Is it now safe to eat romaine lettuce? Not yet, FDA says
The E. coli outbreak linked to romaine lettuce has sickened 43 people in 12 states, with the most recently reported illness happening on October 31, the US Food and Drug Administration said Monday. The FDA said the ongoing outbreak is linked to the "end of season" harvest in some parts of California. Read the full story<https://apple.news/AQ3YWhV6DRkKOsKpg45p8Dg>
Shared from Apple News<https://www.apple.com/news/>
Sent from my iPhone
---------- Forwarded message ---------
From: Kathrynne Holden fivestar(a)nutritionucanlivewith.com
Date: Tue, Nov 20, 2018 at 3:43 PM
Subject: [Nutrition_Reports] Pure Fish Oil Lowers CVD Risk Even If We Don’t
To: Nutrition_Reports(a)yahoogroups.com <Nutrition_Reports(a)yahoogroups.com>
Pure Fish Oil Lowers CVD Risk Even If We Don’t Understand How
John M. Mandrola, MD
November 11, 2018
- 16Read Comments
- Add to Email Alerts
No doubt about it: icosapent ethyl—a purified fish oil supplement—reduced
cardiac events. The stunningly positive primary endpoint slide from the
REDUCE-IT trial earned applause from a packed audience here at the
American Heart Association (AHA) Scientific Sessions 2018 in Chicago.
In a large multicenter randomized controlled trial, patients with high
cardiovascular risk and elevated triglycerides who took 4 g of a purified
eicosapentaenoic acid ethyl ester (EPA) per day vs a mineral oil placebo
had a 4.5% lower risk of dying from cardiac causes or experiencing
myocardial infarction, stroke, coronary revascularization, or unstable
angina necessitating hospital admission.
Here’s how strong the result was: If you assume no difference in the drug
relative to placebo, the chance these results would have been observed (eg,
the *P* value) was 1 × 10– 8.
Strengths of REDUCE-IT include that randomization resulted in well-matched
groups; the 25% relative risk reduction is robust; the active treatment
reduced all components of the composite endpoint (not just softer ones like
coronary revascularization); and the findings showed a consistent effect in
important subgroups (eg, sex, race, high vs low levels of triglycerides,
statin intensity). Finally, the 25% relative risk reduction in REDUCE-IT
comports with the JELIS trial, a non–placebo-controlled trial of
Japanese patients that found a 19% reduction in cardiac events with a lower
daily dose of EPA.
The high-dose EPA did show a trend toward higher rates of overall bleeding,
but the rate of life-threatening bleeding events was similar. An unexpected
but definite 1.4% increased risk for atrial fibrillation occurred in the
By email, Ethan Weiss, MD, from the University of California San Francisco,
highlighted two major concerns with REDUCE-IT. The first is whether the
mineral oil in the placebo group caused harm, thereby making the active arm
look better in comparison. The evidence for this comes from Table 4 of the
supplement accompanying the publication in the *New England Journal of
Medicine*, which showed significant increases in levels of non-high-density
lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol
(LDL-C), apolipoprotein B, and high-sensitivity C-reactive protein in the
His second concern was that active treatment resulted in only modest
reductions in triglycerides. The authors discussed this in the paper,
noting that the benefits of EPA were observed irrespective of the attained
triglyceride level at 1 year (≥150 or <150 mg/dL). They proposed that EPA
might work via other mechanisms.
Weiss concluded that if there are unclear mechanisms of benefit and the
placebo is actually harmful, then how can we assess how “beneficial” the
drug is?” He added: "I’m bummed."
Sanjay Kaul, MD, from Cedars Sinai Medical Center in Los Angeles,
California, downplayed these concerns. He explained via email that the 7-
to 10-mg/dL increase in LDL-C in the placebo arm will likely explain about
5% of the relative risk reduction. That leaves a 20% relative risk
reduction, which is still a large treatment effect.
In a tweet <https://twitter.com/skathire/status/1061354242349391873> following
the presentation, Sekar Kathiresan, MD, from Harvard Medical School in
Boston, Massachusetts, agreed with Kaul, saying that the differences in
non-HDL-C and LDL-C between the active and placebo arm "do not compromise
the integrity of the trial result."
Doctors begin their training by learning the biology of disease. This
creates a frame in which we are drawn to treatments we can explain. If high
levels of a substance are associated with a disease, a drug that lowers
that substance should improve outcomes. Think statins.
Our embrace and reliance on such a physiology-based frame has resulted in
tragic failures—antiarrhythmic drugs for premature ventricular contractions
after myocardial infarction, for example.
This is why evidence-based medicine is so important. It doesn’t care how
something works; it just measures if it works. And it applies here.
REDUCE-IT convincingly shows that if you use 4 g of EPA in patients like
those enrolled in the trial, you will lower the risk for adverse cardiac
outcomes. Even with the caveats on the inertness of the placebo, a major
treatment benefit remains.
You can dislike the first line of the data disclosure statement in which
the authors answer, ‘No’ to the question, "Will the data collected for your
study be made available to others?" You can be concerned that Amarin, the
makers of icosapent ethyl, was responsible for data collection and
analysis. And patients put on this drug will need to know there is a higher
risk for atrial fibrillation.
But if you advocate for the use of evidence in the care of patients, and I
do, the results of REDUCE-IT should be incorporated into practice.
Bhatt DL, Steg PG, Miller M, Brinton EA, et al. Cardiovascular risk
reduction with icosapent ethyl for hypertriglyceridemia. *N Engl J Med*.
Published online November 10, 2018. Article
Yokoyama M, Origasa H, Matsuzaki M, et al. Effects of eicosapentaenoic
acid on major coronary events in hypercholesterolaemic patients (JELIS): a
randomised open-label, blinded endpoint analysis. *Lancet.*
Posted by: Kathrynne Holden <fivestar(a)nutritionucanlivewith.com>
Reply via web post
• Reply to sender
• Reply to group
• Start a New Topic
• Messages in this topic
Have you tried the highest rated email app? <https://yho.com/1wwmgg>
With 4.5 stars in iTunes, the Yahoo Mail app is the highest rated email app
on the market. What are you waiting for? Now you can access all your
inboxes (Gmail, Outlook, AOL and more) in one place. Never delete an email
again with 1000GB of free cloud storage.
Kathrynne Holden, MS RD (retired)
Parkinson Blog Nutrition U Can Live With
Parkinson s - Chew On This
Visit Your Group
[image: Yahoo! Groups]
• Privacy <https://info.yahoo.com/privacy/us/yahoo/groups/details.html> •
<Nutrition_Reports-unsubscribe(a)yahoogroups.com?subject=Unsubscribe> • Terms
of Use <https://info.yahoo.com/legal/us/yahoo/utos/terms/>
*Joanne P. Ikeda, MA, RD*
*Department of Nutritional Sciences*
*University of California, Berkeley*
*Current address: 1777 View Drive*
* San Leandro, CA 94577*
*Phone (510) 895-5300*