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In This Issue:
Second of two parts. Last week, Bulletin examined decades of research that led to the JUPITER Trial.
In November, BWH unveiled research that likely will change the way physicians assess patients’ risk of heart disease and change the care delivered to those patients.
Paul Ridker, MD, director of the BWH Center for Cardiovascular Disease Prevention, and his colleagues have been studying high-sensitivity C-reactive protein, or hsCRP, a biomarker for inflammation that is now in wide clinical use to detect heart disease risk. Ridker and more than a dozen other BWH investigators established that hsCRP predicts high risk of heart attack and stroke among apparently healthy men and women and demonstrated statin therapy could cut that risk in half even when cholesterol levels are low.
The JUPITER trial got underway in 2002 with hopes of shining light on how to use inflammation biology to prevent heart attacks among people who have low cholesterol levels. The JUPITER team studied the effect of statin therapy on otherwise healthy people with low cholesterol levels who were at high cardiac risk due to elevated hsCRP.
The investigators screened more than 80,000 people worldwide, ultimately identifying 17,802 apparently healthy men and women with low levels of cholesterol but high levels of hsCRP. In a collaborative effort involving more than 1,300 physicians worldwide, these patients were randomized into the JUPITER trial such that half received rosuvastatin and half received a placebo or dummy pill. After an average follow-up of just over two years, the trial was stopped early by its Independent Data Monitoring Board because of an unprecedented 44 percent reduction in heart attack, stroke and cardiovascular death. “The logistic heroes of JUPITER include BWH’s Eleanor Danielson and Jean MacFadyen, both of whom dedicated themselves almost full-time to the success of this trial,” Ridker said. Danielson, who traveled to clinical sites throughout the world and to investigator meetings in the in the U.S., Canada, Latin America and Europe, “was the internal glue for this trial,” Ridker said, while MacFadyen “single-handedly has done the work of a dozen programmers, keeping all the data up to date and fully analyzed.”
The JUPITER trial findings are likely to change prevention guidelines in the United States and worldwide. Despite studying a group of patients not currently eligible for drug therapy because they are at risk due to inflammation rather than high cholesterol, JUPITER showed that those taking statin therapy were half as likely to need angioplasty or bypass surgery, half as likely to suffer a heart attack or stroke, and 20 percent less likely to die than participants given the placebo.
BWH’s Robert Glynn, ScD, who served as the JUPITER academic study statistician, conservatively estimates that 250,000 heart attacks in the U.S. could be prevented if the strategy tested in JUPITER were appropriately applied over a five-year period and if guidelines are implemented to put patients with high hsCRP levels on statin therapy, even if their cholesterol levels are low. “JUPITER also provides for the first time clear prevention data for women and for minority patients, groups at risk for heart disease that have been excluded from most prior trials,” Glynn said.
“This is a BWH story with implications for patients around the world. The end game is to now put this knowledge into practice,” said Ridker.