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Statin Island

Dr Kailash Chand

Dr Kailash Chand

 

Last Sunday, The Mail on Sunday published an article on ‘the statin deniers’, without, in my view, ascertaining crucial facts. When drug industry-sponsored trials cannot be examined and questioned by independent researchers, science ceases to exist and becomes nothing more than marketing. 

I have been a GP for more than 30 years and prescribed statins with little concern, until I took statins myself for over two years. I developed side-effects including myalgia, backache and sleep disturbance. However, after I stopped taking statins, my symptoms largely disappeared.

Data from Statin Usage USA (1) suggests that up to 20% of statin users have muscle problems. The higher estimate certainly reflects the many patients I saw when I was practising, who are or were miserable when put on statins. It’s instructive to note that pharmaceutical company and manufacturer of Atorvastatin Pfizer’s own patient leaflet states ‘common side-effects that may affect up to one in ten patients include sore throat, nausea, digestive problems, muscle and joint pain.’ Muscle pain and fatigue are not figments of misattribution and public misinformation. They are too prevalent and recurrent in people who desperately want to stay on statins. Rather than discount a widely observed phenomenon, we should ask why there is such a mismatch with reporting in the trials.

Three quarters of people having a first heart attack, for instance, have normal cholesterol levels. According to the World Health Organization (2), 80% of cardiovascular disease is caused by smoking, inactivity, an unhealthy diet, and other lifestyle factors. An independent Norwegian study on women with no pre-existing heart disease found that the lower a woman’s total cholesterol, the greater her risk of dying - of heart disease or indeed anything else! (3)

When drug industry-sponsored trials cannot be questioned by independent researchers, science becomes nothing but marketing

Recently, two groups of researchers in Japan and France independently questioned the reliability of many of the earlier industry-sponsored studies that show the benefit of statins. Japanese researchers even suggest that statins may be a cause of the increasing population burden of heart failure (4), and reputed French cardiologist Dr Michel De Lorgeril’s analysis shows that all studies published after 2006 reveal ‘no benefit’ of statins for cardiovascular prevention in all groups of patients.

But De Lorgeril (5) calls for a full reassessment of all statin studies. He states that 'physicians should be aware that the present claims about the efficacy and safety of statins is not evidence-based.' There is now also a growing body of research that suggests that lowering your cholesterol too much with statins could be linked to an increased risk of other serious health conditions, such as Parkinson’s disease and diabetes.

For the majority of people, statins actually have very little impact on whether you succumb to heart disease, cost us a huge amount of money, create a range of unpleasant side-effects and increase the workload of overworked GPs. Statins give the illusion of protection to many people who would be much better served by simply walking more and avoiding processed food.

The hard fact is that the chance of a statin increasing your likelihood of avoiding a ‘serious vascular event’ such as a heart attack or a stroke is 140:1 - that is, if you’re healthy with a low risk of cardiovascular disease. And you have to keep taking the statins for five years.

All of which begs the question, if the benefits of statins have been exaggerated and we’re discovering new potential risks, wouldn’t many low-risk people be better off losing a bit of weight and eating the right foods to ward off heart disease?

Good medicine should always be evidence-based and given to the right patient at the right time. There is no doubt that statins have an important role when it comes to the care of patients who have either had heart attacks or been diagnosed with heart disease. But if increasing amounts of people without heart disease take statins, it will be a victory for vested interests over evidence.

The debate about statins in primary prevention is alive and kicking. It is a debate that needs to be resolved as thoughtfully, objectively, and openly as possible, and not by ill-thought, unscientific articles.

Conflict of interest: Dr Aseem Malhotra, Cardiologist mentioned in The Mail on Sunday article, is my son.

Dr Kailash Chand is a retired GP in Tameside

References

http://www.statinusage.com/Pages/key-findings-and-implications.aspx

https://www.who.int/nmh/publications/fact_sheet_diet_en.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3303886/ 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5096253/

http://jcbmr.com/index.php/jcbmr/article/view/11

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Readers' comments (12)

  • David Banner

    Best Pulse article title ever!

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  • "Papa don't preach" I believe is what Madonna famously sang on the Statin Island ferry

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  • Kailash,
    you must be a proud father-he's a bright boy!

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  • Cobblers

    Kailash, "When drug industry-sponsored trials cannot be examined and questioned by independent researchers, science ceases to exist and becomes nothing more than marketing."

    This, more than anything else, gets to the nub of the problem. If the data are confirmatory then why doesn't pharma publish the lot? By refusing it leads to the conclusion they cherry picked and that the data does not support the use of statins as much as current.

    And even now that statins are generic they hold to that refusal as it would show the whole rotten edifice for what it is, a method for marketing.

    How much data is withheld on NOACs then?

