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[The effect of Ginkgo biloba extract in patients with intermittent claudication].

Eighteen patients with stable intermittent claudication were randomized in a double blind cross-over study comparing the effects of the Ginkgo biloba extract GB-8 at a dose of 120 mg o.d. with placebo. All patients were treated for three months with the active extract and three months with placebo. The effects of treatment on arterial insufficiency were quantified by measurements of systemic and peripheral systolic blood pressures, and pain-free and maximal walking distances on a tread-mill. Questionnaires based on visual analogue scales were used to quantify the severity of leg pain, impairment of concentration, and inability to remember. Short-term memory was objectively assessed. We did not find any significant changes in either peripheral blood pressures, walking distances or the severity of leg pain. Systemic blood pressure was reduced both by placebo and GB-8. The impairment of concentration and the inability to remember were both reduced, when comparing results during active treatment to placebo. Short-term memory did not change significantly. In conclusion, our study has shown that treatment with the Ginkgo biloba extract GB-8 improves some cognitive functions in elderly patients with moderate arterial insufficiency, whereas the extract did not change signs and symptoms of vascular disease in the patients.

Aged↗

The effects of pentoxifylline on patients with intermittent claudication.

All patients who had intermittent claudication (IC) over an 18-month period were given prescriptions for pentoxifylline (PTFX) 400 mg, three times daily. Patients were required to purchase their medication at a cost of $28 to $35 per month. The drug was administered regardless of the severity of symptoms, and no patient was offered operation without at least a 6-week trial of PTFX. An assessment of the severity of IC was made at the initial visit based on noninvasive data and the impact of the IC on the patient's life-style. One hundred thirty patients were enrolled in the study and were followed for 9 +/- 1 months. Patients were seen every 2 months for treadmill exercise or induced hyperemic testing and interviews until the effects of the medication were determined. The duration of IC before the start of treatment had no effect on the results. IC did not improve in 88 patients (71%) followed for 7.2 +/- 1 month. Thirty-six of these patients stopped the drug themselves because there was no benefit and the expense of PTFX was a hardship. An initial but short-lived improvement in walking was noted in another 13 patients (10%) following 14 +/- 2 months, and the medication was eventually discontinued. Only 23 patients (19%) followed for 11.6 +/- 2 months felt that IC had improved to the point where they did not feel limited in any way. Gastrointestinal symptoms occurred in 13 patients and were severe in eight patients (6%) who stopped taking the medication. The results of PTFX in this group of patients with IC were disappointing at best.(ABSTRACT TRUNCATED AT 250 WORDS)

Drug Evaluation↗

The prevalence of intermittent claudication. Sex-related differences have been eliminated.

OBJECTIVES: to investigate the prevalence of intermittent claudication (IC) in an unselected population of nearly 20000 individuals between 40 and 69 years of age. DESIGN: epidemiologic investigation of residents in Nord-Trøndelag County, Norway. MATERIAL AND METHODS: between 1995 and 1997, all residents 20 years of age or older in Nord-Trøndelag County, Norway, were invited to attend the HUNT Study. A total of 19748 participants between 40 and 69 years of age responded to questions related to the symptoms of intermittent claudication. We estimated the prevalence of IC based on these questions. RESULTS: the age-adjusted prevalence of intermittent claudication in the total population was 1.1% for men and 1.2% for women. We found an increase in the prevalence of IC by age, however, no sex differences were observed. CONCLUSION: the prevalence of intermittent claudication increased gradually by age. However, in contrast to previous reports, there was no difference by sex.

Adult↗

Intermittent claudication, heart disease risk factors, and mortality. The Whitehall Study.

