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atorvastatin + ezetimibe (CKD 391 / CKD391)

✓ Approved

Chong Kun Dang Pharmaceutical · HMGCR · Small Molecule

What is atorvastatin + ezetimibe?

atorvastatin + ezetimibe is a small molecule developed by Chong Kun Dang Pharmaceutical. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesCKD 391, CKD391
CompanyChong Kun Dang Pharmaceutical
Drug ClassSmall Molecule
Molecular TargetHMGCR, NPC1L1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Chong Kun Dang Pharmaceutical

Mechanism of Action

Molecular Targets

atorvastatin + ezetimibe acts on 2 molecular targets:

HMGCR3-hydroxy-3-methylglutaryl-CoA reductase (LDLCQ3, LGMDR28)
NPC1L1NPC1 like intracellular cholesterol transporter 1 (SLC65A2, LDLCQ7)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

atorvastatin + ezetimibe is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Metabolism and nutrition disordersHypercholesterolaemia✓ Approved
Metabolism and nutrition disordersHyperlipidaemia✓ Approved

Related Research Articles

PubMedJournal of geriatric cardiology : JGC2026-09-19

Safety and efficacy of low-density lipoprotein-lowering drugs in the elderly: a network meta-analysis of randomized controlled trials.

Niaga Karmenia Jessica Kurnia KJK, Supinto Pedro Arruda PA, Tjandra Kevin Christian KC, Martin Alfianto A et al.

Balancing the efficacy of low-density lipoprotein (LDL) reduction with safety presents a significant challenge in the elderly care. While guidelines recommended high-intensity statins as the optimal strategy to lower LDL in high-risk individuals, there are prevailing concerns regarding its side effects and subsequent fatality rate. The effectiveness of different LDL-lowering therapies in this population is also unclear. This study aims to compare the safety and efficacy of various LDL-lowering strategies in elderly population. A systematic search was conducted through six databases until March 2025. Randomized controlled trials (RCTs) that evaluate LDL-lowering agents were included. The primary outcome was adverse effects, while secondary outcomes included composite cardiovascular disease (CVD) events, CVD related mortality, all-cause mortality, and LDL level reduction. Risk of bias was assessed using the RoB-2 tool. A network meta-analyses were performed to compare the safety and efficacy with subgroup analysis based on underlying CVD under the cumulative ranking values. Sixteen RCTs (n = 43,625) with low to moderate risk of bias were included. Among interventions evaluated for adverse events, moderate-intensity pitavastatin had the highest probability of being the safest. Ezetimibe demonstrated the most favorable safety profile for reducing CVD mortality, while evolocumab was most effective in lowering all-cause mortality. For LDL reduction, the combination of moderate-intensity pitavastatin and ezetimibe was the most effective, followed by moderate-intensity rosuvastatin plus ezetimibe. Subgroup analyses revealed significant differences between CVD and non-CVD populations in CVD mortality (P = 0.0059), CVD events (P = 0.0096), and LDL reduction (P = 0.0100), with more pronounced effects in the non-CVD group, suggesting greater efficacy in primary prevention. Moderate-intensity pitavastatin showed the highest safety profile, while its combination with ezetimibe was the most effective for LDL reduction.

PMID 42760936
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PubMedMedicine2026-09-19

Statin use and 28-day survival in critically ill patients with non-acute myocardial infarction cardiogenic shock: A retrospective cohort study accounting for treatment timing.

Cheng Tonghui T, Wang Panji P, Ren Jinxing J, Ji Shaoming S et al.

