Exploring the Evidence: Improving Cardiovascular Outcomes and the Role of Weight Loss Pharmacotherapy

Chair A. Michael Lincoff, MD, discusses obesity in this CME activity titled “Exploring the Evidence: Improving Cardiovascular Outcomes and the Role of Weight Loss Pharmacotherapy.” For the full presentation, downloadable Practice Aids, and complete CME information, and to apply for credit, please visit us at https://bit.ly/3KAO98K. CME credit will be available until April 25, 2025.

1. Exploring the Evidence
Improving Cardiovascular Outcomes
and the Role of Weight Loss
Pharmacotherapy

A. Michael Lincoff, MD

Vice Chair for Research

Department of Cardiovascular Medicine

Professor of Medicine

Cleveland Clinic Lerner College of Medicine of Case
Western Reserve University

Cleveland Clinic

Cleveland, Ohio

Go online to access full CME information, including faculty disclosures.

© 2000-2024, PeerView

2. Our Goals for Today

Appreciate the CV impact of obesity and the need to
prioritize its management

Summarize the relevant data on anti-obesity medications

and their CV effects from the American College of Cardiology
73rd Annual Scientific Session

Integrate these data into cardiology practice when providing
care to people with obesity

2000-2024, PeerView

3. Obesity Directly Influences Cardiovascular Risk,
Warranting Specifically Targeted Management!

Stage 2 Stage 3

Stage 4
Clinical CVD in
CKM syndrome

Stage 0 Metabolic risk Subclinical
No risk factors factors and CVD in CKM
CKD syndrome

QQ

N P Hé

+ Focus on primordial + Overweightobesity + Hypertriglyceridemia + Subclinical ASCVD + CHD

prevention and + Abdominal obesity + Hypertension + Subclinical HF + AF
preserving CV health + Impaired glucose (ronmeatolcebooaies) + Risk equivalents of + HF
tolerance Cee subclinical CVD: + Stroke
+ Moderate to very high-risk CKD; + PAD
Lise. high predicted risk
+ Metabolic syndrome fo" CVD using risk
calculator
1. Ndumele CE eta. Creultion 2023:148:1606. PeerView.com

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4. Obesity Affects a Substantial
Proportion of Patients With HFpEF!

Total HF Hospitalizations and CV Death Total HF Hospitalizations and CV Death

According to BMI ‘According to Waist-to-Height Ratio
qe 2”
In PARAGON-HF FH u Pi P overall =.001
(N = 4,796), greater 32 $
A res ¿E af
abdominal adiposity 38 33
(as assessed by 4 Li
WHR) was associated 5 oa 5 06 07 08 09
with a higher risk of HF BM hate? Waist-to-Height Ratio

de AlL-Cause Death According to BMI Al-Cause Death
hospitalizations and CV ase + According to Waistto-Height Ratio

death, with no e El

evidence for an af ai:
{ EA EA
ga 3

ig 38°

ER ge P overall = 58
3 E.
E SE E à O
BMI, kg/m? Waist-to-Height Ratio.
1.Pokert A to. ACC 24. Abstract 1086-08. PeerView.com

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5. GLP-1 RAs Have an Increasingly Important Role in HF
as They Reveal Improvements in Functional Outcomes’

+ Retrospective cohort study
+ N=3,434
+ Patients with HFpEF and diabetes with matching baseline characteristics
(age, gender, race, BMI) and comorbidities
+ Ata mean 26 months of follow-up
— Rates of HFH were 1.74-fold (95% CI, 1.05-3.01) lower with semaglutide
(54.95 vs. 95.77 per 1,000 patient-years, P = .022)
— Rates of IV diuresis were 2.28-fold (95% Cl, 2.04-2.55) lower with
semaglutide (568.4 vs. 1298.5 per 1,000 patient-years, P < .001)
— Rates of all cause hospitalization with semaglutide were similar to
nonrecipients (RR=0.94; 95% Cl, 0.77-1.14)

1. Gangavell A et al. ACC 24. Abstract 1086-13. PeerView.com

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6. STEP. Effect of Semaglutide 2.4 mg SC Weekly

HFpEF DM

in People With T2DM, Obesity, and HFpEF'!