In the Whitehall study, 18,388 subjects aged 40-64 years completed a questionnaire on intermittent claudication. Of these subjects, 0.8% (147) and 1% (175) were deemed to have probable intermittent claudication and possible intermittent claudication, respectively. Within the 17-year follow-up period, 38% and 40% of the probable and possible cases, respectively, died. Compared with subjects without claudication, the probable cases suffered increased mortality rates due to coronary heart disease and cerebrovascular disease, but the mortality rate due to noncardiovascular causes was not increased. Possible cases demonstrated increased mortality rates due to cardiovascular and noncardiovascular causes. This difference in mortality pattern may be due to chance. Possible and probable cases still showed increased cardiovascular and all-cause mortality rates after adjusting for coronary risk factors (cardiac ischemia at baseline, systolic blood pressure, plasma cholesterol concentration, smoking behavior, employment grade, and degree of glucose intolerance). Intermittent claudication is independently related to increased mortality rates. It is not a rare condition, and simple questionnaires exist for its detection. The latter can be usefully incorporated in cardiovascular risk assessment and screening programs.

Adult↗

Haemostatic and rheological factors in intermittent claudication: the influence of smoking and extent of arterial disease.

Patients with intermittent claudication have been reported to have disturbances in blood rheology and haemostasis. Whether these disturbances are a result of, or largely independent of, smoking history and arterial narrowing has not yet been established. The levels of whole blood and plasma viscosity, haematocrit, von Willebrand factor antigen, fibrin D-dimer antigen and urinary fibrinopeptide A antigen were compared in 617 claudicants and 722 controls from two epidemiological studies in Edinburgh. After adjustment for age and sex, all factors, except whole blood viscosity and haematocrit, were significantly higher in the claudicants compared to controls (P < or = 0.001). The risk of intermittent claudication was significantly raised for unit change in each factor, except for whole blood viscosity and haematocrit. Adjustment for lifetime smoking had little effect on the odds ratios. After further adjustment for the ankle brachial pressure index (as a measure of the extent of peripheral arterial disease), haematocrit, von Willebrand factor and urinary fibrinopeptide A showed a significant independent relationship with the risk of intermittent claudication. We conclude that the association between selected rheological and haemostatic factors and leg ischaemia is largely independent of both smoking history and the extent of arterial narrowing, and may be directly related to microvascular ischaemia.

Aged↗

Natural history of physical function in older men with intermittent claudication.

PURPOSE: This study was undertaken to determine the natural history of physical function in older men limited by intermittent claudication. METHODS: Forty-three men limited by intermittent claudication (mean age, 69 +/- 7 years) were recruited and followed up for 18 months. At baseline the patients reported a history of intermittent claudication for 6.1 +/- 6.1 years, and were able to walk for 1.9 +/- 1.6 blocks before experiencing claudication pain. Measurements during the 18-month study included ankle-brachial index (ABI), calf blood flow, 6-minute walk performance, monitored and self-reported physical activity, self-reported stability while walking, and summary performance score of physical function determined from a 4-m walk test, a chair stand test, and a tandem stand test. RESULTS: Pain-free walking distance during the 6-minute walk test decreased by 22% (P <.05) from baseline (185 +/- 96 m) to follow-up (144 +/- 93 m), and the total 6-minute walk distance decreased by 9% (P <.05), from 368 +/- 106 m to 334 +/- 90 m. Furthermore, monitored physical activity decreased by 31% (P <.05), from 159 +/- 151 kcal/d to 110 +/- 137 kcal/d; self-reported physical activity declined by 27% (P <.05), from 1.5 +/- 1.0 units to 1.1 +/- 0.8 units; tandem stance time declined by 14% (P <.05), from 9.46 +/- 1.83 seconds to 8.12 +/- 2.10 seconds; summary performance score of physical function decreased by 12% (P <.05), from 6.8 +/- 2.4 units to 6.0 +/- 2.4 units; and the percentage of patients reporting ambulatory unsteadiness and stumbling increased from 28% to 43% (P <.05). Calf blood flow measured at rest declined by 18% (P <.05), from 3.72 +/- 1.81 (mL/100 mL(-1)/min(-1)) to 3.04 +/- 1.43 mL/100 mL(-1)/min(-1), whereas ABI did not change (P >.05). CONCLUSION: Older men limited by intermittent claudication experienced decline in ambulatory function, physical activity, physical function, stability, and calf blood flow over 18 months of follow-up, despite no change in ABI.

