Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial)

Abstract

BackgroundStatins 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.MethodsThe 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.ResultsWe 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).ConclusionsThis 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 registrationNCT00171275

All-Cause Mortality and Cardiovascular Death between Statins and Omega-3 Supplementation: A Meta-Analysis and Network Meta-Analysis from 55 Randomized Controlled Trials

“…From the remaining 10 systematic reviews and meta-analyses, 374 RCTs were extracted and accessed to evaluate them for the eligibility criteria. After additionally hand-searching for updated RCTs ( n = 3) and excluding ineligible RCTs ( n = 322), 55 studies [ 5 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , ...…”

Updated evidence on early statin therapy for acute coronary syndromes: Meta-analysis of 18 randomized trials involving over 14,000 patients

“…Seventeen of the 18 included trials investigated four different statins: pravastatin (7 trials) [16,[24][25][26][27][28][29], atorvastatin (4 trials) [30][31][32][33], fluvastatin (3 trials) [34][35][36], and simvastatin (3 trials) [18,37,38] ( Table 1). One trial allowed any statin to be used in the intervention group [17].…”

“…Six trials [17,18,30,33,36,37] reported hsCRP ( Table 2b). The range of mean baseline hsCRP in trials was 5.3 mg/L to 20 mg/L with larger reductions in statin groups during follow-up.…”

Network Medicine: A Clinical Approach for Precision Medicine and Personalized Therapy in Coronary Heart Disease

“…Simvastatin was also tested in combination with ezetimibe. Results from the IMPROVE-IT Trial showed that lipid-lowering therapy with ezetimibe, plus simvastatin, improved clinical outcomes in terms of cardiac death, MI recurrence, and stroke 104) .…”