It’s Official: Prescription Fish Oil

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The U.S. Food and Drug Administration approved the prescription fish oil Vascepa for expanded use on Friday, December 13. The approval for the medication is for the secondary prevention of cardiovascular disease in patients under the following conditions:

  • Triglycerides above 150 mg/dl for everyone with diagnosed CVD and taking a statin medication.
  • Diabetes and two or more additional risk factors for CVD along with taking a statin medication.

The modifiable risk factors for CVD include smoking, obesity, high cholesterol, hypertension, and sedentary living. Remember from our prior series, secondary prevention may help reduce the risk of CVD symptoms developing.

My concerns are the same as they were before. Triglycerides less than 250 mg/dl can be resolved by diet and exercise in most people. Because the mechanism of action is unknown as to how the prescription works, there’s no reason to think that reducing triglycerides by lifestyle change won’t work as well as the prescription; the clinical trial didn’t track this data.

Speaking of lifestyle change, keep in mind the website specials on the Optimal Performance program as we get ready for the New Year. The Basic Meal Plan will teach you how to change your diet to reduce triglyceride levels if your levels are too high.

What are you prepared to do today?

        Dr. Chet

References:
1. http://bit.ly/36EbsYK
2. N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Holiday Eating: The Best Solution So Far

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In our quest to find the best holiday eating strategy, we may have been looking at the wrong metric. Prior researchers have been looking at the subjects reporting of how well they stuck to their eating habits and exercise program. The final study looked at a hard metric: body weight. Here’s what they did.

Researchers recruited subjects who were overweight and obese but had been losing weight, plus a group of normal-weight subjects. They further divided the two groups into control groups and experimental groups. The control groups simply weighed in before the holiday season began at Thanksgiving, after the season ended on January 1st, and again a month later. The experimental groups also weighed in during those times but in addition, they were told to weigh in every day using a scale with Wi-Fi access. Their results were displayed graphically to chart progress.

What happened? The control groups, whether overweight, obese, or normal weight, gained an average of close to six pounds during the holiday season. The normal weight subjects who weighed themselves daily maintained their weight. Those who were overweight and obese continued to lose weight, losing on average 2.5 pounds. At the one month follow-up, the control group lost only half the weight they gained over the holidays. Researchers speculate that annual holiday weight gain contributes to weight gain over years.

The Bottom Line

What’s the best strategy for holiday eating? There are two things that are critical: maintain your exercise program and weigh yourself regularly, preferably every day. True, your daily weight will fluctuate but you won’t let it get away from you—that’s when you get into trouble. As for your eating habits, not every day is a holiday party with mass quantities of food to consume. Chill out a little during the parties and pitch-ins, but for the most part, stick to your regular eating habits; that applies whether you’re overweight or not. I think that’s the best strategy for the holiday season.

What are you prepared to do today?

        Dr. Chet

Reference: Obesity. 2019;27(6):908-916. doi: 10.1002/oby.22454

Is a Relaxed Holiday Eating Plan Better?

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The Portuguese Weight Control Registry is similar to the National Weight Control Registry. While the amount lost is different, 11 pounds, the members still have to have kept the weight off at least a year. Researchers asked what techniques participants used for weight maintenance, comparing weekdays versus weekends and holidays versus non-holidays. The criteria were different. Those researchers were looking at weight regain of 3% or less that was maintained for an additional year. What did they find?

Subjects who relaxed their eating plan on weekends maintained their weight loss better than those who strictly adhered to their diet and exercise regimen. The comparison with holiday and non-holiday habits didn’t show any differences in weight regain. There were a significant number of subjects who dropped out, and that probably impacted the results.

Neither of these studies on the Registries was perfect but it does give us some insight. Depending on your mental make-up, it may be better to stick to your regimen during the holidays or maybe you can relax a little. While not reported, it would depend on your mental willpower at the time. That might change year to year. Well, where does that leave you? One more study to review that might provide the solution.

What are you prepared to do today?

        Dr. Chet

Reference: https://doi.org/10.1186/s12937-019-0430-x

Should You Have a Strict Holiday Eating Strategy?

