PMID- 37818695
OWN - NLM
STAT- MEDLINE
DCOM- 20240313
LR  - 20240313
IS  - 1472-8206 (Electronic)
IS  - 0767-3981 (Linking)
VI  - 38
IP  - 2
DP  - 2024 Apr
TI  - Exploring signals of myopathy associated with statin and contraindicated 
      comedications in the realworld.
PG  - 380-388
LID - 10.1111/fcp.12959 [doi]
AB  - BACKGROUND: Using statins in combination with other drugs was reported to 
      increase the risk of myopathy. However, there was a sparse number of studies on 
      the incidence of adverse events (AEs) associated with the concomitant use of 
      statin and contraindicated drugs in the real world. OBJECTIVES: This study aimed 
      to identify the risk of concomitant use of statins with contraindicated drugs by 
      exploring signals related to statin-drug interactions. METHODS: We performed a 
      disproportionality analysis for drugs and AEs by applying the case/non-case study 
      using the KIDS-KAERS database (KIDS-KD), 2016-2020. A case was defined as an 
      individual case safety reports (ICSRs) including "rhabdomyolysis/myopathy." A 
      non-case was defined as an ICSR, including all other AEs. We applied Omega shrinkage 
      measure model, chi-square statics model, additive model, multiplicative model, 
      and combination risk ratio model to detect signals of myopathy due to statin with 
      concomitant drugs including antiviral agents, immunosuppressants, and 
      antifungals. RESULTS: Among 1 011 234 ICSRs, 2708 were cases, with 861 cases of 
      statin monotherapy and 1248 of concomitant uses of statin. The adjusted reporting 
      odds ratios were 3.27 (95% confidence interval [CI]: 3.11-3.43), 8.70 (95% CI: 
      8.04-9.40), and 1.83 (95% CI: 1.73-1.94), respectively. Several combinations of 
      signals were detected through an additive model or multiplicative model. 
      CONCLUSION: Signals of an increased risk of myopathy associated with the use of 
      statins with concomitant drugs, including contraindicated drugs, were confirmed 
      in a real-world setting.
CI  - (c) 2023 Societe Francaise de Pharmacologie et de Therapeutique. Published by John 
      Wiley & Sons Ltd.
FAU - Park, Sewon
AU  - Park S
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Lee, Ju Won
AU  - Lee JW
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Nam, Dal Ri
AU  - Nam DR
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
FAU - Jung, Sun-Young
AU  - Jung SY
AUID- ORCID: 0000-0003-2032-112X
AD  - College of Pharmacy, Chung-Ang University, Seoul, Republic of Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Republic of Korea.
LA  - eng
GR  - Chung-Ang University/
GR  - 2021R1A6A1A03044296/National Research Foundation of Korea (NRF) funded by the 
      Ministry of Education/
PT  - Journal Article
DEP - 20231011
PL  - England
TA  - Fundam Clin Pharmacol
JT  - Fundamental & clinical pharmacology
JID - 8710411
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
SB  - IM
MH  - Humans
MH  - *Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects
MH  - *Muscular Diseases/chemically induced/diagnosis/epidemiology
MH  - *Rhabdomyolysis/chemically induced/diagnosis/epidemiology
MH  - Drug Interactions
OTO - NOTNLM
OT  - contraindicated comedications
OT  - myopathy
OT  - real-world setting
OT  - safety signal detection
OT  - statins
EDAT- 2023/10/11 06:45
MHDA- 2024/03/13 06:47
CRDT- 2023/10/11 05:32
PHST- 2023/09/22 00:00 [revised]
PHST- 2023/08/11 00:00 [received]
PHST- 2023/09/27 00:00 [accepted]
PHST- 2024/03/13 06:47 [medline]
PHST- 2023/10/11 06:45 [pubmed]
PHST- 2023/10/11 05:32 [entrez]
AID - 10.1111/fcp.12959 [doi]
PST - ppublish
SO  - Fundam Clin Pharmacol. 2024 Apr;38(2):380-388. doi: 10.1111/fcp.12959. Epub 2023 
      Oct 11.