2/10/2016. Patient-Centered Management of Dyslipidemia. No disclosures. What is Patient-Centered Management?

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1 Patient-Centered Management of Dyslipidemia Carl E. Orringer, MD, FACC, FNLA Associate Professor of Medicine University of Miami Miller School of Medicine President, National Lipid Association 1 No disclosures 2 What is Patient-Centered Management? Focus on evidence-based, individualized patient care Recognition that guidelines apply to groups, but that clinical judgment is needed to determine the best care for each individual patient Focus on patient-provider interaction and shared clinical decision making 3 1

2 Patient-Centered Management Depends upon Shared Decision Making (SDM) The SDM approach promotes a process whereby patients and providers decide upon treatment based upon two perspectives: Providers recommend treatments based upon strong evidence that benefits exceed risk. Patients consider how treatments fit their preferences, values and personal context. The provider is the expert on evidence-based medicine and guidelines; the patient is the expert on his or her preferences, values and personal context. Drozda JD et al. JACC 2015; in press 4 Shared Decision-Making Is Key Determinant of Patient Adherence Cost of medication Patient inability to afford co-pay Unclear label instructions Patient forgetfulness Adverse effects from the medication that the patient is too embarrassed to discuss Patient dislike of the idea of taking medication Patient lack of understanding of importance of taking medication in the absence of symptoms Sub-optimal patient-provider relationship Polypharmacy and complexity of regimen Drozda JD et al. JACC 2015; in press 5 Shared Decision Making Journal of Clinical Lipidology 2015;9:

3 Commonalities Between the ACC/AHA Guideline and the NLA Recommendations Focus on identification of high ASCVD risk patients (established ASCVD, diabetes mellitus, familial hypercholesterolemia) Advocate initiation of lifestyle therapy and, following a patient-provider discussion of the pros and cons of therapy, the use of moderate or high-intensity statins Promote regular lipid/lipoprotein monitoring as an important part of ongoing preventive care Acknowledge the need for expert guidance in ASCVD preventive care in special populations 7 Differences Between the ACC/AHA Guideline and the NLA Recommendations Breadth of evidence base employed The value of using lipoprotein goals Treatment algorithm focused on statin benefit groups (ACC/AHA) versus risk factor counting to determine ASCVD risk (NLA) Reliance on risk calculators to guide therapy in asymptomatic adults Advisability of the use of non-statin therapy 8 ACC/AHA Statin Benefit Groups H=High-intensity statin; M=Moderate-intensity statin Clinical ASCVD (H preferred; M if age >75 or if not candidate for H). Primary elevations of LDL-C 190 mg/dl (H preferred; M if not candidate for H). Age years with diabetes, and LDL-C mg/dl, no clinical ASCVD (M if 10-year risk <7.5%; H if 7.5%). Age years, no clinical ASCVD or diabetes, LDL-C mg/dl, and estimated 10-year ASCVD risk 7.5% using Pooled Cohort Risk Equations (M or H). 3

4 The ACC/AHA Risk Calculator ACC/AHA Blood Cholesterol Guideline Statin intensity: high or moderate intensity better outcomes than placebo; high intensity best outcomes Statin dosing: fixed doses of statins of proven benefit; dosage titration of uncertain benefit Non-HDL-C or LDL-C goals: no evidence to support their use Non-statin therapy: risk/benefit ratio does not support the use of non-statins (document published prior to publication of IMPROVE-IT and early PCSK9 inhibitor outcomes data) Lipid monitoring: should be done to assess adherence, not specific levels of LDL-C attained 11 Overview of NLA Recommendations Excessive circulating atherogenic lipoproteins is a root cause of ACSVD. Risk assessment including ASCVD history and risk factor counting is the first step in preventive therapy decisionmaking. Risk reduction intensity should generally be matched to ASCVD risk. Non-HDL-C and LDL-C lowering will generally reduce ASCVD in proportion to reduction of those lipoproteins (lower is better). Non-HDL-C and LDL-C goals should be set and monitored to assess adherence and effective reduction of atherogenic lipoproteins; non-hdl-c goals take precedence. 4

