Have YOU Experienced Side Effects of Statin Drugs?

Have YOU Experienced Side Effects from a Statin Drug?One of the biggest questions facing clinical cardiology today is the decision on when to treat healthy people with statin drugs. Data from randomized clinical trials show that such treatment may be beneficial for individuals with high risk of developing cardiovascular disease. However, statins are not without side effects, therefore we have to be sure that the risk of harm does not outweigh the presumed benefits.

Statins lower blood cholesterol. They also appear to have a few other effects which may be beneficial for people with established cardiovascular disease. Randomized clinical trials have shown that statins reduce the risk of death and new cardiovascular events among individuals with coronary heart disease. Not prescribing statins to people who may benefit from such therapy is considered bad medical practice, unless the patient is intolerant to statin treatment.

If implemented, the 2013 ACC/AHA guidelines on primary prevention will lead to a much higher number of healthy individuals receiving statin therapy. In fact, more than 70 percent of people older than 60 years may become eligible for such treatment. The major criticisms of the guidelines as they pertain to statins are concerns about adverse effects and lack of benefit on total mortality

Today, everybody should know that statins have side effects. Although most are relatively benign, serious life threatening adverse events have been reported. Such side effects are rare, but they are a cause for concern if millions of healthy people are to be treated with these drugs.

How Common Are Side Effects of Statins?

The 2013 ACC/AHA recommendations on statins for healthy individuals mainly rely on evidence from meta-analyses of randomized clinical trials.  Part of the recommendations are based on risk calculation, assuming that when a certain amount of risk is present, the benefit of therapy outweighs the potential harm. However, there are some important questions remaining unanswered such as: How common are side effects from statins in real life, and does the current scientific literature provide reliable data to answer this question?

Recently a study was published in The European Journal of Preventive Cardiology addressing the side effects of statins compared with placebo among more than 80 thousand patients participating in randomized clinical trials of statins. Interestingly, apart from a slightly increased risk of diabetes and mild elevation of liver enzymes, side effects were not more common among patients receiving statins compared with those on placebo. The results have received a lot of media attention with headlines like: ‘Statins have virtually no side effects, study finds’. The Telegraph reports:

Researchers at Imperial College looked back at 29 trials involving more than 80,000 patients taking the cholesterol lowering drugs.

They concluded that the chance of experiencing debilitating symptoms like nausea and fatigue was slightly less among people taking statins than for control groups given a placebo. Now the scientists are calling for drug companies to make it clear on packets that side effects are uncommon so that people are not wrongly dissuaded from treatment.

Around seven million people take statins in Britain, a figure that could rise to 12 million under draft NHS guidelines, currently out for consultation, which will advise the majority of men over 50 and women over 60 to take the drug as a precaution.

Health experts have voiced concerns that the side effects could outweigh the benefits for healthy people.

One of the authors of the paper, Dr. Ben Goldacre has commented on the media reports on his website, Bad Science:

I was surprised to see a study I’m co-author on getting some front page media play today, under the headline “Statins have no side effects”. That’s not what our paper found…

Remarkably, people report typical statin side effects even when they are only receiving placebo: the phenomenon of people getting unpleasant symptoms simply because they expect to is fairly well documented, and it’s called the nocebo effect…

Assessing side effects of statins by using data from randomized clinical trials testing the efficacy of these drugs is problematic in many ways. First, these studies are not designed to study side effects. Second, methods used to detect and assess side effects are not defined. Third, sponsors of clinical trials may have limited interest in searching for potential side effects. Fourth, there is selection bias. Patients selected for participation in clinical trials have to fulfill certain criteria and therefore very often don’t reflect a “real life” patient population. Patients not eligible for clinical trials are often sicker, have more kidney failure, diabetes and high blood pressure. These individuals may have higher risk of side effects from statins. Fifth, many trials have placebo run-in periods to test compliance. This may further select highly motivated patents who are less likely to report side effects.

Dr. Ben Goldacre underlines the importance of having access to the Clinical Study Report (CSR) of a trial. Let me quote him:

These are very long and detailed documents that give a huge amount of detail about the methods and results of a trial, and they’re important, because methodological flaws can often be glossed over in the brief report on a clinical trial that appears as an academic journal paper.

I’d like to repeat the study, using the CSRs on the trials as the source data on the side effects, rather than the academic journal papers. That is a big piece of work because companies generally refuse to share CSRs…

What Are the Most Common Side Effects of Statins?

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Have YOU Experienced Side Effects from a Statin Drug?

Liver and muscle problems are the most common side effects of statin therapy. Liver tests are usually monitored and the drug is stopped if there are significant abnormalities. Muscle ache is common. Muscle damage can occur and in rare cases it may become serious.There appears to be increased risk of diabetes on statin therapy. Some studies have reported changes in memory, attention, or concentration on statins.

