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Effects of High-Dose Modified-Release Nicotinic Acid on Atherosclerosis and Vascular Function
Open accessAbstract
Objectives Our aim was to determine the effects of high-dose (2 g) nicotinic acid (NA) on progression of atherosclerosis and measures of vascular function.Background NA raises high-density lipoprotein cholesterol (HDL-C) and reduces low-density lipoprotein cholesterol and is widely used as an adjunct to statin therapy in patients with coronary artery disease. Although changes in plasma lipoproteins suggest potential benefit, there is limited evidence of the effects of NA on disease progression when added to contemporary statin treatment.Methods We performed a double-blind, randomized, placebo-controlled study of 2 g daily modified-release NA added to statin therapy in 71 patients with low HDL-C (<40 mg/dl) and either: 1) type 2 diabetes with coronary heart disease; or 2) carotid/peripheral atherosclerosis. The primary end point was the change in carotid artery wall area, quantified by magnetic resonance imaging, after 1 year.Results NA increased HDL-C by 23% and decreased low-density lipoprotein cholesterol by 19%. At 12 months, NA significantly reduced carotid wall area compared with placebo (adjusted treatment difference: -1.64 mm(2) [95% confidence interval: -3.12 to -0.16]; p = 0.03). Mean change in carotid wall area was -1.1 +/- 2.6 mm(2) for NA versus +1.2 +/- 3.0 mm(2) for placebo. In both the treatment and placebo groups, larger plaques were more prone to changes in size (r = 0.4, p = 0.04 for placebo, and r = -0.5, p = 0.02 for NA).Conclusions In statin-treated patients with low HDL-C, high-dose modified-release NA, compared with placebo, significantly reduces carotid atherosclerosis within 12 months. (Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function; NCT00232531).
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“In statin-treated patients with low HDL-C, high dose, modified release nicotinic acid, compared with placebo, significantly reduced carotid wall area, quantified by magnetic resonance imaging after 1 year.133”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [133]
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“A recent meta-analysis suggests that nicotinic acid alone or in combination with statin may add further benefit in stroke prevention.133”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [133]
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Self-citationHamilton, S. J., Chew, G. T., Davis, T. M. E., & Watts, G. F. (2010) · Diabetes and Vascular Disease Research · doi:10.1177/1479164110376206 · Cited by 34
“Niacin also improves carotid atherosclerosis in statin-treated subjects with CAD or risk equivalents.(11,12) Our pilot study extends these observations by assessing the impact of niacin therapy on small artery function in statin-treated type 2 diabetic patients with endothelial dysfunction.”
ResultLandmark Lipid‐Lowering Trials in the Primary Prevention of Cardiovascular Disease
Chrispin, J., Martin, S. S., Hasan, R. K., Joshi, P. H., Minder, C. M., McEvoy, J. W., Kohli, P., Johnson, A. E., Wang, L., Blaha, M. J., et al. (2013) · Clinical Cardiology · doi:10.1002/clc.22147 · Cited by 36
Effects of HDL-modifiers on cardiovascular outcomes: A meta-analysis of randomized trials
Verdoia, M., Schaffer, A., Suryapranata, H., & Luca, G. D. (2014) · Nutrition Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2014.09.003 · Cited by 33
“Niacin supplementation has been suggested to prevent atherosclerosis progression at both coronary angiography and carotid IMT measurement and potentially to reduce cardiovascular events [19,34].”
BackgroundKang, H. J., Kim, D. K., Lee, S. M., Kim, K. H., Han, S. H., Kim, K. H., Kim, S. E., Son, Y. K., & An, W. S. (2012) · Kidney Research and Clinical Practice · doi:10.1016/j.krcp.2012.12.001 · Cited by 32
“Recent studies using niacin showed that a typical starting dose of niacin was 500 mg or 1 g/day, and the dose was advanced in phases to reach a given target dose to accommodate the drug’s adverse effects [3,4,10,11].”
Emerging therapeutic strategies to enhance HDL function
Redondo, S., Martínez‐González, J., Urraca, C., & Tejerina, T. (2011) · Lipids in Health and Disease · doi:10.1186/1476-511x-10-175 · Cited by 31
“This technology has made it possible to demonstrate that in animal models atherosclerotic plaques are reduced when HDL function is enhanced [7], and that pharmacologic treatments that modulate lipid profile (enhance HDL and decrease LDL) are able to reduce atherosclerosis progression in humans [8].”
