2023-10-16 20:32:00
With REDUCE-IT, STRENGTH, a large-scale study examining the cardiovascular protective effects of omega-3, the possibility of omega-3 causing atrial fibrillation is becoming established.
Although the conclusions of each study were mixed, a recent meta-analysis tilted the weight towards an increased risk of atrial fibrillation, and the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) decided to reflect this in the side effects of medicines.
According to the European Medicines Agency on the 16th, PRAC members held a pharmacovigilance committee meeting from the 25th to the 28th last month and agreed to add atrial fibrillation as a common side effect to the product information for omega-3 drugs.
Omega-3 is used to treat hypertriglyceridemia when diet and lifestyle modification alone are not sufficient to lower blood triglyceride levels.
The warning regarding the risk of atrial fibrillation from Omega 3 was triggered by REDUCE-IT, a large-scale clinical study published in 2019.
EMA Pharmacovigilance Committee decision. The risk of atrial fibrillation was highest at a dose of 4 g per day, and it was suggested that the medication should be permanently discontinued if atrial fibrillation occurs.
The clinical trial concluded that using a high dose of 4g of purified EPA per day, among omega-3 ingredients, is effective in preventing cardiovascular disease. However, an increase in atrial fibrillation was observed in the omega-3 administration group compared to the placebo group (5.3% vs 3.9%), suggesting that the effect was not only effective. However, the need for verification of safety has emerged.
Subsequently, in the STRENGTH clinical trial released in 2020, an approximately 69% increase in the risk of atrial fibrillation was observed in the omega-3 treatment group, and various research teams began a meta-analysis that synthesized and analyzed multiple studies.
“During the Periodic Safety Assessment Update (PSUSA) process, PRAC considered systematic reviews and meta-analyses of RCTs that showed a dose-dependent increased risk of atrial fibrillation with omega-3 in patients with established cardiovascular disease or cardiovascular risk factors,” it said. “The observed risk is highest at a dose of 4 grams per day,” they noted.
PRAC’s decision is that if atrial fibrillation occurs during omega-3 administration, treatment must be permanently discontinued. PRAC plans to agree to update product information and transmit this information to healthcare professionals to inform healthcare professionals and patients of the risks of atrial fibrillation.
In fact, similar conclusions have been drawn in domestic studies.
Through a meta-analysis of 17 randomized controlled studies, Professor Lim Soo’s research team at the Department of Endocrinology and Metabolism at Seoul National University Bundang Hospital found that omega-3 medication lowers the risk of myocardial infarction and cardiovascular death, but may increase the risk of atrial fibrillation.
As a result of the analysis, the risk of death from cardiovascular diseases in the omega-3 administration group was reduced by 14% compared to the control group, and the risk of fatal or non-fatal myocardial infarction was also reduced by 16%, but the risk of atrial fibrillation also increased in proportion to the dose.
Professor Bae Jae-hyeon of Korea University Anam Hospital said, “Supplementation of omega-3 is effective in lowering the risk of cardiometabolic diseases, especially cardiovascular death and myocardial infarction, but it can also increase the risk of atrial fibrillation. In the case of preventing vascular diseases, EPA monotherapy is more effective. “When deciding on a treatment policy, there is a need to consult with an expert and consider various factors, including the patient’s individual disease,” he said.
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