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PubMedDate not supplied

Pharmacological approaches to the treatment of intermittent claudication.

Intermittent claudication is a common condition of the elderly, occurring in 3 to 20% of individuals over the age of 65 years. Although local disease is usually benign, life expectancy in patients with intermittent claudication is reduced by approximately 10 years due to associated cardiovascular mortality. Several classes of drugs have been used in intermittent claudication, but clinical studies evaluating their efficacy leave much to be desired. Pentoxifylline (oxpentifylline), a rheological agent, and naftidrofuryl, an enhancer of aerobic metabolism, are the 2 most widely investigated and utilised drugs. The combined results of 10 placebo-controlled studies with pentoxifylline and 4 with naftidrofuryl estimate increases in claudication distances of 51 and 42%, respectively. However, due to publication bias, these figures are probably overestimates of the true benefit from treatment with these drugs. It is likely that any benefit from pentoxifylline or naftidrofuryl is small and of little clinical importance. The suggestion that naftidrofuryl has greater efficacy in older patients remains unproven. Other classes of drugs including vasodilators, antiplatelet drugs, anticoagulants and prostaglandins have not been shown to be effective. Only 2 approaches to the management of intermittent claudication have been shown convincingly to be of benefit: stopping smoking and exercising regularly.

Aged↗
PubMed1985

Does beta-blockade provoke intermittent claudication?

Intermittent claudication has been claimed to be a side-effect of beta-adrenoceptor blocking drugs. The confounding effect of coronary heart disease has not been controlled in earlier studies. In this case-control study, the cases were selected from a hospital material of patients with verified intermittent claudication and the controls from a nationwide health survey. The pool of potential cases and controls consisted of persons who had been treated with antihypertensives, but did not have coronary heart disease. The controls and cases were matched for age, sex, place of residence and time of examination. Comparison of current or previous use of beta-blocking drugs among our 55 case-control pairs revealed no association between intermittent claudication and beta-blockade. beta-Blockade is not a risk factor for intermittent claudication.

Adrenergic beta-Antagonists↗
PubMed2000

Impact of a 4-week treatment with prostaglandin E1 on health-related quality of life of patients with intermittent claudication.

Intermittent claudication impairs functional status and quality of life in many patients by limiting walking capacity. The aim of this study was to evaluate the effects of a 4-week treatment with prostaglandin E1 (PGE1), a drug inducing vasodilation and inhibiting platelet aggregation, on improving functional status and health-related quality of life in patients with disabling intermittent claudication. Forty-two untrained outpatients (37 men and five women, mean age 64 +/- 8 years) with intermittent claudication,and maximum walking distance (MWD) of at least 50 and no more than 200 m on treadmill test (5% slope, 3 km/hr) were randomized to 4 weeks of double-blind treatment either with 60 mcg PGE1 daily given IV in 250 mL saline over a period of 2 hours (21 patients) or placebo (250 mL saline, 21 patients). Treatment-free follow-up was completed 8 weeks after the final infusion. Pain free walking distance (PFWD), MWD, and questionnaire evaluation were determined at baseline, after the 4-week treatment period, and at the end of the 8 weeks of the treatment-free follow-up period. After 4 weeks of treatment with PGE1 PFWD and MWD increased from 72 +/- 16 m to 135 +/- 33 m (+87%, p<0.001)and from 140 +/- 30 m to 266 +/- 62 m (+90%, p<0.001), respectively. Analysis of the Walking Impairment Questionnaire responses in the PGE1 group at 4 weeks demonstrated significant improvements in the walking impairment score (+19 percentage points, p<0.001), in the distance score (+25 percentage points, p<0.001), in the speed score (+24 percentage points, p<0.001), in the stair climbing score (+20 percentage points, p<0.001). The RAND survey responses showed improvements in physical function and bodily pain scores (+14 percentage points, p<0.001, and +15 percentage points, p<0.01, respectively). After the treatment-free follow-up period of 8 weeks, increases in PFWD and MWD were maintained (113 +/- 26 m, +57%, p<0.001, and 229 +/- 55 m, +63%, p<0.001, respectively). Similarly, at the end of the treatment-free follow-up, the walking impairment score (+16 percentage points, p<0.001), the distance score (+23 percentage points, p<0.001), the speed score (+22 percentage points, p<0.001), the stair climbing score (+18 percentage points, p<0.001) as well as the RAND physical function and bodily pain scores (+10 percentage points, p<0.001, and +13 percentage points, p<0.01, respectively) were still increased compared with baseline. No change from baseline was found in all the target parameters in the placebo group after 4 weeks of treatment and at the end of the treatment-free follow-up period. These data show that a 4-week treatment with PGE1 improves functional status and quality of life as well as treadmill performance in patients with disabling intermittent claudication as compared with placebo-treated patients. The improvements are also maintained for a period of 8 weeks beyond the end of the treatment. Additional studies are needed to determine the duration of functional benefits after the end of treatment.

