March 16, 1999

LANDMARK TEXAS STUDY RESULTS IN FDA INDICATION

FORT WORTH, Texas -- Results of a major study conducted in Texas, including Fort Worth, have led to the U.S. Food and Drug Administration’s approval of the study medication for the reduction of the risk of first heart attack, unstable angina and coronary revascularization procedures.

The FDA approved a new use for Merck & Co., Inc.’s Mevacor® (lovastatin), a cholesterol-lowering medicine: in people without symptoms of cardiovascular disease, with average to moderately elevated levels of total and LDL ("bad") cholesterol and below average HDL ("good") cholesterol. Mevacor is the first drug to receive FDA approval for the treatment of low HDL cholesterol.

Merck & Co., Inc. released full details of the FDA approval March 15.

Participants in the study did not have symptomatic heart disease; in addition to age, 63 percent had at least one other risk factor for heart disease. The study population had average to moderately elevated total and "bad" cholesterol levels, below average levels of "good" cholesterol, and were at higher risk of cardiovascular disease based on an elevated total cholesterol to "good" cholesterol ratio.

In the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS), the investigation’s official name, researchers studied 6,605 patients for a median of 5.1 years. Their average cholesterol levels were 221 at the beginning of the study with average HDL cholesterol levels of 37. Study findings showed that the cholesterol-lowering drug was the first and only cholesterol medication proven to be effective in preventing first heart attacks and other coronary events in men and women without heart disease who have average levels of LDL ("bad") cholesterol, but reduced HDL ("good") cholesterol levels. The five-year study was conducted at the University of North Texas Health Science Center in Fort Worth and the Wilford Hall Medical Center at Lackland Air Force Base in San Antonio.

UNT Health Science Center investigators were Michael Clearfield, D.O., chairman of the internal medicine department and Stephen Weis, D.O., chief of the endocrinology division.

Final results of the study indicated that therapy with Mevacor resulted in a 37 percent reduction in first major coronary events, such as heart attacks or unstable angina (chest pain), in a broad range of subjects, including women, people with high blood pressure, persons with diabetes, men and women over 65 and smokers. Benefits of the medication were seen across all treatment groups. Preliminary results of the study were presented in November 1997 at the annual scientific meeting of the American Heart Association and published in the May 1998 edition of the Journal of the American Medical Association.

According to Dr. Clearfield, one of the study’s primary investigators, cholesterol levels are likely to be scrutinized much more closely by physicians nationwide because of the study results and the FDA’s ruling.

"This new indication for Mevacor is significant because it identifies a population of people who have cholesterol levels considered normal and average, but who may benefit from cholesterol-lowering treatment," said Dr. Clearfield. "If a person’s HDL or good cholesterol level is too low, and the LDL or bad cholesterol level is average or moderately elevated, that person may be at risk. All adults should have both their LDL and HDL cholesterol levels checked and talk to their physician about appropriate treatment, if necessary," he said.

The AFCAPS/TexCAPS study began in 1990 and was scheduled to conclude in 1998, but was ended in mid-1997 due to the clearly favorable results of the study population.