase in grade of 3.5% every 3 minutes) propagated in the United States. In 50 patients with an absolute claudication distance (ACD) in the C-test of between 50 and 400 m, the two treadmill tests were carried out in randomized order on one and the same day, and repeated on 3 days within 1 week. For the initial claudication distance (ICD), the intraclass correlation was 0.88 in the C-test and 0.87 in the G-test. For the ACD the coefficients were identical at 0.91. The within-subject variation (CVwithin) in the C-test and G-test was 25% and 27% for the ICD and for the ACD 24% and 21%, respectively. The between-subject variation was very similar with 72% and 73% (ICD) and with 78% and 68% (ACD). However, in ACDs below 100 m and between 100 to 150 m, the C-test showed significantly smaller coefficients of variation than the G-test: 13% vs 81% and 14% vs 50%, respectively. In conclusion, the results showed that both C-test and G-test are equally well reproducible.

Analysis of Variance↗
PubMed1997

Impact of angioplasty and arterial reconstructive surgery on the quality of life of claudicants. The Scottish Vascular Audit Group.

Claudicants usually die from concomitant conditions. Therefore, surgical interventions are aimed at improving quality of life, rather than survival. This study compared the impact of percutaneous transluminal angioplasty (PTA), arterial reconstruction and conservative management on quality of life. SF36 questionnaires were completed by 201 newly referred claudicants prior to treatment and six months later. Multiple regression was used to compare the quality of life scores following the three treatments after adjustment for baseline scores, age, sex, site of disease and disease severity. Follow-up data were available on 81% of the 195 patients alive. Nineteen (10%) of these had undergone PTA and 19 (10%) reconstruction. All aspects of quality of life deteriorated following conservative treatment. PTA and arterial reconstruction produced significant improvements in both pain and physical functioning after adjustment for case-mix. Although unlikely to improve survival, PTA and arterial reconstruction are associated with significant improvements in quality of life.

Adult↗
PubMedDate not supplied

Comparison of preference-based utilities of the Short-Form 36 Health Survey and Health Utilities Index before and after treatment of patients with intermittent claudication.

The authors compared SF-36 utilities with Health Utilities Index (HUI) utilities (HUI2 and HUI3) assessed in patients with intermittent claudication. A total of 87 patients with intermittent claudication completed the SF-36 and HUI before and 1, 3, and 12 months after revascularization. Utilities were estimated using SF-36 and HUI published algorithms (i.e., both algorithms were based on standard-gamble utilities assessed in random samples of the general population). The utilities were compared using repeated-measures multivariate analysis of variance, paired t tests, and univariate linear regression analyses. Before treatment, the mean SF-36 and HUI3 utilities were the same (0.66 vs. 0.66, P = 0.92) and less than the mean HUI2 utility (0.70, P = 0.02). After treatment, all utilities showed improvement from before treatment (P < 0.05); the gain in utilities from treatment was lowest when using the SF-36 (e.g., 0.74, 0.80, 0.77 at 3 months for the SF-36, HUI2, and HUI3, respectively). The correlations of changes over time of the SF-36 with HUI2 utilities and of the SF-36 with HUI3 utilities were 0.39 and 0.49, respectively. The relationships between the SF-36 and HUI2 or HUI3 utilities were moderate to good (i.e., range-adjusted R2 = 31% to 72%). The results suggest that SF-36 data can be transformed to preference-based utilities and be used for economic evaluation in health care. The gain in utilities from treatment, however, was less for SF-36 utilities than for HUI utilities.

Algorithms↗
PubMedDate not supplied

Fitting multistate transition models with autoregressive logistic regression: supervised exercise in intermittent claudication.

The purpose of this study was to develop a model that predicts the outcome of supervised exercise for intermittent claudication. The authors present an example of the use of autoregressive logistic regression for modeling observed longitudinal data. Data were collected from 329 participants in a six-month exercise program. The levels of the polytomous outcome variable correspond to states they defined in a Markov decision model comparing treatment strategies for intermittent claudication. Autoregressive logistic regression can be used to fit multistate transition models to observed longitudinal data with standard statistical software. The technique allows exploration of alternative assumptions about the dependence in the outcome series and provides transition probabilities for different covariate patterns. Of the alternatives examined, a Markov model including two preceding responses, time, age, ankle brachial index, and duration of disease best described the data.

Decision Support Techniques↗
PubMed2001

Effects of cilostazol on resting ankle pressures and exercise-induced ischemia in patients with intermittent claudication.

