#4 JUPITER Study, Statins for Healthy Individuals

Overview

Approximately 785,000 Americans will have a heart attack for the first time this year while another 470,000 will
have a repeat attack. Heart attacks strike both men and women, young and old, and in almost 20% of cases, these myocardial infarctions are deadly.

In the past, low levels of blood cholesterol were assumed to indicate a reduced risk for heart attack and premature death. However, the JUPITER trial—which stands for Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin—has changed conventional wisdom, demonstrating that some individuals with normal cholesterol levels benefit from early intervention with a statin medication to prevent disability and premature death from coronary heart disease.

JUPITER is important because it demonstrated that many seemingly healthy people with elevated levels of a biomarker of inflammation called high sensitivity C-reactive protein or hsCRP are actually at relatively high risk for cardiovascular disease and can benefit from statin treatment.

In the Jupiter Trial, participants with normal to low levels of LDL cholesterol (so-called “bad” cholesterol) and elevated levels of inflammation were randomized to receive a statin or placebo.

In the group receiving a statin, the risk of cardiovascular disease and death was reduced by 44% compared with
placebo-treated patients.

JUPITER was an international study enrolling approximately 15,000 patients (average age, 66 years) randomly
assigned to receive the statin drug rosuvastatin (20 mg/day) or placebo despite normal cholesterol levels. Current guidelines consider LDL cholesterol levels less than 130 mg/dL healthy and levels less than 100 mg/dl ideal.

The average LDL-cholesterol of JUPITER study participants was only 108 mg/dl prior to enrollment.
The reason the researchers looked at this seemingly healthy group was the observation that only about half of individuals who develop coronary heart disease have levels of cholesterol that are clearly elevated.

Therefore, if many of the people suffering serious coronary events have cholesterol levels no worse than those of many asymptomatic people, perhaps there is a need for a much more sensitive marker than LDL cholesterol for predicting a person’s heart-attack risk.

Previous studies have shown that levels of hsCRP are strongly predictive of the risk of coronary events including cardiovascular death, stroke, myocardial infarction, hospitalization for unstable angina, or arterial revascularization. The JUPITER study defined a high hsCRP value as levels greater than 2.0 mg/L.

JUPITER study results first published in 2008 in the New England Journal of Medicine reported that the statin used by the study participants cut their risk of cardiovascular disease and death by almost half compared to study individuals treated with placebo.

In 2010, acting on the advice of an independent advisory committee, the U.S. Food and Drug Administration added language to the label of the drug rosuvastatin based upon the Jupiter results.

Experts estimate that using JUPITER findings routinely and then prescribing statins to people with low LDL but high hsCRP levels, five to six million people treated for five years in this fashion would result in approximately 250,000 fewer heart surgeries, angioplasties, heart attacks, strokes, and deaths attributed to heart disease. The potential savings to the health care system may be enormous.

Where Are They Now

JUPITER, an intervention trial, pointed out for the first time that many seemingly healthy people are actually at higher risk for cardiovascular disease than previously thought. It's estimated that about 80% of the people who have a myocardial infarction have cholesterol levels that are no higher than the levels of many people who are not having heart attacks and have not experienced any cardiovascular symptoms. JUPITER study data reported that the use of statin medications by seemingly healthy study participants cut their risk of cardiovascular disease and death by almost 44% compared to those treated with placebo.

Despite JUPITER's promising findings, subsequent reviews of the study found potential flaws in its design and interpretation, partly due to an over-reliance on biomarkers as endpoints. The reviews cast doubts on the efficacy and safety of statin medications. However, many physicians maintain there is evidence from the study that statins help prevent heart disease in certain groups of healthy people. New guidelines published by leading cardiology societies in 2013 advise about 50% of Americans ages 40-75 to take statins, an increase from the previous guidelines of 37.5%. And while there are studies supporting this increase, there is still controversy as to who benefits most from taking statins and only an estimated 25% of Americans in this age group are actually taking statins regularly.

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