This is the first time that the FDA has cleared a drug such as Pravachol, which is a member of the HMG-CoA reductase inhibitor class of drugs, for use in reducing the risk of stroke. In addition, Pravachol is the first drug of its kind to receive FDA clearance for use in reducing the risk of recurrent heart attack and death from heart disease in patients with normal cholesterol levels. These patients represent the majority of people who have survived a heart attack. This indication is even more compelling because the majority of patients in the CARE trial were already taking aspirin, which is known to have an impact on the reduction of stroke. More than four million people world-wide are believed to suffer a stroke each year.
Stroke is the third-leading cause of death and the leading cause of disability.
Approximately two-thirds of the people who suffer a stroke will experience severe disabilities including paralysis, loss of speech and lapses of memory. Pravachol has been shown in a definitive way in two landmark trials to have this benefit. This opens up a new avenue of stroke prevention previously unavailable in the neurotherapeutic armamentarium. In the CARE study patients who received Pravachol reduced their risk of a stroke or TIA by 26 percent, and reduced their risk of recurrent heart attack and death from heart disease by 24 percent. Pravachol is the only drug in its class proven to reduce the risk of a heart attack in patients with and without established coronary heart disease.