Summary
Synopsis
Pentoxifylline 1 (oxpentifylline) is an orally active haemorheological agent for the treatment of peripheral vascular disease, cerebrovascular disease and a number of other conditions involving a defective regional microcirculation. Pentoxifylline acts primarily by increasing red blood cell deformability, by reducing blood viscosity and by decreasing the potential for platelet aggregation and thrombus formation. Extensive open and placebo-controlled studies have shown that pentoxifylline 600 to 1200 mg/day for at least 6 weeks is associated with subjective and objective improvements in 60 to 100% of patients with peripheral vascular disease. The most commonly assessed clinical parameter, walking distance, is usually improved by about 100%, although much greater improvements have also been documented. Other parameters which have been clearly improved include lower limb rest pain, paraesthesia, muscle blood flow, cramps and leg ulcers. Pentoxifylline has produced consistently better results than placebo, and in those studies using comparative drugs, better results than nylidrin, adenosine and naftidrofuryl.
In patients with cerebrovascular disorders, open studies with pentoxifylline, usually at a dosage of 600 to 1200 mg/day (300 to 600 mg/day in Japan), have shown marked overall clinical improvements in about 85% of patients. Symptomatic improvements in rehabilitation psychometric tests, neuromotor and speech deficits and other subjective symptoms have accompanied increased cerebral blood flow, particularly to ischaemic areas. Pentoxifylline would appear to be useful in most types of cerebrovascular disease including transient ischaemic attacks, sequelae of cerebral thrombosis and haemorrhage, and chronic ischaemic disorders. In patients with chronic cerebrovascular disease pentoxifylline 600 to 1200 mg/day conferred significant clinical benefit compared with placebo and in isolated studies proved to be superior to drugs such as co-dergocrine mesylate, adenosine and pyrithioxine.
Preliminary studies indicate that pentoxifylline may also prove useful in vaso-occlusive crises of sickle cell disease, some hearing disorders, disorders of eye circulation, high altitude sickness and asthenozoospermia. Pentoxifylline is usually well tolerated when administered as the conventional controlled release formulation, gastrointestinal symptoms (about 3%) being the most common complaint, although these and other adverse effects have not occurred to a significantly greater extent than with placebo.
Thus, pentoxifylline offers a well-tolerated and effective alternative to the treatment options available for patients with peripheral vascular disease. In cerebrovascular disease its relative place in therapy remains to be clarified with further comparative data.
Pharmacodynamic Studies
The primary pharmacodynamic effects of pentoxifylline are due to increased red blood cell deformability and to decreased blood viscosity. The increased deformability of erythrocytes has been clearly demonstrated in both in vitro and ex vivo studies involving blood from patients with peripheral vascular disease, cerebrovascular disease and a number of other conditions. The mechanism by which this is achieved has been shown to involve increased erythrocyte ATP and other cyclic nucleotide levels. Ex vivo studies have shown pentoxifylline to significantly reduce whole blood viscosity, and plasma viscosity by decreasing plasma fibrinogen concentrations. Pentoxifylline also strongly inhibits spontaneous and induced platelet aggregation in vitro and in vivo via inhibition of membrane-bound phosphodiesterase (leading to raised cAMP levels) and thromboxane synthesis, and increased prostacyclin (prostaglandin I2) synthesis. Platelet adhesion to vessel walls has been decreased with pentoxifylline in animals fed a high cholesterol diet, in a variety of tumour cell lines, and in patients with circulatory disorders. Experimental thrombus formation, either by stenosis or laser treatment, is also decreased with pentoxifylline.
Peripheral blood flow in the lower limbs and in the cerebral circulation is usually significantly increased after administration of pentoxifylline to patients. There is evidence to suggest that most benefit is obtained in ischaemic tissue and that it occurs without causing a ‘steal effect’. There are usually no effects on systemic blood pressure or heart rate and little evidence for a direct vasodilatory action with pentoxifylline after oral administration to patients. However, intravenous doses in animals have caused hypotension and decreased vascular tone in some studies.
Pentoxifylline produced increases in tissue oxygen tension in ischaemic lower limb muscles, in cerebral cortex, and in cerebrospinal fluid of patients with cerebrovascular disease. In animal studies, pentoxifylline increased cerebral oxygen consumption and glucose utilisation, increased cerebral cyclic nucleotide levels and decreased oedema formation. Pentoxifylline may produce favourable effects on electroencephalographic recordings in patients with cerebrovascular disease.
In most studies, pentoxifylline has had either beneficial or no effects on blood sugar and lipid metabolism in healthy subjects or patients with peripheral vascular complications of diabetes.
