Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “INTERMITTENT CLAUDICATION”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 199 records · Page 11Linked to original sources
PubMedDate not supplied

[Pentoxifylline and intermittent claudication: critical analysis of clinical trials].

Drug utility in the treatment of intermittent claudication is controversial, mainly because of data heterogeneity and not too obvious benefit in the clinical trials. Pentoxifylline is the world's largest prescribed drug for intermittent claudication. In an attempt to define its benefit in the global care of the claudicants, we have analysed all the randomized double-blind, placebo-controlled trials listed from the international data-bases. Methodology of these trials have been compared with the European and FDA guidelines. In this respect, the 3 best suitable studies are consistent with one other and with a statistical benefit of pentoxifylline on the claudication distances. Although this effect is not truly predictive of the long term benefit-risk ratio of the drug, it seems clinically useful, especially when considering stable patients and when using the drug after previous physical training.

Clinical Trials as Topic↗
PubMedDate not supplied

Exaggerated endothelin release in response to acute mental stress in patients with intermittent claudication.

Endothelin-1 (ET-1) is an endothelial-derived 21-amino-acid peptide with potent vasoconstrictor and mitogenic properties implicated in several cardiovascular disorders. To evaluate the plasma ET-1 response to mental stress in patients with intermittent claudication, plasma endothelin concentrations were measured by radioimmunoassay in 15 claudicant outpatients (13 men and 2 women; mean age 62 +/- 4 years) and in 15 sex- and age-matched healthy control subjects (12 men and 3 women; mean age 60 +/- 8 years) before and after mental arithmetic performed for 10 minutes. Venous blood samples were drawn from an antecubital vein at baseline, at the end of the mental arithmetic, and at 10 minutes of recovery. Baseline ET-1 values were higher in patients with intermittent claudication as compared with control subjects (4.5 +/- 0.5 pmol/L and 2.2 +/- 0.3 pmol/L, respectively, p < 0.0001). At the end of mental stress, ET-1 levels rose significantly in both groups from baseline (p < 0.001) reaching a higher value in patients with intermittent claudication than in control subjects (5.6 +/- 0.7 pmol/L and 2.4 +/- 0.4 pmol/L, respectively, p < 0.0001). The percent increases (delta%) in ET-1 plasma concentrations from baseline in response to mental stress were significantly greater in claudicant patients than in control subjects (+23 +/- 9% and +9 +/- 7%, respectively, p < 0.0001). ET-1 plasma concentrations returned to baseline values similarly in both groups at minute 10 of the recovery period. These findings show that acute mental stress causes an exaggerated release of ET-1 in patients with intermittent claudication and suggest that this could be a potential pathophysiological mechanism through which mental stress may trigger adverse acute cardiac events and accelerate progression of atherosclerosis in these patients.

Acute Disease↗
PubMed1982

The measured effect of stopping smoking on intermittent claudication.

One hundred and twenty-four limbs in patients suffering from intermittent claudication were studied over 10 months. Changes in ankle pressure and treadmill exercise tolerance over the period were compared between two groups, one of patients who continued to smoke (group 1) and the other of those who gave up (group 2). Resting ankle systolic pressure fell in smokers' limbs by a mean of 10.2 mmHg (t = 3.56, P less than 0.001), and rose in those patients who stopped smoking by a mean 8.7 mmHg (P = n.s.). Ankle pressures after exercise and maximum treadmill walking distance did not change in smokers but significantly improved in past smokers. Stopping cigarette smoking increased the chance of improvement in ankle pressure and exercise tolerance in intermittent claudication.

