Romanian journal of internal medicine = Revue roumaine de medecine interne · 2003
Rovamycine as add-on treatment in unstable angina and 4 year evolution with major cardiovascular events.
Клиническое исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Rădoi Mariana, Bobescu Elena, Agache Ioana
Аннотация
BACKGROUND: Major antibiotic trials targeting Chlamydia Pneumoniae or the pathogen burden in acute coronary syndromes reported conflicting data. Only a minor impact of antibiotic treatment on major cardiovascular events (MACE) incidence was demonstrated in some studies.
METHODS AND RESULTS: 109 unstable angina patients were randomised in: group C receiving conventional treatment, group R treated with Rovamycine 12 days 4.5 MUI iv /day as add-on therapy, group R1 treated with Rovamycine 12 days 4.5 MUI iv/day followed by 6 MUI/day per os for another 12 days add on treatment. Randomisation into the therapeutical groups was independent of the serological status for Chlamydia pneumoniae. The primary adverse end-points of the study were the incidence of major cardiovascular events at 3 months, 6 months and at 4 years and the 4 years cumulated end-point rate. Secondary adverse end-points were the incidence of recurrent stable angina at 3 and 6 months and the incidence of increased serum levels of C reactive protein and fibrinogen at 3 and 6 months. Statistics used multiple regression analysis and Chi square test. At 6 months the incidence of unstable angina with readmission was significantly lower in groups R and R1 compared to group C (p < 0.001, respective p < 0.0001) and significantly lower in group R1 compared to group R (p < 0.0001). The incidence of nonfatal myocardial infarction at 6 months was significantly lower in groups R and R1 compared to group C (p < 0.0001). The incidence of cardiovascular death was significantly lower in group R1 compared to group C and R (p < 0.001). At 4 years the incidence of unstable angina with readmission and the cumulated end point rate were significantly reduced in groups R and R1 compared to group C. The 3 months incidence of increased serum levels of C reactive protein was significantly decreased in group R1 compared to groups C and R (p<0.001). The 3 months incidence of increased serum levels of fibrinogen was significantly lower in groups R and R1 compared to group C (p<0.002, respectively p<0.001).
CONCLUSIONS: In patients with unstable angina Rovamycine as add-on treatment to the conventional treatment lead to a significant decrease of MACE incidence at 6 months and to a significant decrease in the 4 years incidence of unstable angina with readmission. The beneficial effect of Rovamycine was parallel to the decrease in serum inflammations markers concentration.
METHODS AND RESULTS: 109 unstable angina patients were randomised in: group C receiving conventional treatment, group R treated with Rovamycine 12 days 4.5 MUI iv /day as add-on therapy, group R1 treated with Rovamycine 12 days 4.5 MUI iv/day followed by 6 MUI/day per os for another 12 days add on treatment. Randomisation into the therapeutical groups was independent of the serological status for Chlamydia pneumoniae. The primary adverse end-points of the study were the incidence of major cardiovascular events at 3 months, 6 months and at 4 years and the 4 years cumulated end-point rate. Secondary adverse end-points were the incidence of recurrent stable angina at 3 and 6 months and the incidence of increased serum levels of C reactive protein and fibrinogen at 3 and 6 months. Statistics used multiple regression analysis and Chi square test. At 6 months the incidence of unstable angina with readmission was significantly lower in groups R and R1 compared to group C (p < 0.001, respective p < 0.0001) and significantly lower in group R1 compared to group R (p < 0.0001). The incidence of nonfatal myocardial infarction at 6 months was significantly lower in groups R and R1 compared to group C (p < 0.0001). The incidence of cardiovascular death was significantly lower in group R1 compared to group C and R (p < 0.001). At 4 years the incidence of unstable angina with readmission and the cumulated end point rate were significantly reduced in groups R and R1 compared to group C. The 3 months incidence of increased serum levels of C reactive protein was significantly decreased in group R1 compared to groups C and R (p<0.001). The 3 months incidence of increased serum levels of fibrinogen was significantly lower in groups R and R1 compared to group C (p<0.002, respectively p<0.001).
CONCLUSIONS: In patients with unstable angina Rovamycine as add-on treatment to the conventional treatment lead to a significant decrease of MACE incidence at 6 months and to a significant decrease in the 4 years incidence of unstable angina with readmission. The beneficial effect of Rovamycine was parallel to the decrease in serum inflammations markers concentration.