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Quality of life in patients with intermittent claudication: relationship with laboratory exercise performance.

In patients with peripheral arterial disease, limitation of exercise capacity will reduce the level of everyday physical activity and affect the quality of life. This study was designed (1) to examine the health-related quality of life of patients with intermittent claudication, and (2) to verify whether treadmill performance is related to the patient's perceived ability to function in the community. In 251 patients with intermittent claudication and 89 matched normal subjects, quality of life was assessed by a general health index questionnaire, the McMaster Health Index Questionnaire (MHIQ), which covers three dimensions of life (physical, social and emotional function). The maximal walking capacity of intermittent claudication patients was measured by the treadmill test. When controls were compared to intermittent claudication patients using the MHIQ, it was found that intermittent claudication patients showed a significant (p < 0.01) impairment of 'general health' and lower scores for physical (0.90 +/- 0.17 vs 0.65 +/- 0.17; p < 0.01), social (0.71 +/- 0.11 vs 0.63 +/- 0.12; p < 0.01) and emotional (0.75 +/- 0.17 vs 0.65 +/- 0.15; p < 0.01) function. Age, gender and work status had a significant impact upon health scores in several areas. Treadmill performance did not correlate with social or emotional function, whereas there was a small but significant relationship between maximal walking capacity and physical function scores (r = 0.197; p < 0.01). This study suggests that impairment in quality of life experience by patients with intermittent claudication poorly correlates with the reduced exercised capacity assessed by the treadmill test. Therefore, the evaluation of medical and surgical treatment of intermittent claudication should include the administration of a questionnaire for quality of life assessment.

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Cost effectiveness of cilostazol compared with naftidrofuryl and pentoxifylline in the treatment of intermittent claudication in the UK.

OBJECTIVE: To estimate the cost effectiveness of cilostazol (Pletal) compared to naftidrofuryl and pentoxifylline (Trental) in the treatment of intermittent claudication in the UK. DESIGN AND SETTING: This was a modelling study on the management of patients with intermittent claudication who are 40 years of age or above and have at least six months history of symptomatic intermittent claudication, secondary to lower extremity arterial occlusive disease. The study was performed from the perspective of the UK's National Health Service (NHS). METHODS: Clinical outcomes attributable to managing intermittent claudication were obtained from the published literature and resource utilisation estimates were derived from a panel of vascular surgeons. Using decision analytical techniques, a decision model was constructed depicting the management of intermittent claudication with cilostazol, naftidrofuryl and pentoxifylline over 24 weeks in the UK. The model was used to estimate the cost effectiveness (at 2002/2003 prices) of cilostazol relative to the other treatments. MAIN OUTCOME MEASURES AND RESULTS: Starting treatment with cilostazol instead of naftidrofuryl is expected to increase the percentage improvement in maximal walking distance by 32% (from 57% to 75%) for a 12% increase in NHS costs (from 801 pounds sterling to 895 pounds sterling). Treatment with cilostazol instead of pentoxifylline is expected to increase the percentage improvement in maximal walking distance by 67% (from 45% to 75%) and reduce NHS costs by 2% (from 917 pounds sterling to 895 pounds sterling). Treatment with naftidrofuryl instead of pentoxifylline is expected to increase the percentage improvement in maximal walking distance by 27% (from 45% to 57%) and decrease NHS costs by 14% (from 917 pounds sterling to 801 pounds sterling). CONCLUSION: Within the limitations of our model, starting treatment with cilostazol is expected to be a clinically more effective strategy for improving maximal walking distance at 24 weeks than starting treatment with naftidrofuryl or pentoxifylline and potentially the most cost effective strategy. Moreover, the acquisition cost of a drug should not be used as an indication of the cost effectiveness of a given method of care.

