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pitavastatin + valsartan (Livalsartan / Livasartan)

✓ Approved

JW Pharmaceutical · AGTR1 · Small Molecule

What is pitavastatin + valsartan?

pitavastatin + valsartan is a small molecule developed by JW Pharmaceutical. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesLivalsartan, Livasartan
CompanyJW Pharmaceutical
Drug ClassSmall Molecule
Molecular TargetAGTR1, HMGCR
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, JW Pharmaceutical

Mechanism of Action

Molecular Targets

pitavastatin + valsartan acts on 2 molecular targets:

AGTR1angiotensin II receptor type 1 (HAT1R, AT1)
HMGCR3-hydroxy-3-methylglutaryl-CoA reductase (LDLCQ3, LGMDR28)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

pitavastatin + valsartan is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Metabolism and nutrition disordersHypercholesterolaemia✓ Approved
Vascular disordersHypertension✓ Approved

Related Research Articles

PubMedEuropean journal of heart failure2026-08-30

Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials.

Lu Henri H, Claggett Brian L BL, Ostrominski John W JW, Pfeffer Marc A MA et al.

Blood pressure (BP) control is a Class I recommendation for the management of heart failure with preserved ejection fraction (HFpEF); however, evidence supporting systolic BP (SBP) targets remains limited. We investigated associations between BP control and subsequent outcomes in patients with HF with mildly reduced EF (HFmrEF)/HFpEF. We pooled TOPCAT (Americas), PARAGON-HF, DELIVER, and FINEARTS-HF, which tested spironolactone, sacubitril/valsartan, dapagliflozin, and finerenone, respectively, versus placebo or active control in patients with HF and an LVEF >40% (DELIVER), ≥40% (FINEARTS-HF), or ≥45% (TOPCAT-Americas, PARAGON-HF). Daily BPs were estimated by interpolation from standardized office measurements obtained at randomization and prespecified visits. Time in target range (TIR) was the percentage of the first year after randomization during which SBP was 110-<130 mmHg. Continuous associations between TIR and subsequent risk of HF hospitalization or cardiovascular death, its individual components, and all-cause death was assessed using landmark Cox proportional hazards models with linear splines, adjusted for baseline cardiovascular risk factors. Among 17,788 patients (mean age 72±9 years; 47% women; mean baseline SBP 129±15 mmHg), the median TIR was 38% (≈139 days). Randomization to active therapies increased TIR by 2% (95% CI: -2 to 6) with spironolactone, 7% (5 to 9) with sacubitril/valsartan, 2% (0 to 4) with dapagliflozin, and 3% (1 to 5) with finerenone. Higher TIR was associated with lower subsequent risk of the composite outcome (P=0.021), primarily driven by lower HF hospitalization risk (P=0.007); associations with cardiovascular death and all-cause death were not significant. Sensitivity analyses using stricter (120-<130 mmHg) or more liberal ranges (100-<130 and 120-<140 mmHg) yielded qualitatively similar findings. In patients with HFmrEF/HFpEF, BP control during the first year was associated with a lower subsequent risk of HF hospitalization. ClinicalTrials.gov ID NCT00094302 (TOPCAT), NCT01920711 (PARAGON-HF), NCT03619213 (DELIVER), NCT04435626 (FINEARTS-HF).

PMID 42669134
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PubMedJournal of pharmaceutical sciences2026-08-29

Glycerol-rich vesicular matrices as an effective oral platform for valsartan: Box-Behnken optimization and ex vivo/in vivo evaluation.

