FINAL ENDURING OUTCOMES REPORT OVERVIEW This report summarizes consolidated outcomes data from an enduring satellite symposium activity that was launched In March 2017 and ran for 12 months, cumulatively, ending in March 2018. The enduring version of the symposium elucidated new cholesterol practice guidelines focusing on measuring and treating cholesterol and identifying whether someone already has or is at risk for ASCVD and could benefit from treatment (i.e. individualizing treatments). Additional discussion covered emerging data on PCSK9 inhibitors and which population(s) may benefit most from these therapies in the near term. Moreover, stratifying patients by risk allows for appropriate medical therapy (i.e. appropriate drug dosing); therefore, statin intolerance needs to be monitored in patients, and if patients are deemed statin resistant, alternative treatments should be appropriately utilized to mitigate CVD risk. Further discussion hypothesized on potential future areas of research in the hypercholesterolemia disease state, such as the possible role PCSK9 inhibitors and other emerging therapies may play in reducing cardiovascular risk in patients with diabetes. The faculty also discussed anticipated outcomes data from the FOURIER trial (released just after the recording of the enduring content). Certified by the Academy for Continued Healthcare Learning (ACHL) for 1.5 AMA PRA Category 1 Credits Supported by an educational grant from Amgen, Grant ID: GHCCOPS IME 95343
Learning Objectives: Upon completion of this activity, participants will be able to: Outline available lipid guidelines and the clinical implications Describe strategies to optimize lipid management in high risk and other groups of patients to appropriately treat/mitigate CVD risk Formulate individual treatment regimens in patients who have not achieved reductions in LDL C levels despite statin therapy Interpret the efficacy and safety data of available and emerging PCSK9 inhibitors and their role in current treatment paradigms Enduring (Final data, 12 months post launch) Total Number of Participants: 3,327 Total Number of Certificates: 1,113 o Met guarantee for minimum number of participants 2000 and 350+ completions EXECUTIVE SUMMARY The enduring activity included a substantial percentage of primary care physicians and nurses, which likely have less direct familiarity with high risk cholesterol management than cardiologists who participated in the activity. However, the primary care and allied health cohort are likely to encounter patients who will require referral to the cardiology cohort and/or may already be on statins or other cholesterol lowering drugs. Level 1 & 2: Faculty were highly rated (3.55 or greater, out of 4.0) across all categories Learners agreed that they were able to achieve the 4 objectives of the course (3.45 mean rating) 95% of learners would recommend this activity to a colleague 88% of learners did not perceive any bias or commercialism towards any product or drug Level 3 & 4: Knowledge increased (or will increase) after participating in the activity according to 72% of learners 60% of participants indicated projected impact of this activity on their performance. This is a relatively high rate of commitment to change practice (Moore s Level 4) given a slower than expected prescribing rate of the PCSK9 inhibitors due to myriad factors (eg, restrictive FDA clinical indication and related payer formulary restrictions, as well as cost). 46% of learners plan to change the management and/or treatment of their patients by considering the use of newly approved drug classes for patients who may not be responding to more traditional therapies. o 25% would create/revise protocols, policies, and/or procedures by more regularly monitoring patient response to LDL C lowering therapies. Reimbursement/insurance issues (26%) was perceived as the largest barriers to change, followed by Cost (22%) Considerations for Future Education (participants were able to choose more than 1 option): Topics of greatest interest to learners for future activities include: o Clinical trial data on emerging agents/therapies (41%) o Practical strategies for managing statin resistant dyslipidemia/familial hypercholesterolemia and related comorbidities (eg, diabetes) (41%) o Medication management in the surgical/interventional setting (28%) Further education is warranted as pre and post test results showed that less than 50% of clinicians correctly answered questions related to: o Current clinical research surrounding dyslipidemia variations by population subset o Emerging areas of research regarding plaque stabilization Continued education on the clinical application of recent outcomes trial data and ensuring access to PCSK9 inhibitors for appropriate patients 2
