presentation slides final healio - national lipid association · title: microsoft powerpoint -...
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Serving the Underserved: Are We Overlooking HoFH Patients?
A NATIONAL LIPID ASSOCIATION ASSESSMENT
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Financial Disclosure
Supported in part by Aegerion, Inc. and REGENXBIO Inc.
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Background Familial hypercholesterolemia (FH) is one of the most commonly occurring
genetic disorders in the world. It is estimated that 1 in 250 Americans have heterozygous FH and about 1 in
160,000 to 300,000 have homozygous FH (HoFH). Homozygotes are often unresponsive to dietary and pharmacologic
intervention and often develop clinically significant ASCVD before reaching the age of 30.
Most FH patients remain undiagnosed and untreated.
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Background The National Lipid Association (NLA) conducted a survey to evaluate the knowledge and
practice of primary care and other clinicians for patients with HoFH. These clinicians are usually the first in the healthcare community to see these patients. The initiative was led by a steering committee comprised of several NLA thought leaders:
Dean C. Karalis, MD, FACC, FNLA
G. Kees Hovingh, MD, PhD, MBA Anne C. Goldberg, MD, FNLA, FACPLinda C. Hemphill, MD, FACC, FNLA
Jerome D. Cohen, MD, FNLA
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Methods An independent research and
survey vendor was used to conduct the survey.
The survey was sent out via e-mail to 14,904 medical professionals across the United States (US) from a registry of practitioners who agree to take surveys and who matched the specialty requirement.
The survey was fielded from June 26, 2018 to July 16, 2018.
A total of 504 clinicians completed the survey.
Screening Criteria• US-based based clinicians
• Currently treating patients with elevated LDL-cholesterol
• Licensed to prescribe medication
• Eligible medical disciplines: Physician
Nurse Practitioner
Physician Assistant
• Eligible specialty groups: Family Medicine
General Practice
Internal Medicine
Cardiology
Screening Criteria• US-based based clinicians
• Currently treating patients with elevated LDL-cholesterol
• Licensed to prescribe medication
• Eligible medical disciplines: Physician
Nurse Practitioner
Physician Assistant
• Eligible specialty groups: Family Medicine
General Practice
Internal Medicine
Cardiology
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Northeast South Midwest West
24% 35% 23% 18%
Survey Participants by Region
Number of Respondents
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48%(241)
1%(4)
4%(23)
47%(236)
Family Medicine Cardiology
General Practitioner Internal Medicine
7%(34)
85%(430)
8%(40)
Nurse Practitioner Physician
Physician Assistant
Respondent Demographics
Respondents by Medical Discipline
Over four-fifths of respondents (85%) were physicians and almost all respondents (99%) reported a medical area of practice in primary care and general medicine.
Respondents by Medical Area of Practice
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12%(62)
88%(442)
Yes No
8%(39)
92%(465)
Yes No
Respondent DemographicsThe overwhelming majority of respondents do not consider themselves lipid specialists (88%) nor are they certified by the American Board of Clinical Lipidology (ABCL) or Accreditation Council for Clinical Lipidology (ACCL) (92%).
Do You Consider Yourself a Lipid Specialist?
Are You Certified by the ABCL or ACCL?
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67%(338)
22%(109) 9%
(44)
Private PracticeHealth SystemInstitution/AcademicVA/Government Health SystemNone of the Above
14%(70)
56%(281)
30%(153)
Rural Suburban Urban
The majority of respondents (56%) practice in a suburban setting and two-thirds are in private practice.
Respondent Practice Information
Respondents by Practice Location Respondents by Practice Setting
1%(6)
1%(7)
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59%
76%
69%
41%
24%
31%
0% 20% 40% 60% 80% 100%
Family with parent who has LDL-C ≥ 400mg/dL and all offspring have LDL-C 160-400mg/dL?
Pt(s) with treated LDL-C levels >300 mg/dL?
Pt(s) with untreated LDL-C of ≥400 mg/dL?
Yes No
Very High LDL-C in Respondent Practices
In Your Practice Do You Have:
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70%
27%
16%
39%
36%
14%
34%
57%
0
100
200
300
400
500
600
First Choice Second Choice Third Choice
Refer to a SpecalistLifestyle Changes and Repeat Lipids in 6 monthsTreat with Medication
What Steps Would You Take?
53% would diagnose this as HoFH. 70% say their first step would be to treat with medication.
Diagnosis and Management of Patients with an Untreated LDL-C ≥ 400 mg/dL
7%
Num
ber o
f Res
pond
ents
2%
5%
16%
24%
53%
0 100 200 300
FCS
High Cholesteroldue to lifestyle
MixedHyperlipidemia
HeFH
HoFH
What Would Your Diagnosis Be?
Number of Respondents
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68%
29%
13%
39%
42%
19%
32%
55%
0
100
200
300
400
500
600
1 2 3
Refer to a Specialist
Lifestyle Changes and Repeat Lipids in 6 Months
Adjust Medication
3%
The majority no longer recognizes HoFH but does appropriately select adjust medication as next step.