Abdelhameed Asmaa H AH, Farghaly Usama U, Fathalla Zeinab Z, Zayed Gamal G

The current work aims to evaluate the efficacy of glycerol-rich vesicular matrices for enhancing the oral bioavailability and antihypertensive capacity of valsartan (VAL), a poorly soluble medication. These vesicular dispersions were generated employing the thin film hydration technique and optimized through the Box-Behnken design to investigate the effect of cholesterol, phospholipid, and glycerol concentrations on the vesicle size (VS), entrapment efficiency (EE), and drug release after 6 h (%Q6h). The optimized formulation (0.46% w/v cholesterol, 4.47% w/v phospholipid, and 10.12% w/v glycerol) exhibited nano-sized vesicles of 172.76 ± 6.47 nm with a narrow size distribution (PDI = 0.185 ± 0.101), a zeta potential of -42.4 ± 0.85 mV, an EE of 80.87 ± 1.58%, and a Q6h of 96.68 ± 1.92%. Additionally, the physical mixture of optimized components in glycerol hydration medium showed a powerful synergistic solubility enhancement, which aligns with carrier-mediated hydration, thereby facilitating the dissolution of over 71% of the target drug load during processing. Morphological characterization using SEM and TEM unveiled spherical, non-aggregated vesicular matrices. FTIR studies confirmed the absence of chemical interactions between the drug and the formulation components, while DSC and XRD analyses evidenced the loss of crystalline character of valsartan upon vesicular incorporation. Ex vivo permeation of the ultra-elastic formulation displayed a flux value (135.07 ± 7.8 µg/cm² h) twice that of the plain drug. Furthermore, the optimized colloidal dispersion remained stable for three months under refrigerated and ambient conditions. Finally, in vivo investigations in dexamethasone-induced hypertensive rabbits showed a significant reduction in mean arterial pressure and a two-fold increase in systemic bioavailability compared to the unprocessed medication. Consequently, the developed vesicular colloidal delivery system holds significant potential for improving valsartan's oral therapeutic delivery.

PMID 42667956
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PubMedJournal of the American College of Cardiology2026-08-28

Low-Normal Hemoglobin Concentrations and Clinical Outcomes in Heart Failure.

Chimura Misato M, Pellicori Pierpaolo P, Docherty Kieran K, Claggett Brian L BL et al.

The World Health Organization (WHO) defines anemia as hemoglobin concentration <12 g/dL in women and <13 g/dL in men. Although widely used clinically, these thresholds were based on distributions in healthy populations rather than on outcomes. Whether these WHO thresholds adequately reflect the relationship between hemoglobin concentration and clinical outcomes in patients with heart failure (HF) is uncertain. We sought to characterize sex-specific associations between hemoglobin concentration and clinical outcomes and to identify the hemoglobin concentrations associated with the lowest observed risk in patients with HF across the spectrum of left ventricular ejection fraction. Patient-level data were pooled from 6 trials in heart failure with reduced ejection fraction (HFrEF) and 5 trials in heart failure with preserved ejection fraction (HFpEF) or heart failure with mildly reduced ejection fraction (HFmrEF). Associations among baseline hemoglobin and a first HF hospitalization or cardiovascular death, the components of this composite, and all-cause death were examined using Cox proportional hazards models. Sex-specific hemoglobin concentrations associated with the lowest incidence rates were estimated using Poisson regression with restricted cubic splines. Outcomes were also examined by hemoglobin categories defined relative to WHO anemia thresholds. Overall, 25,003 patients with HFrEF (5,581 women, 19,422 men) and 17,210 with HFpEF/HFmrEF (8,763 women, 8,447 men) were included. In HFrEF, median hemoglobin was 13.0 g/dL (Q1-Q3: 12.1-13.9 g/dL) in women and 14.0 g/dL (Q1-Q3: 12.9-15.1 g/dL) in men; corresponding values in HFpEF/HFmrEF were 13.1 g/dL (Q1-Q3: 12.1-14.0 g/dL) and 14.0 g/dL (Q1-Q3: 12.8-15.0 g/dL), respectively. Across HF phenotypes and outcomes, the lowest risk occurred at hemoglobin concentrations of approximately 14 g/dL in women and 15 g/dL in men, above the WHO anemia thresholds. With hemoglobin ≥2 g/dL above the WHO anemia thresholds as the reference, WHO-defined anemia was associated with the highest adjusted risk. Excess risk was also observed at 0 to <1 g/dL above the thresholds. In patients with HF, hemoglobin concentrations associated with the lowest risk of death and HF hospitalization were approximately 14 g/dL in women and 15 g/dL in men. Hemoglobin concentrations above WHO anemia thresholds may still carry prognostic information and, in conjunction with other clinical findings, may prompt consideration of potentially reversible contributors such as iron deficiency. (Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity [CHARM-Added], NCT00634309; Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity [CHARM-Alternative], NCT00634400; Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity [CHARM-Preserved], NCT00634712; A Comparison Of Outcomes In Patients In New York Heart Association [NYHA] Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines [EMPHASIS-HF], NCT00232180; Irbesartan in Heart Failure With Preserved Systolic Function [I-Preserve], NCT00095238; Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT], NCT00094302; This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure [PARADIGM-HF], NCT01035255; Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF], NCT01920711; Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure [DAPA-HF], NCT03036124; Registrational Study With Omecamtiv Mecarbil [AMG 423] to Treat Chronic Heart Failure With Reduced Ejection Fraction [GALACTIC-HF], NCT02929329; Study to Evaluate the Efficacy [Effect on Disease] and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction [Proportion of Blood Expelled Per Heart Stroke] Greater or Equal to 40% [FINEARTS-HF], NCT04435626).

