[Comparative evaluation of antiplatelet efectiveness drugs of original and reproduced enteric forms of acetylsalicylic acid (clinical study ICAR))].
The purpose of the study was a comparative study of antiplatelet activity of acetylsalicylic acid drugs, produced in gastro-resistant form trombopol 75 mg and aspirin cardio 100 mg in patients with high risk of cardiovascular events. Effect of trombopol 75 mg versus 100 mg aspirin cardio on platelet aggregation in 30 patients with high risk of cardiovascular events during 3 week treatment period was studied. Design method: blind, randomized, crossover method. Three weeks before the initial therapy, for those patients, who received antiplatelet platelet therapy at the time of inclusion in the study, this therapy was withdrew ("wash-out period"), after which patient was given one of the study drug (sequence of courses was s determined according to the scheme of randomization) with the recommendation of taking it daily in the morning at the same time. At each visit, before the next dose of the drug, blood samples for determination of ADP-induced platelet aggregation were taken, physical examination, measurement of blood pressure (BP) and heart rate were recorded, adverse events were recorded. Follow-up visit was performed 3 weeks later. 21 days after first study drug withdrawal, a second similar course of therapy with another drug was performed. Antiplatelet efficacy of aspirin was assessed by its effect on spontaneous and ADP- induced platelet aggregation. Aggregation activity was determined by turbidometric method by changing of translucent ability of the blood sample during the formation of aggregates after 2 minutes of exposure. As an inducer of aggregation ADP solutions of three concentrations (0.5, 1 and 2 mM) were used. No significant difference between compared drugs in influence on aggregation ability of platelets after 3 weeks of daily intake was found. No adverse events associated with taking of studied drugs were registered. It was concluded that, generic APD - trombopol 75 mg and aspirin cardio 100 mg were equivalent on antiplatelet efficacy and tolerability.
S Iu
SIu
Martsevich
S N
SN
Tolpygina
Iu V
IuV
Lukina
V P
VP
Voronina
N V
NV
Kiseleva
E S
ES
Boĭchenko
R É
RÉ
Dubinskaia
E N
EN
Khoseva
D000244:Adenosine Diphosphate / Q000378:metabolism; D000284:Administration, Oral; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D004304:Dosage Forms; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010974:Platelet Aggregation / Q000187:drug effects*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
D004304:Dosage Forms; D010975:Platelet Aggregation Inhibitors; D000244:Adenosine Diphosphate; D001241:Aspirin