Ankle↗
PubMed1996

Management of intermittent claudication with pentoxifylline: meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate the efficacy of pentoxifylline therapy in improving the walking capacity of patients with moderate intermittent claudication. DATA SOURCES: A search of MEDLINE for trials published between 1976 and 1994 inclusive, and a bibliographic review of all articles retrieved. STUDY SELECTION: Randomized, placebo-controlled, double-blind clinical trials were selected that evaluated the pain-free walking distance (the distanced walked on a treadmill before the onset of calf pain) and the absolute claudication distance (the maximum distance walked on a treadmill) among patients with moderate intermittent claudication. Twelve study groups in 11 trials were included in the analysis. DATA EXTRACTION: In addition to information regarding the trial design, patient characteristics, dosages and treatment periods, the means and standard deviations were collected for both the pain-free walking and absolute claudication distances. Trial quality was also assessed. DATA SYNTHESIS: Overall, there was a statistically significant improvement in the pain-free walking distance after pentoxifylline therapy (weighted mean difference 29.4 m [95% confidence interval (CI) 13.0 to 45.9 m]); this finding was based on a total sample of 612 patients (308 in the treatment groups and 304 in the control groups). A significant improvement was also noted in the absolute claudication distance (weighted mean difference 48.4 m [95% CI 18.3 to 78.6 m]); this was based on a total sample of 511 patients (258 in the treatment group and 253 in the control group). In a sensitivity analysis of the pain-free walking distance, significant treatment effects and no statistically significant heterogeneity were found when only trials were included that were "medically eligible" (involved patients with stage II disease and a pain-free walking distance of 50 to 200 m). In a similar sensitivity analysis of the absolute claudication distance, the two conditions resulting in a significant treatment effect and no significant heterogeneity were the inclusion of "medically eligible" trials and those with a shorter treatment duration (13 weeks or less). CONCLUSION: Pentoxifylline therapy may be efficacious in improving the walking capacity of patients with moderate intermittent claudication. However, properly conducted clinical trials are required to provide a true estimate of the benefit.

Chi-Square Distribution↗
PubMed1999

Why is training effective in the treatment of patients with intermittent claudication?

Patients with peripheral arterial obstructive disease (PAOD) often have complaints of intermittent claudication. This causes a great limitation in the quality of life because of reduction in walking ability. PAOD is associated with increased morbidity and mortality. Beside other therapies, training has been shown to be an effective treatment option for patients with intermittent claudication. Exercise training significantly increases walking distance and consequently the functional behaviour of the patient. Several authors have identified different mechanisms involved in this beneficial effect. The most important are discussed in this review, namely adaptation or redistribution of the peripheral blood flow, inhibition of the progression of the atherosclerotic disease, changes in blood rheology, metabolic changes, changes in skeletal muscle morphology, economisation of walking, a change in pain perception and an effect on the cardiovascular system. It is concluded that training works through a combination of mechanisms. Further research is needed to clarify the precise mechanisms.

Exercise Therapy↗
PubMed1999

Naftidrofuryl can enhance the quality of life in patients with intermittent claudication.

BACKGROUND: Using a disease specific questionnaire, the CLAU-S, we undertook a double blind, placebo controlled study in patients with intermittent claudication to determine whether the increase in the pain-free walking distance, previously demonstrated with naftidrofuryl, is reflected as an improvement in the patients' quality of life. PATIENTS AND METHODS: 287 patients, with stable intermittent claudication for at least 3 months were entered into the study. Following an initial one month placebo run-in, patients were randomised to either naftidrofuryl, at a dosage of 200 mg three times daily, or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is divided into 6 dimensions, before the start of treatment, at 3 and 6 months. Statistical analysis was undertaken on an intention-to-treat (ITT) basis which included all patients know to have taken at least one dose of the drug and to have provided key data on at least one occasion after baseline. For each of the CLAU-S dimensions the two groups were compared with respect to difference between the initial and final values. RESULTS: 255 patients (133 naftidrofuryl, 122 placebo) were eligible for the ITT analysis. Significant improvements, in favour of the active medication, were seen for the dimensions "daily living", "pain", "disease specific anxiety" and "mood". A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global superiority of naftidrofuryl (p = 0.004). CONCLUSIONS: In this placebo controlled study, using a disease specific questionnaire, naftidrofuryl has been shown to significantly improve several aspects of the quality of life of patients with intermittent claudication.

Aged↗
PubMed2002

Intermittent claudication: cost-effectiveness of revascularization versus exercise therapy.

