Biomaterial Database

Trental 400 in the treatment of intermittent claudication: results of long-term, placebo-controlled administration. 1984

F Roekaerts, and L Deleers

A double-blind, randomized, placebo-controlled long-term clinical study of Trental 400 was carried out, partly under cross-over design, partly as a parallel-group study, in 36 patients suffering from chronic arterial obstructive disorders in the lower limbs, associated with intermittent claudication, in order to evaluate the effectiveness and the safety of this drug administered t.i.d. over a period of 6 months. This controlled period was preceded by a placebo run-in period of 3 months. The clinical results under Trental 400 showed a statistically significant within group improvement of painfree and maximum walking parameters (p less than 0.05) corresponding to an increase to baseline by +96% to +139% respectively and also in comparison to placebo (p less than 0.05). The alterations of walking parameters within the placebo groups, ranging between -25% and +28% were not significant. The subjective parameters (rest pain, paraesthesias, muscular cramps and sensation of heaviness in the legs) paralleled the course of the walking parameters. Under Trental 400, 24 out of 36 patients reported an improvement of these symptoms compared to 7 under placebo. Trental 400 was well tolerated. Minor side effects were mentioned by 7 out of 36 patients. One patient had to stop the drug treatment because of persisting prickling sensation and subsequent insomnia. Drug-related changes in the laboratory findings could not be detected; vital signs varied in function of age, concomitant drug treatments and seasonal factors. The results obtained in these studies suggest Trental 400 as a drug of choice for treating patients with intermittent claudication due to peripheral arterial obstruction according to stage II or III after Fontaine.

UI	MeSH Term	Description	Entries
D007383	Intermittent Claudication	A symptom complex characterized by pain and weakness in SKELETAL MUSCLE group associated with exercise, such as leg pain and weakness brought on by walking. Such muscle limpness disappears after a brief rest and is often relates to arterial STENOSIS; muscle ISCHEMIA; and accumulation of LACTATE.	Claudication, Intermittent
D008297	Male		Males
D009120	Muscle Cramp	A sustained and usually painful contraction of muscle fibers. This may occur as an isolated phenomenon or as a manifestation of an underlying disease process (e.g., UREMIA; HYPOTHYROIDISM; MOTOR NEURON DISEASE; etc.). (From Adams et al., Principles of Neurology, 6th ed, p1398)	Cramp,Limb Cramp,Muscular Cramp,Cramp, Limb,Cramp, Muscle,Cramp, Muscular,Cramps,Cramps, Limb,Cramps, Muscle,Cramps, Muscular,Limb Cramps,Muscle Cramps,Muscular Cramps
D010292	Paresthesia	Subjective cutaneous sensations (e.g., cold, warmth, tingling, pressure, etc.) that are experienced spontaneously in the absence of stimulation.	Dysesthesia,Formication,Paresthesia, Distal,Paresthesia, Painful,Distal Paresthesia,Distal Paresthesias,Dysesthesias,Formications,Painful Paresthesia,Painful Paresthesias,Paresthesias,Paresthesias, Distal,Paresthesias, Painful
D010431	Pentoxifylline	A METHYLXANTHINE derivative that inhibits phosphodiesterase and affects blood rheology. It improves blood flow by increasing erythrocyte and leukocyte flexibility. It also inhibits platelet aggregation. Pentoxifylline modulates immunologic activity by stimulating cytokine production.	Agapurin,BL-191,Oxpentifylline,Pentoxil,Torental,Trental,BL 191,BL191
D010919	Placebos	Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.	Sham Treatment
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man