AstraZeneca’s drug Crestor (rosuvastatin) is no more effective than rival Lipitor (atorvastatin) in reducing arterial plaques and cholesterol levels, according to a major head-to-head trial funded by AZ.
The SATURN trial confirms the value of using high doses of either drug to prevent strokes and heart attacks.
However, their demonstrated equivalence means that Crestor (whose patent will expire in 2016) may struggle to compete with the cheaper generic version of Lipitor about to be launched by Ranbaxy.
The SATURN (Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin) trial tested 1,385 participants in 215 centres over 24 months – the largest such trial ever undertaken.
It confirmed that high doses of Crestor (40mg) and Lipitor (80 mg) successfully reduced levels of arterial plaque – and the frequency of stroke, heart attack and need for angioplasty was reduced by half relative to previous trials with lower doses.
Trial outcomes such as increase in ‘good’ (HLD) cholesterol, reduction in ‘bad’ (LDL) cholesterol and reduction in plaque showed Crestor performing slightly better than Lipitor, but not to a statistically significant degree.
Darwin Labarthe, Professor of Preventive Medicine at Northwestern University, commented: “The study provides no basis to infer differential clinical benefit between the two interventions.”
SATURN trial leader Dr. Stephen J. Nicholls said the trial made a strong case for the use of high statin doses: “Regression of plaque has been the holy grail of heart disease treatment, and in this trial more than two-thirds of the patients had regression.
“Doctors have been reluctant to use high doses of statins, but in this study the drugs were safe, well tolerated and had a profound impact on lipid levels, the amount of plaque in vessel walls and the number of cardiovascular events.”