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Published on: May 28, 2019
Empagliflozin and colchicine in patients with reduced left ventricular ejection fraction following ST-elevation
Sajad Khiali1, Mohammadreza Taban-Sadeghi2, Parvin Sarbakhsh3
1Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Insights
This study investigates empagliflozin and colchicine for non-diabetic patients post-myocardial infarction with reduced ejection fraction. It aims to improve cardiovascular outcomes and reduce heart failure risk.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Patients with acute myocardial infarction face high risks of chronic heart failure and mortality.
- Limited evidence exists on sodium-glucose cotransporter-2 inhibitors for cardiovascular outcomes in non-diabetic patients post-myocardial infarction with reduced ejection fraction.
- The combined effects of empagliflozin and colchicine, or high-dose empagliflozin, remain unevaluated in this patient group.
Purpose of the Study:
- To evaluate the efficacy and safety of early treatment with empagliflozin (standard and high dose) and a combination of empagliflozin and colchicine.
- To assess the impact of these treatments on New York Heart Association functional classification and high-sensitivity C-reactive protein levels.
- To explore novel therapeutic strategies for non-diabetic patients with reduced ejection fraction following ST-elevation myocardial infarction.
Main Methods:
- A prospective, double-blinded, placebo-controlled randomized trial involving 105 patients.
- Patients with reduced left ventricular ejection fraction (≤40%) post-ST-elevation myocardial infarction were randomized.
- Treatment arms included empagliflozin 10 mg daily, empagliflozin 10 mg daily plus colchicine 0.5 mg twice daily, or empagliflozin 25 mg daily for 12 weeks.
Main Results:
- Primary outcomes include changes in New York Heart Association functional classification and high-sensitivity C-reactive protein at 4 and 12 weeks.
- The study will provide data on the comparative effectiveness of different empagliflozin dosages and the combination therapy.
- Safety profiles of the investigated treatment regimens will be assessed.
Conclusions:
- This trial is the first to examine the combination of standard-dose empagliflozin and colchicine, and high-dose empagliflozin in non-diabetic patients post-myocardial infarction with reduced ejection fraction.
- The findings are expected to significantly advance the treatment strategies for this vulnerable patient population.
- Results will inform clinical practice regarding early therapeutic interventions to mitigate adverse cardiovascular events.
Background:
Patients with acute myocardial infarction are at greater risk for chronic heart failure and mortality. Currently, there is limited evidence supporting the beneficial effects of sodium-glucose cotransporter-2 inhibitors on cardiovascular outcomes in non-diabetic patients with reduced left ventricular ejection fraction following acute myocardial infarction. Furthermore, the clinical effects of the combination of standard-dose sodium-glucose cotransporter-2 inhibitors with colchicine and high-dose sodium-glucose cotransporter-2 inhibitors in this setting have not been evaluated yet.
Methods:
A prospective, double-blinded, parallel-group, placebo control randomized trial will be carried out at Shahid Madani Heart Center, the largest teaching referral hospital for cardiovascular diseases, affiliated with Tabriz University of Medical Sciences. A total of 105 patients with reduced left ventricular ejection fraction (≤ 40%) following the first episode of ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention with stent insertion will be randomized 1:1:1 to receive empagliflozin 10 mg daily, a combination of empagliflozin 10 mg daily and colchicine 0.5 mg twice daily, or empagliflozin 25 mg daily for 12 weeks. The primary outcomes are changes in the New York Heart Association functional classification and high-sensitivity C-reactive protein from the randomization through week 4 and week 12.
Discussion:
The present study will be the first trial to evaluate the efficacy and safety of early treatment with the combination of standard-dose empagliflozin and colchicine as well as high-dose empagliflozin in non-diabetic patients with reduced left ventricular ejection fraction following ST-elevation myocardial infarction. The results of this research will represent a significant step forward in the treatment of patients with acute myocardial infarction.
Trial Registration:
Clinical trial ID: IRCT20111206008307N39. Registration date: 27 October 2022.
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