Based on moderate quality evidence , due to concerns about risk of bias and imprecision , initiation of statin therapy within 14 days following ACS does not reduce death , myocardial infa rct ion , or stroke up to four months , but reduces the occurrence of unstable angina at four months following ACS .
Serious side effects were rare
BACKGROUND The early period following the onset of acute coronary syndrome ( ACS ) represents a critical stage of coronary heart disease , with a high risk of recurrent events and deaths .
The short-term effects of early treatment with statins on patient-relevant outcomes in patients suffering from ACS are unclear .
This is an up date of a review previously published in 2011 .
OBJECTIVES To assess the effects , both harms and benefits , of early administered statins in patients with ACS , in terms of mortality and cardiovascular events .
Fluvastatin in the therapy of acute coronary syndrome: Rationale and design of a multicenter, randomized, double-blind, placebo-controlled trial (The FACS Trial)[ISRCTN81331696]
Background Activation of inflammatory pathways plays an important contributory role in coronary plaque instability and subsequent rupture , which can lead to the development of acute coronary syndrome ( ACS ) . Elevated levels of serum inflammatory markers such as C-reactive protein ( CRP ) represent independent risk factors for further cardiovascular events . Recent evidence indicates that in addition to lowering cholesterol levels , statins also decrease levels of inflammatory markers . Previous controlled clinical trials reporting the positive effects of statins in participants with ACS were design ed for very early secondary prevention . To our knowledge , no controlled trials have evaluated the potential benefits of statin therapy , beginning immediately at the time of hospital admission . A previous pilot study performed by our group focused on early initiation of cerivastatin therapy . We demonstrated a highly significant reduction in levels of inflammatory markers ( CRP and interleukin-6 ) . Based on these preliminary findings , we are conducting a clinical trial to evaluate the efficacy of another statin , fluvastatin , as an early intervention in patients with ACS . Methods The FACS-trial ( Fluvastatin in the therapy of Acute Coronary Syndrome ) is a multicenter , r and omized , double-blind , placebo-controlled study evaluating the effects of fluvastatin therapy initiated at the time of hospital admission . The study will enroll 1,000 participants admitted to hospital for ACS ( both with and without ST elevation ) . The primary endpoint for the study is the influence of fluvastatin therapy on levels of inflammatory markers ( CRP and interleukin-6 ) and on pregnancy associated plasma protein A ( PAPP-A ) . A combined secondary endpoint is 30-day and one-year occurrence of death , nonfatal myocardial infa rct ion , recurrent symptomatic ischemia , urgent revascularization , and cardiac arrest . Conclusion The primary objective of the FACS trial is to demonstrate that statin therapy , when started immediately after hospital admission for ACS , results in reduction of inflammation and improvement of prognosis . This study may contribute to new knowledge regarding therapeutic strategies for patients suffering from ACS and may offer additional clinical indications for the use of statins
Based on moderate quality evidence , due to concerns about risk of bias and imprecision , initiation of statin therapy within 14 days following ACS does not reduce death , myocardial infa rct ion , or stroke up to four months , but reduces the occurrence of unstable angina at four months following ACS .
Serious side effects were rare
BACKGROUND The early period following the onset of acute coronary syndrome ( ACS ) represents a critical stage of coronary heart disease , with a high risk of recurrent events and deaths .
The short-term effects of early treatment with statins on patient-relevant outcomes in patients suffering from ACS are unclear .
This is an up date of a review previously published in 2011 .
OBJECTIVES To assess the effects , both harms and benefits , of early administered statins in patients with ACS , in terms of mortality and cardiovascular events .