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document
Double-blind study on the activity of plafibride in the treatment of type IV hyperlipoproteinemia . The effects of a new drug , N-2- ( p-chlorophenoxy ) -isobutyryl-N'-morpholinomethylurea ( plafibride , ITA 104 ) , were studied in a double blind study lasting four months on a group of 30 patients with a type IV hyperlipoproteinemia . In the patients treated with the active drug significant reductions in blood triglycerides were obtained , with a trend to normal . Reduction in blood cholesterol was inconsistent and not significant . As for the lipoproteinogram , a tendency towards a decrease in the pre-beta-lipoprotein fraction was observed and so was a non-significant tendency towards an increase in the alpha- and beta-lipoprotein fractions . Studies on the platelet functioning showed an obvious decrease in platelet aggregation in those patients treated with the active drug . This was very evident for the ADP and adrenaline inductors and rather less significant for collagen . Neither platelet adhesiveness nor aggregation rate changed . Tolerance of the drug was generally excellent . In one patient a decrease in some palpebral xanthelasmas was observed after two months of treatment with the active drug . In only one case there was heartburn and this was corrected with alkalines . In one other case an urticarial rash appeared , but disappeared spontaneously when the drug was temporarily stopped and did not reappear when it was administered again . During the trial no evidence of renal , hepatic or hematological malfunctions were observed . However , a slight tendency towards an increase in the GOT , GPT and LDH was observed , which was not statistically significant . The drug tested may be very useful in the treatment of type IV hyperlipoproteinemia , especially in those forms in which an increase in thromboembolic risk is suspected , either associated with , or secondary to , the actual atherosclerotic disease .
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Intervention_Pharmacological
plafibride
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Intervention_Pharmacological
N-2- ( p-chlorophenoxy ) -isobutyryl-N'-morpholinomethylurea ( plafibride , ITA 104 )
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Outcome_Physical
blood triglycerides
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Outcome_Physical
blood cholesterol
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Outcome_Physical
pre-beta-lipoprotein fraction
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Outcome_Physical
platelet aggregation
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Outcome_Physical
platelet adhesiveness
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Outcome_Physical
aggregation rate
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Outcome_Other
Tolerance
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Outcome_Adverse-effects
palpebral xanthelasmas
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Outcome_Adverse-effects
heartburn
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Outcome_Adverse-effects
urticarial rash
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Outcome_Physical
renal , hepatic or hematological malfunctions
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Outcome_Physical
thromboembolic risk