Aged↗
PubMed1990

Peripheral arterial occlusive disease: conservative treatment of intermittent claudication.

Intermittent claudication is the principal symptom in stage II of peripheral arterial occlusive disease. As this is a multilocular manifestation of atherosclerosis, a distinction must be drawn between treatment of the underlying disease with consideration of the individual risk factors and improvement and abolition of the intermittent claudication. Various therapeutic principles exist, and drug therapy is the subject of controversial discussion. On the basis of eight controlled, randomized studies, it was demonstrated that in comparison with placebo a statistically significant increase in the pain-free walking distance can be achieved by oral drug administration within 3-6 months. This drug therapy should be considered for those patients with intermittent claudication who cannot undergo revascularization, angioplasty, or walking training.

Aged↗
PubMed2003

The role of cilostazol (Pletal) in the management of intermittent claudication.

Intermittent claudication affects 5% of the middle-aged population in developed countries and is associated with a significant reduction in health-related quality of life and cardiovascular morbidity and mortality. The mainstay of treatment is best medical therapy (BMT) comprising smoking cessation, antiplatelet agents, lipid-lowering, advice to exercise, and correction of other modifiable vascular risk factors. Although BMT is highly effective in reducing cardiovascular risk and may also improve walking distance, many patients remain unacceptably symptomatic despite it. Until recently, the only available adjuvant therapies were supervised exercise programmes, angioplasty and surgery. Many patients are unable to comply with the first, and the last two are associated with limited durability and risk. The advent of cilostazol (Pletal) adds evidence-based pharmacotherapy to the vascular specialist's armamentarium for the first time. Here cilostazol and its role in the management of intermittent claudication are discussed.

Aged↗
PubMedDate not supplied

Intermittent claudication.

Intermittent claudication is a painful, debilitating condition that reduces mobility in those affected and has a detrimental effect on quality of life. It is often the first symptom of peripheral arterial disease. This article explains the aetiology of intermittent claudication, the associated risk factors, vascular assessment and the nursing care involved in conservative treatment.

Activities of Daily Living↗
PubMed2001

Proteinuria in a placebo-controlled study of basic fibroblast growth factor for intermittent claudication.

Intermittent claudication is the most common symptom of peripheral arterial disease (PAD), in part due to an inadequate rise in limb blood flow with exercise. Claudication causes a severe impairment in functional capacity and quality of life in over 3 million Americans. Basic fibroblast growth factor (bFGF) stimulates angiogenesis in vivo and improves limb blood flow in several animal models of hindlimb ischemia. However, the relative safety and efficacy of angiogenic molecules in the treatment of claudication has not been fully evaluated in prospective, blinded clinical trials. In this study, a randomized, double-blind, placebo-controlled, phase II trial of recombinant human bFGF for the treatment of intermittent claudication was performed. bFGF was administered weekly by intravenous infusions of 2 microg/kg for 6 sequential weeks (total dose 12 microg/kg). The primary efficacy endpoint was change in peak walking time (PWT) on a graded exercise treadmill protocol. Secondary efficacy endpoints included changes in functional status as measured by validated questionnaires. The study was stopped prematurely after treatment of the first 24 subjects due to proteinuria in five of the 16 subjects who received systemic bFGF, which exceeded 1000 mg/24 h in four of these five subjects. The small sample size limited evaluation of the predefined efficacy endpoints; however, there was no significant difference between the treatment and control groups for any of the measures of efficacy. In conclusion, intravenous administration of bFGF delivered at low doses weekly for 6 weeks was associated with a high rate of severe proteinuria. It is speculated that bFGF-related proteinuria in this study was primarily related to the systemic route of administration and the frequent dosing schedule. Future clinical trials of bFGF protein should carefully monitor renal function and consider alternative dosing schedules and drug administration routes.