There are some reports on changes in mood on statins.  These include loss of interest in activities and loss of interest in social involvement. Studies have confirmed that peripheral neuropathy (tingling and numbness or burning pain) may occur with statins. Sleep problems, sexual function problems, fatigue, dizziness and a sense of detachment are also reported with these drugs.

Have YOU Experienced Side Effects from a Statin Drug?

It is of huge importance for clinicians and patients to have access to reliable information on the risk of side effects of statins. As doctors, we don’t want to inflict harm to our patients. On the other hand, the risk of side effects from statin therapy appears small. Therefore doctors can also inflict harm to their patients by exaggerating potential side effects which might lead to a patients unwillingness to accept treatment that is of potential benefit. Recently, Rory Collins, a Professor of Medicine and Epidemiology at the University of Oxford was quoted in the Guardian saying that:

Doctors worrying about the safety of cholesterol-reducing statins are creating a misleading level of uncertainty that could lead to at the loss of lives…

On the other hand, rare side effects may become important when treatment is given to a large proportion of the population. We’ve recently had patients at our hospital with severe breakdown of skeletal muscle (rhabdomyolysis) resulting in serious kidney failure that appears to be directly associate with treatment with statin drugs.

There’s no doubt that a large majority of individuals taking statins don’t experience any problems with the drugs. However, a substantial number of people experience side effects. I fear these side effects are more common and sometimes more serious than the results from randomized clinical trials have suggested.

People who have experienced side effects often feel that they are not listened to. Many of these side effects are never reported. If you have any experience from statins, good or bad, no matter whether you are a patient, a medical professional or just a medical geek, here might be a good place to tell your story.

Comments

  1. peter hawkins says

    Two months ago i had an arterial occlusion at age 62.. Other than that, I’m in great shape: no history, exercise daily, never smoked, not overweight, et al. It was easy to notice the side effects of the statin @ 80 mg. atorvastatin: a dark cloud, constant case of the runs, body aches. Cutting the dose to 20 mg. the side effects lessened proportionally. Switching to Crestor @ 10 mgs., the body aches increased. My choice is now, which of the alternative side effects are more bearable. Or, at what point do I simply stop taking this stuff?

    • Axel F Sigurdsson says

      Peter
      Muscle ache is the most commonly experienced side effect of statins. Lowering the dose is sometimes helpful but not always. Changing to another statin drug may sometimes help as well. In my experience, muscle pain is the most common reason why people have to stop taking statins.
      Thanks for sharing your experience.

  2. says

    1. Severe leg cramps.
    2. Weakness.
    3. Unsteadiness,fear of falling.
    4. Memory problems,brain fog.
    5. Problems concentrating.
    6. Irritability.
    7. Dizziness when leaning over and standing back up.
    8. Disorientation. The scariest episode of this occurred in a grocery store. I could see where I was but could no longer tell which direction I was facing. This only lasted a few seconds,but it happened several other times out in the yard.
    9 Wounds healing slowly.
    Needless to say I’ve stopped hateastatin against Dr’s orders and refuse to take them again.
    Dr. Wanted me to take Crestor next,which I find outrageous. It was as if she did not even read my complaint list! Anyone who thinks these things have no side effects and are harmless is out of their blooming mind.
    I’m on a hflc regiment now. And have not seen the Dr. in a year.

    • Axel F Sigurdsson says

      @ thehomeschoolingdoctor

      That’s a good question. In theory CoQ10 might reverse some of the side effects of statins. Some researchers have proposed that taking a coenzyme Q10 supplement might reduce the risk of these side effects. However, no large studies have confirmed this theory.

      There are mixed reports on the benefits of CoQ10 in helping statin-associated muscle pain. Most reviews highlight the lack of evidence to support routine CoQ10 supplementation even though there are few safety concerns with such supplementation. I have very limited experience myself with CoQ10 in the context of statin side effects but it seems that more research data is needed to clarify the issue.

  3. charles grashow says

    I take 10mgs Atorvastatin/day. NO side effects at all. BUT – I also take, among other things, 200mgs CoQ10/day.

    @Peter – why would your doctor put you on such a high dose of Atorvastatin? What were your lipids like? TC, LDL-C, HDH-C, Triglycerides, etc.

    Are you and Daci aware that some of the statins are derived from mold. If you have an allergy to mold/yeast you may be experiencing side effects from the allergy.

    • Axel F Sigurdsson says

      Charles.

      Some studies have indicated that higher dose statin therapy is more effective than lower dose therapy in patients with coronary disease. That’s why 80 mg daily of Atorvastatin is often prescribed for example following an acute myocardial infarction (acute coronary occlusion).

