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May 29, 2012 15:15 EDT
Statins and diabetes: A hard look at the data
The data are clear: in primary prevention, when comparing the benefit in preventing heart attack, stroke, and death vs the risk of diabetes, the trade-off is very slim—and the dangers, very real.
See also:
FDA adds warnings to statin label
The Diabetes Dilemma for Statin Users
The creative destruction of medicine: How the digital revolution will create better healthcare
Preiss D, Seshasai SR, Welsh P, et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA 2011; 305:2556-2564. Abstract.
Ridker PM, Danielson E, Fonseca FA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008; 359:2195-207. Abstract.
Sattar N, Preiss D, Murray H, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010; 375:735-742. Abstract.
Heart Protection Study Collaborative Group. MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebo controlled trial. Lancet 2002; 60:7-22. Abstract.
Downgrading the importance of HDL cholesterol
at 11:05 AM, EDT by Eric
Taking point-of-care genetic testing closer to mainstream
at 09:27 AM, EDT by Steven
Talking about a (healthcare) revolution: The digital age ushers in precision medicine
at 11:25 AM, EDT by Eric
An important miscue in clopidogrel pharmacogenomics
at 04:00 PM, EDT by Eric
Big-time progress in cardiovascular genomics
at 01:05 PM, EDT by Steven
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Eric J Topol MD
Director, Scripps Translational Science Institute The Gary and Mary West Chair of Innovative Medicine Chief Academic Officer, Scripps Health La Jolla, CA |
Comments
This is an important issue.
Here's another recent study that shows similar results to those discussed, but in a population that has not been studied that much in regard to statins and diabetes: post-menopausal women.
Statin Uee and Risk of Diabetes Millitus in Postmenopausal Women in the Women's Health Initiative
Annie L. Culver, BPharm; Ira S. Ockene, MD; Raji Balasubramanian, ScD; Barbara C. Olendzki, RD, MPH; Deidre M. Sepavich, MBA;Jean Wactawski-Wende, PhD; JoAnn E. Manson, MD, DrPH; Yongxia Qiao, MD; Simin Liu, MD, ScD; Philip A. Merriam, MSPH;Catherine Rahilly-Tierny, MD, MPH; Fridtjof Thomas, PhD; Jeffrey S. Berger, MD, MS; Judith K. Ockene, PhD, MEd, MA;J. David Curb, MD; Yunsheng Ma, MD, PhD
Arch Intern Med. 2012;172(2):144-152. doi:10.1001/archinternmed.2011.625
http://archinte.ama-assn.org/cgi/content/short/archinternmed.2011.625
Hi, I'm 57, male, natural remedies didn't help lowering cholesterol and I was prescribed on simvastatin 20mg/day from February 2004. It regulated my all cholesterol values (total, HDL, LDL, triglycerides). I know it is not easy to come off statins ( it can cause rapid growth of cholesterol) but I'd like to get rid of them because of the risk of diabetes etc. How to do that and not to endanger my health does anyone know ?
2. Atherosclerotic plaque is due to LDL, which is vulnerable to attack by smoking, glucose and other blood sugars, especially fructose.
3. Oxidized and glycated LDL particles become less efficient in delivering their contents to the cells. Thus, they stick around longer in the bloodstream, and the measured serum LDL level goes up.
4. Statins will decrease the plaque burden acutely, but do long term harm to the cells.
5. Statins are known to interfere with caveolin production. Less membrane cholesterol results in fewer lipid rafts, and this leads to impaired glucose uptake.
6. About a year on statins after an MI the risk benefit begins to disappear. Study show long-term treatment with statins caused a clinically silent but still definite damage to peripheral nerves when the treatment lasts longer than 2 years.
7. Statins do not address the basic problem plaque which is oxidized and glycolysis of LDL.
8. The skin produces cholesterol sulfate in large quantities when it is exposed to sunlight. The skin actually synthesizes sulfate-capturing energy from sunlight in the form of the sulfate molecule, thus acting as a solar-powered battery. The sulfate is then shipped to all the cells of the body, carried on the back of the cholesterol molecule.
9. Treatment of atherosclerotic is not statins. It is spend significant time outdoors; eat healthy, cholesterol-enriched, animal-based foods; eat fermented foods like yogurt and sour cream; eat foods rich in sulfur like onions and garlic. Also bath several time a week in Epsom salts, Magnesium sulfate.
