Prevention Updates and Paradigm Shifts Andrew Freeman, MD, FACC Director of Clinical Cardiology and Operations National Jewish Health Assistant Professor of Medicine National Jewish Health and University of Colorado
Disclosure Andrew Freeman, MD, FACC Consultant: Gilead Speaker: Medtronic
Changes Ahead More than a Decade of LDL goals Regular Lipid Panels Chasing Numbers
Typical Diets?
Gone! New guidelines change the paradigm Perhaps easier, more patient-centric Less numbers based (in some ways)
Don t Forget the Patient Guidelines attempt to meet the needs of patients in most circumstances and are not a replacement for clinical judgment. The ultimate decision about care of a particular patient must be made by the healthcare provider and patient in light of the circumstances presented by that patient. Stone et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults
New Lipid Guidelines Focus on Atherosclerotic Cardiovascular Disease (ASCVD) reduction 4 Statin Benefit Groups New global risk assessment calculator for primary prevention patients Safety recommendations Role of biomarkers and noninvasive tests Planned further updates to cholesterol guideline
New Guideline Departures ABANDONMENT of LDL GOALS RELATIVE ABANDONMENT of nonstatin cholesterol medications unless there are significant troubles attaining goals FOCUS ON lifestyle modification including non-tropical oils, low fat diet
Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
Everyone Else: Calculate Risk Calculator
Key Point 1: 4 Groups http://www.cardiosource.org//~/media/images/advocacy/i13116_infographic_lipids_guidelines_v2.pdf
Secondary Prevention: The No Brainer Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
What Constitutes High Intensity? Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
Large Studies Looking at those with ASCVD LaRosa JC, et al. N Engl J Med. 2005;352:1425-1435.
Primary Prevention LDL > 190 Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
Primary Prevention DM2
Primary Prevention All Others Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
Additional Factors Other factors that may indicate elevated ASCVD risk were not included in the Pooled Cohort Equations. In selected individuals who are not in one of statin benefit groups Primary LDL C 160 mg/dl or other evidence of genetic hyperlipidemias, Family history of premature ASCVD with onset <55 years of age in a first degree male relative or <65 years of age in a first degree female relative, high-sensitivity C-reactive protein >2 mg/l CAC score 300 Agatston units or 75 percentile for age, sex, and ethnicity ankle-brachial index <0.9, or elevated lifetime risk of ASCVD. Additional factors may be identified in the future. Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
ASCVD Risk Estimator App What is it? A companion tool to the 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk. Enables health care providers and patients to estimate 10-year and lifetime risks for atherosclerotic cardiovascular disease (ASCVD) using the Pooled Cohort Equations and lifetime risk prediction tools. Provides Clinician and Patient references Where is it Available? The application is available on ios and Android platforms for both smart phones and tablets. Additionally, a web version is available on CardioSource and at AHA. Search for ASCVD Risk Estimator on itunes or Google Play, or go to http://www.cardiosource.org/science-and-quality/practiceguidelines-and-quality-standards/2013-prevention-guidelinetools.aspx Rollout Statistics Over 27,000 downloads since launch 4,000+ daily user sessions, and growing! Named the top iphone medical app for the month of February by imedicalapps
A Quick Reminder on Efficacy
How Am I Doing? Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
Bored?
Safety Modifiers Use moderate-intensity statin therapy in individuals whom high-intensity therapy is recommended, but characteristics predisposing them to adverse effects: Multiple or serious comorbidities Previous statin intolerance or muscle disorders Unexplained ALT elevations >3 times ULN Patient characteristics or concomitant use of drugs affecting statin metabolism >75 years of age Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
Diabetes Alert Individuals receiving statin therapy should be evaluated for new-onset diabetes mellitus and those who develop diabetes mellitus during statin therapy should engage in CV risk reduction lifestyle modifications and continue statin therapy to reduce their risk of ASCVD Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
Non-Statin Favorites No More! The panel could find no data supporting the routine use of nonstatin drugs combined with statin therapy to reduce further ASCVD events In individuals who are candidates for statin treatment but are completely statin intolerant, it is reasonable to use nonstatin cholesterol lowering drugs that have been shown to reduce ASCVD events in RCTs if the ASCVD risk reduction benefits. Stone NJ, et al. Circulation. 2013: published online before print November 12, 2013.
Other Tests: More Data Needed VAP Not specificially endorsed. Useful for non-fasting checks and particle size measurement. Lp(a) In AIM-HIGH, the additional reduction in non-hdl C [as well as additional reductions in Apo B, Lp(a), and triglycerides in addition to HDL C increases] levels with niacin therapy did not further reduce ASCVD risk in individuals treated to LDL C levels of 40 to 80 mg/dl CRP No specific mention; useful when additional info is needed.
Non Statin Plans Ok well that s all and great, but what about ezetimibe, niacin, PCSK9, fibrates, etc?
Other Possibilities?
Here s Where it Gets Tricky With ASCVD, maximize statin, then Add ezetimibe first Consider PCSK9 second
Onward
With Comorbidities Patients in this group have ASCVD with comorbidities including: diabetes recent (<3 months) ASCVD event ASCVD event while on statin Elevated Lp(a) CKD not on HD
With Comorbidities consideration of the lower LDL-C threshold (<70 mg/dl) non HDL-C threshold (<100 mg/dl for patients with diabetes).
With Comorbidities
Clinical ASCVD and LDL > 190 Can opt for PCSK9 up front, once maximized on statin OR can go with ezetimibe and bile acid sequestrant Lipid apheresis can be used if LDL > 190 in this group if maximally treated and HeFH
No Clinical ASCVD, LDL > 190 Experts suggest PCSK9 only if already on maximal statin; no clear guidance if statin intolerant
DM2, No clinical ASCVD
DM2, No Clinical ASCVD, > 7.5% Risk Use high intensity statin Add ezetimibe if not anticipated results (50% LDL reduction)
Still Some Questions What about statin intolerant patients? What if patients who were on statins have to come off due to LFT, CK, etc elevations? Ezetimibe intolerance?