      However, higher dose statins are associated with statistically significantly increased risks of muscle pain and abnormal liver function tests compared to lower dose statins

  4. comedy79 says

    I was put on Krestor about 10 years ago, and suffered serious muscle pain. I couldn’t hang out a load of washing or make the bed without suffering serious muscle pain similar to over-use pain. We stopped that, and my doctor put me on Lipidil, which sent me to the brink of total kidney failure. So she said she’d find me something else to take, but I told her not to bother, because I wouldn’t take it. I’ve since moved to a very low carb/ultra high fat diet and my triglycerides and HDL are brilliant, while my LDL is high but because the particle sizes are large. My doctor is happy with my biannual cholesterol panels.

    And I’ve also read, in several places, that statins provide no benefits to women whatsoever.

  5. charles grashow says

    “while my LDL is high but because the particle sizes are large”

    Do you have test results – NMR/VAP – that show your LDL particles are large?

  6. charles grashow says

    @Axel

    re the study you referenced

    “In closing, the current literature does prove conclusively that higher dose statin therapy (for example, 80 mg of simvastatin or atorvastatin) in patients with established CAD provides incremental benefits over and above those expected with lower dose statin therapy; however, this literature is insufficient to define optimal LDL targets in these patients. Secondary analyses of the existing randomized trial data using individual patient data and multivariate adjustment will be needed to appropriately examine the incremental benefits of different LDL targets (Hayward 2006), and future trials will have to determine whether lower dose statin therapy plus other lipid lowering agents may achieve better LDL levels and clinical outcomes than maximal dose statin therapy. Indeed, further research is needed to conclusively establish whether the benefits associated with statin treatment are determined by the LDL level achieved, the percent reduction in LDL, the absolute reduction in LDL, or the dose of the statin. Based on the current evidence base, the use of higher dose statin therapy should be restricted to patients with established CAD at this time.”

    Doesn’t prove that high dose statins are necessary.

  7. NateS says

    What they’ve done to me:

    Range of Motion: He shows decreased range of motion of supination
    bilaterally. He has adduction of the thumbs bilaterally. His hip
    abduction is 20 degrees on the right, 18 on the left. Straight leg raise
    is 45 degrees bilaterally. On the mat, he is unable to achieve neutral and
    remains in external rotation. His internal rotation is 0 degrees on the
    left that was on the right the previous. His dorsiflexion lacks 12 degrees
    on the right and 11 degrees on the left.

    Strengths: Hip abduction is 4- bilaterally. Hip extension is 4 on the
    right, 4- on the left. Knee flexion is 3+ bilaterally. Knee extension is
    5. He has increased pain with core activation and has difficulty
    maintaining pelvic tilt to bend and straighten his lower extremities.
    Sensation: Light touch and proprioception are intact. Vibration is absent
    at the lower extremities.

    Posture: He has kyphotic posture with forward head and a flattened lumbar
    spine. He is wearing a back brace.

    Skin: His feet are cold to touch. He has minimal ankle edema. His feet
    are purple in color. His toes are curled. His nails are thickened. His
    lower extremities are hairless. He sees a podiatrist regularly.

    Postural Control: Sitting balance is intact. Forward reach is 2 inch with
    immediate rapid stepping strategies for recovery and discomfort. “I feel
    like I’ll fall on my face.” He active weight shift show very minimal
    posterior excursion. He shows no anterior excursion. He is unable to
    shift his weight forward and bends his knees “I forgot how”I cannot”. In
    induced weight shifts he has increased hip strategies, but no stepping
    strategies. He was unable to balance on his heels or his toes.

    Modified Clinical Tests Of Sensory Integration And Balance: He stood for
    30 seconds with fair quality in a forward bent position with eyes open on
    firm, with eyes closed, he stood for 30 seconds with fair quality and
    increased sway. He required maximum assistance to step onto a foam surface
    and had knee buckling on attempting to step onto the foam.

    Sharpened Romberg: He required moderate assistance with handheld to assume
    sharpened Romberg bilaterally. He was unable to maintain.
    He required moderate assistance with handheld to assume single leg stance
    bilaterally and is unable to maintain.

    Dynamic balance: He ambulates with or without the straight cane and he has
    toe out and shuffling with bilateral Trendelenburg, no trunk rotation. He
    has decreased control on stand to sit transitions. His timed stands for 5
    repetitions was 15.29 and required the use of bilateral upper extremities.
    The timed up and go for 3 meters was 15.19 which is well outside of the
    range of normal and indicates increased fall risk. He showed loss of
    balance on turns. Up and go cognitive was 16.87. He was accurate, but
    showed total loss of balance with turns requiring assistance to recover.

