[The feasibility and tolerability of prolonged treatment with low doses of heparin-calcium administered subcutaneously in infarct patients. A multicenter clinical study].
Practical feasibility and clinical tolerability of low dose heparin given subcutaneously for the prevention of reinfarction were evaluated in this open, multicentric trial of post-marketing surveillance. 309 investigators participated. 2830 evaluable patients (2090 M, 709 F, mean age 63 years) who had in the previous 2 years a myocardial infarction were treated subcutaneously with calcium heparin (Calciparina Italfarmaco, 0.5 ml prefilled syringe) at the daily dosage of 12.500 U. The foreseen treatment length was of 1 year; after 6 months of daily injections, calcium heparin could be taken for cycles of 30 days, with 10 day intervals. The enrolled patients resulted to be representative of the population affected with ischemic cardiopathy. One year treatment with calcium heparin was completed by 2040 patients (72.1%); about 1/4 of the patients did not complete the protocol. Patient's subjective decision to withdraw accounted for 46.3% of withdrawals; poor tolerability accounted for 15% of withdrawals (3.8% of total patients). Overall, 237 patients (8.4%) suffered from adverse reactions (353 complaints). Local reactions at the injection site accounted for 60% of total adverse reactions, involving 7.5% of total cases. To follow, allergic reactions (2.5%) and other different types of adverse reaction (incidence less than 0.5%). By analyzing the reactions that provoked drug withdrawal, no organ or function (e.g.: haemostasis) were found to be at risk during the heparin treatment. 64 patients died during the trial. These deaths were in prevalence due to cardiovascular diseases: ventricular fibrillation, cardiac failure, arterial thromboembolism (cardiac reinfarction, stroke).(ABSTRACT TRUNCATED AT 250 WORDS)
Fernandez
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Servizio di Cardiologia, USL 61, Palermo.
Proto
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Schiassi
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Scotti
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D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004361:Drug Tolerance; D005240:Feasibility Studies; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality; D010349:Patient Compliance; D013997:Time Factors
D005343:Fibrinolytic Agents; C006871:calcium heparin; D006493:Heparin
Fattibilità e tollerabilità di un trattamento prolungato con basse dosi di eparina calcica per via sottocutanea in pazienti infartuati. Studio clinico multicentrico.