Statin Guidelines – The Fight Continues

It’s startling how much debate and disagreement exists about the guidelines for statin use.

Back in November 2013, new guidelines were published by the American Heart Association and the American College of Cardiology. The 2013 guidelines represented a significant shift in cholesterol management: essentially moving away from targeting/treating to a specific cholesterol level and instead encouraging treatment of all individuals with a 10-year risk of heart disease of 7.5% or higher (for specifics, see my post, The NEW guidelines for cholesterol-lowering statin meds).

There then ensued heated arguments over the published Risk Calculator that yields that all-important 10-year level of heart disease risk. Indeed, clicking the AHA’s Heart Attack Risk Assessment page right now yields this frustrating error:

“We’re sorry, but this tool is currently unavailable. The Heart Attack Risk Calculator is being updated and will be available soon. Please check back!”

Luckily, the AHA’s Prevention Guidelines page with a link to the original calculator still exists, so you can still calculate your 10-year risk. (Note: if these links fail, try my RESOURCES page: I’ll try to keep the risk calculator links up-to-date there.)

Assuming one believes at least directionally in the AHA’s risk calculator (and I do), it’s important for those who can use the calculator* and assess your personal level of heart disease risk over the next 10 years. (* You cannot use the calculator if you have heart disease or take statins already. Read more about calculators here.)

Until yesterday, it was clear what to do with your resulting risk: if someone between 40-75** gets a 10-year risk of heart disease of 7.5% or more, statin therapy should be considered and discussed with a doctor. (** See full 11/2013 recommendations below.)

But yesterday, things got a little tricky for anyone whose risk is between 7.5% and 10%.

Because yesterday, the U.S. Preventive Services Task Force issued new guidance for the use of statins which is not exactly the same as the AHA 2013 guidelines. (The USPSTF guidelines were published in the Journal of the American Medical Association; read/download a PDF here).

  • On the plus side, the new USPSTF guidelines support the November 2013 AHA decision in that the new guidelines are also based on the 10-year risk calculator. So the USPSTF added weight to the argument for using 10-year risk calculator, and not treating by managing to a particular LDL cholesterol level.
  • On the tricky side, the new USPSTF guidelines increased the risk of heart disease cutoff from 7.5% to 10%.

So now it’s not entirely clear what someone with a risk rate of 7.5%-10% should do. And whether insurance will cover statins for those individuals.

That’s because, as Ariana Eunjung Cha of The Washington Post astutely points out in her excellent article, New Statin Guidelines: Everyone 40 and older should be considered for the drug therapy, both Medicare and the Affordable Care Act use USPSTF recommendations to guide drug coverage plans. So that MAY call into question whether insurance companies will cover statin drugs for those in the 7.5% to 10% risk group.

In the end, what’s important is this: calculate your 10-year risk of heart disease. Use the calculator, and:

  • If you’re below 7.5%, make sure to keep pursuing a lo-co lifestyle with frequent exercise and a healthy, low-fat, low-sugar, plant-based diet.
  • If your risk is over 10%, get thee to a doctor and discuss statins.
  • If your risk is between 7.5% and 10%, talk to your doctor or cardiologist about what next steps are right for you.

It all starts with your risk: calculate it!  It’s so easy – all you need is your latest cholesterol results and systolic blood pressure (the first number).  Then review your personal results and make a plan with your doctor.

Supplement:
** November 2013 AHA recommendation: if you are in one of the following four groups, you have elevated heart disease risk and should take statins:

  1. those who already have cardiovascular disease
  2. anyone with LDL (bad) cholesterol of 190 mg/dL or higher
  3. anyone between 40 and 75 years of age who has Type 2 diabetes
  4. people between 40 and 75 who have an estimated 10-year risk of cardiovascular disease of 7.5 percent or higher.