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  • Ivan Benett

    The benefits of Statins in Primary Prevention for high and moderate risk (of CHD) outweighs any anecdotal side effects, which are in any case mostly reversible.
    May I present a couple of studies to support this contention and maybe the benefits and risks in the elderly. The only deniers are those who deny patients the opportunity to improve their risk of CVD by withholding statins. Yes I know there are non-physical risks like medicalisation, labelling and dependancy, but they are part of the risk assessment when balancing with benefits.
    Cholesterol Treatment Trialists’ Collaboration. Efficacy and safety of statin therapy in older people: a meta-analysis of individual participant data from 28 randomised controlled trialsLancet 2019; 393: 407–15. 186 854 participants in the 28 trials. Overall, statin therapy or a more intensive statin regimen produced a 21% (RR 0·79, 95% CI 0·77–0·81) proportional reduction in major vascular events per 1·0 mmol/L reduction in LDL cholesterol.
    The proportional reduction in major vascular events was similar, irrespective of age, among patients with pre-existing vascular disease (ptrend=0·2), but appeared smaller among older than among younger individuals not known to have vascular disease (ptrend=0·05). They found a 12% (RR 0·88, 95% CI 0·85–0·91) proportional reduction in vascular mortality per 1·0 mmol/L reduction in LDL cholesterol, with a trend towards smaller proportional reductions with older age (ptrend=0·004), but this trend did not persist after exclusion of the heart failure or dialysis trials (ptrend=0·2). Statin therapy had no effect at any age on non-vascular mortality, cancer death, or cancer incidence.
    Ramos R et al., Statins for primary prevention of cardiovascular events and mortality in old and very old adults with and without type 2 diabetes: retrospective cohort study BMJ 2018;362:k3359 Statins were significantly related to a reduction in incidence of atherosclerotic CVD and in all-cause mortality in people with type 2 diabetes mellitus; this effect was substantially reduced after the age of 85 and disappeared in nonagenarians These results do not support the widespread use of statins in old and very old populations, but they do support treatment in those with diabetes who are younger than 85 years.

    The American Heart Association has issued a “Scientific Statement” titled “Statin Safety and Associated Adverse Events,” which is a comprehensive overview based on data from both randomised and observational studies. The authors focus considerable attention on muscle symptoms: They estimate that myopathy — if defined as muscle symptoms plus creatine kinase (CK) levels at least 10 times the upper limit of normal — occurs in fewer than 1 per 1000 patients who are receiving maximally recommended doses of statins; they also estimate that severe myopathy (rhabdomyolysis) occurs in about 1 per 10,000 patients. The incidence of less-severe muscle symptoms (myalgias with or without mild increases in CK level) is difficult to estimate, given that myalgias are so common in the general population.
    Moderate-intensity and high-intensity statins increase relative risk for diagnosed diabetes by about 10% and 20%, respectively, affecting roughly 1 per 100 statin users during 5 years. Whether the diabetogenic effect is reversible is unclear.
    Severe liver toxicity is rare, occurring in roughly 1 per 100,000 people. The incidence of asymptomatic mild transaminase elevations (which often are transient) is ≈1%. The FDA recommends against routine monitoring of transaminase levels in statin users.
    Conclusions about other postulated adverse effects of statins are as follows:
    • Haemorrhagic stroke: Possible small excess incidence in patients with histories of cerebrovascular disease, offset by fewer ischemic strokes
    • Cognitive function: No definitive evidence of benefit or harm
    • Peripheral neuropathy: An association was noted in observational studies but was not reported in randomised trials
    • Erectile dysfunction: No association
    • Cataracts: Evidence is mixed, but the “preponderance of evidence” suggests no excess risk
    • Renal function: No evidence of any effect (except for the rare rhabdomyolysis)
    • Tendonitis or tendon rupture: No association
    • Cancer: No association
    The evidence is increasing about the benefit of statins in Primary Prevention. Meanwhile, I would suggest sticking to NICE guidance, until it is further updated.

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  • Interesting what the NNT website says about primary prevention - not worth it, don’t it.

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  • Ivan Benett

    NNT for those without know heart disease taking statin for 5 years 1:104 heart attack prevented and 1:154 strokes. No mention of prior risk, dose of statin, age or co-morbidities.
    My point is patients should be informed and we should listen to NICE advice

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  • Are statins ever compared in trials to comprehensive lifestyle modifications? Whose side effects include increased bone density, mood improvement, risk of cancer reduction etc etc

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  • Ivan Benett

    Initially statin trials were against usual treatment which includes lifestyle changes and drugs for hypertension, diabetes etc. As the evidence has become so overwhelming for statins in secondary prevention the issue became how high a dose/ strength of statin should be - as assessed by how low LDL should go.
    The classic Primary prevention trial was WOSCOPS where the placebo arm were 'seen at three-month intervals, and dietary advice was reinforced on each occasion'.
    The conclusion was that treatment with pravastatin significantly reduced the incidence of myocardial infarction and death from cardiovascular causes without adversely affecting the risk of death from non-cardiovascular causes in men with moderate hypercholesterolaemia (non-fasting plasma cholesterol level 6.5 mmol/l) but who had no history of myocardial infarction.
    Prevention of Coronary Heart Disease with Pravastatin in Men with Hypercholesterolemia N Engl J Med 1995; 333:1301-1308

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  • The WOSCOPS trial appears to be showing benefit in its long term follow up I believe. My suggestion is that the actual lifestyle advice given in usual care is not that good and could be improved, and then compared to statins, or see how they work together. And beyond advice you could look at major public health initiatives and see the impact they had on all cause mortality. I think my point I’m labouring to get to is huge amounts are spent on drugs in primary prevention and yet lifestyle measures are not given the same investment. Of course it’s very hard to prove they work in controlled trials but it’s still a worthwhile consideration.

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