The new cholesterol guidelines: Emphasize patient preference

There has been much discussion recently, by journalists and health professionals, on the new guidelines for the treatment of blood cholesterol put forward by the American Heart Association (AHA) and the American College of Cardiology (ACC).    Critics have raised concerns the revised guidelines will increase the number of healthy people who take statin drugs by 70 percent, that treatment thresholds are too low and that some guideline writers have links to the drug industry.

But these discussions have largely missed two key words in the new guidelines: “patient preference.”  The ACC/AHA state clearly, and emphatically — the term is used more than 20 times in the document — that this is a framework for clinical decision making that must incorporate “patient preferences.” To put this into context, the Canadian Cardiovascular Society lipid guidelines from 2006 and 2009 make no mention of patient preferences whatsoever, and while their 2012 version contains the word “preferences”  five times, only once do they actually refer to patient preferences.

This is an important transformation in guideline attitude, and here’s why.  No matter what recommendations this guideline or a health care professional may make, the patient is the one who should decide what’s best.

The biggest limitation of the ACC/AHA guidelines is that they don’t provide information in a manner that easily facilitates a balanced discussion between a patient and a health care professional.  Fortunately, it’s not all that difficult.

One of the most controversial parts of the guidelines is the threshold for treatment they recommended — individuals with a 10-year heart attack and stroke risk of 7.5 percent or greater is where “risk reduction benefit clearly exceeds the potential for adverse effects.” That’s their opinion but what counts is your opinion.

The evidence suggests statins reduce heart attack/stroke risk by approximately 30 percent or roughly 1/3.

What does this mean?  If you take roughly a 1/3 off of 7.5 percent (2.5 percent), the risk for heart attack and stroke would drop to around five percent. Put a different way, this means 40 people need to be treated for 10 years to benefit one person; or 97.5 percent get no clinical benefit whatsoever from statin drugs.

Let’s say a higher threshold like 10 percent had been chosen instead, as some critics have argued should have been the case. Doing similar math, 10 percent goes down to seven percent  (a 30 percent reduction) which is a difference of three percent.  Thus, 33 people need to be treated to benefit one person and 97 percent get no benefit from taking statins.  So the big debate about the threshold is a debate about a 0.5 percent 10-year difference (a three percent vs. a 2.5 percent benefit).

Now on the other end of the risk spectrum, a person with a past stroke/heart attack or an older person with many risk factors may have roughly a 30 percent risk. They would get a 10 percent absolute benefit over 10 years. This means this higher risk person (who has already had a heart attack or stroke) taking a statin for 10 years has about a one in 10 chance of benefiting from the medicine while 90 percent will get no benefit at all.

That’s the benefit, so what about harm?

Muscle aches and stiffness occur in five to 10 per cent of people taking statins, with severe muscle or kidney damage occurring in roughly 1/10,000, and possible abnormal liver lab values in two percent.  Some people experience nausea, constipation, diarrhea, and then, of course, there is the drug cost and the frustration of taking a pill every day.  Fortunately most of these harms are reversible.

There are a few caveats. Most studies with statins have been for five years or less, so we really don’t know about long-term benefit and harm.  You may have also heard statins cause diabetes, but the risk increase for diabetes is only about one percent, and because statins overall reduce the risk for heart attack or stroke (the reason we treat type 2 diabetes), this risk is not clinically important.

If, after thinking about the above information you wish to try a statin, then that is the right choice for you.  If, however, you don’t want to take a statin based on the information, that is also the right choice for you.  In either case, you can always change your mind.

Your health care professional should support you no matter the decision. This is really what the new guidelines should be all about.

James McCormack is a professor, pharmaceutical sciences, University of British Columbia, Canada.  Mike Allan is an associate professor, department of family practice, University of Alberta, Canada. They both co-host the Best Science Medicine Podcast.

