Trial shows benefits of atorvastatin calcium

Atorvastatin calcium (80 mg) was more effective than simvastatin (20 mg–40 mg) in reducing the risk of multiple cardiovascular events in patients with a history of heart attacks, the Incremental Decreases through Aggressive Lipid Lowering (IDEAL) clinical trial showed. 

Cardiovascular events included heart attack, stroke, and cardiac revascularization procedures such as bypass surgery and angioplasty. 

The results were presented at the Annual Scientific Sessions of the American Heart Association.

All 8,888 patients enrolled in the trial had a prior heart attack, and 2,546 of them experienced at least one additional cardiovascular event after entering the trial. 

A new post-hoc analysis (planned after study closed) reported that 1,048 patients had a second cardiovascular event during the course of the trial. 

In those patients treated with atorvastatin calcium 80 mg, there was a significant 24 percent reduction in relative risk of having that second event than those treated with simvastatin.

The analysis also found that 416 patients had a third event during the course of the trial.  In those patients treated with atorvastatin calcium there was a significant 19 percent reduction in relative risk of having that third event compared to simvastatin.

The overall results of this analysis were even more robust in patients who were more adherent to treatment. 

In the original analysis of IDEAL, the primary endpoint of first major coronary event (non-fatal heart attack, coronary heart disease death, cardiac arrest) during the trial was reduced in the atorvastatin calcium patients compared to simvastatin patients by 11 percent, which did not reach statistical significance. 

There was a significant 17 percent reduction in risk for first non-fatal heart attack and significant 13 percent reduction in risk of first major cardiovascular events (major coronary events and stroke) in patients taking atorvastatin calcium.

Dr. Matti Tikkanen, professor of medicine at Helsinki University and lead author of the analysis, said,  “This analysis showed that atorvastatin calcium was more effective than simvastatin in reducing the risk of recurrent cardiovascular events. Our results provide evidence that patients who have already experienced cardiovascular events benefit from atorvastatin calcium 80 mg.”

The analysis is unique because it evaluated all cardiovascular events that occurred during the five-year course of the trial, whereas analyses of most statin trials are usually limited to evaluating the occurrence of the first event only.

Atorvastatin calcium is the most extensively studied and most prescribed cholesterol-lowering therapy in the world, with nearly 133 million patient-years of experience. 

It is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.

Pfizer Inc. is the world’s top ranking investor in research and development with a total expenditure of 5.8 billion euros ($8.18 billion) last year, according to the European Commission.

It is the leader among the four biggest US R&D investors engaged in the pharmaceutical and biotechnology industries.

Pfizer’s search for new treatments spans hundreds of research projects across 18 therapeutic areas.

Approximately 13,000 scientists and support staff are working in nine research and development facilities in five countries to discover new medicines.