A powerful cholesterol drug cut the incidence of heart attack and stroke in half when given to people with elevated levels of inflammation, as a? new clinical trial. The results have attracted much attention because people in the study had normal levels of cholesterol and therefore are not recommended cholesterol-lowering drugs. But the long awaited trial called JUPITER, also comes with notes; more importantly, it is unclear why the drug, Crestor, actually helped these people, and if and how it should change for disease prevention strategies.
led by Paul Ridker, a cardiologist at Brigham and Women's Hospital in Boston, the JUPITER study enrolled nearly 18,000 people who had normal levels of cholesterol and moderate or high levels of protein C reactive protein (CRP), a marker of inflammation in the blood. For about 2 years, half received Crestor, a powerful anti-cholesterol drug in a class known as statins, and half received a placebo. The trial was stopped in March, three years early because Crestor worked so well. Those who took it had 50% fewer heart attacks and strokes, and overall mortality was 20% lower than the placebo group. In absolute terms, however, the differences were quite small: 1.8% of those taking placebo, or 157 people, had a "cardiac event" during the study, compared with 0.9%, or 83 people, taking the drug. The drug also increased the risk of diabetes somewhat.
Crestor reduced LDL or "bad" cholesterol by an average of 50% and CRP 37%, the JUPITER running researchers reported Nov. 9 online in the New England Journal of Medicine and the meeting of the American Heart Association in New Orleans.
test "challenges ... how we do prevention," said Ridker. The fact that patients with CRP received Crestor - much like those taking medication for high cholesterol - means that doctors can use CRP levels to identify people at risk who are now sailing under the radar, said -he. This could help reduce the number of heart attacks and strokes in people with healthy cholesterol level.
Others believe that the situation is more nuanced and that CRP may be less important than JUPITER suggests. For example, it is unclear whether the benefits of JUPITER were entirely due to the decrease in LDL cholesterol, which has long shown to prevent heart disease, and lowering LDL and CRP. "We know there is a straight line of LDL cholesterol in cardiovascular risk," regardless of the starting number, said Mark Pepys of University College London, who has studied CRP for decades. LDL decreased to about 50% by JUPITER - a decline that is consistent with the 54% reduction of heart attack was observed, said Pepys. Although study participants were described as healthy volunteers, most also were overweight, 15% were current smokers, and 40% had metabolic syndrome. These risk factors, not CRP may explain why having more aggressive cholesterol lowering goals can help
Regardless, JUPITER confronts a problem that cardiologists have struggled for a while with nothing to see with CRP :. How to treat patients who have normal cholesterol levels, but some common risk factors such as high blood pressure or obesity. If these people are on statins, too, in order to even lower cholesterol? "I think [JUPITER] broadens thinking about risk factors," says Benjamin Scirica cardiologist at Brigham and Women's Hospital, who was not involved in the trial. Scirica, for his part, said that JUPITER "brings the target goal down to everyone" regarding cholesterol, and expects to treat more aggressive cholesterol now that it serves.
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