add efficacy. add power. Add nexletol.

For appropriate patients currently on maximally tolerated statin therapy, with or without other lipid-lowering therapies1

When patients with ASCVD and/or HeFH need additional LDL-C lowering on top of diet and maximally tolerated statin therapy, adding NEXLETOL can get them significantly lower1

CLEAR Harmony1-3

CLEAR HARMONY: 18% mean LDL-C reduction vs placebo

CLEAR Wisdom1,4,5

CLEAR WISDOM: 17% mean LDL-C reduction vs placebo

ADD NEXLETOL1,2,4

Up to a significant 18% mean LDL-C reduction vs placebo at Week 12

LDL-C changes from baseline (LS mean) in CLEAR Harmony: NEXLETOL: -17% (n=1,488); placebo: +2% (n=742) (P<0.001).

LDL-C changes from baseline (LS mean) in CLEAR Wisdom: NEXLETOL: -15% (n=522); placebo: +2% (n=257) (P<0.001).

CLEAR Harmony (Study 1) was a 52-week, randomized, double-blind, Phase 3 trial in 2,230 patients randomized 2:1 to receive NEXLETOL (n=1,488) or placebo (n=742). CLEAR Harmony included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL, and high-risk patients with ASCVD and/or HeFH. NEXLETOL was added to whatever patient’s maximally tolerated statin dose was, either alone or with other lipid-lowering therapies. Primary endpoint was general safety, which included ARs, clinical safety laboratories, physical examinations, vital signs, and electrocardiogram. Secondary endpoint was % change from baseline to Week 12 in LDL-C.2,3

CLEAR Wisdom (Study 2) was a 52-week, randomized, double-blind, Phase 3 trial in 779 patients randomized 2:1 to receive NEXLETOL (n=522) or placebo (n=257). CLEAR Wisdom included patients aged ≥18 years with fasting LDL-C ≥70 mg/dL, and high-risk patients with ASCVD and/or HeFH. NEXLETOL was added to whatever patient’s maximally tolerated statin dose was (including no statin at all) either alone or with other lipid-lowering therapies. Primary endpoint was % change from baseline to Week 12 in LDL-C. Secondary endpoints were % change from baseline to Week 24 in LDL-C, % change from baseline to Week 12 in non-HDL-C, total C, apolipoprotein B, and hsCRP, and absolute change from baseline to Weeks 12 and 24 in LDL-C.4,5

ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol; LS=least squares; AR=adverse reaction; non-HDL-C=non-high-density lipoprotein cholesterol; total C=total cholesterol; hsCRP=high-sensitivity C-reactive protein.


Add NEXLETOL: significant LDL-C reduction regardless of patients’ statin dose2,4

Mean LDL-C reductions vs placebo at 12 weeks across statin intensity subgroups2,4

Low-to Moderate-intensity Statins: 20% in CLEAR Harmony and 19% in CLEAR Wisdom. High-intensity statins: 17% in CLEAR Harmony and 17% in CLEAR Wisdom.

*Low-intensity statins: simvastatin 10 mg; pravastatin 10 mg to 20 mg; lovastatin 20 mg; fluvastatin 20 mg to 40 mg; pitavastatin 1 mg. Low-intensity statins also included those patients taking low-dose statins using an alternate regimen (ie, every other day, or for a specified number of times per week) and those unable to tolerate any statin at any dose.2,4

Moderate-intensity statins: atorvastatin 10 mg to 20 mg; rosuvastatin 5 mg to 10 mg; simvastatin 20 mg to 40 mg; pravastatin 40 mg to 80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg; pitavastatin 2 mg to 4 mg.2,4

Post hoc analysis.2

§High-intensity statins: atorvastatin 40 mg to 80 mg; rosuvastatin 20 mg to 40 mg.2,4

LDL-C=low-density lipoprotein cholesterol.


