Co esponding au ho : Sa ish Ramesh ao Chi de
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Bempedoic acid in he cu en e a o lipid managemen
Sa ish Ramesh ao Chi de *
DNB (Ca diology), MD (Med) FAPVIS(Asia), FSCAI, FESC Fellowship in In e en ional Ca diology, Sh i Da a Hospi al and
Resea ch Can e , Sh i Ra i aj Naga Lay-ou , Nea Ta a Mo o s, A ni Road, Ya a mal.
Wo ld Jou nal o Ad anced Resea ch and Re iews, 2025, 26(01), 3908-3913
Publica ion his o y: Recei ed on 18 Ma ch 2025; e ised on 23 Ap il 2025; accep ed on 26 Ap il 2025
A icle DOI: h ps://doi.o g/10.30574/wja .2025.26.1.1404
Abs ac
Bempedoic acid, a i s -in-class adenosine iphospha e-ci a e lyase inhibi o , signi ican ly ad ances lipid managemen .
This e iew examines he clinical e idence, e icacy, and sa e y p o ile o bempedoic acid based on majo clinical ials
and ecen me a-analyses. The CLEAR ials p og am demons a ed signi ican low densi y lipop o ein choles e ol
(LDL-C) educ ions anging om 17-28.5% ac oss di e en pa ien popula ions, wi h he CLEAR ou comes ial showing
a 13% educ ion in majo ad e se ca dio ascula e en s. Me a-analyses ha e con i med hese indings, showing
consis en LDL-C educ ions and ca dio ascula bene i s, pa icula ly in s a in-in ole an pa ien s. The medica ion's
unique li e -speci ic ac i a ion mechanism con ibu es o educed muscle- ela ed side e ec s compa ed o s a ins.
Cu en guidelines om bo h he Ame ican College o Ca diology and he Eu opean Socie y o Ca diology posi ion
bempedoic acid as a aluable op ion o high- isk pa ien s equi ing addi ional LDL-C lowe ing, especially hose who
a e s a in-in ole an o unable o achie e goals wi h maximally ole a ed s a in he apy. Bempedoic acid demons a es
a gene ally a ou able sa e y p o ile, moni o ing is ecommended o po en ial ad e se e ec s including ele a ed u ic
acid le els and li e enzymes.
Keywo ds: Bempedoic Acid; Lipid Managemen ; Ca dio ascula Ou comes; Adenosine T iphospha e-Ci a e Lyase
(ACL)
1. In oduc ion
Bempedoic acid is a i s -in-class adenosine iphospha e-ci a e lyase (ACL) inhibi o ha educes choles e ol
syn hesis in he li e and lowe s low densi y lipop o ein choles e ol (LDL-C) le els by up egula ing LDL ecep o
exp ession. Bempedoic acid was i s app o ed by he FDA in he Uni ed S a es in Feb ua y 2020 [1] and ecei ed
ma ke ing au ho isa ion in he Eu opean Union in Ap il 2020 [2]. In India, i was launched in June 2023 unde Bemacip
[3]. Based on clinical e idence, bempedoic acid is indica ed o adul s wi h he e ozygous amilial hype choles e olemia
o es ablished a he oscle o ic ca dio ascula disease (ASCVD) who equi e addi ional LDL-C lowe ing despi e
maximally ole a ed s a in he apy, making i pa icula ly aluable o s a in-in ole an pa ien s o hose who
expe ience muscle- ela ed side e ec s wi h s a ins [4].
1.1. Clinical E idence
Following clinical ials ha e demons a ed he e icacy o bempedoic acid in educing LDL-C le els. These s udies ha e
shown signi ican educ ions in LDL-C, especially in pa ien s who a e in ole an o s a ins.
Wo ld Jou nal o Ad anced Resea ch and Re iews, 2025, 26(01), 3908-3913
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Table 1 Phase III clinical ials on Bempedoic acid
Phase III
Clinical ials
T ial de ails
Rela i e Risk (RR)
CLEAR
Se eni y (July
2016) [5]
A ial speci ically s udied 345 s a in-
in ole an pa ien s. Demons a ed
21.4% LDL-C educ ion wi h bempedoic
acid s placebo o e 24 weeks.
RR educ ion o abou 23% in LDL-C le els a 12 weeks.
