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PubMed1997

Effects of indobufen and pentoxifylline on walking capacity and hemostasis in patients with intermittent claudication: results of six months of treatment.

Seventy-one patients with peripheral arterial occlusive disease (PAOD) were randomized into two groups of different treatment modalities. The diagnosis of PAOD was established by history of intermittent claudication, clinical examination, and by Doppler pressure assessment or lower extremity arteriography. After a three-month washout period, 35 patients (Group 1) started treatment with indobufen (400 mg per day) and 36 patients (Group 2) with pentoxifylline (600 mg per day). Twenty-nine patients from each group completed six months of treatment. Both of the drugs significantly improved maximal and pain-free walking distances, but the effect of indobufen was more pronounced than that of pentoxifylline. Patients with PAOD exhibited signs of hypercoagulation. Fibrinogen, D-dimer, and b-thromboglobulin concentrations did not change significantly following treatment in both of the groups. The authors observed a decrease of platelet aggregation after treatment with indobufen and a decrease of F1 + 2 fragment and PAI-1 antigen after treatment with pentoxifylline.

Fibrinogen↗
PubMed1985

Intermittent claudication: a double-blind crossover trial of pentoxifylline.

The influence of the xanthine derivative pentoxifylline ('Trental' or BL191; Hoechst-Roussel) on exercise tolerance was measured in 38 subjects with stable, severe to moderately severe, intermittent claudication who completed a randomised, double-blind, placebo controlled, cross-over clinical trial. Patients received placebo tablets or 400 mg slow-release pentoxifylline tablets ('Trental 400') twice a day for one week, followed by three times daily for seven weeks, and then crossed over to receive the alternate preparation for another eight weeks. Claudication distance and walking distance were measured on a treadmill before starting treatment and again at four-week intervals during the trial. At the same times, red blood cell filterability, plasma fibrinogen concentration and blood viscosity, resting and post-ischemic calf muscle blood flow, and the resting and post-exercise ankle/brachial systolic pressure ratio were also measured. In this study, the observed effects of pentoxifylline treatment were no greater than those of placebo, even though serum levels of pentoxifylline and its hydroxy-metabolite were within the anticipated range. This was shown by a 'therapeutic effect ratio' of 0.98 for treadmill claudication distance and 0.96 for treadmill walking distance after within-patient analysis at the end of the cross-over (where a ratio of 1.0 means the test drug and placebo effects are identical). These ratios have 95% confidence limits of 0.72-1.34 and 0.74-1.25, respectively.

Aged↗
PubMed2000

Near-infrared spectroscopy grades the severity of intermittent claudication in diabetics more accurately than ankle pressure measurement.

BACKGROUND: The aim of this study was to evaluate near-infrared spectroscopy (NIRS), combined with a treadmill-walking test, as a method of assessment of intermittent claudication (IC) in diabetic patients. METHODS: Some 208 symptomatic legs in 153 consecutive patients who complained of calf IC due to atherosclerotic disease were studied with NIRS and resting ankle : brachial pressure index (ABPI). RESULTS: There was good reproducibility of NIRS measurements. Three distinct types of IC were detected by NIRS. ABPI was significantly different between these three types in non-diabetic patients, but could not grade the severity of IC in diabetic patients. Recovery time (RT) of muscle oxygenation differentiated more accurately between severe and moderate claudication than ABPI in diabetics, although RT and ABPI had similar accuracy in non-diabetics. There was a significant correlation between RT and ABPI in non-diabetic patients and patients who had been diabetic for less than 10 years, while there was no correlation in patients who had had diabetes for over 10 years. CONCLUSION: Measurement of muscle oxygenation during exercise by NIRS graded the severity of IC in diabetic patients more accurately than resting ABPI. An abstract based on this paper was presented to the symposium of the 18th World Congress of the International Union of Angiology in Tokyo, Japan, September 1998

Adult↗
PubMed1985

Mortality and morbidity in patients with intermittent claudication in relation to the location of the occlusive atherosclerosis in the leg.