STEP-HFpEF DM Trial Design

AO 1021060, plus >>
17m9

Semaglutide 2.4 mg SC once weokly

‘Adults 218 years,
BMI 230 kg/m?
T2DM

EF 245 and HFpEF

ebo SC once weekly

N=616
Weeko Week 16
Randomization End of dose escalation End of treatment
Dual primary endpoints Confirmatory secondary endpoints
Change from baseline in + 6-min walk distance
+ KCCQ-Css + Hierarchical composite (win ratio)
+ Body weight + Change in hs-CRP

1.Kosiborod MN et al. JACC Heart Foi. 2023:11:1000-1010. PeerView.com

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7. STEP-

HFPEF DM Fast Facts for Cardiologists’

STEP-HFpEF DM Participants Had Baseline Treatmeı
Obesity-Related HFpEF and T2DM and HF History
N=616 80% used diuretics
44% female; 69 years old (mean)
80% used ACEI, ARB, or ARNI]
E 82% had HTN
Median BMI 37 i
canted || are | | 376 had Ar 83% used $ blockers
BMI235 25% had CAD
34% used MRA
, Median LVEF
vere NE Median CRP 57% 16% had HF hospitalization within 1 year
478 pglmL. 3.7 mg/L NYHA Class II
ve 35% used SGLT2i
Median KCCQ-CSS: 60.4 points
1. Kosborod MN et a. N Engl J Med. 2024 Apri 6 [Epub ahead of print), PeerView.com

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8. Semaglutide Effectively Targets Obesity-Related

HFpEF in People With T2DM'

STEP-
HFpEF DM
Change in KCCQ-CSS
15 Somagiutide |
a
€
É
y
2
3
a Papas
Seca 20 mm mm ww
Pie mm m

Semaglutide reduced A1C, despite well-

controlled glycemia at baseline, without an
increase in clinically significant hypoglycemia

1. Kosiborod MN ot a. N Engl J Med. 2024 Apri 6 [Epub ahead of print,

PeerView.com/MVU827

At 1 year, semaglutide led to larger reductions

in dual primary endpoints in patients with
PR obesity-related HFpEF and T2DM

73 pens
Br ch 41-104)

Pa oo

Change in Bodyweight

1 ® 347 estimated iforonce.

5 porcontage pots
CETTE)
Pe oot
hos

Semaglutide

Change From Baseline, %

NET R 2 8 un
Time Since Randomization, wk

‘Semagiuise 310 207 297 200 250 292 203
Placebo 906 200 200 287 292 209 M2 218 am 210

No. of Partcipante
m m

+ PeerView.com

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9. Feats Semaglutide Increased 6MWD; Resulted in More
Wins in Hierarchical Composite Endpoints’

Stratified Win Ratio for Hierarchical Composite End Point

210-Point Difference in
‘Change in KCCQ-CSS

in se
Change in 6MWD overat
= }
7 À estimates ierenee
° H 143m De
Em | emcaruo
¿ I "Pe 008
2 H Number of HF Events
1: de in |
5 i Time to First HF Event | 99 Stated win ratio, 1.58
. ! (95% Cl, 129-194)
E H p< 001
Ba H 215:Point Difference in ES
80 tf

16 ‘Change in KCCQ-0SS

o 2 rs 25-Polnt Difference in

M Semaglutise winner
Change in KCCQ-CSS
Time Since Randomization, wk

| Placebo winner

No.of Patpants i
Semaguice 210 zu m 230-m Diterencein HN 49 mie
Paco 206 m m anos!
EEE EE
Porcontage .
1. Kosiborod MN et a. N Engl /Med. 2024 Apri [Epub ahead of print} PeerView.com

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10. Semaglutide Decreased CRP Levels in People
With Obesity-Related HFpEF and T2DM'

Change in C-Reactive Protein Level

g os {20877 cesmats reatnont
E H rato, 067
£ H (95% C1, 055.080)
fo Dal ee
3 Semaglutide H
Bo i
2 4
2 02 H
á H
2 E 2 =
Time Since Randomization, wk
No. of Participants
Semogutde 310 208 206 310
Placebo 206 25 au 306
1.Kosiorod MN et aN Engl Med. 2024 Apr 6 [Epub ahead o pr. PeerView.com

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11. Limitations of the STEP-HFpEF DM Trial!