PURPOSE: To compare the costs, effectiveness, and cost-effectiveness of alternative treatment strategies for intermittent claudication. MATERIALS AND METHODS: By combining data from the literature and original patient data, a Markov decision model was developed to evaluate the societal cost-effectiveness. Patients presented with previously untreated intermittent claudication, and treatment options were exercise, percutaneous transluminal angioplasty (with stent placement, if necessary), and/or bypass surgery. Treatment strategies were defined as the initial therapy in combination with secondary treatment options should the initial therapy fail. The main outcome measures were quality-adjusted life days, expected lifetime costs (in 1995 U.S. dollars), and incremental cost-effectiveness ratios. RESULTS: Compared with an exercise program, revascularization (either angioplasty or bypass surgery) improved effectiveness by 33-61 quality-adjusted life days among patients with no history of coronary artery disease. The incremental cost-effectiveness ratio was $38,000 per quality-adjusted life year gained when angioplasty was performed whenever feasible, as compared with exercise alone, and $311,000 with additional bypass surgery. The incremental cost-effectiveness ratios were sensitive to age, history of coronary artery disease, estimated health values for no or mild claudication versus severe claudication, and revascularization costs. CONCLUSION: The results suggest that, on average, the expected gain in effectiveness achieved with bypass surgery for intermittent claudication is small compared with the costs. Angioplasty performed whenever feasible was more effective than was exercise alone, and the cost-effectiveness ratio was within the generally accepted range.

Angioplasty↗
PubMed1999

[Intermittent claudication--a major cardiovascular risk factor. Proposed guidelines for investigation and treatment].

Intermittent claudication is a common disorder, the diagnosis of which can usually be made on the basis of careful history taking and physical examination. Treatment should be focused on abstinence from smoking, increased daily walking distance, risk-factor modification, and aspirin prophylaxis. Laboratory studies including duplex ultrasonography should be limited to cases where uncertainty exists or to the preoperative work-up for invasive intervention. Intermittent claudication patients merit special attention as a category at high risk of cardiovascular disease, and in whom risk factors such as hypertension, hyperlipidaemia and diabetes need to be identified and treated.

Cardiovascular Diseases↗
PubMed2002

The severity of muscle ischemia during intermittent claudication.

PURPOSE: The degree of ischemia during intermittent claudication is difficult to quantify. We evaluated calf muscle ischemia during exercise in patients with claudication with near infrared spectroscopy. METHODS: A Critikon Cerebral Redox Model 2001 (Johnson & Johnson Medical, Newport, Gwent, United Kingdom) was used to measure calf muscle deoxygenated hemoglobin (HHb), oxygenated hemoglobin (O(2)Hb), and total hemoglobin levels and oxygenation index (HbD; HbD = O(2)Hb - HHb) in 16 patients with claudication and in 14 control subjects before, during, and after walking on a treadmill for 1 minute (submaximal exercise). These measures were repeated after a second maximal exercise in patients with claudication and after 7 minutes walking in control subjects. Near-infrared spectroscopy readings during maximal exercise were then compared with a model of total ischemia induced with tourniquet in 16 young control subjects. RESULTS: Total hemoglobin level changed little during exercise in both patients with claudication and control subjects. HHb levels rose, and O(2)Hb level and HbD falls were more pronounced in patients with claudication than in control subjects after submaximal and maximal exercise. During maximal exercise, HbD fell markedly by a median (interquartile range) of 210.5 micromol/cm (108.2 to 337.0 micromol/cm) in patients with claudication compared with 66.0 micromol/cm (44.0 to 101.0 micromol/cm) in elderly control subjects and 41.0 micromol/cm (36.0 to 65.0 micromol/cm) in young control subjects (P <.001). This fall also was greater than the HbD fall induced with tourniquet ischemia at 90.8 micromol/cm (57.6 to 126.2 micromol/cm; P =.006). CONCLUSION: Hemoglobin desaturation in exercising calf muscle is profound in patients with claudication, considerably greater even than that induced with three minutes of tourniquet occlusion. Further studies are necessary to investigate the relationship between the inflammatory response and near-infrared spectroscopy during exercise in patients with claudication.

Adult↗
PubMed1999

Antithrombotic drugs in the primary medical management of intermittent claudication: a meta-analysis.

