by Jeffrey Dach MD

The title speaks for itself. This bombshell article by Rita Redberg, MD, editor of the Archives of Internal Medicine, appeared in April 2012 JAMA advising healthy men with high cholesterol to stay away from statin anti-cholesterol drugs, pointing out there is no mortality benefit.  Dr Redberg goes on with a list of adverse side effects of statin drugs,  namely, myopathy, cognitive dysfunction, etc.   This JAMA article and debate is an outgrowth of the “Less is More” series in the Archives of Internal Medicine.    For fairness, JAMA also posted the opposing view by Dr. Blaha.

For your convenience, I have posted Dr. Rita Redberg’s article here with links to the original.  Above left image: Statin Drug, Lipitor 40 mg tablets, Courtesy of The Week. Click Here for link to Dr Rita Redberg article in April 2012 JAMA.

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Healthy Men Should Not Take Statins (Reprinted here Courtesy of Rita Redberg MD)

by Rita F. Redberg, MD; Mitchell H. Katz, MD ,

Author Affiliations: Division of Cardiology, Department of Medicine, University of California, San Francisco (Dr Redberg); and Department of Health Services, County of Los Angeles, Los Angeles, California (Dr Katz).

Left Image: Courtesy of Wall Street Journal and Dr Rita Redberg.

Dr Redberg is also Editor, Archives of Internal Medicine. Dr Katz is also Deputy Editor, Archives of Internal Medicine.

Here is the Quote from the JAMA Article:

“Should a 55-year-old man who is otherwise well, with systolic blood pressure of 110 mm Hg, total cholesterol of 250 mg/dL, and no family history of premature CHD be treated with a statin? — No “says Rita Redberg MD.

“Extensive epidemiologic data demonstrate that higher cholesterol levels are associated with a greater risk of heart disease. At the population level, higher levels of cholesterol are associated with a diet greater in fatty foods, particularly trans fat and meat, and low intake of fruits and vegetables.

The important questions for clinicians (and for patients) are as follows:

(1) does treatment of elevated cholesterol levels with statins in otherwise healthy persons decrease mortality or prevent other serious outcomes?

(2) What are the adverse effects associated with statin treatment in healthy persons?

(3) Do the potential benefits outweigh the potential risks? The answers to these questions suggest that statin therapy should not be recommended for men with elevated cholesterol who are otherwise healthy.

Benefits of Statin Therapy in Healthy Men With High Cholesterol?

Dr Ray Archives Int Med – NO Reduction in Mortality

What is the benefit of statin therapy in healthy men with high cholesterol levels? Data from a meta-analysis of 11 trials including 65 229 persons with 244 000 person-years of follow-up in healthy but high-risk men and women showed no reduction in mortality associated with treatment with statins.(1 )

Cochrane Review – No Reduction in Mortality

A 2011 Cochrane review of treatment with statins among persons without documented coronary disease came to similar conclusions.(2) The Cochrane review also observed that all but one of the clinical trials providing evidence on this issue were sponsored by the pharmaceutical industry.

Biased Reporting in Industry Sponsored Drug Trials

It is well established that industry-sponsored trials are more likely than non–industry-sponsored trials to report favorable results for drug treatment because of biased reporting, biased interpretation, or both of trial results.(6)

Adverse Effects of Statins

What adverse effects are associated with statin treatment in healthy persons?

Myopathy, Muscle Pain, Weakness

All treatments designed to prevent disease—such as death from coronary disease—can also result in adverse effects. Data from observational studies show much higher rates for statin-associated myopathy and other adverse events in actual use than the 1% to 5% rate reported in clinical trials. This underestimation of adverse events occurs because the trials excluded up to 30% of patients with many common comorbidities, such as those with a history of muscular pains, as well as renal or hepatic insufficiency.(3)

Many randomized trials also excluded patients who had adverse effects of treatment during an open-label run-in period. For example, in the Treat to New Targets trial, after initial exclusions based on comorbidities, an additional 35% of eligible patients, or 16% of patients, were excluded during an 8-week, open-label, run-in phase because of adverse events, ischemic events, or participants’ lipid levels while taking the drug not meeting entry criteria.7 Additionally, the results of randomized trials of statin treatment likely underestimate common symptoms such as myalgia, fatigue, and other minor muscle complaints because these studies often only collect data on more quantifiable adverse effects such as rhabdomyolysis.

