{"id":5948,"date":"2018-11-13T15:19:14","date_gmt":"2018-11-13T20:19:14","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=5948"},"modified":"2018-11-13T15:24:44","modified_gmt":"2018-11-13T20:24:44","slug":"fish-oil-or-vitamin-d-supplementation-as-protection-against-cardiovascular-events-or-cancer-suffers-deteriorating-vital-signs","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=5948","title":{"rendered":"Fish Oil or Vitamin D Supplementation as Protection Against Cardiovascular Events or Cancer Suffers Deteriorating \u2018VITAL\u2019 Signs"},"content":{"rendered":"

The VITAL trial conducted by Manson et al. showed that supplementation with either n\u20133 fatty\u00a0acids\u00a0at a dose of 1 g\/day or vitamin D3 at a dose of 2000 IU\/day was not effective for primary prevention of cardiovascular or cancer events among healthy middle-aged men and women over 5 years of follow-up. The results were reported on Saturday at the American Heart Association Scientific Sessions meeting in Chicago and online in the New England Journal of Medicine<\/em>.<\/a><\/p>\n

In the trial with a total of 25,871 enrollees, with a\u00a05.3-year\u00a0long duration of follow up, the goal was to assess the cardiovascular (CV) and cancer benefits of n\u20133 (also called omega-3) fatty acid and vitamin D3 supplementation compared with placebo among healthy participants. In a 2 x 2 factorial design, healthy participants were randomized in a 1:1 fashion to either vitamin D3 (at a dose of 2000 IU per day) (n = 12,927) or placebo (n = 12,944), or n\u20133 fatty acids (1 g per day as a fish-oil capsule containing 840 mg of n\u20133 fatty acids, including 460 mg of eicosapentaenoic acid [EPA] and 380 mg of docosahexaenoic acid [DHA]) (n = 12,933) or matching placebo (n = 12,938).\u00a0The primary cardiovascular (CV) outcome of CV death, nonfatal myocardial infarction (MI), or stroke, for vitamin D3 vs. placebo, was 3.1% vs. 3.2%, hazard ratio (HR) 0.97, 95% confidence interval (CI) 0.85-1.1. The rates of CV death were 1.1% vs. 1.1%, for vitamin D3 vs. placebo, respectively. Moreover, the rates of stroke, MI and primary cancer outcome were 1.1% vs. 1.1%, 1.1% vs. 1.5% (HR 0.72, 95% CI 0.59-0.90) and 6.1% vs. 6.4% (HR 0.96, 95% CI 0.88-1.06) respectively.<\/p>\n

\"\"[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]\u201cThe observed lack of benefit of vitamin D supplementation for cardiovascular outcomes in our trial is consistent with results of previous trials of vitamin D,\u00a0even at moderate or high doses. Most recently, in\u00a0ViDA,\u00a0\u00a0the rate of cardiovascular disease was not lower among participants who received monthly administration of high-dose vitamin D than among those who received placebo. Neither our trial nor\u00a0ViDA showed\u00a0that vitamin D was associated with a reduced rate of death from any cause; lower-dose vitamin D trials have shown neutral effects or at most modest reductions in this\u00a0endpoint. However, detection of a decreased rate of death from any cause, if present, may require longer follow-up.\u201d- Dr.\u00a0JoAnn Manson, M.D.<\/strong>[\/perfectpullquote]<\/p>\n

The investigators concluded that supplementation with either n\u20133 fatty\u00a0acids\u00a0at a dose of 1 g\/day or vitamin D3 at a dose of 2000 IU\/day was not effective for primary prevention of CV or cancer events among healthy middle-aged men and women over 5 years of follow-up. The finding of a lower MI risk with n\u20133 fatty\u00a0acids\u00a0was hypothesis generating and deserved further study. The authors also noted some interaction with baseline fish consumption, with greater CV\u00a0benefit,\u00a0observed among participants who had\u00a0a low\u00a0fish intake at baseline.\u00a0Speaking of the results, Manson and his colleagues stated, \u201cThe observed lack of benefit of vitamin D supplementation for cardiovascular outcomes in our trial is consistent with results of previous trials of vitamin D,\u00a0even at moderate or high doses. Most recently, in\u00a0ViDA,\u00a0\u00a0the rate of cardiovascular disease was not lower among participants who received monthly administration of high-dose vitamin D than among those who received placebo. Neither our trial nor\u00a0ViDA showed\u00a0that vitamin D was associated with a reduced rate of death from any cause; lower-dose vitamin D trials have shown neutral effects or at most modest reductions in this\u00a0endpoint. However, detection of a decreased rate of death from any cause, if present, may require longer follow-up.\u201d<\/p>\n

