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PubMed1989

Acenocoumarol and pentoxifylline in intermittent claudication. A controlled clinical study. The APIC Study Group.

The efficacy and safety of pentoxifylline (400 mg tid orally) and acenocoumarol, administered singly or in combination, in the treatment of intermittent claudication associated with chronic occlusive arterial disease were evaluated in a multi-center, randomized, factorial, blind clinical trial involving 146 patients. The response to treatment was assessed by measuring pain-free walking time on the treadmill and by Doppler ankle/arm systolic pressure ratio at rest and after treadmill. Both pentoxifylline and acenocoumarol were significantly more effective than placebo in increasing the proportion of patients who improved their performance on the treadmill after one year of treatment. Benefit from active treatment was also apparent from the results of Doppler examinations performed after physical exercise. No significant differences were observed in comparing the effect of one active drug versus the other or versus the combined treatment. Five major hemorrhagic complications were registered in anticoagulated patients, two fatal cerebral hemorrhages and one gastrointestinal bleeding occurring in the group treated with both active drugs. The investigators conclude that (1) pentoxifylline is effective and safe in the treatment of patients with intermittent claudication (2) the benefits of oral anticoagulant therapy are outweighed by the risk of serious bleeding, and (3) the risk of bleeding is probably increased by the combined treatment with pentoxifylline.

Acenocoumarol↗
PubMed1997

Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: results of a multicenter placebo-controlled double-blind trial.

For the first time efficacy and safety of a new prostaglandin E1 (PGE1) regimen in the treatment of intermittent claudication were evaluated in a randomized, double-blind, placebo-controlled multicenter clinical trial. The study involved 213 outpatients with a maximum walking distance of 50 to 200 m measured on the treadmill (3 km/hr, 12% grade). After a 2-week run-in phase they received a 2-hour intravenous infusion of 60 micrograms PGE1 or placebo 5 days a week for 4 weeks. It was followed by a 4-week interval treatment with the same medication administered only twice a week. Patients were monitored for 3 months when they received no study medication. In the PGE1 group the intention-to-treat analysis (n = 208) revealed an increase in walking distance after 4 weeks of 75% (placebo, 43%). At the end of the interval treatment the walking distance had improved to 101% (placebo, 60%). The results remained virtually constant during follow-up (PGE1, 104%, placebo, 63%). Between-group comparisons showed significant differences in favor of PGE1 for all three time points of measurement (p < 0.05, p < 0.01, and p < 0.05). PGE1 was well tolerated; the rate of adverse reactions related to the treatment was 12.8% (placebo, 7.7%). In summary, these results show that the new PGE1 regimen is effective and safe in the treatment of outpatients with intermittent claudication.

Aged↗
PubMed2001

Differential effects of cilostazol and pentoxifylline on vascular endothelial growth factor in patients with intermittent claudication.

Cilostazol is a new phosphodiesterase inhibitor with anti-platelet and vasodilatory properties. Cilostazol and pentoxifylline are the only two drugs that have been approved for the treatment of patients with intermittent claudication. However, the mechanisms by which exercise tolerance is improved remain unclear. Vascular endothelial growth factor (VEGF) is a potent endothelial mitogen that results in angiogenesis when overexpressed in human subjects. To assess the potential role of VEGF in the improvement in exercise tolerance, we investigated plasma levels of VEGF in 50 patients with intermittent claudication who were allocated randomly to groups receiving cilostazol (n=17), pentoxifylline (n=17) or placebo (n=16). Patients given either cilostazol or pentoxifylline showed a significant improvements in maximal walking distance compared with the placebo group (34 m and 33 m respectively, compared with 5 m; both P<0.05). Neither cilostazol nor pentoxifylline increased the ankle-brachial index after treatment. Circulating VEGF levels were increased (from 116+/-29 to 169+/-45 pg/ml; P=0.002), and the levels of VEGF were correlated significantly with exercise tolerance in a positive direction (r=0.88, P=0.004), in those patients treated with cilostazol that did not have diabetes mellitus. In contrast, VEGF levels remained stable after the administration of pentoxifylline. These findings suggest that VEGF may contribute to the cilostazol-related improvement in exercise tolerance in non-diabetic patients. However, pentoxifylline did not affect VEGF levels, although a similar improvement in maximal walking distance was achieved. Thus the mechanisms involved in the pentoxifylline-treated group were different from those in the cilostazol-treated group, and require further study.