Aged↗
PubMed2001

Endovascular and surgical revascularization for patients with intermittent claudication.

Intermittent claudication (IC), the most common symptom of peripheral arterial disease (PAD), most often results from flow-reducing lesions in the arteries of the lower extremity that cause exercise-induced muscle ischemia. Intermittent claudication has a significant impact on quality of life and calls attention to PAD, which is secondary to systemic atherosclerosis and a major marker for cardiovascular morbidity and mortality. Most IC patients improve with a regimen that includes aggressive risk-factor modification, exercise, platelet inhibition, and pharmacotherapy to improve walking distance. Selected patients may require endovascular or surgical intervention if it can be offered with low risk. Endovascular procedures, most often percutaneous balloon angioplasty with or without stenting, are recommended for short-segment stenotic lesions in the aortoiliac and infrainguinal arterial segments. Combined platelet inhibition and endoluminal radiation are under study and may be useful to improve long-term outcome with these procedures. Percutaneous hemostatic puncture closure devices can also be used to reduce bleeding complications and allow more aggressive and immediate antithrombotic therapy, further improving results. Operative revascularization is recommended for patients with long-segment and multisegment disease, especially if obstruction is present. Aortofemoral reconstruction is associated with a low operative mortality and an 80% to 85% 5-year patency rate. Iliac reconstruction is recommended for isolated unilateral iliac arterial disease. Infrainguinal arterial reconstruction is associated with a 60% to 80% 5-year patency rate, with better outcomes noted for autogenous conduits than for prosthetic devices. Mechanical modification and pharmacotherapy with platelet inhibitors and anticoagulants improve long-term patency.

Anastomosis, Surgical↗
PubMed1999

Exercise and nursing therapy for patients with intermittent claudication.

Intermittent claudication is a common manifestation of arterial disease in the second half of life. Invasive treatments may be inappropriate or unsuccessful, leaving patients with a significant handicap. Nursing intervention can improve the functional ability and the general well-being of many patients. This paper provides an account of the development of an out-patient nursing service for patients with intermittent claudication. It focuses on the exercise training and the psychological support given to patients. A review of the first 102 claudicants referred to the programme shows the outcome for the patients in terms of improved walking ability. The details of the nursing intervention reported in the paper should help the growing number of nurses starting similar programmes for vascular patients. They may also be of interest to nurses caring for patients with other chronic health problems.

Adult↗
PubMed2000

Diagnosis and medical management of patients with intermittent claudication.

Intermittent claudication is a symptom complex associated with atherosclerosis of the aorta and lower extremities. It is a clinical marker of systemic atherosclerosis, and therefore, management cannot be considered isolated from treatment of underlying risk factors of atherosclerosis. The focus of the management is twofold. The first is to reduce morbidity and mortality from cardiovascular events, including myocardial infarction and stroke. The second focus is to improve the functional status of patients who have impairment of daily activities secondary to symptoms of claudication through pharmacologic and rehabilitative means, that is, exercise. Exercise is the cornerstone of therapy. A conservative approach is favored in patients who have mild and moderate symptoms of claudication. Intervention with percutaneous techniques or surgery is generally reserved for patients who have severe impairment of lifestyle or threatened tissue.

Activities of Daily Living↗
PubMed2002

Management of patients with intermittent claudication.

Intermittent claudication, the most common symptomatology of peripheral arterial disease, is characterised by lower-extremity discomfort induced by exercise and relieved by rest. The most serious potential outcome of the condition is increased morbidity and mortality from cardiovascular disease, with which it is often associated, thus prompt diagnosis and management are crucial. Therapy consists of structured exercise and reduction of cardiovascular risk factors, followed by or together with pharmacological interventions with anticlaudicants (cilostazol or pentoxifylline) and specific antiplatelet agents (aspirin, clopidogrel). Revascularisation procedures are indicated in those with limb-threatening or lifestyle disabling disease.

Aspirin↗
PubMed1992

[Intermittent claudication].

