The 63rd Annual Scientific Sessions of the American College of Cardiology (ACC.14) was in Washington D.C. the heart of the nation as the ACC president described the U.S. capital. As I expressed in my previous blog, I was eagerly anticipating live debate amongst leading physicians and scientists on the recently released ACC/American Heart Association cholesterol guidelines, as well as presentation of Phase III data on Amgen's PCSK9 inhibitor evolocumab (AMG 145). Cholesterol is close to my heart although hopefully not too close.
Having returned from my sojourn, I can tell you that I was not disappointed on either score. The data for evolocumab was impressive, but our evaluation of the results will be presented in another blog. As for debate on the guidelines, the discussions on the quality, interpretation, and implications of the new blood cholesterol guidelines were frequent, and at times almost heated, across the scientific sessions. Lead author of the guidelines, Professor Neil Stone, and several members of the task force who helped in their development were panelists for several sessions, taking the opportunity to explain the rationale and optimal use of the new guidelines. In these sessions, ACC.14 attendees and panelists expressed their support or concerns over the guidelines, with opinions ranging from excellent through confusing to a waste of time.
All of which are true. At face value, the guidelines are an excellent summary of the highest quality data available on the management of blood cholesterol in the United States. This was the remit set out for the developer of the guidelines only use the strongest evidence available. But in the end that contributed most to the controversy. The highest quality evidence limits the scope of the guidelines to the use of statins in four distinct populations, and did not support the use of lipid targets. In much the same way that clinical trials often do not reflect the real world situations, these guidelines do not provide the broader assistance that the average physicians needs for everyday practice. The lack of support for lipid target led to ACC.14 attendees frequently asking about whether this meant testing of lipids was no longer required, and confusion over how to assess response to treatment. Furthermore, the risk estimator (not calculator) accompanying the guidelines suggests many more patients will be eligible for statin therapy, which raised concerns about the risk of over-treating.
However, some of the critics also seem to be missing the point. The new recommendations may not offer guidance for all possible scenarios, but they advise on the optimal use of statins, and they may stimulate greater discussion between patients and physicians. Primarily, the chief cause of the furor generated by the release of these guidelines was bad marketing. There has been a disconnect between the authors and the audience. The aims of the guidelines and constraints set on their development should have been highlighted much earlier, and more effort should have been put into how the guidelines should be integrated into practice.
So, how will these new guidelines impact on the pharmacotherapy market for dyslipidemia. Not much, actually. For a start, the controversy in of itself will temper adoption of the guidelines. I would think that there may be a gradual increase in statin use over time driven by these guidelines, but statin use is likely to increase in any event with the already widespread appreciation of the efficacy and safety of this drug class, an aging population, and improvements in access to screening and diagnosis of cardiac events. The availability of cheaper generic statins, particular the high potency atorvastatin, will also increase accessibility and use of the class, but limit sales overall. For greater detail on the dyslipidemia market, DRG's Dyslipidemia Pharmacor is due to be released later this year and will be available via the DRG gateway.
Tim Blackstock, M.B. Ch.B., is a business insights analyst in the Cardiovascular, Metabolic, and Renal Disorders team at Decision Resources Group.
In-depth analysis of the dyslipidemia area, with accompanying epidemiology driven sales forecast models, is presented in Decision Resources Group's Dyslipidemia Pharmacor. The most recent edition was updated on January 2, 2014.