Statins are one of the most commonly prescribed drugs, and Pfizer's Lipitor (atorvastatin) still holds the record for the highest peak sales of any prescription drug. The general consensus of thought leaders in the field of lipid disorders and CVD prevention is that the benefits of statins outweigh the risks, although this applies more for secondary prevention that primary prevention. However, the widespread use of statins has long generated an undercurrent of concern over the potential for negative effects in such a large population. Various issues have been raised, ranging from their lack of benefit in women through to safety concerns, and the debate has been fired up by the release of new guidelines recommending even broader use of these agents. In November 2013, the ACC and AHA published new guidelines that included a recommendation for statin therapy in patients with an estimated ten-year risk of atherosclerotic cardiovascular disease (ASCVD) of 7.5 percent or higher. Then, in July 2014, the UK's National Institute for Health and Care Excellence (NICE) released guidelines recommending that patients with a ten-year risk of CVD that exceeds 10 percent should be treated with atorvastatin 20 mg. NICE estimates that if half of the lower risk primary prevention group take statins, an extra 4,000 deaths from heart attack could be saved, and 8,000 strokes and 14,000 non-fatal CV events could be prevented.
However, both sets of guidelines have received mixed feedback. In a letter to NICE, UK experts expressed concerns about a variety of topics like the medicalization of healthy individuals and the true levels of adverse events. For them, the benefits are simply not convincing enough to justify five million people being started on a drug for life. NICE argued their case in a letter of their own. Various experts and professional organizations have also expressed concerns over the U.S. guidelines, including a group from the Mayo Clinic that has just published their opinion here. Debate also continues over the safety of the class: new-onset diabetes, myopathy, and cognitive problems are all associated with statin use. But, as is the case with a lot of scientific research, the quality varies, and different studies have found different results. This has led to a dispute over safety research published in the BMJ, which, because of the common use of these drugs, has been picked up by the lay press.
So, how will all of this affect prescribing and sales of statins? Will we see the public health equivalent of them being added to the drinking water? The guidelines? recommendations are based on a wealth of solid evidence showing CV benefit with statin use, and encourage a discussion between physicians and patient over taking statins. In addition, the statins are now almost all available as generics making them inexpensive and more accessible. However, the fact that the class is almost totally genericized is likely to mean there will be little impact on sales, despite the increasing prevalence of dyslipidemia. Moreover, the ongoing controversy about the guidelines, combined with the slow and often limited adoption of guidelines by the average physician, suggests to us that there will not be a mass shift in physician practice. You can lead a physician to statins in the water, but you can't make them drink.
Stefanie Hoffart, M. Sc., is a Research Associate and Tim Blackstock, M.B. Ch.B., M.Phil., is a Business Insights Analyst in the Cardiovascular, Metabolic and Renal Disorders team at Decision Resources Group.
In-depth analysis of type 2 diabetes, with accompanying epidemiology driven sales forecast models, are presented in Decision Resources Group's Type 2 Dyslipidemia Pharmacor, available here. A new edition of this product is planned for November 2014.