pitavastatin / Generic mfg. - LARVOL DELTA

Beyond Lipid Lowering: A Narrative Review and Expert Perspective on Precision Cardiovascular Prevention in People with HIV After REPRIEVE. (PubMed, Biomolecules) - "In the REPRIEVE study, treatment with pitavastatin was shown to reduce the rate of first cardiovascular events among individuals with HIV receiving antiretroviral therapy...We also examine a growing number of therapeutic options that address residual inflammation and atherogenic metabolic disturbance in individuals with HIV on long-term, effective antiretroviral therapy. Significantly, after REPRIEVE, we must move from prescribing statins to all individuals with HIV toward more individualized cardiovascular disease prevention strategies, integrating clinical information, a variety of biomarkers, imaging studies, and even molecular information to generate optimal individualized cardiovascular disease prevention regimens that reflect the complexity of this outcome in naturally diverse individuals."

Journal • Review • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Heart Failure • Human Immunodeficiency Virus • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders • Oncology

Safety and efficacy of low-density lipoprotein-lowering drugs in the elderly: a network meta-analysis of randomized controlled trials. (PubMed, J Geriatr Cardiol) - "Moderate-intensity pitavastatin showed the highest safety profile, while its combination with ezetimibe was the most effective for LDL reduction."

Journal • Retrospective data • Cardiovascular • Dyslipidemia

Physiologically-based pharmacokinetic modeling of coproporphyrin I, an endogenous OATP1B substrate, in cynomolgus monkeys: Bridging the inhibitory effect of rifampicin to humans. (PubMed, Drug Metab Pharmacokinet) - "First, reported DDIs involving an OATP1B substrate pitavastatin and an OATP1B inhibitor rifampicin at several doses were simultaneously analyzed using PBPK coupled with a cluster Gauss-Newton method (CGNM), estimating the in vivo inhibition constant (Ki,u,OATP1B,PTV) in the cynomolgus monkeys. Both parameters were several-fold higher in monkeys than in humans, suggesting the difference in the DDI sensitivity. In conclusion, this study demonstrates that the integrated PBPK-CGNM approach enables quantitative assessment of OATP1B-mediated DDIs in preclinical species while accounting for interspecies differences."

Journal • PK/PD data

Primary Cardiovascular Prevention in People Living With HIV: Rethinking Statin Therapy in the Post-REPRIEVE Era. (PubMed, Curr HIV/AIDS Rep) - "REPRIEVE demonstrated that pitavastatin reduced major adverse cardiovascular events in PWH aged 40-75 years receiving antiretroviral therapy and at low-to-moderate estimated cardiovascular risk...Statin therapy is an evidence-based component of primary cardiovascular prevention in PWH aged 40-75 years, but guideline-level eligibility does not imply uniform absolute benefit. Outside the REPRIEVE age range, decisions should integrate the distinct balance of relative and absolute risk, general-population evidence, comorbidity, frailty, drug-drug interactions, treatment burden, and individual preferences rather than rely on age alone."

Journal • Review • Cardiovascular • Dyslipidemia • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders

A microdose cocktail and population pharmacokinetic study suggests potentially reduced CYP3A and P-gp activities in type 2 diabetes. (PubMed, Front Pharmacol) - "The activities of CYP3A and transporters P-gp, OATP and BCRP were evaluated in type 2 diabetes patients and healthy volunteers (HVs) following a single oral dose of five probe drugs (midazolam, dabigatran etexilate, pitavastatin, rosuvastatin, and atorvastatin). Additionally, factors such as sex, BCRP genotype, and Clostridium_XlVb partly explained the IIV in probe drugs exposure. The findings regarding altered DMET activities and identified influence factors help to identify specific drug classes that may warrant closer clinical attention in type 2 diabetes patients."

Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

High-Intensity Statins and the Post-Discharge Clinical Outcomes at 1 Year After Percutaneous Coronary Intervention: Insights From STOPDAPT-3. (PubMed, Circ Rep) - "We performed a post hoc analysis of STOPDAPT-3, which compared 1-month aspirin-free prasugrel monotherapy followed by clopidogrel monotherapy with 1-month dual antiplatelet therapy (DAPT) followed by aspirin monotherapy in patients with ACS or a high bleeding risk undergoing PCI. High-intensity statins were defined as the maximum approved dose of strong statins in Japan (e.g., rosuvastatin 10 mg, atorvastatin 20 mg, or pitavastatin 4 mg)...The 1-year post-discharge cumulative incidence of cardiovascular events was similar between patients who received high-intensity statins and those who did not (3.90% vs. 4.27%, P=0.51; adjusted HR 1.03; 95% CI 0.74-1.44; P=0.84). In STOPDAPT-3, high-intensity statin therapy at discharge was not associated with a reduced risk of cardiovascular events 1 year after PCI, under the limitations of having no laboratory test or prescription data available during the follow up."

Clinical data • Journal • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Dyslipidemia

Study of ECC4703 With Sulfasalazine and Pitavastatin (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Eccogene | Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Efficacy and Safety of Pitavastatin Plus Ezetimibe versus Pitavastatin Monotherapy in Adults with Hypercholesterolemia (AHA 2026) - "Abstract is embargoed at this time."

Clinical • Monotherapy • Dyslipidemia • Metabolic Disorders

Enantiodivergent C3-Selective Reduction of Arylvinyl-Substituted 3,5-Dicarbonyl Esters Enabled by Engineered Ketoreductases. (PubMed, Org Lett) - "Complementary (R)-products were obtained using KmCR2 and several other variants with up to 97% conversion and >99% ee, including a key intermediate for the synthesis of pitavastatin. Preparative-scale reactions (greater than 100 mg) further demonstrated the practicality of this platform. Protein-ligand docking among the substrate, cofactor, and KREDs provided mechanistic insights for great stereoselectivity."

Journal

Associations between inflammatory markers and myocardial injury in patients treated with pitavastatin : A retrospective clinical study. (PubMed, Pak J Pharm Sci) - "In pitavastatin-treated patients, inflammatory markers correlate with myocardial injury; monitoring hs-CRP, IL-6, TNF-α improves prognosis."

Biomarker • Journal • Retrospective data • Atherosclerosis • Cardiovascular • Dyslipidemia • Oncology • CCL2 • CRP • IL6 • MB • TNFA • TNNI3

A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults. (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion

RP CLARITI: Safety Evaluation Study of Pitavastatin PLGA Nano-particle for Retinitis Pigmentosa (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: Kyushu University

New P1 trial • Genetic Disorders • Inherited Retinal Dystrophy • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinitis Pigmentosa

Beyond gluten-free diet: repurposing pitavastatin and lubiprostone as cathepsin S inhibitors for celiac disease therapy. (PubMed, In Silico Pharmacol) - "A focused screening of FDA-approved drugs identified pitavastatin and lubiprostone as promising cathepsin S inhibitors for CeD therapy. Established safety profiles and well-established pharmacokinetics are just a few of the substantial advantages these medicines offer for clinical translation."

Journal • Celiac Disease • Immunology

Coproporphyrin I PBPK model in the open systems pharmacology suite enables precise prediction of OATP 1B- mediated drug interactions through calibrated In vivo inhibition constants. (PubMed, Front Pharmacol) - "It was integrated into a DDI network comprising the precipitants rifampicin, probenecid, and cyclosporine A, and the object drugs atorvastatin, pitavastatin, and rosuvastatin. It demonstrates that calibrating participant models using early clinical biomarker data enables reliable prospective prediction of OATP1B-mediated DDIs. This workflow supports model-informed drug development (MIDD) strategies, potentially reducing the need for dedicated clinical DDI studies."

Journal • Preclinical

Safety Profile of Statins: An Umbrella Review of Systematic Reviews and Meta-analyses. (PubMed, Eur Cardiol) - "Statins were associated with an increased risk of new-onset diabetes, particularly rosuvastatin and atorvastatin, whereas pitavastatin may be protective. Therapy should be tailored to individual patient factors. Further research is needed to clarify rare or inconsistent outcomes."

