August 21st, 2014

The Niacin Controversy: What Do You Say to Your Patient?

This post is the fifth in our series “What Do You Say to Your Patient?” In this series, we ask members to share how they interpret a complex or controversial issue for patients. To review earlier posts, click here.

The following scenario stems from the controversial HPS2-THRIVE study published in The New England Journal of Medicine last month.

Your 62-year-old male patient who has been on statin therapy for 10 years comes in to see you.

For the past five years he has been taking atorvastatin 80 mg and niaspan 2g once daily with no discernible side effects. His LDL is 90 mg/dl, HDL is 42 mg/dl, and triglycerides are 120 mg/dl. He had a PCI 12 years ago, but has had no procedures since.

Your patient recently read in the paper that there is new information about niacin. He asks if there is anything he should know – and whether his regimen should be changed.

What do you tell him?

22 Responses to “The Niacin Controversy: What Do You Say to Your Patient?”

  1. I would say that the study involved two drugs in one, niacin and laropiprant and that it is not clear to me whether the second medication perhaps negated the beneficial effects of the first. That said, we have seen studies that resulted in similar changes in practice (eg. ezetimibe) and I would be more than happy to see the patient d/c niacin given the potential adverse effects, including diabetes. Additionally, I would prepare the patient for the potential negative changes in his lipid profile, explaining that, in my opinion, all our lipid guidelines are in transition and cholesterol testing as we know it will soon be obsolete as nutrigenomics becomes more widely understood. Eat right and exercise, my friends!

  2. H Robert Silverstein, MD says:

    Continue on your current medications: In fact, we likely will need to add Zetiain order to get your non-HDL to 90. that is an LDL level of about 60). Coronary artery disease essentially ceases to occur at a non-HDL of 90 (LDL of 60). Your triglycerides are close to ideal(100 is ideal). However, we need to see that you’re A1c is not above 5.8, your uric acid not above 5.5, your BUNs not above 12, that you’re walking about 3 miles a day 5 days a week, and that you’re percent body fat is as close as possible to 25% or less. Diet should be mostly unprocessed organic whole foods vegetarian,blood pressure 135/80 or less,limit alcohol to 4 drinks a week or less. Then we have protected you not only from coronary artery disease, but also diabetes, many cancers, considerable arthritis, and you’ll enjoy the psychological freedom of knowing that you are doing it correctly. HRS, MD, FACC

  3. Already an interesting set of responses to the question of what do you say to your patient. Thank you – and look forward to hearing more.

  4. James McCormack, Pharm D says:

    Here is what I would say – or at least something like this.

    1) Evidence and approaches to treatment evolve over time. Many things we used to think in the past were effective, we now know are not effective. Regardless, we are all trying to the best we can for you. It seems now (and the new guidelines support this) that we have focused too much on lipid levels and not enough on just using treatments that have been shown to reduce important clinical endpoints.

    In fact. over the last 5 years, 20 large well designed clinical studies in a row designed to test the impact of new agents for diabetes, BP and lipids or aggressive treatment of these numbers on important clinical endpoints have all shown either no benefit or some harm. For this reason some CVD guidelines are changing.

    2) We recently have new information that, to some degree, questions the use of niacin (you could describe it a bit if you wish). Based on the fact that we have very little if any solid evidence to support the use of this medication, if you would like to stop it I will support you doing that.

    3) For “lipids” given that we have very little other than statins that have evidence of reducing cardiovascular endpoints why don’t we stop measuring your lipids because all it does is confuse us and waste our time and energy and money.

    4) Let’s focus our attention on getting you to eat healthy. Although nobody really knows exactly what that means, nonetheless, the Mediterranean diet in moderation has at least some clinical evidence and seems reasonable as long as you enjoy that type of food.

    PS – don’t worry if you occasionally want to eat a fast food hamburger) or some such thing) – eating enjoyable food is very important to quality of life.

    5) Let’s get you to be as active as possible doing things you enjoy. Your goal is not necessarily to lose weight – unless they are really heavy or having limitations because of their weight – but rather to be active.

    6) Enjoy your life – which does not include regularly sitting in my office waiting to see me or measuring every lab value known to medicine.