5 Overview of NLA Recommendations Consider the use of risk calculators in selected moderate-risk patients, but recognize that all risk calculators have their strengths and limitations. Employ moderate- or high-intensity statins as drugs of choice for prevention. Consider adding non-statins for persistently elevated non-hdl-c and LDL-C. 13 Steps to Using the NLA Part I Recommendations in Patient Care Identify the highest ASCVD risk level applicable to the patient. Rule out secondary causes of dyslipidemia. Establish non-hdl-c and LDL-C treatment goals. When present, address triglyceride disorders. If drug therapy is clinically indicated, engage the patient in a risk/benefit discussion. Treat to non-hdl-c and LDL-C goals and periodically re-check their levels to assess adherence to lifestyle and medication and to assure that lipoprotein goals continue to be met. 14 Risk Category Low Moderate High Very High NLA Recommendations for ASCVD Risk Assessment, Treatment Goals and Lipoprotein Levels at which to Consider Drug Therapy Criteria TreatmentGoal ConsiderDrug Therapy 0-1 majorascvd risk factors Consider other risk indicators, if known 2 majorascvd risk factors Consider quantitative risk scoring Consider other risk indicators 3 major ASCVD risk factors Diabetes mellitus* (Type 1or 2) 0-1 other major ASCVDrisk factors, and No evidence of end organ damage Chronic kidney disease stage 3B or 4 LDL-C 190 mg/dl (severe hypercholesterolemia) Quantitative risk score reaching the high-risk threshold ASCVD* Diabetes mellitus* (Type 1or 2) 2 other major ASCVD risk factors or Evidence of end organ damage <130 <100 <130 <100 <130 <100 <100 <70 Non-HDL-C mg/dl LDL-C mg/dl *For patients with ASCVD or diabetes mellitus, consideration should be given to use ofmoderate-or high-intensity statin therapy, irrespective of baseline atherogenic cholesterol levels. 15 5

6 NLA Recommendations Rationale for Lipid/Lipoprotein Goal Setting Places focus on the cause of the disease. Aids in the process of shared decision-making. Encourages longitudinal follow-up and the importance of monitoring of both lifestyle and medication adherence. Provides consistent messaging with management of other co-existing ASCVD riskrelated conditions for which goal setting dictates standards of care (HBP, DM). 16 Addressing the Evidence Gaps to Improve Patient-Centered Care NLA Recommendations for the Patient- Centered Management of Dyslipidemia- Part II (December 2015) ACC Expert Consensus Panel on the Use of Non-Statin Therapy (March 2016) 17 6

7 Lipid Management in Special Populations The lifespan Children and adolescents Women Older patients Ethnic groups Hispanics/Latinos African Americans South Asians American Indians and Alaskan Natives Chronic inflammatory states HIV disease Rheumatoid arthritis Recurrent ASCVD events or progressive ASCVD despite statins and lifestyle therapy Children and Adolescents Screen at 9-11 years. At age 2 if positive family history of premature ASCVD or dyslipidemia. Screen with fasting lipid panel or-non fasting non-hdl-c. If LDL-C 130 or non-hdl-c 145 mg/dl, obtain and average 2 fasting lipid profiles. If above values confirmed, initiate lifestyle intervention (RD-N) and screen family members. Consider statins beginning at age 8 for LDL-C 190 or non-hdl-c 220 mg/dl. Resins safe but adherence is a problem; limited data on other agents. LDL apheresis may be considered for homozygous FH patients beginning at age Women For primary prevention, women and men of comparable ASCVD risk experience similar reduction in ASCVD events with statins. Women and men with ASCVD demonstrate significant and similar relative risk reduction with statins. Women and men with type 2 diabetes demonstrate significant and similar relative risk reduction in all cause and vascular mortality with statins. Moderate- or high-intensity statins are the drugs of choice, but women are more likely to experience adverse drug reactions. Except for colesevelam, lipid medications should be stopped 1-3 months prior to planned conception and during nursing. Polycystic ovarian syndrome is associated with insulin resistance; lifestyle management is the treatment of choice, followed by metformin. 21 7

8 Older Patients The Cholesterol Treatment Trialists meta-analysis of statin 26 RCT s identified 4,032 subjects aged >65 to 75 years and 885 subjects >age 75 years. Relative risk reduction of ASCVD was similar to younger populations with no increase in cancer risk or cancer death. For secondary prevention for patients age 80 years, moderateintensity statin therapy should be considered after a patient-provider discussion of the risks and benefits of such therapy. Consider potential for drug-drug interactions, polypharmacy, concomitant medical conditions including frailty, cost considerations and patient preference. Older, as compared to younger patients, are: More likely to experience muscle symptoms No more likely to develop type 2 DM or cognitive dysfunction 22 Ethnic Considerations: Statins Are the Drugs of Choice, But Hispanic/Latinos have variable ASCVD risk, depending upon country of origin; in general, risk of T2DM and metabolic syndrome is higher, but ASCVD risk lower ( Hispanic paradox ) than non-hispanic Whites. African Americans have a lower prevalence of metabolic syndrome, less coronary calcium and less dyslipidemia-related risk, but more T2DM, higher Lp(a), higher prevalence and earlier onset of target organ damage due to HBP, including LVH, heart failure, CKD and endstage renal disease and higher rates of CHD, premature CHD, stroke and CVD mortality than do NHW s. South Asian Indians, despite lower BMI s and smaller waist circumferences than NHW s, have lower HDL-C, higher TG, more T2DM and increased ASCVD risk compared to NHW s. American Indians and Alaskan natives have shorter life spans, more obesity, T2DM, cigarette smoking & ASCVD risk than NHW s. 23 HIV Disease ASCVD risk is increased in patients with HIV disease, especially in those with CD4 counts <200 cells per mm 3. HIV disease is associated with low HDL-C, high TG and increased non-hdl-c, with or without HAART. The presence of HIV disease should be considered, to be equivalent to one additional ASCVD risk factor. The response to statins and fibrates in patients with HIV disease is similar to that of the general population. Newer anti-retroviral regimens are associated with less impact on blood lipids and a lower risk of MI than previous regimens. 24 8