Pharmacokinetic Studies
Pentoxifylline is rapidly and extensively absorbed from the gastrointestinal tract both in animals and in humans. It is also rapidly metabolised systemically, with peak plasma concentrations of pentoxifylline (about 1100 µg/L) and one of its major metabolites (about 2000 µg/L) being reached at 1.05 and 1.8 hours, respectively, after administration of a 400mg capsule dose. Following administration of a 400mg sustained release dose (the commercially available dosage form), peak plasma concentrations of pentoxifylline and metabolite of about 300 and 343 µg/L were reached at 3.3 and 3.2 hours, respectively. Absolute bioavailability has been calculated as about 30 and 20% for the capsules and sustained release tablet formulations, respectively. However, recovery of metabolites in the urine accounted for almost the complete dose, suggesting that extensive enterohepatic recycling occurs. Pentoxifylline does not appear to significantly bind to plasma proteins and distribution was relatively uniform throughout body tissues. There seems to be no accumulation of drug with repeated doses.
Metabolism is primarily by reduction, to form metabolite 1 and by oxidation to form metabolites 4 and 5. Several other metabolites have been detected but exact metabolic pathways have yet to be determined. Rapid excretion into the urine occurs — primarily as metabolite 5 and, to a lesser extent, metabolite 4. Urinary recovery of these metabolites accounts for about 45 and 5% of the dose, respectively. Patients with renal insufficiency show decreased clearance of pentoxifylline. The elimination half-lives of pentoxifylline given as the capsule formulation (used in clinical trials) and conventional sustained release tablet formulations are about 0.8 and 3.4 hours, respectively.
Therapeutic Trials
The results of a large number of open and controlled studies show that pentoxifylline usually at a dosage of 600 to 1200 mg/day for at least 6 weeks is effective in improving symptoms of peripheral vascular disease in 60 to 100% of patients. In placebo-controlled studies, overall success rates have been significantly better with pentoxifylline (59 to 74%) than with placebo (5 to 29%). Subjective symptoms are improved in most patients — walking distance, rest pain, paraesthesia, cramps, ulcer healing, oedema, cyanosis — as are objective measurements such as reactive hyperaemia, and oscillographic, thermographic, plethysmographic, scintigraphic and ultrasound tests. Walking distance improvements have ranged markedly from study to study; open studies have usually shown increases approximating or exceeding 100%. Placebo-controlled clinical trials have generally confirmed the beneficial effect of pentoxifylline on walking distances. Studies on the effects of pentoxifylline on trophic leg ulcers have shown overall clearance or marked improvements in 61 to 87%, with one study showing clear superiority over placebo. In studies where patients were stratified according to initial severity of disease, pentoxifylline appeared to produce better results in more severely affected limbs, although between-study comparisons do not support these data.
In a limited number of comparative studies in patients with peripheral vascular disease, pentoxifylline has compared favourably (with respect to standard subjective and objective measures of disease activity) with most other agents. Pentoxifylline 1200 mg/day has produced significantly better results than nylidrin 9 mg/day and adenosine 7.2 mg/day, while a lower dose of 300 to 600 mg/day was as effective as pyridinolcarbamate 1500 mg/day and was superior to (recommended doses of) naftidrofuryl. However, in 2 studies comparing lower than recommended doses of pentoxifylline (800 mg/day and 300 mg/day) with buflomedil (600 mg/day and 450 mg/day), poor responses were seen to both drugs. Similarly, inconclusive results were seen in a comparison of pentoxifylline 1200 mg/day and flunarizine 15 mg/day.
Pentoxifylline has been studied in a few trials in diabetic patients with vascular complications, and has been shown to improve the symptoms of lower limb peripheral vascular disease. Other secondary complications, such as retinopathy may be improved, although further studies in this area are needed. Blood glucose concentrations and lipid metabolism in these patients are usually unaffected or improved. In one study in patients treated with pentoxifylline 1200 mg/day or dipyridamole 150 mg/day plus acetylsalicylic acid 1050 mg/day after vascular surgery, reocclusion of vessels occurred in 10% versus 20%, respectively.
In patients with cerebrovascular disorders, pentoxifylline has also shown evidence of therapeutic efficacy. However, few well controlled studies have been conducted, making it difficult to assess the relative efficacy of pentoxifylline in this therapeutic area. In one multicentre study 86% of nearly 13,000 patients showed clinical improvements during treatment with pentoxifylline 300 to 600 mg/day for 8 weeks. Significant improvements were documented for psychometric symptoms (disorientation, hypomnesia, loss of spontaneity, depression, insomnia — 64 to 78% of patients), speech disturbances (65%) and subjective symptoms such as tinnitus, cold extremities, headache, vertigo (76 to 87%). Stratification of these cerebrovascular disorder patients reveals improvements in high proportions of patients with transient ischaemic attacks (93%), cerebral infarction or thrombosis (85%) and in those with cerebral arteriosclerosis (89%).