Mortality and morbidity from cerebrovascular and coronary arterial disease over a period of six years were studied in 224 non-diabetic patients with intermittent claudication. Patients with multiple arterial stenoses in the leg had a lower six-year survival than patients with single stenoses (55% versus 77%), with a higher mortality from cardiac deaths. These differences were still significant after adjustment for differences in clinical characteristics at the initial examination. This might indicate that patients with multiple arterial stenoses in the legs have a more widespread and more progressive atherosclerotic disease.

Aged↗
PubMedDate not supplied

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

Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of policosanol and ticlopidine in patients with moderately severe intermittent claudication (IC). The study had a 4-week baseline step, followed by a 20-week double-blinded, randomized treatment period. Twenty-eight eligible patients were randomized to policosanol 10 mg or ticlopidine 250 mg tablets twice daily (bid). 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 baseline. Compared with baseline, policosanol significantly increased (p < 0.01) mean values of initial (ICD) and absolute (ACD) claudication distances from 162.1 to 273.2 m and from 255.8 to 401.0 m, respectively. Ticlopidine also raised significantly (p < 0.01) ICD (166.2 to 266.3 m) and ACD (252.9 to 386.4 m). Comparisons between groups did not show significant differences. Policosanol, but not ticlopidine, significantly (p < 0.05), but modestly, increased the ankle/arm pressure ratio. After 10 weeks, policosanol significantly (p < 0.001) lowered low-density lipoprotein-cholesterol (LDL-C), total cholesterol (TC) (p < 0.01), and TC/HDL-C and raised (p < 0.05) high-density lipoprotein-cholesterol (HDL-C). At study completion, policosanol lowered (p < 0.001) LDL-C (30.2%), TC (16.9%), and TC/HDL-C (33.9%), increased (p < 0.01) HDL-C (+31.7%), and left triglycerides unchanged. Ticlopidine did not affect the lipid profile variable. Policosanol induced modest, but significant, reductions (p < 0.01) of fibrinogen levels compared with baseline and ticlopidine. Treatments were well tolerated and did not impair safety indicators. Three ticlopidine patients (21.4%) withdrew from the trial, only 1 owing to a serious adverse experience (AE) (unstable angina). Three other ticlopidine patients experienced mild AE (headache, diarrhea, and acidity). It is concluded that policosanol (10 mg bid) can be as effective as ticlopidine (250 mg bid) for improving walking distances of claudicant patients, and it could be advantageous for the global risk of these individuals owing to its cholesterol-lowering effects. This study is, however, just a pilot comparison, so that further studies in larger sample sizes are needed for definitive conclusions of the comparative effects of both drugs on patients with IC.

Adult↗
PubMed1973

Clinical, haemodynamic, rheological, and biochemical findings in 126 patients with intermittent claudication.

Increased blood viscosity has been shown to be an important factor in reducing blood flow in a review and analysis of the history, clinical findings, and haemodynamic, rheological, radiological, and biochemical measurements in 126 patients with intermittent claudication. In some patients increased viscosity seemed to be the determining cause of claudication. A raised plasma fibrinogen was the most common single biochemical abnormality. The results of conventional serum lipid and lipoprotein estimations were abnormal in the series as a whole but did not correlate with clinical findings or flow measurements at individual patient level. There was, however, a significant correlation between some clinical findings and the susceptibility of the red cells to autoxidation.

Adult↗
PubMed1989

Effects of regular physical training in a supervised class and additional intravenous prostaglandin E1 and naftidrofuryl infusion therapy in patients with intermittent claudication--a controlled study.

