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At least 19 recordsLinked to original sources

Randomized placebo-controlled, double-blind trial of ketanserin in claudicants. Changes in claudication distance and ankle systolic pressure. PACK Claudication Substudy.

The effect of ketanserin on intermittent claudication (measured by treadmill walking distance and ankle systolic pressure) was assessed in 594 patients, a subset of the 3,899 patients who composed a double-blind study of the effect of ketanserin on cardiovascular events. Complete data sets at the beginning and end of 1 year's treatment with ketanserin or placebo were available in 436 patients. There was no difference between the groups in the improvement in pain-free treadmill walking distance. The placebo effect on treadmill walking distance increased continuously for at least 1 year at the rate of about 15% every 6 months. There was no significant change in either group in the ankle systolic pressure at the end of the treatment period but in the group given ketanserin, brachial systolic pressure was decreased and the ankle to arm systolic pressure ratio therefore increased. There was only a very weak association between treadmill walking distance and ankle to arm systolic pressure ratio both at the beginning and in terms of change over 1 year. Therefore, this pressure ratio is probably not a useful way of assessing the effects of medical treatment of claudication.

Blood Pressure↗

Effect of cloricromene on intermittent claudication. A randomized, double-blind, placebo-controlled trial in patients treated with aspirin: effect on claudication distance and quality of life. CRAMPS Investigator Group. Cloricromene Randomized Arteriopathy Multicenter Prospective Study.

The main aim of medical treatment for intermittent claudication (IC) is the reduction of mortality and morbidity from ischemic cardiovascular disease. However, symptomatic treatment with the aim of improving exercise performance and the overall quality of life may also be an important target of the clinical management of patients with intermittent claudication. Cloricromene, a drug with antithrombotic and anti-ischemic activities, has previously shown some promising results in patients with claudication. We have carried out a clinical trial to assess the effect of cloricromene on the claudication distance and on the quality of life of patients with IC chronically treated with aspirin. A total of 159 patients with IC, Stage II (Fontaine), were enrolled in a double-blind, randomized, prospective, multicenter study comparing cloricromene (100 mg orally b.i.d.) or an identical placebo for 6 months. All patients received 160 mg/day aspirin. The primary end-point was the improvement of initial claudication distance (ICD) at 6 months as measured by a standardized treadmill test. The secondary end-points were the absolute claudication distance (ACD) at 6 months, the percentage of patients defined as responders to treatment (improvement of ICD of at least 40%), changes in the ischemic window (IW), quality of life as assessed by the SF-36 questionnaire, and the occurrence of major cardiovascular events. The ICD increased in both treatment groups, with a non-significant difference at 6 months in favor of cloricromene of +12.3 m. The ACD, percentage of responders to treatment and ischemic window also improved in both groups with a slight, non-significant trend in favor of cloricromene. Pretreatment quality of life scores showed only a slight worsening compared with an age-matched, healthy population and did not change upon treatment. A post hoc subgroup analysis showed a significant benefit from cloricromene in patients with an ICD at enrollment higher than the median of the patient population. In conclusion, treatment with cloricromene for 6 months does not significantly improve claudication in patients with Stage II Fontaine peripheral arteriopathy chronically treated with aspirin. An improvement of 40-60 m in the ICD on a standardized treadmill test does not translate into a self-perceived improvement in the quality of life as assessed by the SF-36 questionnaire.

Adult↗

A randomized, double-blind, placebo-controlled, crossover study to assess the immediate effect of sublingual glyceryl trinitrate on the ankle brachial pressure index, claudication, and maximum walking distance of patients with intermittent claudication.

PURPOSE: The goal of the present study was to assess the immediate effect of sublingual glyceryl trinitrate (GTN) in patients with intermittent claudication. METHODS: We conducted a randomized, double-blind, placebo-controlled crossover study. Inclusion criteria consisted of history of intermittent claudication, resting ankle brachial pressure index (ABPI) of 1.00 or less, a 20% or greater fall in ABPI after exercise, and maximum walking distance (MWD) of less than 250 m. Patients already receiving nitrates were excluded. In study 1, patients (n = 25) underwent a standard exercise test after randomization to receive either 800 microg of sublingual GTN or placebo. The postexercise ABPI was recorded. Then, the crossover portion of the study was performed. In study 2, patients (n = 22) had their claudication distance and MWD measured. They then were randomized to receive either GTN or placebo spray, and the exercise test was repeated, with the claudication distance and MWD recorded, followed by the crossover portion of the study. Statistical analysis was performed with the Wilcoxon matched pairs signed ranks test and the Mann-Whitney U test. RESULTS: In study 1, the median postexercise ABPIs for placebo and GTN were 0.29 and 0.36 (P =.0001). In study 2, the median claudication distance for both placebo and GTN groups was 70 m (P =.59). The median MWD for the placebo and GTN groups was 105 and 125 m (P =.0084) CONCLUSION: GTN can decrease the fall in ABPI after exercise and increase the MWD.

Administration, Sublingual↗

Natural history of claudication: long-term serial follow-up study of 1244 claudicants.

