|JUPITER trial could extend its reach into the guidelines. Image Source: NASA|
More than 11 million Americans may become eligible for statin therapy if findings from the JUPITER trial are adopted into clinical practice guidelines, according to a new analysis of the trial data published Jan. 13 online in Circulation: Cardiovascular Quality and Outcomes.
“Based on our analysis, more than 44.7 million older Americans might have an indication for statin therapy when you consider those who already meet current guidelines for statin therapy and those who might be eligible based on the criteria proposed in JUPITER,” said the study’s lead author Erica S. Spatz, MD, an internist and fellow in the Robert Wood Johnson Clinical Scholars Program at Yale University, New Haven, Conn. “That's nearly 80 percent of this segment of the population who could potentially be recommended a statin therapy if those criteria were adopted into guidelines.”
Using data from the 1999 National Health and Nutrition Examination Survey (NHANES), researchers conducted a numerical analysis of using statins to aggressively lower cholesterol and high sensitivity C-reactive protein (hsCRP) in people not currently considered candidates for that therapy. Researchers said that the exclusion criteria for study participants in the JUPITER trial may make it difficult to generalize those findings.
Spatz used information from NHANES to examine data from a subset of 2,322 older men and women who answered the NHANES survey questionnaires and also allowed researchers to take a fasting blood sample to test for a variety of cardiovascular risk factors, including cholesterol level and level of hsCRP.
They found that 33.5 million Americans (men age 50 years and older and women age 60 years and older) are currently taking a statin (24.4 percent) or have risks that would indicate a need for statin therapy based on current guidelines, but do not take a statin (33.5 percent). The researchers estimated that an additional 19.2 percent of older adults could be considered eligible for statin therapy if they match the inclusion criteria used in JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin).
Spatz, who was not involved in the JUPITER trial, said that even under current treatment guidelines, fewer than half (42 percent) of older Americans who qualify for statin therapy actually receive it. Although there are many possible reasons for the lack of treatment, many patients who could benefit are being missed—and this problem is likely to increase if the size of the population eligible for statins increases, she said.
Spatz and colleagues estimated that another 13.9 percent (8 million) of the older population would be candidates for statin therapy if hsCRP is at or above 2 mg/L and low-density lipoprotein cholesterol (LDL) under 130 mg/dL. Another three million people would qualify for statins under an expanded, but still plausible, treatment criteria of hsCRP at or above 2 mg/L and LDL cholesterol between 130 and 160 mg/dL.
Overall, the people who may now qualify for a statin based on JUPITER’s findings share many characteristics with those who already qualify for a statin medication. The two groups were similar in age, race and socioeconomic status and had equal degrees of high blood pressure and abdominal obesity, both of which are risk factors for heart disease. Compared to people who have no indication for a statin medication, the JUPITER group was distinguishable in that they were more likely to be female and older, and to have obesity, high blood pressure and the metabolic syndrome.
“This further suggests we may be missing a group of people who in addition to having an elevated hsCRP, have other features that put them at risk for heart disease, and for whom a statin medication may be beneficial,” Spatz said.
Spatz said that she hopes her study will help provide important information for the development of future guidelines about using statin medications to reduce cardiovascular disease by providing some of the information necessary to determine whether the number of people who would get statin therapy under JUPITER criteria would be cost-effective from a public health standpoint.