Journal • Review • Cardiovascular • Diabetes • Hepatology • Liver Failure • Metabolic Disorders • Myositis

Mechanisms and Predisposing Conditions for Statin-Induced New-Onset Type 2 Diabetes Mellitus: A Paradox Relative to Their Pleiotropic Metabolic Effects. (PubMed, Endocrinol Diabetes Metab) - "Atorvastatin, simvastatin and rosuvastatin possess the most pronounced diabetogenic properties. In contrast, lovastatin, fluvastatin, pitavastatin and most notably pravastatin exert either neutral or advantageous effects with respect to glucose metabolism."

Journal • Review • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CDC42 • RAC1

Association of Pitavastatin Versus Atorvastatin Therapy With Glycaemic Control and New-Onset Diabetes in Older Adults With Atherosclerotic Cardiovascular Disease. (PubMed, Br J Hosp Med (Lond)) - "Compared with atorvastatin, pitavastatin may be associated with better glycemic outcomes and a lower risk of new-onset diabetes in elderly ASCVD patients, supporting its consideration in clinical practice where glycemic control is a concern."

Clinical • Journal • Retrospective data • Atherosclerosis • Cardiovascular • Diabetes • Metabolic Disorders

The Synergistic Effects of Metformin with Pitavstatin Against MDA-MB-468 Breast Cancer Cells. (PubMed, Asian Pac J Cancer Prev) - "These findings indicate that the combination of metformin and pitavastatin exerts a synergistic anticancer effect against MDA-MB-468 breast cancer cells and may represent a promising therapeutic strategy for triple-negative breast cancer."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Study of ECC4703 With Sulfasalazine and Pitavastatin (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Eccogene

New P1 trial • Dyslipidemia • Hepatology • Metabolic Dysfunction-Associated Steatotic Liver Disease

A multi-center, open-label, observational study to evaluate the efficacy and safety of LivaloZet® tablets in patients with dyslipidemia and metabolic syndrome: PIVOT study protocol. (PubMed, Front Endocrinol (Lausanne)) - P | "LivaloZet® Tablet (pitavastatin/ezetimibe fixed-dose combination) addresses this need by combining complementary cholesterol-lowering mechanisms with the glucose-neutral profile of pitavastatin. As a non-randomized, single-arm observational study, this design cannot establish causal effects or comparative efficacy versus other lipid-lowering regimens. Findings should be interpreted descriptively, acknowledging potential confounding by indication, selection bias, and inter-laboratory variability."

Journal • Observational data • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Hypertension • Metabolic Disorders • Myositis • Obesity • CRP

Formulation and evaluation of sustained-release pitavastatin-loaded chitosan nanoparticles for enhanced anti-hyperlipidemic activity. (PubMed, Pak J Pharm Sci) - "Chitosan-based Pitavastatin nanoparticles successfully enhanced drug solubility and provided sustained release, leading to improved ex-vivo permeability and greater in-vivo anti-hyperlipidemic activity in albino rats. This approach represents a promising strategy for enhancing therapeutic potential of Pitavastatin."

Journal • Dyslipidemia

OPTIMAR: Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) (clinicaltrials.gov) - P3 | N=300 | Active, not recruiting | Sponsor: Kirby Institute | Trial completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Congestive Heart Failure • Human Immunodeficiency Virus • Infectious Disease • CD4

A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults. (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed

Cost-Effectiveness of Pitavastatin in Dyslipidemia: A Systematic Review. (PubMed, Healthcare (Basel)) - "This study aims to assess the cost-effectiveness of pitavastatin in comparison with atorvastatin (ATOR) and rosuvastatin (ROS). Because of the small number and heterogeneity of studies, it is not possible to draw firm conclusions about the cost-effectiveness of PIT. Further model-based analyses with an adequate sample size and comprehensive costing are needed to clarify the economic role of PIT."

HEOR • Journal • Review • Cardiovascular • Dyslipidemia • Metabolic Disorders