There’s a new cholesterol-lowering medicine making waves. Many health professionals are convinced that there is no such thing as too low a golf score or a cholesterol level. They are right about golf, but we’re not so sure about cholesterol. The FDA approved Repatha to lower LDL cholesterol in 2015. It is starting to catch on with doctors and patients. How good is the evidence it will save lives and what are the potential complications?
The FDA Guidelines (Indications) for Use of Repatha (Evolocumab):
Gird your loins! We are about to pass through the looking glass of FDAspeak. We usually do not like to quote the technical language the FDA requires on drug labels. That’s because it is hard to understand. This is worse than usual, but it is important, so please bear with with us. It was changed on December 1, 2017:
INDICATIONS and USAGE:
- “to reduce the risk of myocardial infarction, stroke, and coronary
revascularization in adults with established cardiovascular disease. (1.1)
- “as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C). (1.2)
- “as an adjunct to diet and other LDL-lowering therapies (e.g., statins,
ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C. (1.3)”
What the FDAspeak Means:
We interpret the official “indications” for evolocumab above to mean that when diet and other cholesterol-lowering treatments (like high-dose statin therapy) don’t achieve the desired results, then Repatha to lower LDL cholesterol might be added to the mix. This would be for people diagnosed with familial hypercholesterolemia or atherosclerotic cardiovascular disease. Your average Joe with elevated LDL cholesterol would not be included in these official indications, unless he has diagnosed cardiovascular disease.
Please note that the FDA used to require the company to state that the ability of the drug to prolong life “has not been determined.” That was dropped when the labeling was changed in December, 2017.
TV Commercial For Repatha to Lower LDL Cholesterol:
Have you seen the television commercial for Repatha to lower LDL cholesterol? An announcer asks:
“Working hard to lower your LDL bad cholesterol? Not making enough progress? You eat well. Take the highest dose statin you can, but still aren’t getting where you need to be. Now there’s Repatha, a different way to reduce LDL and get on the path to dramatically lower numbers.”
The video shows a man pedaling a bicycle downhill as fast as he can but making very little progress. Other people go zipping by at normal speed. One guy looks disdainfully at our frustrated bike rider as he passes by. Another fellow is shown trying to slowly walk down the up escalator. People go past him fast on the down escalator.
Later we see our bike rider going down hill at a normal clip and our escalator walker moving fast on the down escalator. Presumably, they are modeling downward progress thanks to Repatha to lower LDL cholesterol. See the commercial yourself at this link.
We may have missed it, but nowhere in the commercial did we see or hear reference to the FDA approved indications. In other words, neither familial hypercholesterolemia nor clinical atherosclerotic cardiovascular disease were mentioned. Our average Joe might assume that Repatha to lower LDL cholesterol might be just the ticket. He just might follow the announcer’s suggestion to “ask if Repatha can you get on the path to way lower LDL.”
Drug companies would not spend big bucks making television commercials and buying air time if they didn’t work. Here is a question we received from a reader:
Q. There is a strong possibility that my husband and I might need to start taking the new product called Repatha to lower LDL cholesterol. We have read some disturbing reviews about the side effects of this drug. In addition, the cost is almost prohibitive. Can you please shed some light on this new drug?
A. The injectable drug Repatha (evolocumab) was approved by the FDA in 2015 for people with very high cholesterol that runs in the family. It is supposed to be used with statins or other cholesterol-lowering drugs. Some doctors are beginning to prescribe Repatha for people who can’t tolerate statins, however.
Repatha (Evolocumab) Side Effects:
Side effects may include infections of the respiratory system or urinary tract. Some people also experience headache, dizziness, cough, back pain, muscle pain or reactions at the injection site. Life-threatening allergic reactions are the most serious complication.
The Repatha website lists this Important Safety Information:
“What are the possible side effects of Repatha®?
“Repatha® can cause serious side effects including: Repatha® may cause allergic reactions that can be serious. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.
“The most common side effects of Repatha® include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes), and redness, pain, or bruising at the injection site.
“Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
“These are not all the possible side effects of Repatha®. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects.”
“You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
The High Cost of Repatha:
If your insurance company won’t cover Repatha, you may end up spending at least $1,200 a month each.
Here is what some readers have to say:
JuneBug 14 offered this perspective:
“I looked up Repatha and the mortality rate is the same as NOT taking it. Insurance won’t pay for it, and why would I put my family through that expense?”
Steven in Georgia is caught in a bind:
“I have tried many statin-type cholesterol-lowering drugs through my doctor to no avail. Every one of them gave me severe muscle pain. Repatha became available and I got on the trials of that. This drug knocked my numbers down from my 290-300 to barley 100 or so. But after months of trying, my doctor could not get my insurance company to approve it.
“He sent me to a cardiologist to see if he could get my insurance company to approve it. The cardiologist started me on Praluent, a somewhat similar drug. I tried it a couple of times and it just made me feel different. That’s about the best description I can give on that. Then my muscles started hurting again…Needless to say, I stopped using it. Now I am on the road to a natural fix for my cholesterol.”
A Message from Danish Physician, Uffe Ravnskov:
A renowned cholesterol skeptic and author of The Cholesterol Myths, Uffe Ravnskov, MD, PhD, wrote this on our website on April 18, 2017:
“The Repatha trial was originally planned to go on for 4 years, but as the number of heart events was significantly lower in the treatment group already after 26 months, the authors decided to stop the trial.
“But the number of deaths, both from heart disease and from other causes, had increased! Not with statistical significance, but it might have become significant if the trial had continued. A relevant question is therefore: Did they stop the trial because the total number of events had become significantly lower in the treatment group, or because the number of deaths was increasing?
“How do they explain that 444 died in the treatment group, but only 426 among the untreated? I mean, if ‘bad’ high LDL-cholesterol was the cause of atherosclerosis and heart disease, then we should expect that a 59% lowering of this ‘poisonous’ molecule should lower mortality, not increase it.
“The reason is of course that a high level of LDL-cholesterol is not poisonous; it is beneficial, as we have documented in a review of 19 studies including more than 68,000 people above the age of 60 published in BMJ Open (http://bmjopen.bmj.com/content/bmjopen/6/6/e010401.full.pdf). Almost all studies found that elderly people with the highest levels of the ‘bad’ LDL-cholesterol live the longest; even longer than those on statin treatment; no study found the opposite. A reasonable question is therefore: Why should we lower the bad cholesterol if those with the highest values live the longest?”
What’s Your Experience with Repatha to lower LDL Cholesterol?
We would love to know more about how people are faring with Repatha or Praluent. Share your story below in the comment section.