    The activities specific balance scale was completed, his score was 35.63
    which indicates significant decreased confidence and fear of falling. He
    waso, least confident in bending to pick up an object from the floor standing
    on a chair, standing on his tip toes, sweeping the floor, walking on a ramp
    in a crowded area or on an often escalator without upper extremity
    assistance as well as on icy sidewalk. He also reported difficulty with
    stepping on and off and escalator.

  8. nico says

    Simvastatin 40mg/day three months later anxiety , memory loss , mood swings , anger , psychosis , aches , stiffness and general feeling of being unwell. Fortunately most of these side effects have now stopped or improved vastly since i stopped taking Statins . For me Statins have been a very scary dark experience.

  9. says

    My husband had when he was placed on a statin and after only seven weeks he developed rhabdomyolysis, acute renal failure, then stroke. The ONLY reason his doctor put his on a statin was because of a family history. This was in 2002. While on a statin he had terrible nightmares, impotence, confusion, muscle pain…. Since then he has made great progress but has some residual problems with widespread pain, cognitive changes to name a few. I have read so much information in the last 11 years which contradicts everything I thought I knew about cardiovascular risk. In addition we have had an enormous struggle for 3 years with ACC our compulsory insurance company in New Zealand. Further information about our struggle is in the following link to a website about adverse reactions to medications. I am happy to answer any questions you may have. nzstatinalert@gmail.com

    Heres the link:
    http://wp.rxisk.org/the-legacy-effects-of-statins-a-role-for-rxisk/

  10. Dolores G says

    I took 10mg of simvastatin for 1 year and 8 months while I tried to clean up my lifestyle by eating a low-fat, low-calorie diet and strenuously exercising 5-6 hours per week. I had always had muscle cramps in my legs and feet at night especially after a lot of physical activity, so I wasn’t too worried about the additional cramping that the statin and exercise caused. Months later, I started having serious muscle and joint pain in places that I never had pain before: Gout-like pain in my big toe and pain that shot up the side of my neck and into my head. A year after starting the statin, I started having shortness of breath. This was really odd because by then I was in the best physical shape of my life despite the pain. After various tests on my heart and lungs two times, a lung doctor thought I had asthma though there were no triggers and the medication didn’t help. Now I’m pre-diabetic and have diastolic dysfunction and peripheral neuropathy. I cannot exercise because of the pain, weakness, fatigue, and shortness of breath. At age 61, I can barely get through my daily, routine activities, and I use a cane if I have to walk more than 50 meters. I was told last year that my back is that of a 85- to 90-year old and I will need surgery for that soon as well as knee replacements and surgery on my hand and foot. The back doctor said that I may have an autoimmune disorder, but a rheumatologist had previously ruled that out. While I didn’t experience any great mental dysfunction from statin use, I can’t focus, concentrate, and recall as well as I used to. This could very well be because the physical effects have been so distracting. I think of my pain, limitations, and “old feeling” almost all the time and wonder how many years are being taken off my life because of that poison. I should find an new primary care doctor, but I’m afraid that he or she will want me to have more tests and take more drugs. I’ve become very discouraged and distrustful of the entire medical establishment especially when they talk about giving statins to people who are much healthier than I and downplay the side effects.

    As a side note, I started taking CoQ10 soon after I stopped taking the statin, up to 1200mg per day, but that hasn’t seemed to help although I continue to take it. A calcium citrate/magnesium supplement taken every day helps me with the night-time cramping though.

    Thank you for asking this important question, Doctor! I’ve been suffering for over 2 and a half years since quitting the drug with hardly any relief.

    • Peter Hawkins says

      Dolores G. In reading your reply I just took my Atorvastatin and threw it out. I’ve been on it for 3 months. Whatever good immediate effect it may have had, that period is over. I’m 62 and am an athlete. I’m noticing the very beginning symptoms of many of the issues you discuss. It’s easy to blame other things until I read your response. Thank you for sharing this valuable, life saving information.
      Peter

  11. JustMEinT says

    Axel…. in the year 2001 after cardiac stenting I was placed on a multiplicity of ‘heart healthy’ drugs and went down in a physical heap almost immediately. Tests were run and nothing was found and NO BLAME was ever ascribed to cholesterol lowering medication. I was placed on statins and triglyceride lowering drugs, and they were changed several times by my cardiologist to try and get my ‘numbers’ lower etc. The drugs did not work and I went from being a normal healthy 47 year old to almost a complete invalid – including memory and speech issues almost overnight.

