Adverse events associated with inclisiran: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS)
Open accessAbstract
Objective To gain an improved comprehension of inclisiran safety in real-world settings by data mining from FAERS. Methods Data were gathered between 1 December 2020 and 31 December 2023. The Medical Dictionary for Regulatory Activities (MedDRA) corresponding preferred term (PT) and system organ class (SOC) were used to categorize adverse medication reactions in AE reports (AERs). By using reported odds ratio (ROR) method, positive signals were identified. Results There were 2,652 reports of inclisiran, and 150 of those AEs had significant disproportionality. Among the 44 PTs with moderate clinical priority, 35 PTs were discovered on the medicine label, including 12 IMEs and 2 DMEs. Of note, 9 PTs were unanticipated AEs that were not discovered in the medication label or reported clinical studies, such as movement disorder (ROR: 3.05; 95%CI: 1.73,5.37), aphonia (ROR: 3.77; 95%CI: 1.79,7.91), and pulmonary congestion (ROR: 3.47; 95%CI: 1.44,8.34). Inclisiran was found to be related to 12 serious AEs. The median TTO of 1896 cases was 13.5 (IQR 0-100) days. Conclusion We identified not only known AEs, but also new AE signals such as movement disorder. However, signals does not reveal actual risk, prospective clinical trials are still required to verify their causal connection.
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Injection-site reactions with mild symptoms are the most prevalent adverse events of Inclisiran.
“Injection-site reactions with mild symptoms proved to be the most prevalent adverse events [30].”
Cites
Global Burden of Cardiovascular Diseases and Risk Factors, 1990–2019
Roth, G. A., Mensah, G. A., Johnson, C. O., Addolorato, G., Ammirati, E., Baddour, L. M., Barengo, N. C., Beaton, A. Z., Benjamin, E. J., Benziger, C. P., et al. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.11.010 · Cited by 11,449 · see citing works
Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
Sabatine, M. S., Giugliano, R. P., Keech, A. C., Honarpour, N., Wiviott, S. D., Murphy, S. A., Kuder, J. F., Wang, H., Liu, T., Wasserman, S. M., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1615664 · Cited by 6,138 · see citing works
Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events
Robinson, J. G., Farnier, M., Krempf, M., Bergeron, J., Luc, G., Averna, M., Stroes, E. S., Langslet, G., Raal, F. J., El Shahawy, M., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1501031 · Cited by 2,296 · see citing works
Interpretation of the evidence for the efficacy and safety of statin therapy
Collins, R., Reith, C., Emberson, J., Armitage, J., Baigent, C., Blackwell, L., Blumenthal, R., Danesh, J., Smith, G. D., DeMets, D., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(16)31357-5 · Cited by 1,857 · see citing works
Borén, J., Chapman, M. J., Krauss, R. M., Packard, C. J., Bentzon, J. F., Binder, C. J., Daemen, M. J., Demer, L. L., Hegele, R. A., Nicholls, S. J., et al. (2020) · European Heart Journal · doi:10.1093/eurheartj/ehz962 · Cited by 1,601 · see citing works
Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events
Sabatine, M. S., Giugliano, R. P., Wiviott, S. D., Raal, F. J., Blom, D. J., Robinson, J., Ballantyne, C. M., Somaratne, R., Legg, J., Wasserman, S. M., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1500858 · Cited by 1,509 · see citing works
The reporting odds ratio and its advantages over the proportional reporting ratio
Rothman, K. J., Lanes, S., & Sacks, S. T. (2004) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.1001 · Cited by 1,112 · see citing works
Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia
Raal, F. J., Kallend, D., Ray, K. K., Turner, T., Koenig, W., Wright, R. S., Wijngaard, P. L. J., Curcio, D., Jaros, M. J., Leiter, L. A., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1913805 · Cited by 818 · see citing works
A highly durable RNAi therapeutic inhibitor of PCSK9
Fitzgerald, K., White, S., Borodovsky, A., Bettencourt, B. R., Strahs, A., Clausen, V., Wijngaard, P., Horton, J. D., Taubel, J., Brooks, A., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1609243 · Cited by 768 · see citing works
Variation in<i>PCSK9</i>and<i>HMGCR</i>and Risk of Cardiovascular Disease and Diabetes
