Treating Patients with “Normal” Cholesterol Levels.
Treatment with cholesterol lowering drugs is well proven to reduce the risk of a cardiovascular event (i.e. heart attack or stroke) in patients with elevated cholesterol but no prior history of cardiovascular disease. However, significant numbers of heart attacks occur in patients with “normal” cholesterol levels. How can we differentiate between high risk and normal risk patients with normal cholesterol levels? A blood test can measure levels of a substance called C-Reactive Protein (CRP) which itself is an indirect measure of inflammation. In 2002, elevated CRP levels were shown to be an accurate predictor of an increased risk of heart attack (see the full article about CRP levels).
The problem in 2002 was that we didn’t know whether treating patients with elevated CRP levels but normal cholesterol levels would be effective in reducing this risk. Now we know.
The new JUPITER study found that treating these at risk patients with a statin (cholesterol lowering) medication DID reduce their risk of developing cardiovascular disease (i.e. myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes) over a two year period. However, there a few concerns.
First, this study was in part funded by AstraZeneca the makers of Crestor (the brand name rosuvastatin) which was the only statin medication used in the study despite there being far cheaper generic statin drugs available. Though this does not mean that cheaper statin medications wouldn’t be just as effective in this patient population, such an assumption is still just that; an assumption. It’s irritating that major medical journals like the NEJM still accept for publication these types of studies that do not use the cheapest drug alternative available while not stating any scientifically valid reasons for this. The cost differences between using brand name and generic statins are substantial (see below*).
Second, there’s a question of the costs involved in treating all these additional patients who would have normally not been treated with a statin medication under existing guidelines. The number needed to treat (NNT) in the JUPITER trial was 82 meaning that 82 patients would need to take Crestor over almost 2 years to prevent a single cardiovascular event (i.e. 81 patients get no benefit).
*JUPITER Trial (no CAD hx and LDL levels < 130 and CRP levels > 2.0) NNT=82 (2 years). Crestor (Rosuvastatin) cost is $110/month for 20 mg tablets x 24 months x 81 patients = $216,480 every two years to prevent a single cardiovascular event. Generic Pravastatin cost is $26/month (40 mg tablets) x 24 months x 81 patients = $50,544 every two years to prevent a single cardiovascular event. RRR was 43% BUT the ARR was only 1.22%
When used as primary prevention (i.e. in patients without a history of cardiovascular disease), statin medications have seriously high NNT numbers and this translates into seriously high costs. The JUPITER trial is no exception. Now we have this potentially huge new market of people who may benefit from taking a statin. The additional costs of treating all these patients may outstrip any advantage gained by the cost savings of hospitalization and care of the one cardiovascular event that is prevented (keep in mind that many patients treated with a statin will still develop cardiovascular disease). We still do not know how big this new market for statin medications will be.
The costs are certainly much higher than other measures that can be done to reduce the risk of cardiovascular disease including smoking cessation, weight loss, regular exercise, and a healthy diet. Exercise in particular has been shown to reduce cholesterol levels and cardiovascular risk and a healthy diet can reduce CRP levels (JAMA 2003 Jul 23;290(4):502-10). All of these healthy lifestyle measures have many additional health benefits (decreased risk of osteoarthritis and cancer for example) that statin medications DO NOT provide. But it is far easier for patients to take a single statin pill nightly rather then eat healthy and exercise.
Score another one for the disconnect between American’s preference for unhealthy lifestyles and their “pill culture” and the incessant complaining about the high costs of health insurance.