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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↗
PubMed1996

Clinical evaluation of satigrel in intermittent claudicators.

OBJECTIVE: Satigrel is a new antiplatelet agent which was previously shown to inhibit platelet aggregation and have an anti-thrombotic effect in various animal thrombosis models. The present study assessed the effect of oral satigrel on cutaneous circulation in patients with intermittent claudication due to arteriosclerosis obliterans. EXPERIMENTAL DESIGN: Prospective clinical trial with more than 4 weeks follow-up. SETTING: Outpatient department of a university hospital. PATIENTS: Ten patients with intermittent calf claudication were studied (14 limbs with obstruction, 6 limbs without obstruction, and chest wall). INTERVENTIONS: After giving informed consent and one week wash-out of effected agents, a 2 mg oral dose of satigrel twice daily was administered for more than 4 weeks. MEASURES: Transcutaneous partial pressure of oxygen (PtcO2), skin temperature, ankle pressure, and the treadmill test were determined just before therapy, after 2 and 4 weeks of satigrel therapy, and at treatment termination. The paired student's t-test was used for statistical analysis. RESULTS: The PtcO2 in the foot of the ischemic leg showed a significant increase at the end of therapy compared with before therapy (p < 0.05). Skin temperature showed a significant difference in both the ischemic and healthy legs. The walking distance was also significantly extended at therapy termination. CONCLUSIONS: Satigrel improved the cutaneous circulation and symptoms of patients with intermittent claudication.

Adult↗
PubMed1998

A placebo-controlled study of the effects of intravenous Buflomedil on foot skin microcirculation in patients with severe intermittent claudication.

Buflomedil hydrochloride (Buflomedil), a vasoactive drug, has been proven to improve pain-free walking distance in patients with peripheral arterial occlusive disease stage II of the lower extremities. In the present double-blind, randomized study, resting skin flux motion activity and skin flux response to a local heat stress at the hallux were assessed by laser Doppler fluxmetry (LDF) in claudicants. Twenty of 39 enrolled patients with severe intermittent claudication received a daily intravenous dose of 400 mg Buflomedil, and the other 19 patients received 0.9% NaCl as placebo over a 5-day period. Before treatment mean LDF skin resting flux, flux frequency, and flux amplitude were 2 +/- 0.8 Arbitrary Units (AU), 8.4 +/- 0.5 cycles per minute (c/min), and 0.12 +/- 0.01 AU, respectively in the Buflomedil group, and 2.3 +/- 0.3 AU, 8.7 +/- 0.7 c/min, and 0.13 +/- 0.02 AU in the placebo group (NS). Also the response to heat stress was identical in both groups: a slow initial increase of skin flux, followed by a reflex reduction, with a maximal initial flux increase to 138 +/- 12% of the resting value in the Buflomedil group, and 155 +/- 16% in the placebo group (NS). After 5 days of treatment the mean LDF skin resting flux, flux frequency, and flux amplitude were unchanged in both patient groups. The response to heating on the contrary was dramatically enhanced in the Buflomedil group (226 +/- 33%), against that in the placebo group, which remained unchanged (144 +/- 13%) after 3 minutes (P < 0.05), while after reflex reduction the flux in the Buflomedil group remained stable at 200% of resting value during further heating and was only approximately 140% in the placebo group (P < 0.05). It is concluded that Buflomedil, administered in a daily intravenous dose of 400 mg, does not alter the mean LDF skin flux and flux motion at the hallux in claudicants in resting conditions. Local skin heating on the contrary provokes a significant LDF-monitored skin flux increase, suggesting an improved capacity of cutaneous microvessel perfusion in stressed conditions.

Aged↗
PubMed1991

beta blockade and intermittent claudication: placebo controlled trial of atenolol and nifedipine and their combination.

