Delving into the Latest Updates on Simvastatin/Nicotinic Acid with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Niacin/simvastatin, Niaspan/simvastatin, Nicotinic acid/simvastatin

+ [4]

Target

HCAR3 x HMG-CoA reductase x NIACR1

Mechanism

HCAR3 agonists(HM74 nicotinic acid GPCR agonists), HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors), NIACR1 agonists(Hydroxycarboxylic acid receptor 2 agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

HypertriglyceridemiaPrimary hypercholesterolemiaPrimary Hyperlipidemia

Inactive Indication-

Originator Organization

AbbVie, Inc.

Active Organization-

Inactive Organization

Abbott Laboratories

Drug Highest PhasePhase 3

First Approval Date

US (15 Feb 2008),

Dyslipidemias

Regulation-

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Structure

Molecular FormulaC31H43NO7

InChIKeyWNWXXAPGHTVCDL-OKDJMAGBSA-N

CAS Registry1054452-10-6

对辛伐他汀烟酸缓释片进行人体药代动力学评价；测定主要成分辛伐他汀、烟酸和代谢物辛伐他汀酸、烟酰胺和烟脲酸的经时血药浓度和尿药浓度，估算其主要药代动力学参数，了解辛伐他汀烟酸缓释片在健康人体内的吸收、分布、消除、代谢规律。

[Translation]

To evaluate the pharmacokinetic properties of simvastatin niacin sustained-release tablets in humans; to determine the time-dependent plasma and urine concentrations of the main components simvastatin, niacin, and metabolites simvastatin acid, niacinamide, and nicotinuric acid, to estimate their main pharmacokinetic parameters, and to understand the absorption, distribution, elimination, and metabolism of simvastatin niacin sustained-release tablets in healthy humans.

Start Date21 Dec 2012

Sponsor / Collaborator

Shandong Bestcomm Pharmaceutical Co., Ltd.

NCT01178320 / CompletedNot ApplicableIIT

Carotid Plaque Characteristics by MRI in AIM-HIGH

Heart attacks and strokes caused by the unstable atherosclerotic plaques remain the leading cause of death in the United States. Unstable plaques often have more fat than stable plaques. This study will investigate if a treatment with LDL-lowering plus HDL-raising compared with LDL-lowering alone would more effectively reduce the plaque fat content assessed by magnetic resonance imaging (MRI), therefore, further reducing heart attacks and strokes.

Start Date01 Mar 2008

Sponsor / Collaborator

University of Washington

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100 Clinical Results associated with Simvastatin/Nicotinic Acid

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100 Translational Medicine associated with Simvastatin/Nicotinic Acid

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100 Patents (Medical) associated with Simvastatin/Nicotinic Acid

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8

Literatures (Medical) associated with Simvastatin/Nicotinic Acid

01 Dec 2019·TrialsQ4 · MEDICINE

The Evaluation of Vitiligous lesions Repigmentation after the Administration of Atorvastatin calcium salt and Simvastatin-acid sodium salt in patients with active vitiligo (EVRAAS), a pilot study: study protocol for a randomized controlled trial

Q4 · MEDICINE

ArticleOA

Author: Kowaliszyn, Bogna ; Winnicki, Andrzej ; Kosmalski, Tomasz ; Niezgoda, Anna ; Czajkowski, Rafał ; Krysiński, Jerzy

BACKGROUNDVitiligo is a chronic skin disorder presenting with depigmentation, the pathogenesis of which is complex but the autoimmune theory is now preferred. Multiple immunologic processes, including stimulation of the T-helper (Th)1 response, formation of autoreactive melanocyte-specific CD8⁺ T lymphocytes, a decrease in the blood concentration of T regulatory (Treg) cells, and an increase in interleukin (IL)-17 and interferon (IFN) concentration, have been shown to contribute to vitiligo progression and maintenance. The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with nonsegmental vitiligo (NSV). According to available data, statins act through several immunological pathways, potentially reversing undesirable phenomena underlying autoimmune vitiligo pathogenesis.METHODS/DESIGNA study has been designed as a single-center, randomized, double-blind, placebo-controlled pilot study with the enrollment of at least 24 active NSV patients presenting with vitiligous lesions on both upper and lower limbs. The clinical effects of ointments containing 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb will be assessed in comparison with vehicle ointment applied on the opposite limb. All study participants will undergo clinical evaluation using body surface area (BSA) and Vitiligo Area Scoring Index (VASI) scales at baseline and at weeks 4, 8, and 12 time points. A precise assessment of skin lesions will be performed using photographic documentation obtained during each study visit and processed with NIS-Elements software.DISCUSSIONCurrently available vitiligo topical therapeutic approaches including calcineurin inhibitors and corticosteroids remain poorly effective and are associated with either relatively high cost or potentially dangerous adverse effects. The clinical application of orally administrated statins, widely used as systemic cholesterol-lowering agents, in vitiligous patients has only been tested in two clinical trials; however, data on their potential usefulness is scarce. Moreover, due to a high risk of clinically significant toxicity, topical administration was recommended by researchers. This study is the first to evaluate safety and efficacy of the topical use of statins in patients presenting with NSV.TRIAL REGISTRATIONClinicaltrials.gov, NCT03247400 . Registered on 05 August 2017.

01 Sep 2011·Geriatric NursingQ3 · MEDICINE

Focus on Statin Safety Concerns

Q3 · MEDICINE

Article

Author: Lefkovitz, Allen ; Zarowitz, Barbara

Muscle complaints, including rhabdomyolysis (severe muscle damage), related to the cholesterol-lowering medications known as statins, are a class effect. Following preliminary data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial showing increased muscle injuries, the Food and Drug Administration (FDA) began reviewing the safety of simvastatin, particularly the high-dose 80-mg simvastatin, in March 2010. On June 8, 2011, the Food and Drug Administration (FDA) released the updated product information with revised safety warnings regarding myopathy and rhabdomyolysis associated with products for high cholesterol that contain simvastatin. Simvastatin is the generic form of Zocor and is the statin contained in both Vytorin (simvastatin and ezetimibe) and Simcor (simvastatin and niacin extended-release). From the SEARCH trial and analysis of the FDA’s Adverse Event Reporting System (AERS) database, the FDA found that fatal rhabdomyolysis was significantly more common with 80 mg compared with 20 mg of simvastatin, and that overall rates of myopathy and rhabdomyolysis were higher in simvastatin 80 mg versus lower doses of simvastatin or other statins (e.g., atorvastatin, pravastatin, etc.). The risks for both myopathy and rhabdomyolysis were highest for 80 mg simvastatin during the first 12 months of treatment and are shown in Table 1. Both older age and female sex were seen as risk factors for

01 Nov 2010·Drugs in R&DQ4 · MEDICINE

Niacin Extended Release (ER)/Simvastatin (Simcor®)

Q4 · MEDICINE

ReviewOA

Author: Lyseng-Williamson, Katherine A

Oral fixed-dose niacin extended release/simvastatin is associated with clinically relevant improvements in plasma lipid profiles, including lowering of non-high-density lipoprotein cholesterol levels, relative to simvastatin monotherapy in patients with mixed dyslipidemias who had not responded fully to simvastatin monotherapy, and is generally well tolerated.

100 Deals associated with Simvastatin/Nicotinic Acid

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