9 Statin Use in HIV-Infected Patients Statins are first line therapy for elevated LDL-C and non- HDL-C. Generally avoid using lovastatin and simvastatin because of an increased potential for drug-drug interactions. Nucleoside reverse transcriptase inhibitors, and integrase inhibitors, except when boosted with cobicistat, do not have any significant drug-drug interactions with statins. Pitavastatin is the only statin not known to have interactions with ART and does not require dosage adjustments. Atorvastatin and rosuvastatin may also be used, but may require dosage adjustment depending upon the type of ART used. Rheumatoid Arthritis ASCVD risk in patients with RA is 1.5 to 2 fold higher than that of the general population. Elevated ASCVD risk in RA patients is most likely due to chronic inflammation. RA patients as a group have lower total cholesterol and LDL-C level than the general population, despite higher ASCVD risk. For primary prevention, RA should be counted as an additional ASCVD risk factor. Statins are first line therapy for dyslipidemia. LDL-C levels tend to be inversely related to disease activity; thus, lipid levels measured during an RA flare should not be used to assess success of lipid-lowering therapy. 26 Progressive ASCVD Despite Lifestyle and Pharmacologic Therapy: Key Questions Is the patient taking medication as prescribed? Are statin-related side effects playing a role? Are sociocultural factors responsible for less than optimal response to therapy? Are poor lifestyle habits sabotaging effective lowering of non-hdl-c and LDL-C? Are sub-optimally controlled non-lipid major risk factors accelerating ASCVD risk? Are other risk factors accelerating ASCVD risk (increased non-hdl-c, elevated hs-crp, Lp(a) elevation, prothrombotic states)? 9

10 Candidates for Statin/Non-Statin Combination Therapy High or very-high risk patients with a less-thandesirable response to moderate- or high-intensity statin therapy Patients who have recurrent ASCVD events or progressive symptoms despite high-intensity statin therapy Patients with FH, especially with ASCVD or poorly controlled non-lipid risk factors, and less than optimal non-hdl-c or LDL-C levels Patients with recent acute coronary syndromes on at least moderate-intensity statin therapy Combination Therapy Expert Opinion Multiple Guideline Documents NLA Patient-Centered Recommendations-Part II ACC Expert Consensus Clinical Pathway on Non-Statin Therapies December 2015 Spring ACC Expert Consensus Clinical Pathway on Lipid Management Writing panel was assembled from broad-based stakeholders following the LDL: Address the Risk Think Tank meeting in September Participants identified the need for expert consensus recommendations on incorporation of non-statin therapies into treatment strategies for higher risk patients if the response to statins is deemed inadequate. A 9-person Writing Group was selected, chaired by Donald Lloyd-Jones, MD and included a majority of members without relevant RWI; authors with relevant RWI were not permitted to draft or vote on content or recommendations pertaining to their RWI. Peer reviewers were established and the respective executive boards of the professional societies provided final review and approval of the document. 10

11 Questions Addressed by the ACC Expert Consensus Panel 1) In whom should non-statin therapies be considered? 2) In what situations should non-statin therapies be considered, i.e. when is the amount of LDL-C lowering (percent LDL-C reduction or LDL-C range achieved on therapy) less than anticipated, less than desired, or inadequate, and what should be done with patients who are truly statin intolerant? 3) If non-statin therapies are to be added, which agents or therapies should be considered and in what order? Patient-Centered Management of Dyslipidemia: Summary Patient-centered management of dyslipidemia entails knowledge of evidence-based therapy and shared decisionmaking. Patient-centered management and shared decision-making enhance patient adherence and quality of preventive care. Knowledge of the characteristics of special populations enhances patient-centered management. Evidence-based guidelines and expert opinion may be useful to fill in the gaps in those cases in which available evidence does not adequately address important clinical questions in ASCVD preventive care. 32 Key References Stone NJ, Robinson JG, Lichtenstein AH et al ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce ASCVD Risk in Adults. Circulation 2014;129:S1-45. Drozda JD, Ferguson TB Jr, Jneid Hani et al ACC/AHA Focused Update on Secondary Prevention Lipid Performance Measures. J Am Coll Cardiol 2015; in press. Jacobson TA, Ito MK, Maki KC, Orringer CE, et al. National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 1-Full Report. Journal of Clinical Lipidology 2015;9:

12 Key References (continued) Jacobson TA, Maki KC, Orringer CE et al. National Lipid Association Recommendations for the Patient-Centered Management of Dyslipidemia: Part 2. Journal of Clinical LIpidology 2015;9: S Orringer CE. Key Aspects of the NLA Recommendations for the Patient-Centered Management of Dyslipidemia. December 11, Accessed January 4, cardiology/articles/2015/12/11/13/50/key-aspects-of-the-nlarecommendations-for-the-patient-centered-management-ofdyslipidemia 34 12