In a comparative study of pentoxifylline 1200 mg/day and dipyridamole 150 mg/day plus acetylsalicylic acid 1050 mg/day in patients with transient ischaemic attacks, 12-month follow-up revealed incidences of new ischaemic attacks to be 10 to 13%, and 28 to 31%, respectively, and stroke incidences to be less than 5% with both treatments. Clinical improvements correlated with improved cerebral blood flow. In open studies in patients with acute cerebrovascular accidents pentoxifylline therapy has resulted in improvements in gross neuromotor and speech deficits, and overall rehabilitation. Comparative studies have demonstrated that pentoxifylline and xanthinol nicotinate both produce marked improvements in motor deficit in patients with cerebral thrombosis, with parenteral pentoxifylline also improving memory performance. A somewhat higher rate of rehabilitation was seen with parenteral pentoxifylline 400 mg/day than with a combination of hexobendine, ethamivan and etofylline in non-haemorrhagic stroke. Open studies in chronic cerebrovascular disorders have revealed improvements in about 60 to 90% of patients, and placebo-controlled studies have shown significant benefits with pentoxifylline, with improvements (haemorheological as well as clinical) in over 90% vs 15 to 20% of patients, respectively. Vertigo, headache and memory disturbances appeared to respond particularly well whereas visual disturbances were less responsive. Again, clinical improvements were accompanied by increased cerebral blood flow. Comparative studies in small numbers of patients with chronic cerebrovascular disorders have shown pentoxifylline up to 1200 mg/day to produce superior clinical improvements to treatment with codergocrine mesylate 6 mg/day (70% vs 10% of patients), and adenosine 7.2 mg/day (100% vs 37.5% of patients). Comparison of pentoxifylline 1200 mg/day, dipyridamole 300 mg/day or a combination of the two resulted in clinical improvements in 67%, 67% and 83% of patients, respectively. However, in a similar study comparing pentoxifylline 1200 mg/day with placebo, piracetam 4800 mg/day or a combination of pentoxifylline with piracetam, significant clinical improvements were observed only with the combination therapy.
Pentoxifylline has also shown some potential for use in a number of other disorders including the vaso-occlusive crises of sickle cell disease, high altitude sickness, asthenozoospermia (but not oligospermia), acute and chronic hearing disorders, and disorders of eye circulation. However, the encouraging preliminary results in these areas need further confirmation.
Side Effects
In placebo-controlled studies in patients with peripheral vascular disorders, the conventional sustained release formulation of pentoxifylline has been very well tolerated by most patients. Gastrointestinal symptoms (about 3%) are the most common complaint, although these and other side effects have not occurred to a significantly greater extent than with placebo. Discontinuation due to adverse effects occurred in 3.1 and 0% of patients receiving pentoxifylline and placebo, respectively. In patients with cerebrovascular disease, gastrointestinal disturbances were again most common, with side effects of other organ systems occurring in less than 0.25% of patients treated with pentoxifylline 300 to 600 mg/day.
Dosage and Administration
The usual adult oral dosage of pentoxifylline in the treatment of peripheral vascular disease is 1200mg daily in 3 divided doses with meals. Therapy should be maintained for at least 8 weeks. In cerebrovascular diseases the most often used dosage in clinical trials has been 300 to 600mg daily, although the currently recommended dosage is 600 to 1200mg daily.
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Various sections of the manuscript reviewed by: J.L. Ambrus, Roswell Park Memorial Institute, Buffalo, New York, USA; J.A. Dormandy, St James’ Hospital, London, England; A.M. Ehrly, University Medical School, Frankfurt, West Germany; H. Gastpar, Universitäts-Hals-Nasen-Ohrenklinik München, Munich, West Germany; M. Guerrini, Instituto di Patalogia Speciale Medica e Metodologia Clinica dell’Universita Degli Studi di Siena, Siena, Italy; H. Katsunuma, Tokyo Medical College, Tokyo, Japan; J.S. Meyer, Veterans Administration Medical Center, Houston, Texas, USA; J.M. Porter, Oregon Health Sciences University, Portland, Oregon, USA; A. Strano, Istituto di Clinica Medica Generale e Terapia Medica I dell’Università di Palermo Policlinico, Palermo, Italy.
‘Trental’ (Hoechst).
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Ward, A., Clissold, S.P. Pentoxifylline. Drugs 34, 50–97 (1987). https://doi.org/10.2165/00003495-198734010-00003
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DOI: https://doi.org/10.2165/00003495-198734010-00003