OBJECTIVE: The purpose of this study was to delineate the natural history of claudication and determine risk factors for ischemic rest pain (IRP) and ischemic ulceration (IU) among patients with claudication. METHODS: We prospectively collected data on 1244 men with claudication during a 15-year period, including demographics, clinical risk factors, and ankle-brachial index (ABI). We followed these patients serially with ABIs, self-reported walking distance (WalkDist), and monitoring for IRP and IU. We used Kaplan-Meier and proportional hazards modeling to find independent predictors of IRP and IU. RESULTS: Mean follow-up was 45 months; statistically valid follow-up could be carried out for as long as 12 years. ABI declined an average of 0.014 per year. WalkDist declined at an average rate of 9.2 yards per year. The cumulative 10-year risks of development of IU and IRP were 23% and 30%, respectively. In multivariate analysis using several clinical risk factors, we found that only DM (relative risk [RR], 1.8) and ABI (RR, 2.2 for 0.1 decrease in ABI) predicted the development of IRP. Similarly, only DM (RR, 3.0) and ABI (RR, 1.9 for 0.1 decrease in ABI) were significant predictors of IU. CONCLUSION: This large serial study of claudication is, to our knowledge, the longest of its kind. We documented an average rate of ABI decline of 0.014 per year and a decline in WalkDist of 9.2 yards per year. Two clinical factors, ABI and DM, were found to be associated with the development of IRP and IU. Our findings may be useful in predicting the clinical course of claudication.

Diabetes Complications↗

[Neurogenic claudication and claudication by arteritis of the lower limbs].

Intermittent claudication of neurogenic origin can be traced to three basic causes: --either a chronic circulatory deficiency in the arteries leading to the spinal cord, whether these arteries be the site of an atheroma of the ostia, an inflammation or a loco-regional compression. In such cases, the claudication is painless which differentiates it from the arteritis claudication of the lower limbs. --or to a compression of the roots of the cauda equina and to a lesser degree of the spinal cord, through a narrow rachidian canal that is hereditary or acquired, and relative or absolute. --or finally to a sheathing peripheral neuropathy of the lower limbs. The two latter causes are accompanied by pain, and make it necessary to widen the classical notion of the intermittent claudication (Dejerine's non painful intermittent claudication of the spinal cord).

Aged↗

Drug therapy in intermittent claudication: an objective assessment of the effects of three drugs on patients with intermittent claudication.

It has been suggested that, by reducing the viscosity of blood, flow through capillaries is increased with consequent improvement in the symptoms of patients with peripheral vascular disease. We examined the effects of treatment with drugs purported to reduce blood viscosity to test the validity of this claim. Measurements of viscosity and the rate of blood flow to the leg were made in a group of patients before and after treatment with three different drugs--tetranicotinoylfructose (Bradilan), oxypentifylline (Trental) and cinnarizine (Stugeron). All patients had intermittent claudication in one leg and the distribution of arteriosclerosis was similar in each patient. After treatment there was little or no change in blood viscosity and no change in the rate of flow recorded in the symptomatic legs. We did not find any objective evidence to support the use of these drugs in patients with intermittent claudication.

Aged↗

Spinal claudication versus arterial claudication.

Ninety-three consecutive treadmill exercise stress test were performed for the assessment of peripheral vascular function. Thirty-one were for atypical claudication-like symptoms including pain on standing, relief on sitting and back pain. Pedal pulses were palpable in 24 patients. Twenty-five patients (81%) had a negative stress test, suggesting a non-vascular aetiology and this finding was subsequently confirmed in 24 of the 25. The final diagnoses were spinal stenosis 13, [CT = 3, myelogram = 5, neurosurgeon opinion = 4, MRI = 1], myositis 2, restless leg syndrome 2 and osteoarthritis 7. Four patients had symptoms due to a combination of peripheral occlusive arterial disease and spinal stenosis; the latter was considered the predominant disorder in all four. Of the original 31 patients with atypical symptoms, spinal stenosis was present in 13 (42%). Atypia- in the common syndrome of intermittent claudication should alert the surgeon to the possibility of spinal canal disorders. Further investigation may identify significant pathology spinal stenosis in particular.

Adult↗

Effect of lower extremity blood pressure on physical functioning in patients who have intermittent claudication. The Chicago Claudication Outcomes Research Group.