Cognitive Impairment

Numerous anecdotal reports as well as a small trial (8 – 9) have suggested that statin therapy causes cognitive impairment, but this adverse outcome would not have been captured in randomized trials. The true extent of cognitive impairment associated with statins remains understudied. It is disappointing that more data are not available on important adverse events associated with statin treatment, despite millions of prescriptions and many years of use. This information could be easily collected in observational studies and from registries. (8)(9)

One population-based cohort study in Great Britain of more than 2 million statin users found that statin use was associated with increased risks of moderate or serious liver dysfunction, acute renal failure, moderate or serious myopathy, and cataract.(4)

The risk of diabetes with statin use has been seen in randomized clinical trials such as JUPITER, which found a 3% risk of developing diabetes in the rosuvastatin group, significantly higher than in the placebo group.

In observational data from the Women’s Health Initiative, there was an unadjusted 71% increased risk and 48% adjusted increased risk of diabetes in healthy women taking statins.(5)

Do the potential benefits outweigh the potential risks?

Based on all current evidence, a healthy man with elevated cholesterol will not live any longer if he takes statins. For every 100 patients with elevated cholesterol levels who take statins for 5 years, a myocardial infarction will be prevented in 1 or 2 patients.(7)

Preventing a heart attack is a meaningful outcome. However, by taking statins, 1 or more patients will develop diabetes and 20% or more will experience disabling symptoms, including muscle weakness, fatigue, and memory loss. (3)

NONDRUG APPROACHES TO REDUCING CORONARY RISK

There are effective methods for reducing cardiovascular risk in otherwise healthy men: dietary modification, weight loss, and increased exercise.

These strategies are effective in increasing longevity and also result in other positive benefits, including improved mood and sexual function (10) and fewer fractures. Although these strategies are challenging, prescribing a statin may undermine them. For example, some patients derive a false sense of security that because they are taking a statin they can eat whatever they want and do not have to exercise.

Belief in Benefits of Statins for Patients Without CAD

For some clinicians, evidence that statins reduce the risk of recurrent coronary events in patients with documented coronary disease leads to the belief that statins also “must” be beneficial for patients without coronary disease.

However, recent history is rife with examples of interventions that are proven to work in patients with serious disease yet are not efficacious when generalized to patients without serious disease.

CABG Not a Good Choice for Single Vessel Disease

For example, coronary artery bypass graft (CABG) surgery is lifesaving for patients with symptomatic left main disease. However, CABG surgery would not be a good choice for single-vessel coronary artery disease (CAD) because risks would outweigh benefits in less extensive CAD. Similarly, the benefits of carotid endarterectomy in preventing stroke outweigh the risks for symptomatic patients with tight carotid artery stenosis, but not for asymptomatic patients with less critical stenosis. In addition, the use of aspirin is similar to statins for prevention.

Aspirin Not Useful For Primary Prevention

The data show clear benefit for aspirin in secondary prevention of cardiovascular disease, but not for primary prevention. Practitioners should not be generalizing from other settings when good data indicate that statins are not effective in improving length or quality of life when used for primary prevention.

For the 55-year-old man in this scenario, his risk of myocardial infarction in the next 10 years based on the Framingham Risk Score varies from 10% to 20%. His risk is driven mostly by his age rather than by his cholesterol level. Increasing age has a much larger influence on risk for cardiovascular disease than do increasing levels of cholesterol.

Recent data on increased risk of diabetes, cognitive dysfunction, and muscle pain associated with statins suggest that there is risk with no evidence of benefit.

Advising healthy patients to take a drug that does not offer the possibility to feel better or live longer and has significant adverse effects with potential decrement in quality of life is not in their interest.

At the same time, there are significant opportunities for improvement in lifestyle counseling and interventions. Even small changes in diet and increases in physical activity and smoking cessation can lead to significant personal and population health benefits. Such positive lifestyle changes have the key advantage of helping patients feel better and live longer. Lifestyle counseling should remain the focus of primarily prevention efforts—at the physician and public health levels.

AUTHOR INFORMATION: Corresponding Author: Rita F. Redberg, MD, Division of Cardiology, University of California, San Francisco, 505 Parnassus Ave, M1180, San Francisco, CA 94143 (r______@medicine.ucsf.edu).