PMID 42663359
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PubMedDiagnostics (Basel, Switzerland)2026-08-27

Reverse Remodeling Following Sacubitril/Valsartan Initiation in CRT-Treated HFrEF Patients: Insights from a Real-World Cohort.

Pătru Oana O, Cozma Dragoș D, Luca Silvia S, Văcărescu Cristina C et al.

Background: Sacubitril/valsartan is a cornerstone of guideline-directed medical therapy for heart failure with reduced ejection fraction (HFrEF), yet data regarding reverse remodeling after ARNI initiation in patients previously treated with cardiac resynchronization therapy (CRT) remain limited. This study evaluated echocardiographic reverse remodeling following sacubitril/valsartan initiation in a real-world cohort of CRT-treated patients and explored the association between treatment timing and remodeling response. Methods: This single-center retrospective pilot study included 188 patients with HFrEF treated with CRT who subsequently initiated sacubitril/valsartan. Patients were categorized into early (≤12 months after CRT, n = 112) and late (>12 months, n = 76) initiation groups. Echocardiographic parameters and functional status were assessed at baseline and at approximately 12 months. Reverse remodeling was evaluated using changes in left ventricular ejection fraction (LVEF), ventricular volumes, and clinical status. Multivariable logistic regression was used to explore factors associated with reverse remodeling (ΔLVEF ≥ 10%). Results: Sacubitril/valsartan therapy was associated with significant improvements in LVEF, left ventricular end-diastolic volume, left atrial volume, and NYHA functional class in both groups. The magnitude of improvement in echocardiographic parameters was similar between early and late initiation groups. In exploratory multivariable analyses, earlier ARNI initiation was associated with clinically meaningful reverse remodeling (ΔLVEF ≥ 10%) (OR 6.36, 95% CI 1.59-25.50, p = 0.009). SGLT2 inhibitor therapy was also associated with reverse remodeling (OR 5.76, 95% CI 1.86-17.87, p = 0.002), while a longer CRT-to-ARNI interval was associated with lower odds of response (OR 0.77 per year, 95% CI 0.62-0.96, p = 0.018). Analysis of CRT-to-ARNI interval as a continuous variable showed only a weak association with reverse remodeling, while receiver operating characteristic analysis did not identify a meaningful temporal threshold (AUC 0.497). Conclusions: Sacubitril/valsartan initiation after CRT was associated with significant reverse remodeling, including in patients who initiated therapy several years after CRT implantation, although the late-initiation subgroup was of limited size, and treatment intervals beyond the interquartile range (4.0-7.0 years) were sparsely represented. Absolute echocardiographic improvements were broadly similar between groups, and receiver operating characteristic analysis did not identify a discriminative temporal threshold (AUC 0.497), indicating no discriminative ability beyond chance. Exploratory multivariable analysis identified an association between earlier initiation and clinically meaningful reverse remodeling, but this finding was not supported by a clinically meaningful temporal threshold.