A relatively high self reported bias detection rate of 12% is likely reflective of the broader enduring participant cohort s lower baseline knowledge of PCSK9 inhibitors, since the primary care/allied health cohort typically does not treat these patients. Educational Impact: This activity increased participants knowledge and competence with respect to: o Familiarity with the efficacy and safety profiles associated with FDA approved PCSK9 inhibitors o Therapy intensification, including the use of available PCSK9 inhibitors o The association between LDL C and VLDL and cardiovascular health, as well as genetic variants that may contribute to increased levels of hypercholesterolemia and/or statin resistance o Genetic components of PCSK9 inhibition/lack of inhibition in various populations 3
PRE VS POST COMPARISON/INTENT TO CHANGE 1. According to the ARIC study (Atherosclerosis Risk In Communities), 2.6% of African American patients had 28% lower LDL, and a corresponding decreased risk of CVD of what percentage? A. 10% B. 32% C. 25% D. 88% Enduring Pre Vs Post 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 44% 38% 30% 29% 26% 10% 17% 6% A B C D Enduring Pre Enduring Post Pre: N= 1,281 Post: N= 1,113 Analysis: In the enduring activity, the mostly non cardiology learners (primary care physicians, nurses, allied health, and other medical practice specialties) had a low level of baseline knowledge regarding the potential impact of genetic variants of PCSK9. While learners knowledge increased substantially post activity (44% versus 6%, a 633% increase), it still illustrates a need for further education on the impact of genetic variants related to hypocholesterolemia for most clinicians. 2. Learners answered the following question based on Case RK s patient background. Patient History/Background: RK is a 58 year old man who presented with angina 1 year ago and underwent cardiac catheterization that showed 90% proximal LAD stenosis. A drug eluting stent (DES) was implanted successfully. A lifetime nonsmoker, RK s past medical history is significant for type 2 diabetes mellitus and hypertension. Patient Case Question: RK started atorvastatin 80 mg daily on discharge but developed incapacitating myalgias after 2 3 weeks w/o CK elevation. Reversible causes excluded. After improvement of symptoms over 2 3 weeks w/o statin, RK again developed myalgias upon re challenge; now tolerate rosuvastatin 5 mg, 3 days a week. He has been on this dose for 9 months w/o issues. RK returns for a follow up visit and reports feeling well/walking 0.5mile daily. RK s LDL C has dropped from 140 mg/dl a year ago to 100 mg/dl today (28% reduction). TC=175 and non HDL=130 mg/dl. Which of the following is the next BEST course of action? A. He is on maximally tolerated dose of statin and has had a 30% reduction in LDL. Continue this and encourage more intensive lifestyle changes. B. He would benefit from addition of ezetimibe (an intestinal cholesterol absorption blocker) C. He would benefit from addition of niacin 1 gram daily D. He would benefit from addition of fenofibrate because he is diabetic 4
Enduring Pre Vs Post 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 97% 59% 27% 9% 1% 1% 5% 1% A B C D Enduring Pre Enduring Post Pre: N= 1,281 Post: N=1,113 Analysis: Learner baseline knowledge on intensification of therapy for this theoretical case patient increased from 59% to 97%. These data may be indicative of the fact that this broad cohort of learners has strong familiarity with common comorbid conditions such as type 2 diabetes mellitus and hypertension. 3. After 3 months of being on rosuvastatin 5 mg 3x/week and ezetimibe 10 mg/d, RK s lipid profile now is: LDL 80 (down from 100), TC 155 and non HDL 110 mg/dl. Which one of the following choices is the next BEST course of action? A. He is on maximally tolerated dose of statin ezetimibe combo and has had a ~ 45% reduction in LDL from baseline. Continue this and encourage more intensive lifestyle changes. B. He would benefit from the addition of a PCSK9 antibody C. He would benefit from the addition of mipomersen (an antisense inhibitor of apob 100 mrna) or lomitapide (a microsomal triglyceride transfer protein inhibitor) D. He is at high risk and would benefit from referral to a lipid specialist for LDL apheresis Enduring Pre Vs Post 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 93% Enduring Pre 47% 36% 12% 4% 1% 5% 2% A B C D Pre: N= 1,281 Post: N= 1,113 Enduring Post Analysis: Baseline knowledge on this question was low, at only 36%, likely an indicator of the mostly non cardiology/primary care practice area of enduring participants. However, performance on this question rose to 93% (a nearly 160% increase), indicating highly effective education for practitioners. 5
