Should I Take Cholesterol Medication?

Posted in: Lifestyle Medicine
By Alona Pulde, MD & Matthew Lederman, MD
Apr 16, 2010 - 8:36:14 PM

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A recent article in the New York Times, “Risks Seen in Cholesterol Drug Use in Healthy People,” rightfully called into question the Food and Drug Administration’s (FDA) approval of new criteria for the use of Crestor (a cholesterol lowering medication). The new criteria were based on a study that looked at CRP, a marker of inflammation that has never been proven to directly correlate to heart disease, and concluded that men over 50 or women over 60 with an elevated CRP plus one other risk factor (smoking, high blood pressure, etc) qualify to take Crestor. This translates into an additional 6.5 million Americans, without elevated cholesterol or a history of heart disease, requiring medication.

What was the fantastic benefit of taking Crestor in this 2008 New England Journal of Medicine study evaluating Crestor? The authors of the study purported a 50% reduction in cardiac events when taking Crestor. But what does that really mean? This 50% reduction is known as a relative risk reduction and simply compares two numbers. For example, if a pill reduces a heart attack from 2 out of 10 to 1 out of 10, the relative risk reduction is 50%. But the number we should really be concerned about is the absolute risk reduction (the difference in the event rate between the control group and the treated group). In this case, the absolute risk reduction would be 10%. Let’s take another example, if a pill reduces a heart attack from 2 out of 100 down to 1 out of 100 the relative risk reduction is still 50% (the difference between the 2 and 1) but the absolute reduction now becomes 1%. Finally, if a pill reduces a heart attack from 2 out of 1000 down to 1 out of 1000 the relative risk reduction once again remains 50% but the absolute reduction is now only 0.1%. So, as we can see, relative risk reduction becomes a rather useless number for us to use when trying to decide whether or not to start a medication. On the other hand, knowing that a pill causes an absolute reduction in heart attack risk of 10% versus an absolute risk reduction of 0.1% tells you a lot about that pill and whether or not it is worth taking. Now, going back to the Crestor article, although the relative risk reduction was 50% the absolute risk reduction was only 0.9% over 1.9 years.

We are certainly not against prescribing medication but we are against medical misinformation that results in prescribing unnecessary medication. Here is what we would tell our patients regarding Statins in general and the Crestor study in particular:

"As your doctor, my goal is not to get you to take a drug or not take a drug rather it is to try to help you decide if the benefits of taking this drug outweigh the risks. In the New England Journal of Medicine article on Crestor, the patients did not have heart disease. They had LDL cholesterol (the “bad” kind) of less than 130, elevated CRP  (average 4.2), total cholesterol averaging 186, median Body Mass Index (BMI) of 28.3 (indicating that they are overweight), and an average blood pressure of 134/80. So the closer your numbers are to these numbers in the study the more likely these results apply to you. This study ultimately showed that if you are similar to this population, then your overall risk of dying over the next year is about 12 out of 1000 and your risk of a heart attack is about 4 out of 1000. Now if 1000 people (with these similar health numbers) took Crestor for one year then 2 people will prevent a death while 998 will have NO benefit and 2 people will prevent a heart attack while 998 will have NO benefit. Interestingly, there were 3 MORE fatal heart attacks in the Crestor group compared to the placebo group in that study. Just to make sure you understand what these numbers really mean, as a result of taking this “miracle drug,” Crestor, for 1 year your chance of living increases from 98.8% to 99% and your chance of making it through the year without a heart attack goes from 99.6% up to 99.8%. In other words, not a very big bang for your buck!

In addition, there are some serious risks with taking a drug like Crestor. Some concerns to consider are that this class of drugs (Statins) has been shown to cause some level of biopsy proven muscle damage in 70% of people, decreased leg strength and increased risk of falls, potential increased risk of liver damage, increased diabetes risk (note that if 6.5 million new people take Statins that will result in over 25,000 new cases of diabetes), and possibly increased cancer risk. We are not positive about this increased cancer risk because studies have been too short to assess this appropriately but we do have reason for concern. For example, in the PROSPER study looking at people age 70-82 (elderly people are most likely to show a cancer the soonest if an increased risk existed with these pills), after 4 years of taking a Statin there were 13 MORE cases of cancer per 1000 people taking Statins and NO reduction in overall mortality. Remember the benefit with Crestor was only 9 less cardiac events per 1000 after 1.9 years, so is that worth potentially 13 more cases of cancer? Add to that the other side effects that occur in 1-10 people per 100 taking this drug which include headaches, dizziness, constipation, nausea, abdominal pain, muscle aches and weakness. One more thing to consider is that many of these findings have resulted from only 1.9 years of studying Crestor but most people will end up taking this drug for life…who knows how many more side effects or other problems will pop up over time as is often the case with new medications.

On a positive note, a low fat, whole foods, plant based diet and healthy lifestyle will lower your CRP as well as your LDL (“bad” cholesterol) and other risk factors that would have made you eligible for this study/drug in the first place. In fact, this diet has been shown to reverse heart disease not just slow it down, slow and in some cases reverse cancer, reverse diabetes, lower cholesterol and blood pressure, reverse arthritis, induce weight loss, and improve energy levels among many other things. Oh, and it doesn’t cost an additional $1260 per year. Now given all of that information…how would you like to proceed?"

REFERENCES:

Draeger et al. Statin therapy induces ultrastructural damage in skeletal muscle in patients without myalgia. J Pathol. 2006 Sep;210(1):94-102.

Wilson, Duff. “Risks Seen in Cholesterol Drug Use in Healthy People,” New York Times. March 30, 2010. http://www.nytimes.com/2010/03/31/business/31statins.html

Ridker et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med 2008;359:2195-207.

Sattar e al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375: 735–42.

 Scott et al. Statin therapy, muscle function and falls risk in community-dwelling older adults. QJM. 2009 Sep;102(9):625-33. Epub 2009 Jul 24.

Shepherd et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360: 1623–30.



Editor's Note:  This article was originally written for the Exsalus Health & Wellness Center newsletter and is republished here with permission.  It has been slightly reformated for this website.