The Statin Debates Have Begun. Crestor Is Approved for Prevention of Heart Disease in Healthy People & Not All Physicians Approve - Consider the Risks and Benefits

Graph from NYT March 10, 2010

Click here for the web-version of this post with all the links if you've received this via email

"My view has always been that you start with the basics--and do the simple things before you go to drugs.  Lots of people are not doing the sensible things.  They're not eating the right diet, they're not exercising, they're still smoking.  It is so much easier to prescribe a drug than to change behavior, and that is my worry.  We're heading down that road.  Cardiovascular risk prevention is moving in the wrong direction."

-Dr. Mark Hlatky, Professor of Health Research, Policy, and Medicine, Stanford University-

"You have to go with the scientific evidence.  A clinical trial was done and there was a substantial reduction in morbidity and mortality in people treated with this drug (Crestor).  This is one example where the FDA got it exactly right."

-Dr. Steven E. Nissen, Chairman of Cardiovascular Medicine, Cleveland Clinic-

"(The key issue is) Millions of healthy American women are taking statins, which have never been shown to reduce myocardial infarction or lengthen life and have an untold number of side effects, worse in women than men."

-Dr. Rita Redberg, Cardiologist, Director of the Women's Cardiovascular Services, University of California, San Francisco-

"Muscle problems are the best known of statin drugs' adverse side effects.  But cognitive problems and peripheral neuropathy, or pain or numbness in the extremities like fingers and toes, are also widely reported."

-Dr. Beatrice Golomb, MD, PhD, Director of the UC San Diego Statin Study Group, Dr. Marcella A. Evans,  UCSD School of Medicine   Am J Cardiovasc Drug 2008;8(6):373-418-

In Case You Missed It - There's Been Big News Breaking in the Statin World Recently

Here's the timeline:

November 9, 2008:  Landmark JUPITER Study rocks the American Heart Association Conference.  Evidence was presented that will forever change the standards for testing CRP levels (C-Reactive Protein--a measure of inflammation) and prescribing statins to prevent heart attacks &  strokes in healthy individuals.   The JUPITER (Justification for the Use of Statins in Primary Prevention) Study looked at almost 18,000 men & women with low LDL levels (median 108 mg/dL), and CRP levels greater than 2.0 mg/L. 

"The group that was put on a moderate dose of statins (20 mg of Crestor) decreased their cholesterol levels, lowered their CRP levels, reduced their triglyceride levels and cut their risk of heart attack and stroke in half." 

To read the full report click here.  To the read the accompanying article published in the New England Journal of Medicine, click here.

To read my post that explains the JUPITER study and the non-statin ways to treat inflammation, click here

February 9, 2010:  Crestor is Approved for Use in Healthy People for Prevention.  Based on the landmark results of the JUPITER Study (which was sponsored by Crestor's maker--AstraZeneca) the FDA approved Crestor--for the prevention of heart disease or stroke in people with normal or near-normal cholesterol levels.

"The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.

Specifically, this includes men 50 years of age and older and women 60 years of age and older who have an elevated amount of a substance known as high sensitivity C-reactive protein (CRP) in their blood and at least one additional traditional cardiovascular risk factor such as smoking, high blood pressure, a family history of premature heart disease, or low amounts of high-density lipoprotein or HDL cholesterol, the so-called “good cholesterol.”'  Click here Q & A from the FDA about the new approval.

February 16, 2010:  Statins and Risk of Diabetes. Article published in Lancet finds there is a 9% increased risk of developing diabetes associated with statin use.  The risk is highest in older patients, but it had no relation to their BMI (weight), or their LDL levels.  According to the authors, "No worries! The benefit of taking statins to reduce cardiovascular risk outweighs the risk of developing diabetes by 9:1"  OK, if you say so.

March 19, 2010:  Zocor & Muscle Injury. FDA issues an advisory statement about the risk of muscle injury for those taking Zocor (simvastatin) at the highest approved dose--80 mg.  FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury. Click here to read the statement.

March 29, 2010:  Do Statins Benefit Women? TIME Magazine article appears,  "Do Statins Work Equally for Men and Women?" by Catherine Elton.  It's a must-read article for women who are taking statins for prevention--not because of diagnosed heart disease--or a previous cardiac event.  

In light of the FDA's recent approval of Crestor for primary heart disease prevention in healthy men & women--Elton looked at the research, and interviewed cardiologists and statin-users to find out if it makes sense for healthy women to start taking statins strictly for prevention.  Turns out that the majority of current statin users are already healthy people who don't have heart disease but simply have high cholesterol--and this is before Crestor even got it's "prevention approval".

