Cardiovascular outcome trial · JAMA 2005
IDEAL trial
High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial.
The bottom line
High-dose atorvastatin lowered LDL-C more than usual-dose simvastatin and reduced some secondary cardiovascular endpoints and nonfatal MI, but did not significantly reduce the primary composite of major coronary events or all-cause mortality after prior MI.
No significant benefitUS status: US-approved
At a glance
- Medicine
- High-dose atorvastatin (80 mg/d; n=4439)
- Compared with
- Usual-dose simvastatin (20 mg/d; n=4449)
- People
- 8,888
- Who took part
- Patients aged 80 years or younger with a history of acute myocardial infarction
- Design
- prospective, randomized, open-label, blinded end-point evaluation trial
- Follow-up
- median follow-up of 4.8 years
- Main question
- Occurrence of a major coronary event, defined as coronary death, confirmed nonfatal acute MI, or cardiac arrest with resuscitation
Main result
A major coronary event occurred in 463 simvastatin patients (10.4%) and in 411 atorvastatin patients (9.3%) (hazard ratio [HR], 0.89; 95% CI, 0.78-1.01; P = .07)
Effect on LDL cholesterol
During treatment, mean LDL-C levels were 104 (SE, 0.3) mg/dL in the simvastatin group and 81 (SE, 0.3) mg/dL in the atorvastatin group
Other results
Death from any cause occurred in 374 (8.4%) in the simvastatin group and 366 (8.2%) in the atorvastatin group (HR, 0.98; 95% CI, 0.85-1.13; P = .81). Major cardiovascular events occurred in 608 and 533 in the 2 groups, respectively (HR, 0.87; 95% CI, 0.77-0.98; P = .02).
Safety
Patients in the atorvastatin group had higher rates of drug discontinuation due to nonserious adverse events; transaminase elevation resulted in 43 (1.0%) vs 5 (0.1%) withdrawals (P<.001). Serious myopathy and rhabdomyolysis were rare in both groups.
In the trial's own words
“A major coronary event occurred in 463 simvastatin patients (10.4%) and in 411 atorvastatin patients (9.3%) (hazard ratio [HR], 0.89; 95% CI, 0.78-1.01; P = .07).”
Quoted from the abstract of JAMA 2005, checked word for word against PubMed. PubMed 16287954 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Statins
Common questions
What did the IDEAL trial find?
High-dose atorvastatin lowered LDL-C more than usual-dose simvastatin and reduced some secondary cardiovascular endpoints and nonfatal MI, but did not significantly reduce the primary composite of major coronary events or all-cause mortality after prior MI.
Who was in IDEAL?
8,888 people. Patients aged 80 years or younger with a history of acute myocardial infarction.
What was IDEAL's main result?
A major coronary event occurred in 463 simvastatin patients (10.4%) and in 411 atorvastatin patients (9.3%) (hazard ratio [HR], 0.89; 95% CI, 0.78-1.01; P = .07)
How much did LDL cholesterol change in IDEAL?
During treatment, mean LDL-C levels were 104 (SE, 0.3) mg/dL in the simvastatin group and 81 (SE, 0.3) mg/dL in the atorvastatin group
Related trials
- TNT (2005)In patients with stable coronary disease, treating to a much lower LDL target with high-dose atorvastatin (80 mg) further reduced major cardiovascular events compared with the standard 10 mg dose, though with more liver enzyme elevations and no difference in overall mortality.
- CARDS (2004)In people with type 2 diabetes but no prior cardiovascular disease and no high LDL-cholesterol, taking atorvastatin 10 mg daily substantially lowered the risk of heart attacks, revascularization, and stroke, with no increase in adverse events.
- PROVE IT-TIMI 22 (2004)In patients recently hospitalized for acute coronary syndrome, intensive lipid lowering with high-dose atorvastatin (80 mg) reduced death and major cardiovascular events more than standard-dose pravastatin (40 mg).
- SPARCL (2006)In patients with a recent stroke or TIA but no known coronary disease, high-dose atorvastatin modestly reduced recurrent stroke and cardiovascular events, though it slightly increased hemorrhagic stroke risk and did not improve overall mortality.
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