Diagnosis and Management of PatientsWith a Treated LDL-C >300 mg/dL
What Would Your Next Steps Be?
Num
ber o
f Res
pond
ents
2%
5%
20%
32%
41%
0 100 200 300
FCS
High Cholesteroldue to lifestyle
MixedHyperlipidemia
HeFH
HoFH
What Would Your Diagnosis Be?
Number of Respondents First Choice Second Choice Third Choice
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Family with parent who has LDL-C >400mg/dL and all offspring have LDL-C 160-400mg/dLDiagnosis of HoFH was not improved by knowledge of elevated cholesterol levels in all offspring.
Yes
3%
5%
15%
26%
51%
0 100 200 300
FCS
High Cholesteroldue to lifestyle
MixedHyperlipidemia
HeFH
HoFH
Do you have a family where one parent has a LDL-C ≥ 400 mg/dL and all
offspring have LDL-C 160-400 mg/dL?
What Would Your Diagnosis Be (of patient(s) with an
Untreated LDL-C ≥400 mg/dL)?
1%
4%
17%
21%
57%
0 100 200 300
FCS
High Cholesteroldue to lifestyle
MixedHyperlipidemia
HeFH
HoFH
Number of Respondents Number of Respondents
What Would Your Diagnosis Be (of patient(s) with an
Untreated LDL-C ≥400 mg/dL)?
59%(297)
41%(207)
No
No Yes
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Yes
67%(338)
33%(166)
Yes No
64%(218)
36%(120)
Yes No
Three-quarters of respondents have a patient that was diagnosed with HoFH, of those, 64% have a patient on a PCSK9 inhibitor.
HoFH Patient Demographics
Do You Have Patients That Have Been Diagnosed with HoFH?
Do You Have an HoFH Patient on a PCSK9 Inhibitor?
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Yes
24%(81)
76%(257)
Yes No
67%(338)
33%(166)
Yes No
HoFH Patient Demographics Of the three-quarters of respondents who report having a patient diagnosed with HoFH, one-quarter (24%) have an HoFH patient on LDL-apheresis.
Do You Have Patients That Have Been Diagnosed with HoFH?
Do You Have an HoFH Patient on LDL-Apheresis?
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33%(168)
24%(119)
43%(217)
LDL-C decrease 50% LDL-C <70 mg/dL
LDL-C <100 mg/dL
HoFH Patient Demographics 43% of respondents have a treatment goal of LDL-C <100 mg/dL for those HoFH patients who are free of Clinical ASCVD.
What Treatment Goal Would You Use for an HoFH Patient Who is Free of Clinical ASCVD?
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57%(285)
43%(219)
Yes No
37%(105)
63%(180)
Genetic testing Clinical criteria
Yes
The majority of respondents report diagnosing a patient with HoFH. Of those, almost two-thirds (63%) used clinical criteria to diagnose.
HoFH Diagnosis and Treatment Plan
Have You Diagnosed Patients with HoFH?
What Method Did You Use to Diagnose HoFH?
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53%
55%
66%
87%
90%
0 200 400 600
Non-HDL
Lipoprotein(a)
CACScoring
LDL-C
FamilyHistory
HoFH Patient Risk AssessmentRespondents use family history and LDL-C most often as the risk factors to determine CVD risk.
What Risk Factors Would You Use to Determine CVD Risk?
Number of Respondents
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82%(411)
18%(93)
Yes No
HoFH Patient Risk AssessmentOver four-fifths (82%) of respondents used risk calculators to determine if patients were at high risk of ASCVD.
Would You Use Risk Calculators for Determining High Risk of ASCVD?
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80%63% 60%
39%29%
17% 15% 14% 13% 11% 8% 7%
1.5
2.8
2.3
3.1
4.1
3.7
4.2 4.2
3.9
2.8
4.5
3.6
1.0
2.0
3.0
4.0
5.00
50
100
150
200
250
300
350
400
450
Highdose statin
Diet andexercise
PCSK9inhibitor
Ezetimibe Fish oil Fibrate Bile acidsequestrant
Niacin LDL-Apheresis
Low/Moderatedose statin
Plantsterols
Lomitapide
Choi
ce R
ank
# of
Res
pond
ents
Sel
ectin
g
Treatment of HoFH PatientsFour-Fifths of respondents would use high dose statins to treat HoFH patients. High dose statins were also ranked the highest of all the therapies (1.5 average).
What Would You Use to Treat HoFH Patients?
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63%(320)
37%(184)
Yes No
Access to Lipid SpecialistsTwo-thirds (63%) of respondents report their practice has access to a lipid specialist.
Does Your Practice Have Access to a Lipid Specialist?
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Access to Lipid Specialists by Respondents Who Do Not Consider Themselves Lipid SpecialistsAlmost two-thirds of respondents (61%) who do not consider themselves lipid specialists report their practice does have access to a lipid specialist.