Very instructive for every Dr to read "How we Do Harm" by oncologist and Chief Medical Officer of the American Cancer Society, Otis Brawley M.D. Things have gone very wrong in medicine. Statins are a symptom of a much bigger problem.
Hi Dr. Topol,
Thank you for your comments and explaining the data for statins as a preventative against these new findings...it sure seems there are diminishing returns with respect to statin benefits and diabetes risk. I am a 46 year old male and have been on atorvastatin now for 15 + years to treat high cholesterol levels which is heriditary. Late in 2010 I was diagnosed with diabetes (type 1.5, I'm quite sensitive to insulin), yet I'm not aware of any family history around it. I have to wonder now if I am one of the 1:200 who have been affected by long term statin use. I'd be curious to know if there are any data out there that suggests discontinuing statin use may help improve glycemic control?
You are to be commended for taking such a brave medical stand in your:
"The data are clear: in primary prevention, when comparing the benefit in preventing heart attack, stroke, and death vs the risk of diabetes, the trade-off is very slim—and the dangers, very real."
This is the year atorvastatin goes off patent. Does that have any relationship to answer the question: Why now? Why not 5 to 10 years ago? Are we always to remain so far behind the curve on these larger patient risk tradeoff realities?
From a different point of view; What percent of those patients who quit taking their prescribed statins (in general 30+%) how many are preventing themselves from becoming diabetic?
Can we get more definitive data on current patterns of statin/diabetes for those who are on secondary prevention?
Might certain statins also be linked to other medical issues such as causing Erectile Dysfunction Syndrome necessitating Viagra etc?
What about statins causing Gynecomastia?
Might we not need to rethink our risk trade off and side effects paradigms to bring them up to the level of better prevention rather than trying to close the barn door after significant damage has been done?
Drug development and manufacturing is no longer in the horse and buggy stage, the neither should be our evaluations and prescribing of new drugs.
Actually I am a physician treating individuals with extreme dyslipidemias and rapidly advancing atherosclerosis,
I have no drug company connections.
CETP inhibitors will probably solve many difficulties associated with statins by enhancing reverse cholesterol transport.
This may allow many young children and adults to suspend LDL apheresis and live productive lives despite their genomic anomalies.
"the tradeoffs are narrow and this is a big deal"
Time to abandon biomarkers (in this case glucose). I could not more vociferously disagree with the implication that statin use should be restricted due to a 1/200 increased risk of glucose intolerance. "Diabetes avoidance" should not be a goal trumping prevention of cardiovascular adverse outcomes. If a trial sufficiently powered and randomized showed an increased incidence of glucose intolerance but less adverse cardiovascular events would you abandon that therapy based on the laboratory analysis of a failed biomarker? That would cause you to abandon the only antihypertensive to extend lifespan (chlorthalidone) and the beta blocker with greatest anti-anginal effect (atenolol). And in ACCORD what had a greater effect on prognosis - glycemic control or statins? I think we need to be very careful here. When the margins are narrow but favor therapy in hard endpoint reduction we usually trumpet this as a gtreat success. In this argument there is a small benefit but an abnormal lab (maybe not randomized replicated data) and so we abandon the benefit? I am not sure I follow the reasoning here. Finally if glucose intolerane/diabets was diagnosed with a 0.5-0.8% greater frequency yet carried no consquences what really is the argument? Doesn't seem like a big deal with the strength of the data at this point.
Please do not substitute this for the advice of your physician.
Having a similar diagnosis of familial dyslipidemia I would advise high dose statin and forget about the numbers. The notion of biomarker guided event reduction has never been proven to have any value aside from highest tolerable dose statin therapy and combination therapy has been tested and thus far has not been additive (niacin and fenofibrate). CTEP inhibitors may be of assistance but that is under study. For all the deserved criticism that interventional cardiology has received the real scam artists are the interventional lipidologists - however well meaning the data just isn't there.
It was great to get data translated into simple, easy to understand numbers.
In my practice, the numbers mean that I have to be more vigilant and more expressive and thorough with patients about encouraging and monitoring nutrition and lifestyle change, not just prescribing statins. Statins, I believe, are very, very useful, and MUST BE part of a whole picture effort in helping people change their risk profile to get healthier outcomes.
Has anybody looked at whether the risk of diabetes with statins applies to people with elevated BMI?
Has anybody looked if the risk of diabetes with statins applies to vegans or those who avoid food products from cows?
There needs to be some additional data mined if possible, as medicine begins to financially (finally) incentivize healthy nutrition and lifestyle with medication used as necessary.