* The percentage of Black participants was lower than what
has been reported nationally among patients with HFpEF,
potentially limiting the trial’s generalizability

« Follow-up duration was limited to 1 year

— The effects of semaglutide suggest persistent
improvements but the durability of these effects beyond
1 year cannot be presumed

* The trial was not designed nor powered to evaluate events
such as hospitalizations and urgent visits for HF

1. Kosiborod MN ot al. N Engl J Med. 2024 Apr 6 [Epub ahead of prin, PeerView.com

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12. STEP-HFpEF DM Confirms Previously
Reported Findings From the STEP-HFpEF Trial!2

+ Consistency between the two trials provides greater reassurance that
semaglutide is an efficacious treatment option with a favorable safety
profile in a broad population of patients

+ Semaglutide improves HF-related outcomes regardless of whether or not
the patients have received SGLT2 inhibitors

+ Findings from the two trials suggest that the mechanisms of benefit with
semaglutide may extend beyond weight loss and include direct effects on
decongestion; vascular, skeletal muscle, and mitochondrial function;
epicardial adipose tissue; and inflammation

1. Kosiborod MN ot a. N Engl J Med. 2024 Apri 6 [Epub ahead of print. 2. Butler Jet al. Lancet. 2024. 2024 Apr 7 [Epub ahead of prin. PeerView.com

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13. Obesity Metrics Affirm Interplay Between Body Fat
Composition and Cardiovascular Well-Being’

Quantile Regression for Predicting Plaque Volumes Across Various Measures of Obesity

BMI Waist Circumference Waist-to-Hip Ratio
Unadjusted Fully adjusted Unadjusted Fullyadjusted Unadjusted Fullyadjusted

Non-calcified plaque volume, mm?

Non-obese Reference Reference Reference

Obese 43851051) 19(11t027) 18(12t025) 14(84t020) 25(20%031) 7(1.910 12)
Calcified plaque volume, mm?

Non-obese Reference Reference Reference

Obese -89(51t0-27) -32(42t0-23) -22(32t0-12) -1.3(-1.9t0-0.63) 0.9(-0.241020) -0.4(-1.1 00.27)
Total plaque volume, mm?

Non-obese Reference Reference Reference

Obese 41(3110 51) -14(351056) 20(11t028) 12491019) 20(221036) 6.7(1.71012)

+ Data are represented as B-coefficients with corresponding 95% CI
+ The fully adjusted model included the following covariates: age, sex, race/ethnicity, LDL-C, HDL-C, diabetes mellitus, systolic and
diastolic BP, statins medications, and aspirin

1. Anwaar MF etal. ACC 24. Abstract 1453-212. PeerView.com

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14. Real-World Evidence: AOM Use Has Increased, But
Cardiologists Need to Engage In Anti-Obesity Care More Often’

New Prescriptions of FDA-Approved Anti-Obesity Medications in the Mass General Brigham
Healthcare System by Type and Provider Specialty, 2018-2022

AOM Type Provider Specialty

:
3

E À 7500 m Ligue om) ES 7.500 = Cardiology
a8 mm Natonesupopen ER Endocrinology
22 500 m Oristat DI so 1m Primary care!
3% mm Phontermine-opiramate 23 lisa
33 mm Semagluide (24m) 35 mm Weight management
28 250 BB 250 um Other/unclassified
e a
o o
2018” 2019” 2020” 2021 202 2018” 2019” 2020 2021 2022
Time, y Time, y
1. Ostrominisk J etal, ACC.24. Abstract 1453-217. PeerView.com

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15. FDA-Approved Anti-Obesity Medications (AOMs)'*

LP-1 RA
RA/amylin analo:

+ Approved for shorttem use ony.
1. Side courtesy of Jame Amandot, MD. 2. Tak YJ, Loe SY. Cur Obes Rep, 2021:10:14-90 3, Gruzzi N. Cin Diabetes. 202096:313-314. a
4. Angeli AM et al. Endocr Rev. 2022:43:507-557. 5. Brandt SJ et al. Peptides, 2018;100:190-201. 6. Tschóp M etal. Diabetologia. 2023:66:1796-1808. PeerView.com

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16. GLP-1 Has Broad Activity’?