Dr. Scott Grundy of the University of Texas Southwestern Medical Center in Dallas has been a long-time advocate of prescribing statins to women who are at moderate risk of heart disease & he says the benefits outweigh the risks.  Dr. Rita Redberg of UCSF, and Dr. Beatrice Golomb of UCSD, who is one of the world's experts in the adverse effects of statins, think otherwise.  Golomb thinks "many doctors may be so unfamiliar with the side effects of statins that they deny their connection to the drugs, and that may contribute to the under-filing of adverse-drug-reaction reports with the FDA."

The two examples of "statin horror stories" that Elton reports on in her article are certainly anecdotal--but may put "statin-doubts" into many who read her article:

"Lynne Newhouse Segal was the picture of robustness. At 59, the slim former lawyer was an avid runner, golfer and yoga practitioner. Segal, who lives in San Francisco, was healthy by nearly every measure — except her cholesterol level, which a routine test four years ago revealed was high. High cholesterol is a key risk factor for heart disease, especially in a patient Segal's age and with her family history (several close relatives had had heart attacks), so her doctor put her on a cholesterol-lowering statin drug as a preventive measure.

But Segal's statin ended up preventing her from living a heart-healthy lifestyle. A month after she started taking the drug, she suffered muscle pain so severe, she had to stop all physical activity and was unable to sleep at night. Although her husband, who was worried about her risk of heart attack, pleaded with her to stay on the drug, she discontinued using it. The muscle pain receded. "My husband was scared for me. Doctors scare you. But I was in so much pain, I told him I would have rather died than stay on them," says Segal.

And then there's Margaret--a 59 year old woman who asked that her last name be withheld.  She says her experience with statin side effects was harrowing. Margaret was in her early 50s and had high cholesterol and diabetes when her doctor put her on statins. Soon after, she says, she forgot how to do basic math and got lost driving to familiar places. But when she described the symptoms, she says, her doctor refused to believe they were related to the drugs. "I felt like I was going crazy," says Margaret, "but within a week or two of stopping the statins, my brain started to work again." 

For more on the cognitive side effects of statins, read click here "Do Statins Make Your Stupid?  Asks Wall Street Journal & New York Times"

March 30, 2010:  The Heartwire responds to Elton's Time Magazine article, with one of their own, "Time Magazine Questions Statin Risks and Benefits in Women, But Experts Say Drugs Safe and Effective"  click here to read it.   The overwhelming tenor of the article is pro-statin, but it's interesting that every physician that was interviewed--except for Dr. Rita Redberg who is anti-statin for primary prevention in women--is affiliated with one or more pharmaceutical companies.  The best part of the Heartwire article is the wide mix of pro- and con- comments that follow it.  Take a look.

March 30, 2010:  The New York Times business section reports, "Risks Seen in Cholesterol Drug Use in Healthy People" by Duff Wilson. Not to be missed are the 424 comments (many on side effets) that follow this article.  The NYT stopped accepting comments within 1 day of publishing Wilson's article.  The following is an excerpt of Wilson's article:

"With the government’s blessing, a drug giant is about to expand the market for its blockbuster cholesterol medication Crestor to a new category of customers: as a preventive measure for millions of people who do not have cholesterol problems.

Some medical experts question whether this is a healthy move.

They point to mounting concern that cholesterol medications — known as statins and already the most widely prescribed drugs in the United States — may not be as safe as a preventive medicine as previously believed for people who are at low risk of heart attacks or strokes.

Statins have been credited with saving thousands of lives every year with relatively few side effects, and some medical experts endorse the drug’s broader use. But for healthy people who would take statins largely as prevention — which would be the case for the new category of Crestor patients — other experts suggest the benefits may not outweigh any side effects."

The FDA approved the new criteria last month for Crestor, which is made by AstraZeneca and is the nation’s second best-selling statin, behind Lipitor by Pfizer.  AstraZeneca plans soon to begin a new marketing and advertising campaign for Crestor, based on the new F.D.A.-approved criteria.

Under those criteria, an estimated 6.5 million people in this country who have no cholesterol problems and no sign of heart problems will be deemed candidates for statins. That is in addition to the 80 million who already meet the current cholesterol-based guidelines — about half of whom now take statins.

Some patients have long complained of muscle aches from taking statins.  Doctors, though, have generally seen those risks as being more than offset by the drugs’ benefits for people with high levels of “bad” cholesterol and a significant risk of cardiovascular disease.

