So, what is the truth here? There are a few facts about IMPROVE-IT that might get lost in all the data crunching. If one has to send out a reminder that the trial "met the primary end point" just moments before actually hearing that the trial "met the primary end point," that's kind of like feeling compelled to tell someone how great, beautiful, or intelligent you are. People that do that just make us want to look more closely. Add to that our knowledge that every single week that we don't learn about the data, profits of millions of dollars per day for the sale of a compound are solid. . . . Well, forgive us for being a little paranoid.
So here's what I'm telling patients about ezetimibe (Zetia, Merck/Schering-Plough) on Monday morning:
1. Relax, it's safe. You're not going to get cancer from it or need to take your gallbladder out because of it. There's probably no huge increased risk of muscle pain.
2. It makes you look fantastic on paper—kind of like Photoshop. We will brag for endless ages about how great your LDL looks. It will shorten your office visits because it will make us practitioners forget about the time needed to discuss diet and exercise.
3. It will cost your health insurance plan more money. Plain 40-mg simvastatin for a 30-day supply is $15; 10-mg ezetimibe plus 40-mg simvastatin (Vytorin, Merck) 30-day supply is $200—a number verified at a local pharmacy with a phone call this morning.
4. If you were placed on this med as a stable outpatient (not within 10 days of a heart attack or unstable-angina admission), the questions regarding benefit are still completely unknown. (Most patients treated with this combination were not within 10 days of an ACS admission, but of course it will be heavily extrapolated to the masses.)
5. If you were placed on the combination within 10 days of an ACS admission, the number needed to treat in this study was 50 at the outset. Translation: There is about a one in 350 chance that you can enjoy a 2% to 10% risk reduction in event rates with no mortality benefit in the long term. Your chances of landing in the hospital are 2% to 10% less, but your chances of dying are about the same on or off the drug.
6. We do know that lowering LDL cholesterol is validated as beneficial. What we don't know is that once your LDL is below 70, is it cost-effective to lower it to the 50s? Again, it appears your death rate is the same at LDL levels of 50, 55, 60, 65, 69, etc. High-dose simvastatin (and in some cases low-dose simvastatin) can produce similar results, or, heaven forbid, even using another statin.
7. I promise the following isn't swamp water I'm trying to sell you. I can nearly guarantee you that instead of a one in 50 chance that this compound will help you, there is a nearly 100% chance that the Mediterranean diet and a 30-minute walk daily will drop your death rate by 50%. Plus, I'll help your osteoporosis risk, lower your blood pressure, and decrease your risk of developing diabetes. Your quality-of-life indicators will improve. Shortness of air will improve. Heck, it can even cure diabetes in some.
So will our patients rather take an extra pill or buy a treadmill and use it?
Sadly, we all know the answer, and we know many will take advantage of that sad opportunity.
A few final thoughts:
Sometimes the truth and its implications are more difficult to find than others.
Sometimes you see yourself in a trial as one of those patients and you just aren't there.
Spin, spin, spin=Spend $, spend $, spend $.
That's what I'm telling my patients come Monday morning about the addition of ezetimibe to simvastatin.
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Cite this: What I'm Telling Patients About Ezetimibe on Monday Morning - Medscape - Nov 17, 2014.