Aged↗
PubMed2004

Economic evaluation of a short-course intensive rehabilitation program in patients with intermittent claudication.

AIM: The aim of this study was to provide cost-description and cost-effectiveness of a short-course intensive in-hospital rehabilitation program in patients with intermittent claudication. METHODS: Costs per case treated were calculated according to a local standard protocol including diagnostic evaluation of peripheral arterial disease and other related cardiovascular conditions, physical training, and secondary prevention. Three additional less structured scenarios were also evaluated. RESULTS: All 107 enrolled patients (males 91%, mean age 65+/-8 years) completed the program (4-week duration; twice a day walking exercise) and showed significant increases in walking performance, as evaluated by constant treadmill-test. At admission, the mean values of initial claudication distance (ICD) and absolute claudication distance (ACD) were 150+/-111 and 432+/-327 m, respectively. At the end of the program, 12 (11%) patients completed the treadmill test without pain, while 31 (29%) completed the test without stopping due to maximal pain. Among the remaining 64 (60%) patients, the ICD and ACD increased by 137% and 112%, respectively. The cost per case treated ranged from Euro 1733.2 (standard protocol) to Euro 918.9 (physical training only). By adding the cost of hospitalization and indirect costs, the same costs ranged from Euro 4626.2 to Euro 3811.9. The average cost to walk one additional meter without pain as a result of the rehabilitation program was Euro 57.5, while the cost to walk one additional meter before stopping was Euro 27. As showed by sensitivity analysis, the maintenance of the expected level of treatment success was crucial for program's cost-effectiveness. CONCLUSION: From the societal viewpoint, short-course intensive rehabilitation may be cost-effective in patients with stable intermittent claudication and could be considered in decision models evaluating different therapeutic options.

Aged↗
PubMed1979

Fibrositic myofascial pain in intermittent claudication. Effect of anesthetic block of trigger points on exercise tolerance.

The blocking of trigger points in the calf by the local injection of an anesthetic agent was performed in 15 patients with intermittent claudication. Reactive and exercise hyperemia, work load and duration of exercise were recorded before and after infiltration of the trigger points. Reactive hyperemia does not change, but the exercise tolerance of the leg significantly improves after local blocking of the trigger areas and the exercise hyperemia increases because of the higher work load. The pain pattern of intermittent claudication can be activated by the summation of abnormal input from muscles, due to contraction in the presence of anoxia, with activity from trigger points. Local infiltration of trigger areas blocks theirir activity. The vicious cycle of pain is interrupted and the exercise tolerance of the leg is increased, without improving blood circulation.

Adult↗
PubMed1981

Reproducibility of treadmill exercise in patients with intermittent claudication.

The reproducibility of pain limited exercise time (ET) and heart rate (HR) have been evaluated in repeated treadmill exercise tests in 24 patients with arterial occlusive disease of the lower limbs and intermittent claudication. The protocol includes a walking speed of 1 m/s and load increments of 10 watt/min and the two tests were separated by 1--14 days. The total ET was systematically increased by about 30 sec (P less than 0.05) at the second exercise test. The reproducibility of ET at the onset of leg pains was 34%, whereas the corresponding value at maximal leg pain was 16%. HR at the termination of the test did not differ systematically between the two tests and the reproducibility of HR was 6.1% and 5.5% at the onset of pain and maximal pain, respectively. It is concluded that a slight improvement in walking capacity at a second exercise test must be taken into account when evaluating different types of therapy in patients with intermittent claudication and, furthermore, that ET, walking distance or work load, should preferably be evaluated at or near maximal leg pain.

Adult↗
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↗
PubMed2005

Intermittent claudication: functional capacity and quality of life after exercise training or percutaneous transluminal angioplasty--systematic review.