Adult↗

The intermittent claudication questionnaire: a patient-assessed condition-specific health outcome measure.

INTRODUCTION: As yet, there is no patient-assessed, condition-specific instrument for the assessment of health-related quality of life in intermittent claudication. We evaluated the intermittent claudication questionnaire (ICQ) for properties required of a measure of health outcome. METHODS AND RESULTS: Interviews with patients with intermittent claudication and vascular specialist opinion produced a pool of statements used to itemize a self-completed ICQ. This was piloted in 20 patients for practicality and then administered to 124 stable claudicants. Reliability was assessed through a retest in 63 (51%) patients at 14 days and analysis of Cronbach's alpha for internal consistency. Spearman's correlation coefficient was used to assess construct validity in comparisons between the ICQ and ankle brachial pressure index, treadmill-walking distances, the walking impairment questionnaire, the EuroQol, and the Short Form-36. Responsiveness of the ICQ to changes in health was assessed in 60 patients treated conservatively and 40 patients undergoing angioplasty. The standardized response mean was used to identify the most responsive instrument in the study. A 16-item ICQ with a test-retest intraclass correlation of 0.95 and Cronbach's alpha of.94 was produced. One hundred twenty-one (98%) patients completed the ICQ (mean time, 3.7 minutes). The ICQ correlated better with the EuroQol (r = 0.58) and 7 out of 8 subscales of the Short Form-36 (r = 0.33-0.68) compared with the walking impairment questionnaire. The ICQ demonstrated the largest standardized response mean in relation to health transition compared with the other instruments. CONCLUSIONS: The patient-assessed ICQ is a practical, reliable, valid, and responsive measure of patient health-related quality of life in intermittent claudication.

Adult↗

Reduction of remnant lipoprotein cholesterol concentrations by cilostazol in patients with intermittent claudication.

BACKGROUND: Elevated triglyceride-rich lipoproteins and reduced high-density lipoproteins (HDL) are associated with the development of intermittent claudication (IC), a life-limiting symptom of peripheral arterial disease. Cilostazol, a potent platelet inhibitor and vasodilator, lowers triglycerides and increases HDL concentrations in addition to increasing walking distance in patients with intermittent claudication. However, the association of remnant lipoproteins (a more atherogenic subset of triglyceride-rich lipoproteins) and peripheral arterial disease and the effects of cilostazol on remnant lipoproteins have not been studied. METHODS AND RESULTS: We quantified plasma remnant lipoprotein concentrations using the remnant lipoprotein-cholesterol assay (RLP-C). Patients with intermittent claudication (n = 415) had significantly higher remnant lipoprotein concentrations compared to reference subjects (n = 874; 0.31 +/- 0.32 versus 0.24 +/- 0.17 mmol/l, P < 0.001) in addition to elevated total triglyceride (2.67 +/- 1.92 versus 1.92 +/- 1.24 mmol/l, P < 0.001) and reduced high-density lipoprotein (HDL) cholesterol concentrations (1.06 +/- 0.31 versus 1.22 +/- 0.36 mmol/l, P < 0.001). Cilostazol treatment (100 mg, b.i.d.) in patients with intermittent claudication (n = 56) for 6 months resulted in 20% reduction of remnant lipoprotein-cholesterol (from 0.27 +/- 0.21 to 0.22 +/- 0.09 mmol/l, P < 0.05) versus no significant change (from 0.26 +/- 0.17 to 0.27 +/- 0.12 mmol/l) in the placebo group (n = 67). Cilostazol also reduced triglyceride concentrations significantly (from 2.32+/-1.46 to 1.79+/-0.72 mmol/l, P < 0.01, in the cilostazol group versus 2.38 +/- 1.39 to 2.25 +/- 1.19 mmol/l in the placebo group) and increased HDL cholesterol concentrations (from 1.06 +/- 0.23 to 1.24 +/- 0.34 mmol/l, P < 0.001) in the cilostazol group versus no significant change (1.06 +/- 0.34 to 1.09 +/- 0.36 mmol/l) in the placebo group. Pentoxifylline (400 mg, t.i.d.) did not have any significant effects on lipid variables (n = 66). CONCLUSIONS: Remnant lipoprotein concentrations are significantly elevated in patients with intermittent claudication and can be reduced by cilostazol. Reduction of remnant lipoproteins may provide a long-term benefit to the patients with symptomatic peripheral arterial disease.