Heart

Kidney (% A qe

1 Natriuresis 1 Cardioprotection | Coagulation

1 Diuresis
e, | Blood | Postprandial
pressure lipids
Blood itesine
Vessel
ie | Glucose | Hypoglycemia
LA matón eo en 1 Inflammation hdr
ES & 1 cio } Glucose uptake 1 Endothelial function
Ex a bon [ischemic injury! Vasodilation
E (Ov) LV function 1 Plaque stability
Bi + insulin secretion frs
rain pa 1 Heart rate 1 u
Fat and Other Y nel ici | À Smooth muscle proliferation
Tissues 4 Apont | Platelet aggregation
Beneficial effects on A1C, blood pr nd weight only partly explain CV effects
1. Drucker DJ. Cell Metab. 2016:24:15-30. 2. Wong SY etal. Cardiovasc Drugs Ther. 2022 Jul 12. Online ahead of print. PeerView.com
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17. SELECT: Semaglutide Reduces the
Risk of Adverse Cardiovascular Events!

+ Overweight and obesity are key pathophysiological drivers of the
incidence and progression of CVD

+ At mean follow-up of 39.8 months in patients with pre-existing CVD and
overweight or obesity but without diabetes, semaglutide 2.4 mg was
shown to be superior to placebo in reducing the incidence of death from
cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke

+ Aprimary cardiovascular end-point event occurred in 6.5% of patients in
the semaglutide group vs 8.0% of patients in the placebo group
(HR, 0.80; 95% Cl, 0.72 to 0.90; P< .001)

1: Lincoff AM at al. N Engl J Mod, 2023; 389:2221-2202, PeerView.com

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18. Findings Appear to Be Generalizable:
A Real-World Population With Established CVD‘

+ In SELECT, semaglutide 2.4 mg reduced recurrent CVD by 20% vs placebo in
patients with BMI >27 kg/m? and established CVD

+ Using the SELECT inclusion and exclusion criteria, 43,854 patients in the
Mass General Brigham health system with a BMI 227 kg/m? had a diagnosis of
MI, stroke, or PAD documented in the EHR

+ Of this SELECT-eligible population, 47 (0.1%) were currently prescribed
semaglutide 2.4 mg, highlighting that baseline prescription of anti-obesity
pharmacotherapy is rare and represents a substantial opportunity to improve
secondary risk reduction

* Still, the findings from SELECT appear to be broadly generalizable to this
real-world population with established CVD

+ As guideline committees consider updates to incorporate the SELECT
findings, these data support the potential to benefit over half of patients with
CVD living with excess weight or obesity

1. Blood A et al. ACC 24. Abstract 1447-160. PeerView.com

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19. GLP-1 RAs Appear to Improve Epicardial Adipose Tissue (EAT)
Health, Possibly Explaining the Observed Cardiovascular Benefits!

EAT Volume at Baseline EAT Density at Baseline
and 12-Month Follow Up and 12-Month Follow Up
Visit 1 Visit 2
8
E 5
€ 2
3 rn
5 &
E E
a
Visit 1 Visit 2 = -924
to M Semaglutide sit M Semaglutide
pon

Im Pracebo

+ EAT volume and density are imaging biomarkers believed to be implicated in
atherosclerosis development and are associated with increased risk of CV events

+ EAT volumes decreased in the semaglutide group on average 10.7+24.6 vs
increase in the placebo group, 6.4+22.8, P= .001

1. Manubolu VS et al. ACC 24. Abstract 1042-13, PeerView.com

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20. Cardiorenal Effects of Semaglutide Are Consistent In People
With High CV Risk, Regardless of Baseline BMI or Prior CVD‘

301/10 (3.3) 29822 (7.4) — — 0.46 (022-096)

