image1The next GP Journal Club will be discussing the paper: Lorgeril M, Rabaeus M. Beyond confusion and controversy, can we evaluate the real efficacy and safety of cholesterol-lowering with statins? JCBMR 2016;1(1):67

You can download it here.

Angharad Powell is a Portfolio GP based in North Wales, working in a salaried role, as a tribunal doctor, and as a GP appraiser.

Statins – where next?

Prescribing statins has become a daily part of life for GPs. Early statin trials, such as 4S and WOSCOPS, appeared to demonstrate dramatic and conclusive benefits for statins over placebo, leading to their recommendation for a rising percentage of the population.1,2 Over recent years the waters have muddied with regard to the safety and efficacy of these drugs, with increasing controversy about the quality of the evidence base, and validity of the diet-heart hypothesis.3

Since 2014 NICE has recommend that GPs offer atorvastatin 20 mg for the primary prevention of CVD to people who have a 10% or greater 10-year risk of developing CVD.4 These new guidelines have received a mixed reaction among doctors and researchers, uncertain as to whether the benefits outweigh the risks, as evidence emerges of previously unrecognised effects such as doubling of diabetes risk.5

The 2013 clash between Sir Rory Collins and Fiona Godlee, editor of the BMJ on the publication of an article suggesting that 18-20% of patients on statins suffer side effects brought many of the problems with statin trial evidence to light.More recently Dr Aseem Malhotra, a prominent cardiologist, also highlighted the discrepancy between side effects reported in industry sponsored trials and real world experience, calling for a full reassessment of all the statin studies.7

As doctors prescribing drugs to healthy people with the promise that they may prevent an unwanted outcome, we must be very sure that we are following our moral duty to “first do no harm”. The uncertainties raised by these analyses raise the possibility that we are not currently meeting that obligation. We risk the trust of out patients if we do not take a step back and take a critical look at the evidence base to determine the appropriate place of statins in our practice.

This paper by Michel de Lorgeril and Mikael Rabaeus provides a challenge to the current viewpoint, and I hope will provide the foundation for a lively debate on the topic.8

Proposed questions:

·What do you think about the study design?

·Do you agree that the “entire ecosystem of drug evaluation and regulation could be flawed”?

·Comments on the authors’ conclusion that “physicians should be aware that the present claims about the efficacy and safety of statins are not evidence based.”

Feel free to suggest questions – via Twitter or leave them in the comments box below.

References:

1. The Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 people with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383–9.

2. Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998;339:1349–57.

3. Ioannidis JA. More Than a Billion People Taking Statins? Potential Implications of the New Cardiovascular Guidelines. JAMA 2014;311(5):463-464. doi:10.1001/jama.2013.284657.

4. Cardiovascular disease prevention | Guidance and guidelines | NICE [Internet]. Nice.org.uk. 2010 [cited 6 April 2016]. Available from: https://www.nice.org.uk/guidance/ph25

5. Mansi I, Frei C, Wang C, Mortensen E. Statins and New-Onset Diabetes Mellitus and Diabetic Complications: A Retrospective Cohort Study of US Healthy Adults. J Gen Intern Med. 2015;30(11):1599-1610.

6. Independent statins review panel | The BMJ [Internet]. Bmj.com. 2016 [cited 6 April 2016]. Available from: http://www.bmj.com/about-bmj/independent-statins-review-panel

7. The Great Statin Con? [Internet]. The Huffington Post UK. 2016 [cited 6 April 2016]. Available from: http://www.huffingtonpost.co.uk/dr-aseem-malhotra/great-statin-con_b_9607316.html

8. Lorgeril M, Rabaeus M. Beyond confusion and controversy, can we evaluate the real efficacy and safety of cholesterol-lowering with statins? JCBMR 2016;1(1):67.