On March 10, 2018 at the annual American College of Cardiology (ACC) meeting, an “on the scene” video was released reporting the results of the new PCSK9 cholesterol-lowering medication Praluent. (1) This new class of LDL-cholesterol lowering medications works differently than statins. PCSK9 inhibiters block an enzyme naturally produced in the body—PCSK9—which can dramatically lower LDL-cholesterol levels. PCSK9 inhibitors are more effective at lowering LDL-cholesterol levels than statin drugs.
I have written about the failure of statin drugs in many blog posts and in my book, The Statin Disaster. When I published that book, I predicted that PCSK9 inhibitors would prove to be no better than statin drugs at preventing heart disease. Remember, statins are about 1% effective, in the best of the studies, at lowering one’s risk for heart disease.
The trial reported at the ACC meeting (1) compared the safety and efficacy of Praluent compared with placebo among patients with recent acute coronary syndrome already on intensive or maximum tolerated statin therapy.
In the video, the doctor stated (slightly parapharased) that the bottom line is simple: First, there was a 15% reduction in MACE (major adverse cardiac events) defined as coronary heart disease deaths, MI (heart attacks), stroke and unstable angina. The bonus finding was that there was a 15% lower all-cause mortality risk…in the treated group compared to placebo.
Let’s look at this data. For MACE, the treatment group had an outcome rate of 9.5% and the placebo group’s outcome rate was 11.1%. The relative risk difference is 15% (9.5/11.1). However, I have been writing and lecturing for well over 15 years about why relative risk data should never be used for clinical decisions. Relative risk analysis is used by Big Pharma to make a poorly-performing drug or therapy appear better than it actually is. When making a clinical decision, a healthcare professional should use the absolute risk differences so that he/she can determine how many patients need to be treated with the drug to prevent the outcome desired. In this case, the absolute risk difference to prevent MACE is: 1.6% (11.1%-9.5%). A better representation of the data would state, “The use of Praluent for 48 months (the length of the study) resulted in a 1.6% decline in MACE. In other words, the drug failed 98.4% who took it.” Furthermore, 62 patients would need to be treated for 48 months with Praluent to prevent one MACE.
How much does it cost to prevent one case of MACE using Praluent for 48 months? Praluent costs $14,600 per year. To prevent one MACE, 62 patients would have to be treated for 48 months. The cost would be: 62 x 48 x $14,600 = $3,620,800.
Boy, that sounds like a cost-effective therapy to me.
Let’s look at the second point in the video—all-cause mortality. The difference between the treatment and placebo groups was 3.5% versus 4.1%. The relative risk difference is 15% (3.5%/4.1%). The absolute risk difference is 0.6% (4.1% – 3.5%). That means 166 patients would need to take Praluent for 48 months to prevent one death.
How much does that cost? $14,600 x 4 years x 166 patients = $19,694,400.
What a deal.
Folks, I did not even get into the side effects of PCSK9 inhibitor drugs here which include an increased risk for infections, diabetes, and mental decline. All of these adverse effects are easily predicted by looking at the mechanism of action of PCSK9 inhibitors.
I think we could spend our scarce health dollars much better than on PCSK9 inhibiters. I will go out on a limb and state that teaching people to eat better and drink water would provide better results at a much lower price than PCSK9 inhibitors.
I would like to know how the FDA can approve poorly-performing drugs like PCSK9 inhibitors. All the more reason for President Trump to start draining the swamp of the FDA.
More information about why you should not take statin drugs or PCSK9 inhibitors can be found in my book, The Statin Disaster.
I would like to hear from any cardiologists out there. Any comments/opinions, pro or con, are welcome. DrB