Women and statins: evidence-based medicine or wishful thinking?

14 Dec

by Carolyn Thomas    @HeartSisters

Are you:

A.  a healthy woman who’s never had any issues with your heart, but . . .

B you know heart disease is the #1 killer of women, so . . .

C.  you’re wondering what you can do to help prevent B from happening to you?

Warding off a first heart attack is what physicians call “primary prevention”. It’s also what respected cardiologists representing both the American Heart Association and the American College of Cardiology are now telling us can be effectively accomplished by taking one of the cholesterol-lowering drugs known as statins.

But it turns out that many other equally-respected cardiologists don’t believe that taking a powerful drug every day for the rest of your natural life for a disease you don’t even have is appropriate for primary prevention – particularly in women

Instead, they believe that proven non-drug cardioprotective measures like regular exercise, a Mediterranean-type diet, smoking cessation, stress management, getting a good night’s sleep, maintaining a healthy weight, and other lifestyle improvements are equal to or even better than pharmaceuticals at primary prevention of heart disease.

This second group of cardiologists includes Dr. Roger Blumenthal, director of the Ciccarone Preventive Cardiology Center at Johns Hopkins, who explains:

“Statin therapy should not be approached like diet and exercise as a broadly-based solution for preventing coronary heart disease. These are lifelong medications with potential side effects.”

Also included is Kentucky electrophysiologist and blogger Dr. John Mandrola, a strong advocate for the cardioprotective benefits of regular exercise and heart-smart eating, who once wrote:

“If you don’t have heart disease, the best way to avoid getting it is so simple, so easy to understand, and so not up to your doctor.  Pills should never be the basis of preventing heart disease.”

Between these two groups of duelling cardiologists (and all of us confused patients) are a handful of academics who have waded bravely into the fray, including Martin Wells and Theodore Eisenberg at Cornell University.

In their paper published in the journal Future Cardiology(1), Wells and Eisenberg cite a number of primary prevention studies on statins: 

“The cholesterol-heart attack link and the achievement of lowered cholesterol without protective effect is an important scientific puzzle.”

Last year, I wrote here about the new 284-page pro-statin cardiovascular treatment guidelines for physicians published in 2013. In a nutshell, the likely result of these significantly revised practice guidelines (as I predicted here and here) is the ultimate recommendation that, if you have a detectable pulse, you should probably be taking statins.

Statins have, in fact, become the most widely-prescribed family of pharmaceuticals in the world.

In their landmark report called Evidence for Caution: Women and Statin Use, Canadian researchers Drs. Harriet Rosenberg and Danielle Allard at Women and Health Protection reviewed the effectiveness and safety of statin medications for women.

Equally importantly, they observed that having cholesterol is now somehow thought of as a virtual disease state.

Yet we know that cholesterol performs many vital functions in the body. For example:

  • it maintains cell wall structure
  • it’s crucial for hormone and Vitamin D synthesis
  • it’s important in bile salt production
  • it’s required for digestion, brain and neuron function
  • it’s critical in fetal development
  • it’s an essential component of breast milk

Rosenberg and Allard also remind us:

“There are many modifiable risk factors associated with heart disease, including smoking, diet, poverty and exposure to environmental pollutants, but cholesterol has become the most prominent and feared risk – perhaps because it can conveniently be addressed by taking a pill.”

Indeed, if you do have pre-existing cardiovascular disease, chances are that taking the statins your doctors have no doubt already prescribed for you may in fact provide “secondary prevention” (lowering an existing heart patient’s risk of having another cardiac event).

But so will regular physical exercise, as a number of studies have already clearly suggested.

For example, research(2) published recently in the British Medical Journal found:

“No statistically detectable differences were evident between exercise and drug interventions in the secondary prevention of coronary heart disease.”

But taking pills is very good for the pill business, as Dr. Howard Brody at the University of Texas told Bloomberg Business Week:

“The whole statin story is a classic case of good drugs pushed too far.

“The drug business is, after all, a business. Companies are supposed to boost sales and returns to shareholders.  The problem they face, though, is that many drugs are most effective in relatively small subgroups.

“With statins, these are the patients who already have heart disease.

“But that’s not a blockbuster market. So companies have every incentive to market their drugs as being essential for wider groups of people, for whom the benefits are, by definition, smaller.”

Dr. Bryan Liang, co-director of the San Diego Center for Patient Safety, added:

“What the shrewd drug marketing people at Pfizer and the other pharmaceutical companies did was spin it to make everyone with high cholesterol think they really need to reduce it.

“It was pseudo-science, never telling you the bottom-line truth, [which is] that statins don’t help unless you have pre-existing cardiovascular disease.”

In fact, a central component of those new 2013 guidelines is that although your doctors may have previously told you to take statins to lower your high LDL (bad) cholesterol, those arbitrary targets for cholesterol-lowering all those years are in fact unsupported by scientific evidence.