The USPSTF November 2016 recommendation:
“The USPSTF recommends that adults without a history of cardiovascular disease (CVD) (ie, symptomatic coronary artery disease or ischemic stroke) use a low- to moderate-dose statin for the prevention of CVD events and mortality when all of the following criteria are met: 1) they are aged 40 to 75 years; 2) they have 1 or more CVD risk factors (ie, dyslipidemia, diabetes, hypertension, or smoking); and 3) they have a calculated 10-year risk of a cardiovascular event of 10% or greater.”

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Is the New Class of Cholesterol-Lowering Drugs For You?

The quick answer to ‘Am I a candidate for one of the two new PCSK9 cholesterol-lowering drugs?’ is Probably Not (unless you have FH or have heart disease / have had a heart attack.)

The reason? Two, actually. First, this totally new class of (injectable) cholesterol-lowering drugs is approved ONLY for those with high cardiac risk. And secondly, clinical study results with key safety data won’t be available for YEARS.

The two new drugs, Praluent and Repatha, were approved this past summer by the FDA only for those with a serious, genetically inherited disease that causes very high LDL (bad) cholesterol called Familial Hypercholsterolemia (FH) and/or for those who have heart disease / have suffered a heart attack. Said differently, this new class of drugs is NOT for those with “regular” high cholesterol — and that’s key because these drugs have potentially serious (neurological and other) side effects which won’t be fully known until clinical results are released in 2017.

As reported by CNN’s FDA Approves Second In New Class of Cholesterol Lowering Drugs:

“Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” Dr. John Jenkins, director of the FDA Office of New Drugs, Center for Drug Evaluation and Research, said in a news release.”

A similar CNN article, FDA Approves New Cholesterol Lowering Drug, explains:

“It focuses on those who’ve truly had clinical disease or those who start out with such high levels of LDL they can’t get anywhere near where they should be and I think those are the most at-risk people,” said Dr. Donald A. Smith, associate professor of medicine and cardiology at Mount Sinai Hospital in New York.”

So, yes, this new class of drugs is amazing news for those with FH and those with cardiac disease who cannot tolerate statins. These folks should run, not walk, to their cardiologists. But for the rest of us, Repatha and Praluent are drugs we can ask our internists and cardiologists about at our next appointments, not race there with questions now.

What’s fascinating frustrating to me about these new drugs is that there is a lack of clarity from the American Heart Association (AHA) and the American College of Cardiologists about how this new class of drugs fits in with their 2013 “New Guidelines” for treating high cholesterol.  Indeed, in ‘Understanding The New Guidelines,’ the new class of drugs is not even mentioned. I find this exasperating – this is an ONLINE instrument and should be current. I found exactly one article on AHA’s site (their blog, actually) called FDA Approves New Cholesterol Drug. In a nutshell, what the AHA said about the new class of drugs is that MAYBE WE SHOULD THINK ABOUT IT VIS-A-VIS OUR GUIDELINES? (emphasis mine, obviously.)

Seriously? That’s it, AHA? Very disappointing. Here’s a quote from that article:

“The AHA revised its scientific guidelines about cholesterol in 2013. They de-emphasize the setting of specific LDL targets and recommend statin use for all at-risk patients with elevated LDL. The recommendations also suggest statin treatment for people who don’t have cardiovascular disease but who by using an at-risk estimator tool are determined to have at least a 7.5 percent risk of developing it over a decade.

Now with the possibility of having ultra-low levels of LDL, Eckel, who sat on that guideline-writing panel, said it is unclear whether there will be a move soon to rewrite the guideline to take into account the developments with PCSK9 inhibitors.

“Some people feel the guideline could be re-written now and others believe it should wait until the PCSK9 outcome trials are completed,” he said.”

(NOTE: ‘he’ refers to “Dr. Robert H. Eckel, an endocrinologist and professor at the University of Colorado Anschutz Medical Campus and director of the medical school’s Lipid Treatment Clinic” who sat on the AHA/ACC new guidelines panel.) 

This equivocating statement (and no real guidance at all) is the sum total of what I could find in terms of opinion from the American Heart Association about this new class of drugs. One can only hope they are providing more to doctors and cardiologists, but I doubt it. Which leaves doctors deciding on treatment based on information presented by (necessarily biased) drug companies. Because you can be sure reps from Amgen and Sanofi are banging down the doors of US cardiologists.

