PMID- 37222994
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230525
IS  - 1078-4497 (Print)
IS  - 1945-337X (Electronic)
IS  - 1078-4497 (Linking)
VI  - 40
IP  - 2
DP  - 2023 Feb
TI  - Muscle-Related Adverse Events Associated With PCSK9 Inhibitors in a Veteran 
      Population.
PG  - 62-67
LID - 10.12877/fp.0357 [doi]
AB  - BACKGROUND: Statins and PCSK9 inhibitors (PCSK9i) are used to lower low-density 
      lipoprotein cholesterol and reduce cardiovascular events, yet some patients are 
      unable to tolerate statin therapy due to muscle-related adverse events (AEs). The 
      effect of PCSK9i on muscle-related AEs is not well studied, and available data 
      show inconsistent incidence rates. METHODS: The primary study outcome was to 
      determine the percentage of patients who developed muscle-related PCSK9i AEs. A 
      secondary outcome was to analyze data based on 4 subgroups: tolerated a full 
      PCSK9i dose; tolerated alternative PCSK9i following initial intolerance; required 
      a PCSK9i dose reduction, or discontinued PCSK9i. In addition, the percentage of 
      statin- and/or ezetimibe-intolerant patients in these 4 groups was determined. 
      Another secondary outcome was the management strategies taken for patients who 
      were on a reduced (monthly) dose of PCSK9i who did not reach their low-density 
      lipoprotein cholesterol goal. Statin intolerance was defined as intolerable 
      skeletal muscle AEs on at least 3 different statins. We conducted a 
      single-center, retrospective review of patients prescribed a PCSK9i between 
      December 1, 2017, and September 1, 2021, at a patient aligned care team clinic at 
      the Wilkes-Barre Veterans Affairs Medical Center. RESULTS: The study included 137 
      veterans. Twenty-four patients (17.5%) developed a muscle-related AE while on a 
      PCSK9i. In predefined subgroups studied, statin intolerance ranged from 68.1% to 
      100%, ezetimibe intolerance ranged from 41.6% to 83.3%, and both statin and 
      ezetimibe intolerance ranged from 36.3% to 83.3%. CONCLUSIONS: In this study, 
      muscle-related PCSK9i AEs occurred at a similar incidence rate to that reported 
      in previous clinical trials and exceeded the incidence rate reported in the 
      prescribing information for alirocumab and evolocumab. It also appears that 
      patients who have a prior muscle-related intolerance to a statin and/or ezetimibe 
      have a higher likelihood of developing a muscle-related AE to a PCSK9i.
CI  - Copyright (c) 2023 Frontline Medical Communications Inc., Parsippany, NJ, USA.
FAU - Cencetti, Joseph
AU  - Cencetti J
AD  - Wilkes-Barre Veterans Affairs Medical Center, Pennsylvania.
FAU - Abramowitz, Callie
AU  - Abramowitz C
AD  - Philadelphia Veterans Affairs Medical Center, Pennsylvania.
FAU - Spoonhower, Heather
AU  - Spoonhower H
AD  - Wilkes-Barre Veterans Affairs Medical Center, Pennsylvania.
LA  - eng
PT  - Journal Article
DEP - 20230215
PL  - United States
TA  - Fed Pract
JT  - Federal practitioner : for the health care professionals of the VA, DoD, and PHS
JID - 9500574
PMC - PMC10201936
COIS- Author disclosures The authors report no actual or potential conflicts of 
      interest or outside sources of funding with regard to this article.
EDAT- 2023/05/24 13:08
MHDA- 2023/05/24 13:09
PMCR- 2023/02/01
CRDT- 2023/05/24 11:39
PHST- 2023/05/24 13:09 [medline]
PHST- 2023/05/24 13:08 [pubmed]
PHST- 2023/05/24 11:39 [entrez]
PHST- 2023/02/01 00:00 [pmc-release]
AID - fp-40-02-62 [pii]
AID - 10.12877/fp.0357 [doi]
PST - ppublish
SO  - Fed Pract. 2023 Feb;40(2):62-67. doi: 10.12877/fp.0357. Epub 2023 Feb 15.