Aged↗

Cilostazol: treatment of intermittent claudication.

OBJECTIVE: To review the pharmacology and clinical utility of cilostazol, an antiplatelet and vasodilator agent approved for the management of intermittent claudication. DATA SOURCES: Primary literature on cilostazol was identified from a comprehensive MEDLINE literature search (1980-February 2000). Selected meeting abstracts and manufacturer literature were also used as source material. Indexing terms included cilostazol, intermittent claudication, platelet inhibitors, and restenosis. STUDY SELECTION: Human clinical, pharmacokinetic and randomized comparative trials performed in the US and Asia were reviewed. Selected in vitro, ex vivo, and animal studies were evaluated when human data were not available. DATA SYNTHESIS: Intermittent claudication, defined as reproducible discomfort of a muscle group induced by exercise and relieved by rest, is the most common clinical manifestation of peripheral arterial disease (PAD). Cilostazol, a specific inhibitor of cyclic adenosine monophosphate phosphodiesterase in platelets and vascular smooth-muscle cells, is a potent antiplatelet agent and vasodilator that reduces vascular proliferation and has lipid-lowering effects in vivo. Recent multicenter, randomized, placebo-controlled trials have led to approval of cilostazol by the Food and Drug Administration for relief of intermittent claudication in patients with stable PAD. Cilostazol doubled walking distances and improved quality of life compared with placebo in these studies. One trial found that cilostazol was more effective than pentoxifylline, the only alternative pharmacologic therapy for claudication. Although frequent (approximately 50%) minor adverse effects, including headache, diarrhea, and palpitations, may occur in clinical practice, cilostazol has not been associated with major adverse events or increased mortality. Small, nonblind studies suggest that cilostazol may prove useful in preventing thrombosis and restenosis following percutaneous coronary interventions, although these remain unlabeled uses. CONCLUSIONS: The unique combination of antiplatelet, vasodilatory, and antiproliferative effects of cilostazol appear to make it an attractive agent for use in patients with PAD. Clinical trials demonstrating a significant improvement in walking distances with cilostazol therapy suggest that it will be an important tool in improving symptoms and quality of life in patients with intermittent claudication.

Cilostazol↗

[Personality traits (type A) in patients with intermittent claudication. 1. Results of the Bortner test].

It has never been considered whether type A (coronary prone) behavior can also be found in patients with peripheral atherosclerotic disease (intermittent claudication). This question has been studied by means of the 14-item (Bortner) questionnaire. The questionnaire was filled out by 10 patients (self-assessment) with coronary artery disease and intermittend claudication, 13 with intermittent claudication alone and 10 with comparably severe, but not arteriovascular disease and independently by their wives (relative's assessment). In the self-assessment the test discriminated significantly between the three groups (Kruskal-Wallis p less than 0.05). The correlation coefficient (Spearman) between expression of type A behavior and extent of atherosclerosis was 0.3720 (p less than 0.02). In the relative's assessment the groups were also differentiated significantly (Kruskal-Wallis p less than 0.05). The correlation coefficient (Spearman) was 0.4080 (p less than 0.009). The results indicate that patients with intermittent claudication demonstrate a predilection for type A behavior, which is more pronounced in those with additional coronary artery disease. The multiple stepwise regression indicated that type A behavior is related to atherosclerosis independently of other factors.

Coronary Disease↗

Multicriteria decision analysis for determining drug therapy for intermittent claudication.