UNLABELLED: The aim of this study was to investigate if PGE1 i.v.-therapy after active physical training further increases the walking distance in PAOD stage IIb according to Fontaine. 48 outpatients with intermittent claudication underwent a standardized active walking training of about 6 months twice weekly. Afterwards patients were randomly given once daily an i.v. infusion of 60 micrograms PGE1 (3 ampoules prostavasin) or 600 mg naftidrofuryl. The therapy lasted for 3 weeks with the exception of Saturdays and Sundays. Besides laboratory and doppler parameters, painfree and maximum walking distance (treadmill, 10% incline, 3.5 km/h) were determined. RESULTS: Under active physical training the patients' walking distance increased significantly to more than double the baseline levels. Further significant increase of the painfree walking distance was seen after a 3 week treatment with PGE1 from 136 to 270 m (99%) as well as with naftidrofuryl from 117 to 230 m (97%). While this difference was not significant there was a significant difference in favour to PGE1 after the follow-up period (p less than 0.01). In the PGE1-group the painfree walking distance showed a further increase (from 270m to 306m) whereas it decreased in the naftidrofuryl-group (from 230m to 210m). At the same time under PGE1 the ankle/arm index increased significantly in comparison to naftidrofuryl (p less than 0.01). Side effects differed significantly in respect of the frequency and severity. In the PGE1-group in 20.8% of the patients side effects occurred, whereas in 91.6% of the patients in the naftidrofuryl-group side effects were observed. In no case therapy had to be discontinued because of side effects.

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PubMed2006

Postoperative outcomes for patients undergoing elective revascularization for critical limb ischemia and intermittent claudication: a subanalysis of the Coronary Artery Revascularization Prophylaxis (CARP) trial.

OBJECTIVE: To determine the perioperative mortality, myocardial infarction rate, and long-term survival of patients with critical limb ischemia (CLI) compared with those with intermittent claudication (IC) within a cohort selected for significant coronary artery disease, a secondary analysis was conducted of a prospective, randomized, multicenter trial of Coronary Artery Revascularization Prophylaxis (CARP) before peripheral vascular surgery. This multicenter trial was sponsored by the Cooperative Studies Program of the Department of Veterans Affairs. METHODS: Of the 510 patients enrolled in the CARP trial and randomized to coronary revascularization or no revascularization before elective vascular surgery, 143 had CLI and 164 had IC as an indication for lower limb revascularization; >95% of each group were men. The presence of coronary artery disease was determined by cardiac catheterization. Eligible patients had at least one treatable coronary lesion of > or =70%. Those with significant left main disease, ejection fraction of <20%, and aortic stenosis were excluded. Patients were randomized to coronary artery disease revascularization or no revascularization before vascular surgery and followed for mortality and morbidity perioperatively and for a median of 2.7 years postoperatively. Medical treatment of coronary artery disease was pursued aggressively. RESULTS: Patients with IC had a longer time from randomization to vascular surgery (p = .001) and more abdominal operations (p < .001). Patients with CLI had more urgent operations (p = .006), reoperations (p < .001), and limb loss (p = .008) as well as longer hospital stays (p < .001). The IC group had more perioperative myocardial infarctions (CLI, 8.4%; IC, 17.1%; p = .024), although perioperative mortality was similar (CLI, 3.5%; IC, 1.8%; p = .360). In follow-up, the IC group also had numerically more myocardial infarctions (CLI, 16.8%; IC, 25%; p = .079), but mortality was not different (CLI, 21%; IC, 22%; p = .825). Coronary artery revascularization did not lower perioperative or long-term mortality in either group. CONCLUSIONS: Our data indicate that patients with significant coronary artery disease and either CLI or IC can undergo vascular surgery with low mortality and morbidity, and these results are not improved by coronary artery revascularization before vascular surgery. Furthermore, when selected for the presence of symptomatically stable, severe coronary artery disease, there is no difference in long-term survival between patients with CLI and IC. Finally, the better-than-predicted outcomes for these patients with advanced systemic atherosclerosis may be due to aggressive medical management with beta-blockers, statins, and acetylsalicylic acid.

Aged↗
PubMed1977

Self-administration of a questionnaire on chest pain and intermittent claudication.

A total of 18 403 men aged between 40 and 64 years took part in a screening examination which included a self-administered version of the London School of Hygiene questionnaire on chest pain and intermittent claudication. The yield of positives for "angina" and "history of possible infarction" was about twice as high as with interviewers, but the positive groups obtained by the two techniques differed little in their association with electrocardiographic findings or in their ability to predict five-year coronary mortality risk. This risk ranged from 0-9% in men negative to questionnaire and electrocardiograms (ECG), to 4-3% for those with positive ECG but no symptoms, 4-5% for those with angina and negative ECG, up to 16% for those with angina and positive ECG. The self-administered version of this questionnaire provides a simple and convenient means of identifying individuals with a high risk of major coronary heart disease.

