[INTERMITTENT CLAUDICATION].
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The clinical efficacy of picotamide was investigated in a randomized, double-blind, placebo-controlled study in patients with peripheral occlusive arterial disease of the lower limbs at functional stage II of the Fontaine classification. Forty patients with a history of claudication for at least six months were admitted to the study and were given either 3 x 300 mg tablets of picotamide (20 subjects) or three identical placebo tablets (20 subjects) for six months. The two groups of patients were similar in regard to clinical features and potential risk factors. At the end of treatment painfree walking distance and systolic ankle-arm pressure ratio improved more in the picotamide than in the placebo group (p = 0.05). Systolic ankle pressure curves, determined before and after the six-month treatment, showed a positive trend to a higher postexercise ankle pressure and a faster return to the preexercise levels in the picotamide group; however, the difference was not statistically significant. Laboratory monitoring revealed a slight prolongation of bleeding time, a significant decrease in arachidonic acid-induced platelet aggregation, and an enhanced fibrinolysis with absence of interference with hemostasis in the picotamide group. One patient in the placebo group developed a major cardiovascular event (angina pectoris) during the study. These results indicate that picotamide is an effective drug that may modify the natural course of intermittent claudication and associated vascular problems.
BACKGROUND: The purpose of this study was to determine whether peripheral arterial disease (PAD) subjects have impaired balance and a higher prevalence of falls than non-PAD controls and to determine whether balance and falls are related to the severity of PAD and functional status. METHODS: A total of 367 PAD subjects (aged 68 +/- 1 years; mean +/- SEM) and 458 non-PAD controls (aged 67 +/- 1 years) were recruited. Unipedal stance time, history of ambulatory stumbling and unsteadiness, and history of falling were recorded. Additionally, subjects were characterized on age, ankle/brachial index (ABI), anthropometry, measured and self-reported ambulatory function, and monitored daily physical activity. RESULTS: Unipedal stance time was 28% shorter ( p <.001) in the PAD subjects than in the non-PAD controls (15.9 +/- 0.9 vs 22.1 +/- 1.0). History of ambulatory stumbling and unsteadiness was 86% more prevalent ( p <.001) in the PAD group (150/367 = 41%) than in the controls (101/458 = 22%), and history of falling was 73% more prevalent ( p <.001) in the PAD subjects (95/367 = 26%) than in the controls (69/458 = 15%). Within the PAD group, 6-minute walk distance, self-reported ambulatory function, and daily physical activity were significantly related to the balance and falling measures ( p <.05), whereas ABI was unrelated ( p >.05). CONCLUSIONS: Compared with the controls, PAD subjects with intermittent claudication had impaired balance and a greater likelihood of falling, both of which were associated with ambulatory function and daily physical activity.
Twenty four male hypertensive patients suffering also from peripheral obstructive arterial disease were randomly subdivided in two groups and after a period of farmacological wash-out of one month Group I was treated with Captopril (C 50 mg bid) or Ticlopidine (T 250 mg bid) for three months and then with the association C plus T for three months again. After placebo administration for one month, patients were further treated with C plus T at low doses (25 mg bid and respectively 250 mg daily). In the first part of the study, patients of Group II received an inverse sequence of the drugs (before Ticlopidine 250 mg bid and then Captopril 50 bid). In both groups of patients C induced a significant decrease of blood pressure and an increase of PFWD, TWD, and WI. T did not modify blood pressure but slightly increased PFWD, TWD, and WI. The improvement was more evident during administration of C plus T, whereas placebo administration induced a trend toward baseline values. Finally, the chronic administration of C plus T for twelve months induced a further improvement of all considered parameters. In conclusion, chronic administration of C plus T may be useful in the treatment of hypertensive patients suffering from intermittent claudication, improving significantly PFWD and TWD.