BackgroundTherapeutic Potential of Emerging NAD+-Increasing Strategies for Cardiovascular Diseases
Rotllán, N., Camacho, M., Tondo, M., Diarte‐Añazco, E. M. G., Canyelles, M., Méndez‐Lara, K. A., Benı́tez, S., Alonso, N., Mauricio, D., Escolá‐Gil, J. C., et al. (2021) · Antioxidants · doi:10.3390/antiox10121939 · Cited by 31
A Reappraisal of the Risks and Benefits of Treating to Target with Cholesterol Lowering Drugs
Alla, V. M., Agrawal, V., DeNazareth, A., Mohiuddin, S., Ravilla, S., & Rendell, M. (2013) · Drugs · doi:10.1007/s40265-013-0072-9 · Cited by 33
“Lee [51] 71 Niacin (2 g/day) vs placebo in statin treated patients with HDLc \40 mg% 1 year MRI of carotid arteries Change in carotid artery wall area Niacin superior to placebo in decreasing carotid atherosclerosis”
BackgroundYadav, R., Liu, Y., Kwok, S., Hama, S., France, M. W., Eatough, R., Pemberton, P., Schofield, J. D., Siahmansur, T. J., Malik, R. A., et al. (2015) · Journal of the American Heart Association · doi:10.1161/jaha.114.001508 · Cited by 29
Self-citationArea-Preserving Mapping of 3D Carotid Ultrasound Images Using Density-Equalizing Reference Map
Choi, G. P. T., Chiu, B. C. Y., & Rycroft, C. H. (2020) · IEEE Transactions on Biomedical Engineering · doi:10.1109/tbme.2019.2963783 · Cited by 29
Effects of Established Hypolipidemic Drugs on HDL Concentration, Subclass Distribution, and Function
Gomaraschi, M., Adorni, M. P., Banach, M., Bernini, F., Franceschini, G., & Calabresi, L. (2014) · Handbook of experimental pharmacology · doi:10.1007/978-3-319-09665-0_19 · Cited by 27
“Recent studies analyzed the effect of niacin treatment in patients with established CAD on top of the existing statin therapy; two of them failed to detect any significant improvement of FMD, while in one case FMD was significantly increased only in the subgroup of patients with a low baseline HDL-C level (Lee et al.…”
BackgroundNicotinic Acid Receptor GPR109A Is Down-Regulated in Human Macrophage-Derived Foam Cells
Chai, J. T., Digby, J. E., Ruparelia, N., Jefferson, A., Handa, A. I., & Choudhury, R. P. (2013) · PLoS ONE · doi:10.1371/journal.pone.0062934 · Cited by 27
Self-citationCardiovascular MRI in clinical trials: expanded applications through novel surrogate endpoints
Pitcher, A., Ashby, D., Elliott, P., & Petersen, S. E. (2011) · Heart · doi:10.1136/hrt.2011.225904 · Cited by 26
van Wijk, D. F., Strang, A. C., Duivenvoorden, R., Enklaar, D.-J. F., van der Geest, R. J., Kastelein, J. J. P., de Groot, E., Stroes, E. S. G., & Nederveen, A. J. (2013) · Magnetic Resonance Materials in Physics Biology and Medicine · doi:10.1007/s10334-013-0407-2 · Cited by 26
“In agreement, several other studies have demonstrated a high reproducibility[6-9] and feasibility to utilize carotid MRI as a surrogate endpoint in clinical trials[10-12].”
ResultPhilpott, A. C., Hubacek, J., Sun, Y., Hillard, D., & Anderson, T. J. (2012) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2012.10.067 · Cited by 26
Nicotinic Acid is a Common Regulator of Heat-Sensing TRPV1-4 Ion Channels
Ma, L., Lee, B. H., Clifton, H. L., Schaefer, S., & Zheng, J. (2015) · Scientific Reports · doi:10.1038/srep08906 · Cited by 26
Extended-release niacin with laropiprant: a review on efficacy, clinical effectiveness and safety
Yadav, R., France, M. W., Younis, N., Hama, S., Ammori, B. J., Kwok, S., & Soran, H. (2012) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2012.690395 · Cited by 27
“03) and there was an inverse relationship between this outcome and HDL-C [91].”
BackgroundKlančič, T., Woodward, L., Hofmann, S. M., & Fisher, E. A. A. (2016) · Molecular Metabolism · doi:10.1016/j.molmet.2016.03.001 · Cited by 29
“2009([75]) Modified-release niacin þ23 Change in carotid wall area, quantified by MRI Significant reduction in carotid wall area at 12 months in the niacin group, compared with placebo Placebo (all received statin therapy) þ3”
MethodEnergy Drink Ingredients and their Effect on Endothelial Function: A Review
Higgins, J. P. (2014) · International Journal of Clinical Cardiology · doi:10.23937/2378-2951/1410006 · Cited by 25
“Another study evaluating niacin therapy for twelve months also showed a significant decrease in carotid intima-media thickness as well as an improvement in ECF [37].”
BackgroundYan, T., Ye, X., Chopp, M., Zacharek, A., Ning, R., Venkat, P., Roberts, C. J., Lü, M., & Chen, J. (2013) · PLoS ONE · doi:10.1371/journal.pone.0081199 · Cited by 25
“Niacin significantly reduced carotid arteriosclerosis, substantially increased HDL and decreased LDL [55] and exhibits anti-inflammatory and antiarteriosclerosis effects [56].”