Even veteran cardiologist Dr. Noel Bairey Merz of Cedars Sinai Hospital in Los Angeles (coincidentally a co-author of the 2013 guidelines) made this revealing admission about women’s heart disease risk while responding to a New York Times piece called Don’t Give More Patients Statins:

“Clinical trials of LDL cholesterol-lowering generally are lacking for this risk category.”

And after being reminded that even the massive 2008 JUPITER study on the statin known as Crestor also showed there was “no treatment benefit” when women who took statins were studied as a subgroup, Dr. Merz conceded to CNN that the evidence isn’t perfect” and that “there are no clinical trials of statin use in women alone”.

Part of this puzzle may stem from older cholesterol studies done on men – not women – in which researchers assumed that any benefits to taking statins observed in men would also likely be true for women of similar risk.

But as Wells and Eisenberg reported, there seems to be no statistically significant cardioprotective effect of statins for women:

“It is not just that there is no direct evidence of benefit for women, but extrapolation from men to women is statistically inappropriate.”

There was even more jumping to conclusions going on, according to the Future Cardiology paper. These jumps included this interpretation of results from statin studies on secondary prevention:

“Results from these secondary prevention studies were used to support statin use in primary prevention, even though the risk profiles for women in the two groups obviously differ.”

Perhaps physicians need to rethink what might seem a knee jerk practice of pulling out a prescription pad to prevent heart disease – at least until we get robust evidence of statin benefits in primary prevention – particularly among healthy women.

And traditionally, as Wells and Eisenberg remind us, the scientific burden of proof of benefit is on the proponent of the treatment.

 © 2014 Carolyn Thomas  ~  Heart Sisters – http://www.myheartsisters.org

(1) Theodore Eisenberg, Martin T. Wells. “Statins, Cholesterol, Women and Primary Prevention: Evidence-Based Medicine or Wishful Thinking?” Future Cardiology.  2009;5(1):1-4.
(2) Huseyin Naci, John P A Ioannidis. Comparative effectiveness of exercise and drug interventions on mortality outcomes. BMJ 2013;347:f5577 

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DISCLAIMER:

Please remember to discuss your own health issues with your physician. Do not stop taking any prescription drugs based on what you read here or anywhere else. For excellent decision-making resources, discuss with your doctor either Mayo Clinic’s Statin Choice Decision Aid, or the Therapeutics Education Collaboration’s Cardiovascular Disease Risk/Benefit Calculator, or the excellent independent site The NNT.

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 Q:  What have you and your doctors decided about statins?

See also:

* from my other site, The Ethical Nag: Marketing Ethics for the Easily Swayed

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8 Responses to “Women and statins: evidence-based medicine or wishful thinking?”

  1. Jane August 28, 2015 at 4:47 pm #

    I took one 10 mg Lipitor (brand) today. First time. I appreciate reading “Gill’s” comment as it is, as you know, nearly impossible to find comments from people that find medication helpful. I admit, however, that I am somewhat suspicious of Gill’s comment – wondering if this isn’t a comment made to advance the use of statins.

    I notice an exacerbation of tinnitus. I had a mild headache for the first few hours after I took the Lipitor. But, mostly, what I find I’m weighing is this: if after tremendous reluctance to take the Lipitor for my high cholesterol (quite probably familial), and triglyceride levels, coronary artery disease, and increasing shortness of breath, should I take it as a clue that maybe I should allow the blasted angiogram and subsequent “fixes.”

    I don’t know that I will take a second Lipitor. The atenolol 12.5 mg I take once a day, seems to have negative effects without adding another drug. Bottom line – this all stinks, especially given the abhorrent lack of information provided by cardiologists, even when they are asked.

    Like

    • Carolyn Thomas August 28, 2015 at 7:40 pm #

      Jane, I’m confused by your conflicting opinions of Gill’s comments (below) because you say both that you appreciated her well-informed personal decision to take statins while at the same time saying you’re “suspicious” of the same person for “advancing the use of statins”. Also, it is not true at all that it’s “nearly impossible to find people that find medication helpful”. In fact, there are millions of people who take prescription meds (including statins) because they do indeed believe them to be helpful. So, again – confusing.

      It is the choice of every informed patient to take or not to take any drug. Ideally, have a fulsome discussion with your own doctor to help with such choices. Do your homework. Educate yourself. And if you ever meet a cardiologist providing an “abhorrent lack of information even when asked”, why not immediately seek another medical professional?

      Like

  2. Gill January 2, 2015 at 2:05 pm #

    I am 51 with as yet undiagnosed heart problems, weeks of chest pains and other symptoms, 2 ambulance trips to Accident and Emergency due to abnormal and unstable ECG, including first being sent home with diagnosis of acid reflux, then next time a stay overnight in the cardiac ward. Awaiting angiogram and results of echocardiogram.