In a non-randomized, open-label study results after a structured institution-based peripheral arterial occlusive disease (PAD) rehabilitation program were compared with the results of training at home. Three groups were compared: group 1 (n = 19) PAD rehabilitation; group 2 (n = 19) PAD rehabilitation + clopidogrel 75 mg once daily; group 3 (n = 21) home-based training. The training period was 3 months for all groups, which was followed by a 3-month observation phase (without prescribed training). The rehabilitation program consisted of 3 training hours per week. Background variables, demographics, and baseline claudication distances were comparable between groups. After 3 months of training the absolute claudication distances (ACD) improved by 82.7%, 131.4%, and 5.4% for groups 1, 2 and 3. The initial claudication distances (ICD) changed by 163.8%, 200.6%, and 44.4%, respectively. All changes, except the ACD result for group 3, were statistically significant (p < or = 0.05). Structured training groups (1 and 2) performed significantly better than group 3 (p < or = 0.05). When results from groups 1 and 2 were pooled, ACDs changed from 493.3 +/- 218.1 to 1026.0 +/- 468.9 m, delta 546.0 +/- 378.8 m [95% CI 417.8-674.2 ml; p < or = 0.05. ICDs improved from 175.3 +/- 110.8 m to 493.1 +/- 326.7 m, delta 320.8 +/- 315.9 m [95% CI 213.9-427.7 m]; p < or = 0.05. The difference between the pooled mean results of the structured training groups and the results of group 3 amounted to 474.3 m [95% CI 270.2-678.4 m] and 242.4 m [95% CI 99.0-385.7 m], for ACD and ICD, respectively. Structured, supervised PAD rehabilitation is a highly efficacious treatment for intermittent claudication and may be regarded as the present gold standard among conservative treatment options.
The purposes of this study were to quantify the degree and distribution of lower extremity weakness in patients with peripheral arterial occlusive disease (PAOD) compared to apparently healthy older patients and to determine if performance of a simple functional measure correlates with lower extremity strength. Older patients (n = 46), 31 with PAOD (mean age = 69.9 years; mean ankle-brachial index = 0.67) and 15 without PAOD (mean age = 62.6 years; mean ankle-brachial index = 1.20), underwent isometric strength testing of hip, knee, and ankle musculature. In patients with PAOD, dorsiflexion strength was 15% lower (p < 0.05) in the more affected limb (55 +/- 4 Newton-meters; mean +/- SE) versus the less affected limb (65 +/- 5 Newton-meters). Overall, the dorsiflexor muscles of the more affected extremity were 22% weaker (p < 0.05) in the PAOD group than in the non-PAOD group (73 +/- 6 Newton-meters). No other significant differences in strength were found between the PAOD and the healthy elderly groups or between the more affected and less affected limbs in the PAOD patients. The time to perform five sequential sit-to-stand transfers using an armless chair was 23% greater (p < 0.01) in the PAOD group (13.0 +/- 0.5 s) than in the healthy elderly (10.7 +/- 0.9 s). In the PAOD patients, dorsiflexor strength was correlated with chair stand time (r = -0.37, p < 0.05). The authors conclude that PAOD patients with intermittent claudication are functionally limited by dorsiflexion weakness, impairing their ability to perform tasks requiring distal lower extremity strength.
In Germany, high quality health care is offered to just about all socio-economic groups. The question is rarely asked, though, if there are social differences in the utilisation and quality of health care among those with similar needs. These differences are analysed by looking at a group of persons with type 2 diabetes mellitus. Another group of persons without diabetes is included as well. The data are taken from the KORA-A Study in Augsburg, southern Germany. KORA-A is a case-control study based on patients with type 2 diabetes from the MONICA surveys S2 (1989/90), S3 (1994/95) and the Myocardial Infarction Registry, and controls, matched by age and sex to the cases. In 1997/98, these persons were contacted for the KORA-A study. The dataset includes data from 378 type 2 diabetic patients. The group without diabetes comprises 438 persons. The results indicate that the prevalence of "pain while walking" increases with decreasing educational level, and that this association is stronger for persons with type 2 diabetes (OR 3.53; 95 % CI 1.32 - 9.44) than for persons without diabetes (OR 2.02; 95 % CI 0.97 - 4.23). The prevalence of intermittent claudication can serve as an indirect assessment of the quality of health care received by diabetic persons. It is concluded that health care should be improved especially for those persons with type 2 diabetes who belong to the group with low socioeconomic status.