BackgroundAdiels, M., Chapman, M. J., Robillard, P., Krempf, M., Laville, M., & Borén, J. (2018) · Journal of clinical lipidology · doi:10.1016/j.jacl.2018.03.083 · Cited by 25
Chen, Y., Li, P., Zhen, R., Wang, L., Feng, J., Xie, Y., Yang, B., Xiong, Y., Niu, J., Wu, Q., et al. (2022) · International Immunopharmacology · doi:10.1016/j.intimp.2022.109054 · Cited by 25
Incremento de las HDL como arma terapéutica en la aterotrombosis
Badimón, J. J., & Ibáñez, B. (2010) · Revista Española de Cardiología · doi:10.1016/s0300-8932(10)70091-9 · Cited by 25
High-density lipoprotein levels and risk of cardiovascular events
Mureddu, G. F., Brandimarte, F., & Luca, L. D. (2011) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0b013e32834bb3c8 · Cited by 26
Gianfrilli, D., Lauretta, R., Dato, C. D., Graziadio, C., Pozza, C., Larichaudy, J. D., Giannetta, E., Isidori, A. M., & Lenzi, A. (2011) · Andrologia · doi:10.1111/j.1439-0272.2011.01234.x · Cited by 24
“In patients with atherosclerotic disease, low-density lipoprotein cholesterol (LDL-C) reduction with 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (‘statins’) has consistently shown reduction in major cardiovascular events and mortality (Lee et al., 2009).”
BackgroundNicholls, S. J. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.02.021 · Cited by 23
“More recent studies using magnetic resonance maging demonstrated similarly beneficial effects of niacin n carotid atherosclerosis in some (10), but not all (11), tudies.”
BackgroundNiacin reduces plasma CETP levels by diminishing liver macrophage content in CETP transgenic mice
Li, Z., Wang, Y., van der Sluis, R. J., van der Hoorn, J. W. A., Princen, H. M. G., Eck, M. V., van Berkel, T. J. C., Rensen, P. C. N., & Hoekstra, M. (2012) · Biochemical Pharmacology · doi:10.1016/j.bcp.2012.06.020 · Cited by 23
“Several clinical trials have shown that niacin reduces cardiovascular disease and myocardial infarction incidence, providing an emerging rationale for the use of niacin in the treatment of atherosclerosis [4,5].”
BackgroundNiacin Alternatives for Dyslipidemia: Fool’s Gold or Gold Mine? Part II: Novel Niacin Mimetics
Goel, H., & Dunbar, R. L. (2016) · Current Atherosclerosis Reports · doi:10.1007/s11883-016-0570-9 · Cited by 23
Holzhäuser, E., Albrecht, C., Zhou, Q., Buttler, A., Preusch, M. R., Blessing, E., Katus, H. A., & Bea, F. (2011) · Journal of Cardiovascular Pharmacology · doi:10.1097/fjc.0b013e31820dc1db · Cited by 23
Carotid Artery Disease and Stroke: Assessing Risk with Vessel Wall MRI
Kerwin, W. S. (2012) · ISRN Cardiology · doi:10.5402/2012/180710 · Cited by 23
“Thus, the importance of plaque burden for characterizing risk remains uncertain, although burden remains important for studies evaluating plaque progression and response to treatment [68–71].”
BackgroundHochholzer, W., Berg, D. D., & Giugliano, R. P. (2011) · Therapeutic Advances in Cardiovascular Disease · doi:10.1177/1753944711419197 · Cited by 24
“After 1 year, the extended-release niacin group had a significant reduction in mean carotid wall area compared with placebo ( 1.1±2.6 mm2 compared with + 1.2±3.0 mm2; p¼ 0.03) [Lee et al. 2009].”
MethodInfluential
Metadata
- Authors
- Lee, J. M. S., Robson, M. D., Yu, L.-M., Shirodaria, C. C., Cunnington, C., Kylintireas, I., Digby, J. E., Bannister, T., Handa, A., Wiesmann, F., Durrington, P. N., Channon, K. M., Neubauer, S., & Choudhury, R. P.
- Affiliations
- University of Oxford (GB)
- University of Manchester (GB)
- Corresponding author
- Choudhury, Robin P.
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2009-11
- Volume
- 54
- Issue
- 19
- Pages
- 1787-1794
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W2104463342
- Cited by
- 246
- References
- 53
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 11 · 2023: 4 · 2022: 4 · 2021: 3 · 2020: 4 · 2019: 7 · 2018: 8 · 2017: 8 · 2016: 8 · 2015: 13 · 2014: 16 · 2013: 29 · 2012: 40
- FWCI
- 43.15
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- Funders
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Merck KGaA
- Wellcome Trust
- National Institute for Health and Care Research (NF-SI-0508-10247)
- University of Oxford
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
- Keywords
- nicotinic acid, atherosclerosis, carotid intima-media thickness, vascular function, statin therapy, low HDL cholesterol, type 2 diabetes, coronary artery disease, endothelial function, lipid-lowering therapy
- MeSH terms
- Aged, Hypolipidemic Agents, Carotid Artery Diseases, Delayed-Action Preparations, Double-Blind Method, Drug Administration Schedule, Female, Humans, Cholesterol, HDL, Cholesterol, LDL, Magnetic Resonance Imaging, Male, Middle Aged, Niacin, Time Factors, Triglycerides, Confounding Factors, Epidemiologic, Treatment Outcome, Tunica Intima, Tunica Media
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