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December 2019 (Vol. 4 Issue 10)

Cholesterol theory discredited by drugs trial failure
About the author: 
Bryan Hubbard

Cholesterol theory discredited by drugs trial failure image

For years, medicine has told us that we need to raise our ‘good’ HDL cholesterol, while reducing ‘bad’ LDL levels, to avoid heart disease—a theory that gave birth to statin drugs. But the theory has taken a severe knock after a new drug achieved both outcomes with interest and yet still didn’t prevent anyone from getting a heart attack or stroke.

The drug, evacetrapib, has now been pulled by its manufacturer, Eli Lilly, after it failed to prevent one single case of heart attack, stroke, by-pass surgery, or angina—even though it successfully doubled levels of ‘good’ cholesterol and lowered ‘bad’ cholesterol.

“Here we’ve got an agent that more than doubles the levels of good cholesterol and lowers bad cholesterol, and yet has no effect on clinical events. We were disappointed and surprised by the results,” said lead researcher Stephen Nicholls from Australia’s University of Adelaide.

More than 12,000 patients who were at high risk of developing heart disease had been given the drug or a placebo (sugar pill) for 18 months. By the end of the trial, those taking the drug had increased their HDL levels by 137 per cent, and lowered their LDL cholesterol by 37 per cent—and yet there was no difference between the two groups when it came to the rate of heart disease.

It’s not just a blow to the cholesterol theorists—it’s also a knock for the new family of heart drugs, the cholesteryl ester transfer protein (CETP) inhibitors. Evacetrapib is the third CETP failure. The first, torcetrapib, actually increased the rate of cardiovascular deaths and disease despite lowering bad cholesterol levels.

Following the failure of the latest study, Eli Lilly discontinued its development of evacetrapib, and wrote off $90m of research and development costs.


References

(Source: proceedings of the 65th session of the American College of Cardiology, April 3rd, 2016)

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