Issue 15 / 5 May 2014

A LEADING cardiologist says GPs are still seeing patients planning to discontinue statin therapy after a controversial television program last year questioned the value of the drugs.

In an MJA Perspectives article, Professor Ian Hamilton-Craig, professor of internal medicine and preventive cardiology at Griffith University, Queensland, said despite rebuttals of the program in subsequent media reporting and by the National Heart Foundation of Australia (NHF), patients were still stopping their statins without medical advice. (1)

Professor Hamilton-Craig’s advice that ongoing public concern about statin therapy provided an opportunity for doctors to re-evaluate patients’ risk of cardiovascular disease (CVD) and ensure their treatment was in line with the current guidelines has been echoed by other experts.

Dr Rob Grenfell, the NHF national cardiovascular health director, said Professor Hamilton-Craig’s succinct summation of the real issues surrounding statin prescribing in Australia and advice to health professionals was “spot on”.

“Doctors need to take this opportunity to re-evaluate their patient’s absolute CVD risk and modify their statin therapy in accordance with the current National Vascular Disease Prevention Alliance guidelines”, Dr Grenfell said. (2)

He said for primary prevention of CVD, statin therapy was recommended for moderate risk patients (5-year CVD risk 10%–15%) if 3–6 months of lifestyle intervention did not reduce low-density lipoprotein cholesterol (LDL-C) levels or the overall absolute CVD risk score.

For all high-risk patients (5-year CVD risk greater than 15%), doctors should prescribe a statin straightaway to reduce their LDL-C level and overall risk score.

Dr Grenfell said the MJA article clearly demonstrated the low prevalence of side effects from statin use. “Rhabdomyolysis occurs rarely — one in one million statin prescriptions — myalgia in 10% of patients in clinical practice, and diabetes in 6% of patients who mostly have features of the metabolic syndrome”, he said.

In a recent systematic review of randomised controlled trials, UK researchers found that most side effects attributed to statin treatment occurred almost as frequently in patients taking a placebo. (3)

While they found an increased risk of new-onset diabetes in primary prevention trials, they determined that only one in five cases was caused by a statin.

Professor Anthony Keech, professor of medicine, cardiology and epidemiology at the University of Sydney and deputy director of the NHMRC Clinical Trials Centre, said statins were some of the most powerful drugs available to prevent mortality, and were “here to stay”.

“Doctors are working to explain to individual patients why it’s important that they don’t stop their statins. Generally speaking, decisions to start statins are very appropriate; if they’re not, all of this controversy triggers discussions between doctors and patients about why they’re on statins and whether they should remain on them”, he said.

Professor Keech, a member of the Cholesterol Treatment Trialists’ Collaboration, said while the recognition of side effects of statins had grown over the years, they remained small compared with the “very large” benefits of statin therapy.

He pointed to research his group published in 2010 that showed statins reduced the risk of mortality by 10% per 1 mmol/L reduction in LDL-C and reduced major vascular events by 20%–25% per 1 mmol/L reduction in LDL-C over 5 years. (4)

Professor Keech said the risk reduction was seen across patients from low to high CVD risk.

“At the end of the day, patients have to make up their own mind. We need to make sure that they do that with proper advice from their doctors who have the best information available — and we are making sure that that information is available [to them].”

In his MJA article Professor Hamilton-Craig also wrote that the long-term cost-effectiveness of statins remained a “major issue”.

“Although generic statins have cut costs in Australia by around 25%, they remain expensive by international standards. Lower costs may encourage changes to the PBS criteria, which would allow the use of statins for primary prevention of CVD in broader groups of patients as recommended in recent US guidelines.”

 

1. MJA 2014; 200: 440-441
2. Australian absolute cardiovascular disease risk calculator
3. Euro J Prev Cardiol 2014; Online 12 March
4. Lancet 2010; 376: 1670-1681

6 thoughts on “Seize the day on statins

  1. Dr Kate Duncan says:

    Before we start adding statins to the water supply could we please remember that STATINS ARE TERATOGENIC, that there is very little evidence of any primary prevention benefit for women, that an increasing number of women are having babies in their 40s and that about 40% of pregnancies are unplanned.

  2. craranjo@optusnet.com.au says:

    We know that all specialists are sponsored by the pharmaceutical companies to use their leadership to strongly promote their statins. The adverse side-effects, including fatal and non-fatal coronary events, are largely and deliberately under estimated The system is flawed, and these Key Opinon Leaders are given far too much importance in regard to the statin ‘risk’ issue, whilst deliberatey keeping patients in the dark about adverse side-effects of statin

  3. Guy Hibbins says:

    Whlie some people may be overtreated with statins, a recent Australian emergency department survey of 534 patients showed that over 20% had undiagnosed hypercholesterolaemia with a total cholesterol of over 6.0mmol/L which is well above the normally accepted cut-off.  If we reevaluated everyone’s cardiovascular risks, I suspect we would find that on average they were underassessed rather than overassessed.

    See Feasibility and outcomes of screening for cardiovascular risk factors in the emergency department. Emergency Medicine Australasia. 2013 Apr; 25 (2):175-81

  4. craranjo@optusnet.com.au says:

    Certain Facts need consideration:

    1 Data proving the pathogenesis of cholesterol-rich plaque arising from cholesterol in the blood is yet lacking

    2 Cholesterol is essential for the healthy functioning of every cell in the human body

    3 Statins inhibit the essential enzyme HMG-Co A Reductase, resulting in many serious adverse effects not necessarily cardio-vascular

    4 When for example, the adverse effect manifests as Peripheral Neuropathy, do we ignore this and bully the patient into taking the statin, regardless?  Another example:when hypersensitivities from Type 1 through to Type 4 manifest, what then?

    5 Are the PBS rules for prescribing statins to be manipulated and statins prescribed? Moreover, what of the upper limit of 7.5 mmls/L in some classes of patients—are they all going to get heart attacks? Rashly prescribing a statin with flimsy ‘risks’ is good?

    6 Pharmceutical Cos are bound by law to provide in detail all aspects of their drugs, whereas prescrbers are not bound by law to recognise the many dangers associated with the drug. Were I to know that by taking a statin drug it is no guarantee that I will never suffer a non-fatal or even fatal coronary event, would I agree to take it?

    7 Currently, no heed is given to the depletion of ubiquinone in those taking a statin drug, nor that statins inhibit steroids synthesis, a dangerous trend indeed

     

  5. Sue Ieraci says:

    Anonymous poster says ”Were I to know that by taking a statin drug it is no guarantee that I will never suffer a non-fatal or even fatal coronary event, would I agree to take it?” My impression is that people understand about risk reduction and don’t see statins as any ”guarantee”. The research I have read on steroid hormone synthesis shows that, although lipid-lowering activity might theoretically impair the synthesis of steroid hormones, this does not acutally occur when tested. Does the anonymous poster have any evidence to the contrary?

  6. TIM Bailey says:

    When statins were first trialled in Europe in the early 1990’s, the trials were abandoned. This was due to the unacceptably higher rates of both death and morbidity of various types in the NON TREATED portion of the trial group. I think critics of statin therapy would do well to seek out the results of those original trials and re-examine their position, based on that information.

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