|Problem||Recent ACS (within 10 days)|
|Format||Double-blinded multi-center RCT|
|Inclusion criteria||Men and women who were at least 18 years old were eligible for inclusion if they had been hospitalized for an acute coronary syndrome â€” either acute myocardial infarction (with or without electrocardiographic evidence of ST-segment elevation) or high-risk unstable angina â€” in the preceding 10 days.
Patients had to be in stable condition and were to be enrolled after a percutaneous revascularization procedure if one was planned.
Finally, patients had to have a total cholesterol level of 240 mg per deciliter (6.21 mmol per liter) or less, measured at the local hospital within the first 24 hours after the onset of the acute coronary syndrome or up to six months earlier if no sample had been obtained during the first 24 hours.
Patients who were receiving long-term lipid-lowering therapy at the time of their index acute coronary syndrome had to have a total cholesterol level of 200 mg per deciliter (5.18 mmol per liter ) or less at the time of screening in the local hospital.
|Exclusion criteria||Patients excluded if they:
Had coexisting condition that shortened expected survival to less than two years
Receiving therapy with any statin at a dose of 80 mg per day at the time of their index event
Taking lipid-lowering therapy with fibric acid derivatives or niacin that could not be discontinued before randomization
Had received drugs that are strong inhibitors of cytochrome P-450 3A4 within the month before randomization
Were likely to require such treatment during the study period (because atorvastatin is metabolized by this pathway)
Had undergone percutaneous coronary intervention within the previous six months (other than for the qualifying event) or coronary-artery bypass surgery within the previous two months or were scheduled to undergo bypass surgery in response to the index event
Had factors that might prolong the QT interval
Had obstructive hepatobiliary disease or other serious hepatic disease
Had an unexplained elevation in the creatine kinase level that was more than three times the upper limit of normal and that was not related to myocardial infarction
Had a creatinine level of more than 2.0 mg per deciliter (176.8 Î_mol per liter).
|Follow-up||18 to 36 months (mean, 24)|
|Primary endpoint||Composite of death from any cause, myocardial infarction, documented unstable angina requiring rehospitalisation, revascularization (performed at least 30 days after randomisation), and stroke.|
|Secondary endpoint(s)||Risk of death from coronary heart disease, nonfatal myocardial infarction, or revascularization (if it was performed at least 30 days after randomization)
The risk of death from coronary heart disease or nonfatal myocardial infarction
The risk of the individual components of the primary end point
-Death from any cause
-Unstable angina requiring rehospitalisation
-Revascularisation >30d after randomisation
|Brief summary:||Significantly reduced CVD events following MI with high-dose atorva vs. prava|
|PAPER: Intensive versus moderate lipid lowering with statins after acute coronary syndromes.|
|Date||8 Apr 2004|
|Journal||N Engl J Med. 2004 Apr 8;350(15):1495-504.|
|Information||Non-inferiority study assessing
-If lower LDL in ACS patients is associated with reduced CVD events
-Efficacy and safety of aggressive LDL cholesterol lowering
In patients already receiving statin
-LDL unaffected by prava 40
-32% reduction by atorva 80 (p<0.001)
Primary endpoint RRR of 16% for atorva 80 (26.3%->22.4%; p<0.005)
-Benefit as early as 30 days
-Pravastatin failed to meet equivalence
Similar rates of discontinuation
-Increased rate of abnormal LFT for atorva (3.3% vs 1.1% prava)