Ference, B. A., Robinson, J. G., Brook, R. D., Catapano, A. L., Chapman, M. J., Neff, D. R., Voros, S., Giugliano, R. P., Davey Smith, G., Fazio, S., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1604304 · Cited by 743 · see citing works
Lamb, Y. N. (2021) · Drugs · doi:10.1007/s40265-021-01473-6 · Cited by 375 · see citing works
Ray, K. K., Troquay, R. P. T., Visseren, F. L. J., Leiter, L. A., Scott Wright, R., Vikarunnessa, S., Talloczy, Z., Zang, X., Maheux, P., Lesogor, A., et al. (2023) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(22)00353-9 · Cited by 328 · see citing works
Swiger, K. J., Manalac, R. J., Blumenthal, R. S., Blaha, M. J., & Martin, S. S. (2013) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2013.07.013 · Cited by 232 · see citing works
Da Dalt, L., Ruscica, M., Bonacina, F., Balzarotti, G., Dhyani, A., Di Cairano, E., Baragetti, A., Arnaboldi, L., De Metrio, S., Pellegatta, F., et al. (2019) · European Heart Journal · doi:10.1093/eurheartj/ehy357 · Cited by 209 · see citing works
PCSK9 Biology and Its Role in Atherothrombosis
Barale, C., Melchionda, E., Morotti, A., & Russo, I. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22115880 · Cited by 176 · see citing works
Ray, K. K., Stoekenbroek, R. M., Kallend, D., Nishikido, T., Leiter, L. A., Landmesser, U., Wright, R. S., Wijngaard, P. L. J., & Kastelein, J. J. P. (2019) · JAMA Cardiology · doi:10.1001/jamacardio.2019.3502 · Cited by 172 · cited 1× · see citing works
“During the administration of Inclisiran, injection site reactions, discomfort, erythema, rash, and other symptoms were observed [24,28].”
Navarese, E. P., Kołodziejczak, M. M., Winter, M., Alimohammadi, A., Lang, I. M., Buffon, A., Lip, G. Y. H., & Siller-Matula, J. M. (2016) · International Journal of Cardiology · doi:10.1016/j.ijcard.2016.10.084 · Cited by 134 · see citing works
PCSK9 inhibition and inflammation: A narrative review
Ruscica, M., Tokgözoğlu, L. S., Corsini, A., & Sirtori, C. R. (2019) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2019.07.015 · Cited by 130 · see citing works
Effect of inclisiran on lipids in primary prevention: the ORION-11 trial
Ray, K. K., Kallend, D., Leiter, L. A., Raal, F. J., Koenig, W., Jaros, M. J., Schwartz, G. G., Landmesser, U., Garcia Conde, L., Wright, R. S., et al. (2022) · European Heart Journal · doi:10.1093/eurheartj/ehac615 · Cited by 116 · see citing works
Safety and Tolerability of Inclisiran for Treatment of Hypercholesterolemia in 7 Clinical Trials
Wright, R. S., Köenig, W., Landmesser, U., Leiter, L. A., Raal, F. J., Schwartz, G. G., Lesogor, A., Maheux, P., Stratz, C., Zang, X., et al. (2023) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2023.10.007 · Cited by 84 · see citing works
Cornelius, V. R., Sauzet, O., & Evans, S. (2012) · Drug Safety · doi:10.2165/11599740-000000000-00000 · Cited by 76 · see citing works
Inclisiran, Low-Density Lipoprotein Cholesterol and Lipoprotein (a)
Katsiki, N., Vrablı́k, M., Banach, M., & Gouni‐Berthold, I. (2023) · Pharmaceuticals · doi:10.3390/ph16040577 · Cited by 75 · see citing works
Barale, C., Bonomo, K., Frascaroli, C., Morotti, A., Guerrasio, A., Cavalot, F. L., & Russo, I. (2019) · Nutrition Metabolism and Cardiovascular Diseases · doi:10.1016/j.numecd.2019.09.012 · Cited by 70 · see citing works
Grześk, G., Dorota, B., Wołowiec, Ł., Wołowiec, A., Osiak, J., Kozakiewicz, M., & Banach, J. (2022) · Biomedicine & Pharmacotherapy · doi:10.1016/j.biopha.2022.113957 · Cited by 61 · see citing works
PCSK9 Inhibition With Monoclonal Antibodies: Modern Management of Hypercholesterolemia
Ito, M. K., & Santos, R. D. (2017) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.766 · Cited by 59 · see citing works
Giunchi, V., Fusaroli, M., Hauben, M., Raschi, E., & Poluzzi, E. (2023) · Drug Safety · doi:10.1007/s40264-023-01345-w · Cited by 52 · see citing works
Ayyar, V. S., Song, D., Zheng, S., Carpenter, T., & Heald, D. (2021) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1124/jpet.121.000805 · Cited by 50 · see citing works
First clinical experiences with inclisiran in a real-world setting
Mulder, J. W. C. M., Galema-Boers, A. M. H., & Roeters van Lennep, J. E. (2023) · Journal of Clinical Lipidology · doi:10.1016/j.jacl.2023.09.005 · Cited by 49 · see citing works
PCSK9 and neurocognitive function: Should it be still an issue after FOURIER and EBBINGHAUS results?