The ial showed good ole abili y in pa ien s who
p e iously couldn' ake s a ins.
CLEAR
Wisdom (July
2016) [6]
A 52-week ial included 779 high- isk
pa ien s wi h ASCVD o he e ozygous FH
on maximally ole a ed s a in he apy.
RR educ ion o 17.4% in LDL-C le els compa ed o
placebo a 12 weeks. The ial demons a ed sus ained
e icacy o e 52 weeks.
CLEAR
T anquili y
(Augus 2016)
[7]
S udied bempedoic acid in combina ion
wi h eze imibe in 269 pa ien s wi h high
LDL-C who we e s a in-in ole an .
Showed 28.5% addi ional LDL-C
educ ion s eze imibe alone.
RR educ ion o 28.5% in LDL-C compa ed o eze imibe
alone, demons a ing he addi i e bene i o combining
hese medica ions.
CLEAR
Ha mony
(No embe
2016) [8]
A 52-week ial included 2,230 pa ien s
wi h ASCVD and/o he e ozygous
amilial hype choles e olemia on
maximally ole a ed s a in he apy.
Reduc ion o 18.1% in LDL-C le els compa ed o
placebo. The s udy demons a ed long- e m sa e y and
sus ained e icacy o e 52 weeks.
CLEAR
Ou comes
(Decembe
2016) [9]
The mos signi ican ca dio ascula
ou comes ial in ol ed 13,970 s a in-
in ole an pa ien s o e 3.4 yea s.
Risk Ra io educ ion o 13% in majo ad e se
ca dio ascula e en s (MACE) compa ed o placebo.
This included a 23% educ ion in hea a acks and a
19% educ ion in co ona y e ascula iza ion
p ocedu es. The ial was no able o being he i s o
demons a e ca dio ascula bene i wi h bempedoic
acid in s a in-in ole an pa ien s.
Table 2 Recen sys ema ic e iew and me a-analysis on Bempedoic acid
Au ho Name (yea )
Resul s
Li e al (2024) [10]
Included 16 Randomized Con olled
T ials (RCTs)
Bempedoic acid ea men educed low-densi y lipop o ein choles e ol
le els mo e han placebo (mean di e ence -2.97%, 95% con idence
in e al [CI] -5.89% o -0.05%)
The isk o dea h (Odds a io [OR] 1.18, 95% CI 0.70 o 1.98) and muscle-
associa ed occu ences (OR 1.00, 95% CI 0.77 o 1.31) was no impac ed
by bempedoic acid.
Discon inua ion o ea men was mo e equen ly caused by ad e se
e en s in he bempedoic acid g oup (OR 1.13, 95% CI 1.01 o 1.27).
A zal e al (2024) [11]
17,782 pa icipan s om 7 RCTs, 53.6 %
in he Bempedoic acid (BA) g oup (n =
9535) and 46.4 % in he placebo g oup
(n = 8247).
Dec eased MACE (OR: 0.86; 95 % CI 0.78–0.95; p = 0.03), non- a al
myoca dial in a c ion (OR 0.72; 95 % CI 0.61–0.85; p = 0.0001), and new
onse /wo sening diabe es (OR:0.55; 95 % CI 0.30–0.98, p = 0.04), while
educing LDL-C le els by 22.5 % (mean di e ence [MD]: −22.53 %; 95 %
CI -25.54 o −19.52, p < 0.00001)
Goyal e al (2023) [12]
5 RCTs wi h a o al o 18,848
pa icipan s.
Bempedoic acid showed a signi ican educ ion in LDL-C [Leas -squa e
mean (LSM) di e ence in %: -25.24; 95 % CI: -30.79 o -19.69; p <
0.00001], o al choles e ol [LSM di e ence in %:-21.28; 95 % CI:-30.58 o-
11.98; p < 0.00001], non-HDL-C [LSM di e ence in %: -23.27; 95 % Cl: -
29.80 o -16.73 p < 0.00001], and HDL-C [LSM di e ence in %:-3.37, 95 %
CI:-3.73 o-3.01, p < 0.00001] compa ed o placebo.