OBJECTIVE: To determine the effects of the beta 1 selective adrenoceptor blocker atenolol, the dihydropyridine calcium antagonist nifedipine, and the combination of atenolol plus nifedipine on objective and subjective measures of walking performance and foot temperature in patients with intermittent claudication. DESIGN: Randomised controlled double blind four way crossover trial. SETTING: Royal Hallamshire Hospital, Sheffield. SUBJECTS: 49 patients (40 men) aged 39-70 with chronic stable intermittent claudication. INTERVENTIONS: Atenolol 50 mg twice daily; slow release nifedipine 20 mg twice daily; atenolol 50 mg plus slow release nifedipine 20 mg twice daily; placebo. Each treatment was given for four weeks with no washout interval between treatments. MAIN OUTCOME MEASURES: Claudication and walking distances on treadmill; skin temperature of feet as measured by thermistor and probe; blood pressure before and after exercise; subjective assessments of walking difficulty and foot coldness with visual analogue scales. RESULTS: Atenolol did not significantly alter claudication distance (mean change -6%; 95% confidence interval 1% to -13%), walking distance (-2%; 4% to -8%), or foot temperature. Nifedipine did not alter claudication distance (-4%; 3% to -11%), walking distance (-4%; 3% to -10%), or foot temperature. Atenolol plus nifedipine did not alter claudication distance but significantly reduced walking distance (-9%; -3% to -15% (p less than 0.003)) and skin temperature of the more affected foot (-1.1 degrees C; 0 to -2.2 degrees C (p = 0.05)). These effects on walking distance and foot temperature seemed unrelated to blood pressure changes. CONCLUSIONS: There was no evidence of adverse or beneficial effects of atenolol or nifedipine, when given singly, on peripheral vascular disease. The combined treatment, however, affected walking ability and foot temperature adversely. This may have been due to beta blockade plus reduced vascular resistance, which might also explain the reported adverse effects of pindolol and labetalol on claudication.

Adult↗
PubMed2000

Oral Beraprost sodium, a prostaglandin I(2) analogue, for intermittent claudication: a double-blind, randomized, multicenter controlled trial. Beraprost et Claudication Intermittente (BERCI) Research Group.

BACKGROUND: Beraprost sodium (BPS) is a new stable, orally active prostaglandin I(2) analogue with antiplatelet and vasodilating properties. We report the results of a phase III clinical trial of BPS in patients with intermittent claudication. METHODS AND RESULTS: Patients (n=549) with a pain-free walking distance of between 50 and 300 m were entered into a 4-week single-blind placebo run-in phase. Patients whose pain-free walking distance had changed by <25% were then randomized to receive either BPS (40 microg TID, n=209) or placebo (n=213) in a double-blind manner for 6 months. Pain-free and maximum walking distances were measured on the occasion of treadmill exercise tests performed at baseline and 1.5, 3, 4.5, and 6 months after randomization. Success was defined as an improvement of >50% in pain-free walking distance at month 6 and in > or =1 earlier treadmill exercise test in the absence of critical cardiovascular events. Success was observed more frequently in the BPS group (43.5%) than in the placebo group (33.3%, P=0.036). Pain-free walking distances increased by 81.5% and 52.5%, respectively, in the BPS and placebo groups (P=0.001) and maximum walking distances by 60.1% and 35.0%, respectively (P=0.004). The incidence of critical cardiovascular events was 4.8% in the BPS group and 8.9% in the placebo group. CONCLUSIONS: These results show that BPS is an effective symptomatic treatment of patients with intermittent claudication. The beneficial effects of BPS on critical cardiovascular events should be confirmed in appropriate clinical trials.

Administration, Oral↗
PubMed1980

Intermittent claudication: is a supervised exercise class worth while?

Twenty-one patients (19 men and two women) with disabling exercise-related leg pain attended a physiotherapy department on one afternoon each week for an exercise training programme lasting one month. The clinical diagnosis of intermittent claudication and localisation of the atherosclerotic occlusions were confirmed in all but one case by pulse volume recordings and segmental Doppler systolic pressure measurements. Two patients whose symptoms worsened underwent arterial reconstruction. Post-training assessment at six months showed that the remaining 18 patients walked 80% further and performed 75% more step-ups. They also felt much healthier, having unduly restricted their activities before because they had feared the onset of ischaemic leg pain. These results suggest that supervised exercise training is a simple and effective method of treating patients with intermittent claudication.

Blood Pressure↗
PubMed1994

Thermal biofeedback in the treatment of intermittent claudication in diabetes: a case study.

The objective of the present case study was to examine the therapeutic effects of thermal biofeedback-assisted autogenic training on a patient with non-insulin-dependent diabetes mellitus (NIDDM), vascular disease, and symptoms of intermittent claudication. The patient received thermal biofeedback from the hand for five sessions, then from the foot for 16 sessions, while hand and foot skin temperature were monitored simultaneously. In addition, the patient was instructed in autogenic training and practiced daily at home. Follow-up measurements were taken at 12 and 48 months. Within-session foot temperature rose specifically in response to foot temperature biofeedback and starting foot temperature rose between sessions. Posttreatment blood pressure was reduced to a normal level. Attacks of intermittent claudication were reduced to zero after 12 sessions and walking distance increased by about a mile per day over the course of treatment. It would appear that thermal biofeedback and autogenic training are potentially promising therapies for persons with diabetes and peripheral vascular disease.