Evidence regarding statin therapy in non-acute myocardial infarction cardiogenic shock is limited, and retrospective medication studies are vulnerable to treatment-timing bias. We examined whether the association between statin exposure and 28-day mortality persisted after accounting for the timing of statin administration. This retrospective cohort study used medical information mart for intensive care IV data from 991 adults with non-acute myocardial infarction cardiogenic shock. Statin exposure was ascertained from medication records that included atorvastatin and other statin agents. In the conventional time-fixed analysis, exposure was defined as receipt of any statin during the intensive care unit (ICU) stay. A 24-hour landmark analysis included patients alive at 24 hours, classified exposure according to statin administration during the 1st 24 hours, and began follow-up at the landmark. Separate 1:1 propensity-score matching (PSM) procedures and Cox models were performed for each exposure definition. Statin agent, 1st recorded dose, route, and time to 1st administration, together with specific mechanical-support, anti-inflammatory, and vasoactive co-treatments, were descriptively summarized in the matched cohorts. In the conventional cohort, 475 patients received a statin during the ICU stay and 516 did not; 255 patients per group remained after PSM. Conventional analyses suggested lower 28-day mortality before matching (adjusted hazard ratio [HR], 0.703; 95% confidence interval [CI], 0.539-0.918; P = .010) and after PSM (adjusted HR, 0.709; 95% CI, 0.507-0.993; P = .045). In the 24-hour landmark cohort, 311 patients received a statin within 24 hours and 680 did not; 255 patients per group remained after PSM. The association was absent before matching (adjusted HR, 1.127; 95% CI, 0.854-1.487; P = .398) and after PSM (adjusted HR, 1.190; 95% CI, 0.833-1.701; P = .339). Atorvastatin was the predominant 1st statin in both matched exposed groups. In 4-category analyses, the apparent benefit among new initiators in conventional models disappeared after the 24-hour landmark definition was applied. The apparent survival advantage associated with conventional time-fixed statin exposure was not reproduced after treatment timing was addressed. These findings do not support an independent 28-day survival benefit from statin administration within the 1st 24 hours of ICU admission and highlight the potential influence of immortal-time, treatment-selection, and co-treatment biases.

PMID 42760718
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PubMedCJC open2026-09-18

Rationale and Design of the Canadian Lipoprotein(a) Registry.

Kramer Adam I AI, Abdel-Qadir Husam H, Abramson Beth L BL, Baass Alexis A et al.

Lipoprotein(a) [Lp(a)] is an independent, heritable risk factor for atherosclerotic cardiovascular disease. Guidelines recommend Lp(a) testing once in a lifetime and recognize it as a risk-enhancing factor. However, management of elevated Lp(a) in real-world clinical practice is not well described. Here we describe the rationale, design, and preliminary baseline characteristics of the Canadian Lp(a) Registry, a prospective, longitudinal observational study of patients with Lp(a) ≥ 100 nmol/L (≥ 50 mg/dL). Patient demographics, cardiovascular risk factors, laboratory results, and clinical outcomes are collected at baseline and at annual follow-up. The primary objective is to evaluate the clinical management and outcomes of patients with elevated Lp(a). From April 2024 to April 2025, 127 patients (mean age 57.5 ± 12.7 years, 48.8% female) were enrolled with a median Lp(a) level of 225 nmol/L (interquartile range 186-346 nmol/L), and 51.2% had multiple Lp(a) levels obtained. The most recent mean low-density lipoprotein cholesterol (LDL-C) was 2.49 ± 1.74 mmol/L. At the time of registry entry, 104 (81.9%) patients were receiving lipid-lowering therapies, including statins (74.8%), ezetimibe (48.0%), and proprotein convertase subtilisin/kexin type 9 inhibitors (27.6%), whereas 18.1% were not taking prescription lipid-lowering therapy. There were 66 (52.0%) patients with an LDL-C < 2.0 mmol/L. The Canadian Lp(a) Registry is an ongoing prospective, observational study designed to evaluate the clinical management, cardiovascular risk profile, and outcomes for patients with elevated Lp(a). It is expected to improve our understanding of how elevated Lp(a) is managed in contemporary clinical practice and to identify opportunities to improve care.

PMID 42756755
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PubMedInternational journal of cardiology. Cardiovascular risk and prevention2026-09-17

Real-world patterns in lipid profile testing and lipid-lowering therapy in hospitalized patients: The Jurasz Lipid Study.

Ostrowska Małgorzata M, Ratajczak Jakub J, Ziółkowski Marcin M, Adamski Piotr P et al.

The aim of the Jurasz Lipid Study was to provide real-world evidence on lipid profile testing, as well as the prevalence of lipid-lowering therapy (LLT) in consecutive patients hospitalized in a tertiary multi-specialist hospital in Poland. A total of 40,646 patients were hospitalized across all analyzed departments. The majority of patients hospitalized in the cardiology and neurology departments underwent lipid profile evaluation (93.6% and 95.0%, respectively), while it was rarely performed in surgical department (14.9%). Patients receiving LLT, compared with untreated patients, more frequently had a history of atherosclerotic cardiovascular disease (ASCVD) and lipid profile testing. The prevalence of LLT use ranged from 0.1% in pediatrics to 35.1% in vascular surgery, 37.1% in neurology, up to 65.7% in cardiology and 69.1% in the cardiac surgery department. Statin monotherapy remained the standard of care, with atorvastatin and rosuvastatin being the most frequently used agents. The proportion of patients receiving high-intensity statin therapy ranged from 29.2% in neurology to 71.7% among ASCVD patients in cardiology. The combination of a statin with ezetimibe was used in up to 36.1% of ASCVD patients hospitalized in cardiology. Other LLT combinations were rarely observed. Lipid profile evaluation was routinely performed by cardiologists and neurologists, but rarely ordered by surgeons. The majority of patients with ASCVD were treated with LLT, but only up to 29.4% achieve treatment goals. Statin monotherapy remained the cornerstone of LLT. Statin with ezetimibe was the most common therapeutic combination.