Associa ed wi h a lowe isk o co ona y e ascula iza ion [RR:0.81; 95 %
CI:0.66 o 0.99; p = 0.04], hospi aliza ion o uns able angina [RR:0.67; 95
Wo ld Jou nal o Ad anced Resea ch and Re iews, 2025, 26(01), 3908-3913
3910
% CI:0.50 o 0.88; p = 0.005], and myoca dial in a c ion [RR:0.76; 95 %
CI:0.66 o 0.88; p = 0.0004].
Co de o e al (2023) [13]
4 clinical ials e alua ed 17,324
pa ien s; 9,236 ecei ed bempedoic acid
o a median o 46.6 mon hs. The mean
baseline LDL was 129.4 (22.8) mg/100
ml
T ea men wi h bempedoic acid signi ican ly educed he incidence o
MACE (haza d a io [HR] 0.88, 95% CI 0.81 o 0.96), myoca dial in a c ion
(HR 0.76, 95% CI 0.66 o 0.89) and myoca dial e ascula iza ion (HR 0.82,
95% CI 0.73 o 0.92)
The c ude incidence o s oke, ca dio ascula o all-cause mo ali y was
lowe in pa ien s in he bempedoic acid g oups al hough no signi ican isk
educ ion was obse ed.
Bhaga a hula (2023) [14]
3 phase II and III RCTs, included 388
pa ien s. 49.2% we e ea ed wi h
bempedoic acid and eze imibe, and 197
con ols, we e iden i ied. The du a ion
o ea men was 12 weeks.
Bempedoic acid and eze imibe signi ican ly educed low-densi y
lipop o ein choles e ol (MD - 29.14%, 95% CI - 39.52 o - 18.76; p < .001),
o al choles e ol (MD - 15.78%, 95% CI - 20.84 o - 10.72; p = 0.01), non-
high-densi y lipop o ein choles e ol (MD - 18.36%, 95% CI - 24.60 o -
12.12; p = 0.01), and hs-C- eac i e p o ein (CRP) le els (MD - 30.48%,
95% CI - 44.69 o - 16.28; p = 0.04).
No signi ican e ec s on iglyce ides (MD - 8.35%, 95% CI - 16.08 o -
0.63; p = 0.72) and imp o emen in high-densi y lipop o ein choles e ol
(MD 1.63%, 95% CI - 4.03 o 7.28; p = 0.92) we e obse ed wi h he ixed-
dose combina ion he apy.
Filippo e al. (2022) [15]
11 s udies, including 18,315 pa ien s
(9854 on BA s 8461 on placebo/no
ea men )
BA was associa ed wi h a educed isk o MACE (OR 0.86, 95% CI 0.79-
0.95), myoca dial in a c ion (OR 0.76, 95% CI 0.64-0.88) and uns able
angina (OR 0.69, 95% CI 0.54-0.88) compa ed o con ol, o e a median
ollow up o 87 (15-162) weeks.
BA was associa ed wi h a educ ion o LDL-C (MD-22.42,95% CI - 24.02%
o - 20.82%), o al choles e ol (- 16.50%,95% - 19.21% o - 13.79%), Apo-
B lipop o ein (- 19.55%, - 22.68% o - 16.42%) and high-sensi i i y CRP (-
27.83%, - 31.71% o - 23.96%) a 12 weeks.
BA was associa ed wi h a highe isk o gou (OR 1.55, 95% CI 1.27-1.90)
as compa ed wi h placebo.
1.2. Posi ion o Bempedoic Acid in Guidelines
Figu e 1 Diag am o managing LDL le els by s a in and non-s a in [16]
Wo ld Jou nal o Ad anced Resea ch and Re iews, 2025, 26(01), 3908-3913
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The Ame ican College o Ca diology (ACC) Expe Consensus Decision Pa hway on no el he apies o ca dio ascula
isk educ ion [17] and he 2023 Eu opean Socie y o Ca diology (ESC) [18] Guidelines on he managemen o
dyslipidemia ecommends he use o bempedoic acid. In he ACC pa hway, bempedoic acid is ecommended as an
addi ional op ion o high- isk pa ien s who equi e u he LDL-C lowe ing despi e maximally ole a ed s a in he apy,
pa icula ly in hose who a e s a in-in ole an . The ACC acknowledges i s ole as an adjunc he apy, especially when
used in combina ion wi h eze imibe. The ESC guidelines posi ion bempedoic acid as a ea men op ion o pa ien s who
a e s a in-in ole an o hose who canno achie e LDL-C goals wi h maximally ole a ed s a in he apy and eze imibe.
