Tag Archive for: cardiovascular disease

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.

News on Food as Medicine

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As a conventional medical journal and one of the leading medical journals in the world, The Journal of the American Medical Association doesn’t often publish reviews of the impact of food on health. However, a recent edition of the Journal included a summary of three such studies, and that’s the topic for this week.

The first study examined whether mushrooms, which are full of vitamins, minerals, and phytonutrients, decrease the risk of cardiovascular disease (CVD) or type 2 diabetes (T2D). The researchers re-analyzed the data from the Nurses’ Health Study and the Health Professionals Follow-up Study. When they compared more than five servings of mushrooms per day with less than one serving per day, they found no differences in the rate of symptoms or markers associated with CVD or T2D. One interesting note was that if mushrooms were substituted for meat, there was a decreased risk of T2D.

This is one of the first studies to acknowledge the problems with nutrition data in these types of studies. The data on mushrooms were only collected at the beginning of the studies; that doesn’t allow for comparisons over time. Further, the questionnaire didn’t allow for data on a variety of types of mushrooms. The best observation at this point is that we don’t know whether mushrooms or specific types of mushrooms are beneficial for reducing the risk of disease until more research is done.

We do know they’re good for you, so enjoy your mushrooms; sautéed mushrooms are a great addition to many dishes. Here’s another way to enjoy mushrooms: Creamy Mushroom Soup from the Health Info page at drchet.com. Check out the other recipes while you’re there.

We’ll look at another study on Thursday.

What are you prepared to do today?

        Dr. Chet

P.S. Don’t forget to complete the survey on Dr. Chet’s Traveling Health Show. I could be coming to a city near you in 2020! Click the link below to go to the survey.

Survey

Reference: AJCN https://doi.org/10.1093/ajcn/nqz057.

Should You Try Prescription Fish Oil?

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The final marketing point that the prescription fish oil supplement makes is that the DHA omega-3 fatty acid found in many heart healthy fish oil blends may raise LDL-cholesterol. That’s the cholesterol, known as the lousy cholesterol, associated with an increased risk of cardiovascular disease.

Based on the studies I read, there may be a small increase in LDL-cholesterol in some studies. What they fail to mention is that there’s more than one type of LDL-cholesterol. The small, dense LDL cholesterol has been shown to be associated in CVD even when LDL-cholesterol is in the normal range; the large and fluffy LDL-cholesterol seems to have no relationship with CVD. The supplement fish oils that contain DHA seem to raise only the large LDL-cholesterol. That has led other researchers to call the effect of fish oil on LDL to be cardioprotective at best and benign at worst.

The Issues with the Marketing of Rx Fish Oil

Every company wants to put their best foot forward and prescription fish oil is no different. In reviewing the marketing materials as well as the research, here are my concerns:

  • The results of the studies they cite show a decrease in triglycerides of 33%. The mean level of triglycerides in one of the studies was about 660 mg/dl. That means it dropped the mean level to 440 mg/dl. While statistically significant, there’s no way to know whether that’s clinically significant in reducing the overall risk of CVD because the studies were so short.
  • The company clearly states that this medication is clinically relevant only to people with triglycerides greater 500 mg/dl; that’s a very small percentage of patients who may have familial high cholesterol. For the typical person with high triglycerides, this medication is not appropriate. That doesn’t mean it’s illegal to prescribe it for people with triglycerides between 250 and 500, but there’s also no evidence that it’s better than a change in diet or exercise. Will it be prescribed only for people with high triglycerides? We’ll see.
  • The company did not run comparative studies against fish oil supplements or with diet and exercise alone. Seems like that would be obvious.
  • Finally, while there are programs to get this medication for lower prices, I checked with my prescription plan and the cost would be $375 per month. For that kind of money, you can have someone prepare healthy meals specifically designed to reduce your triglycerides or take a class to learn to prepare them yourself; you could definitely join and inexpensive gym and buy more fresh fruits and vegetables.

The Bottom Line

Similar to statin medications when they were introduced decades ago, prescription fish oil should be limited to a very specific part of the population with familial high triglycerides. That’s all—no one else.

As for fish oil supplements, the issues they point out in their marketing material are not significant. You never use dietary supplements to treat any disease, but that doesn’t mean they can’t help you compensate for nutritional deficiencies. There will be a difference in the quality of any supplement so make sure you choose a quality manufacturer.

For the bulk of the population to reduce their triglycerides, reducing refined carbohydrates, saturated fats, and alcohol, increasing vegetable and fruit intake, and getting some exercise will help most. Like I always say: Eat better. Eat less. Move more.

What are you prepared to do today?

        Dr. Chet

References:
1. http://dx.doi.org/10.1016/j.atherosclerosis.2016.08.005.
2. J Clin Endocrinol Metab. 2018 Aug 1;103(8):2909-2917.
3. Am J Clin Nutr. 2004 Apr;79(4):558-63.

Fish Oil: Medication versus Supplements

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Before I address the concerns about fish oil supplements put forth by the Vascepa® prescription omega-3 website, it’s important to understand that all prescription and over-the-counter medications have been approved by the U.S. Food and Drug Administration (FDA). That means they have spent a significant amount of money—sometimes over $1 billion—to prove that the treatment claims are significant, and you can’t take that away from them. But marketing is a different story, so let’s look at what they say.

“Fish oil supplements are not FDA-approved.” True; no dietary supplement is FDA-approved, but that doesn’t mean they’re not regulated. They also can’t make claims about curing diseases.

“Daily dose could require 10 to 40 capsules to equal the prescription EPA omega-3.” That depends on the brand purchased, so that critique is weak.