    I am fortunate that I have a brain which likes to read and research and I took myself off these drugs with some – NOT ALL – issues resolving. It took over six years and a diabetes diagnosis before I learned that many things tied in together. The vascular damage I had suffered via lifestyle choices (food etc) could be controlled via LCHF living. NO DOCTOR ever discussed this with me – all that was ever offered were more and more and yet even more drugs. Can you blame patients for wanting to take control of their own health Axel? The drugs which are prescribed do not cure, they do not fix….. they are ‘band-aid’ treatments at best, and at worst can and do inflict worse damage on some patients.

    There are many thousands of us who are victims of these drugs and the care-not attitudes of medical practitioners who prescribe STATINS to all and sundry ‘just in case’……. I am a victim of ‘just in case’ or ‘perhaps it may help’ or ‘the government says you must take these’ medicines and am permanently damaged!

    I get very angry when I read headlines stating it is all in my mind!

  12. says

    david venables March 31, 2014
    I took simvastatin for seven short months, 20 mg. I stopped when my lower legs utterly locked up in bed one night. I now have what appears to be a lifetime neuromuscular disease. STATINS CAN HAVE HORRID ADVERSE EFFECTS. Here are some good predictors of who will get their lives destroyed, as I have:

    High HDLs, high LDLs, BUT great ratio (mine was under 3)
    Low triglycerides, high HDL’s, great ratio (mine was under .7)
    Physically very active.
    Older (I was 68 and had just returned from trekking in the Himalayan foothills.)

    One aspect of the massive statin drugging of our population is who might benefit. But that’s only half the story.
    The other, and massively ignored aspect, is who will have their health destroyed: constant burning pain, muscle fasciculations, shocking atrophy, inability to walk or stand for more than 15-20 minutes. In spite of the fact that one of our nation’s astronauts and flight surgeons was trashed by statins, prescribing doctors deny these adverse effects and refuse to report occurrences.
    In my case, when I asked, before taking statins, about LDL-P and Apo B, I was told “the science isn’t there yet”. Two separate doctors said the following exact words, “Some people think statins should be in the water supply. Statins are the reason Americans live longer now.” I got an incredibly hard sell on statins. It doesn’t matter to me at this point that the doctors who were selling were also on the drug themselves. The possible adverse effects are horrendous, and although they didn’t get them, I and thousands of others did. I haven’t read of anyone who’s recovered after a year or two, which is where I now am.

  13. Nern says

    Started taking 20mg Lipitor at the age of 46. Total cholesterol was about 275. Script was mainly due to a family history of heart disease. After several years, I started to develop quite a few aches and pains in my legs and ankles. This was very noticeable especially rising in the morning. A bit further in time, I started to notice that I was losing grip strength in my hands. After countless EMGs, MRIs, lumbar punctures, blood tests and a muscle biopsy, it was determined that I have sporadic Inclusion Body Myositis (sIBM). I stopped taking my statin at the recommendation of a Dr from the US National Institutes of Health. I now get IVIG infusions 3 times/month in effort to slow the progression of the IBM. The prognosis is that I will eventually end up in a wheel-chair. While the sIBM will not kill me, it will deteriorate the quality of my life as I grow older.

    While I have no proof that the statins triggered my chronic disease, I have zero doubt in my mind that they are at the root of the problem. My heart goes out to all the yet to be realized victims of the side effects of these drugs. The drug companies say that the collateral damage to people is “acceptable”. I beg to differ.

  14. says

    I am taking this info to my Dr. to help determine why I continue to have sharp debilitating pain in my right thigh. I take the usual 20 mg. of Lipitor. After a fall last Sept. I started seeing a Chiropractor for sciatica on both sides…when I described the pain in my thigh it was diagnosed as “in conjunction” with my low back problem. Now, I’m not so sure. It is April 9th and the sciatica is better but the pain in my thigh continues. I liked reading the experience & tests given by those who had side effects of Lipitor and this info. may help my health care provider help me figure out what is going on with me…it may not be the Lipitor but I’d like to be able to rule that out and get to the reason for my pain.