4. True or False: New research indicates cholesterol lowering drugs reduce clinical events by stabilizing plaques. Correct Answer: True. Enduring Pre Vs Post 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 99% 85% 15% 1% 1 0 TRUE FALSE Enduring Pre Enduring Post Pre: N= 1,281 Post: N= 1,113 Analysis: Primary care and allied health practitioners demonstrated they had a high level of baseline knowledge, 85%, regarding statins mechanisms of action regarding plaques, rising to 99% post test, a 16% increase. 6
FINAL ENDURING EVALUATION SUMMARY 1. Evaluate faculty (4=Excellent, 3=Good, 2=Fair, 1=Poor) Ability to effectively convey the subject matter Ability to deliver an objective and balanced presentation Ability to present scientifically rigorous information Expertise on the subject matter Faculty 3.54 3.53 3.54 3.58 2. Did you perceive any bias or commercialism towards any product or drug in this activity? A. No 88% B. Yes. If yes, please explain 12% Comments: PCSK9 3. Please evaluate A. Quality of educational content Excellent/Good 95% B. Effectiveness of teaching method used Excellent/Good 93% C. Appropriateness and effectiveness of active learning strategies (questions, cases, discussion, etc) Excellent/Good 93% No. of Respondents 1065 7
4. Learning Objectives (4=Excellent, 3=Good, 2=Fair, 1=Poor) A. Outline available lipid guidelines and the clinical implications 3.45 Rating B. Describe strategies to optimize lipid management in high risk and other groups of patients to appropriately treat/mitigate CVD risk C. Formulate individual treatment regimens in patients who have not achieved reductions in LDL C levels despite statin therapy D. Interpret the efficacy and safety data of available and emerging PCSK9 inhibitors and their role in current treatment paradigms 3.46 3.45 3.43 5. Please rate the importance of your reasons for attending this educational activity A. Topics Extremely/Very Important B. CME/CE credit Extremely/Very Important 92% 93% No. of Respondents 1058 6. Please rate the projected impact of this activity on your knowledge, competence, performance and patients outcomes: This activity increased my knowledge. A. Yes. If yes, please describe: 72% B. No 8% C. No Change 20% 7. This activity increased my competence. A. Yes If yes, please describe: 62% B. No 11% C. No Change 27% 8
8. This activity will improve my performance. A. Yes If yes, please describe: 59% B. No 13% C. No Change 28% 9. This activity will improve my patient outcomes. A. Yes. If yes, please describe: 55% B. No 14% C. No Change 31% 10 Please identify how you will change your practice as a result of attending this activity (select all that apply) A. Change the management and/or treatment of my patients by considering the use of newly approved drug classes for patients who may not be responding to more traditional therapies. Please specify: 46% B. Create/revise protocols, policies, and/or procedures by more regularly monitoring patient response to LDL C lowering therapies across various patient subgroups. Please specify: 25% C. This activity validated my current practice; no changes will be made. 37% D. Other Change Please specify: 5% 9
11. Please indicate any barriers you perceive in implementing these changes. (check all that apply) A. Cost 22% B. Lack of experience 19% C. Lack of opportunity (patients) 12% D. Lack of resources (equipment) 8% E. Lack of administrative support 14% F. Lack of time to assess/counsel patients 10% G. Reimbursement/insurance issues 26% H. Patient compliance issues 19% I. Lack of consensus or professional guidelines 5% J. No barriers K. Other, please specify: % 2% Comments: Technologist Role Only 12. Number of patients in your care with dyslipidemia: A. 0 16% B. 1 10 26% C. 11 20 15% D. 21 50 10% E. >50 33% 10
13. Would you recommend this activity to a colleague? A. Yes 92% B. No 5% No. of Respondents 1065 14. What topic areas would you like to see in future activities? (check all that apply) A. Clinical trial data on emerging agents/therapies 41% B. Practical strategies for managing statin resistant dyslipidemia/familial hypercholesterolemia 41% C. Medication management in the surgical/interventional setting 28% D. Other 2% 15. What is one pearl you took away as a result of your participation? (See Appendix) 16 General Comments (See Appendix) 11