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Tis the season for gaining weight. It began on Thanksgiving, but we’re in it big time now. If you’ve lost weight and want to make sure you don’t see it again, what do you do? Let’s review some of the research on strategies that people who’ve lost weight and maintained it have used.

The first is a report from the National Weight Control Registry. In order to be a subject in that study, you have to lose 30 pounds and maintain it for at least a year. Researchers took a group of recent additions to the study and asked them specific question on their strategies during the upcoming holiday season at that time, and then tracked how they did. They also recruited a group of normal weight people and did the same thing.

Most of the experimental group said they were going to follow their typical routine as related to diet and exercise plan. In other words, they were going to try to strictly follow their weight loss routine. The normal weight individuals didn’t really have any special plans. Most successful losers did follow their plan although it was more difficult during the holiday season. About the same percentage of successful losers and normal weight subjects gained weight, maintained their weight, or lost weight during the holiday season. The difference was that the successful losers found it more challenging to do so based on their response to survey questions.

Is that the best strategy? Stay the course? Another study on Thursday.

What are you prepared to do today?

        Dr. Chet

Reference: J Consult Clin Psychol. 2008. 76(3): 442–448.

Will the Diet of Your Culture Improve Your Microbiome?

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Does the diet of your ancestors impact your microbiome? A review examined whether the common foods found in specific cultures can benefit people of that culture who are following a diet high in refined carbohydrate and low in fiber, as is common in the U.S. Let’s take a look.

The Gold Standard: the Mediterranean Diet

The Mediterranean diet has been studied more than any other; it emphasizes vegetables, whole grains, fish and seafood, nuts and seeds, olive oil, fruit, and limited sweets. The benefits for reducing heart disease, hypertension, and T2D are well documented, and we’ve always assumed that the Mediterranean diet is appropriate for everyone. But is it? The point to this review is that while there are similarities, there are cultural differences that may be important.

For example, there are more tubers (root vegetables) in African diets and virtually none in most Asian cultures. The Latin diet has more dairy products while some Asian diets contain almost none. If you want to become more familiar with cultural diets, check out www.oldwayspt.org. It’s a non-profit organization that has developed cultural appropriate diets and teaches people to prepare foods using traditional cultural spices.

It makes sense; one size does not fit all. One interview in the paper was with an Eastern Indian physician who had always recommended the Mediterranean diet to her clients of Indian descent, but the whole grains of the Mediterranean diet were not the same as traditional Indian grains. Once she changed the types of grains and other high-fiber foods to more culturally appropriate choices, her patients did better in following a higher fiber diet.

The Benefits of a Culturally Appropriate Diet

Simply stated, people are more inclined to follow a healthier, high-fiber diet if it’s based on their own culture. The differences in grains and vegetables may be subtle but seem to be important. The tastes and flavors may be more familiar to first or second generation immigrants.

There is also speculation that the microbiomes of people from varying cultures may have an evolutionary aspect. In other words, whether you’re a recent immigrant or a fourth generation of immigrants as I am, your microbiomes may respond better to foods that your ancestors have eaten for generations. Remember the short-chain fatty acids (SCFA) in the Thursday Memo this week? They may be dependent, not just on fiber, but fiber from the foods of your ancestors.

The Bottom Line

This paper gives us something to think about. What if we ate a more plant-based diet that’s more culturally based? I think it’s worth a try. It doesn’t mean that you won’t benefit from eating a high-fiber food that’s not culturally based; there’s no question that you will. But if you ate culturally based foods and they were prepared based on cultural tastes, you might decide to eat more of them and you might get more benefit.

The first thing I did was to look at traditional foods from my ancestors in Poland and other eastern European cultures. I’m not done yet, but it seems cabbages and root vegetables are definitely part of my future diet; I’ll keep you posted as I research my diet further. In the meantime, check out Oldways to get some perspective on what culturally appropriate foods may benefit your diet. If you’re an African-American man married to a Chinese-Canadian woman, you’re going to have some very interesting meals.

What are you prepared to do today?

        Dr. Chet

References:
1. JAMA. 2019; doi: 10.1001/jama.2019.18431.
2. www.oldwayspt.org.

Does Fiber Improve Your Microbiome?