Drugs of various classes are prescribed for intermittent claudication. However, there is some discrepancy between medical practice and the scientific basis for drug selection. We have developed a quantitative criteria-based decision analysis to evaluate all implications of drug treatment choices for intermittent claudication. Pentoxifylline, buflomedil, naftidrofuryl and ticlopidine were the drugs selected for analysis. The evaluation criteria were 1) therapeutic efficacy, 2) safety, 3) patient acceptance and 4) cost. A review panel of experts determined the relative importance of each criterion by assigning points (or utility values) to each one. The points were 48, 20, 14 and 18, respectively, for criteria 1, 2, 3 and 4. A probability value, or numerical estimate of how well a drug meets a criterion, was assigned to each drug for each of the 4 criteria. The probability value was multiplied by the utility value to determine the score for each drug and criterion. The criteria points for each drug were added for a total score for the drug. The drug with the highest overall score was pentoxifylline, with 69 points out of an ideal score of 100. The rank order for the other drugs was buflomedil, ticlopidine and naftidrofuryl. A sensitive analysis showed that the relative ranking of the drugs remained unchanged over a series of data modifications.

Decision Support Techniques↗

A new pharmacological treatment for intermittent claudication: results of a randomized, multicenter trial.

BACKGROUND: Effective medication is limited for the relief of intermittent claudication, a common manifestation of arterial occlusive disease. Cilostazol is a potent inhibitor of platelet aggregation with vasodilation effects. OBJECTIVE: To evaluate the safety and efficacy of cilostazol for the treatment of intermittent claudication. METHODS: Thirty-seven outpatient vascular medicine clinics at regional tertiary and university hospitals in the United States participated in this multicenter, randomized, double-blind, placebo-controlled, parallel trial. Of the 663 screened volunteer patients with leg discomfort, a total of 516 men and women 40 years or older with a diagnosis of moderately severe chronic, stable, symptomatic intermittent claudication were randomized to receive cilostazol, 100 mg, cilostazol, 50 mg, or placebo twice a day orally for 24 weeks. Outcome measures included pain-free and maximal walking distances via treadmill testing, patient-based quality-of-life measures, global assessments by patient and physician, and cardiovascular morbidity and all-cause mortality survival analysis. RESULTS: The clinical and statistical superiority of active treatment over placebo was evident as early as week 4, with continued improvement at all subsequent time points. After 24 weeks, patients who received cilostazol, 100 mg, twice a day had a 51% geometric mean improvement in maximal walking distance (P<.001 vs placebo); those who received cilostazol, 50 mg, twice a day had a 38% geometric mean improvement in maximal walking distance (P<.001 vs placebo). These percentages translate into an arithmetic mean increase in distance walked, from 129.7 m at baseline to 258.8 m at week 24 for the cilostazol, 100 mg, group, and from 131.5 to 198.8 m for the cilostazol, 50 mg, group. Geometric mean change for pain-free walking distance increased by 59% (P<.001) and 48% (P<.001), respectively, in the cilostazol, 100 mg, and cilostazol, 50 mg, groups. These results were corroborated by the results of subjective quality-of-life assessments, functional status, and global evaluations. Headache, abnormal stool samples or diarrhea, dizziness, and palpitations were the most commonly reported potentially drug-related adverse events and were self-limited. A total of 75 patients (14.5%) withdrew because of any adverse event, which was equally distributed between all 3 treatment groups. Similarly, there were no differences between groups in the incidence of combined cardiovascular morbidity or all-cause mortality. CONCLUSION: Compared with placebo, long-term use of cilostazol, 100 mg or 50 mg, twice a day significantly improves walking distances in patients with intermittent claudication.

Adult↗

Effects of ethaverine hydrochloride on the walking tolerance of patients with intermittent claudication.