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Clear harmony and clear wisdom trials: robust evidence in over 3,000 patients1

52-week, randomized, double-blind, Phase 3 trials in patients with ASCVD
and/or HeFH primarily taking moderate- to high-intensity statins (N=3,009)1,2,4

CLEAR Harmony (Study 1)
(N=2,230)1-3
CLEAR Wisdom (Study 2)
(N=779)1,4,5
NEXLETOL in the trials NEXLETOL was added to patients’ maximally tolerated statin dose (in CLEAR Wisdom, this dose included no statin at all) either alone or with other lipid-lowering therapies
Mean LDL-C at baseline 103.2 mg/dL 120.4 mg/dL
History of ASCVD 97.6% 94.5%
History of HeFH with
or without ASCVD
3.5% 5.5%

ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; LDL-C=low-density lipoprotein cholesterol.


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Add nexletol: a demonstrated safety profile

Incidence of most common ARs was generally comparable to placebo1

Based on a pooled analysis of 2 clinical studies of up to 52 weeks in duration.1

ARs occurring in ≥2% of patients with ASCVD and HeFH using NEXLETOL
(and more frequently than placebo)1

Adverse reaction NEXLETOL*
(n=2,009)
Placebo
(n=999)
Upper respiratory tract infection 4.5% 4.0%
Muscle spasms 3.6% 2.3%
Hyperuricemia 3.5% 1.1%
Back pain 3.3% 2.2%
Abdominal pain or discomfort 3.1% 2.2%
Bronchitis 3.0% 2.5%
Pain in extremity 3.0% 1.7%
Anemia 2.8% 1.9%
Elevated liver enzymes§ 2.1% 0.8%

Discontinuation rates due to ARs1: NEXLETOL: 11%; placebo: 8%

Incidence of skeletal muscle ARs comparable to placebo1

Muscle spasms: NEXLETOL: 3.6%; placebo: 2.3%

Please see Important Safety Information, including Contraindications, and Warnings and Precautions about Hyperuricemia and Tendon Rupture, below.

*Patients received NEXLETOL 180 mg orally once daily plus maximally tolerated statin therapy alone or in combination with other lipid-lowering therapies.1

Included patients with hyperuricemia and patients with increased blood uric acid.1

Included patients with abdominal pain, upper abdominal pain, lower abdominal pain, and abdominal discomfort.1

§Included patients with increased AST, increased ALT, increased hepatic enzyme, and increased liver function test.1

AR=adverse reaction; ASCVD=atherosclerotic cardiovascular disease; HeFH=heterozygous familial hypercholesterolemia; AST=aspartate aminotransferase;

ALT=alanine aminotransferase.


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ADD NEXLETOL: ORAL, ONCE-DAILY DOSING FLEXIBILITY

WHEN ADDED TO MAXIMALLY TOLERATED STATIN THERAPY, NEXLETOL HAS THE FLEXIBILITY TO BE COMBINED WITH EXISTING LIPID-LOWERING MEDICATIONS FOR APPROPRIATE PATIENTS1

Oral,
once-daily
tablet

Taken with
or without
food

Does not
need to be
titrated*

Does not require
refrigeration for
storage

Pill image is not actual size.

NEXLETOL, 180 mg QD, #30, Refills #2

One 180-mg tablet for all appropriate patients1


Pill image is not actual size.



Lipid levels should be analyzed within 8 to 12 weeks after initiation of NEXLETOL.1

*Concomitant use of simvastatin or pravastatin with NEXLETOL may require adjustments for these medications. Please see "Drug Interactions" in the Important Safety Information below.1


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Bempedoic acid is the active ingredient in NEXLETOL,
and a component of NEXLIZET1,6

EXPLORE THE MOA OF BEMPEDOIC ACID



References: 1. NEXLETOL. Prescribing information. ESPERION Therapeutics, Inc.; 2020. 2. Data on file. CSR 1002-040. October 2018. 3. Ray KK, Bays HE, Catapano AL, et al. Safety and efficacy of bempedoic acid to reduce LDL cholesterol. N Engl J Med. 2019;380(11):1022-1032. 4. Data on file. CSR 1002-047. January 2019. 5. Goldberg AC, Leiter LA, Stroes ESG, et al. Effect of bempedoic acid vs placebo added to maximally tolerated statins on low-density lipoprotein cholesterol in patients at high risk for cardiovascular disease: the CLEAR Wisdom randomized clinical trial. JAMA. 2019;322(18):1780-1788. 6. NEXLIZET. Prescribing information. ESPERION Therapeutics, Inc. 11/2020.