Mannarino, M. R., Sahebkar, A., Bianconi, V., Șerban, M.-C., Banach, M., & Pirro, M. (2018) · Journal of clinical lipidology · doi:10.1016/j.jacl.2018.05.012 · Cited by 48 · see citing works
Shu, Y., Chen, J., Ding, Y., & Zhang, Q. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1169735 · Cited by 47 · see citing works
KEECH, A. C., Oyama, K., Sever, P., Tang, M., Murphy, S. A., Hirayama, A., Lu, C., Tay, L., DEEDWANIA, P. C., Siu, C., et al. (2021) · Circulation Journal · doi:10.1253/circj.cj-20-1051 · Cited by 46 · see citing works
Alenzi, K. A. O., Alsuhaibani, D. S., Batarfi, B. S., & Alshammari, T. M. (2024) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1364110 · Cited by 46 · see citing works
Recent Advances in Gene Therapy for Familial Hypercholesterolemia: An Update Review
Fu, Q., Hu, L., Shen, T., Yang, R., & Jiang, L. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11226773 · Cited by 38 · see citing works
Luo, Z., Huang, Z., Sun, F., Guo, F., Wang, Y., Kao, S., Yang, G., Huang, J., Li, J., Zhao, S., et al. (2023) · Journal of Clinical Lipidology · doi:10.1016/j.jacl.2023.04.010 · Cited by 38 · see citing works
Identifying adverse drug reactions from free‐text electronic hospital health record notes
Wasylewicz, A. T. M., van de Burgt, B. W. M., Weterings, A., Jessurun, N. T., Korsten, E. H. H. M., Egberts, T. C. G., Bouwman, R. A., Kerskes, M., Grouls, R. J. E., & van der Linden, C. M. J. (2021) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.15068 · Cited by 36 · see citing works
PCSK9 and infection: A potentially useful or dangerous association?
Khademi, F., Momtazi‐Borojeni, A. A., Reiner, Ž., Banach, M., Al‐Rasadi, K., & Sahebkar, A. (2017) · Journal of Cellular Physiology · doi:10.1002/jcp.26040 · Cited by 33 · see citing works
Statin associated muscle symptoms: An update and review
Dicken, W., Mehta, A., Karagiannis, A. D., Jain, V., Vavuranakis, M., Sperling, L. S., & Cassimatis, D. C. (2022) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2022.11.010 · Cited by 30 · see citing works
Wang, W., Li, W., Zhang, D., Mi, Y., Zhang, J., & He, G. (2024) · Genes · doi:10.3390/genes15010132 · Cited by 19 · see citing works
Marcusa, D. P., Giugliano, R. P., Park, J., de Lemos, J. A., Cannon, C. P., & Sabatine, M. S. (2020) · JAMA Cardiology · doi:10.1001/jamacardio.2020.6184 · Cited by 18 · see citing works
Landmesser, U., Köenig, W., Leiter, L. A., Raal, F. J., Ray, K. K., Wright, R. S., Han, J., Conde, L. G., & Schwartz, G. G. (2023) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2023.117354 · Cited by 17 · see citing works
Nagashima, S., Morishima, K., Okamoto, H., & Ishibashi, S. (2016) · Journal of clinical lipidology · doi:10.1016/j.jacl.2016.05.004 · Cited by 17 · see citing works
Jamialahmadi, T., Panahi, Y., Safarpour, M. A., Ganjali, S., Chahabi, M., Reiner, Ž., Solgi, S., Vahedian‐Azimi, A., Kianpour, P., Banach, M., et al. (2019) · Journal of Clinical Medicine · doi:10.3390/jcm8101742 · Cited by 16 · see citing works
Duarte-de-Araújo, A., Teixeira, P., Hespanhol, V. P., & Correia-de-Sousa, J. (2020) · Pulmonology · doi:10.1016/j.pulmoe.2020.02.003 · Cited by 14 · see citing works