Personally, I’m confused. Every single adult in my family takes statins to lower cholesterol. ALL of them.  But I’m trying not to; I’m trying to manage my risk with lifestyle and diet. And following the American Heart Association’s guidance, I should not be taking statins (my results from the AHA ‘risk calculator’ are below. And clearly I’m not a candidate for the PCSK9 drugs as I don’t have FH nor have had a heart disease event, yet. And further, my advanced lipid panel testing also confirms I am not at great cardiac risk.

But what if they’re wrong? What if the AHA changes the guidelines again and I waste two years not taking statins? Or find out that everyone should be taking PCSK9 to lower cholesterol dramatically?

Dr. Mercola doesn’t think that will happen. In his FDA Approves Potentially Disastrous Cholesterol-Lowering Drug, he argues this new class of drugs is likely to be widely prescribed before it’s safety is known, and that there are early indicators of safety issues.

But I’m left wondering.  Luckily I have a follow up appointment with my cardiologist in December, so I’ll ask him what he thinks of the 2013 Guidelines now that two PCSK9 drugs have been approved. I plan to ask if he thinks I should continue to follow AHA/ACC guidelines or consider further tests or treatment.

**************

RESOURCE: CALCULATING YOUR CARDIOVASCULAR RISK:

If you haven’t used the AHA/ACC’s  2013 CV Risk Calculator, you should. It’s free, online (or an app) and is simple to use – all you need are your cholesterol results and your blood pressure (both my internist and my cardiologist used this app during my appointment). Click on the link and fill in the very few boxes and you’ll get a personalized result.

For reference, here’s a summary of my personal inputs and result/recommendation.

“Based on the data entered (assuming no clinical ASCVD and LDL-C 70-189 mg/dL):

  • “Total Cholesterol: 240
  • HDL-Cholesterol: 88
  • Systolic Blood Pressure: 130
  • Hypertension Treatment: No
  • Diabetes: No
  • Smoker: No

Not In Statin Benefit Group Due To 10-Year ASCVD Risk <5%   (THIS IS MY RECO)

In individuals for whom after quantitative risk assessment a risk-based treatment decision is uncertain, additional factors may be considered to inform treatment decision making. These factors may include primary LDL-C ≥160 mg/dL or other evidence of genetic hyperlipidemias, family history of premature ASCVD with onset <55 years of age in a first degree male relative or <65 years of age in a first degree female relative, high-sensitivity C-reactive protein ≥2 mg/L, CAC score ≥300 Agatston units or ≥75 percentile for age, sex, and ethnicity, ankle-brachial index <0.9, or elevated lifetime risk of ASCVD. Additional factors may be identified in the future. (IIb C)

Lifestyle Recommendations

AHA/ACC guidelines stress the importance of lifestyle modifications to lower cardiovascular disease risk. This includes eating a heart-healthy diet, regular aerobic exercises, maintenance of desirable body weight and avoidance of tobacco products.”

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New Chart Helps Identify Heart Disease Risk

The National Lipid Association (NLA) recently released an ‘infographic’ that, according to the person who contacted me on behalf of the NLA, is intended “to help people better understand their cholesterol to help reduce the risk of heart attack and stroke.”

And indeed, I think it’s a very useful chart.  Essentially, it helps you visualize your heart disease risk by turning the major risk factors into a series of easy questions; these questions help determine your heart disease risk and serve as a basis for discussion with your doctor:

NLA Infographic FINAL

You can also find this chart on the National Lipid Association’s “Learn Your Lipid” site.