Biofeedback, Psychology↗
PubMed2002

Effect of cilostazol on treadmill walking, community-based walking ability, and health-related quality of life in patients with intermittent claudication due to peripheral arterial disease: meta-analysis of six randomized controlled trials.

OBJECTIVES: To assess whether cilostazol, a phosphodiesterase III inhibitor, improves treadmill and community-based walking ability and health-related quality of life (HQL) in patients with intermittent claudication resulting from peripheral arterial disease (PAD). DESIGN: Retrospective meta-analysis of data pooled from six Phase 3, multicenter, double-blind, placebo-controlled, parallel-group, randomized studies. SETTING: Patients were recruited from outpatient ambulatory medical care facilities. PARTICIPANTS: Patients' (n = 1,751) mean age +/- standard deviation was 65 +/- 9, and they had a history of PAD for 6 months or longer and an ankle brachial index (ABI) of 0.90 or less. INTERVENTION: Cilostazol 50 mg bid or 100 mg bid for 12, 16, or 24 weeks. MEASUREMENTS: ABI; maximal walking distance (MWD); pain-free walking distance on a graded and constant-load treadmill; and HQL, measured using the Walking Impairment Questionnaire (WIQ) and the Medical Outcomes Study Short Form-36 (SF-36). RESULTS: Maximal treadmill walking distance improved more in both cilostazol groups than in the placebo group (both P <.0001). WIQ and SF-36 physical summary scores improved significantly more with cilostazol than with placebo (for instance, WIQ distance score, P <.0001 and SF-36 physical summary score, P <.0001, comparing persons taking cilostazol with controls). Improved MWD correlated with improvements in WIQ (correlation with distance score, r = 0.34, P <.0001) and SF-36 physical summary scores (r = 0.29, P <.0001). CONCLUSIONS: Treatment with cilostazol was associated with greater improvements in community-based walking ability and HQL in patients with intermittent claudication than treatment with placebo. These improvements correlated with increased MWD. This analysis of effects of cilostazol on improving walking ability in persons with claudication is the first cilostazol study focused on community-based measures of functional status and HQL. Questionnaires assessing walking ability and HQL provide important patient-based information about clinical outcomes of claudication therapy.

Aged↗
PubMed2003

Quality of life and objective disease criteria in patients with intermittent claudication in general practice.

BACKGROUND: The quality of life (QoL) of patients with chronic diseases is an important decision criterion for medical treatment, especially in primary care settings. It is known that subjective sickness feelings often cannot be correlated with objective disease criteria. OBJECTIVE: The aim of the study was to determine the QoL of patients with intermittent claudication with the arterial morphology, haemodynamic parameters and functional disability of peripheral arterial occlusive disease (PAOD). METHODS: In 150 patients with stable intermittent claudication, the health-related QoL was compared with the angiogram score, the resting Doppler pressure values, and the initial claudication distance (ICD) and absolute claudication distance (ACD) with treadmill exercise. RESULTS: The QoL did not correlate significantly with either the angiogram score or the ankle systolic blood pressure and ankle brachial index. ICD and ACD correlated significantly with the QoL activity subscales of pain, complaints and functional status (P < 0.001). In a multiple regression analysis, ACD and body mass index were the most predictive variables for the QoL. CONCLUSION: The QoL of PAOD patients is independent of the peripheral Doppler pressure and the angiographic severity of the disease. The most important criterion for the QoL is the patient's functional disability.

Affect↗
PubMed1987

Angina pectoris, intermittent claudication and congestive heart failure in middle-aged male hypertensives. Development and predictive factors during long-term antihypertensive care. The Primary Preventive Trial, Göteborg, Sweden.

A group of middle-aged male hypertensives, derived from a random sample of a Swedish urban population, has been treated and followed for 10 years. The development of angina pectoris, intermittent claudication and congestive heart failure have been analysed. The initial prevalence and the average yearly incidence of angina pectoris was 3.9% and 1.3% p.a., of intermittent claudication 1.7% and 0.6% p.a. and of heart failure 1.0% and 0.8% p.a. ECG signs indicating subclinical heart disease (major Q wave, ST depression, T wave inversion) were risk factors for development of angina pectoris and congestive heart failure. Heart enlargement on chest X-ray was also a risk factor for development of congestive heart failure, as were a high serum creatinine, body mass index, serum uric acid and proteinuria. Smoking was found to be a strong and independent risk factor for any one of these cardiovascular disorders. After 10 years about one fourth of all patients, still attending the clinic, had at least one cardiovascular complication. Hence, the risk of developing cardiovascular disorders is substantial and seems to be potentiated by the same risk factors known to operate in the general population.