Conflict of Interest Disclosures: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

Additional Contributions: We thank Deborah Grady, MD, University of California, San Francisco, for her input in the writing of this Viewpoint. She was not compensated for her contribution.” end quote

REFERENCES

1) Ray KK, Seshasai SR, Erqou S,  et al.  Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants.  Arch Intern Med. 2010;170(12):1024-1031, PubMed

2) Taylor F, Ward K, Moore TH,  et al.  Statins for the primary prevention of cardiovascular disease.  Cochrane Database Syst Rev. 2011;(1):CD004816
PubMed

3) Fernandez G, Spatz ES, Jablecki C, Phillips PS. Statin myopathy: a common dilemma not reflected in clinical trials.  Cleve Clin J Med. 2011;78(6):393-403. PubMed

4) Hippisley-Cox J, Coupland C. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database.  BMJ. 2010;340c2197. PubMed

5) Culver AL, Ockene IS, Balasubramanian R,  et al.  Statin use and risk of diabetes mellitus in postmenopausal women in the Women’s Health Initiative.  Arch Intern Med. 2012;172(2):144-152. PubMed

6) Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review.  BMJ. 2003;326(7400):1167-1170 PubMed

7) LaRosa J, Grundy SM, Waters DD,  et al.  Intensive lipid lowering with atorvastatin in patients with stable coronary disease.  N Engl J Med. 2005;352(14):1425-1435 PubMed

8) Muldoon MF, Barger SD, Ryan CM,  et al.  Effects of lovastatin on cognitive function and psychological well-being.  Am J Med. 2000;108(7):538-546
PubMed CrossRef

9) Muldoon MF, Ryan CM, Sereika SM, Flory JD, Manuck SB. Randomized trial of the effects of simvastatin on cognitive functioning in hypercholesterolemic adults.  Am J Med. 2004;117(11):823-829 PubMed CrossRef

10) Gupta BP, Murad MH, Clifton MM, Prokop L, Nehra A, Kopecky SL. The effect of lifestyle modification and cardiovascular risk factor reduction on erectile dysfunction: a systematic review and meta-analysis.  Arch Intern Med. 2011;171(20):1797-1803
PubMed

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Links to Articles with Related Content:

You Tube Videos by Dr Dach:

Links to all four parts of this series on You Tube:

part one: http://youtube.com/watch?v=b-iUJd4IxRM

part two: http://youtube.com/watch?v=RozkhmdHPac

part three: http://www.youtube.com/watch?v=_To64-NWKao

Part four: http://youtube.com/watch?v=gd6f8_GjAsg

Heart Disease Prevention

Familial Hypercholesterolemia

Saving Time Russert and George Carlin

Healthy Men Should Not Take Statin Drugs

Heart Disease Vitamin C and Linus Pauling

Getting Off Statin Drug Stories

How to Reverse Heart Disease with the Coronary Calcium Score (part one)

Reversing Heart Disease Part Three

Cholesterol Lowering Drugs for the Elderly, Bad Idea

Cholesterol Lowering Statin Drugs for Women Just Say No

More links and references

Listen to Debate Audio

http://www.ihi.org/knowledge/Pages/AudioandVideo/AIRShouldHealthyManBeTreatedWithaStatin.aspx
Audio of Debate on Statins for Healthy Men in JAMA article with  Dr Rita Redberg vs Michael Blaha (opposition)

Author in the Room: Should a Healthy 55-Year-Old Man Be Treated with a Statin?
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May 2012 Author in the Room® Teleconference  Authors and Articles:

Michael Blaha, MD, MPH, suggests that the available data do support treatment:

Statin Therapy for Healthy Men Identified as “Increased Risk”

Rita Redberg, MD, MSc, suggests that the available data do not support treatment.
Healthy Men Should Not Take Statins

Summary Points:Summary Points from Dr. Michael Blaha: High-quality literature supports statins for reduction of first heart attack and stroke, in addition to a mild decrease in all-cause mortality over 3 to 5 years.The key to efficient use of statins in primary prevention is risk stratification.We must demand high-quality evidence for benefit and for harm in a potentially beneficial medication class such as statins.Physicians should adhere to national guidelines to guide statin use in primary prevention.