  15. Kevin O'Connell says

    Rosuvastatin (Crestor 5mg) late 2006-late2011.
    ca. 2008 noticeable ‘sensations’ in my feet, memory lapses, gynecomastia,…
    Of course, it couldn’t have been the rosuvastation because it has no side effects.
    2009 diagnosis of prostate cancer, steadily losing all feeling in soles of feet, memory problems worse,…
    Of course, it couldn’t have been the rosuvastation because it has no side effects.
    2010 diagnosis of peripheral neuropathy
    Of course, it couldn’t have been the rosuvastation because it has no side effects. Consultant neurologist fingered the cordarone (Amiodarone) I had been taking.
    2011 loss of balance, difficulty in walking, worse memory problems, worse gynecomastia, Vitamin D measured – 9ng/ml!! – not, of course, due to CoQ10 depletion from blocking mevalonate pathway, which also, of course, could not have been behind the peripheral neuropathy, nor could it have been down to insufficient cholesterol substrate for D3 manufacture…
    Started to do my own research – immediately added D3 supplement, changed to LCHF mode of eating and rapidly ditched rosuvastatin (+ the other meds I was taking: allopurinol, olmesartan, hydrochlorothiazide – all with initially reluctant acceptance of my doctor). Anticoagulant (last med) finally ditched this year.
    Health generally excellent (vastly superior to 2006-2011), memory lapses resolved, albeit peripheral neuropathy almost certainly irreversible (slight improvement in two years since ditching statin) because of destruction of myelin sheath (Of course, it couldn’t have been the rosuvastation because it has no side effects.)
    I will never, ever knowingly touch another statin (possible exception – if I ever suffer an MI, then maybe, but only maybe, I would consider taking a statin, but only for a very short period).
    I can’t imagine anyone who examines the basic biochemistry of the mevalonate pathway (and the effect of statins on that) doing anything different to what I have done (‘unstatinating’ myself).

  16. charles grashow says

    @Andres – I was taking CoQ10 BEFORE I started taking a statin drug – I just upped the dosage from 100 to 200mgs/day

    @Kevin – I currently take 5000 Vit D3/day – last blood test had level at 46 – I’m trying to get this to between 60-80 so I may increase the dosage to 10,000/day

    My last CT scan – 2/14 – CAC score was 48 – increase from 30 in 1/08 – so progression is slowing

    My goal is regression – per Dr William Davis Track Your Plaque program

    LDL MUST BE <60 for regression to occur – since I will NEVER go on an Ornish type diet statin plus other supplements are the only way IMHO

    your thoughts

  17. Mie says

    Kevin:

    If the fact that statins have side effects came as a surprise to you, perhaps you ought to try reading the package labels. Or if you seriously believe that you can connect your statin use to everything deleterious under the sun that happened to you after starting statin therapy (e.g. cancer), perhaps you should google “post hoc ergo propter hoc”.

    And since statins also have beneficial effects (which, in the population who should be taking statins, clearly outweigh the negative ones), the idea on “unstatinating” should be considered cautiously.

  18. Kevin O'Connell says

    Mie:

    My Latin is not too bad, thanks very much.

    I did read the AZN Crestor leaflet (probably more than my doctor did). In the small print on p15 (of 43!) there is a mention of some ‘very rare’ post-market adverse reactions, including memory loss and gynecomastia. The guff on p5 about CoQ10 is distinctly ‘weasel-worded’. However, like most (almost all?) patients, I was (at that time) relying on my doctors to look after me and warn me of potential problems.

    There is absolutely no mention of either peripheral neuropathy or cancer in the leaflet. That, despite the fact that peripheral neuropathy has been known to be a problem since 2005 (regrettably not by me or my doctors,
    apparently). I informed them of what I found in the ‘Bulletin d’information de Pharmacovigilance de Toulouse’ (that’s the register of adverse reactions maintained by the main CHU – Centre Hospitalier Universitaire – in my
    Midi-Pyrenees region of France. It’s one of the 31 around France that maintain these records).

    There are plenty of references to statins and cancer. Did rosuvastatin cause my PCa? Almost certainly not. Did rosuvastatin make matters worse? Very likely (cf 9ng/ml D3, if nothing else). Even the pre-Vioxx RCTs generally
    showed NO benefit in terms of mortality (fewer CHD & CVD being balanced by more cancers & others).

    Statins HAD beneficial results in quite a few RCTs – those that predated the Vioxx affair when the pharma companies were able to do pretty much as they liked – see for instance de Lorgeril’s book ‘Cholesterol: Mensonges et propagande’ (a new edition is available in English).

    They have consistently failed to show any beneficial effect whatsoever since the partial clean up of RCTs that followed that dismal affair. Further developments (e.g. AbbVie giving up its pathetic legal action against the EMA, to keep its data secret, although I am concerned that their ‘very limited redacrions’ may unnecessarily limit the ‘significant portion of data’ that they will now disclose; GSK’s bribes in China and Poland – revealed just today) must also surely lead to stricter control).

  19. Mie says

    Kevin:

    “In the small print on p15 (of 43!) there is a mention of some ‘very rare’ post-market adverse reactions, including memory loss and gynecomastia. The guff on p5 about CoQ10 is distinctly ‘weasel-worded’. However, like most (almost all?) patients, I was (at that time) relying on my doctors to look after me and warn me of potential problems.”

    If you’ve had a look at these leaflets, they’re always very long – due to the fact that all the possible side effects must be mentioned. As for “weasel-worded”: care to be more specific? You do realize that data on the role of CoQ10 supplementation for people on statins is just slowly building up and is anything but robust?