But then came the unexpected evidence linking statins to a diabetes risk, reported last month in the British medical journal The Lancet. That report was based on an analysis of most of the major clinical studies of statins — including unpublished data and the results of the Crestor study that the F.D.A. reviewed.

“We’ve had this drug for a while, and we’re just now finding out that there’s this diabetes problem with it?” said Dr. Mark A. Hlatky.

“The benefit is vanishingly small,” said Dr. Steven W. Seiden, a cardiologist in Rockville Centre, N.Y.

“It just turns a lot of healthy people into patients and commits them to a lifetime of medication.”'

Last June I summarized the current research on the side effects of statins.  Now just might be a good time to revisit it--if you take statins, are basically healthy, and do not have heart disease.  Click here to read that post.

What The Experts Say About The Side Effects Of Statins. What Are They? What Causes Them? Who Is Most At Risk? How Are They Treated?   June 27, 2009

As in most everything else--there is no one size-fits-all-solution.  If I had heart disease, or experienced a heart attack, I'd be the first to get my prescription filled.   But the evidence is strong that the best prevention is a plant-based diet, exercise, and stress management.  Why take a drug with potential side effects for the rest of your life if you don't have to?  To get the brush up course read:  The Huffington Post Interviews Dr. Caldwell Esselstyn about Heart Disease: What Causes It, How to Prevent It, and How to Reverse It With a Plant-Based Diet

Comments

[Chris]

This statin promotion for healthy people reminds of the aspirin situation.

For the last few years it was recommended to take a low dose aspirin daily to prevent heart disease. Recently it has been strongly recommended not to so due to the risk of internal bleeding and because it does not prevent cardiovascular disease deaths. See http://news.bbc.co.uk/1/hi/health/8338763.stm

So, aspirin a drug that is least a century old has been the subject of such a volte face and statins - relatively new drugs - are now also being recommended as a daily requirement for healthy people.

I think it best to wait a few years for more evidence and even then always to prefer lifestyle interventions in preference.

[Ken Leebow]

Thank you for your information.

You have some excellent quotes and I'd like to add some more:

It’s much easier to do prevention than treatment. - Dr. Michael Roizen

Genes load the gun, but lifestyle pulls the trigger. - Dr. Caldwell Esselstyn

Exercise is better than any drug or anything else we have for aging. There's no downside. If this were a drug, it would be the safest, most effective drug in the universe. Dr. James O. Hill

It's unfortunate that our environment has gotten so bad that we have to depend on drugs.

Dr. Esselstyn was instrumental for me in obtaining knowledge about "normal" cholesterol. Most people go by the standard of 200. With diet and lifestyle changes, I got mine down from 202 to 155 in a few months. It's not that hard.

Ken Leebow
http://www.FeedYourHeadDiet.com

[Gael in Vermont]

Again, a wonderful posting Deb. I want to be a medical librarian in my next life!
I don't know how these pharma people sleep at night...it reminds me of the NPR piece on osteopenia and the drugs that followed that "diagnosis." It's unconscionable. I was placed on Lipitor after fighting it for years, low dosage, because of family history and high cholesterol. I took it for a bit then switched to Red Yeast Rice with the sanction of both PCP and naturopath. Numbers have come down BUT this past summer I leaned heavily into a gluten-free and plant based diet and now LOVE IT and the way I feel. I just had blood work done last week (no results yet) but am very curious to see the numbers. After months on this diet and drinking my green smoothies from my monster Vita-Mix, I expect to see quite a difference. I wholeheartedly agree that our modern society would love to just take a pill and make everything go away. Unfortunately, things usually get more complicated.

[The Healthy Librarian]

That was my point--guess I didn't make it clearly. She can get her heart rate up much higher than I can--because she is 30 years younger. She can stay in the 160 range and be working in an aerobic range--while, I'd be anaerobic if I was in the 160 range--and couldn't maintain it for as long as she could.

[Postive Massage Therapy]

My own narrow professional perspective is to remind anyone in the bodywork or fitness business that if a client presents any of common symptoms, statin use should be explored.

For better or worse, it is often the front-line workers who people tell about medical conditions first.
Steven
Positive Massage Therapy

[tom wil]

after taking the drug pravastatin in 3/09, for high cholesterol, it affected an old injury received 40+ years ago. my eye has become very swollen, painful, developed a sore that continuously drains and now i’m unable to see clearly out of that eye