Adult↗
PubMed1996

Copper-induced low density lipoprotein oxidation is not a risk discriminator for intermittent claudication.

Oxidative modification of low density lipoprotein (LDL) is supposed to be important in atherogenesis. Recently it was shown that subjects with coronary atherosclerosis have an increased susceptibility of their LDL to copper-induced oxidation. We investigated if patients with intermittent claudication (IC) might have an increased susceptibility of LDL to copper-induced oxidation. Fifty-eight males were randomly selected from an epidemiological study of IC, 29 with IC and 29 healthy controls matched for age, sex and smoking habits. All subjects performed a standard exercise test to confirm or exclude peripheral atherosclerosis. Claudicants had a lag phase of 99.7 +/- 14.8 minutes (mean +/- SD) and in healthy controls it was 104.6 +/- 12.9 minutes. The difference between the groups was not significant and neither was there any association between lag phase and degree of peripheral atherosclerosis in IC. Lag phase showed a positive and significant correlation to the plasma concentration of high density lipoprotein-2 (HDL2-) cholesterol. The correlation for the whole group was r = 0.41, p < 0.01. We conclude that the susceptibility of LDL to copper-oxidation does not discriminate between claudicants and healthy controls. The results also suggest that high plasma concentrations of HDL2-cholesterol may have a protective effect on LDL against oxidation.

Arteriosclerosis↗
PubMed2000

Basic fibroblast growth factor in patients with intermittent claudication: results of a phase I trial.

OBJECTIVES: This phase I study was designed to evaluate the safety, tolerability and pharmacokinetics of intra-arterial basic fibroblast growth factor (bFGF) in patients with atherosclerotic peripheral arterial disease (PVD) and intermittent claudication. We also assessed the effects of basic fibroblast growth factor (bFGF) on calf blood flow as a measure of biologic activity. BACKGROUND: Preclinical studies have shown that bFGF, an angiogenic peptide, promotes collateral development in animal models of myocardial and hind limb ischemia. The safety and efficacy of bFGF in patients is unknown, and early clinical trials are underway in coronary and peripheral arterial disease. METHODS: A double-blind, placebo-controlled, dose-escalation trial was conducted in patients with claudication demonstrating ankle/brachial index <0.8. Patients were randomly assigned to placebo (n = 6), 10 microg/kg of bFGF (n = 4), 30 microg/kg of bFGF once (n = 5) and 30 microg/kg of bFGF on two consecutive days (n = 4). Study drug was infused into the femoral artery of the ischemic leg. Detailed safety information including retinal photography for neovascularization were obtained through one year. Calf blood flow was measured with strain gauge plethysmography in the two higher dose treatment groups and in four placebo patients at baseline, one month and three to seven months after treatment. RESULTS: Intra-arterial bFGF was safe and well-tolerated. The half-life was 46 +/- 21 min. Calf blood flow increased at one month by 66 +/- 26% (mean +/- SEM) and at six months by 153 +/- 51% in bFGF-treated patients (n = 9, p = 0.002). Flow did not change significantly in the placebo group. CONCLUSIONS: In this initial randomized, double-blind, placebo-controlled trial in patients with atherosclerotic PVD and claudication, bFGF was well-tolerated. The data suggest a salutary biologic effect, and initiation of phase 2 trials is warranted.

Aged↗
PubMed1997

Intermittent claudication in 8343 men and 21-year specific mortality follow-up.

