- |||||||||| niacin extended-release formulation / Generic mfg.
THERAPEUTIC POTENTIAL OF NIACIN IN PS19 TAUOPATHY MICE () - Mar 10, 2025 - Abstract #ADPD2025ADPD_1217;
Our results indicate that hippocampal HCAR2 expression is increased in 9- month-old PS19 mice. Moreover, treatment with Niaspan
- |||||||||| niacin extended-release formulation / Generic mfg.
Enrollment open: Nicotinic Acid for the Treatment of Alzheimer's Disease (clinicaltrials.gov) - Dec 13, 2024
P1/2, N=30, Recruiting,
Niacin, nicotinic acid, is a vitamin used for many decades as anti-dyslipidaemic and anti-cholesterol drug product under the commercial name of Niaspan Not yet recruiting --> Recruiting
- |||||||||| niacin extended-release formulation / Generic mfg.
Trial completion date: Nicotinic Acid for the Treatment of Alzheimer's Disease (clinicaltrials.gov) - Sep 29, 2024
P1/2, N=30, Not yet recruiting,
Not yet recruiting --> Recruiting Trial completion date: Aug 2026 --> Feb 2026
- |||||||||| niacin extended-release formulation / Generic mfg., omega-3 ethylester concentrate / Generic mfg.
Journal: Effects of niacin and omega-3 fatty acids on HDL-apolipoprotein A-I exchange in subjects with metabolic syndrome. (Pubmed Central) - Mar 1, 2024
However the combination had no statistically significant effect, 10% (-9, 31 CI, P = 0.39). With regard to P-OM3 therapy in particular, the HAE assay detected an increase in this property in the absence of a concomitant rise in HDL-C and apoA-I levels, suggesting that the assay can detect functional changes in HDL that occur in the absence of traditional biomarkers.
- |||||||||| niacin extended-release formulation / Generic mfg.
Journal: Cholestatic Drug-Induced Liver Injury in a Patient Taking High-Dose Niacin for Hyperlipidemia. (Pubmed Central) - Jan 9, 2024
Although mode of liver injury remains unknown, the use of extended-release niacin formulations and prolonged high-dose supplementation is associated with enhanced hepatotoxicity. Careful review and counseling of commonly available supplements remains an important task of both hospital and primary care physicians.
- |||||||||| niacin extended-release formulation / Generic mfg.
Retrospective data, Review, Journal: Effects of Niacin on apolipoprotein A1 and B levels: A systematic review and meta-analysis of Randomised Controlled Trials. (Pubmed Central) - Dec 19, 2023
Subgroup analyses revealed that the beneficial effects of Niacin on Apo A1 were observed at a dosage of >1500 mg/day (p < 0.001), and Extended-Release Niacin was more effective compared to other forms (p < 0.001)...This meta-analysis highlights Niacin's potential role in improving lipid profiles and cardiovascular health. Further well-designed clinical trials are needed to elucidate and confirm optimal dosages and durations of Niacin interventions for influencing Apolipoproteins A1 and B.
- |||||||||| NN1213 / Novo Nordisk
Enrollment change, Trial withdrawal: EAVaLL: Early Aortic Valve Lipoprotein(a) Lowering Trial (clinicaltrials.gov) - Oct 25, 2023
P1, N=0, Withdrawn,
Further well-designed clinical trials are needed to elucidate and confirm optimal dosages and durations of Niacin interventions for influencing Apolipoproteins A1 and B. N=238 --> 0 | Unknown status --> Withdrawn
- |||||||||| Journal: Lipid-lowering drugs. (Pubmed Central) - Sep 20, 2022
However, plaques with IPH showed greater increases in lipid content and greater decreases in lumen area than plaques without IPH. No abstract available
- |||||||||| niacin extended-release formulation / Generic mfg.
