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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Cholesterol Treatment – Guidelines Pocket Cards for Doctors

Did you know that any old person (and by ‘any old’ I mean a regular, non-doctor person, not any OLD person!) can purchase the American Heart Association’s “guidelines pocket cards” meant to keep doctors up to date on latest treatment protocols/recommendations?

On the American Heart Association website, these pocket cards are described as:

“These quick reference tools provide instant access to current AHA/ASA and ACCF/AHA guidelines in a clear, concise format – available in print and in the Guideline Central Mobile app for iPhone, iPad and Android.”

AHAlogo_lifeiswhy-logoFor months, I have been wondering whether there have been any updates or changes to the November 2013 Cholesterol Guidelines – and how doctors are following – or not – the new guidelines. (More info about the 2013 guidelines here: The NEW guidelines for cholesterol-lowering statin meds).

To me, there’s been a startling dearth of information about how treatment of high cholesterol has changed – or not – since these guidelines were issued. So I was pleased to stumble upon these pocket guidelines for doctors – updated with the latest recommendations.  For just $8.99 I downloaded the cholesterol pocket guidelines and found them largely unchanged since the new guidelines were issued in November 2013.

Which is good, I guess.

That said, one new thing I learned from this pocket guide is that there are established goals for the more in-depth cholesterol tests like C-Reactive Protein and Coronary Artery Calcium – both tests I think I might benefit from.

While my $8.99 purchase would NOT let me print (grr), I was able to grab some text via the handy iPhone app. Love that.

So if you would like a peak at the ‘pocket guidelines’ your doctor may well use when considering how to treat your high cholesterol, read on. Fair warning: it’s, um, quite detailed and uses acronyms (it is, after all, for doctors) so I’ve included a simple glossary for some of the medical terms.

Here goes – what follows is the ‘key points’ section of the doctor ‘pocket guide’ for treating high cholesterol:

TITLE: Cholesterol Adult Management

KEY POINTS

  • Encourage adherence to a heart-healthy lifestyle. A healthy diet, regular aerobic physical activity, smoking cessation and maintenance of a healthy weight are critical components of ASCVD risk reduction. Control hypertension and diabetes, when present.
  • Statin therapy is recommended for adults in groups demonstrated to benefit. ASCVD risk reduction clearly outweighs the risk of adverse events based on a strong body of evidence in 4 groups:
    • Secondary prevention in individuals with clinical ASCVD
    • Primary prevention in individuals age ≥ 21 years with primary elevations of LDL-C ≥ 190 mg/dL
    • Primary prevention in individuals with diabetes 40 to 75 years of age who have LDL-C 70 to 189 mg/dL
    • Primary prevention in individual without diabetes and with estimated 10-year ASCVD risk ≥ 7.5%, 40 to 75 years of age who have LDL-C 70 to 189 mg/dL
  • Statins have an acceptable margin of safety when used in properly selected individuals and appropriately monitored. If no baseline abnormality, monitoring of hepatic transaminases is not routinely needed. CK should not be routinely measured unless there is a personal or family history of muscle problems. You may need to discontinue and then restart the statin to determine the cause of muscle symptoms.
  • Engage in a clinician-patient discussion before initiating statin therapy, especially for primary prevention. Discuss the potential for ASCVD event reduction, adverse effects, drug–drug interactions, and patient preferences. Additional factors may be considered when a risk-based decision is uncertain.
    • These include LDL-C ≥ 160 mg/dL, family history of premature ASCVD, hs-CRP ≥ 2.0 mg/L, CAC ≥ 300 Agatson units, ABI < 0.9; lifetime risk of ASCVD.
  • Use the newly developed Pooled Cohort Equations for estimating 10-year ASCVD risk. Calculating the estimated 10-year ASCVD risk should be the start of the clinician-patient discussion and should not automatically lead to statin initiation.
    • For other ethnic groups, use the equations for non-Hispanic whites, although these estimates may underestimate the risk for persons from some race/ethnic groups, especially American Indians, some Asian Americans (e.g., of south Asian ancestry), and some Hispanics (e.g., Puerto Ricans), and may overestimate the risk for others, including some Asian Americans (e.g., of east Asian ancestry) and some Hispanics (e.g., Mexican Americans).
  • Initiate the appropriate intensity of statin therapy to reduce ASCVD risk.
  • Evidence is inadequate to support treatment to specific LDL-C or non–HDL-C treatment goals. “Treating to goal” may result in treatment with less-than-optimum statin intensity or adding unproven nonstatin therapy.
  • Regularly monitor patients for adherence to lifestyle and appropriate intensity of statin therapy. Obtain a fasting lipid panel before and after initiating statin or other drug therapy.
  • Nonstatin drug therapy may be considered in selected individuals.”