94582 (55) 917177 (84) a 063045090) ‘18
4,989/107(54) 2.02423 (6.1) Fert 088 (068-119)
: ES RECO) Lun
witout piorrevasculaizaion 1.1273 (4.0) 175298 (56) + 0.71 (053-096)
3 m i
wih pro MI joss me) 11511085) 02006010 se
SE | HS) ies E Rates)
StokeIA H
wth por SORT 499140 (8.0) 522/80 (06) re 08108420) 582
witout prior stokeTIA 2701207) 271972103) Hel 0.74 (059.092)
eM
5 25 kgm 12954.) 131/16 (122) a! 032012088) ogg
E 22510 So im? A737 66) 45985 7.7) at 045 (025.080)
= 220 kgm? 104940 (38) 4.061149 (46) =" 082054125)
E Revascularzaion i
5 ‘with prior evascularization 694/26 (3.7) 721135 (4.9) am 0.77 (0.46-1.27) 256
B —winoutproerovascuarizaion 954/36 (3.8) 928185 (7.0) en 053035070)
ES m 1
7 wh prior 529721 (4.0) 64225 (46) a 08504815) 70
3 nos pr Mi en OMS) = 0831096077)
5 Strokema
3 with por SUOKEITIA 251247) 25911766) pee oro@say 675
wnat pr Sroke TA 30150 66) 139013 (60) en 059042084
01 05 10 50
Data tom SUSTAIN 6 and PIONEER 6 HR GS a
1. Zu J et al ACC 24. Abstract 1413-213. Favors semaglutide Favors placebo PeerView.com

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21. Effects of Disparities In Gender, Race/Ethnicity,
Comorbidities, and Social Risk!

Premature Mortality Rates by SDOH Burden
and Obesity Class

Disparities in gender, race/ethnicity,
comorbidities, and social risk
highlight the need for equitable
patient management and access
to efficacious treatment with
GLP-1 RAs
+ Mortality rates are consistently
higher with higher SDOH

AAMR, per 100,000 patient-years.
3

Non-Obese Obesity Obesity Obesity burden and obesity class
Class | Class '" Class Il SSM) —
BMUSDOH Category

IM sooHo1 MO? MOS MM SDOHOs

1. Pip Jet al ACC 24. Abstract 1372-223. PeerView.com

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22. a | Meet Social Disadvantage and Mortality Risk

wl ee Higher In Adults With Severe Obesity!

‘SELECT ‘SUSTAIN ‘SELECT. ‘SUSTAIN ‘SELECT ‘SUSTAIN
Sample 5,101 1.966 1446 ma 730 696 oo
Weighted sample 15,902,862 (51.5) 1.484.073 (68.4) 1,055,654 (41.6) 524,549(61.2) 499.403.4868) 500,938 (50.8) 484,431 (49.2)
Demographic factors
‘Age category
4564 1454827) 814 439) 484 (8.6) 345 (65.0) 321 483) 241 (540) 2491564)
65.74 1323253) 603(904) 539 (823) 231,907) 292 (97.0) 197253) 231,003)
75% 2324420) san 423281) 137 (143) 117148) 188 20.7) 111133)
Female 2458 (453) 849985) 625 (8.4) 377 464) 362458) 498 678) 415 (6.4)
Racolthnicty
Non-Hispanic Write 4029(002) 1507076) 100012) 510740) 477 679) 489 (130) 446 673)
Non-Hispanic Black 530 (8.9) 265 (11.1) 247 (147) 116 (130) 450175) 129 (17.6) 17075)
Asianlotner 237 (54) 50 (26) en 20 (29) 26 (24) 15(18) zen
Hispanic 305 (57) 186) 158 (10.9) 61 (10.1) 82022) EIN 78 (125)
‘Social determinants of health
Low fami income 197157) 754009) 655 (42.1) 302 (98:3) 342 (435) 355 (49.0) 381 (632)
<High school 207380) 979(490) 790 (532) 366 (514) 386 (55.1) 353 609) 32.655)
Uninsured men 93 (48) 54 (24) 4166) 1520) 40(50) 2560)

Food inswcurty 595 (10.6) 297 (136) 253 (152) 08 (133) 178007) 152073) 187.053)