12%(62)
88%(442)
Yes No
61%(269)
39%(173)
Yes No
No
Do You Consider Yourself a Lipid Specialist?
Does Your Practice Have Access to a Lipid Specialist?
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29%(148)
71%(356)
Yes No
Access to LDL-Apheresis CentersLess than one-third (29%) have access to an LDL-apheresis center.
Does Your Practice Have Access to an LDL-Apheresis Center?
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Patients on LDL-Apheresis by Practice Access to an LDL-Apheresis Center Access to an LDL-Apheresis Center has a major impact on whether or not a respondent has an HoFH patient on LDL-Apheresis.
NoYes 24%(81)
76%(257)
Yes No
84%(68)
16%(13)
Yes No
23%(58)
77%(199)
Yes No
Do you have an HoFH patient on LDL-apheresis?
Does Your Practice Have Access to an LDL-Apheresis Center?
Does Your Practice Have Access to an LDL-Apheresis Center?
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Access to an LDL-Apheresis Center is lacking across all regions, with approximately two-thirds of respondents not having access in each of the four US Census Regions.
27%(47)
73%(128)
Yes No
29%(34)
71%(83)
Yes No
33%(40)
67%(82)
Yes No
30%(27)
70%(63)
Yes No
Access to an LDL-Apheresis Center by Region
Does Your Practice Have Access to an LDL-Apheresis
Center?
Does Your Practice Have Access to an LDL-Apheresis
Center?
Does Your Practice Have Access to an LDL-Apheresis
Center?
Does Your Practice Have Access to an LDL-Apheresis
Center?
Northeast South Midwest West
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Access to an LDL-Apheresis Center by Practice Location
Access to an LDL-Apheresis Center is lacking across all locations, with rural practices having the least access.
SuburbanSuburban UrbanUrbanRuralRural
30%(84)
70%(197)
Yes No
13%(9)
87%(61)
Yes No
36%(55)
64%(98)
Yes No
Does Your Practice Have Access to an LDL-Apheresis Center?
Does Your Practice Have Access to an LDL-Apheresis Center?
Does Your Practice Have Access to an LDL-Apheresis Center?
Rural Suburban Urban
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24%
54%
17%
5%
0
50
100
150
200
250
300
<18 Yrs 19-29 Yrs 30-39 Yrs >40 Yrs
20%
51%
19%
10%
0
50
100
150
200
250
300
<18 Yrs 19-29 Yrs 30-39 Yrs >40 Yrs
Age at Which Respondents Would Start HoFH Patients on LCL-C Lowering Medications
The majority of respondents would start an HoFH patient on LDL-C lowering medications at 19 to 29 years of age, for both males and females (54% and 51%, respectively).
What Age Would You Start a malePatient on LDL-C Lowering Medication?
What Age Would You Start a femalePatient on LDL-C Lowering Medication?
Num
ber o
f Res
pond
ents
Num
ber o
f Res
pond
ents
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Age at Which Respondents Would Start HoFH Patients on LCL-C Lowering Medications by SpecialtyThe age at which respondents would start a patient with HoFH on LDL-C lowering medications remains consistent regardless of the respondent’s medical specialty.
13%
28%
9%
2%
11%
26%
8%
3%
0
20
40
60
80
100
120
140
160
<18 Yrs 19-29 Yrs 30-39 Yrs >40 Yrs
Family Medicine/General Practitioner
Internal Medicine/Cardiology
11%
27%
9%
4%
9%
24%
10%
6%
0
20
40
60
80
100
120
140
160
<18 Yrs 19-29 Yrs 30-39 Yrs >40 Yrs
Family Medicine / General Practitioner
Internal Medicine/Cardiology
What Age Would You Start a malePatient on LDL-C Lowering Medication?
What Age Would You Start a femalePatient on LDL-C Lowering Medication?
Num
ber o
f Res
pond
ents
Num
ber o
f Res
pond
ents
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Conclusion
Many clinicians:
Do not recognize HoFH. Do not adequately treat HoFH. Do not have access to a lipid
specialist. Do not have access to a LDL-
apheresis center.
There is a need for:
More education for clinicians in recognizing and treating HoFH
Greater access to lipid specialists.
Greater access to LDL-apheresis centers.
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Quick EHR Search Terms Untreated LDL-C ≥ 400 mg/dL Treated LDL-C >300 mg/dL Family history of high cholesterol Family history of premature CV disease
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Raal, FJ, Sjouke B, Hovingh GK, Isaac BF. Phenotype diversity among patients with homozygous familial hypercholesterolemia: A cohort study. Atherosclerosis. 2016; 248: 238–244. doi:10.1016/j.atherosclerosis.2016.03.009.
Sjouke B, Kusters DM, Kindt I, et al. Homozygous autosomal dominant hypercholesterolaemia in the Netherlands: prevalence, genotype–phenotype relationship, and clinical outcome. Eur Heart J. 2015; 36: 560–565. doi:10.1093/eurheartj/ehu058.