Side Effects of niacin: A Synthesis of Findings from 19 Studies

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Original Abstract of the Article

Major Research Findings

Niacin is an effective lipid-regulating drug that can positively modify lipid disorders like elevated LDL cholesterol, elevated non-HDL cholesterol, elevated triglycerides, elevated lipoprotein(a), and reduced HDL cholesterol. 9 However, several studies have found that high-dose niacin is associated with a number of metabolically induced side effects such as prostaglandin (PG) mediated flushing and hepatic toxicity. 6 , 7 , 4 One study found that niacin modulated parameters and showed overall improvement in Parkinson's disease patients without any side effects. 1 The effects of different hypolipidemic treatment strategies on emerging atherosclerosis risk factors remain unknown. 16

Reasons for Side Effects

The transmembrane G-protein coupled receptor GPR109A has been previously shown to function as a receptor for niacin in mediating antilipolytic effects. 7 However, high doses of niacin are often accompanied by disturbing side effects such as flushing, liver damage, glucose intolerance, or gastrointestinal problems. The release of vasodilatory prostaglandins (PGs) such as PGE2 can elicit niacin-associated flushing side effects. 10 Niacin activates GPR109A, which leads to the release of these vasodilatory PGs, causing these side effects. These side effects limit the clinical use of niacin despite its positive effects on lipid profiles. 5

Common Side Effects

Flushing

Flushing is a common side effect of niacin, and it is characterized by a reddening of the face, neck, and chest. 4 , 10 This side effect is caused by the release of vasodilatory prostaglandins from the skin.

Liver Effects

Niacin can have a negative impact on the liver. 9 , 11 This includes the possibility of liver damage, liver abnormalities and hepatitis.

Platelet Effects

Niacin can activate platelets, which can increase the risk of thrombosis. 11 This is especially important for those with a history of thrombosis. Furthermore, PGD2 biosynthesis is augmented during platelet activation in humans. 4

Microvascular Reactivity Effects

Niacin/laropiprant has been shown to have detrimental effects on microvascular reactivity and red cell deformability. 5 This might explain the lack of clinical net benefit of niacin/laropiprant.

Digestive System Effects

Niacin can also cause gastrointestinal issues, such as stomach pain, nausea, and diarrhea. ,

Measures to Address Side Effects

Measures for Flushing

One method to reduce flushing is to take niacin with a meal or drink a cold beverage afterward. 10 , 4 Additionally, a sustained-release formulation can help reduce the intensity of the flushing. 6

Measures for Liver Effects

To monitor for liver effects, regular liver function tests are necessary. 9 , 11 If any liver abnormalities are detected, it is crucial to consult a doctor immediately.

Measures for Platelet Effects

Individuals with a history of thrombosis should consult their doctor before taking niacin. 11 Regular blood tests are recommended while taking niacin.

Measures for Microvascular Reactivity Effects

If microvascular reactivity deteriorates, discontinuation of niacin is advised. 5

Comparison of Studies

Commonalities of Studies

Many research studies have indicated that niacin can induce side effects including flushing, liver effects, platelet effects, and microvascular reactivity effects.

Differences in Studies

The frequency and severity of reported side effects can vary among studies. The specific causes and the most effective methods for managing these side effects may also differ between research findings.

Precautions for Applying to Real Life

Niacin's effectiveness in lowering cholesterol levels is well-established; however, it is crucial to acknowledge its associated side effects. When considering niacin, consult a doctor to discuss the potential risks and how to manage them effectively. Alternative cholesterol-lowering medications may be a better option if side effects are a significant concern.

Limitations of Current Research

Despite existing research, there are still many unknowns about niacin's side effects. Further investigation is required to comprehensively understand long-term effects and the potential for individual differences to influence these effects.

Directions for Future Research

The development of novel niacin formulations designed to minimize side effects is a priority. Research focused on understanding the mechanisms by which side effects occur is critical. Furthermore, research aimed at identifying individuals who are more likely to experience benefits from niacin and those who are at increased risk for side effects is crucial.

Conclusion

While niacin is an effective cholesterol-lowering agent, it is essential to be aware of its potential side effects, which include flushing, liver effects, and platelet effects. Before taking niacin, it is crucial to consult with a doctor, thoroughly understand the risks and management strategies for side effects, and follow their instructions. If side effects are a concern, alternative cholesterol-lowering medications may be considered.