+ Higher obesity classes were more likely to be non-elderly, female, non-Hispanic Black, and have higher unfavorable social determinants
+ 25% higher mortality risk with hypertension, stroke, kidney disease, and COPD more common with class 3 obesity compared to non-obesity

1. Taha Metal. ACC 24. Abstract 1393-210, PeerView.com

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23. Semaglutide Produces Significant Weight Loss; Dosing,
_Uptitration, and Availability May Affect Real-World Outcomes? | Outcomes’

100
so
o
®
in
io
Ë
3
E “0
E
= 2
0
o
‘3Months — GMonths — 12Months 3Months GMonths — 12Months 3Months 6Months 12 Months
No T2DM
M Noweightioss MN <5% MM 5% 10 <10% MM 220 o
1 AvenatiE et a ACC 24, Abstract 1116-09 PeerView.com
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24. Successful Initiation of GLP-1 RA and SGLT2is Can Be
Achieved Through a Pharmacist-Driven Program!

Patients with or at risk for CVD
enrolled in this program until they
were on target doses of medication
or the medication was discontinued
81/103 patients have completed
this program

80% in both the GLP-1 RA and
SGLT2i groups were able to reach
target doses

15% of patients had to stop
medication; 9% for intolerable side
effects, 4% for cost, and 2% for
worsening renal function

1. Lee K et al, ACC 24. Abstract 1413-217.

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Hypertension
Coronary er disease

HFIEF.%

HFEF, &

Aal fxitaton,%

Chronic kidney disease, %

Stroke, %

‘Outcomes for Patients Who Have Completed This Program.

Mean folow up, days (SD)
Median change in A1C. mp (IQR)
Median change in BMI, kg? (OR)

68 (10) vom)

25129) sum
35473) 326(57)
69(13) 7304)

67 (79) 19483)
13(15) oo
ne) 2101)
52161) 15465)
so 407)
1204 sm
14:10) sen
26 1) 99)
30) sw
GLPIRA(n=60) SGLT2I(n = 21)
48 co) won
so 2067)
9 (82) 4 (60)
155 (80) 2827)
06 (4010-02) 05(061002)
191351008) -10(41910-04)

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25. Tirzepatide: Possible Treatment Alternative for Patients With
Multi-Morbidities or With Cardiometabolic Syndrome’

+ 10 RCTs (n = 9,517)
+ Tirzepatide significantly reduced SBP compared to placebo

Tirzepatide also reduced DBP compared to placebo

« 15 mg and 10 mg doses significantly outperformed 5 mg dosage but they
were associated with more AEs; no difference was seen in serious AEs

.

Tirzepatide not only improves glycemic and weight control but also lowers
both SBP and DBP, offering the potential as a single drug alternative that
may improve better patient compliance and outcomes

1. Sethi etal. ACC 24. Abstract 1116-11 PeerView.com

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26. Novel Agents: New Trigonal GLP-1, GIP, and Glucagon
Receptor Agonist Showing Promise for Metabolic Syndrome’
+ 3RCTs, including 685 participants

+ At 24 weeks, retatrutide significantly reduced fasting blood sugar levels
(-21.09 mg/dL), A1C (-0.95%) and weight (-10.54 kg)

+ Decreased SBP (-5.70 mmHg) and DBP (-1.68mm Hg)

+ Improvement in serum HDL cholesterol (-2.01 mg/dl) and triglyceride
levels (-21.64 mg/dl)

+ Risk ratios for all adverse and serious adverse events were 1.16 and
1.01, respectively

1.Nacem H etal. ACC 24. Abstract 1413-215 PeerView.com

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27. Implications for Clinical Practice

+ Data continue to expand the
observed benefits of GLP-1 RAs on
biomarkers and outcomes related to
CV ischemic events, HF
complications, and kidney function in
people with diabetes and/or obesity

While mechanisms of benefit remain
incompletely defined, there is
growing evidence of physiologic
effects beyond weight loss or
glycemic control

+ Outcomes have spurred tremendous
interest in the development of novel
agents with multiple receptor actions
and specificity, routes of
administration, and durations
of action

+ Major challenges remain in
expanding access and affordability
to the large populations who would
benefit from these agents,
particularly those with higher social
determinants of health burdens

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