PURPOSE: As Western populations live longer, peripheral vascular disease will become a greater individual and public health problem. Therefore, the long-term natural history of intermittent claudication (IC) needs further delineation. The study objective was to describe the 21-year mortality and relative risk for cause-specific mortality for subjects with incident IC. METHODS: The subjects were 8343 Israeli male governmental employees aged 40-65 years who were free of coronary heart disease and symptomatic peripheral vascular disease in 1963. These men were followed for 21 years to measure differences in mortality between those who did and did not develop incident IC. Incident IC was diagnosed in 1965 and 1968 by the London School of Hygiene IC Questionnaire. All other cardiovascular disease risk factors were measured by standardized and validated procedures. Cause-specific mortality through 1986 was determined through death certificates from the Israeli Mortality Register. RESULTS: A total of 360 men with IC and 7983 symptom-free men were followed for survival from 1965 to 1986; 159 men with IC (44%) and 2330 symptom-free men (29%) died. For total mortality, the Kaplan-Meier 21-year survival probabilities were 56% for IC and 71% for symptom-free men (P < 0.0001 for the entire 21-year survival difference between the two groups). For coronary heart disease (CHD), stroke, and other causes of death, the survival probabilities for men with IC and symptom-free men were, respectively: 85% vs. 90%, 89% vs. 97%, and 79% vs. 83% (P = 0.0004; P < 0.0001; and P = 0.007, respectively, for the entire 21-year survival difference between the two groups). Cox's proportional hazards model was used to control confounding from incident myocardial infarction and angina through 1968, as well as for demographic, physiologic, psychosocial, and other cardiovascular disease risk factors. The 21-year adjusted all-cause mortality relative risk for IC was 1.50 (95% confidence interval (CI), 1.28-1.77). For stroke deaths the relative risk was 2.76 (95% CI, 1.89-4.02). For stroke mortality, IC was the third strongest predictor of death after elevated systolic blood pressure and increasing age. Incident IC had a relative risk of CHD deaths of 1.31, but it was not statistically significant (P = 0.08; 95% CI, 0.97-1.77). IC was not statistically significantly related to other causes of death (P = 0.10) after adjustment for covariates. CONCLUSIONS: IC is strongly predictive of long-term cerebrovascular disease mortality among men. Incident IC is a stronger indicator of cerebrovascular than of CHD death.

Adult↗
PubMed2006

Intravascular ultrasound-guided creation of re-entry sites to improve intermittent claudication in patients with aortic dissection.

PURPOSE: To report percutaneous fenestration of aortic dissection flaps to relieve distal ischemia using a novel intravascular ultrasound (IVUS)-guided fenestration device. CASE REPORTS: Two men (47 and 62 years of age) with aortic dissection and intermittent claudication had percutaneous ultrasound-guided fenestration performed under local anesthesia. Using an ipsilateral transfemoral approach, the intimal flap was punctured under real-time IVUS guidance using a needle-catheter combination through which a guidewire was placed across the dissection flap into the false lumen. The fenestration was achieved using balloon catheters of increasing diameter introduced over the guidewire. Stenting of the re-entry was performed in 1 patient to equalize pressure across the dissection membrane in both lumens. The procedures were performed successfully and without complications. In both patients, ankle-brachial indexes improved from 0.76 to 1.07 and from 0.8 to 1.1, respectively. Both patients were without claudication at the 3- and 6-month follow-up examination. CONCLUSION: Percutaneous intravascular ultrasound-guided fenestration and stenting at the level of the iliac artery in aortic dissection patients with claudication is a technically feasible and safe procedure and relieves symptoms.

Aortic Dissection↗
PubMed1995

Propionyl-L-carnitine in intermittent claudication: double-blind, placebo-controlled, dose titration, multicenter study.