PURPOSE: Claudication patients' perceptions of walking impairment often influence recommendations for peripheral bypass and angioplasty. The actual relationship between lower extremity blood flow and physical functioning, however, has rarely been explicitly studied. METHODS: Patients were enrolled at a visit to one of 16 vascular surgery offices and clinics that participated in a prospective outcomes study. A total of 555 patients (445 men and 110 women) with an abnormal ankle-brachial index (ABI), none of whom had had previous leg revascularization or symptoms of rest pain, skin ulcers, or gangrene, completed the SF36 Health Survey and the Peripheral Arterial Disease Walking Impairment Questionnaire (WIQ). Stepwise multiple regression analysis was used to test the statistical significance and strength of association between patients' ABI level and SF36 physical functioning (PF) and WIQ community walking distance scores, controlled for sociodemographic characteristics and the presence and severity of comorbid conditions. RESULTS: Univariate correlations with ABI were modest but significant (PF score, r = 0.12, p = 0.004; WIQ distance score, r = 0.18, p < 0.001). ABI was a very significant predictor of both PF (b = 18.8; p = 0.001) and WIQ scores (b = 0.33; p < 0.0001) in the multiple regression analysis. Other positive predictors of PF scores were high-school graduation and male sex. Negative predictors of PF scores were heart, lung, and cerebrovascular disease; knee arthritis and chronic back pain; and enrollment at a Veterans Administration clinic rather than a private community or academic office. CONCLUSION: Cross-sectional findings indicate that a 0.3 improvement in ABI is associated with an average improvement of 5.6% in PF or 10.3% in WIQ distance score. However, proper selection of individual candidates for interventional therapy, that is, those patients who have lower ABIs, lower initial functioning, and fewer disabling comorbidities would be predicted to produce a much greater functional benefit. Surgeons should make a rigorous functional evaluation when recommending interventional management of claudication.

Aged↗

Neurogenic claudication and root claudication treated with calcitonin. A double-blind trial.

Forty-two patients with either neurogenic claudication or unilateral root claudication were analyzed in a double-blind comparison of salmon calcitonin (SCT) and placebo, receiving either 100 IU SCT or 1 ml saline four times a week for 8 weeks. Five of 20 SCT and one of 22 placebo patients were classified as responders. There was no statistically significant difference between the treatment groups in the proportion of responders. Seven of eighteen of the placebo group who later received salmon calcitonin improved their walking distance. The authors have not established that this is an organic response.

Back Pain↗

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↗

Downslope claudication in eosinophilic fasciitis: a fourth type of claudication--case presentations.

Two patients who presented with discomfort in the calves while walking down a slope were diagnosed as suffering from eosinophilic fasciitis of the lower limbs. Following therapy of the underlying disease, this peculiar discomfort remitted concomitantly with the disappearance of the subcutaneous abnormalities. The authors posit that downslope claudication of the calves in eosinophilic fasciitis constitutes an additional variant of claudication of the lower limbs.

Aged↗

Improvement of walking distance by defibrotide in patients with intermittent claudication--results of a randomized, placebo-controlled study (the DICLIS study). Defibrotide Intermittent CLaudication Italian Study.

Defibrotide is an antithrombotic drug which enhances prostacyclin production and activates fibrinolytic system. The aim of this study was to investigate the improvement of walking distance in patients with intermittent claudication treated with defibrotide. DICLIS was a double blind, placebo-controlled study which included patients with walking distance autonomy at a standardized treadmill test < or =350 > or =100 meters. A total of 310 patients were randomly allocated to placebo (n = 101), defibrotide 800 mg/day (n = 104) or defibrotide 1200 mg/day (n = 105). During a one year follow-up, the Absolute Walking Distance (AWD) was measured six times (0, 30, 60, 90, 180, 360 days). Similar improvement in walking distance was found in the three groups until the 90th day; thereafter placebo group showed no further increase, while AWD continued to increase in the defibrotide groups. Between the 180th and 360th day visits, AWD was significantly higher (P <0.01) in patients given defibrotide than in patients given placebo. No difference in efficacy was observed between the two dosages of defibrotide. No differences in side effects were observed among the three groups. The results of the present trial suggest that long-term administration of defibrotide improves walking distance in patients with intermittent claudication.

Adult↗

The effect of exercise upon cutaneous oxygen delivery in the extremities of patients with claudication and in a human laboratory model of claudication.

Transcutaneous PO2 measurements have been shown previously to reflect local cutaneous oxygen delivery in patients with severe peripheral arterial insufficiency. In the present studies, transcutaneous PO2 measurements indicated that exercise of the involved extremity lowered cutaneous oxygen delivery in patients with moderate peripheral arterial insufficiency (claudication). These exercise-related changes in transcutaneous PO2 were reproduced in a human laboratory model of claudication. The pattern of change in transcutaneous PO2 observed in this model during and after exercise correlated closely with the pattern of change in mean systemic blood pressure during the same time period.

Ankle↗

The fate of the claudicant--a prospective study of 1969 claudicants.

A prospective study of 1969 patients with intermittent claudication receiving placebo medication for a minimum of 1 year is reported. Patients were carefully monitored and only four patients were lost to follow-up. Annual mortality was 4.3%. Thirty-six patients developed a definite myocardial infarction, 27 a major stroke, 32 required a major amputation and 111 required surgical or radiological intervention for deteriorating ischaemia of the leg. The entry characteristics of the patients were analysed as a predictor of serious cardiovascular events. The most sensitive predictors of total mortality were age, history of coronary heart disease and an ankle/arm pressure ratio below 0.5. Of the laboratory measurements performed only the initial white cell count was a significant predictor of myocardial infarction, stroke and vascular deaths.

Amputation, Surgical↗