PMID 42751564
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PubMedDrug delivery and translational research2026-09-17

Chitosan-TPP modification of SNEDDS enhances mucin interaction, apparent epithelial transport, and oral exposure of ezetimibe.

Lee Ju Young JY, Song Ji Ho JH, Cho Jung Hyun JH

Poor aqueous solubility limits the oral absorption of ezetimibe, and conventional self-nanoemulsifying drug delivery systems (SNEDDS) primarily address the solubilization barrier. In this study, ezetimibe-loaded SNEDDS were associated with a chitosan-tripolyphosphate (TPP) ionic network to generate chitosan-TPP-modified SNEDDS colloids (CS-SNEDDS) with additional mucin-interactive characteristics. The resulting CS-SNEDDS had a mean particle size of approximately 142 nm and a positive zeta potential, while retaining the apparent solubilization and rapid dispersion properties of the SNEDDS component. Compared with conventional SNEDDS, CS-SNEDDS showed markedly greater mucin association and increased apparent apical-to-basolateral transport across Caco-2 monolayers. Following oral administration to rats, CS-SNEDDS produced an AUC₀-₂₄h of 4715.62 ± 854.07 ng·h/mL, compared with 3647.39 ± 753.54 ng·h/mL for SNEDDS and 2176.84 ± 426.58 ng·h/mL for crystalline ezetimibe. The AUC₀-₂₄h of CS-SNEDDS was significantly higher than that of SNEDDS, whereas no significant difference in Cmax was detected between the two nanoformulations. These findings indicate that chitosan-TPP modification of ezetimibe-loaded SNEDDS introduced mucin-interactive cationic properties and was associated with an additional improvement in apparent epithelial transport and systemic exposure beyond that achieved by SNEDDS alone. This lipid-polymer interfacial modification strategy may provide a useful formulation approach for improving the oral delivery of poorly water-soluble drugs.

PMID 42749906
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PubMedEpilepsia2026-09-16

Statin use and risk of remote seizure after first new onset status epilepticus.

Orlandi Niccolò N, Giovannini Giada G, Taruffi Lisa L, Burani Margherita M et al.

Preclinical evidence supports the role of statins as antiepileptogenic agents. In this study, we investigated the risk of remote unprovoked seizures (RS) according to the use of statin therapy in a cohort of first-ever status epilepticus (SE) survivors. Retrospective analysis was made of adult patients (age ≥ 14 years) with a first SE who were consecutively and prospectively admitted to the Modena Academic Hospital, Italy (September 2015-December 2023) and included in the Modena Status Epilepticus Registry. Kaplan-Meier survival analyses were used to calculate the probability of RS following the index SE event, whereas Cox proportional hazard and competing risk regression models were used to assess predictors of RS occurrence. A total of 314 patients were included (mean age = 70 years, 63% females). The statin-exposed cohort included both patients already receiving statins before SE (n = 68) and patients in whom statin administration was started during the hospitalization (n = 18). Atorvastatin (69/86, 80%) was the most frequently prescribed statin. Overall, 67 patients (21.3%) developed RS (mean follow-up = 31.5 months). Cumulative probability of RS occurrence was 16%, 23%, and 32% at 12 months, 2 years, and 5 years after SE, respectively. Median time from index event to first RS was 6.9 months (interquartile range = 11.6 months). Cumulative probability of RS was significantly lower in statin users compared to nonusers (log-rank p = .038). After adjusting for confounders, the risk of RS was lower for those patients who used statins after the index event (hazard ratio = .48, 95% confidence interval [CI] = .26-.90, p = .023). The overall risk of RS was moderate and temporally confined within a few years from the index event. Statin exposure was associated with a lower incidence of RS. Our findings expand knowledge regarding a possible antiepileptogenic role of statins after SE and support further studies in this field.

PMID 42745495
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