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No Clear Evidence for Ultra-Low Cholesterol Targets?

ments.”

For the new paper, the authors examined every study cited by the NCEP panel in their 2004 report that led to the current ultra-low recommendations, and other studies that assessed the relationship between LDL cholesterol and cardiovascular outcomes in patients with LDL under 130 mg/dL. They also contacted more than 20 experts from around the world and none could identify any valid clinical evidence supporting that achieving a low LDL level was important independent of statin therapy.

The problem is not solely a lack of studies, but how past studies have been analyzed, says Hayward. Many studies have looked at associations between LDL and outcomes, but such studies didn’t distinguish between whether the LDL level achieved was important or whether the statin dose given was important. They also didn’t assess whether patients actually took their statins regularly — a crucial factor — and often didn’t consider whether the accuracy of the blood test that measures LDL is adequate to guide patient therapy.

“This is an ongoing problem in the medical literature,” says Hayward. “We do randomized controlled trials well, but when it comes to analyzing subgroups or a treatment’s mechanism of action, we often get the science all wrong. We need to do better, and in this paper we have tried to lay out a better statistical approach to analyzing treatment goals and clinical trials in the future, including those examining LDL cholesterol.”

Also, almost all the published clinical trials on this topic were designed to see how well a statin did against a placebo, or how well patients did on different doses of statins. None were based on getting patients to a specific LDL target using multi-drug therapy and seeing how they did once they were there.

In fact, he says, the evidence strongly suggests that a high dose of a statin produces the same benefit in a person who has an LDL level of 100 mg/dL as it does in a person with
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