PMID- 30053327
OWN - NLM
STAT- MEDLINE
DCOM- 20191113
LR  - 20211204
IS  - 1532-6535 (Electronic)
IS  - 0009-9236 (Print)
IS  - 0009-9236 (Linking)
VI  - 105
IP  - 2
DP  - 2019 Feb
TI  - Adverse Events Associated With PCSK9 Inhibitors: A Real-World Experience.
PG  - 496-504
LID - 10.1002/cpt.1193 [doi]
AB  - In randomized clinical trials (RCTs) proprotein convertase subtilisin/kexin 9 
      (PCSK9) inhibitors showed a favorable safety profile, however, "real-world" data 
      on adverse events (AEs) is scarce. Three datasets, a hospital registry (n = 164), 
      and two Pharmacovigilance databases, Lareb (n = 149) and VigiLyze (n = 15,554), 
      reporting AEs attributed to PCSK9 inhibitors (alirocumab or evolocumab) 
      prescribed in clinical practice were analyzed. In the hospital registry, 41.5% of 
      the patients reported any AE, most often injection-site reactions (33.8%) and 
      influenza-like illness (27.9%). Twelve patients (7%) discontinued PCSK9 inhibitor 
      treatment. Most common AE reported in the Lareb and VigiLyze database was myalgia 
      (12.8% and 8.3%, respectively). No clinically relevant differences in gender or 
      between drugs were observed. No specific subgroup of patients could be identified 
      at risk of developing AEs. During follow-up, AEs resolved in most patients 
      (71.1%). In a real-world setting, PCSK9 inhibitors are well tolerated with an 
      overall safety profile comparable to RCTs.
CI  - (c) 2018 American Society for Clinical Pharmacology and Therapeutics.
FAU - Gurgoze, Muhammed T
AU  - Gurgoze MT
AD  - Erasmus MC, University Medical Centre Rotterdam, Department of Cardiology, 
      Rotterdam, The Netherlands.
FAU - Muller-Hansma, Annemarie H G
AU  - Muller-Hansma AHG
AD  - Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
FAU - Schreuder, Michelle M
AU  - Schreuder MM
AD  - Erasmus MC, University Medical Centre Rotterdam, Department of Internal Medicine, 
      Rotterdam, The Netherlands.
FAU - Galema-Boers, Annette M H
AU  - Galema-Boers AMH
AD  - Erasmus MC, University Medical Centre Rotterdam, Department of Internal Medicine, 
      Rotterdam, The Netherlands.
FAU - Boersma, Eric
AU  - Boersma E
AD  - Erasmus MC, University Medical Centre Rotterdam, Department of Cardiology, 
      Rotterdam, The Netherlands.
FAU - Roeters van Lennep, Jeanine E
AU  - Roeters van Lennep JE
AD  - Erasmus MC, University Medical Centre Rotterdam, Department of Internal Medicine, 
      Rotterdam, The Netherlands.
LA  - eng
PT  - Journal Article
DEP - 20180907
PL  - United States
TA  - Clin Pharmacol Ther
JT  - Clinical pharmacology and therapeutics
JID - 0372741
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Enzyme Inhibitors)
RN  - 0 (PCSK9 Inhibitors)
RN  - EC 3.4.21.- (PCSK9 protein, human)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticholesteremic Agents/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Databases, Factual
MH  - Enzyme Inhibitors/*adverse effects
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Middle Aged
MH  - Myalgia/chemically induced/epidemiology
MH  - *PCSK9 Inhibitors
MH  - Pharmacovigilance
MH  - Registries
MH  - Risk Factors
MH  - Young Adult
PMC - PMC6704355
COIS- J.E. Roeters van Lennep reports personal fees from AKCEA, grants from AMRYT, paid 
      to the institution, outside the submitted work. A.M.H. Galema-Boers reports 
      personal fees from Sanofi-Aventis Netherlands B.V. for publication of her thesis 
      and Amgen for presentation at congress, outside the submitted work. All other 
      authors declared that there is no conflict of interest regarding the publication 
      of this article.
EDAT- 2018/07/28 06:00
MHDA- 2019/11/14 06:00
PMCR- 2018/09/07
CRDT- 2018/07/28 06:00
PHST- 2018/06/14 00:00 [received]
PHST- 2018/07/19 00:00 [accepted]
PHST- 2018/07/28 06:00 [pubmed]
PHST- 2019/11/14 06:00 [medline]
PHST- 2018/07/28 06:00 [entrez]
PHST- 2018/09/07 00:00 [pmc-release]
AID - CPT1193 [pii]
AID - 10.1002/cpt.1193 [doi]
PST - ppublish
SO  - Clin Pharmacol Ther. 2019 Feb;105(2):496-504. doi: 10.1002/cpt.1193. Epub 2018 
      Sep 7.