Dear Colleagues!  Today is Pharma Veterans Blog Post #181. Pharma Veterans shares the wealth of knowledge and wisdom of Veterans for the benefit of entire Pharma Community. It aims to recognize and celebrate the Pharma Industry Professionals. Pharma Veterans Blog is published by Asrar Qureshi on WordPress, the top blog site. If you wish to share your stories, ideas and thoughts, please email to for publishing your contributions here.

Continued from Previous……

The Controversies of Statin Therapy: Weighing the Evidence

The first part has been taken from the published article in Journal of the American College of Cardiology Volume 60, Issue 10, 4 September 2012, Pages 875-881.1

Statin therapy has been associated with following negative long-term effects; perception or evidence as we may prefer to call it.

  1. Cognitive Decline
  2. Incidence of cancer
  3. Development of Diabetes mellitus

The US FDA has expanded the warning for statins with the statement that statins use may lead to cognitive impairment.

In the article cited above, authors J. WouterJukemaMD, PhD⁎†‡Christopher P.CannonMD§Anton CraenMSc, PhDRudi G.J.WestendorpMD, PhD¶#StellaTrompetMSc, PhD review all levels of evidence for the probability of above-mentioned long term effects. The authors conclude that “there is no increased risk of cognitive decline or cancer with statin use. However, statin use is related to a small increased risk of type 2 diabetes mellitus. In view of the overwhelming benefit of statins in the reduction of cardiovascular events, we believe the small absolute risk for development of diabetes is outweighed by the cardiovascular benefits in patients for whom statin therapy is recommended. We, therefore, suggest that clinical practice for statin therapy should not be changed on the basis of the most recent Food and Drug Administration informational warnings.”

Another supporting voice is raised by Professor Robin Choudhury in Health Spectator UK2. Professor Choudhury says “I remember clearly hearing the results of the landmark Scandinavian Simvastatin Survival Study as a trainee cardiologist in London in 1994. This clinical trial studied 4,444 patients with both prior heart attack and high cholesterol (even after lifestyle advice and modification). The results were startling: over the five and a half years median follow-up period, simvastatin lowered total cholesterol by 25 per cent. In the placebo group 256 patients (12 per cent) died compared with 182 (8 per cent) in the simvastatin group. So, the risk of death was reduced by about a third. In other words, for every 100 patients treated for about five years after a heart attack, four people who would otherwise have died did not. The probability that this was a ‘chance’ result (i.e. wrong) was less than one in 1,000.”

“So what about the uncertainties? For the most part these start where the margins of the clear evidence base start to fray and partially informed (albeit well-intentioned) speculation begins. In part, this is where risk calculators (like QRISK2) and guidelines come in — to plug the gap where trial data are lacking. Current algorithms such as QRISK2 combine a number of variables including age, cholesterol, blood pressure, smoking history, family history etc. and compute a 10-year risk of cardiovascular events. Equipped with this type of individualized assessment of risk, it is possible for bodies such as NICE to make recommendations for treatment with carefully considered but ultimately arbitrary thresholds.

“So what to do? Given a high lifetime risk of coronary disease and the early onset of the process, one could take a view that an individual, even in early life, should be able to prospectively survey their future risk and make a decision on their approach to interventions that may ameliorate that risk before it reaches a high level. This would include lifestyle modification but could also include preventive treatment, e.g. with statins. Clearly healthy, symptom-free patients taking drugs over long periods requires very careful consideration of the potential risks and benefits.”

He concludes by saying “(1) a given individual, properly equipped with knowledge of the risks and benefits of a treatment, and in consultation with their physician, should be able to make informed choices (and to revisit and revise them as the evidence accumulates) and (2) a more robust understanding of both the processes of medical decision-making and the extent and nature of the body of evidence, including its gaps and deficiencies, will leave patients less susceptible to the shock waves of new or unexpected findings and less exposed to the manipulative sensationalism that characterizes some lay reporting, particularly, it seems, when it comes to statins.”





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