The US Food and Drug Administration (FDA) has approved the cholesterol-lowering medication Crestor (rosuvastatin) to reduce the likelihood of a heart attack or stroke for patients who are at increased risk of heart disease but have not been diagnosed with it.
The new indication will allow producer AstraZeneca to provide the drug to patients who are at risk but have not been diagnosed with heart disease to reduce the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries.
The indication specifically targets men 50 years of age and older and women 60 years of age and older who have an elevated amount of high sensitivity C-reactive protein in their blood and at least one additional traditional cardiovascular risk factor such as smoking, high blood pressure, a family history of premature heart disease, or low amounts of high-density lipoprotein or HDL cholesterol.
The new indication is based on results of the JUPITER trial, which compared 8,901 patients who received Crestor to the same number of patients who received a placebo for two years.
Patients who took Crestor experienced fewer cardiac events, including heart attacks and strokes, and underwent fewer procedures such as coronary angioplasty or coronary artery bypass surgery to treat or revascularise their arteries.
This new indication does not support the use of Crestor in individuals who have an elevated amount of high sensitivity C-reactive protein but no traditional cardiovascular risk factors.