    I love your blog, in particular the section about why women don’t report heart symptoms, so I am not the only one with classic heart attack symptoms who did not go to the doctor for weeks because the family or work took priority. Stupid me. I now know that even if I had gone a couple of hours later they could have detected troponin in the blood.

    Anyway, back to statins. I am now on a low dose of statins along with blood pressure tablets, calcium channel blockers, and aspirin.

    In the UK there is an organisation called NICE which reviews the effectiveness of all drugs before they can be used. Their web site includes detailed data on the effectiveness of statins. I was very concerned after all the recent bad press on statins, but decided, after reading the NICE website, that on balance they would be beneficial.

    I am happy that this is right for me. My blood cholesterol is normal, but anything which controls it won’t do harm per se, and anyway it is the cholesterol stuck to the artery walls that is the problem, not the stuff floating around.

    There is a tiny risk of diabetes, but I will try to mitigate this with healthy diet and exercise. My family has no history of diabetes but strong history of cardiovascular disease, so I think the reduced risk of stroke and heart disease outweighs the risk of diabetes for me.

    One thing I have changed. After my second visit to A&E, I was told to take the statins in the evening, and I make sure I take the aspirin and bp tablets after breakfast. Before this I took them in one big handful when I got out of bed, probably causing indigestion and all sorts. I did notice some discomfort in calf muscles but this was minor and has now stopped.

    I would like to comment that although heart disease or cholesterol levels CAN be reduced with exercise and good diet, this does not mean that you should not take statins. I think it is better to do both, i.e take the statins AND eat healthily and exercise.

    Like

    • Carolyn Thomas January 2, 2015 at 2:36 pm #

      Hi Gill,
      It’s a pleasure to hear from such a well-informed reader! You seem to have done your homework, considered both individual risks and benefits, and, in partnership with a medical team, made a thoughtful decision that works for you – particularly important when you have both a family history and recent frightening episodes of potential cardiac issues. Best of luck to you in solving the medical mystery…

      Like

  3. Elizabeth Y., RN, BSN December 15, 2014 at 5:18 am #

    I think the percentage of people, men and women, who do not tolerate statins is much higher. It’s either that or we all read the same material and comment. Last time I was told that “You must be on a statin.” I replied with “You must try to walk a mile in my shoes.”

    I have since gained back the weight (+) I lost when I went off the statin, in order to placate my Cardio team. I simply can’t move more than I have to to keep my job, so exercise is out.

    Thanks for this article Carolyn; you always seem to know what I am struggling with at the time.

    Like

    • Carolyn Thomas December 15, 2014 at 6:27 am #

      Hello Elizabeth – you may be right about tolerating statin side effects, described by Dr. David Newman as “less publicized than benefits, but well-documented.”

      Since 2004, Dr. Beatrice Golomb and her colleagues at the University of California San Diego have been compiling information on statin-related side effects which can include memory loss, aggressive mood behaviours, muscle problems and weakness which can affect patients’ ability to undertake proven heart-protective exercise programs. Their research has estimated that, although clinical trials may report 1 to 7% of patients experience adverse drug reactions, the number of adverse reactions with statin use may be closer to 15%.

      Like

  4. Barbara Keddy December 14, 2014 at 3:18 pm #

    This blog is so relevant to me right now. For almost two years I took Lipitor until I developed statin myopathy and could barely walk. I came off of it for two weeks and could walk again! I was so relieved.

    I have now been on Simvastatin 10 mgs for two weeks and just now beginning to feel the digestive side effects and some insomnia. It is a low dose but I asked him to “go low, go slow” and he agreed. I will have my cholesterol checked in four more weeks.

    Now I am faced with the dilemma:
    I want to come off statins altogether. Of course my family physician is completely against the idea since I have had a heart attack and a stent. I know you have written elsewhere that there is strong evidence to support taking a statin to prevent a second attack.

    This has been such a difficult journey for me. If I do come off completely, it won’t be a decision I have made lightly. Unfortunately no one can make it for me. I have spoken to the nurse practitioner at the Cardiac Unit, my pharmacist and family physician and they are all adamant I must stay on one. I understand their position.

    However, I am convinced statins are toxic, dreadful drugs with terrible side effects.

    I think 10-20 years from now evidence-based research will show they were not as effective at secondary prevention as once thought…

    Like

    • Carolyn Thomas December 14, 2014 at 3:47 pm #

      Such good points, Barbara – and each of them valid, particularly if you’re among the identified patients who cannot tolerate statins. What do your “adamant” health care providers recommend for their patients who find themselves in this minority? Stay on statins no matter what? This decision is ultimately up to the patient, with input from all your health care providers whose opinions you have considered carefully. Best of luck in choosing the path that works for you.

      Like

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