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
Highlights
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)
Fluvastatin and placebo groups were comparable in the baseline characteristics including medical history, clinical characteristics, and concomitant medication (Table 1)
At day 30, open-label statin therapy was initiated in all patients; at the end of one-year follow-up, 75% of patients were treated with statin in the fluvastatin group and 78% in placebo group
Summary
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). An increasing number of observations demonstrates, that statins may play a beneficial role in early secondary prevention and directly in the therapy of ACS, i.e. when statin treatment is started as first-line care in clinically unstable patients This therapeutic approach is supported by (i) experimental studies, showing the protective effect of statins under the condition of acute ischemia [4,5,6,7,8], (ii) analysis of different registers and trials, demonstrating better prognosis of statin-treated patients with ACS [9,10,11], and (iii) small clinical trials, describing an improvement in some pathogenic factors and markers as a result of immediate statin therapy [12,13,14,15,16,17,18]. A prospective, placebo-controlled trial, testing the hypothesis that statin, when administered at admission in patients with ACS, suppresses the inflammatory burden and improves clinical outcomes
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