BACKGROUND: There is no consensus on the efficacy of the antithrombotic drugs available for patients with intermittent claudication. METHODS: A Medline and manual search was used to identify relevant publications. Uncontrolled or retrospective studies, double reports or trials without clinical outcomes were excluded. Included studies were graded as level 1 (randomised and double- or assessor-blind), level 2 (open randomised), or level 3 (non-randomised comparative). Mortality, cerebro- or cardiovascular events, amputations, arterial occlusions or number of revascularization procedures performed in the lower limbs, pain-free and total walking distance, ankle brachial index and calf blood flow, were the main outcomes considered. When feasible, end of treatment results, either continuous or binary, were combined with appropriate statistical methods. RESULTS: Mortality was significantly decreased by ticlopidine compared to placebo (common odds ratio 0.68, 95% C.I., 0.49 - 0.95); clopidogrel decreased vascular events in comparison to aspirin (odds ratio 0.76, 95% C.I., 0.63 - 0.92) in level 1 studies. Arterial occlusions and the number of revascularization procedures performed were statistically significantly decreased by aspirin and ticlopidine, respectively. A small but statistically significant improvement in pain-free walking distance was determined by picotamide, indobufen, low molecular weight heparins, sulodexide and defibrotide, in small studies. CONCLUSIONS: Clopidogrel and ticlopidine do reduce clinically important events in patients with intermittent claudication and could be added to the primary medical treatment of these patients. The use of aspirin in these patients cannot be based on direct evidence, but only on analogy with coronary and cerebral atherosclerosis, where it has documented efficacy. Other antithrombotic drugs were not properly evaluated in patients with intermittent claudication.

Fibrinolytic Agents↗
PubMed1998

Intermittent claudication and risk of cardiovascular events.

To determine the natural history of intermittent claudication, 110 patients were followed up for a mean period of 24.4 +/- 1.2 months. Four patients died during the follow-up. Of the survivors, 24 experienced a nonfatal cardiovascular event, myocardial infarction being the most frequent. Cumulative cardiovascular morbidity was 29% at 3 years. Cox proportional-hazards analysis showed initial ankle-brachial pressure index (ABPI) as a significant predictor for nonfatal cardiovascular events (p<0.002). With an initial ABPI >0.70, cardiovascular morbidity rate was 12% compared with 33% for those with initial ABPI ranging from 0.70 to 0.50, and 60% for those with ABPI <0.50 (p<0.005). Critical limb ischemia occurred in only four patients, amputation was required in two, and arterial reconstruction in five. Of the 85 patients who participated in the treadmill test, maximum walking capacity worsened in 26% and improved in 27%. This study elucidates the neglected area of cardiovascular morbidity in intermittent claudication. It has shown that ABPI identifies a subgroup of patients for whom the risk of cardiovascular events is especially pronounced. On the other hand, based on objective evaluation of the patient status, the relatively benign prognosis for the claudicant limb has been confirmed.

Female↗
PubMed1990

Activation and decreased deformability of neutrophils after intermittent claudication.

This study investigated local alterations in neutrophil activation and deformability after intermittent claudication. In 17 patients with one-sided peripheral arterial occlusive disease, neutrophil count, proportion of activated neutrophils (by nitro blue tetrazolium test), and neutrophil filterability as a measure of passive deformability were assessed in the femoral arterial and venous blood of the diseased leg and in the femoral venous blood of the healthy leg (n = 10). The values were obtained at rest, immediately after claudication, and 10 minutes after claudication induced by repetitive toe stands. Immediately after exercise, the arterial and venous blood differences in the diseased leg were 1) neutrophil count, 9% (95% confidence interval [CI], 5-14%; relative increase in the venous blood compared with arterial blood); 2) the proportion of activated neutrophils, 26% (CI, 10-42%); and 3) the neutrophil filterability, -10% (CI, -4% to -15%). At rest and 10 minutes after exercise, neutrophil parameters did not differ significantly between the femoral arterial and venous blood. Furthermore, no arterial and venous blood differences in the neutrophil parameters were found in the healthy leg. In addition to local changes, systemic changes occurred immediately after exercise. In the femoral arterial blood, the total neutrophil count had risen by 13% (CI, 8-18%), the proportion of activated neutrophils had risen by 41% (CI, 25-58%), and average neutrophil rigidity had risen 17% (CI, 11-22%) compared with the values obtained before exercise. At 10 minutes after exercise, all neutrophil parameters were still elevated. We conclude that even short periods of ischemia, as in intermittent claudication, cause local alterations in neutrophil function and distribution.

Arteries↗
PubMed2004

Drug treatment of intermittent claudication.