Actuarial Analysis↗
PubMed1988

Systemic effects associated with intermittent claudication. A model to study biochemical aspects of vascular disease?

Patients with intermittent claudication were used as a clinical model to study the effects of transient episodes of ischaemia. Compared with age and sex matched controls significantly greater increases in serum lipid peroxides and urinary microalbumin occurred after exercise. These results suggest that even relatively minor ischaemic episodes, as occur with claudication, are sufficient to cause tissue damage which may be mediated by oxygen derived free radicals. There are also changes in renal permselectivity suggestive of a generalised increase in vascular permeability. These preliminary findings may have important diagnostic, aetiological and therapeutic implications for patients with vascular disease.

Aged↗
PubMed1973

Prognostic significance of rheological and biochemical findings in patients with intermittent claudication.

To assess the prognostic significance of clinical and laboratory findings in intermittent claudication a group of 62 untreated patients was followed up in detail for periods of from one to three years. There was a significant correlation between progressive deterioration of the peripheral circulatory disturbance and the initial blood viscosity, the plasma fibrinogen level, and the susceptibility of red cell lipids to autoxidation.

Adult↗
PubMed1989

Effects of exercise training on common femoral artery blood flow in patients with intermittent claudication.

Exercise training is a commonly used rehabilitative therapy for patients with intermittent claudication (IC). However, it is not known whether blood flow through the major conduit vessel of the leg, the common femoral artery (CFA), increases with exercise training. We tested the hypothesis that peak CFA blood flow will increase with a supervised, lengthy, and individualized exercise training program. Subjects were 10 IC patients (eight men, two women) with a mean age of 61 +/- 7 (mean +/- SD) years who had either aortoiliac (n = 7) or femoropopliteal (n = 3) stenosis. Using noninvasive Doppler flowmetry, we measured CFA blood flow and ankle pressure at rest and after a maximum symptom-limited graded treadmill test before (T1) and after 3 (T2) and 5 (T3) months of exercise training. Variables were measured in the supine and upright postures at rest and during recovery. Total walking distance and claudication distance on the treadmill were determined for T1, T2, and T3. After training, CFA blood flow and ankle pressure were not significantly higher at rest or at 1 minute after exercise compared with pretraining despite significant increases in claudication and total walking distances. The rate of CFA blood flow recovery was slower at T3, suggesting the accrual of a larger metabolic debt during exercise due to more work performed. We conclude that changes in CFA blood flow are not responsible for measured changes in performance with exercise training in IC patients.

Blood Flow Velocity↗
PubMed1979

[The influence of chronic pentroxifylline medication on ergometric and hemodynamic parameters in intermittent claudication (author's transl)].

In an open clinical trial 14 patients with intermittent claudication caused by an obliteration of the femoral artery received 400 mg pentoxifylline 3 times daily over a period of 6 months. The walking distance, time to peak flow and calf ergometry showed a significant increase. Minor improvement of working hyperemia and peak flow could be found. The systolic pressure gradient over the obstruction didn't change. No patient complained about side effects.

Arterial Occlusive Diseases↗
PubMedDate not supplied

[Intermittent claudication. Its direct treatment using intra-arterial injections].

The treatment of intermittent claudication in our polyclinic is fivefold: general treatment of atherosclerosis including: suppression of nicotine intoxication, animal fats free diet replaced by vegetal diet (fish permitted) supply of vitamins B and C. Local treatment: increase of the vascularisation by: leg muscles exercises; frequently repeated intra-arterial injections, in the femoral artery, of 1 p. cent lidocaine which tend to decrease the vascular tone permanently by systematic destruction of the intramural sympathetic nodes (according to Henri Reboul).

Aged↗
PubMed1983

Peripheral vasodilators versus pentoxifylline for the treatment of intermittent claudication.

It should be recalled that the seven-center study conducted in the United States was initiated at a time when American physicians had recognized that past attempts to prove efficacy of peripheral vasodilators in treadmill testing had failed. The positive results derived from pentoxifylline treatment are significant because, for the first time, treadmill testing can prove the effectiveness of a hemorheologic drug, such as pentoxifylline, in the treatment of patients with intermittent claudication. Since treadmill testing is regarded as the most objective measurement of therapeutic success in claudicant patients, the positive results can assure us that hemorheologic drugs increasing erythrocyte flexibility are highly desired in treating peripheral vascular insufficiency, such as intermittent claudication.

Absorption↗