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Now let’s look at the results of increasing dietary fiber for people with diabetes. Researchers recruited over 50 type 2 diabetics (T2D) for a 12-week study. The control group was given standard recommendations for a healthy diabetic diet. All current medications were maintained and both groups received acarbose, a starch blocker. The experimental group was put on a diet of prepared high-fiber foods and a diet higher in vegetables and fruits. Stool samples were collected periodically to assess the impact of the diet on the microbiome.

While the variables were straightforward, the analytic techniques were extraordinarily complex. It’s easy to say you want to examine the microbiome, but that’s not simple to do with thousands of types of microbes to analyze. Several types of bacteria from different species responded to the increase in fiber: bacteria that produced short-chain fatty acids (SCFA). The SCFAs are important because they feed the cells in the gut that do all the work during digestion and absorption.

HbA1c levels decreased faster and in a higher percentage of subjects in the experimental group than the control group. The fiber group also lost more weight and their blood lipids improved more than controls.

This was a small study, limited by the complexity of analyzing the microbiome, but the improvement in T2D simply due to an increase in fiber from foods is important. One more thing: this was a Chinese study, so typical high fiber foods from China were used. Is that important? We’ll find out Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: Science. 2018. 359:1151–1156.

How Your Microbiome Affects Exercise Benefits

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It seems every day, there are several studies on the microbiome and its impact on our health. At this point, they’re preliminary but the picture is emerging that as goes your gut, so goes your health. I’ve picked three new studies to review this week.

As an exercise physiologist who’s done research on this topic, I’ve always recommended exercise as a way to improve control of blood sugar for prediabetics; that’s why this study surprised me. Researchers assigned 39 prediabetic men who had never used medication to either a control group or a high-intensity exercise group for three months. All men in the exercise group had similar improvement in fitness and weight loss. But only 70% of the men demonstrated an improvement in insulin resistance.

The way the responders processed protein and carbohydrates was different from non-responders. The researchers collected stool samples and then transplanted the microbiome of responders and non-responders into a group of mice; the mice responded to exercise in the same way as the man whose microbiome they received. The microbiome somehow responded differently to exercise and modified the expected results.

We don’t know about dietary differences between subjects that might have impacted the outcome because the subjects were told to maintain their current diet, but the results were surprising nevertheless. But I would still give the same recommendation for exercise to all prediabetics. The only difference would be to make sure they tracked blood sugars to see how their blood sugar responded.

What are you prepared to do today?

        Dr. Chet

Reference: Cell Metabolism, DOI: 10.1016/j.cmet.2019.11.001.

Prescription Fish Oil: Questions Remain

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The REDUCE-IT clinical trial formed the basis for the expanded recommendations for use of Vascepa, the prescription fish-oil medication. This was an expensive trial, involving 11 countries and hundreds of medical centers with 999 physicians who recruited subjects, collected data, and kept track of the subjects for close to five years. With over 8,000 subjects, this was no easy task. As I said in Thursday’s Memo, they examined the primary and secondary prevention when the medication is taken with statins versus a placebo with statins.

While this was a tremendous effort, there are still some concerns, in my opinion.

Study Concerns

A board made up of physicians and the pharmaceutical company’s staff designed the study and helped execute it; the pharmaceutical company paid for the clinical trial, collected and managed the data, analyzed the data, and interpreted the results. Then the statistics were reviewed by an independent statistician. This creates a huge conflict of interest regardless of safeguards that may have been put in place.

When any type of study is supported by companies with vested interests in the outcome, there will always be questions. That has been true for every dietary supplement manufacturer that’s ever funded a study as well as the milk and sugar industry. It’s especially true for this study. I began by talking about a report from the financial sector. Billions of dollars are on the line. That has to be considered by the FDA before final approval is given.

I have a tendency to have faith in science, as skeptical as I may be at times. And that’s where my concerns lie; not in the financial aspect but in the study design and results.