The US FDA has approved two drugs for the management of intermittent claudication: pentoxifylline and cilostazol. The mechanism of action that provides symptom relief with pentoxifylline is poorly understood but is thought to involve red blood cell deformability as well as a reduction in fibrinogen concentration, platelet adhesiveness and whole blood viscosity. The recommended dose of pentoxifylline is 400 mg three times daily with meals. Cilostazol is a potent, reversible, phosphodiesterase III inhibitor. The inhibition of phosphodiesterase allows for the increased availability of cyclic adenosine monophosphate (cAMP). cAMP mediates many agonist-induced platelet inhibitory, vasodilatory and vascular antiproliferative responses. Cilostazol, at a dose of 100 mg twice daily, is recommended to be taken 30 minutes before or 2 hours after breakfast and dinner. In addition to pentoxifylline and cilostazol, clinical trials indicate many other drugs may relieve the symptoms of intermittent claudication. Ginkgo biloba, available as an over-the-counter extract, provides symptom relief comparable to pentoxifylline. Two European agents, naftidrofuryl and buflomedil, also have efficacy that is reported to be similar to pentoxifylline. Policosanol is a mixture of fatty alcohols derived from honeybee wax which, according to very limited data, reduces symptoms of claudication. Amino acids, certain peptides and prostaglandins may have a therapeutic role. Finally, novel approaches including angiogenesis mediated by growth factors, are currently under investigation.

Animals↗
PubMed1996

Functional outcome after surgical treatment for intermittent claudication.

PURPOSE: Although patency data for lower extremity bypass grafts are readily available, few reports have focused on patients' satisfaction after surgical reconstruction for claudication. We reviewed our experience with surgical treatment for claudication, focusing on late outcome from the patients' perspective to further refine surgical decision making in patients with intermittent claudication. PATIENTS AND METHODS: From February 1987 through April 1994, 114 consecutive patients underwent surgical bypass for intermittent claudication. Nine patients were lost to follow-up, leaving the study cohort composed of 105 patients with a mean age of 63 years (range 42 to 82 years). Sixty-two percent of the procedures were inflow reconstructions, and the remainder were infrainguinal bypasses. Clinical and demographic data were gathered from record review, and late follow-up was obtained by return visit or telephone interview. Patient satisfaction and level of function were assessed by a simple five-point questionnaire administered by a research nurse. Actuarial methods were used to calculate late graft patency and survival. Cox regression analysis was used to identify clinical and anatomic factors predictive of late survival and favorable outcome. RESULTS: Cardiac risk assessment revealed that 75% of patients either had no clinical markers for cardiac disease or had been treated with previous coronary artery bypass grafting or percutaneous transluminal angioplasty; despite this 61% of patients underwent specific preoperative cardiac testing. Most (68%) inflow procedures were aortobifemoral bypass grafts, and 93% of outflow procedures were femoropopliteal bypass grafts. Two thirds of infrainguinal grafts were performed with autogenous conduits, with prosthetic femoropopliteal bypass grafts performed only to the above-knee popliteal artery. Early graft failure with successful immediate revision occurred in 5% of patients. No operative deaths or early or late amputations occurred. At a mean follow-up of 4.5 years 96% of surviving patients had a patent graft. However, primary unassisted patency at 4 years was superior for inflow (92% +/- 4%) versus outflow (81% +/- 6%) procedures (p = 0.009). Late readmission for cardiac-related events occurred in 12%, and late cardiac-related death occurred in 5%. Actuarial survival at 5 years was 80% +/- 5%, with diabetes being the only negative survival predictor (risk ratio 2.6, 95% confidence interval 1 to 7, p = 0.049); 60% of late deaths were cancer-related. Satisfactory late results were reported by 82% of patients, with age < or = 70 years (odds ratio 4.01, 95% confidence interval 1.2 to 13.7, p = 0.026) and normalization ( > or = 0.85) of ankle/brachial index (odds ratio 5.7, 95% confidence interval 1.6 to 20, p = 0.008) being powerful independent predictors of patient satisfaction. CONCLUSIONS: After considering cardiac-related short- and long-term prognosis, we conclude that lower extremity bypass grafting for intermittent claudication will produce optimal results when restricted to younger ( < 70 years) nondiabetic patients in whom near normalization of the postoperative ankle/brachial index can be anticipated.

Blood Vessel Prosthesis↗
PubMed1982

Aorto-iliac reconstructions for intermittent claudication.

Over a 12-year period, 290 aortofemoral reconstructions were performed for intermittent claudication involving 449 legs in 262 patients. The accumulative patency rate in surviving patients was 79 per cent at 5 years. The patency rate was significantly better in patients who stopped smoking after operation, and in men compared with women. Dacron grafts were significantly more successful than endarterectomy in men. If there was no associated superficial femoral artery occlusion, endarterectomy and Dacron bypass grafts were equally successful, but Dacron bypass grafts were significantly superior to endarterectomy if the superficial femoral artery was severely stenosed or occluded. The success rates for improving the patients' intermittent claudication were 90 per cent at 3 months and 72 per cent at 3 years. The success rate at 3 years was 80 per cent if the superficial femoral artery was patent but only 62 per cent if the superficial femoral artery was severely stenosed or occluded. Mortality and morbidity rates fell markedly in the last 6 years of the study.

