MIRACL Study
MIRACL Study
Effects of Atorvastatin on Early Recurrent Ischemic Events in Acute Coronary Syndromes: The MIRACL Study
Jama 2001; Vol. 285, 1711-1718
History
-Statins are known to reduce death and CV events over long-term in pts with CAD
-Prior trials excluded pts with recent UA/MI
-This is the period pts experience highest rate of death and recurrent events
-Statins may improve endothelial fn, decrease PLT aggregability, reduce vasc inflamm.
Goal
-Show that treatment c atorvastatin soon p UA/NQWMI reduces early events/death
Methods
-122 centers in 4 different continents
-Inclusion: adults with CP/discomfort 15mins at rest/min exertion w/in 24h before hospitalization
-One of: new/dynamic ST-TW changes at least 2 contiguous leads
-new WMA by Echo
-reversible perfusion defect by radionuclide scan
-elevated cardiac enzymes
-Exclusion criteria: total cholesterol > 270, planned cor revascularization, QWMI w/in 4 wks
-CABG w/in 3 months, PCI w/in 6 months, LBBB/paced, class III/IV HF
-concurrent lipid lowering agent use. Renal failure, transaminases > 2x ULN
-insulin-dependent DM, pregnancy/lactation
-Design: atorvastatin 80mg/d vs. placebo start w/in 24-96 hrs, continue 16weeks
-Primary combined end point: death, nonfatal acute MI, cardiac arrest, recurrent ischemia-16wks
Results
-1538 assigned to atorvastatin vs. 1548 placebo; avg 65yo, mostly white, ¼ prior MI
-Equal number (about 200) pts dropped out of each arm – adverse eff/lost to follow up
-Similar use of ASA, IIb/IIIa, heparin, nitrates, B-blockers
-Mean time to start of study drug 63 hours
-Lipid levels at start identical in both groups: mean LDL 124, TG 184, HDL 46
-At 16weeks, LDL increased 12% placebo vs. decrease 40% in atorvastatin
-Primary end point event in 17.4% placebo vs. 14.8% in atorvastatin; (RRR .84 CI .70-1.00)
-No difference in death/nonfatal MI or cardiac arrest; major diff was risk recurrent ischemia
-Effects were independent of baseline LDL
-Abnormal liver transaminases (> 3x ULN) occurred 2.5% statin group vs. 0.6% placebo
Conclusions
-Early treatment with high dose statin reduced ischemic events over 16-week period
-Study not powered to show reduction in mortality
-Excluded STEMI/revasc pts in order to avoid confounding of short-term events; efficacy statin acutely not known but likely beneficial
-High dose statin chosen to produce maximum effect, however optimal dose not known – high dose statin likely a/w greater degree transaminitis and myositis, therefore use much lower doses (10-40mg).
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- treatment options for paraneoplastic neurological
- rituximab in the treatment of refractory adult and
- myositis ossificans traumatica of the temporalis muscle a
- covid 19 vaccines and myositis faqs
- be part of clinical research national institute of
- pittsburgh myositis center
- thejohnshopkins myositiscenter hopkins medicine
- therapies for myositis how and why
- new jersey medicaid state plan
- label food and drug administration
Related searches
- why should we study philosophy
- why study business
- why should i study business
- why study business administration
- why study law
- why study philosophy
- why study financial management
- english comp 1 study guide
- why should anyone study philosophy
- why study business finance
- why study finance
- bible study for women worksheets