Perspective: Cholesterol lowering drug: When a breakthrough isn’t

April, 2017

By Charles A. Pilcher MD FACEP

The media were all a-twitter on Friday, March 17, about the “dramatic” results from a study of evolocumab (Repatha), a new cholesterol-lowering drug that – allegedly – reduces the chance of heart attack and stroke by 20%. The drug lowers “bad cholesterol” or LDL, and the placebo-controlled study of over 26,000 patients was reported in the New England Journal of Medicine.

NBC, for example, interviewed an obese man who had previously had 6 stents placed in his heart. His LDL had dropped a huge amount, from 131 to 19 (anything under 100 is optimal.) He was ecstatic that  now he “didn’t have to worry about having another heart attack.”

Not so fast! All this study proves is that the media is easily swayed when “big pharma” issues a press release.

Here’s the actual results from the study as published in the NEJM:

Evolocumab significantly reduced the risk of the primary composite end point (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.) The primary end point occurred in 1344 patients (9.8%) in the evolocumab group and in 1563 patients (11.3%) in the placebo group. Likewise, evolocumab significantly reduced the risk of the key secondary composite end point (cardiovascular death, myocardial infarction, or stroke.) The key secondary end point occurred in 816 patients (5.9%) in the evolocumab group and in 1013 patients (7.4%) in the placebo group.

So where is the “20% reduction” in heart attacks and strokes? Here’s how it works:

  1. First, forget about the “primary end point,” which was the main thing the research intended to study. Instead, consider only the secondary end point, because it had a better result.
  2. Then compare the results of the placebo group to the study group. In the placebo group, 7.4% had the bad outcome. In the study group it was only 5.9%.
  3. Then, you take the difference (1.5%) in outcomes between the two groups and divide by the baseline (placebo) outcome (7.4%) and you get a 20.2% improvement in outcome for those on the study drug.

But that’s the “relative” improvement. The real improvement is the “absolute” improvement, which is still only 1.5%. The drug thus helps only 1 person out of 67.

And it costs $14,000 per year.

Bottom line: If 67 people spend $14,000 a year on this drug (total cost $938,000.00 per year), only ONE of them will have a better outcome than the other 66. And that “better outcome” means only not having a heart attack or stroke – which might or might not be fatal.

And here’s a few more things to consider:

  • The study followed patients for an average of only 2.2 years. How do we know what will happen later?
  • The drug’s manufacturer, Amgen, paid for the study, helped design it, collected the data and helped write the paper.
  • The drug must be taken for the rest of one’s life, so a 45 yo patient taking it for 30 years would incur $420,000 in drug costs.
  • By my calculations, 67 people taking the drug for 30 years to help just one of them makes the cost for the benefit to that one patient $28,14o,000.00.

And people wonder why our healthcare costs are out of control.

For more on the high cost of prescription drugs, check out this article in Kaiser Health Newson “Direct to Consumer” marketing.

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