魚油は心房細動再発を軽減しなかった

高用量オメガ3は心房細動再発を軽減しないようである
High-dose omega-3 does not appear to reduce recurrence of atrial fibrillation
魚油など由来のオメガ3脂肪酸のサプリメントにより心房細動(AF)治療が改善する可能性があるとのいくつかのデータが示されていたが、600人以上の患者を対象とした無作為化トライアルにおいて高用量の処方オメガ3は6ヵ月間のAF再発を減少させなかったことが示されたとのレイトブレイキング臨床試験の結果が2010年AHA学会で発表され、JAMA 12月1日号に掲載される。このスタディでは、実質的な器質的心疾患を有さない確認された有症状の発作性または持続性AF外来患者(それぞれ542人および121人)計663人を対象とした。対象者は処方薬オメガ-3(1日8mg)またはプラセボを最初の7日間、次いで処方薬オメガ-3(1日4mg)またはプラセボを第24週まで投与された。その後6ヵ月間に発作性心房細動患者群に認められた有症状のAFまたは心房粗動イベントはプラセボ群で129件(48%)であり実薬群で135件(52%)であった。持続性AF患者群では有症状のAFまたは心房粗動がプラセボ群で18件(33%)、実薬群で32件(50%)認められ、発作性、持続性群を合計するとプラセボ群で147イベント(46%)であり実薬群で167件(52%)であった。
Full Text

Although some data have suggested that omega-3 fatty acid supplements, such as from fish oil, may improve treatment of atrial fibrillation, a randomized trial with more than 600 patients finds that treatment with high-dose prescription omega-3 did not reduce the recurrence of atrial fibrillation over six months, according to a study that will appear in the December 1 issue of JAMA. The study is being released early online because it was presented as a Late Breaking Clinical Trial at the American Heart Association's 2010 annual meeting.

"Atrial fibrillation (AF) is a highly prevalent disease that is responsible for reduced quality of life, costly hospitalizations, heart failure, stroke, and death. No current therapy, drug, device, or ablation is uniformly effective, and several available therapies have the potential to cause harm. Consequently, useful alternatives are being sought," the authors write. "Limited data from small trials suggest omega-3 polyunsaturated fatty acids may provide a safe, effective treatment option for AF participants."

Peter R. Kowey, M.D., of the Lankenau Institute for Medical Research, Wynnewood, Pa., and colleagues conducted a randomized clinical trial to assess the efficacy of a pure prescription formulation of omega-3 fatty acids (prescription omega-3), at a dose considerably higher than what has been tested in previous trials, for preventing recurrent atrial fibrillation. The study included 663 U.S. outpatient participants with confirmed symptomatic paroxysmal (sudden attacks) (n = 542) or persistent (n = 121) AF, with no substantial structural heart disease, who were recruited from November 2006 to July 2009 (final follow-up was January 2010). Participants received prescription omega-3 (8 grams/day) or placebo for the first 7 days; prescription omega-3 (4 grams/day) or placebo thereafter through week 24.

After 6 months of follow-up, the researchers found that in the paroxysmal group, there were 129 documented symptomatic AF or flutter (abnormal, rapid heart beat) events (48 percent) in the placebo group and 135 (52 percent) in the prescription group. In the persistent AF group, there were 18 documented symptomatic AF or flutter events (33 percent) in the placebo group and 32 (50 percent) in the prescription group, while in the 2 groups combined there were 147 events (46 percent) in the placebo group and 167 (52 percent) in the prescription group.

None of the secondary efficacy end points, including first recurrence of AF or flutter in the persistent group and both groups combined, reached statistical significance. Sixteen participants (5 percent) taking placebo, and 12 (4 percent) taking prescription omega-3 discontinued study medication due to an adverse event.

"In this population of patients with symptomatic paroxysmal AF or persistent AF, and no evidence of substantial structural heart disease, prescription omega-3 did not show evidence of reducing the recurrence of symptomatic atrial fibrillation," the authors write.

They add that several factors might contribute to the discordance between their findings and those of other studies. "Either the positive results reported in some trials represent a chance effect of small sample sizes or the differences are real. If the latter, there are several possibilities, including differences in the study populations, in population-specific AF mechanisms, in dosing regimens and product formulations, or in concomitant therapies. In our study, nearly half the events occurred during the first 2 weeks of follow-up, suggesting that fish oil may not have rapid effects, even with high-loading doses."