OBJECTIVES: The aim of this double-blind, placebo-controlled, dose titration, multicenter trial was to assess the efficacy and safety of propionyl-carnitine in intermittent claudication. BACKGROUND: Human and animal studies indicate that propionyl-L-carnitine increases carnitine content and improves energy metabolism in the ischemic skeletal muscle. METHODS: After a 2-week preliminary period to assess maximal walking distance, 245 patients were randomly assigned to receive propionyl-L-carnitine (n = 118) or placebo (n = 127). The initial oral dose of 500 mg twice daily was increased at 2-month intervals to 2 g/day and then to 3 g/day in patients showing improvement in treadmill performance < 30% over baseline. Efficacy analysis was conducted for the 214 patients who completed the 24 weeks of treatment by comparing the effect of placebo and propionyl-L-carnitine on day 180. RESULTS: Analysis of variance showed a significant improvement of 73 +/- 9% (mean +/- SE) in maximal walking distance with propionyl-L-carnitine (n = 99) compared with 46 +/- 6% for placebo (n = 115, p = 0.03). For distance walked at onset of claudication, propionyl-L-carnitine showed about double the improvement of placebo; however, the difference was not statistically significant. There were no changes in electrocardiographic and routine biochemical and hematologic tests that would indicate an adverse effect of propionyl-L-carnitine. Adverse events requiring drug discontinuation (11 in the propionyl-L-carnitine group, 3 in the placebo group) were unrelated to study medication. The dose titration design of the study also provided information on the dose-response relation. Slightly less than 67% of patients were expected to improve their maximal walking distance by at least 30%, assuming 2 g/day of propionyl-L-carnitine (95% confidence interval 0.51 to 0.70). The response rate during the entire titration course was significantly in favor of propionyl-L-carnitine compared with placebo. CONCLUSIONS: Although the precise mode of therapeutic action requires clarification, propionyl-L-carnitine, at a dose of 1 to 2 g/day, appears to be effective and well tolerated, with minimal adverse effects.

Administration, Oral↗
PubMed2001

Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial.

OBJECTIVE: To determine the effects of a 6-month exercise program on ambulatory function, free-living daily physical activity, peripheral circulation, and health-related quality of life (QOL) in disabled older patients with intermittent claudication. DESIGN: Prospective, randomized controlled trial. SETTING: University Medical (Center and Veterans Affairs Medical Center, Baltimore, Maryland. PARTICIPANTS: Thirty-one of 61 patients with Fontaine stage II peripheral arterial occlusive disease (PAOD) were randomized to exercise rehabilitation and 30 to usual-care control. Three patients from the exercise group and six patients from the control group dropped out, leaving 28 and 24 patients, respectively, completing the study in each group. INTERVENTION: Six months of exercise rehabilitation. MEASUREMENTS: Treadmill distance walked to onset of claudication and to maximal claudication, ambulatory function, peripheral circulation, perceived QOL, and daily physical activity. RESULTS: Compliance with the exercise program was 73% of the possible sessions. Exercise rehabilitation increased treadmill distance walked to onset of claudication by 134% (P < .001) and to maximal claudication by 77% (P < .001), walking economy by 12% (P = .003), 6-minute walk distance by 12% (P < .001), and maximal calf blood flow by 30% (P < .001). Changes in distance walked to maximal pain correlated with changes in walking economy (r = -.50, P = .013) and changes in maximal calf blood flow (r = .38, P = .047). Exercise rehabilitation increased accelerometer-derived daily physical activity by 38% (P < .001); this change correlated with the change in distance walked to maximal pain (r = .45, P = .020). These improvements were significantly better than the changes in the control group (P < .05). CONCLUSION: Improvements in claudication following exercise rehabilitation in older PAOD patients are dependent on improvements in peripheral circulation and walking economy. Improvement in treadmill claudication distances in these patients translated into increased accelerometer-derived physical activity in the community, which enabled the patients to become more functionally independent.

Activities of Daily Living↗
PubMedDate not supplied

Intermittent claudication and muscle fiber fine structure: morphometric data on mitochondrial volumes.

The mitochondrial volume densities (Vmit) of the different fiber types (type 1, type 2A, type 2B) were estimated in bilaterally obtained biopsies from 22 patients with unilateral intermittent claudication. These data, which were obtained from structurally intact fibers, were compared with clinical data from the same subject. In both the asymptomatic and symptomatic legs, Vmit 1 greater than Vmit 2A greater than Vmit 2B. Furthermore, Vmit 1 covariated with Vmit 2A and Vmit 2A with Vmit 2B in the asymptomatic legs (as in healthy subjects) but not in the symptomatic legs. Vmit 2 (mainly Vmit 2A) covariated with the age of the subjects in both legs. Vmit Tot was higher in the symptomatic legs than in the asymptomatic legs. This was mainly due to increase in the oxidative fibers, type 1 and type 2A. Usually, Vmit in the asymptomatic legs covariated significantly with the results of the functional tests (initial pain and maximum walking tolerance), while only Vmit 2A in the symptomatic legs showed such a correlation. However, the difference between the two legs concerning Vmit 1 was also correlated to the walking tolerance. Patients with high stenosis or occlusion showed higher Vmit Tot than did those with low obstacles. The results conclusively show that a fiber type-specific adaptation to ischemia occurs through an increase of mitochondrial content of oxidative fibers, which suggests that hypoxia may influence the control of synthesis or degradation of mitochondrial proteins.