The Role of PCSK9 in Infectious Diseases
Magnasco, L., Sepulcri, C., Antonello, R. M., Bella, S. D., Labate, L., Luzzati, R., Giacobbe, D. R., & Bassetti, M. (2021) · Current Medicinal Chemistry · doi:10.2174/0929867328666210714160343 · Cited by 13 · see citing works
PCSK9 Inhibition in Atherosclerotic Cardiovascular Disease
Delialis, D., Dimopoulou, M., Papaioannou, M., Kotsira, G., Maneta, E., Mavraganis, G., Loutos, C., Georgiopoulos, G. A., & Stamatelopoulos, K. S. (2023) · Current Pharmaceutical Design · doi:10.2174/1381612829666230412105238 · Cited by 13 · see citing works
Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
Muñoz, M. A., Pan, G. J. D., Wei, Y. J., Xiao, H., Delcher, C., Giffin, A., Sadiq, N., & Winterstein, A. G. (2024) · Drug Safety · doi:10.1007/s40264-024-01397-6 · Cited by 11 · see citing works
Nair, H. P., Kulkarni, A. R., Maheswari, E., & Subeesh, V. (2023) · Arab Journal of Gastroenterology · doi:10.1016/j.ajg.2022.10.012 · Cited by 8 · see citing works
So low… so far so good: neurocognitive impact of lowering LDL-C levels with PCSK9 inhibitors
Gencer, B., & Mach, F. (2018) · European Heart Journal · doi:10.1093/eurheartj/ehx742 · Cited by 6 · see citing works
He, Y., Guan, X., Zhang, Y., Zhu, Z., Zhang, Y., Feng, Y., & Li, X. (2024) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2024.2348562 · Cited by 6 · see citing works
Self-citationGuan, X., Yang, Y., Li, X., Feng, Y., Li, J., & Li, X. (2024) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1417951 · Cited by 6 · see citing works
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- Authors
- Li, B., Chen, Y., Zhang, Y., Qian, M., Shan, Q., Qian, J., & Guo, J.
- Affiliations
- Chinese People's Liberation Army (CN)
- Jinan Key Laboratory of Individualised Clinical Drug Safety Monitoring and Pharmacovigilance Research, PLA 960th Hospital
- Changhai Hospital (CN)
- PLA 960th Hospital
- Venue
- Expert Opinion on Drug Safety
- Publisher
- Informa UK Limited
- Published
- 2025-02-25
- Volume
- 25
- Issue
- 4
- Pages
- 657-668
- ISSN
- 1474-0338 (ISSN-L)
- 1744-764X
- OpenAlex
- W4407828355
- Cited by
- 6
- References
- 50
- Citations by year
- 2026: 6
- FWCI
- 3.08
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Expert Opinion on Drug Safety (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Taishan Scholars (tsqn202312385)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
- Keywords
- adverse drug reactions, pharmacovigilance, FDA Adverse Event Reporting System, disproportionality analysis, safety signals, pancreatitis, deafness, myocardial infarction, cardiac arrhythmias, movement disorders, aphonia, pulmonary congestion, PCSK9 inhibitors, real-world safety, drug labeling, signal prioritization, underreporting
- MeSH terms
- Adolescent, Adult, Aged, Female, Humans, Male, Middle Aged, United States, United States Food and Drug Administration, Adverse Drug Reaction Reporting Systems, Young Adult, Data Mining, Pharmacovigilance, Drug-Related Side Effects and Adverse Reactions
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