During exercise, patients with intermittent claudication (IC) have decreased limb arterial blood pressure that recovers during rest. A novel method for assessing dynamic recovery of function is measurement of the hemodynamic response after exercise. Cilostazol (Pletal), a new agent for the treatment of IC, increases walking distance and may decrease ischemic burden. The objective of this study was to assess the effect of cilostazol versus placebo on hemodynamic measurements after exercise-induced ischemia in patients with IC. Two double-blind, placebo-controlled studies with similar inclusion/exclusion criteria and duration (24 weeks) were pooled. Patients walked on a treadmill at 2.0 miles/h (3.2 km/h) on a 12.5% grade until the claudication-limited maximal walking distance (MWD) was reached. Anterior and posterior tibial pressures were measured with Doppler ultrasound at baseline and at 1, 5, and 9 min during recovery. Area under the curve (AUC), a measure of the time course of recovery of systolic pressure after exercise-induced ischemia, and ankle-brachial index (ABI) were calculated and compared using analysis of variance (ANOVA). All three treatment groups (308 patients randomized to cilostazol 100 mg bid, 303 to cilostazol 50 mg bid, and 299 to placebo) had similar baseline characteristics. Mean post-exercise AUC for cilostazol 100 mg and 50 mg bid versus placebo increased by 0.31 (p = 0.001) and 0.26 (p = 0.004), respectively. Mean resting ABI increased by 0.03 (p = 0.0039) and 0.04 (p = 0.0001) in the cilostazol 100 mg and 50 mg bid groups, respectively. In conclusion, following 24 weeks of treatment, cilostazol increased the ABI at rest and improved the recovery time of ankle pressures post-exercise.

Aged↗
PubMed1996

Claudication as an 'orphan disease': rationale and goals of drug therapy for peripheral arterial disease.

Patients with peripheral arterial disease are often perceived to suffer from a disorder whose pathogenesis and symptoms are not amenable to drug therapies. This clinical misperception remains prevalent despite an abundance of data suggesting that diverse pharmacotherapies may modulate the natural history of this disease. Patients with chronic limb arterial occlusive disease suffer from a disease that is characterized by: (1) a prolonged asymptomatic state that can be identified by simple physical examination and confirmed by measurement of the ankle brachial index; (2) a multi-year period of symptomatic claudication; and (3) a variable rate of progression to critical limb ischemia or acute arterial occlusion. This stage-dependent disease progression is mediated via the dynamic, but as yet incompletely understood, interaction of factors that elicit endothelial dysfunction, atherogenesis, and thrombosis. Current data suggest that each of these contributory disease processes can be modulated by extant pharmacotherapies. Additionally, many novel pharmacotherapeutic agents that are currently under investigation may further improve the ability of clinicians to modulate these fundamental biologic processes. Pharmacologic therapies should be targeted to decrease the rate of limb arterial disease progression, to improve limiting symptoms, and to prolong life. Symptoms of claudication can be objectively assessed via both exercise testing and disease-specific questionnaires. The presence of lower extremity atherosclerotic disease is predictive of the presence of coronary heart disease and a foreshortened five-year survival. Current data suggest that clinical investigations should be able to effectively stratify this relative risk via use of both clinical variables (e.g., age, diabetes mellitus, tobacco use, etc.) or by measurement of the ankle brachial index (ABI). The role of the physician is to decrease suffering and to prolong life. Judicious administration of medical therapies can play a critical role in helping the vascular practitioner accomplish these goals.

Arteries↗
PubMedDate not supplied

Giant cell (temporal) arteritis diagnosed following upper limb claudication.

Giant cell arteritis or temporal arteritis occurs almost exclusively in people over 50 years of age. It classically presents with new onset temporal headache, scalp tenderness and jaw claudication. Proximal muscle pain and stiffness is often present because of frequent association with polymyalgia rheumatica. In most cases, the erythrocyte sedimentation rate is markedly elevated. Uncommon presentations include systemic symptoms and symptoms related to large artery involvement. We report a case of giant cell arteritis without symptoms related to the temporal artery, diagnosed angiographically following upper limb claudication and confirmed by temporal artery biopsy.

Aged↗
PubMed2005

The association between smoking and the prevalence of intermittent claudication.

The objective of this study was to investigate the association between smoking and the prevalence of intermittent claudication (IC). Between 1995 and 1997, all residents aged 20 years or older in Nord-Trøndelag County, Norway, were invited to take part in the Nord-Trøndelag Health Study (Helseundersøkelsen i Nord-Trøndelag: HUNT 2). A total of 19748 participants aged 40-69 years attended. Responses to 12 questions on IC (including a Norwegian translation of the Edinburgh Claudication Questionnaire) had been previously tested against the ankle-brachial pressure index (ABPI < 0.9), and an algorithm of the best test properties was used to identify people with IC. Using logistic regression analysis we computed age-adjusted prevalence odds ratios (OR) for the association between smoking and IC. Both current (ORmen = 3.8, confidence interval (CI) 2.1-6.7, ORwomen = 2.2, CI 1.4-3.4) and former smokers (ORmen = 1.7, CI 0.9-3.2, ORwomen = 1.7, CI 1.1-2.7) had a higher prevalence of IC compared with those who had never smoked, and individuals who had stopped smoking more than 20 years previously had a substantially lower prevalence of IC (ORmen = 0.2, CI 0.1-0.5, ORwomen = 0.4, CI 0.2-0.8) than current smokers. We found no association between passive smoking and IC in either men or women. Current and previous smoking habits were positively associated with the prevalence of IC, and smoking cessation was negatively associated in men and women. Passive smoking was not associated with IC in this study.

Adult↗