Preclinical, Journal: The niacin receptor HCAR2 modulates microglial response and limits disease progression in a mouse model of Alzheimer's disease. (Pubmed Central) - Apr 27, 2022
These data provide direct evidence that HCAR2 is required for an efficient and neuroprotective response of microglia to amyloid pathology. Administration of Niaspan potentiates the HCAR2-mediated microglial protective response and consequently attenuates amyloid-induced pathology, suggesting that its use may be a promising therapeutic approach to AD that specifically targets the neuroimmune response.
- |||||||||| niacin extended-release formulation / Generic mfg.
Journal: The role of microglia niacin receptor (HCAR2) in Alzheimer's disease. (Pubmed Central) - Feb 4, 2022
HCAR2 is a potential therapeutic target to modulate microglia phenotype towards beneficial outcomes in AD. Our results indicate that the activation of HCAR2 with the FDA-approved formulation of niacin, Niaspan®, leads to neuroprotective effects in AD, even after the onset of severe amyloid pathology, highlighting the translational potential of this strategy into clinical practice, supporting further study of this therapeutic approach.
- |||||||||| niacin extended-release formulation / Generic mfg.
Clinical, Review, Journal: HDL ch olesterol concentrations and risk of atherosclerotic cardiovascular disease - insights from randomized clinical trials and human genetics. (Pubmed Central) - Jan 1, 2022
This robust inverse association fuelled the enthusiasm towards development of HDL cholesterol increasing drugs, exemplified by the cholesteryl ester transfer protein (CETP) inhibitor trials and the extended-release niacin HPS2-THRIVE trial...A likely explanation for the strong observational association between low HDL cholesterol and high ASCVD risk is the concomitant inverse association between HDL cholesterol and atherogenic triglyceride-rich lipoproteins. The purpose of the present review is to bring HDL cholesterol increasing trials into a human genetics context exemplified by candidate gene studies of key players in HDL biogenesis as well as by HDL cholesterol related genome-wide association studies.
- |||||||||| Niagen (nicotinamide riboside) / ChromaDex
Review, Journal: Therapeutic Potential of Emerging NAD+-Increasing Strategies for Cardiovascular Diseases. (Pubmed Central) - Dec 27, 2021
Thus, NAD+ replenishment by either genetic or natural dietary NAD+-increasing strategies has been recently demonstrated to be effective for improving the pathophysiology of cardiac and vascular health in different experimental models, as well as human health, to a lesser extent. Here, we review and discuss recent experimental evidence illustrating that increasing NAD+ bioavailability, particularly by the use of natural NAD+ precursors, may offer hope for new therapeutic strategies to prevent and treat cardiovascular diseases.
- |||||||||| niacin extended-release formulation / Generic mfg., omega-3 ethylester concentrate / Generic mfg.
Enrollment change: Niacin, N-3 Fatty Acids and Insulin Resistance (clinicaltrials.gov) - Oct 26, 2021
P4, N=68, Completed,
Here, we review and discuss recent experimental evidence illustrating that increasing NAD+ bioavailability, particularly by the use of natural NAD+ precursors, may offer hope for new therapeutic strategies to prevent and treat cardiovascular diseases. N=10 --> 68
- |||||||||| niacin extended-release formulation / Generic mfg.
[VIRTUAL] The role of microglia niacin receptor (HCAR2) in Alzheimer's disease () - Aug 2, 2021 - Abstract #AAIC2021AAIC_2395;
HCAR2 is a potential therapeutic target to modulate microglia phenotype towards beneficial outcomes in AD. Our results indicate that the activation of HCAR2 with the FDA-approved formulation of niacin, Niaspan®, leads to neuroprotective effects in AD, even after the onset of severe amyloid pathology, highlighting the translational potential of this strategy into clinical practice, supporting further study of this therapeutic approach.
- |||||||||| niacin extended-release formulation / Generic mfg.
Journal, Monotherapy: Effect of niacin monotherapy on high density lipoprotein composition and function. (Pubmed Central) - Jul 28, 2021
Our results indicate that the activation of HCAR2 with the FDA-approved formulation of niacin, Niaspan®, leads to neuroprotective effects in AD, even after the onset of severe amyloid pathology, highlighting the translational potential of this strategy into clinical practice, supporting further study of this therapeutic approach. Extended-release niacin therapy, in the absence of other lipid-modifying medications, can increase HDL-associated SAA, an acute phase protein associated with HDL dysfunction.