PURPOSE: To systematically review published data about the short- and long-term effects of exercise training and angioplasty on functional capacity and quality of life of patients with intermittent claudication. MATERIALS AND METHODS: Articles published between January 1980 and February 2003 were included if patients had intermittent claudication treated with exercise training or angioplasty and if both functional capacity and quality-of-life scores from Medical Outcomes Study 36-Item Short Form health survey were reported for at least 3 months of follow-up. Data were pooled by using a random effects model and weighted means. Pooled results were compared between the treatment groups by using the chi2 test and the Student t test (alpha = .05, two sided). RESULTS: In the analyses, five studies (202 patients) were included in the exercise group, and three studies (470 patients), in the angioplasty group. At 3 months of follow-up, the ankle-brachial index was significantly improved in the angioplasty group (mean change, 0.18; P < .01) but not in the exercise group (mean change, 0.01; P = .29). At 3 months, quality of life was significantly improved with regard to ratings of physical functioning and bodily pain in the exercise group (mean change, 18 and 10, respectively; P < .01) and physical role functioning in the angioplasty group (mean change, 30; P = .03). Mean change in ankle-brachial index significantly differed between the two treatment groups at 3 and 6 months (P < .01); mean change in quality-of-life scores did not. CONCLUSION: Improvement in quality of life was demonstrated after both exercise training and angioplasty, whereas functional capacity showed significant improvement after angioplasty. The ankle-brachial index significantly differed between the two treatment groups at 3 and 6 months, whereas the quality-of-life scores did not.

Angioplasty, Balloon↗
PubMed2006

Plantar flexion as an alternative to treadmill exercise for evaluating patients with intermittent claudication.

OBJECTIVE: The aim of this study was to examine whether the plantar flexion test could adequately replace treadmill testing in patients who were unable to exercise. DESIGN: Prospective observational study. PATIENTS: Twenty-seven patients with intermittent claudication secondary to peripheral arterial disease (PAD). METHODS: Patients performed two treadmill tests and two plantar flexion tests. Ankle pressure, near infrared spectroscopy (NIRS) data, heart rate and blood pressures were monitored along with pain-free and maximum walking distances for treadmill, pain-free and maximum exercise time for plantar flexion. RESULTS: Maximum exercise time and walking distance were well correlated (R=0.74). Eleven patients (41%) developed non-claudicating symptoms during the treadmill test but not during the flexion test. Rate pressure product was significantly higher after the treadmill but not after the plantar flexion. CONCLUSIONS: Plantar flexion test showed good reliability and correlation. Plantar flexion may serve as an alternative to treadmill testing in evaluating muscle pain in patients with intermittent claudication.

Aged↗
PubMed1985

[Evaluation of the effectiveness of medical treatment of intermittent claudication].

The effectiveness of drugs to improve the walking distance in intermittent claudication patients is looked into five points: pathophysiology, drugs, methodology of clinical trials, sample survey among the members of the hemodynamic section of the French College of Vascular Diseases and biometric aspects. Finally, some important points of a clinical trial in this field are presented.

Biometry↗
PubMed2006

Fibrinolytic risk factor clustering and insulin resistance in healthy male relatives of men with intermittent claudication.

BACKGROUND: Raised fibrinolytic factors predict cardiovascular risk in healthy subjects. The aim of this study was to measure fibrinolytic factors and insulin resistance in healthy male first-degree relatives of men with intermittent claudication younger than 65 years. METHODS: The study compared 165 healthy first-degree relatives with 165 age-, sex- and race-matched control subjects free from a personal or family history of premature cardiovascular disease. Primary outcome measures were plasminogen activator inhibitor 1 (PAI-1), tissue plasminogen activator (tPA) and D-dimer levels. Insulin resistance was estimated by Homeostasis Model Assessment. Clinical and biochemical risk factors were measured and subjects genotyped for the PAI-1 4G/5G polymorphism. RESULTS: First-degree relatives had significantly higher mean PAI-1 (10.23 versus 7.85 ng/ml; P = 0.024), tPA (9.98 versus 8.29 ng/ml; P < 0.001) and D-dimer levels (56.6 versus 46.1 ng/ml; P = 0.004). They also had significantly higher insulin resistance (1.85 versus 1.53; P < 0.001) and clustered multiple atherogenic risk factors. On multivariate analysis the association between both tPA and D-dimer levels and relative status was independent of other variables. CONCLUSION: Raised levels of PAI-1, tPA, D-dimer and estimated insulin resistance were present in the healthy male first-degree relatives of men with intermittent claudication. These data support the hypothesis of fibrinolytic risk factor clustering in this high-risk population.

