Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial)
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- 作者：Petr Ostadal (1)
David Alan (2)
Jiri Vejvoda (2)
Jiri Kukacka (3)
Milan Macek (4)
Petr Hajek (2)
Martin Mates (1)
Milan Kvapil (5)
Jiri Kettner (6)
Martin Wiendl (6)
Ondrej Aschermann (1)
Josef Slaby (7)
Frantisek Holm (8)
Peter Telekes (8)
David Horak (8)
Peter Blasko (9)
David Zemanek (2)
Josef Veselka (2)
Jana Cepova (3) - 刊名：Trials
- 出版年：2010
- 出版时间：December 2010
- 年：2010
- 卷：11
- 期：1
- 全文大小：899KB
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David Alan (2)
Jiri Vejvoda (2)
Jiri Kukacka (3)
Milan Macek (4)
Petr Hajek (2)
Martin Mates (1)
Milan Kvapil (5)
Jiri Kettner (6)
Martin Wiendl (6)
Ondrej Aschermann (1)
Josef Slaby (7)
Frantisek Holm (8)
Peter Telekes (8)
David Horak (8)
Peter Blasko (9)
David Zemanek (2)
Josef Veselka (2)
Jana Cepova (3)
1. Heart Center, Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic
2. Department of Cardiology, University Hospital Motol, Prague, Czech Republic
3. Department of Clinical Biochemistry and Pathobiochemistry, University Hospital Motol and Charles University, 2nd Faculty of Medicine, Prague, Czech Republic
4. Institute of Biology and Medical Genetics, University Hospital Motol and Charles University, 2nd Faculty of Medicine, Prague, Czech Republic
5. Department of Internal Medicine, University Hospital Motol and Charles University, 2nd Faculty of Medicine, Prague, Czech Republic
6. Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
7. Department of Medicine, Hospital Kolin, Kolin, Czech Republic
8. Department of Cardiology, Regional Hospital Liberec, Liberec, Czech Republic
9. Internal Medicine Department, Faculty Hospital Nitra, Nitra, Slovakia
文摘
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