Trial reportJournal of atherosclerosis and thrombosis2022
Pitavastatin-Incorporated Nanoparticles for Chronic Limb Threatening Ischemia: A Phase I/IIa Clinical Trial.
Trial report in Journal of atherosclerosis and thrombosis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 17 citations in OpenAlex.
- Nanomedicine-based theranostics in atherosclerotic cardiovascular diseases.Journal of biomedical science · 2026Review
- Reengineering statin therapy to protect skeletal muscle: nanocarrier strategies for mitigating mitochondrial dysfunction and myotoxicity.Inflammation and regeneration · 2026Review
- Applications of Biodegradable Polymeric Nanomaterials as Drug Delivery Systems.Current drug delivery · 2026Review
- Engineered immune-driven theranostics for clinical cardiology.Military Medical Research · 2025Review
- Preclinical Evaluation of Pitavastatin Nanoparticles for Preserving Cone Photoreceptors in Mouse Models of RP.Investigative ophthalmology & visual science · 2025Article
- Comparative pharmacokinetic evaluation of nanoparticle-based vs. conventional pharmaceuticals containing statins in attenuating dyslipidaemia.Naunyn-Schmiedeberg's archives of pharmacology · 2024Review
- Comparative Analysis of Transcriptome Profiles in Patients with Thromboangiitis Obliterans.Genes · 2023Article
- Association of Smoking, Diabetes, and Dialysis with the Presence of Popliteal Lesions in Femoropopliteal Artery Disease.Journal of atherosclerosis and thrombosis · 2023Article
- Review
- Therapeutic angiogenesis and tissue revascularization in ischemic vascular disease.Journal of biological engineering · 2023Review
- Statins and Peripheral Arterial Disease: A Narrative Review.Frontiers in cardiovascular medicine · 2021Review
Corrections and comments
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo assess the results of a phase I/IIa open-label dose-escalation clinical trial of 5-day repeated intramuscular administration of pitavastatin-incorporated poly (lactic-co-glycolic acid) nanoparticles (NK-104-NP) in patients with chronic limb threatening ischemia (CLTI).
methodsNK-104-NP was formulated using an emulsion solvent diffusion method. NK-104-NP at four doses (nanoparticles containing 0.5, 1, 2, and 4 mg of pitavastatin calcium, n=4 patients per dose) was investigated in a dose-escalation manner and administered intramuscularly into the ischemic limbs of 16 patients with CLTI. The safety and therapeutic efficacy of treatment were investigated over a 26-week follow-up period.
resultsNo cardiovascular or other serious adverse events caused by NK-104-NP were detected during the follow-up period. Improvements in Fontaine and Rutherford classifications were noted in five patients (one, three, and one in the 1-, 2-, and 4-mg dose groups, respectively). Pharmacokinetic parameters including the maximum serum concentration and the area under the blood concentration-time curve increased with pitavastatin treatment in a dose-dependent manner. The area under the curve was slightly increased at day 5 compared with that at day 1 of treatment, although the difference was not statistically significant.
conclusionsThis is the first clinical trial of pitavastatin-incorporated nanoparticles in patients with CLTI. Intramuscular administration of NK-104-NP to the ischemic limbs of patients with CLTI was safe and well tolerated and resulted in improvements in limb function.
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