PMID- 37897527
OWN - NLM
STAT- MEDLINE
DCOM- 20240114
LR  - 20240206
IS  - 1432-1041 (Electronic)
IS  - 0031-6970 (Linking)
VI  - 80
IP  - 1
DP  - 2024 Jan
TI  - Empagliflozin and colchicine in patients with reduced left ventricular ejection 
      fraction following ST-elevation myocardial infarction: a randomized, 
      double-blinded, three-arm parallel-group, controlled trial.
PG  - 93-104
LID - 10.1007/s00228-023-03582-5 [doi]
AB  - PURPOSE: There is accumulating evidence regarding the potential benefits of 
      empagliflozin in individuals with acute myocardial infarction (MI). Based on the 
      literature, colchicine could also reduce the risk of MI and death in individuals 
      with cardiovascular disease (CVD). However, trials investigating the effects of 
      the combination of empagliflozin with colchicine and high-dose empagliflozin 
      monotherapy in this setting are lacking. METHODS: In this trial, 106 
      non-diabetic participants with reduced left ventricular ejection fraction (LVEF) 
      following recent ST-elevation MI were randomly assigned to empagliflozin 10 
      mg/day, empagliflozin 10 mg/day plus colchicine 0.5 mg twice daily, or 
      empagliflozin 25 mg/day groups within 72 h after primary percutaneous coronary 
      intervention (PCI). The study's primary outcomes were the changes in New York 
      Heart Association (NYHA) functional class and high-sensitivity C-reactive protein 
      (hs-CRP) over 12 weeks. RESULTS: The baseline characteristics of individuals were 
      statistically similar between the study groups. Changes in NYHA functional class 
      over 12 weeks were not significantly different between the study groups. hs-CRP 
      was significantly reduced in all groups (all P < 0.001); however, there was no 
      significant change between the groups over the study period. Changes in tumor 
      necrosis factor-alpha (TNF-alpha), LVEF, and left ventricular end-diastolic dimension 
      (LVEDD) during the research period did not differ significantly between groups. 
      CONCLUSION: This study showed that neither the combination treatment of 
      empagliflozin 10 mg/day with colchicine nor the monotherapy of empagliflozin 25 
      mg/day was superior to empagliflozin 10 mg/day in terms of changes in clinical, 
      inflammatory, and echocardiographic outcome parameters in patients with recent 
      MI with reduced LVEF over 3 months. Further studies are warranted to confirm the 
      findings. TRIAL REGISTRATION: Clinical trial ID: IRCT20111206008307N39. 
      Registration date: 27 October 2022. https://www.irct.ir/trial/66216.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Khiali, Sajad
AU  - Khiali S
AUID- ORCID: 0000-0002-2476-4430
AD  - Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of 
      Medical Sciences, Tabriz, Iran.
FAU - Taban-Sadeghi, Mohammadreza
AU  - Taban-Sadeghi M
AUID- ORCID: 0000-0001-9577-0099
AD  - Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, 
      Iran.
FAU - Sarbakhsh, Parvin
AU  - Sarbakhsh P
AUID- ORCID: 0000-0002-4213-5152
AD  - Department of Statistics and Epidemiology, Faculty of Public Health, Tabriz 
      University of Medical Sciences, Tabriz, Iran.
FAU - Khezerlouy-Aghdam, Naser
AU  - Khezerlouy-Aghdam N
AUID- ORCID: 0000-0001-5446-1492
AD  - Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, 
      Iran.
FAU - Entezari-Maleki, Taher
AU  - Entezari-Maleki T
AUID- ORCID: 0000-0003-3653-3653
AD  - Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of 
      Medical Sciences, Tabriz, Iran. tentezari@gmail.com.
AD  - Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, 
      Iran. tentezari@gmail.com.
LA  - eng
GR  - 69372/Tabriz University of Medical Sciences/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20231028
PL  - Germany
TA  - Eur J Clin Pharmacol
JT  - European journal of clinical pharmacology
JID - 1256165
RN  - 9007-41-4 (C-Reactive Protein)
RN  - SML2Y3J35T (Colchicine)
RN  - HDC1R2M35U (empagliflozin)
SB  - IM
EIN - Eur J Clin Pharmacol. 2023 Dec 2;:. PMID: 38040994
MH  - Humans
MH  - C-Reactive Protein
MH  - Colchicine/therapeutic use/pharmacology
MH  - *Percutaneous Coronary Intervention/methods
MH  - *ST Elevation Myocardial Infarction/drug therapy
MH  - Stroke Volume
MH  - Ventricular Function, Left
MH  - Double-Blind Method
OTO - NOTNLM
OT  - Clinical trial
OT  - Colchicine
OT  - Empagliflozin
OT  - Heart failure
OT  - Myocardial infarction
EDAT- 2023/10/29 06:43
MHDA- 2024/01/11 07:41
CRDT- 2023/10/28 11:04
PHST- 2023/08/04 00:00 [received]
PHST- 2023/10/15 00:00 [accepted]
PHST- 2024/01/11 07:41 [medline]
PHST- 2023/10/29 06:43 [pubmed]
PHST- 2023/10/28 11:04 [entrez]
AID - 10.1007/s00228-023-03582-5 [pii]
AID - 10.1007/s00228-023-03582-5 [doi]
PST - ppublish
SO  - Eur J Clin Pharmacol. 2024 Jan;80(1):93-104. doi: 10.1007/s00228-023-03582-5. 
      Epub 2023 Oct 28.