As I wrote about in both The NEW Guidelines For Cholesterol-Lowering Statin Meds and also, New Cholesterol Guidelines – An App For That, when the American Heart Association published the new cholesterol guidelines in November 2013, there was a new focus on determining a person’s 10-year risk of heart disease rather than treating LDL (bad) cholesterol to a specific level.  In broad strokes the new guidelines state that if you are in one of the following four groups you have elevated heart disease risk and should take statins:

  1. those who already have cardiovascular disease
  2. anyone with LDL (bad) cholesterol of 190 mg/dL or higher
  3. anyone between 40 and 75 years of age who has Type 2 diabetes
  4. people between 40 and 75 who have an estimated 10-year risk of cardiovascular disease of 7.5 percent or higher.

What’s great about this NLA chart is that it works in tandem with the new guidelines – and helps people easily see if they are at risk. Net, this infographic quickly flags those who may fall into risk groups #2 or #4 above.

For example, for risk group #2, using the NLA infographic will ensure you know your total cholesterol – so you can see if LDL cholesterol is 190 mg/dL or higher and thus at risk.

And for risk group #4, the questions asked by the NLA infographic help you determine (without using a calculator!) if you might be at an elevated risk of heart disease.  That’s because the questions asked in the chart (if you smoke, are overweight, have diabetes and/or high blood pressure, etc) are the very factors that feed into the AHA’s 10-year risk calculator. (If this link doesn’t work, check my RESOURCES page for updates.)

So have a look at this chart and if you answer ‘yes’ to the items in step 1, make sure you have your total cholesterol checked and talk to your doctor about your heart disease risk.

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Why You Should Use the New Cholesterol Guideline Calculator

The new cholesterol treatment guidelines were unveiled on November 12, 2013 and controversy flared almost immediately.

The issue?

A duo of doctors are concerned that the new calculator used in one part of the guidelines seriously over-estimates heart disease risk (the calculator delivers a person’s 10-year risk of heart disease: the new guidelines state those with a risk above 7.5% should take a statin). If they are right, the result would be millions of new people taking a statin — who maybe don’t need this drug.

A serious concern, indeed.

Am about to go into a bit of detail about why it might be over-calculating: if you know already/have been following in the news (or don’t care for the details) skip down to BOLD below!

Harvard professors Dr. Paul M. Ridker and Dr. Nancy Cook tested the risk calculator using THREE studies they chose, of thousands of people over the last decade — and found the calculator over-predicted risk by 75-150 percent. One possible reason for the (alleged) over-prediction is that the new guidelines were based on MANY studies (usually a GOOD thing) but in this case, that means that some of these studies included people from more than a decade ago (a time when far more people smoked than currently do, and thus had more heart attacks.)

The AHA’s response?

As reported by the Boston Globe, “the two organizations that published the guidelines — the American Heart Association and the American College of Cardiology — said that while the calculator was not perfect, it was a major step forward, and that patients and doctors should discuss treatment options rather than blindly following a calculator.”

The article goes on to state that according to Dr. Sidney Smith, executive chairman of the guideline committee, “the concerns “merit attention.” But, he continued, “a lot of people put a lot of thought into how can we identify people who can benefit from therapy.” Further, said Smith, a professor of medicine at the University of North Carolina, “What we have come forward with represents the best efforts of people who have been working for five years.”

So, what’s the deal? Should you use the calculator or not?

I vote YES, emphatically!

Of course, I’m not a doctor (and you shouldn’t believe everything you read on the internet)… but here’s let me tell you why I say YES, you should use the calculator.

As stated in my last post, The New Guidelines, the RATIONALE behind these new guidelines makes all the sense in the world.  The new guidelines no longer tie statin medication to achieving a particular cholesterol number.

Said differently, the new guidelines recommend statins only for those AT RISK of heart disease. For those who have high cholesterol but low heart disease risk, statins are NOT recommended.

This makes more sense conceptually (to me) than the prior mandate of hitting a certain cholesterol goal number – especially since those ‘goal numbers’ were not, apparently, tied to anything scientific!

To illustrate, I’ll use, um, me.  Yes, I totally get that an n=1 is not useful for anything other than as an example, but I’ll make an example nonetheless.

