Greater blood ranges of omega-3 fatty acids from prescription fish oil confirmed no impact on CV occasions
Sufferers at excessive danger for cardiovascular occasions who had the very best ranges of eicosapentaenoic acid (EPA) of their blood one yr after taking every day omega-3 carboxylic acid, a prescription-grade fish oil, had comparable charges of main cardiovascular occasions as individuals taking a corn oil placebo, in line with a secondary evaluation of the STRENGTH trial offered on the American Faculty of Cardiology’s seventieth Annual Scientific Session. Researchers additionally discovered no improve in cardiovascular occasions amongst sufferers with the very best ranges of docosahexaenoic acid (DHA) in comparison with placebo.
The impetus for this post-hoc evaluation was to additional look at the strikingly divergent outcomes between STRENGTH and REDUCE-IT, one other giant, randomized scientific trial that used a special omega-3 fatty acid formulation (icosapent ethyl, purified EPA solely) and mineral oil because the placebo.
“That is an intensely controversial space. One fish oil trial after one other has been impartial, however REDUCE-IT reported a putting 25% discount in occasions in contrast with a placebo tablet containing mineral oil. However in our evaluation, amongst sufferers handled with fish oil we discovered no proof that EPA is helpful or that DHA is dangerous,” stated Steven Nissen, MD, MACC, heart specialist at Cleveland Clinic and the examine’s lead writer. “So, we have now many sufferers taking fish oils however no proof that they’ve favorable results on the guts.”
The double-blind, multicenter STRENGTH trial enrolled 13,078 individuals at excessive danger for main cardiovascular occasions from 675 websites in 22 international locations between Oct. 30, 2014 and June 14, 2017. Sufferers had been randomized to obtain both 4 grams every day of omega-3 carboxylic acid (a mixture of EPA and DHA) or corn oil because the placebo. As beforehand reported, researchers discovered no distinction between the 2 teams when it comes to the first consequence—a composite of cardiovascular loss of life, coronary heart assault, stroke, want for procedures to open blocked arteries or chest ache that required hospitalization.
This remained true within the present evaluation, which examined a subset of 10,382 sufferers (5,175 receiving omega-3 carboxylic acid and 5,207 within the corn oil group) with out there omega-3 fatty acid ranges. Occasions occurred in 11.1% of sufferers handled with fish oil and 11% of sufferers within the placebo group. General, this group of sufferers was 62.5 years previous on common, one-third had been ladies and one other third had diabetes.
Researchers grouped sufferers into thirds (tertiles) primarily based on achieved EPA and DHA ranges assessed by bloodwork at baseline and 12 months after randomization. The median plasma EPA stage for sufferers taking fish oil was 89 (46-131) μg/mL and 91 (71-114) μg/mL for DHA, with the highest tertile reaching ranges of 151 (132-181) and 118 (102-143) μg/mL, respectively.
Researchers discovered no distinction within the incidence of the prespecified main consequence amongst sufferers handled with omega-3 carboxylic acid who had been within the prime tertile of achieved EPA ranges at one yr in contrast with occasions seen in sufferers handled with corn oil; the occasion fee was 11.3% and 11%, respectively. For the highest tertile of achieved DHA, the occasion fee was 11.4%. Researchers stated they might have anticipated to see a distinction in occasions amongst these sufferers if greater ranges of EPA have a protecting function. Additional analyses examined adjustments in EPA or DHA over time and equally confirmed impartial results on cardiovascular outcomes.
“To be thorough, we seemed on the information a number of methods—absolute EPA and DHA ranges, change in ranges of those omega-3 fatty acids, pink blood cell ranges, and by main and secondary prevention subgroups,” Nissen stated. “All of those analyses confirmed no advantages or harms.”
Nissen stated there are a number of attainable causes for the very totally different outcomes rising from the STRENGTH and REDUCE-IT trials.
“It may very well be that EPA actually is helpful or it may very well be that the administration of DHA in STRENGTH might have prompted hurt, thereby undermining the advantages of EPA; nevertheless, the present examine discovered no profit from EPA and no hurt from DHA,” he stated. “Alternatively, the differing outcomes from these research might have occurred as a result of REDUCE-IT used mineral oil because the placebo, leading to a false constructive trial. Not like corn oil, which is inert, mineral oil has main antagonistic results. When you give a poisonous placebo, then the lively drug could look actually good.”
Within the STRENGTH trial, the highest tertile of achieved median EPA stage was 151 μg/mL, which compares favorably with the median stage reported within the REDUCE-IT trial (144 μg/mL).
Nissen stated that if there is no such thing as a advantage of fish oil in stopping main cardiovascular occasions, the potential harms should then be thought-about. Though absolutely the numbers had been small, there was a 69% improve in new onset atrial fibrillation, a harmful coronary heart rhythm dysfunction, amongst people taking fish oil, which occurred in 2.2% of sufferers within the fish oil group in contrast with 1.3% of these taking corn oil.
“Fish oils improve the danger of atrial fibrillation considerably, and there’s no stable proof that they assist the guts in anyway,” Nissen stated. “It is a unhappy story for cardiology.”
A key limitation of the examine is that it’s a post-hoc evaluation.
Fish oil dietary supplements linked with coronary heart rhythm dysfunction
Steven E. Nissen et al, Affiliation Between Achieved ω-3 Fatty Acid Ranges and Main Adversarial Cardiovascular Outcomes in Sufferers With Excessive Cardiovascular Threat, JAMA Cardiology (2021). DOI: 10.1001/jamacardio.2021.1157
Greater blood ranges of omega-3 fatty acids from prescription fish oil confirmed no impact on CV occasions (2021, Could 17)
retrieved 17 Could 2021
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