AstraZeneca has unveiled new data from the landmark JUPITER study which shows that its cholesterol-lowering blockbuster Crestor significantly reduced the risk of blood clots in the veins.
Specifically, a new analysis of JUPITER, a 17,802-patient study of patients with low to normal “bad” LDL cholesterol levels but elevated levels of high-sensitivity C-reactive protein shows that Crestor (rosuvastatin) 20mg cut the risk of venous thromboembolism by 43%. The analysis was presented at the American College of Cardiology meeting in Orlando, Florida.
The most common form of VTE is deep vein thrombosis and additional results of this secondary endpoint analysis of JUPITER showed that Crestor produced a 55% reduction in the risk of DVT. It also demonstrated a non-significant 23% reduction in pulmonary embolisms, or blood clots lodging in the lungs.
Alex Gold, executive director of clinical development at AstraZeneca’s US unit, noted that this is the first time a statin has been shown to reduce the risk of VTE in a randomised, prospective study”. He added that “this result is in addition to the effect on cardiovascular events already demonstrated by Crestor in the primary analysis of JUPITER”, released in November.
The Anglo-Swedish drugmaker confirmed it expects to file a regulatory submission including the JUPITER data in the first half of this year and if approved will begin promotional activities within the approved labelling. Crestor brought in $3.6 billion in sales last year and that figure would rise significantly if the label is changed.
Crestor/TriLipix combo impresses
The ACC meeting also saw the presentation of promising data from a new study of a low dose of Crestor (5mg) in combination with Abbott Laboratories’ TriLipix (fenofibric acid). The Phase III study showed that the combination did significantly better at lowering LDL cholesterol and triglycerides, as well as raising levels of “good” HDL cholesterol in patients with multiple lipid disorders.
After 12 weeks of therapy, the combo reduced LDL by 28.7% compared with 4.1% on TriLipix alone, while triglycerides decreased by 40.3% compared with 17.5% with Crestor alone. The combination raised HDL by 23% compared with 12.4% with rosuvastatin alone.