PMID 42651070
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PubMedFrontiers in cardiovascular medicine2026-08-27

Dose reduction and discontinuation of sacubitril/valsartan over time in patients undergoing maintenance hemodialysis.

Guo Ying Y, Yin Min M, Li Qianyu Q, Guo Shuojie S et al.

This study aims to evaluate the therapeutic effects and dose adjustment patterns of sacubitril/valsartan (SV) over time in patients undergoing maintenance hemodialysis (HD). The clinical data of end-stage renal disease patients receiving maintenance HD at our center were retrospectively reviewed. A total of 151 patients treated with SV were included. All patients were followed up regularly in the dialysis outpatient clinic. The clinical characteristics, biochemical parameters, and echocardiographic measurements were collected at baseline and during follow-up. The efficacy, safety, and dose adjustment patterns of SV therapy were analyzed. A six-month observation period was selected for analysis to ensure adequate follow-up while maximizing the number of eligible patients included in the study. SV dose reduction was observed in 62 patients, and 48 patients had discontinued concomitant antihypertensive medications. The greatest reduction in the proportion of patients receiving SV combined with other antihypertensive agents occurred at the fourth month after dialysis initiation (39.8%). Patients receiving SV without dose reduction and in combination with other antihypertensive drugs had higher interdialytic and intradialytic blood pressure, when compared with patients receiving SV monotherapy or reduced/discontinued SV. The multivariate analysis identified diabetes mellitus [odds ratio [OR]: 3.085, 95% confidence interval [CI]: 1.137-8.376, p = 0.027], higher baseline N-terminal pro B-type natriuretic peptide (OR: 1.870, 95% CI: 1.109-3.152, p = 0.019), and higher interdialytic weight gain-to-dry weight ratio (OR: 4.083, 95% CI: 1.763-9.457, p = 0.001) as independent predictors of intradialytic hypotension. During follow-up, six composite events occurred in the SV combination or monotherapy group, while 13 composite events occurred in the SV dose reduction or discontinuation group. There was no significant difference between groups. In real-world practice, the dose reduction or discontinuation of SV is common in HD patients. Clinicians should carefully balance individual risks and benefits, apply SV with caution, and closely monitor patients receiving this therapy.

PMID 42656599
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PubMedPharmacy (Basel, Switzerland)2026-08-26

Frequency and Profiles of Drug Combinations Constituting the Triple Whammy in Japan: An Analysis of a Patient Estimation Database.

Maese Mari M, Ito Nozomi N, Shiokawa Haruka H, Kondo Shingo S et al.

"Triple whammy" prescriptions, combining non-steroidal anti-inflammatory drugs (NSAIDs), renin-angiotensin system (RAS) inhibitors, and diuretics, increase acute kidney injury (AKI) risk. To clarify the frequency and profiles of these prescriptions and identify vulnerable populations, we analyzed the AHI partners database to estimate the number of individuals prescribed these three drug classes. In the single-agent analysis, loxoprofen was the most commonly prescribed NSAID (66.3%), olmesartan (19.4%) and telmisartan (15.9%) were the predominant RAS inhibitors, and furosemide (19.6%) and spironolactone (16.0%) were the most frequently used diuretics. Dual-drug combinations showed patterns consistent with the single-agent results for NSAIDs and diuretics. By contrast, sacubitril/valsartan was the most common RAS inhibitor when combined with diuretics, frequently utilized for heart failure management. In triple whammy prescriptions, NSAIDs and diuretics patterns mirrored those of single-agents. The annual number of triple whammy prescriptions showed a statistically significant downward trend over the study period by the Mann-Kendall trend test (p = 0.048). Notably, sacubitril/valsartan was the leading RAS inhibitor (46/199 patients, 23%), showing a higher proportion than its single-agent use (7.4%). Heart failure patients prescribed these two causative drugs are highly vulnerable to "triple whammy" prescriptions. Awareness of inadvertent NSAID additions is warranted to mitigate potential AKI risks.

PMID 42646348
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