    “There is absolutely no mention of either peripheral neuropathy or cancer in the leaflet.”

    Back in 2006? Could be. Nowaways, neuropathy is indeed mentioned mentioned as a side effect:

    http://www.drugs.com/sfx/crestor-side-effects.html

    As for cancer, if you have any clinical or epidemiological data indicating that rosuvastatin increases the risk of cancer, please do reference it. I’m not aware of any.

    “Statins HAD beneficial results in quite a few RCTs – those that predated the Vioxx affair when the pharma companies were able to do pretty much as they liked – see for instance de Lorgeril’s book ‘Cholesterol: Mensonges et propagande’ (a new edition is available in English).

    They have consistently failed to show any beneficial effect whatsoever since the partial clean up of RCTs that followed that dismal affair.”

    I’ve heard this often. And I’m still not convinced.

    First of all, yes: most of the major statin trials where statins were compared to placebo were conducted before the mid-2000s. However, if you claim that they where flawed, do show that explicitly – this is the necessary requirement for any kind of meaningful criticism. De Lorgeril sure hasn’t done that up to this date.

    Secondly, more recent trials have compared statins against other statins or then examined their efficacy in more specific patient populations, which of course translates to not-so-signigicant benefits. Yet, studies such as JUPITER (and yes, I’m aware of de Lorgeril’s rather impotent criticism of it) have shown the efficacy in statin vs placebo setting.

  20. Kevin O'Connell says

    CoQ10 – yes, word has been slow getting out, even though we’ve just passed the 25th anniversary of US Patent Application by Brown for Merck to combine CoQ10 with their statin. Patent 4,933,165 was granted in 1990.

    Cancer: a few refs for you:
    Polsky, Brown, Siperstein; Feedback control of cholesterol synthesis…; J.Clin.Invest (1973).
    Ravnskov, McCully, Rosch; The statin low cholesterol cancer conundrum; Q.J.Med (2011).
    Brown, Goldstein,Siperstein; Regulation of cholesterol synthesis in normal and malignant tissue; Fed.Proc. (1973)
    Siperstein; The relationship of cholesterol biosynthesis to cancer; Trans.Am.Clin.Climatol.Assoc (1972).
    Endo; The discovery and development of HMG-CoA reductase inhibitors; Journal of Lipid Research (1992).
    Heber; Nutritional Oncology (chapter 38); Academic Press, Elsevier (2006).

    For the flaws in the trials, see the books: de Lorgeril; Cholesterol and Statins; Thierry Souccar (2014) and, if you can read French, Even; La vérité sur le cholestérol; le cherche midi (2013) – notably chapter 8 and especially the sections on JUPITER.

  21. Mie says

    None of your references is relevant here.

    1) The older references: did you read them? Presuming you did, did you know that

    a) the levels of LDL reduction produced by statins in no way goes beyond

    b) the physiological levels of circulating LDL shown to be optimal in the function of e.g. cholesterol receptors?

    Therefore, would you care to explain in your own words WHAT in these papers suggests that this level of cholesterol reduction could be carcinogenic? Go ahead.

    2) Ravnskov et al is precisely the kind of BS you’d expect of him and his lackeys: epidemiological data indicating associations with cholesterol and cancer (nevermind that his cherry-picked prospective cohorts weren’t powered to inspect the association properly), statistically non-significant finding from a clofibrate trial, cherry-picking incidence data (e.g. calculating 4S and HPS together without ANY regard for adjusting for counfounders) etc. etc.

    3) None of your references is a meta-analysis of statin trials, inspecting the incidence of cancer. These are:

    http://jama.jamanetwork.com/article.aspx?articleid=202141

    http://www.ncbi.nlm.nih.gov/pubmed/19228482

    And I’m sure you can read the results yourself. If anything, statins have been associated (although not very robustly) with LOWER cancer incidence in many cases. Why? Here’s why:

    “Specifically, statins reduce (or block) the activity of the enzyme HMG-CoA reductase and thereby reduce the levels of mevalonate and its associated products. The mevalonate pathway plays a role in cell membrane integrity, cell signaling, protein synthesis, and cell cycle progression, all of which are potential areas of intervention to arrest the cancer process.”

    http://www.cancer.gov/cancertopics/factsheet/prevention/statins

    4) Concerning de Lorgeril: if he has anything else to say about JUPITER than what he already published all the way back in 2006, please summarize it briefly. His criticism was duly answered & shot down by Ridker et al.

  22. Z.M. says

    Mie: “Concerning de Lorgeril: if he has anything else to say about JUPITER than what he already published all the way back in 2006, please summarize it briefly. His criticism was duly answered & shot down by Ridker et al.”