The guidelines pa icula ly no e i s u ili y in pa ien s wi h high ca dio ascula isk who need addi ional LDL-C lowe ing.
1.3. Lipid p o ile wi h Bempedoic acid
Bempedoic acid demons a es consis en e icacy in educing LDL-C le els ac oss a ious pa ien popula ions. I wo ks
by inhibi ing ATP ci a e lyase, an enzyme in ol ed in choles e ol syn hesis, e ec i ely educing LDL-C le els. As a,
Mono he apy 15-25% educ ion in LDL-C [19]; Addi ion o s a ins: 15-20% addi ional LDL-C educ ion [20];
Combina ion wi h Eze imibe: Up o 38% educ ion in LDL-C [21]. E ec s on o he lipid pa ame e s: Modes educ ion
in iglyce ides (5-10%) [22]; Small dec ease in high-sensi i i y C- eac i e p o ein (hs-CRP) [19]; Minimal e ec on
HDL-C [19]. One o i s key ad an ages is p o iding an al e na i e ea men op ion o pa ien s who canno ole a e
s a ins due o side e ec s. The d ug's unique ac i a ion mechanism in he li e may con ibu e o educed muscle-
ela ed side e ec s compa ed o s a ins. Fu he mo e, i can be used as a s andalone ea men o in combina ion wi h
o he choles e ol-lowe ing medica ions, including a con enien combina ion pill wi h eze imibe o enhanced e icacy.
1.4. Ad e se E en s and Con aindica ions
Like all medica ions, bempedoic acid comes wi h po en ial isks and side e ec s ha need ca e ul conside a ion. Pa ien s
may expe ience uppe espi a o y ac in ec ions, back pain, abdominal pain, and b onchi is. Mo e conce ning isks
include ele a ed u ic acid le els, which could inc ease he isk o gou , and he po en ial o endon up u e, pa icula ly
in olde pa ien s. The medica ion can also cause ele a ed li e enzymes, necessi a ing egula moni o ing o li e
unc ion [23]. Bempedoic acid is con aindica ed du ing p egnancy and b eas eeding, and i s long- e m sa e y p o ile
is s ill being es ablished h ough ongoing clinical ials [24]. While he d ug shows p omise in choles e ol managemen ,
i s e ec s on ca dio ascula ou comes a e s ill unde in es iga ion.
1.5. Recommended Dose
Bempedoic acid is a ailable in 180 mg o daily dose. The li e is he p ima y si e o me abolism. Exc e ion happens
mainly ia kidneys (70% o pa en d ug and me aboli es) whe eas 30% is ia he aecal ou e [25].
1.6. Ongoing Resea ch
Ongoing esea ch in bempedoic acid encompasses se e al exci ing a enues ha aim o expand ou unde s anding o
his medica ion's he apeu ic po en ial. The d ug's e icacy in he p ima y p e en ion o ca dio ascula e en s in s a in-
in ole an pa ien s, sugges s po en ial bene i s in educing majo ad e se ca dio ascula e en s [26]. Resea ch has also
examined he impac o bempedoic acid on ca dio ascula ou comes by sex, indica ing simila educ ions in
ca dio ascula isk and LDL-C le els in bo h emales and males [27]. Real-wo ld e idence s udies a e collec ing da a on
medica ion adhe ence, pa ien sa is ac ion, and clinical ou comes ou side he con olled ial en i onmen .
2. Conclusion
Bempedoic acid has eme ged as a aluable addi ion o he he apeu ic a senal o lipid managemen . Clinical ials and
sys ema ic e iews consis en ly demons a e i s e icacy in lowe ing LDL-C, o al choles e ol, and in lamma o y
ma ke s, wi h addi ional ca dio ascula bene i s in educing e en s such as myoca dial in a c ion and co ona y
e ascula iza ion. These indings a e e lec ed in majo guidelines, posi ioning bempedoic acid as a key adjunc i e
he apy in high- isk pa ien s. Bempedoic acid s ands as a es amen o he e ol ing landscape o lipid-lowe ing
he apies, o e ing hope o be e -managing hype choles e olemia and associa ed ca dio ascula isks in pa ien s wi h
unme needs.
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