Based on the primary end point results, "the study provides no basis to infer differential clinical benefit between atorvastatin and rosuvastatin," commented Dr. Darwin R. Labarthe, professor of preventive medicine at Northwestern University in Chicago and the designated discussant for the report at the meeting.
The study showed "a low number of clinical and biochemical adverse events in both groups," said Dr. Nicholls. An elevated ALT level occurred in 2.0% of the atorvastatin patients and in 0.7% of the rosuvastatin patients, a statistically significant difference. Proteinuria occurred in 3.8% of the rosuvastatin patients and in 1.7% of those on atorvastatin, also a statistically significant difference. No patient had rhabdomyolysis, and the two groups did not differ significantly in their rates of major adverse cardiovascular events, which occurred in 7.1% of the atorvastatin patients and in 7.5% of those on rosuvastatin.
Although Dr. Nicholls highlighted the high level of coronary-atheroma regression seen among most patients in both study arms, some experts dismissed the immediate importance of this finding without evidence for the association of this regression with clinical end points.
Dr. Robert H. Eckel
"The question is whether plaque stability is any different," commented Dr. Robert H. Eckel, professor of medicine and an atherosclerosis specialist at the University of Colorado at Denver, Aurora. "It is possible that with regression the plaque is more stable, but it is a surrogate marker. We don’t know whether that will translate into a clinical benefit." The U.S. cholesterol-treatment goals set by the National Heart, Lung, and Blood Institute, which are now in late stages of revision, "are directed by evidence-based outcomes," and hence the findings from SATURN "will not influence" goal revisions, he said in an interview.
Dr. Eckel and other experts also said they believe that the results would prod insurers and patients to focus more on treatment with generic atorvastatin and less on treatment with a pricier, proprietary rosuvastatin. "Price will drive treatment decisions," Dr. Eckel said. "In many cases, third-party payers and patients won’t pay for Crestor."
The SATURN study was sponsored by AstraZeneca, which markets rosuvastatin (Crestor). Dr. Nicholls said that he has been a consultant to and has received honoraria from AstraZeneca, Eli Lilly, Anthera, Omthera, Merck, Takeda, Resverlogix, Sanofi-Aventis, CSL Behring, Esperion, and Boehringer Ingelheim. He said he has received research support from AstraZeneca, Anthera, Eli Lilly, Novartis, Resverlogix, Roche, and LipoScience. Dr. Rader has been a consultant or advisor to Genentech, Merck, and Roche, and he has spoken on behalf of and has received research grants from Merck. Dr. Labarthe, Dr. Eckel, and Dr. Lloyd-Jones said that they had no relevant disclosures.