Published: December, 2008
By J.L. WEBB
Last month's release of the JUPITER study is being viewed with cautious optimism by Central and South Florida cardiologists who are joining colleagues across the nation in unraveling the results of a landmark study of the cholesterol-lowering statin drug rosuvastatin.
The acronym-heavy study (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) was a broad-based trial that included 17,802 subjects in 26 countries. It was limited to men older than 50 and women older than 60. Its format was random, placebo-controlled, double-blind and lasted two years. The result was that of the people who took 20 milligrams of the brand-name pharmaceutical Crestor, half as many had heart attacks or strokes than the half that received placebos.
Still, despite JUPITER's comprehensive structure and its solid statistics, it is creating a stir about the advisability of prescribing statin drugs to patients with low levels of LDL cholesterol and high levels of C-reactive protein (CRP). Because a higher level of CRP is an indicator of inflammation, which increases the risk of cardiovascular disease, the JUPITER study suggests that statins could help prevent heart attacks in patients who are otherwise heart-healthy.
It will be tempting for some physicians to use JUPITER's scientific findings as justification for prescribing statins as preventive medicine for more of their patients they believe are compromised for cardiovascular disease, but who have not yet exhibited high LDL cholesterol. But that impulse should be tempered with healthy skepticism for the time being, said cardiologist Arnold Einhorn, MD.
"This (study) is statistically significant," said Einhorn, 54, chief of staff at Orlando Health and president of Mid-Florida Cardiology, which has offices in Orlando, Ocoee and Clermont. "It suggests that people who are relatively healthy with LDL cholesterols below 130, but who have another potential risk of high-sensitive C-reactive Protein, that they may be a targeted group to go after."
But, he quickly added, "I think we need to look at the CRP a little bit better to make sure that is a marker we truly want to identify for heart disease."
Einhorn said he routinely orders a CRP test on all of his patients when he does cholesterol checks. "But I don't know if it should be absolutely considered a marker for coronary artery disease at this time," he said.
One area of concern Einhorn cited about the JUPITER study was "when you broke it down in the Crestor group (of test subjects), there seemed to be a propensity for diabetes," he said. "Their sugars were a little high, which is an interesting finding."
The question Einhorn believes remains unanswered: Is CRP now a marker we need to shoot for? "A lot of people believe it is, but I think there's still some controversy in the field," he said.
That observation was shared by Tampa Bay-area interventional cardiologist Adel Eldin, MD. Eldin acknowledged JUPITER is significant, but not particularly revealing.
At his practice, Brooksville Cardiology in Hernando County, "we've been strong believers. We knew all the statins not only stabilize the plaque, but can reverse atherosclerosis," Eldin said. "JUPITER is okay, but it is nothing that we didn't know about."
Every time there is the demise of one statin, there is the rise of another, said Eldin, suggesting that this is Crestor's time to shine.
"Crestor is filling the gap that was created in the reduction of the market demand for Vitorin, Zetia, et cetera," said Eldin. "The bottom line is we always need a more potent cholesterol-lowering agent."
Eldin, 46, said he would like to see a "head-to-head" study with Crestor and Lipitor to see which one lowers CRP the most.
As for the connection to CRP measurements, Eldin said he usually measures CRP only in high-risk coronary patients, especially if they have concomitant rheumatoid or connective tissue disease. "It'll definitely benefit those who are at risk, but I don't think (CRP testing) will be justified for everybody," Eldin said.
Neither Eldin nor Einhorn see the JUPITER study as a green light to start dispensing prescriptions for statins, Crestor or others.
"The devil is going to be in the details of how this (information) is evaluated... I would not go gangbusters on putting everyone on (statins) yet," said Einhorn.
That sentiment is shared by Bernadine Healy, MD, a career cardiologist, author and health editor of U.S. News and World Report. Healy recently opined on the magazine's "Heart to Heart" blog: "It sounds easy, if not breathtaking. But I'm inclined to line up with those who say 'slow down.' Before doctors translate what are undoubtedly important scientific findings into an enthusiasm for placing 6 million people on a strong drug forever, JUPITER needs to provide further analysis of what on closer look is a highly varied group of patients carrying a wide range of health risks."
Einhorn has his own opinion about better ways to assess the risk of heart disease in patients who are asymptomatic.
More than CRP measurements, Einhorn said, "I'd love to start seeing calcium scores on people. The calcium scores can be done quickly and they can tell you if you if you really do have coronary artery disease. It takes two seconds … it's just a CAT scan that takes a quick x-ray. You'll know right then and there if you have any calcific disease of the heart."
But how would he determine which patients should be tested?
"If they have intermediate risk and they are asymptomatic, they should be getting a calcium score," Einhorn said.
To bolster his position, Einhorn pointed to the comprehensive and widely-respected MESA study (Multi-Ethnic Study of Atherosclerosis), which he said found that patients, particularly women, with normal cholesterol and no history of hypertension were at increased risk for cardiovascular events based on the level of coronary calcium.
Still, lowering patients' cholesterol below 100 is the goal of most cardiologists, agreed Einhorn and Eldin, and if JUPITER has done nothing more than heighten awareness of that objective, it has furthered the debate about the relevance of statin pharmaceuticals in preventing heart disease.t of acute disease to actual prevention of the disease, or at least prevented progression of already established disease by preventing recurrent events such as heart attacks, strokes, repeat bypass surgery or more stents. We should change our total vision from looking into a "spot fix'' to a comprehensive fix.
Since the founding of the Association of Black Cardiologists 34 years ago, the rate of heart disease and stroke in our community has decreased by 50 percent. In fact, the life expectancy of African-Americans has increased 100 percent over the past 100 years. This trend may reverse, however, because, since 1975, the rate of obesity and diabetes in our community has increased 50 percent every 10 years with devastating effects, and it doesn't seem to be slowing down among our youth. This may be the first generation of children who will not outlive their parents.
Believing that the best strategy for advancing high blood pressure, cholesterol, obesity and diabetes control is to empower patients by educating them, the ABC pioneered many innovative programs. We were the first to organize churches, clubs and barbershops as Health Promotion Centers by training lay volunteers to operate clinics in these convenient locations, starting in 1979. We also developed church programs and community-based interventions that have proved to be effective.
While cardiovascular disease has been viewed as unavoidable in the past, we can now shout from the rooftops that it is, in fact, largely preventable. Dying from heart attack or stroke is no longer a fact of life that we have to accept.