This post was authored by Christie M. Ballantyne, MD, FACC, chair and moderator of the ACC’s LDL: Address the Risk Think Tank, and Kim Birtcher, MS, PharmD, AACC, chair of the ACC’s LDL: Address the Risk Oversight Workgroup.
In view of recent evidence of the benefit of non-statin therapy and the emergence of PCSK9 inhibitors, clinicians are faced with a number of important issues when considering combination therapy in high-risk patients. To address these issues, representatives from medical specialty societies and other stakeholder groups attended the LDL: Address the Risk Think Tank this week, at ACC’s headquarters.
The LDL: Address the Risk Think Tank was developed under the LDL: Address the Risk Initiative – a multi-stakeholder quality initiative launched with the goal of improving patient outcomes by increasing awareness of the gaps in lipid management and the importance of managing LDL-related risks. The initiative kicked off with the first LDL: Address the Risk Think Tank in 2013 where participants identified perceived statin intolerance as one of the major barriers to statin adherence and a key contributor to the underutilization of statin therapy.
This year’s Think Tank was designed to encourage open discussion around additional gaps in care and to inform the development of ACC practical guidance for clinicians. ACC President Kim Allan Williams, Sr., MD, FACC, kicked off the meeting and emphasized the importance of identifying the best lipid management strategies and closing gaps in care in order to improve the health of populations.
Think Tank participants then went on to discuss non-statin therapy and atherosclerotic cardiovascular disease (ASCVD) risk reduction as they relate to the ACC/AHA’s 2013 Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. Participants examined the conceptual framework of the guidelines, which consider absolute risk for CVD events and LDL-C levels for initiation of therapy, and how that framework can be applied to the decision process of when to initiate non-statin therapy. Participants highlighted that the current guidelines permit discretion to discern if LDL-C reduction is adequate or if non-statin therapy may be used. Additionally, participants pointed out the gaps between current ACC/AHA cholesterol guidelines and recent evidence of benefits/potential benefits of combination therapy for LDL-C management.
The participants also addressed considerations for using non-statin therapy. They noted that PCSK9 inhibitors may not be cost-effective for many patients at current prices, which further highlights the need to identify which high risk individuals may have the greatest benefit of this therapy. Non-cost related issues from the point of view of the clinician and patient should also be considered before prescribing non-statin therapy. The participants also identified the need for tools to facilitate and maintain the extra documentation that may be required when prescribing non-statin, including efforts to optimize statin therapy, patient’s experience with other lipid lowering therapies, and other information that may be requested from the patient’s insurance company.
The Think Tank closed with a discussion around clinical strategies for managing muscle-related symptoms on statin therapy and the role of non-statin therapies in statin intolerance. While statin therapy is the gold standard for the management of the patient with ASCVD, the participants discussed the potential for using non-statin therapies in selected patients who otherwise do not tolerate adequate statin dosing. The ACC’s Statin Intolerance App was also mentioned as a tool to facilitate and add structure to the clinician-patient discussions about possible statin-related muscle symptoms with the goal of keeping appropriate patients on statin therapy.
Moving forward, the discussions and recommendations coming out of the Think Tank will be used to further develop tools and resources to help health care providers navigate this sometimes complicated landscape. The College will also look to collaborate with other stakeholders to create more effective strategies for clinicians and patients to assist in ensuring guideline-recommended therapy.
The LDL: Address the Risk program is supported by Amgen, Inc. Additional support for the 2015 LDL: Address the Risk Think Tank was provided by CVS Health, Eli-Lilly and Pfizer.