Women at greater risk for side effects when taking statin drugs for cholesterol

9 Oct

by Carolyn Thomas  @HeartSisters

Statins are the largest selling class of prescription drugs on earth, and account for over 40% of all heart  medications. Lipitor, for example, at over $26 billion in global sales, was the world’s biggest selling drug, manufactured by the world’s biggest drug company, Pfizer.

Because of their effectiveness in managing cholesterol levels, statins are often prescribed to lower total cholesterol in the belief that lower numbers will mean fewer heart attacks. Most people who are prescribed statins are healthy people who don’t have heart disease but who simply have high cholesterol. They will take these drugs for the rest of their lives, making statins a dream drug for the pharmaceutical companies that make them.

For some people, the side effects of statins can include:

  • Muscle pain – can also feel like weakness or extreme fatigue especially on exertion
  • Liver damage – get a liver function test six weeks after starting statins, and then every 3-6 months afterwards, especially if your dosage has increased
  • Digestive problems – nausea, diarrhea, or constipation may be reduced if you take the statin in the evening with a meal
  • Rash or flushing – particularly common if you’re taking the statin Simcor, or a combination of a statin plus niacin; try taking an aspirin before taking your statins
  • Neurological side effects – the jury’s still out on this possibility; some researchers suspect that memory loss may be linked to statin use
  • Mood disorders and violent or aggressive behaviour – you won’t find these mentioned on the drug company’s package inserts, but researchers have found associations between aggressive behaviour and statin use that were not reported in clinical trials. This research* found that some statin users who had mood and memory problems also had muscle problems and weakness, which would affect their ability to undertake proven heart-protective exercise programs.
  • As much as a 48% higher risk of diabetes (particularly in middle-aged or older women)

NOTE: See your physician immediately to report any of these symptoms.

The rationale for prescribing statin drugs, according to Dr. Harriet Rosenberg‘s report called Evidence For Caution: Women and Statin Use for the Canadian Women’s Health Network, is based on something called the cholesterol hypothesis.

This theory argues that drugs that lower total cholesterol or LDL cholesterol (often called “bad” cholesterol) or raise HDL (“good”) cholesterol will prevent heart disease. Measurements of these improved levels is called a surrogate or intermediate endpoint, which is different from the measurement of the more important primary or hard endpoints of decreased heart disease or death – since that’s the whole point of taking a statin drug every day for the rest of your natural life. Dr. Rosenberg explains:

“Having high LDL cholesterol is often thought of as a virtual disease state in itself. However, cholesterol performs many vital functions in the body: it maintains cell wall structure, is crucial for hormone and Vitamin D synthesis, bile salt production and digestion, brain and neuron function. It is critical in fetal development and is an essential component of breast milk.”

She also cites one of the most in-depth reviews of women and statin trials, undertaken in 2004 by researchers Walsh and Pignone. They evaluated data from every significant clinical trial about women and cholesterol-lowering drugs (both statins and non-statin drugs). After reviewing over 1,500 articles, they concluded that for women without heart disease, lowering cholesterol does not reduce the death rate from heart disease or the overall death rate. They also noted that there is not enough evidence to know if events such as non-fatal heart attacks or strokes are reduced.

Dr. Rosenberg refers to further analysis by researchers at the Therapeutics Initiative at the University of British Columbia, who studied 10,990 women; these researchers also found no evidence that statin therapy reduced coronary events in women without heart disease. Reserchers reported:

“The coronary benefit (of statins) in primary prevention trials appears to be limited to men.”

In addition, an overview in the medical journal The Lancet (2007) also emphasized that there has never been a single clinical trial showing that statin therapy is beneficial for women who don’t already have heart disease or diabetes.

Researchers question the evidence base for guidelines promoting statin use for this large population of women (75% of women statin users do not have heart disease) which is based on research which even the guideline authors say is “generally lacking” for women and extrapolated from men’s results.

Dr. Shah Ebrahim, a professor of public health at the U.K.’s London School of Hygiene and Tropical Medicine agrees. He and his team analyzed 14 drug trials dating from 1994 to 2006 that involved a total of 34,272 patients taking statin drugs, the majority of whom had no history of heart disease. This review was prepared by the Cochrane Collaboration — an international network that collects the best available evidence at the time and summarizes it for doctors. Dr. Ebrahim’s conclusions?