Going Lo-Co GLOSSARY:

  • ASCVD -atherosclerotic cardiovascular disease
  • Hypertension – high blood pressure
  • Statin Therapy – treatment with statin drugs, like Lipitor
  • Individuals with clinical ASCVD  – people with cardiovascular disease or who have had a ‘cardiac event’ like a heart attack
  • LDL-C – level of LDL cholesterol in the blood
  • 10 year ASCVD risk – risk of a cardiac event in 10 years, as measured by the calculator issued with the November 2013 guidelines.  More here: Going LoCo Calculator Post
  • hs-CRP – measure of “C-Reactive Protein” which is a marker for inflammation
  • CAC – coronary artery calcium which measures the thickness of fatty accumulation in the arteries and is used to predict heart disease risk

While managing cholesterol down to a specific goal is no longer the treatment standard, that doesn’t mean you shouldn’t be tracking your cholesterol and managing non-dangerous/risky high cholesterol with lifestyle choices. And remember, if your LDL cholesterol is at/over 190 mg/dL or you have other risks, discuss a statin with your doctor.

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The NEW guidelines for cholesterol-lowering statin meds

It was another big week for cholesterol news.

Last week the FDA declared that partially hydrogenated oils (PHOs), a very common processed food ingredient, are now not safe. As explained in FDA: Trans Fats are not GRAS, if PHOs are indeed declared not GRAS (generally regarded as safe), FDA will have found a way to significantly reduce unhealthy trans fats from the American food supply. Which is huge.

Then this week, more enormous cholesterol news.  On November 12, 2013, the American Heart Association and the America College of Cardiology released new guidelines for the treatment of high blood cholesterol. The new guidelines will very likely result in a dramatic increase in the number of Americans taking statin medications to lower cholesterol and heart disease risk.

Both in the span of just one week

And it wasn’t even National Cholesterol Education Month.  (That was September.)

What gives? Why these two huge announcements now, within days of each other?

While I have no idea if the timing was coordinated (or not), I do know that both moves have the potential to significantly reduce cholesterol and heart disease risk. And that one move (banning PHOs) is a no-brainer while the other (the new statin guidelines) has many up in arms.

As you know, I am not statin-girl (unless clearly warranted) so it’s potentially troubling that the new guidelines will prompt millions of new statin prescriptions. So I empathize with those who are unhappy with the new guidelines. That said, I am all for the RATIONALE behind these new guidelines — which focus on heart disease risk, not on reducing a particular cholesterol number in an otherwise healthy, low-risk individual.

This makes sense to me.

And OK, so I’m not a doctor, so who cares that it makes sense to me? On the other hand, I do think a great deal about medical issues… and to me, these new guidelines are logical. And logical=good, right? In effect, 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.

So, what exactly are the new guidelines? Broadly… 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. (And there’s a calculator available online ** so you can figure out if this applies to you. It’s an Excel spreadsheet download – click the red ‘Download CV Risk Calculator’ box and save it to your computer. Do it soon because they may take it down…)** NOTE – the ‘risk calculator’ is occasionally taken down, edited, etc.  If the above link doesn’t work, check my RESOURCES page as I’ll try to keep that one current.

That’s it in a nutshell (well, that and the elimination of the old guideline to get LDL to an ‘as-low-as-possible’ level — in the new guidelines, there is no set LDL goal level).

Is that all? Of course not – there was a ton of media coverage last week, and there’s a lot more in-depth understanding of the guidelines that can be had. As it’s an important (and can be confusing topic), I wanted to provide what I found to be the best primary sources in case you want to dive in and read more.

(If, on the other hand, you prefer to read one piece providing an overview of the new guidelines, how they are different from the old guidelines, and how to calculate your personal heart disease risk, you might find this article I just published on Answers.com more useful: “New Cholesterol Statin Drug Guidelines.”)

But if you want more in-depth information, here are some sources:

Perhaps the new guidelines will result in millions more Americans taking statin drugs – but perhaps, if they are the RIGHT people to take statins, that will be a good thing.  If you are wondering if you should take a statin, read up on the new guidelines, calculate your heart disease risk online, and talk to your doctor.

If you already take statins (or have heart disease already) the online calculator won’t work for you — in that case, talk to your doctor about what the new guidelines mean for you.  Maybe your doctor will recommend going off statins for a bit to see what your baseline cholesterol level is now. Or maybe your doc will want you to stay on statins, but will switch you to a different one.

Either way, the times have changed. Read up on the new guidelines and talk to your doctor about how they apply to your situation.

I know I will.

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