Intermittent claudication is a symptom triggered from the musculature during walking. The pathogenesis of the pain is unknown. All patients with peripheral vascular disease must abstain from smoking, perform physical exercise and dietary advice is sometime needed. Reconstructive vascular surgery or percutaneous transluminal angioplasty (PTA) are indicated when the occupational pattern and, in some instances, the recreational activities, are threatened. The results of these treatments are good. For various reasons a number of patients, however, cannot be offered these treatments. These patients must be informed of the importance of physical exercise and discontinuation of smoking. Some of these patients can be offered supplementary medical treatment (e.g. pentoxifylline).

Diagnosis, Differential↗
PubMed2001

Pharmacotherapy of intermittent claudication.

Intermittent claudication (IC) is leg muscle pain, cramping and fatigue brought on by exercise and is the primary symptom of peripheral arterial disease. The goals of pharmacotherapy for IC are to increase the walking capacity/quality of life and to decrease rates of amputation. In 1988, pentoxifylline was the only drug that had reasonable supportive clinical trial evidence for being beneficial in IC. Since then a number of drugs have shown benefit or potential in IC. Cilostazol, a specific inhibitor of phosphodiesterase 3 and activator of lipoprotein lipase, clearly increases pain-free and absolute walking distances in claudicants. However, cilostazol does cause minor side effects including headache, diarrhoea, loose stools and flatulence. Naftidrofuryl, a serotonin (5-HT2) receptor antagonist and antiplatelet drug, is beneficial in claudicants. Inhibitors of platelet aggregation (including nitric oxide from L -arginine or glyceryl trinitrate) and anticoagulants (low molecular weight heparin, defibrotide) probably have both short and long-term benefits in IC. In addition, intravenous infusions of prostaglandins (PGs) PGE1 and PGI2 have an established role in severe peripheral arterial disease and the recent introduction of longer lasting and/or oral forms of the PGs makes them more likely to be useful in the IC associated with less severe forms of the disease. There are some exciting new approaches to the treatment of IC, including propionyl-L-carnitine and basic fibroblast growth factor (bFGF).

Animals↗
PubMed2002

Clinical manifestation of atherosclerotic peripheral arterial disease and the role of cilostazol in treatment of intermittent claudication.

Intermittent claudication (IC) is the symptomatic expression of peripheral arterial disease (PAD), which itself is a manifestation of systemic atherosclerosis. Like other forms of atherosclerosis, PAD is associated with elevated rates of cardiovascular and cerebrovascular morbidity and mortality. Until recently, therapeutic options for the treatment of the symptoms of IC have been limited, and the efficacy of available treatment has been questioned. Cilostazol, a selective phosphodiesterase III inhibitor with vasodilator, antiplatelet, and antiproliferative properties, has recently been approved for the treatment of IC symptoms in the United States. Cilostazol significantly improves maximal and pain-free walking distances. Clinical studies have also demonstrated that cilostazol favorably alters plasma lipids (elevates HDL-cholesterol, lowers triglycerides). These properties may contribute to the benefit of this drug in IC and in other diseases secondary to atherosclerosis.

Arteriosclerosis↗
PubMed2002

A rational approach to diagnosis and treatment of intermittent claudication.

Intermittent claudication (IC), the first recognizable symptom of peripheral arterial disease, is prevalent among older persons and associated with significant morbidity and mortality. The diagnosis of IC involves taking a thorough patient history, conducting a physical examination with an emphasis on the cardiovascular system, and noninvasive testing with functional assessment. The goals of treatment for IC are to prevent progression of vascular disease and cardiovascular complications and to improve exercise performance, functional status, and quality of life. The cornerstones of therapy are risk-factor modification, particularly smoking cessation, and exercise. In patients for whom non-pharmacologic therapy does not provide adequate pain relief and improvement in physical function, medical therapy with 1 of 2 drugs approved for the treatment of IC may be appropriate. Revascularization or intervention is generally reserved for patients with incapacitating disease. Early diagnosis of IC and implementation of effective therapy can reduce the development of morbidity and mortality.

Algorithms↗
PubMed2002

Measuring treatment effects of cilostazol on clinical trial endpoints in patients with intermittent claudication.