Cardiovascular Diseases↗
PubMed2004

Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication.

BACKGROUND: The purpose was to compare the changes in claudication pain, ambulatory function, daily physical activity, peripheral circulation, and health-related quality of life following a program of exercise rehabilitation in smoking and nonsmoking patients with peripheral arterial disease (PAD) limited by intermittent claudication. Methods and results Thirty-nine smokers (63 +/- 4 pack-year smoking history; mean +/- SE) and 46 nonsmokers (former smokers who had a 51 +/- 7 pack-year smoking history who quit 14 +/- 2 years prior to investigation) completed the study. The 6-month exercise rehabilitation program consisted of intermittent treadmill walking to near maximal claudication pain 3 days per week, with progressive increases in walking duration and intensity during the program. Measurements were obtained on each patient before and after rehabilitation. Following exercise rehabilitation the smokers and nonsmokers had similar improvements in these measures, as initial claudication distance increased by 119% in the smokers (P <.001) and by 97% in the nonsmokers (P <.001), and absolute claudication distance increased by 82% (P <.001) and 59% (P <.001) in the smokers and nonsmokers, respectively. Furthermore, exercise rehabilitation improved (P <.05) ambulatory function, daily physical activity, peripheral circulation, and health-related quality of life in the smokers and nonsmokers. CONCLUSION: Exercise rehabilitation is an effective therapy to improve functional independence in both smoking and nonsmoking patients with PAD limited by intermittent claudication. Therefore, smokers with intermittent claudication are prime candidates for exercise rehabilitation because their relatively low baseline physical function does not impair their ability to regain lost functional independence to levels similar to nonsmoking patients with PAD.

Aged↗
PubMed1989

Longterm neuroendocrine and metabolic effects of physical training in intermittent claudication.

Twenty-five elderly patients with peripheral vascular disease and intermittent claudication were prospectively followed during a six-month session of physical training. Neuroendocrine and metabolic patterns as well as effects on walking performance were assessed during the training period. At the initial evaluation there was an inverse association between walking distance and serum cortisol and blood glucose levels. The walking distance increased during the training period. A positive effect on glucose homeostatis was seen with decreased basal fructosamine levels after training. During physical exercise a decrease in insulin and an increase in growth hormone was seen. Changes in growth hormone were, in contrast to insulin, more related to the pain level perceived than to the work load imposed. Apart from the marked effects on physical performance the results of the study suggest an improvement of hormonal and metabolic balance after physical training. This regularly applied exercise program improved the health status of rather old people.

Aged↗
PubMed1992

[Indication and results of surgical treatment of intermittent claudication].

In order to clarify the propriety of surgical treatment for intermittent claudication caused by arteriosclerosis obliterans (ASO), indication for vascular reconstruction and efficacy of surgery on patient's quality of life were investigated. Bypass surgery or laser angioplasty (PTLA) was undertaken in 149 of 188 ASO patients. Because of high risk factors (renal failure, ischemic heart disease, cerebro-vascular disturbance or malignant tumor), 39 patients were treated conservatively. Intellectual dysfunction in aged patient was evaluated by Okabe's brief mental scale test. Coronary artery disease was revealed by coronary angiography performed next to routine dipyridamole-loaded ECG in 19 to 78 patients. CABG or PTCA was performed prior to peripheral vascular reconstruction in 3 patients with serious coronary disease. Extra-anatomical bypass or PTLA was indicated mainly in patients with coronary artery disease or intellectual dysfunction. The anatomical bypass and the extra-anatomical bypass were undertaken in 88 and 61 patients respectively. Graft occlusion was observed in 8 cases. Patency rate of the anatomical bypass was 96.6% and that of the extra-anatomical bypass was 91.8%, at 32 months of postoperative mean follow-up period. The operative mortality rate was 2.7%. There was no major amputation due to graft occlusion.