http://www.healthnewsreview.org/2012/04/dueling-viewpoints-should-a-healthy-middle-aged-man-with-elevated-cholesterol-take-a-statin-drug/
Dueling viewpoints: Should a healthy middle-aged man with elevated cholesterol take a statin drug?  Posted by Gary Schwitzer in Journal practices

http://www.theheart.org/article/1383271.do
Should statins be used in primary prevention? JAMA gets in on the debate
April 10, 2012 Michael O’Riordan

http://www.dailymail.co.uk/debate/article-2147218/Should-everybody-fifty-Statins-reduce-health-risks.html
Should everybody over fifty take statins to reduce health risks?  By Dr Robert Lefever

http://www.vasculardoc.com/opinion-commentry/healthy-men-should-not-take-statin-drugs-for-cholesterol_133.aspx

Healthy men should not take statin drugs for cholesterol
Apr 12, 2012- In the latest issue of the Journal of the American Medical Association (JAMA – April 11, 2012) opposing viewpoints are offered by two leading cardiologists with regard to the following question:  Should a 55-year-old man who is otherwise well, with systolic blood pressure of 110 mm Hg, total cholesterol of 250 mg/dL, and no family history of premature coronary artery disease, be treated with a statin?

http://www.jonbarron.org/heart-health/statin-drugs-jama-lower-ldl-cholesterol
Statin Drugs – the JAMA Debate – The April 14th issue of the Journal of the American Medical Association inaugurated a new feature called “Viewpoint” — an “in magazine” debating forum for arguing out key medical issues of the day. Think of it like a civilized version of Dan Aykroyd and Jane Curtain’s Point/Counterpoint sketches on Saturday Night Live.1  Date: 04/23/2012 Written by: Jon Barron

http://www.natap.org/2012/HIV/041112_01.htm
Should statins be used in primary prevention?
theheart.org April 12 2012 Michael O’Riordan
Baltimore, MD and San Francisco, CA – Differing opinions on the use of statins in primary prevention make the pages of one of the leading medical journals this week, with the Journal of the American Medical Association (JAMA) the latest in a line of professional and mainstream media outlets getting in on the contentious topic [1,2]. Introduced by the JAMA editors to encourage discussion and debate [3], the inaugural “dueling viewpoints” kicks off its new series by considering the clinical question of whether or not a healthy 55-year-old male with elevated cholesterol levels should begin taking the lipid-lowering medication.

http://anthonycolpo.com/?p=3479
Why Asians Should Ignore the Cholesterol Sham, and Why Healthy People Should Not Take Statins.  Anthony Colpo | Saturday, April 28th, 2012

http://www.minnpost.com/second-opinion/2012/04/duel-over-statins-use-healthy-people-moves-new-venue
‘Duel’ over statins’ use in healthy people moves to new venue
By Susan Perry | 04/17/12

<<<<<<<<<<<<<  Zocor on this web page .>>>>>>>>>>>>
http://cardiobrief.org/2012/01/23/rita-redberg-and-roger-blumenthal-clash-over-statins-for-primary-prevention-in-the-wall-street-journal/
January 23, 2012
Rita Redberg and Roger Blumenthal Clash Over Statins for Primary Prevention in the Wall Street Journal 8    by Larry Husten • Uncategorized • Tags: mortality benefit, primary prevention

The debate over whether statins should be used for primary prevention moved to the Wall Street Journal with opposing perspectives from cardiologists Roger Blumenthal and Rita Redberg.

Blumenthal argues that “there is a mountain of high-quality scientific evidence” to support the use of statins in people without known heart disease but “demonstrated to be at high risk for heart disease.”
Redberg argues that “for most healthy people, data show that statins do not prevent heart disease, nor extend life or improve quality of life. And they come with considerable side effects. That’s why I don’t recommend giving statins to healthy people, even those with higher cholesterol.”

http://www.lifediscoverywellness.com/archives.html
Healthy Men Should Not Take Statins-Neither should Women! 04/23/2012
Most of you know what cholesterol lowering drugs are.  Below is a list of the names of the most common drugs out there.  The most unethical event is taking place to people that you know and care about.  The amount of cholesterol drugs consumed is up and the drug companies bottom line has gone up, but there is no change in the amount of heart disease.  In fact heart disease is still the number one killer by far and it continues to go up and up and up.  So what in the health are the statins for?

