Pfizer Inc, new analysis showed that high dose Lipitor (atorvastatin calcium) 80 mg significantly reduced the risk of major cardiovascular events, including heart attack and stroke, by 27 percent in patients with heart disease who had previous coronary bypass surgery compared with patients taking the 10 mg dose of Lipitor. This analysis, designed and completed following the closure of the five-year treating to New Targets (TNT) study, was published in the “Journal of the American College of Cardiology.”
The TNT study was an investigator-led trial coordinated by an independent steering committee and funded by Pfizer. The primary endpoint was the reduction of major cardiovascular events, including death from heart disease, non-fatal heart attacks, resuscitated cardiac arrest, and fatal or non-fatal strokes.
The study enrolled 10,001 men and women with coronary heart disease aged 35 years to 75 years in 14 countries and followed them for an average of five years. In this analysis, 4,654 patients who had previous coronary bypass surgery were compared with 5,347 patients who did not. Lipitor 80 mg is not a starting dose.
Intensive Lipitor therapy also provided a significant 30 percent reduction in the need for either repeat coronary bypass surgery or angioplasty, another type of interventional heart surgery, compared with Lipitor 10 mg.
Each year in the U.S., approximately 470,000 bypass surgeries are performed on 270,000 people. Patients in the TNT study who had undergone previous bypass surgery had a much higher likelihood of cardiovascular events than those who did not have prior bypass surgery. This especially high risk population tends to be under-treated with lipid-lowering therapy.
“Patients may be under the impression that once they have had coronary bypass surgery, they are no longer at high risk for heart attacks and strokes,” said Dr. Rochelle Chaiken, vice president of Pfizer’s global cardiovascular and metabolic medical team. “Although these patients continue to be at an increased risk for major cardiovascular events and repeat heart surgery, statins are considerably underused. This analysis highlights not only the importance of treating, but also treating aggressively with Lipitor 80 mg.”
Both doses of Lipitor (80 mg and 10 mg) were well-tolerated in patients with prior coronary bypass surgery, and the safety profile of Lipitor 80 mg was comparable to Lipitor 10 mg, a finding that was consistent with the overall TNT population. |