Aorta↗
PubMed1991

[The fate of patients with intermittent claudication--comparison of surgical and non-surgical treatment].

The purpose of this study was to determine the operative indication for patients with intermittent claudication because of arteriosclerosis obliterans, and to compare the late result of the surgical treatment group (130 cases, 175 limbs) with that of the non-surgical treatment group (27 cases, 31 limbs). There were 3 operative deaths and 21 late deaths in the surgical group, and 11 late deaths in the non-surgical group. The number one cause of death was heart failure, including ischemic heart disease, in both groups. The 5-year cumulative patency rate was 92.5% in the aorto-iliac, 70.6% in the femoro-distal and 82.0% in the aorto-femoro-distal arterial reconstructions. Long term symptom free rates of the surgical group and the non-surgical group, except fatal cases, were 87.2% and 25.0% in the aorto-iliac, 57.7% and 25.0% in the femoro-distal, 86.7% and 0% in the aorto-femoro-distal arterial regions, respectively. Late result of intermittent claudication in the surgical group was better than that in the non-surgical group. We conclude that intermittent claudication should be considered to be the indication for surgery, except for the cases with high risk diseases or malignant diseases.

Female↗
PubMed1991

Pentoxifylline in the nonoperative management of intermittent claudication.

To assess the clinical effectiveness of pentoxifylline (Trental) in the treatment of intermittent claudication and ischemic rest pain, 129 patients were retrospectively interviewed with respect to compliance and improvement of symptoms. Risk factors for the development of atherosclerosis were tabulated, as was the severity of symptomatic lower extremity peripheral vascular insufficiency. The duration of pentoxifylline treatment was 35.8 +/- 45.0 weeks (mean +/- 1 S.D.). Forty-eight percent of the patients discontinued pentoxifylline on their own, most commonly because of side effects (13%) or perceived lack of improvement (23%). Of those patients taking pentoxifylline for eight weeks or more (n = 110), 64% noted some improvement, with 31% reporting increased claudication distance and 52% reduced claudication pain. Pentoxifylline provided pain relief in 52% of patients with ischemic rest pain (n = 27). Neither diabetes, hypertension, concomitant antiplatelet therapy, the severity of claudication, nor pretreatment ankle-brachial Doppler pressures were related to treatment outcome. Increased daily walking exercise during treatment was associated with successful outcome (p = 0.04). Clinical response to pentoxifylline was inversely related to the number of cigarettes smoked daily in those with 1 block claudication (n = 71, p = 0.05). Pentoxifylline was not very effective in increasing reported claudication distance. This review suggests that pentoxifylline may be of value for patients with ischemic rest pain when arterial reconstruction is not possible. Whether pentoxifylline is useful adjunctive therapy for intermittent claudication requires further scrutiny.

Aged↗
PubMedDate not supplied

Ketanserin in intermittent claudication. A double-blind placebo-controlled study.

Twenty patients with intermittent claudication and having an ankle/arm blood pressure ratio less than or equal to 0.75 were randomized to receive ketanserin 40 mg b.i.d. or placebo for three months under double-blind conditions following a six-week run-in period. A placebo was administered for an additional six weeks at the end of the double-blind phase. Results indicated that ketanserin significantly increased (p less than 0.04) the pain-free walking distance by 36% versus a non-significant 10% rise with placebo. During the run-out period, this parameter remained significantly increased (p less than 0.04) with ketanserin. Changes in the total walking distance during the double-blind period were 15% and 11% for ketanserin and placebo, respectively, with a significant (p less than 0.05) increase to 30% occurring in the ketanserin group during the run-out phase. There was a decrease in the ankle/arm blood pressure ratio in the worst leg in both groups. The rise of systemic blood pressure after exercise was attenuated with ketanserin. Side-effects were reported in only one patient in the placebo group. These data indicate that ketanserin may be of value in patients suffering from intermittent claudication. Other studies are, however, warranted to determine whether this beneficial effect is general or restricted to a subgroup of patients.

Aged↗