Intermittent claudication (IC) comprises the most common presenting symptoms of peripheral arterial disease (PAD), which itself is a manifestation of systemic atherosclerosis. Typical symptoms of IC are aching pain, numbness, and fatigue in the lower extremities. Symptoms are induced by walking or exercise and usually resolve with rest. The cornerstone of treating IC is risk-factor reduction and a supervised exercise regimen. Pharmacotherapy specifically indicated for the treatment of IC includes a new drug, cilostazol, and the traditional drug, pentoxifylline. Cilostazol also has antiplatelet, antithrombotic, and vasodilatory activity, as well as a positive effect on serum lipids. Eight multicenter clinical trials, seven in the U.S. and one in the U.K., used objective and subjective clinical endpoints to assess the treatment efficacy of cilostazol. Objective endpoints included maximal and pain-free walking distance (MWD and PFWD, respectively), the ankle-brachial index, peripheral hemodynamic measurements, and serum lipid levels. Subjective endpoints, assessed by patient questionnaires, included perceived functional status and health-related quality of life. Cilostazol treatment showed statistically significant increases in MWD and PFWD within 4 weeks, as well as improvements in physical functional status at 24 weeks, compared with placebo and pentoxifylline. Increases in high-density lipoprotein cholesterol and decreases in plasma triglycerides were also noted. Subjective assessments appeared to match objective parameters.

Aged↗
PubMed2000

The "galloping" history of intermittent claudication.

Intermittent claudication (IC) due to arterial occlusive disease was first diagnosed by the French veterinary surgeon Jean-François Bouley jeune in a horse drawing a cabriolet in the streets of Paris as early as 1831. The animal was repeatedly exercised and always started to limp with the hind legs at similar work loads. Autopsy revealed partially thrombosed aneurysm of the abdominal aorta and occlusions of both femoral arteries which were correctly identified as the cause of IC. In 1858 the famous neurologist Jean-Martin Charcot working at the Salpêtrière in Paris first discovered the condition in a patient, who was wounded by a bullet during the conquest of Algery and developed iliac artery aneurysm obliterated by a thrombus. He was aware of the first description in veterinary medicine. In Germany IC was also first mentioned in horses (Rademacher, 1838). 13 reports of patients were contributed by the neurologist Heinrich Erb in 1898 and 1904. Some interesting features of the phenomenon of IC like the amount of exercise necessary to provoke it, localization, social relevance, prolongation of the Achilles tendon reflex, decrease of maximal plantar flexion force of the foot and production of "Lewis factor p" are summarized. In human patients arteriosclerosis is the well recognized principal cause of arterial obstructions, in horses, however, the lesions are due to infection by the roundworm Strongylus vulgaris. In the fascinating life cycle the larvae migrate into the intima of small and large arteries and provoke aneurysms and intravascular thrombosis.

Animals↗
PubMed2001

Intermittent Claudication.

Intermittent claudication is the most common symptom in patients with peripheral arterial disease (PAD). As such, it is mandatory for clinicians to treat both the PAD-specific symptoms (to decrease functional impairment and thereby improve quality- of-life, as well as to decrease rates of amputation) and the underlying systemic atherosclerosis (and thereby reduce cardiovascular ischemic events, especially myocardial infarction and stroke). Most patients with claudication can successfully decrease their exertional limb symptoms via a combination of exercise (preferably supervised) and pharmacotherapeutic interventions (eg, cilostazol). Endovascular revascularization currently serves as an effective therapy for patients with high-grade stenoses of the proximal limb arterial segments, (eg, the distal aorta, common iliac artery, or external iliac artery, and occasionally the proximal common femoral artery). Surgical revascularization usually is reserved for patients who present with severe aortoiliac disease in whom long-term patency is likely to be achieved (eg, aortobifemoral or femoral-femoral bypass) and who have a low cardiovascular perioperative ischemic risk. Patients who undergo successful revascularization also are likely to benefit from exercise rehabilitation programs. All patients with PAD, of any severity, must successfully normalize atherosclerosis risk factors and use antiplatelet therapies. Such interventions include complete smoking cessation, glycemic control, normalization of blood pressure (less than 130/90 mm Hg), and lowering of low-density lipoprotein (LDL) cholesterol to less than 100 mg/dL. Antiplatelet agents (eg, clopidogrel, aspirin) should be prescribed to decrease rates of cardiovascular ischemic events in all patients with PAD, unless otherwise contraindicated.

Journal Article↗