Placebo Controlled Double Blind Study with Pentoxifylline of Walking Performance in Patients with Intermittent Claudication

Perri, T. Di; Guerrini, M

doi:10.1177/000331978303400105

Cited by 53 publications

(15 citation statements)

References 2 publications

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“…Eleven out of 12 trials purported to show some benefit from oxpentifylline, but three of these trials were uncontrolled, and two were comparisons against other pharmacologically active agents (which themselves have no proven efficacy). There were seven placebo-controlled trials, four of parallel-group design (Donaldson et al, 1984;Roekaerts & Deleers, 1984;Bollinger & Frei, 1977) and three cross-over trials (Strano et al, 1984;DiPerri & Guerrini, 1983;Roekaerts & Deleers, 1984). The main findings in the seven placebocontrolled trials of oxpentifylline are summarised in Table 3.…”

Section: Trials Of Oxpentifylline For Intermittent Claudicationmentioning

confidence: 99%

Drug treatment of intermittent claudication: a critical analysis of the methods and findings of published clinical trials, 1965‐1985 [see comments]

Cameron

Waller

Ramsay

1988

Brit J Clinical Pharma

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1 All trials of drug therapy for intermittent claudication published in English during the period 1965-1985 were reviewed. A total of 75 trials had studied 33 different pharmacological agents. Treadmill exercise, the most reproducible method of evaluating symptoms in this condition, was used in 49% of trials. 2 Oxpentifylline was the drug that had been most frequently studied. In seven placebocontrolled trials the average response to oxpentifylline, compared with placebo and weighted for sample-size, was 65% improvement in claudication distance. There was, however, a significant negative relation between sample-size and response (rs = -0.79, P < 0.05), suggesting that this estimate was likely to have been biased by non-publication of negative results. 3 One third of all trials were uncontrolled; 84% of these reported benefit from drug treatment, compared with 32% of placebo-controlled trials (P < 0.001). Sample-sizes varied from seven to 227 patients; 31% of trials reported data from less than 20 patients and these were likely to have had insufficient statistical power. 4 Overall, 57 of the 75 trials (76%) had at least one of the following deficiencies: an uncontrolled design; not double-blind; failure to use treadmill exercise; less than 20 patients included in the analysis. Thus, a priori three-quarters of all trials were unlikely to have made a satisfactory assessment of drug efficacy. 5 The information available does not establish convincingly that any drug consistently improves exercise performance in intermittent claudication. In view of the deficiencies in previous trials, we propose guidelines for future studies with regard to trial design, sample-size and methods of exercise testing.

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Section: Trials Of Oxpentifylline For Intermittent Claudicationmentioning

confidence: 99%

Drug treatment of intermittent claudication: a critical analysis of the methods and findings of published clinical trials, 1965‐1985 [see comments]

Cameron

Waller

Ramsay

1988

Brit J Clinical Pharma

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“…From all the reports 17 double-blind, placebo-controlled studies were available for review. 28,43,[49][50][51][52][53][54][55][56][57][58][59][60][61][62] The original studies were obtained and studied. Two drug information pharmacists working in the statewide drug information service independently evaluated the studies.…”

Section: Methodsmentioning

confidence: 99%

The Trials and Tribulations of Pentoxifylline

Effeney¹,

Stokes²,

Trenerry³

1992

Perspectives in Vascular Surgery and Endovascular Therapy

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The syndrome of intermittent claudication is the most common reason a patient with atherosclerosis of the abdominal aorta, its iliac branches or leg arteries, presents for an opinion about therapy. The prevalence of this syndrome is approximately 1.5% to 6% in menl2 and slightly less than 2% in women.3 The Framingham study data suggest a 2:1 male-female ratio at presentation.' The rate of presentation increases with age up to 75 years, after which the incidence rate levels off.Intermittent claudication has a favorable prognosis in terms of limb salvage. Only 5% to 6% of the claudicant population progress to ischemia severe enough to require amputation within 5 years of presentation.5-' Claudication is, however, an important predictor of the presence of atherosclerosis in other vascular beds. It is a marker of increased cardiovascular mortality.8-10 Despite the increased mortality ratios for both men and women, 70% to 80% of claudicants survive 5 years, 40% survive 10 years, and 26% are still alive 15 years after first presentations. 11,12 The diagnosis of atherosclerotic involvement of the lower extremity can be made with great accuracy on clinical grounds. 13 The features of pain, heaviness, and tiredness or fatigue in the muscles of the lower extremity brought on by walking, relieved by rest, and occurring again after walking the same distance are the key elements in the history. The claudication distance is an accurate indicator of the severity of the problem and is indicative of the number of levels of the arterial tree that are involved. Physical examination reveals the absence of pulses or their quality when present. The sites of flow disturbance may be detected by the presence of a bruit along the vessel. The state of the skin is an accurate reflection of nutritive blood flow in patients with more advanced atherosclerosis.The simple o~ce test of Doppler-derived ankle blood pressures allows quantification by means of the ankle / brachial systolic pressure index and excludes almost all cases of pseudoclaudication.

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“…The clinical trials evaluating the use of pentoxifylline do not consistently demonstrate a benefit in PFWD or MWD when compared with placebo ( Table 3). [80][81][82][83][84][85][86][87][88][89][90][91][92][93] These trials vary in sample size (< 50 patients in half of the trials), follow-up time (2-12 mo), dosage (600-1600 mg/day), patient baseline characteristics, and route of administration, with at least two that evaluated an intravenous formulation. There is also There are only four trials of pentoxifylline 400 mg 3 times/day in which more than 100 patients were randomized.…”

Section: Pentoxifyllinementioning

confidence: 99%

Pharmacologic Therapy for Intermittent Claudication

2009

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Peripheral artery disease, defined as atherosclerosis in the lower extremities, affects nearly 8.5 million people in the United States. Due to the frequent asymptomatic manifestation of peripheral artery disease, diagnosis may be delayed and its true incidence underestimated. However, some patients may experience aching pain, numbness, weakness, or fatigue, a condition termed intermittent claudication. Peripheral atherosclerosis is associated with cardiovascular risk and physical impairment; therefore, treatment goals are aimed at decreasing cardiovascular risk, as well as improving quality of life. Little debate exists regarding the management of cardiovascular risk reduction, which consists of both antiplatelet therapy and risk factor modification. Despite recently published guidelines, the treatment of intermittent claudication is less well established and the management remains controversial and uncertain. Exercise remains the first-line therapy for intermittent claudication; however, pharmacologic treatment is often necessary. Although only two prescription drugs have been approved by the U.S. Food and Drug Administration for the treatment of intermittent claudication, several supplements and investigational agents have been evaluated. Therapeutic optimization should balance the anticipated improvements in quality of life with the potential safety risks.

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Placebo Controlled Double Blind Study with Pentoxifylline of Walking Performance in Patients with Intermittent Claudication

Cited by 53 publications

References 2 publications

Drug treatment of intermittent claudication: a critical analysis of the methods and findings of published clinical trials, 1965‐1985 [see comments]

Drug treatment of intermittent claudication: a critical analysis of the methods and findings of published clinical trials, 1965‐1985 [see comments]

The Trials and Tribulations of Pentoxifylline

Pharmacologic Therapy for Intermittent Claudication

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