ABSTRACT
BACKGROUND: Statins have been proved to be effective in reduction of mortality and morbidity when started in the early secondary prevention in stabilized patients after acute coronary syndrome (ACS). The safety and efficacy of statin administration directly in the first-line therapy in unstable ACS patients is not clear. The aim of our study was, therefore, to assess the effect of statin treatment initiated immediately at hospital admission of patients with ACS. METHODS: The trial was stopped prematurely after enrollment of one hundred and fifty-six patients with ACS that were randomized at admission to fluvastatin 80 mg (N = 78) or placebo (N = 78). Study medication was administered immediately after randomization and then once daily for 30 days; all patients were then encouraged to continue in open-label statin therapy and at the end of one-year follow-up 75% in the fluvastatin group and 78% in the placebo group were on statin therapy. RESULTS: We did not demonstrate any difference between groups in the level of C-reactive protein, interleukin 6, and pregnancy-associated plasma protein A on Day 2 and Day 30 (primary endpoint). Fluvastatin-therapy, however, significantly reduced one-year occurrence of major adverse cardiovascular events (11.5% vs. 24.4%, odds ratio (OR) 0.40, 95% CI 0.17-0.95, P = 0.038). This difference was caused mainly by reduction of recurrent symptomatic ischemia (7.7% vs. 20.5%, OR 0.32, 95% CI 0.12-0.88, P = 0.037). CONCLUSIONS: This study failed to prove the effect of fluvastatin given as first-line therapy of ACS on serum markers of inflammation and plaque instability. Fluvastatin therapy was, however, safe and it may reduce cardiovascular event rate that supports immediate use of a statin in patients admitted for ACS. TRIAL REGISTRATION: NCT00171275.
Subject(s)
Acute Coronary Syndrome/drug therapy , Fatty Acids, Monounsaturated/administration & dosage , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Indoles/administration & dosage , Secondary Prevention/methods , Acute Coronary Syndrome/immunology , Acute Coronary Syndrome/mortality , Aged , C-Reactive Protein/metabolism , Chi-Square Distribution , Czech Republic , Double-Blind Method , Drug Administration Schedule , Early Termination of Clinical Trials , Fatty Acids, Monounsaturated/adverse effects , Female , Fluvastatin , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Indoles/adverse effects , Inflammation Mediators/blood , Interleukin-6/blood , Kaplan-Meier Estimate , Male , Middle Aged , Odds Ratio , Patient Admission , Patient Selection , Placebo Effect , Pregnancy-Associated Plasma Protein-A/metabolism , Prospective Studies , Risk Assessment , Sample Size , Time Factors , Treatment OutcomeABSTRACT
We investigated the performance of brain natriuretic peptides (BNP and NT-proBNP) in detecting various degrees of left ventricular systolic dysfunction. The NT-proBNP assay (Roche) and the BNP assay (Bayer Shionoria) were performed in 46 patients (mean age 50 years; range 20-79 years) with various types of heart disease (chronic heart failure due to coronary artery disease, cardiomyopathy, acquired valve disease, congenital heart diseases) and different impairment of left ventricular systolic dysfunction was assessed by echocardiography. Patients were divided into four groups according to the left ventricular ejection fraction (LVEF) correlated with clinical severity. Significant differences in medians of NT-proBNP and BNP values between all groups were determined (P= 0.0161 for NT-proBNP and P=0.0180 for BNP). For identifying patients with severe systolic dysfunction (LVEF<40%), receiver operating characteristic (ROC) analysis for both BNP and NT-proBNP was performed. The diagnostic performances expressed as areas under the curve were of 0.69 for NT-proBNP (cut off value 367 pg/ml) and 0.60 for BNP (cut off value 172 pg/ml). However, the BNP showed higher sensitivity (85 % vs. 63 %) and a higher positive predictive value (69 % vs 55 %) than the NT-proBNP. The negative predictive values of BNP and NT-proBNP were similar (70 % and 71 % respectively). Brain natriuretic peptides are promising markers for the diagnosis of severe left ventricular systolic dysfunction.
Subject(s)
Natriuretic Peptide, Brain/blood , Peptide Fragments/blood , Ventricular Dysfunction, Left/diagnosis , Adult , Aged , Biomarkers/blood , Female , Humans , Male , Middle Aged , Stroke Volume , Ventricular Dysfunction, Left/blood , Ventricular Dysfunction, Left/physiopathologyABSTRACT
BACKGROUND: Brain natriuretic peptides are relevant markers of heart impairment. AIM: We investigated the relevance of investiging brain natriuretic peptides (NT-proBNP, BNP) in monitoring different types of cardiovascular disease (chronic heart failure due to coronary artery disease, cardiomyopathy, acquired valve disease, congenital heart diseases). METHODS: The NT-proBNP assay (Roche) was performed on 280 patients (mean age 49 years; range 20-89 years) and 48 healthy controls (mean age 43 years; range 13-65 years) and BNP assay (Bayer Shionoria) was performed in a subgroup of 42 patients (mean age 50 years; range 20-79 years). Patients were divided into four groups characterized by severity of heart failure according to the New York Heart Association classification. RESULTS: NT-proBNP concentrations differed in patients with cardiovascular diseases from controls (median 371 ng/l versus 41.5 ng/l, p < 0.0001). The cut off value of NT-proBNP determined in 280 patients with cardiovascular diseases was at 130 ng/l (AUC-area under curve = 0.93; sensitivity 98 %; specificity 79 %). Comparison of NT-proBNP and BNP values in patients showed significant correlation (r = 0.93; p < 0.0001). NT-proBNP showed significant differences between groups. CONCLUSIONS: Measurement of brain natriuretic peptides is useful and relevant in various types of heart diseases including congenital.