Advicor  (lovastatin with niacin) – Abbott
Altoprev (lovastatin) – Shionogi Pharma
Caduet [atorvastatin with amlodipine (Norvasc)] – Pfizer
Crestor (rosuvastatin) – AstraZeneca
Lescol (fluvastatin) – Novartis
Lipitor (atorvastatin) – Pfizer
Mevacor (lovastatin) – Merck
Pravachol (pravastatin) — Bristol-Myers Squibb
Simcor (niacin/imvastatin) – Abbott
Vytorin (ezetimibe/simvastatin) – Merck/Schering-Plough
Zocor (simvastatin) – Merck

http://www.ucsfhealth.org/rita.redberg

Rita Redberg, F.A.C.C., M.Sc., M.D.

Cardiologist Dr. Rita Redberg is a cardiologist specializing in heart disease in women. She earned her medical degree from the University of Pennsylvania School of Medicine, in Philadelphia. She completed her residency at Columbia-Presbyterian Medical Center in New York, where she went on to complete a fellowship in cardiology. Then she completed a fellowship in non-invasive cardiology at Mount Sinai Medical Center, also in New York. In addition, Redberg has a masters of science in health policy and administration from the London School of Economics in England. Also she is currently a Robert Wood Johnson health policy fellow.
Redberg has written, edited and contributed to many books, including “You Can Be a Woman Cardiologist,” “Heart Healthy: The Step-by-Step Guide to Preventing and Healing Heart Disease,” and “Coronary Disease in Women: Evidence-Based Diagnosis and Treatment.”

Clinics Cardiovascular Care and Prevention Center at Mission Bay  535 Mission Bay Blvd. South  San Francisco, CA 94158
Phone: (415) 353-2873  Fax: (415) 353-2528

http://www.pace-cme.org/therapeutic-areas/opinion-statins-for-healthy-people
Statins for healthy people
Commentary by Prof John E Deanfield

Recently, prescribing statins to healthy people was discussed in the Journal of the American Medical Association. The main question is: should a healthy man aged 55 who has a blood pressure of 110 mm Hg, an LDL-cholesterol level of 6.46 mmol /L without family history take statins? Besides, the New England Journal of Medicine published a reflective publication on statins and the risk of diabetes. Links to these articles you will find below.

According to prof. John E. Deanfield (University College, London), statin therapy is a key part of multifactorial risk reduction strategies. Long term surveillance of risks and benefits are required, particularly for drugs given to very large numbers of people. The data we have so far are highly encouraging for statins.

Deanfield gives four good reasons to continue prescribing statins:

The benefits of a healthy lifestyle should always be emphasised, but this is rarely adopted by patients.
Statins provide an effective way of prolonging an event free survival and are generally safe, with increasing benefit over time. Thirdly the extremely well investigated potent statins atorvastatin and simvastatin are both generic and cheap
It is important to consider the lifetime benefits of cardiovascular risk reduction in discussions with patients and not merely 5 and 10 year risks in those with cardiovascular disease..

References:

Healthy Men Should Not Take Statins :
JAMA. 2012;307(14):1491-1492. doi:10.1001/jama.2012.423
Rita F. Redberg, MD; Mitchell H. Katz, MD

Statin Therapy for Healthy Men Identified as “Increased Risk”
JAMA. 2012;307(14):1489-1490. doi:10.1001/jama.2012.425
Michael J. Blaha, MD, MPH; Khurram Nasir, MD, MPH; Roger S. Blumenthal, MD

Statins: Is It Really Time to Reassess Benefits and Risks?
N Engl J Med 2012; 366:1752-1755May 10, 2012
Allison B. Goldfine, M.D.

Wall Street journal – <<<<<<<<<<Redberg Illustration  >>>>>>>>>>>

http://online.wsj.com/article/SB10001424052970203471004577145053566185694.html

Should Healthy People Take Cholesterol Drugs to Prevent Heart Disease?
http://www.kardeanutrition.com/content/healthy-high-cholesterol-should-you-be-taking-statins

Healthy But With High Cholesterol: Should You Be Taking Statins?  Posted By Rob Leighton On 04/16/2012 – 8:05 am in the following categories : Your healthy and feeling great, but you just found out that your LDL (bad) cholesterol is high. You do not have any of the standard risk factors, like a parent with heart disease.  Should you be taking a statin medication – perhaps for the rest of your life?

More and more doctors are coming to the conclusion that the answer is no. In the April 2012 Journal of the American Medical Association (JAMA), two perspectives were presented.

Jeffrey Dach MD
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