BACKGROUND: Carnitine metabolism is altered in peripheral arterial disease. L-carnitine supplementation may correct these alterations and improve walking performance. METHODS AND RESULTS: Plasma levels of carnitine and its esters were measured at rest and after maximally tolerated exercise in 22 claudicant patients and 8 normal subjects. One week later, this protocol was repeated in patients after random administration of placebo or L-carnitine (500 mg IV as a single bolus). Two groups of patients emerged. In 10 patients (group IC1), the plasma level of acetylcarnitine at rest was 3.7 +/- 0.2 micromol/L and increased significantly (P<.01) at maximally tolerated exercise. In 12 patients (group IC2), the resting level of plasma acetylcarnitine was elevated (7.9 +/- 0.7 micromol/L, P<.01) and decreased with exercise. Furthermore, group IC2 patients had a significantly lower walking capacity than group IC1 patients. In both groups, placebo did not affect the metabolic profile, nor did it improve exercise performance. Conversely, after L-carnitine administration, all but one patient in group IC2 (n=7) showed an increase in plasma acetylcarnitine concentration during exercise versus the decrease observed without L-carnitine. This metabolic effect was accompanied by a significant increase (P<.01) in walking capacity. Interestingly, in group IC1 patients (n=5), L-carnitine neither improved walking capacity nor modified the metabolic profile. Statistical analysis showed that changes in walking capacity with L-carnitine treatment were influenced exclusively by exercise-induced changes in plasma acetylcarnitine. CONCLUSIONS: In patients with intermittent claudication, assessment of plasma acetylcarnitine at rest and after exercise may be a means to select a target population for L-carnitine therapy.
PURPOSE: We performed a randomized, double-blind, placebo-controlled, multicenter trial to evaluate the relative efficacy and safety of cilostazol and pentoxifylline. PATIENTS AND METHODS: We enrolled patients with moderate-to-severe claudication from 54 outpatient vascular clinics, including sites at Air Force, Veterans Affairs, tertiary care, and university medical centers in the United States. Of 922 consenting patients, 698 met the inclusion criteria and were randomly assigned to blinded treatment with either cilostazol (100 mg orally twice a day), pentoxifylline (400 mg orally 3 times a day), or placebo. We measured maximal walking distance with constant-speed, variable-grade treadmill testing at baseline and at 4, 8, 12, 16, 20, and 24 weeks. RESULTS: Mean maximal walking distance of cilostazol-treated patients (n = 227) was significantly greater at every postbaseline visit compared with patients who received pentoxifylline (n = 232) or placebo (n = 239). After 24 weeks of treatment, mean maximal walking distance increased by a mean of 107 m (a mean percent increase of 54% from baseline) in the cilostazol group, significantly more than the 64-m improvement (a 30% mean percent increase) with pentoxifylline (P <0.001). The improvement with pentoxifylline was similar (P = 0.82) to that in the placebo group (65 m, a 34% mean percent increase). Deaths and serious adverse event rates were similar in each group. Side effects (including headache, palpitations, and diarrhea) were more common in the cilostazol-treated patients, but withdrawal rates were similar in the cilostazol (16%) and pentoxifylline (19%) groups. CONCLUSION: Cilostazol was significantly better than pentoxifylline or placebo for increasing walking distances in patients with intermittent claudication, but was associated with a greater frequency of minor side effects. Pentoxifylline and placebo had similar effects.
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