Under the old guidelines, statin medication was possibly warranted for me simply because my cholesterol numbers were near certain figures — even though I eat well, exercise a lot, and don’t have ANY OTHER risk factors. Net, under the old guidelines my doctor actually TALKED to me about taking a statin, even though I’m healthy and don’t have any heart disease risk factors EXCEPT for “high” cholesterol.

I decided no. But it wasn’t necessarily an easy thing to do.

Under the new guidelines?

Shocker –  I am nowhere near that 7.5% heart disease risk cutoff.

That’s because the new guidelines take into account the fact that:

  • My LDL (bad) cholesterol is far, far lower than 190
  • I’m a female (here’s another huge shock – the original guidelines were created using mostly data from white men.  Sigh.)
  • My blood pressure is low/normal, and I do not take blood pressure medication
  • I’m not diabetic
  • I do not smoke.

To me, even just reading this list of inputs into the heart disease risk calculator “proves” this is a significantly better way to estimate heart disease risk than the old guidelines, (which put me as at risk simply because “my cholesterol is above 200.”)  The new guidelines just make FAR more sense: they endeavor to predict risk, not get to a cholesterol goal.

So download the calculator (and do it soon in case the AHA gets under so much pressure they take it down) – just click the red button that says, “Download CV Risk Calculator” and save it to your desktop. USE IT!  (And if the above link doesn’t work, check my RESOURCES page for latest link.)

Yes, OK, there could be a problem with the calculator…

But don’t decide not to use it because of the potential issue.  Instead, use it wisely!

If your result is at or near that 7.5%, take that as a clue to talk to your doctor.  Don’t blindly decide you need to start a statin with that result — but do talk to your doctor. Maybe he or she will decide to run some further tests (like C-reactive protein, ApoB and LDL-P – read more here) to really understand your risk.

But do download the calculator and get a sense of your 10-year risk.

  • It could save your life. You could truly need a statin and not know it.
  • Or you could find out you are at/near the 7.5% risk – and if you do, you can decide what to do about it, with your doctor.
  • Or you could be like me and find out statins aren’t indicated – even if the calculator is over-estimating risk.

But now, at least, the calculator means your discussion with your doctor will be focused on the right thing – what, truly, is your individual level of heart disease risk. And you can form a plan based on that, rather than a (seemingly somewhat arbitrary) cholesterol goal number.

So even if the calculator is over-estimating, the most likely result will NOT be millions taking statins unnecessarily. The most likely result will be millions ASKING their doctors about their level of heart disease risk.  So they can create a plan together.

Which is the point, no?

To read more about the new guidelines – and why using the new online calculator makes sense – I found these articles particularly insightful:

And just a quick reminder: to use the calculator, you need three pieces of info: your total cholesterol, your HDL (good) cholesterol, and your systolic blood pressure (the first number in the blood pressure measurement).

And last but not least, the calculator cannot be used if you already have heart disease or if you currently take statins: if that’s you, best bet is to talk with your doctor about what the new guidelines mean for you.

 

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Calculate Your Heart Attack Risk Online

Did you know there are quick, easy-to-use, online calculators that will tell you how likely you are to have a heart attack in the next 10 years?

There are several, in fact.  Most of these online risk calculators are based on the Framingham risk score, which assesses heart disease risk in the next 10 years based on six pieces of information: age, sex, total cholesterol, HDL cholesterol, smoking status and systolic blood pressure.

The Reynolds risk score goes beyond the Framingham risk score.  In addition to all the factors required by the Framingham risk score, the Reynolds risk score asks for C-reactive protein test results (which are not included in a typical lipid panel) and whether a parent had a heart attack before age 60.

While these online calculators are certainly not the be all and end all, they can be very handy in discussing with your doctor whether (and how long) you can manage high cholesterol without turning to statin Rx medication.  You can read about how these heart disease risk calculators work and where to find them online in my recently published article on Answers.com: Calculating Heart Disease Risk.

And you can find a link to the American Heart Association’s Risk Calculator – born when the 2013 guidelines debuted – on my RESOURCES page.

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