TUESDAY, Aug. 03, 2004 (HealthDayNews) --
Pfizer Inc.'s cholesterol drug Lipitor has been approved by the U.S. Food and Drug Administration to reduce a person's risk of heart attack, the company announced Monday.
Until now, the company was limited to marketing the top-selling drug as a way to lower high cholesterol. The FDA's action means Lipitor can also be prescribed to reduce the risk of heart attack in people with fairly normal cholesterol levels, but with other risk factors for heart disease like family history, smoking, diabetes, and obesity, Pfizer said in a statement.
The FDA based its decision on trials involving more than 10,300 people with normal or borderline cholesterol levels. Lipitor users' risk of heart attack fell 36 percent, compared to those who took a nonmedicinal placebo, Pfizer said. Because of the significant benefits seen, the trials were halted two years early, the company added.
The new approval also allows the medication to be marketed as a way to reduce angina (chest pain) and to lower the need for artery-opening procedures like balloon angioplasty.
Lipitor is among a class of drugs called statins, which include competing medications like Merck's Zocor and Bristol-Myers Squibb's Pravachol. Both have been sold on their power to cut the risk of heart attack for almost 10 years, the Wall Street Journal reported.
For more information about Lipitor, visit Medline.