Literature analysis of 19 papers
Positive Content
15
Neutral Content
1
Negative Content
3
Article Type
4
0
0
7
17
1.

Low-dose niacin supplementation modulates GPR109A, niacin index and ameliorates Parkinson's disease symptoms without side effects.

Author: WakadeChandramohan, ChongRaymond, BradleyEric, MorganJohn C

Parkinson's disease improvement
Not specified

Niacin treatment improved GPR109A expression, niacin index, UPDRS scale, handwriting test, and quality of sleep in a 65-year-old male Parkinson's disease patient. These improvements were sustained after niacin was stopped.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.

Language : English

3.

Modeling, Synthesis, and Biological Evaluation of Potential Retinoid X Receptor (RXR)-Selective Agonists: Analogues of 4-[1-(3,5,5,8,8-Pentamethyl-5,6,7,8-tetrahydro-2-naphthyl)ethynyl]benzoic Acid (Bexarotene) and 6-(Ethyl(5,5,8,8-tetrahydronaphthalen-2-yl)amino)nicotinic Acid (NEt-TMN).

Author: HeckMichael C, WagnerCarl E, ShahaniPritika H, MacNeillMairi, GrozicAleksandra, DarwaizTamana, ShimabukuMicah, DeansDavid G, RobinsonNathan M, SalamaSamer H, ZillerJoseph W, MaNing, van der VaartArjan, MarshallPamela A, JurutkaPeter W

CTCL treatment

This study synthesized and evaluated sulfonic acid analogues of bexarotene and NEt-TMN as selective retinoid X receptor (RXR) agonists. The study identified several compounds with improved biological selectivity and potency compared to known therapeutics.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Niacin and biosynthesis of PGD₂by platelet COX-1 in mice and humans.

Author: SongWen-Liang, StubbeJane, RicciottiEmanuela, AlamuddinNaji, IbrahimSalam, CrichtonIrene, PrempehMaxwell, LawsonJohn A, WilenskyRobert L, RasmussenLars Melholt, PuréEllen, FitzGeraldGarret A

Cardiovascular protection
Reduced flushing

This study investigates the cardiovascular biology of PGD₂ and its role in niacin-induced flushing. The authors show that PGD₂ biosynthesis is augmented during platelet activation in humans and that PGD₂ may function as a homeostatic response to thrombogenic and hypertensive stimuli, particularly during niacin therapy.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Detrimental effects of niacin/laropiprant on microvascular reactivity and red cell deformability in patients with elevated lipoprotein(a) levels.

Author: CioniGabriele, ManniniLucia, LiottaAlessandrello Agatina, D'AlessandriGiovanna, FatiniCinzia, BandinelliBrunella, CostanzoMaria, AbbateRosanna, MarcucciRossella

Lipid profile improvement
Lp(a) reduction
Blood rheology worsening
Endothelial dysfunction

Nicotinic acid/laropiprant treatment resulted in a significant reduction in Lp(a) levels but also worsened endothelial function and blood rheology in patients with Lp(a) ≥500 mg/L.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
LetterA written message for communication and exchange of information between individuals.

Language : English

6.

Effects of formulation design on niacin therapeutics: mechanism of action, metabolism, and drug delivery.

Author: CooperDustin L, MurrellDerek E, RoaneDavid S, HarirforooshSam

Treats hyperlipidemia
Flushing
Hepatic toxicity

Niacin is a lipid-regulating drug with significant side effects, including flushing and hepatic toxicity. This article discusses the various approaches to niacin delivery, such as transdermal formulations and polymeric micro/nanoparticle encapsulation, that have been explored to reduce these side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Lipoprotein(a) and Atherosclerotic Cardiovascular Disease: Current Understanding and Future Perspectives.

Author: WuM F, XuK Z, GuoY G, YuJ, WuY, LinL M

ASCVD risk reduction
Elevated Lp(a)

This review highlights the importance of Lp(a) as a risk factor for ASCVD and the need for its measurement in specific patient populations. New therapeutic approaches, such as IONIS-APO(a)-LRx, hold promise for reducing Lp(a) levels and improving cardiovascular health.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Formulation and in vitro evaluation of niacin-loaded nanoparticles to reduce prostaglandin mediated vasodilatory flushing.