The effect of ethaverine hydrochloride on exercise tolerance of patients with intermittent claudication was evaluated in a double-blind, placebo-controlled study conducted at three sites. Forty-five patients with symptoms of occlusive arterial insufficiency of the lower extremities were randomly assigned to receive ethaverine 200 mg or placebo four times daily. The patients were evaluated biweekly for 12 weeks with treadmill claudication tests, patient and investigator assessments of symptom severity, and reports of adverse reactions. Doppler ankle/brachial pressure ratios were recorded for 26 patients. Walking tolerance improved for patients in both groups during the course of the study. Increases in distance-to-claudication were significantly greater for patients receiving ethaverine after 6, 8, 10, and 12 weeks of therapy. Ankle/brachial pressure index after exercise was unchanged in both groups. Incidence of adverse reactions was similar for the two groups. Although patients were generally unaware of any improvement in symptoms, the investigators judged significant relief of claudication among those receiving ethaverine compared to those receiving placebo. It was concluded that ethaverine safely increased distance-to-claudication in patients with intermittent claudication.

Ankle↗

The Baltimore activity scale for intermittent claudication: a validation study.

The purpose of this study was to develop and cross-validate the Baltimore Activity Scale for Intermittent Claudication (BASIC) questionnaire in patients with peripheral arterial disease limited by intermittent claudication, and to determine whether the BASIC questionnaire score changed following a supervised program of exercise rehabilitation. A total of 702 consecutive patients with peripheral arterial disease and stable intermittent claudication were characterized on physical activity level using the BASIC questionnaire and an accelerometer. The first 351 patients tested were included in the validation group, whereas the final 351 patients were included in the cross-validation group. Subsequently, 61 of these patients participated in a randomized, controlled trial in which 28 patients completed 6 months of exercise rehabilitation and 24 patients completed usual care control. The sum of 5 questions from the BASIC questionnaire (0-10 point scale) was predictive of daily physical activity using the following regression equation: Daily Physical Activity (kcal/day) = 102.2 + (49.6 x BASIC score); R = 0.76, R(2) = 0.58, standard error of estimate = 52.0 kcal/day, P < .0001. This equation was successfully cross-validated on an independent group of patients, as the predicted daily physical activity (339 - 181 kcal/day, mean - SD) was similar (P = .501) to measured daily physical activity (347 - 266 kcal/day, mean - SD). Furthermore, the BASIC score increased 38% following 6 months of exercise rehabilitation (P < .01), whereas no change was observed in the control group (P > .05). A composite of 5 questions obtained from the self-administered BASIC questionnaire accurately estimates daily physical activity in patients with peripheral arterial disease limited by intermittent claudication, and is sensitive to change in physical activity following a program of exercise rehabilitation.

Aged↗

Intermittent claudication: pharmacoeconomic and quality-of-life aspects of treatment.

The purpose of this article is to review the literature on the pharmacoeconomics of treatment for intermittent claudication and to discuss the importance of quality-of-life assessment for evaluating treatment strategies. Systemic risk reduction is the primary objective in the treatment of patients with intermittent claudication, as these patients have a high future risk of cardiovascular morbidity and mortality. Modification of cardiovascular risk factors accompanied by antiplatelet therapy is likely to improve overall survival, reduce myocardial infarction and stroke, and will, perhaps, also reduce the risk of ulcers and amputation at acceptable cost-effectiveness ratios. The second goal in the treatment of patients with intermittent claudication is to improve their walking capacity and community-based functional status. Supervised exercise training is the most effective noninvasive intervention to improve walking capacity, but may have elevated indirect costs. Among patients with disabling claudication who are candidates for invasive therapeutic procedures, angioplasty is cost effective in those with femoropopliteal stenosis or occlusion and in those with critical limb ischaemia and a stenosis. For all these therapeutic strategies there is a need to relate the costs to a relevant and comprehensive measure of effectiveness. Quality-of-life evaluation by using questionnaires exploring the specific problems encountered by patients with intermittent claudication in their daily life appear to be the most appropriate tool to evaluate the net result of a treatment. Cost-utility studies by combining pecuniary and quality-of-life evaluations provide information that is extremely useful to patients with intermittent claudication, regulatory authorities, the pharmaceutical industry and healthcare providers.

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