\"\"[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]\u201cDespite the negative findings regarding the primary endpoints in VITAL, the secondary endpoints will undoubtedly draw attention. It will be tempting to note the lower incidence of myocardial infarction and of death from myocardial infarction with n\u22123 fatty acids than with placebo and the lower mortality from cancer with vitamin D than with placebo and then to cite these findings as evidence that these supplements can benefit some patients in preventing coronary heart disease or cancer death. However, these \u201cpositive\u201d results need to be interpreted with caution.\u201d-\u00a0Dr. John F. Keaney, Jr., M.D.<\/strong>[\/perfectpullquote]<\/p>\n

Commenting on the new findings, the lead author Dr. JoAnn Manson, chief of the division of preventive medicine at Brigham and Women\u2019s Hospital in Boston, noted that among fish oil recipients, the rates of death from any cause, death from cancer and death from heart disease, in general,\u00a0were not significantly different than for people not taking fish oil supplements. Additionally, the collective odds of having a heart attack, stroke or death from any cardiovascular cause were essentially the same whether people were taking fish oil or placebo. The primary endpoint was attenuated by the non-coronary endpoints as, \u201cIt was only when the individual elements of heart disease were teased out – such as the rate of heart attack, the rate of fatal heart attack and the need for angioplasty – that a benefit stood out.\u201d For people taking vitamin D who developed cancer, the death rate from cancer was 25 percent lower, possibly because the vitamin \u201cmay affect the biology of the tumor so it\u2019s less likely to spread and become metastatic,\u201d explained Dr. Mason.<\/p>\n

\"\"[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]\u201cThe VITAL study evaluated fish oil that contained a mix of EPA and DHA at lower doses in people with no history of heart disease and was negative. REDUCE-IT evaluated purified EPA at high doses in people with heart disease or diabetes + elevated triglycerides and was positive. Many people are confused by the divergence in the VITAL & REDUCE-IT fish oil trial results but these 2 trials evaluated 2 different formulations in 2 different doses in 2 very very different populations and arrived at 2 different conclusions.\u201d- Dr. C. Michael Gibson, M.D.<\/strong>[\/perfectpullquote]<\/p>\n

Comparing and contrasting the results of the VITAL and REDUCE-IT trials, Dr. C Michael Gibson, CEO of Baim \/ PERFUSE Research Institute, Harvard Professor and Cardiologist at Beth Israel Deaconess Medical Center remarked, \u201cThe VITAL study evaluated fish oil that contained a mix of EPA and DHA at lower doses in people with no history of heart disease and was negative. REDUCE-IT evaluated purified EPA at high doses in people with heart disease or diabetes + elevated triglycerides and was positive. Many people are confused by the divergence in the VITAL & REDUCE-IT fish oil trial results but these 2 trials evaluated 2 different formulations in 2 different doses in 2 very very different populations and arrived at 2 different conclusions.\u201d\u00a0In an accompanying editorial<\/em><\/a>, Dr. John F. Keaney, Jr., M.D.,\u00a0and Clifford J. Rosen, M.D.\u00a0\u00a0wrote, \u201cDespite the negative findings regarding the primary endpoints in VITAL, the secondary endpoints will undoubtedly draw attention. It will be tempting to note the lower incidence of myocardial infarction and of death from myocardial infarction with n\u22123 fatty acids than with placebo and the lower mortality from cancer with vitamin D than with placebo and then to cite these findings as evidence that these supplements can benefit some patients in preventing coronary heart disease or cancer death. However, these \u201cpositive\u201d results need to be interpreted with caution.\u201d They concluded, \u201cIn the absence of additional compelling data, it is prudent to conclude that the strategy of dietary supplementation with either n\u22123 fatty acids or vitamin D as protection against cardiovascular events or cancer suffers from deteriorating VITAL signs.\u201d<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

The VITAL trial conducted by Manson et al. showed that supplementation with either n\u20133 fatty\u00a0acids\u00a0at a dose of 1 g\/day or vitamin D3 at a dose of 2000 IU\/day was not effective for primary prevention of cardiovascular or cancer events among healthy middle-aged men and women over 5 years of follow-up. The results were reported […]<\/p>\n","protected":false},"author":8,"featured_media":5956,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12,184,29,8],"tags":[47],"ppma_author":[1033],"class_list":{"0":"post-5948","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-cardiovascular-prevention","8":"category-clinical-trials","9":"category-conferences","10":"category-news","11":"tag-featured","12":"author-sudarshana-datta"},"authors":[{"term_id":1033,"user_id":8,"is_guest":0,"slug":"sudarshana-datta","display_name":"Sudarshana Datta, M.D.","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/b79d07e34756cd9e4c6fe8c77835538219f3ec30c82a6bf8f218760a5f29c84a?s=96&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/5948","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5948"}],"version-history":[{"count":7,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/5948\/revisions"}],"predecessor-version":[{"id":5962,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/5948\/revisions\/5962"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/5956"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5948"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5948"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5948"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=5948"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}