    7) Anytime you have questions or concerns I’m here to help you try to get answers and make decisions – because all these decisions are ultimately yours.

    8) Do you have any symptoms that are bothering you or are causing concern? – maybe we can do something about those.

    9) If not – have a great day – remember we all die at the end so enjoy the ride.

    • Ronald Hirsch, MD says:

      Fantastic answer! This patient has been on these medications for 10 years “with no discernable side effects,” besides added cost to him and his insurer, added risk of diabetes, and the fact that until he stops it, he won’t know how he feels without it. Perhaps he has gotten used to that evening flush or loose stool and doesn’t remember the days before that occurred.

      Clinical inertia is difficult to overcome but it’s the right thing to do; somehow we were able to stop treating syphilis with mercury. Perhaps Niacin is the mercury of the modern era.

    • ” – remember we all die at the end so enjoy the ride.”

      This is very true however it is all in the timing. My goal is for patients to live until the end of their lives, not die prematurely from a preventable illness. If his niacin was responsible for his current lack of symptoms, why would you support stopping it?

      “Do you have any symptoms that are bothering you or are causing concern? – maybe we can do something about those.”

      The majority of coronary deaths occur in subjects without symptoms until their initial fatal event. Treating coronary disease by treating symptoms seems overly conservative.

      • James McCormack, Pharm D says:

        Thanks William – you are absolutely correct but when I said symptoms I didn’t in any way mean “cardiac” symptoms – I just meant general symptoms, N and V, non-chest pain, heartburn, diarrhea, constipation etc. As health care professionals I think we can sometimes help those.

        I am unaware that niacin has been shown to reduce cardiac symptoms so stopping them is based on limited if any evidence that they reduce the risk of cardiac events – sorry for the confusion!

  5. Carlos Cuneo, MD says:

    Tell him: There is some new information that shows lack of effect of this combination.
    He should increase dose of atorvastatin to maximun tolerated and discontinue niacin.
    The target now is LDL < 70 mg/dl (despite ATP IV).

    • remember that in both AIM-HIGH and HPS2-THRIVE, the baseline LDL was around 70. If you stop the niacin, you will likely see an increase in LDL to 110-120. I don’t think there is an “evidenced based
      indication for stopping his niacin.

  6. Carlos Cuneo, MD says:

    Sorry, he is on maximum dose of atorvastatin.
    If IMPROVE IT shows some beneficial effects of ezetimibe in combination with atorvastatin, he should change niacin to ezetimibe.

  7. Judith Andersen, AB, MD says:

    I would say, at the risk of seeming curmudgeonly and not receptive to “new” information, that the jury is still out. Niacin, in “effective” dosing, is unpleasant, but the most recent trial data are — like those of several other recent studies — not compelling. Nor are the data on niacin and diabetes. Physicians, particularly those in family or general internal medicine practice, who care for patients with multiple disorders, are at the mercy of much-heralded “data” from every recently-reported clinical trial. And are encouraged to change practice based upon the results of the most recent “definitive” clinical trials, often to the detriment of the health of patients stably improved with the regimen they are employing. Data from this most recent trial are not those upon which I would change a treatment regimen in a patient who is doing well. For one who is not, I would review all relevant clinical trials, assess the strength of the outcome conclusions, consult commentary by those most conversant with the strengths and weaknesses of the data,and change strategy based upon the best data available. Often not that arising from the most recently-reported studies, particularly those that involve more than one trial drug.
    Further, it seems that the mechanism for informing the physician community of important new information from clinical trials all too often comes from newspaper articles, reports in the Wall Street Journal upon the effect of the presentation/publication upon market issues, and manufacturers representatives
    “shopping” the new information to physicians in practice. I don’t really see a way around this and value “freedom of information” issues as much as anyone — but I feel that physicians should not alter their practice decisions based upon clinical study presentations at national/international meetings or the resulting publications,until there is enlightened commentary from the medical community at large. Curmudgeon, I am.