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  • Dr. Drake Ramoray

    Lots of posts about the new cholesterol guidelines. I know some docs in corp med who say it doesn’t matter because they are under PQRS guidelines for target levels. Better get that LDL down to get that performance payment!

    We suffer the same problem with A1cs. In the future I will get dinged for A1cs above 7.0 in 85 year olds with frequent hypoglycemia.

    Medicine has lost it’s way.

    • Peter Elias

      Yes, my institution is among the many still using old data and old paradigms and does indeed plan to reduce compensation for failure to meet hard (and inappropriate) targets. But the times they are a changin’.

      • Dr. Drake Ramoray

        While I don’t share the same rosy outlook as you do, or at least I think things are going to get worse before they get better, I can’t but point out that you are missing the point of my original post.

        Why is some beuracratic third party, in this case goals established by Medicare getting between the physician and the patient in the first place. In addition there is a movement to tie physician payment to these goals established by bureacrats. What an individual institution does, or physician for that matter, is not seeing the bigger picture of the further dilution of the responsibility of the patient, both in cost and obtaining the best health. I’m a physician, a guide, I have discussions with patients already, and give the best advice and guidance I can.

        This relationship is being compromised at a much higher institution than where I may work.

      • http://onhealthtech.blogspot.com Margalit Gur-Arie

        So instead of the old paradigm, now you’ll have a checkbox for assessing need for statins for all patients over some age, and another checkbox saying that counseling was provided, and that’s to start with. Later you will have a data field for the calculated risk (a new vital sign), and a new quality measure for the percent of patients that are at risk that were prescribed a statin. Is this better?

        • Dr. Drake Ramoray

          No.

          Why even have a doctor. I bring you HARP (Hal 9000′s evil physician cousin) “Heuristically programmed Algorithmic and highly Regulated Physician.” Insurance companies already tell me how to practice medicine, soon they will pay me on how well I do what I’m told, and there are thought leaders on this blog who think we should have acute visits online. Why bother having a doctor. Just program HARP with all insurance formularies, algorithms, and meaningful use criteria.

          We can even program it with different personalities. There is the original HAL-9000 deadpan voice over. “I’m sorry Dave, a statin is not indicated for your heart condition.”

          A nice one, maybe modeled off the hypnosis tape Chandler uses to try and quit smoking on Friends. “Your are a strong and confident woman…..”

          And the aggressive one like Dick’s last resort. “Hey fatty, put down the donut!”

          All accessed from the convenience of your own home. Who says housecalls are dead?

        • Peter Elias

          Nope.

          I wish I didn’t agree. I was trying to stay optimistic, but (sadly) I think my optimism is probably wishful wishful thinking than rational assessment.

          • http://onhealthtech.blogspot.com Margalit Gur-Arie

            I actually think yours is the rational assessment, but those who make the rules have been watching too much Star Trek. I am certain that in the distant future we will be able to usefully quantify things, but we can’t right now, and confusing sci-fi with sci is reaching epidemic proportions.

          • southerndoc1

            Why are you part of “an institution” that treats doctors and patients that way?

          • Peter Elias

            I get your point.

            If I were 36 instead of 66, I would not be. But I have a deep commitment to the patients I have cared for over the last 35 years. Rather than leaving them in the lurch, I will stay where I am, advocate for quality and transparency at an institutional level, and (above all) live up to my own standards in the care of patients.

    • NewMexicoRam

      Yep, that’s the performance measures in our group.
      Gotta have that LDL below 100, even if the patient is 93 years old.
      Medicine is all about the insurance companies anymore.
      Someday, physicians will strike. Someday.

  • Peter Elias

    The trend is slowly but steadily moving away from hard targets and one-size-fits-all recipes towards guidelines that guide rather than decide. The guideline should be where the discussion begins, not where it ends.

    I hope many see and follow the emphasis on patient preferences. Thank you for this post.

    • LeoHolmMD

      Perhaps physicians will stop being bludgeoned with their own guidelines now.