“Prescribing statins to people at low risk of heart attack – for example, middle-aged women with no major risk factors other than a modest elevation in cholesterol – is both wasting money and exposing people to potential adverse effects.”

But for women who already have pre-existing heart problems, statin use according to the survey by Walsh and Pignone, has been shown to reduce coronary events and coronary death.

But they don’t reduce deaths overall, according to Dr. Beatrice Golomb*, a professor of medicine at the University of California, San Diego. She told Time magazine interviewers last March:
“Any reduction in death from heart disease seen in the data has been completely offset by deaths from other causes.”

Since 2004, Dr. Golomb and her colleagues have been compiling information on statin-related problems, including memory loss, mood disorders and violent or aggressive behaviour. Their work has found associations between aggressive behaviour and statin use not seen in clinical trials. This research found that some statin users who had mood and memory problems also had muscle problems and weakness, which would affect their ability to undertake proven heart-protective exercise programs.

Their research has also estimated that, while clinical trials may report that only 1-7% of all statin patients experience adverse drug reactions, the number of adverse reactions with statin use may actually be closer to 15%.

So you might wonder:  if statins do not help prolong women’s lives, why are so many women taking them?

And who’s most at risk for developing side effects?

Not everyone who takes a statin drug will have side effects, of course, but some may be at greater risk than others. Risk factors include:

  • taking multiple medications to lower your cholesterol
  • being a female
  • having a smaller body frame
  • being age 65 and older
  • having kidney or liver disease
  • having type 1 or 2 diabetes

For more useful information about intermediate (surrogate) endpoints in clinical research, read Your Health, Ball Possession, and the World Cup.

See also:

.

* Rosenberg H. “Women and statin use: a women’s health advocacy perspective”.  Scandinavian Cardiovascular Journal. 2008 Aug;42(4):268-73.

** Criqui MH and Golomb BA 2004. “Low and lowered cholesterol and total mortality.” Journal of the American College of Cardiology 44(5): 1009-10.

WARNING:  Do not start or stop any prescription drug without consulting your own physician.

7 Responses to “Women at greater risk for side effects when taking statin drugs for cholesterol”

  1. JustMEinT Musings August 4, 2013 at 11:31 pm #

    Reblogged this on Just ME in T's Health Stuff and commented:
    “Time more information like this was circulated to those who are being pressured to taking statin medications”

    Like this

  2. Cheryl July 10, 2012 at 4:06 pm #

    I want to stop taking pravastatin; the side effects are awful! I want my health back… I have high cholesterol (over 230) but the other numbers are good (HDL/LDL/trig).. I am looking for alternatives so I can get back into feeling healthy again!! Any ideas?

    Thanks!! Love this website too!

    Like this

    • Carolyn Thomas July 10, 2012 at 9:08 pm #

      Hello Cheryl,
      Nobody should continue to live with “awful” side effects. Please report your side effects to your physician and request an alternative treatment option.

      Like this

  3. R.W.T. April 15, 2011 at 5:11 am #

    I stopped taking Pravastatin cold-turkey after a series of unpleasant side effects manifested: muscle pain, severe exhaustion, weakness and general malaise, skin rash, insomnia. My cholesterol wasn’t high to begin with, I had to assume that the only reason it had been prescribed was because it’s part of the “protocol.” It’s unfortunate that the only “solutions” they can devise for individual problems and/or drug reactions is to replace one drug with another. I’m now on the fourth new drug regimen in less than six months,

    Like this

  4. Scandia December 8, 2010 at 3:03 pm #

    Thanks for this clear overview on this controversial topic. My PCP is really pushing me to go onto statins but I’ve read a number of sources like this one from Mayo Clinic that have made me doubt the wisdom of these blanket recommendations for statins, given that my cholesterol numbers are good! Just read of a new Johns Hopkins study this morning that questioned the JUPITER results raving about statin benefits in lowering CRP levels. Who knows who to believe? When studies are funded by drug companies?

    Like this

  5. HK Cleaver December 4, 2010 at 5:16 am #

    Thanks for this. I’ve been reading more and more about the other side of statin drugs especially for women. I will pass this on to my friends. I love your website!

    Like this

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