  8. Jean-Pierre Usdin, MD says:

    I will say: not necessary to change a winning team ! follow the same regimen (exercise and treatment) Cholesterol levels are in the (roughly) good range and you have no side effect (it may change after reading the paper about the “benefits” of Niacin)

  9. 1. I would question the dose of statin as well as the dose of niacin. A lower dose of statin would be associated with fewer toxicities as would a lower dose of niacin. The data supporting the long term use of high dose statin does not exist.

    2. encourage 8 servings of fruits and vegetables a day with at least 2 of those servings constituting pigmented berries

    3. encourage him to consume high quality fish oil to get at least 2,000 mg of DHA + EPA daily.

    4. encourage modest exercise, the equivalent of a brisk walk for 20 minutes three times a week.

    5. suggest increased consumption of tree nuts, especially almonds and walnuts.

    6. encourage increased consumption of beneficial facts such as olive oil and avocado.

    7. encourage excellent dental hygiene with daily flossing and routine dental visits.

    8. I would carefully explain that the noise he has been hearing in the media about the lack of benefit from niacin and omega-3 fatty acids is based on over interpretation of a few poorly engineered studies while the “experts” ignore the results from some impressive studies demonstrating significant benefit.

    9. I would further explain how the multi billion dollar statin industry has poured hundreds of millions of dollars into the academic “institutions of excellence” over the last 3 decades which has clouded the thought process to the point that these folks actually believe that statins are the only proven treatment for heart disease and that high dose statins are exceedingly safe. While statins are not bad, a paltry 25% reduction in heart attacks and 17% reduction in death is hardly something to consider a resounding success.

  10. H Robert Silverstein, MD says:

    Puh-lease forgive my naivete(and possibly egotism). Did I not settle the issue wi my comment above? I would add, as others here have also said: “never get off a winning horse.” Wi that patient, so far so good. Change nothing. I agree that AIM-HIGH & HPS2-THRIVE both made the mistake of looking for a further improvement in risk when maximal achievable benefit had already been obtained & further improvement is not possible. I consider both AIM-HIGH and HPS2-THRIVE unethical as the question of further benefit was asked after maximal benefit had already been reached. Blanchett & Usdin above are right on. HRS, MD, FACC

  11. Interesting discussion! Judith: I am very interested in your comment that you do not change your practice until there is ‘enlightened commentary from the medical community at large.” So what are you looking for in that respect – at what point would you change your practice. For niacin, for example, there is unlikely to be new trial evidence for a long time. What is it that would be helpful to you at this point.

    • Harlan, you have taken a hard line that niacin and fish oil omega-3 has no benefit on coronary disease. Are you not a little concerned that maybe you are wrong, and physicians will follow your advice, and people will suffer unneeded heart attacks and die?

      As moderator of this prestigious blog, I feel that you have a responsibility to judge slowly as you weld great credibility.

      This is of particular concern considering the relatively weak quality of the results from AIM-HIGH and HPS2-THRIVE as well as your previously referenced meta-analysis on omega-3 for reaching any hard conclusions.

  12. Pablo Corral, MD says:

    I think we have to tell him….
    Great treatment!!! a success!!!!
    12 years since the last procedure… “you are asymptomatic, with very good levels of lipids, good tolerance” and seems he feels well…so, the treatment works!!!
    We have to say also, that this last study, HPS2-THRIVE, had another active component (laropiprant) and we can’t translate the results to him…
    Finally, don’t change anything, “you are fine”….

  13. Enrique Guadiana, Cardiology says:

    I will tell him : better the devil you know than the devil you don’t.

  14. In response to William Blanchet: what did I say in this string of comments that was directional. I have just been trying to listen to the views expressed by our readers. Curious what you think I said that was judgmental.

    • I was referring to previous posts suggesting that fish oil omega-3 was of no value and HPS2-THRIVE was the last nail in the niacin coffin.

      Am I misinterpreting your position? Do you believe that there is a role for niacin and fish oil derived omega-3 in coronary prevention?

  15. I am the moderator in this post. Trying to encourage discussion among the readers. With respect to CX more generally, we are open to all opinions, voiced respectfully and not too repetitively. The Editor does have opinions too and is allowed to express them respectfully and not too repetitively.