    All Dr. de Lorgeril asks for is for properly conducted trials. BTW, de Lorgeril has more on his website including replies to Dr. Ridker. I more side with de Lorgeril because I can’t get over the premature discontinuation, inconsistent reporting, lack of CVD mortality benefit and uncertain mortality benefits, and obvious conflicts of interest. I don’t buy the explanations given by Ridker.

  23. Kevin O'Connell says

    Mie

    As someone who has suffered (a lot) from statin ‘therapy’, I thought I could make a useful contribution to this debate, especially since I have studied the biochemistry involved.

    However, I don’t have the time or inclination to discuss these matters with a committed statin supporter who has apparently unlimited time for this, and writes under an anonymous moniker of ‘Mie’…

    That made me suspicious and a quick Google revealed your comments (supporting statins and their wondrous wonders) on various sites. Just the first 2 pages of a not very ‘tight’ Google search produced your comments at:
    http://www.abc.net.au (concerning one of their TV programmes that had questioned the cholesterol theory of heart disease and the value of statins)
    http://www.sciencebasedmedicine.org
    http://www.thecholesteroltruth.com
    & two that I occasionally read (I think that’s why I recognized your moniker, thus prompting the Google search):
    http://www.drbriffa.com
    http://www.zoeharcombe.com

    I can only speculate why it is that you pop up all over the internet as soon as someone says anything against statins and/or the cholesterol theory of heart disease, almost as if you received an alert whenever those things are mentioned. How ever do you find the time? I have to earn a living and I also spend what free time I have researching things that might help mitigate or even reverse the ill effects I have suffered. Perhaps you are retired.

  24. Mie says

    Z.M.,

    we’d all want to see more rigorously conducted trials, yes. However, this doesn’t change what I stated above. If you want, please do raise one point which de Lorgeril has added to his initial criticism of JUPITER. The premature discontinuation certainly isn’t valid, unless he has been able to explicitly prove dishonesty/fraud in the decision. As far as the lack of reduction of CVD mortality goes, you do realize that a) this was a trial in primary prevention setting with people who had more or less normal LDL levels and that b) two years is too short a time to show anything solid in this kind of population? Conflict of interest is – at best – of secondary interest, coming into picture only if the study itself justifies considering its role. And I’d be kinda silent about this, considering that de Lorgeril is a member of THINCS :-)

    Having read your statin “criticism” from both Briffa’s blog (where, btw, my posts don’t get published, for some reason … ) and from Carb Sane’s comment section, your refusal to buy the explanation doesn’t strike me as surprising. :-)

  25. Z.M. says

    Mie: “As far as the lack of reduction of CVD mortality goes, you do realize that a) this was a trial in primary prevention setting with people who had more or less normal LDL levels and that b) two years is too short a time to show anything solid in this kind of population?”

    Yes, I do realize those factors as possibilities, but this does not change the fact that a CVD mortality (and CHD mortality) benefit was not shown, and so cannot be claimed. If the trial wasn’t prematurely discontinued, we would have gotten a clearer picture of what cause-specific and overall mortality benefits there were (and toxic effects), if any.

    Mie: “Having read your statin “criticism” from both Briffa’s blog (where, btw, my posts don’t get published, for some reason … ) and from Carb Sane’s comment section, your refusal to buy the explanation doesn’t strike me as surprising.”

    Glad you know how I feel. My views are represented in more detail here – http://diettrialclaims.blogspot.com/

    How many comments have you posted on Dr. Briffa’s blog that were not published? I posted a comment a few days ago and it was never published. First time it happened to me though.

  26. Z.M. says

    Mie: “As far as the lack of reduction of CVD mortality goes, you do realize that a) this was a trial in primary prevention setting with people who had more or less normal LDL levels and that b) two years is too short a time to show anything solid in this kind of population?”

    Yes, I do realize those factors as possibilities, but this does not change the fact that a CVD mortality (and CHD mortality) benefit was not shown, and so cannot be claimed. If the trial wasn’t prematurely discontinued, we would have gotten a clearer picture of what cause-specific and overall mortality benefits there were (and toxic effects), if any.

    Mie: “Having read your statin “criticism” from both Briffa’s blog (where, btw, my posts don’t get published, for some reason … ) and from Carb Sane’s comment section, your refusal to buy the explanation doesn’t strike me as surprising.”

    Glad you know how I feel. My views are represented in more detail here – http://diettrialclaims.blogspot.com/

    How many comments have you posted on Dr. Briffa’s blog that were not published? I posted a comment a few days ago and it was never published. First time it happened to me though.

  27. charles grashow says

    @Z.M
    @Mie

    I too have been banned by Dr. Briffa – seems the good doctor cannot take criticism

Let me know what you think!