Aged↗
PubMed1992

EDTA treatment of intermittent claudication--a double-blind, placebo-controlled study.

A double-blind, randomized multicentre study was undertaken to evaluate the possible effect of chelation treatment with ethylenediamine-tetraacetic acid (EDTA) in patients with severe intermittent claudication. A total of 153 patients received 20 intravenous infusions of either 3 g Na2EDTA or placebo during a period of 5-9 weeks. Vitamin, mineral and trace element supplements were administered orally. The changes observed in the pain-free and maximal walking distances, measured on a treadmill, were similar in the two groups. During the 3-month (n = 149) and 6-month (n = 123) follow-up period, no long-term therapeutic effect of EDTA could be demonstrated. The ankle-brachial blood pressure index remained unchanged throughout the study period. This study failed to demonstrate any effect of EDTA chelation treatment in intermittent claudication.

Aged↗
PubMed1990

Effects of pentoxifylline administration on blood viscosity and leukocyte cytoskeletal function in patients with intermittent claudication.

We have previously shown that pentoxifylline, a drug used in intermittent claudication, causes depolymerization of actin in leukocytes in vitro. In this study we evaluated several parameters in peripheral blood obtained from 17 patients receiving pentoxifylline, before therapy and at 1 and 2 months after initiation of drug therapy. Total blood viscosity decreased at 1 month and was further reduced at 2 months. The plasma viscosity remained unchanged during the course of the therapy (1.770 +/- 0.147, 1.776 +/- 0.162, and 1.772 +/- 0.164 centipoise at 0, 1, and 2 months, respectively; mean +/- SD, n = 14 to 17). No changes were observed in stimulus-induced actin polymerization in granulocytes, concanavalin A-induced capping in granulocytes and lymphocytes, and anti-IgG-induced caps in lymphocytes, before and after therapy. Similarly, there was no difference in the magnitude of depolymerization caused by pentoxifylline when added in vitro. Thus none of the parameters altered by pentoxifylline treatment in vitro have been observed ex vivo in patients receiving this drug. However, the decrease in total blood viscosity along with unaltered plasma viscosity suggests that the rheology of the cellular elements is being affected by the administered drug. In addition to the direct effects on the cell membrane and the cytoskeleton, pentoxifylline may exert indirect effects through its inhibitory action on cytokine production. Subtle changes in a number of parameters in leukocytes, which taken alone fail to show demonstrable changes, might ultimately be responsible for the therapeutic benefit noted with pentoxifylline.

Actins↗
PubMed1999

Relationship between free-living daily physical activity and peripheral circulation in patients with intermittent claudication.

The purpose of this study was to determine the relationship between free-living daily physical activity and peripheral circulation under resting, reactive hyperemia, and maximal exercise conditions in peripheral arterial occlusive disease (PAOD) patients with intermittent claudication. Sixty-one PAOD patients (age = 70 +/- 6 years, ankle/brachial index [ABI] = 0.57 +/- 0.24) were recruited from the Vascular Clinic at the Baltimore Veterans Affairs Medical Center and from radio and newspaper advertisements. Free-living daily physical activity was measured as the energy expenditure of physical activity (EEPA), determined from doubly labeled water and indirect calorimetry. Patients also were characterized on ankle/brachial index, calf blood flow, calf transcutaneous oxygen tension (TcPO2), and calf transcutaneous heating power (TcHP). ABI and calf blood flow served as markers of the macrocirculation of the lower extremity, while TcPO2 and TcHP served as markers of the microcirculation. The claudication patients were sedentary, reflected by a mean EEPA value of 486 +/- 274 kcal/day. EEPA was related to calf TcHP at rest (282 +/- 24 mW; r = -0.413, p = 0.002), after postocclusion reactive hyperemia (275 +/- 22 mW; r = -0.381, p = 0.004), and after maximal exercise (276 +/- 20 mW; r = -0.461, p<0.001). ABI, calf blood flow, and calf TcPO2 were not related to EEPA under any condition. In conclusion, higher levels of free-living daily physical activity were associated with better microcirculation of the calf musculature in older PAOD patients with intermittent claudication.

Activities of Daily Living↗