      • southerndoc1

        And they’ll get retroactive refunds for doing the right thing in the past according to the new guidelines?

        Guess again. The doctor is always wrong in pay for performance

  • Peter Elias

    It is sobering to realize that even in the highest risk group – those who have already had a heart attack or stroke – only 10% benefit and 90% take a medication for 10 years without benefit. When I have conversations with patients about what the data actually shows (rather than what both the patient and the clinician would like to believe about how effective our treatments are) the disbelief is palpable.

    • Suzi Q 38

      Thank you for reaffirming what I have read.

  • NewMexicoRam

    I think the article does point out the critics’ main charge.
    Look at the statistical analysis presented. Pretty clear to me.

    • saurabh jha

      You are correct that they present the numbers needed to treat for the new threshold. They don’t address why the increase in the number of healthy people being medicalized and overdiagnosed is worth the reduction in the threshold.
      Patient preference is a truism independent of where the line is drawn.

  • http://www.myheartsisters.org/ Carolyn Thomas

    Thank you for this reminder, which might easily be lost in the din surrounding the new guidelines’ implication that basically, anyone with a detectable pulse should consider statins. While ‘the patient’s choice’ may be what the new guidelines should be all about, the reality for many time-crunched doctors is that the new guidelines’ controversial risk calculator can put many otherwise-low risk patients at risk based solely on their age. Patients and their docs have been well-indoctrinated to focus only on those ‘bad’ LDL numbers, although there appears now to be little scientific evidence for such focus. Pay no attention to the man behind the curtain. . .

    But as Michael O’Riordan of TheHeart.Org astutely asked AHA/ACC cardiologists during the American Heart Association’s scientific meetings in Dallas last month:

    “How do you have a serious discussion about the patient’s risk if the risk calculator doesn’t accurately calculate risk?”

    Personally, I like Dr. Mark McConnell’s five common sense guidelines that he uses in his internal medicine practice in Wisconsin: http://myheartsisters.org/2013/12/01/statin-guidelines-women/ Dr. M also includes this recommendation: “For patients without existing heart disease, I use the best risk calculator I’ve found” – which happens to be your own Best Science risk calculator, available here: http://bestsciencemedicine.com/chd/calc2.html

    Congratulations on this very common-sensical approach.

  • JPedersenB

    I also think that there is a humongous conflict of interest here with physicians essentially being paid to get a certain percentage of patients on a drug! Not sure why the insurance company should have that kind of access to patient records, either….

  • Dorothygreen

    I did a calculation for myself at age 73 and I do not need statins. I added 3 years with nothing else changing – same total cholesterol, same HDL, acceptable triglycerides (which are not part of the calculations), follow a healthy diet and ride my bike but the guidelines say now I should start statins .
    Does this make sense to you as a physician? Would you recommend I start statins?

    • Suzi Q 38

      You have to do what you and your doctor think is best.
      There is growing information that these statins affect women differently than men.
      If it isn’t “broke,” don’t fix it.
      The statins can cause muscle aches and pains, liver damage,
      and so much more. I suspect that some of my muscle and nerve problems were made worse with these drugs. Ditto for diabetes.
      I think they increase blood sugar levels. Check out the side effects carefully before you let any doctor put you on this type of a drug.

  • Suzi Q 38

    “……And if your health system is encouraging A1c < 7 for all patients, it needs to do a serious re-evaluation of the evidence. Take a look at the VA/DoD guideline for DM which empahsizes INDIVIDUALIZED A1c goals based on expected harms and benefits. Very refreshing! Pax"

    Is there a link for us so that we can look at the VA/DoD guidelines for DM?

  • Suzi Q 38

    Thank you, Mark.
    I will definitely look at the link to this.
    I got the results back for my labs.
    My A1c was 5.6 this time, without the use of statins for the last 4 months.

    For me, the statins were not good.
    I am going to have to find another way, maybe not eat any meat or fats. Go vegetarian, which is not fun for me.