Author: CooperD L, CarmicalJ A, PanusP C, HarirforooshS

Niacin delivery
Flushing

Niacin, a GPR109A agonist, can cause flushing due to the release of PGE2. This study evaluated the in vitro effects of niacin-loaded PLGA or PLA nanoparticles on PGE2 expression in whole human blood. The results suggest that encapsulating niacin in nanoparticles may reduce PGE2 release and potentially mitigate flushing side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Comparison of switch to the highest dose of rosuvastatin vs. add-on nicotinic acid vs. add-on fenofibrate for mixed dyslipidaemia.

Author: KeiA, LiberopoulosE N, MikhailidisD P, ElisafM

Lipid reduction
Side effects

The study compared the efficacy of switching to the highest dose of rosuvastatin, adding extended release nicotinic acid (ER-NA)/l-aropiprant (LRPT), or adding fenofibrate for mixed dyslipidaemia. Switching to the highest dose of rosuvastatin and adding ER-NA/LRPT showed better results than adding fenofibrate.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

13.

HPS2-THRIVE randomized placebo-controlled trial in 25 673 high-risk patients of ER niacin/laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment.

Author:

Lipid improvement
Diabetes
GI side effects
Myopathy
Skin side effects

Adding extended-release niacin to statin therapy increased the risk of myopathy, particularly in Chinese patients. However, many patients tolerated this treatment for up to four years.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Management of cardiovascular disease risk factors in older adults with type 2 diabetes mellitus: 2002-2012 literature review.

Author: MorenoGerardo, MangioneCarol M

Cardiovascular disease risk

Type 2 diabetes mellitus (DM) is a common chronic condition in older adults, often accompanied by comorbidities and geriatric syndromes. Managing cardiovascular disease risk factors in older adults with DM is crucial. This review examined the evidence for managing blood pressure, lipid control, glycemic control, and aspirin use in older adults with type 2 DM. The review found that intensive systolic blood pressure control (<130 mmHg) did not significantly reduce myocardial infarction or mortality compared to less-intensive control. Lipid-lowering statins are effective for reducing cardiovascular events, but data on niacin and fibrates are limited. RCTs on lipid-lowering drugs do not evaluate the cardiovascular effects of different low-density lipoprotein cholesterol targets. No RCTs included significant numbers of adults aged 80 and older with or without DM. Intensive glycemic control did not reduce primary cardiovascular endpoints, and one study reported higher mortality with glycosylated hemoglobin levels below 6%. Aspirin did not significantly reduce primary cardiovascular endpoints compared to control groups. The need for further research is highlighted, especially in older adults aged 80 and older or with significant comorbidities, to better tailor care for individuals with DM.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

Effect of hypolipidemic treatment on emerging risk factors in mixed dyslipidemia: a randomized pilot trial.

Author: KeiAnastazia, LiberopoulosEvangelos, TellisKostantinos, RizzoManfredi, ElisafMoses, TselepisAlexandros

Reduced LDL particle size
Reduced hsCRP
Reduced small dense LDL cholesterol
More side effects with ER-NA/LRPT

Add-on extended release nicotinic acid (ER-NA)/laropiprant (LRPT) and switch to the highest dose of rosuvastatin were associated with more pronounced beneficial modifications in emerging cardiovascular risk factors compared with add-on fenofibrate in patients with mixed dyslipidaemia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

17.

Lp(a) and cardiovascular risk: Investigating the hidden side of the moon.

Author: BucciM, TanaC, GiamberardinoM A, CipolloneF

Reduced CV risk

Lipoprotein (a) (Lp[a]) is an independent risk factor for cardiovascular disease (CVD), including coronary heart disease, ischemic stroke, and peripheral artery disease. Statins and fibrates have limited effects on Lp[a] levels. LDL apheresis is currently the treatment of choice for high Lp[a] levels in high-risk patients. New drugs selectively inhibiting Lp[a] are being developed.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Role of lipoprotein(a) in atherosclerotic cardiovascular disease: A review of current and emerging therapies.

Author: AlhomoudIbrahim S, TalasazAzita, MehtaAnurag, KellyMichael S, SissonEvan M, BucheitJohn D, BrownRoy, DixonDave L

ASCVD prevention

This review discusses current recommendations for screening and managing elevated lipoprotein(a), the effects of current lipid-lowering therapies, and emerging therapies targeting lipoprotein(a).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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