Crestor is not significantly better at stabilizing plaque and reducing cholesterol, compared to Lipitor, a Pfizer drug that Ranbaxy Laboratories will launch in much cheaper generic versions in two weeks' time. AstraZeneca's Crestor (rosuvastatin) will be harder to sell because it is much more expensive than generic atorvastatin (Lipitor), now that no significant clinical advantage has been shown in a trial funded by AstraZeneca. Crestor's patent expires in 2016.
The SATURN (Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin) trial results were presented at the American Heart Association's Scientific Sessions 2011, as well as being published today in NEJM (New England Journal of Medicine.
The 24-month trial, which included 1,385 participants, led by Stephen J. Nicholls, M.D., Ph.D., showed that high doses of Crestor and Lipitor - rosuvastatin (40 mg) and atorvastatin (80 mg) - reversed coronary artery disease by reducing the amount of plaque in arteries that supply blood to the heart. The SATURN trial was carried out in 215 different centers - it is the "largest study using intracoronary ultrasound to measure changes in the amount of plaque in coronary arteries."
The trial compared the impact of Crestor versus Lipitor in reducing LDL cholesterol, known as "bad cholesterol", and their varying effects on HDL cholesterol, known as "good cholesterol".
Previous trials had shown that Crestor raised good cholesterol by between 7% and 15%, while Lipitor's effect on HDL was only very slight.
In this study, atheroma volume dropped by 0.99% in the Lipitor group and 1.22% in the Crestor group - the researchers described the difference as "not statistically significant". The atheroma volume is the amount of plaque in the assessed part of the coronary artery.
Dr. Stephen J. Nicholls said:
"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. It's a very positive outcome for patients and shows the benefits of high doses of statins."
Below are some additional findings from the SATURN trial:
- In a different method for analyzing atheroma volume (using ultrasound too), Lipitor lowered plaque by 4.4 cubic mm, while Crestor did so by 6.4 cubic mm.
- Lipitor lowered total plaque in 64.7% of participants, compared to 71.3% in the Crestor group
- Average LDL cholesterol levels in the Lipitor group were 70 mg/dl, compared to 62.6 mg/dl in the Crestor group (lower number is better, LDL is bad cholesterol)
- Average HDL cholesterol levels in the Lipitor group were 48.6 mg/dl, versus 50.4% in the Crestor group (higher number is better, HDL is good cholesterol)
"The differences between the two drugs were modest and the difference in HDL levels was less than we were anticipating based on previous studies."
In the SATURN trial, incidence of stroke, heart attack or having to undergo an angioplasty was less than half, compared to prior trials with lower doses.
Dr. Nicholls said:
"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."
Darwin Labarthe, professor of preventive medicine at Northwestern University's medical school, said during the AHA Scientific Meeting:
"The study provides no basis to infer differential clinical benefit between
the two interventions."
In September this year, AstraZeneca had warned that the SATURN trial had missed its primary goal - demonstrating Crestor's significant superiority to Lipitor in lowering arterial plaque. The company added that full details of the trial would not be revealed until today.
Even so, Crestor does improve cholesterol levels, as well as reducing plaque accumulation in the arteries, AstraZeneca stressed in a communiqué.
Howard Hutchinson, Chief Medical Officer, AstraZeneca, said:
"These results are good news for patients with cardiovascular disease and provide further support of what we already know about Crestor. Crestor consistently and significantly lowers LDL-C, increases HDL-C and helps patients get to target LDL-C of less than 70 mg/dL. In addition, SATURN once again shows us that Crestor helps to reduce plaque build-up in the arteries."
Written by Christian Nordqvist