- |||||||||| padnarsertib (KPT-9274) / Karyopharm
Enrollment change, Trial termination, Trial primary completion date: PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA) (clinicaltrials.gov) - Jun 25, 2021
P1, N=60, Terminated,
Extended-release niacin therapy, in the absence of other lipid-modifying medications, can increase HDL-associated SAA, an acute phase protein associated with HDL dysfunction. N=130 --> 60 | Recruiting --> Terminated | Trial primary completion date: Aug 2021 --> Feb 2021; sponsor decision
- |||||||||| niacin extended-release formulation / Generic mfg.
Clinical, Clinical protocol, Journal: The efficacy of niacin supplementation in type 2 diabetes patients: Study protocol of a randomized controlled trial. (Pubmed Central) - Apr 7, 2021
Diabetic patients were randomized (1:1) to receive 3-month treatment with extended-release niacin or matching placebo...We assumed that adding the niacin to the medication in patients with type 2 diabetes would reduce dyslipidemia and achieve target lipid levels. This study protocol was registered in Research Registry (researchregistry5925).
- |||||||||| padnarsertib (KPT-9274) / Karyopharm
Trial completion date, Trial primary completion date: PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA) (clinicaltrials.gov) - Jan 29, 2021
P1, N=130, Recruiting,
This study protocol was registered in Research Registry (researchregistry5925). Trial completion date: May 2021 --> Aug 2021 | Trial primary completion date: May 2021 --> Aug 2021
- |||||||||| niacin extended-release formulation / Generic mfg.
[VIRTUAL] Therapeutic potential of niacin in Alzheimers disease () - Aug 2, 2020 - Abstract #AAIC2020AAIC_3473;
These preliminary data suggest that Niaspan treatment has neuroprotective effects in AD, even after the onset of severe amyloid pathology, through an induction of A cleareance by microglia. Niaspan is a FDA-approved drug, thus there is a translational potential of this strategy into clinical practice, supporting further study of this therapeutic approach.
- |||||||||| niacin extended-release formulation / Generic mfg.
Preclinical, Journal: Biorelevant In Vitro Release Testing and In Vivo Study of Extended-Release Niacin Hydrophilic Matrix Tablets. (Pubmed Central) - Jul 22, 2020
We demonstrate how this behavior is similar for both marketed and test products. In this context, we describe how a robust ER matrix and well-designed formulation does not guarantee the test product's bioequivalence to the comparator one out of reasons unrelated to technology and biopharmaceutical properties, but because of the active compound's intrinsic pharmacokinetic characteristics, i.e., highly variable, extensive metabolism of nicotinic acid.
- |||||||||| niacin extended-release formulation / Generic mfg.
Review, Journal: Niacin for treatment of nonalcoholic fatty liver disease (NAFLD): novel use for an old drug? (Pubmed Central) - Jul 21, 2020
An uncontrolled clinical trial in 39 hypertriglyceridemic patients with steatosis showed reduction of liver fat by 47% and reductions in liver enzymes and C-reactive protein from the baseline when treated with niacin extended-release for 6 months These hypothesis-generating data indicate a novel repurposed use of niacin for NAFLD...In select patients, it may benefit frequently associated atherogenic dyslipidemia. A randomized placebo-controlled double-blind parallel trial (with niacin alone or in combination with another drug in development) to assess the safety and efficacy of niacin on steatosis, inflammation, and fibrosis in patients with nonalcoholic steatohepatitis/NAFLD is warranted.
- |||||||||| NN1213 / Novo Nordisk
Trial completion, Enrollment change: NOFAT: Effects of Niacin On Fatty Acid Trapping (clinicaltrials.gov) - Jul 9, 2020
P1, N=26, Completed,
As PCSK9 inhibitors reduce plasma apoE and Lp(a) concentrations, apoE could be the link between PCSK9 and Lp(a). Active, not recruiting --> Completed | N=20 --> 26
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