My Concerns

As complicated as this study was, it was incomplete in my opinion. They did not collect any data on the subjects’ diet; a small change in diet could have reduced triglycerides (TG) enough to have a positive impact on secondary outcomes. The median change in TG over five years with the medication was 45 mg/dl, from about 215 down to 170 in the medication group, while it was reduced 13 mg/dl in the placebo group. We don’t know whether a group that focused on dietary changes to reduce TG would have the same reduction in CVD events; that would have been an excellent addition to the study design.

They also didn’t have a group using fish oil from dietary supplements. True, it’s not their responsibility, but we can’t know whether the same benefit might not occur if the dosing of EPA were equal:

  • Almost every study that has used fish oil to examine whether CVD outcomes could be reduced has used fish oil with 1 gram of EPA.
  • If the amount of EPA were the same, a head-to-head comparison between a supplement and medication that each had 4 grams EPA might have found a similar benefit.

The real issue is that we don’t know what makes the fish-oil medication work, just like we don’t know completely how dietary omega-3 fatty acids work. Is it just the reduction in the TG or how the oils work in the body? Are genetics involved? Diet? The microbiome? We have no idea at this time.

The Bottom Line

I’ll keep on eye on the approval process for this fish-oil pharmaceutical and let you know how it will be prescribed in the future. The decrease in TG found in the study can be done with lifestyle changes alone, so is it going to be worth the cost of a pharmaceutical for a slight reduction in CVD events? Remember the difference between medication and placebo was just 4.8%. If you fall in that category, you’ll have to decide for yourself: pharmaceutical fish oil or lifestyle change. In this case, a little work may go a long way.

What are you prepared to do today?

        Dr. Chet

P.S. This will be the last Memo until after Thanksgiving. Paula and I are doing something we haven’t done in 20 years: go on a real vacation, just us, just for fun. No work of any type. Talk to you again December 3.

Reference: N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Primary vs. Secondary Meds

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One of the key questions for the FDA advisory panel to consider was whether the prescription fish oil was a primary preventer of cardiovascular disease or a secondary preventer. What’s the difference? Primary prevention of CVD would impact the disease and stop events before they occurred in the subjects taking the fish-oil medication. Secondary prevention would prevent additional CVD events from happening in those with established CVD.

If you were a type 2 diabetic with an additional risk for CVD such as obesity or being a smoker, taking the prescription fish oil with a statin would prevent a heart attack or stroke from happening; that’s primary prevention. Based on the Reduction of Cardiovascular Events with Icosa-pent Ethyl–Intervention Trial (REDUCE-IT) that didn’t happen, but it did prove to be a secondary preventer of additional cardiac events in those subjects in the study with established disease.

The question is whether the FDA will approve the prescription fish oil as a primary prevention or a secondary prevention pharmaceutical. The advisory panel seemed split on that count. The assumption by some was that there was disease present even though the event had yet to occur. Others said “prove it” by doing an actual clinical trial to examine that question. We’ll find out how the FDA decides later this year. As I mentioned yesterday, the financial implications are huge.

There are still some things to consider with the clinical trial, and I’ll cover that on Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: N Engl J Med 2019;380:11-22. DOI: 10.1056/NEJMoa1812792.

Prescription Fish Oil Update

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“This Fish-Oil Heart Drug Could Be Big, Could Be Huge.” That was the headline in a well-known financial report after a Food and Drug Administration panel unanimously voted in favor of an expanded use for the prescription fish-oil drug. I mentioned this was a possibility when I first talked about Vascepa in October. The FDA is expected to make a final decision by the end of the year.

What is the expanded use? The medication could be prescribed to those who have established heart disease or type 2 diabetes with another CVD risk factor and are already taking statin medications to lower cholesterol. The advisory panel approved the use because research showed that when combined with statins, it could reduce CVD endpoints such as death, heart attacks, and strokes by an additional 4.8% when compared to a placebo over a 4.9 year follow-up period, 17.2% versus 22%.

One more thing. The medication could be prescribed to those with triglycerides as low as 150 mg/dl. That would include millions more potential users in the U.S. and Canada alone. You can see why the headline was in the financial news; the potential profit for investors could be huge. A lot is riding on what the FDA decides. I’ll explain that on Thursday.

What are you prepared to do today?

        Dr. Chet

Reference: Bloomberg Online. Max Nisen. Posted 11-15-2019.