One in Five Middle-Aged Adults Newly Eligible for Statins Based on JUPITER

Michael O'Riordan

January 14, 2009

January 14, 2009 (New Haven, Connecticut) — When the results of Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) were presented a few short months ago, the study generated a lot of discussion, particularly because the findings suggested that a lot more patients would now be eligible for statin therapy.

Now, a new analysis puts some hard numbers on those suspicions, with investigators concluding that roughly one in five middle-aged men and women not currently meeting existing criteria would be newly eligible for statin therapy [1]. On the basis of JUPITER's findings, Dr Erica Spatz (Yale University School of Medicine, New Haven, CT) and colleagues estimate that an additional 19.2% of adults with elevated high-sensitivity C-reactive protein (hs-CRP) and normal LDL-cholesterol levels fit the bill for primary-prevention statin therapy.

"When we heard that JUPITER had been terminated early last year, we, like many others, suspected that a sizable proportion of the population would be potentially impacted by the results of the trial," Spatz told heartwire .

The study is published online January 13, 2009 in Circulation: Cardiovascular Quality Outcomes.

The JUPITER Trial

JUPITER, led by Dr Paul Ridker (Brigham and Women's Hospital, Boston, MA) and presented at the American Heart Association 2008 Scientific Sessions, in New Orleans, LA, was a placebo-controlled, randomized clinical trial that included 17 802 healthy men and women with normal LDL-cholesterol but elevated CRP (>2.0 mg/L) assigned to rosuvastatin (Crestor, AstraZeneca) 20 mg or placebo.

Stopped after 1.9 years of follow-up, treatment with rosuvastatin significantly reduced the primary composite end point 44% compared with placebo. This reduction was observed among nearly all of the individual end points, including a 55% reduction in nonfatal MI, a 48% reduction in the risk of nonfatal stroke, and a 47% reduction in the risk of MI, stroke, and death from cardiovascular causes.

Impact of JUPITER

In this newest analysis, investigators used data from the National Health and Nutrition Examination Survey (NHANES 1999–2004) to estimate the size of the population that would be affected by the JUPITER findings as well as to describe the population for whom statin therapy might now be indicated.

The group identified 2322 individuals with complete data to determine statin eligibility. More than half, 57.9%, and representing more than 33 million US adults, had a National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) indication for statin therapy. Of these, only 42% were currently taking a statin.

Of the remaining 976 subjects, 13.9%, representing eight million US adults, met the strict JUPITER criteria of hs-CRP >2.0 mg/L and LDL cholesterol <130 mg/dL. Another 5.3%, representing three million adults, had an extended JUPITER indication--elevated CRP and LDL-cholesterol levels between 130 and 160 mg/dL--for statin therapy.

"In the middle-aged and older population, there are already a huge number of people--58%, or 33 million Americans--who meet the current recommendations to take a statin," Spatz told heartwire . "If we are to adopt JUPITER to clinical practice, this would add an additional 11 million people, or another 20% of the population."

As noted, the secondary analysis of the NHANES data revealed that less than half of patients currently meeting the existing recommendations for statin therapy are receiving the lipid-lowering drugs.

"Clearly, we're already missing people who would benefit from statins," she said. "If the JUPITER findings are borne out to be truly beneficial, healthcare providers will certainly be challenged to meet that goal. This is an important question when we're developing our guidelines."

In looking at patient characteristics, the researchers noted that compared with individuals in whom statins would not be indicated, the JUPITER patients were more likely to be female and older. There were also more likely to be obese, hypertensive, and have the metabolic syndrome. They also noted that many of JUPITER patients shared similar characteristics, including sociodemographic factors, abdominal obesity, and hypertension, as those who qualified for statin therapy based on the NCEP ATP III guidelines.

An analysis of cardiovascular risk scores showed that Framingham risk score (FRS) was higher in patients who met the NCEP ATP III guidelines for statin therapy but similar in the JUPITER patients and patients without an indication for statin therapy. The Reynolds risk score, which includes additional risk factors beyond the FRS, including hs-CRP, was able to differentiate risk between those who met the criteria for statins based on JUPITER patients and those without an indication for the drugs, said Spatz.

The Cost of Primary Prevention

Last November, Drs James Stein and Jon Keevil (University of Wisconsin, Madison) performed an analysis based on NHANES data from 1999–2002.  These data include 171 million adult Americans between 20 and 79 years of age, and with this, the two used these data and JUPITER results to evaluate its potential financial impact.   They determined that 7.4 million adult Americans met the major JUPITER entry criteria. In other words, roughly 4.3% of all adult Americans would have qualified for JUPITER, said Stein.   According to their math, if rosuvastatin costs $1200/year, treating this entire subpopulation would cost $8.9 billion/year. If a generic statin is used, and statin therapy costs $60/year, the cost is $443 million/year.

AstraZeneca sponsored the JUPITER study.

  1. Spatz ES, Canavan ME, Desai MM. From here to JUPITER. Circ Cardiovasc Qual Outcomes 2009; DOI:10.1161/circoutcomes.108.832592. Available at: http://circoutcomes.ahajournals.org.



face="Verdana" size="1">The complete contents of Heartwire , a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

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