Biopsy↗
PubMed1991

A multicenter study of doxazosin in the treatment of patients with mild or moderate essential hypertension and concomitant intermittent claudication.

This study assessed the efficacy and safety of once-daily doxazosin in the treatment of patients (n = 19) with mild or moderate essential hypertension (sitting diastolic blood pressure [DBP] 95 to 114 mm Hg) and concomitant intermittent claudication (Doppler ankle/arm ratio of less than 0.80 and walking tolerance of less than 700 m on the treadmill). After 14 weeks of treatment with doxazosin, a significant (p less than 0.05) reduction in systolic blood pressure and DBP was observed. Mean blood pressures were reduced from 170/100 mm Hg at baseline to 161/93 mm Hg at the end of treatment. Minor changes in heart rate occurred, which with continued treatment were not statistically significant from baseline. In 12 of 16 (75.0%) efficacy-evaluable patients blood pressure was normalized (DBP to less than or equal to 90 mm Hg with an greater than or equal to 5 mm Hg reduction from baseline) with a mean daily dose of 7.6 mg/day. Doxazosin improved the hypertension severity category in 13 of 16 (81.3%) patients. The blood pressure ratios between both the thighs and arms and ankles and arms showed no statistically significant changes after treatment with doxazosin. Thigh blood flow at rest and the reactive hyperemia after 3 minutes of arterial occlusion did not change statistically. There was a tendency for pain-free distance to improve. Laboratory data were not significantly changed after treatment with doxazosin. Of the 19 patients studied, 5 reported mild or moderate side effects that were either tolerated or disappeared with continued treatment. No patient had therapy withdrawn and no patient required a dose reduction.(ABSTRACT TRUNCATED AT 250 WORDS)

Antihypertensive Agents↗
PubMed2003

Effects of simvastatin on walking performance and symptoms of intermittent claudication in hypercholesterolemic patients with peripheral vascular disease.

PURPOSE: To analyze the effects of short-term therapy with simvastatin on walking performance in hypercholesterolemic patients with peripheral vascular disease. METHODS: Eighty-six patients with peripheral arterial disease (Fontaine stage II), intermittent claudication, and total cholesterol levels >220 mg/dL were enrolled in a randomized, placebo-controlled, double-blind study. Forty-three patients were assigned to simvastatin (40 mg/d); the remaining 43 patients were assigned to placebo treatment. All patients underwent an exercise test and clinical examination, and completed a self-assessment questionnaire at 0, 3, and 6 months. Pain-free and total walking distance, resting and postexercise ankle-brachial indexes, and questionnaire scores were determined at each follow-up. RESULTS: At 6 months, the mean pain-free walking distance had increased 90 meters (95% confidence interval [CI]: 64 to 116 meters; P <0.005) more in the simvastatin group than in the placebo group. Similar results were seen for the total walking distance (mean between-group difference in the change, 126 meters; 95% CI: 101 to 151 meters; P <0.001), and for the ankle-brachial index at rest (mean, 0.09; 95% CI: 0.06 to 0.12; P <0.01) and after exercise (mean, 0.19; 95% CI: 0.14 to 0.24; P <0.005). There was also a greater improvement in claudication symptoms among patients treated with simvastatin. The effects on walking performance, ankle-brachial indexes, and questionnaire scores had also been significant at 3 months. CONCLUSION: High-dose short-term therapy with simvastatin may improve walking performance, ankle-brachial pressure indexes, and symptoms of claudication in hypercholesterolemic patients with peripheral vascular disease.

Aged↗