Nearly two years ago, a study known as the JUPITER trial hinted at a new era in the use of statins -- one in which the cholesterol-busting drugs could be used to stave off heart-related death in many more people than just those with high cholesterol.
Now, however, researchers behind a new review that takes a second look at the findings of the landmark study say that these results are flawed -- and that they do not support the benefits initially reported.
Not only did this second look turn up no evidence of the "striking decrease in coronary heart disease complications" reported by investigators behind JUPITER (Justification for the Use of Statins in Primary Prevention), but it has also called into question drug companies' involvement in such trials, according to an article in the June 28 issue of Archives of Internal Medicine.
Moreover, Dr. Michel de Lorgeril of Joseph Fourier University and the National Center of Scientific Research in Grenoble, France, and coauthors argue that major discrepancies exists between the significant reductions in nonfatal stroke and heart attacks reported in the JUPITER trial and what has been found in other research.
"The JUPITER data set appears biased," Lorgeril and coauthors wrote in conclusion.
Dr. Paul Ridker of Harvard Medical School and Brigham and Women's Hospital in Boston dismissed de Lorgeril's criticisms. Ridker reported the JUPITER results at the American Heart Association meeting in 2008.
In an email to MedPage Today, Ridker said that JUPITER data "overwhelmingly stand for themselves. Among a group of individuals with low levels of cholesterol, we clearly demonstrate that those with elevated levels of [the inflammation marker] hsCRP are in fact a high-risk population, and that using statin therapy in this group cuts event rates for [heart attack] and stroke in half."
Ridker also pointed out that the "FDA has extensively reviewed these data, found the trial to be well conducted, and recently provided a new indication for the use of statins in primary prevention on the basis of the JUPITER data."
AstraZeneca, maker of the popular statin Crestor (known generically as rosuvastatin), also defended the JUPITER results and the way in which the study was conducted.
Donna Huang, an AstraZeneca spokesperson, told MedPage Today in an email that the study "was undertaken with a fully independent steering committee, data and safety monitoring board, and academic study statistician."
She also said Ridker and his co-investigators controlled all data. "AstraZeneca played no role in conducting data analyses and had no access to unblinded trial data," she wrote.
De Lorgeril and coauthors point out that nine of 14 authors of the JUPITER article have financial relationships with AstraZeneca, which sponsored the trial. Ridker has a patent interest in the assay for C-reactive protein (CRP), an inflammation biomarker evaluated in all JUPITER trial participants.
"The sponsor's pervasive role is clearly described in the second paragraph of the 'Methods' section of the report: 'the sponsor collected the trial data and monitored the study sites,'" the authors wrote.
De Lorgeril and coauthors concluded that "the results of the JUPITER trial are clinically inconsistent and therefore should not change medical practice or clinical guidelines. The results of the JUPITER trial support concerns that commercially sponsored clinical trials are at risk of poor quality and bias."