Thank you for your efforts,
Harvey Zarren, M.D.
Dr Topol,
Thanks for your insightful comments on this topic. What a game changer ! This is going to dramatically change practice patterns in primary prevention. It seems that very little is better than regular physical activity and healthy eating habits. Perhaps we should invest more of our resources in preventing the epidemic of obesity esp. in children, as far as primary prevention goes. That and tobacco cessation ultimately will save tens of thousand more lives than statins it appears!
I hope you are well.
your former fellow,
Ryan
It is refreshing to hear a non-biased review of these problematic drugs. The increased risk of diabetes in statin users is cause for great concern.
Barbara Roberts, MD
Statins show very little benefit in primary prevention, with large increases in rates of diabetes. Talk w/your Dr. http://blogs.theheart.org/topolog/2012/3/1/statins-and-diabetes-a-hard-look-at-the-data-2
Huh??? A doctor prescribes statins and then, one is told to ask his/her doctor if statins cause diabetes or are safe. Doctors are trained and indoctrinated to write prescriptions and cut out body parts. That is how they make a living. So, do you think they will risk losing their income. The best way to take care of your health is Mind, Body Spirit health. See a Naturopath who doesn't prescribe pharmeceuticals. See a Holistic Health Care practitioner and attend to your spiritual needs vis-a-vis NON-religious venues.
The issue of effectiveness of reducing LDL with a statin for primary prevention of coronary events is unresolved. The mean age of participants enrolled in the statin trials was 63 years. This means that treatment with a statin in these groups was being used to merely stabilize the underlying atherosclerotic burden. We need trials of long term reductions with statin or other therapies to reduce LDL to determine if preventing (rather than treating) coronary atherosclerosis is possible. I wonder what the ACC.12 Late Breaker on "Mendelian" randomized trial of lowering LDL early in life is all about?
Would it not be the simplest thing to prescribe a modest does of a Statin and, shoudl that not prove sufficient, then provide niacin or other medication(drug or spplement) in addition, particularly for primary use? I speak as a lay non-statin induced, well controlled diabetic who takes 20mg of Lipitor and has LDL readings regularly of between 70 and 80.
1166
Metabolism, Vol 51, No 9 (September), 2002: pp 1166-1170
I think you will find a viable answer there.
I commend Dr. Topol for enabling this open discussion.
Dear Topol,
what are the mechanisms associated to diabete induced by statins?
In Eric Topol’s book ‘The Creative Destruction of Medicine’ my question is how will Cardiology-Medicine continue to exist? The Cholesterol-Statin Hypothesis seems to be a terrible lie. The medical-pharm establishment has probably been fatally wounded.
How will society trust the prolonging of health and the development of new treatments based to money rather than improving the health of the species? The foods sold in the modern supermarket are terribly flawed. The ramped obesity and autoimmunity is diet not genes.
Human disease, especially auto-immune problems is more related to diet, the human genome is stable for 50,000 years.
The Paleo Diet concept in about 1985 by Dr. Boyd Eaton’s seminal New England Journal of Medicine paper, Paleolithic Nutrition the genome is not the problem.
<!--EndFragment--><!--StartFragment--><!--EndFragment-->And my particular point of view is here (in spanish): http://medicablogs.diariomedico.com/santos/2012/04/15/estatinas-de-la-discordia/
Dr. Topol:
I was impressed with your analysis of the statin literature and appreciate your taking the time to present your assessment. Is a transscript of your video presentation available?
By the way, a Google search turned up some of the high-profile, courageous and inspiring positions you have taken in the past on other pharmaceutical issues. I find your decision to place your esteemed professional position at risk by serving as an unrelenting advocate for patient safety truly remarkable and commendable. Quite an inspiring story sir...a story more laudatory than your incredible publication record in my humble opinion!
Lewis
I am genuinely appreciatve of the 40+ comments here, which I think sets a new record for this video blog over the 5 years since it started!
For anyone who questions whether the risk of diabetes is real or that there is lack of a cause and effect story, I guess there will never be a data set that will be adeqautely convincing.
Especially grateful to Lewis Watts, above, for his exceptionally kind perspective.
I think I am witnessing the ‘destruction’ of the American population by food poisoning. Your own history with the power of the Pharmaceutical Industry is sobering. I read your book, but I also benefited by Dick Hill audible version on my Kindle.
As discussed in your book: The VA’s Vista and DOD are working on ‘BLUE BUTTON’ databases for patients to manage their data.