“Fish oil supplements can leave a fish-y aftertaste.” Really? It’s fish oil, what would you expect? (Keeping the supplements in the refrigerator may help with that as well as taking fish oil before meals.) They suggest that the oils turn rancid and that causes the taste, but they offer no proof of that claim.

The last critique they make of fish oil supplements is that “Many contain another omega-3 fatty acid called DHA.” They say DHA can raise LDL cholesterol. I’ll address that claim and provide some concerns I have with the prescription omega-3 and how it’s being marketed on Saturday.

What are you prepared to do today?

        Dr. Chet

Treatment for High Triglycerides

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Hypertriglyceridemia, the medical term for high triglycerides, is a risk for cardiovascular disease. Recently I spotted a health headline from a medical newsletter that read “Omega-3 Fatty Acid Medications Can Boost Cardiovascular Health.” The word that caught my attention was “medications” so I checked it out.

The article described the benefits of recently approved medications based on marine omega-3 fatty acids. I checked out the latest one called Vascepa®. This is a purified form of fish oil that, according to the data on its website, can lower triglycerides up to 33%. Sounds impressive.

Back to the newsletter article: the author interviewed the lead author of a review paper that stated that prescription omega-3s are effective in lowering high triglycerides. Then she went on to say to avoid omega-3s from dietary supplements because they haven’t been proven to lower triglycerides as the prescription omega-3s have.

The website for Vascepa went a lot further in criticizing omega-3 supplements. What were their objections? Is a prescription the best way to go to treat hypertriglyceridemia? That’s what I’ll cover the rest of this week.

What are you prepared to do today?

        Dr. Chet

Reference: https://www.medicalnewstoday.com/articles/326146.php

What Would You Invest in a Healthier Diet?

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Would you eat more vegetables and fruit if your health insurance paid for it? How about an overall healthier diet that also included whole grains, nuts and seeds, fish, and healthy oils? Would you eat healthier if it didn’t cost you more?

Researchers from Tufts and Harvard examined the potential cost and benefits of subsidizing 30% of the costs of both approaches in Medicare and Medicaid programs. This was a computer simulation using data from NHANES on dietary intake and the relationship to cardiovascular disease and type 2 diabetes. They used the CVD events and mortality data and the current costs of treatment. Then they created models, one with increasing vegetable and fruit intake and another increasing all the aforementioned food, to find out if a healthier diet would affect disease events, deaths, and costs associated with the treatments.

Their estimates found that over a lifetime, the vegetable and fruits model would prevent 1.93 million CVD events and 350,000 CVD deaths while saving $40 billion in healthcare costs. The healthy food model would prevent 3.28 million CVD cases and 620,000 CVD deaths, prevent 120,000 diabetes cases, and save $100 billion in healthcare costs.

However, the net cost of the first model—subsidies minus healthcare savings—would be $84 billion while the second would cost $111 billon. It would improve the quality of life, but at a price. It’s easy to get lost in big numbers so let’s bring it down to the individual. After deducting healthcare savings, it would cost $110 per person per year for the fruit and vegetable subsidy and $185 per person per year for the healthy foods model. Does that seem like a reasonable investment for a healthier life for everyone?

The unknowns are whether physicians would actually write the prescriptions for foods; they’re not known for their nutrition knowledge and have a tendency to look for a pharmaceutical solution. But I think that’s minor; the real unknown is whether people will actually buy healthier foods and eat them.

We’ll find out: $25 million has been set aside in the 2018 Farm Bill to run pilot programs. It will be years before we know the results, but it’s a start to see if the theoretical will meet the actual.


The Bottom Line

Using food to improve health and quality of life makes sense. Whether having insurance companies or government pay 30% for healthier foods will work, I’m not convinced. I get the reduction of CVD events and deaths that could potentially be saved and the reduction in healthcare costs, but I question the $100 billion price tag without a public health education program to go along with it. Maybe a better approach would be to invest in the public health education program to teach people and physicians how they can use food to be healthier.

But now you know how a healthier diet could affect your life. What are you prepared to do today?

        Dr. Chet

Reference: PLoS Med 16(3): e1002761. https://doi.org/10.1371/journal.pmed.1002761.

Drop and Give Me 41

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The study on firefighters, push-ups, and CVD was interesting—not only for the relationship between push-ups and CVD, but also for the other relationships between the number of push-ups and other variables. Here’s a summary:

As the number of push-ups increased:

  • Body mass index decreased
  • Systolic and diastolic blood pressure decreased
  • Blood sugar decreased
  • Total cholesterol, LDL-cholesterol, and triglycerides decreased
  • HDL-cholesterol increased

One more thing: age decreased as well. In other words, the men in the study who could do more push-ups were younger. Was that the real reason—they were younger so naturally they could do more push-ups? They accounted for age in the statistical analysis, so it doesn’t appear to be so.

Does this study show cause and effect? No, because it’s observational. What it shows is that the lifestyle of the subject is important in the development of CVD. The subjects who had the greatest reduced risk had the highest aerobic and strength fitness, which may be reflective of an overall healthy lifestyle. Because push-ups require no equipment, progress can be easily tracked in a physician’s office. That was the actual point of the study: a simple test that could be predictive of CVD among other factors.

Here’s my challenge to you. After you see how many you do as a baseline, work at doing push-ups every day until you can hit 41. If you can’t do one, start with knee push-ups, push-ups from an exercise ball or chair, or wall push-ups (stand more than an arm’s length from the wall). As you can get to 41 one way, move to the next more difficult type.

When you get to 41, send me an email saying you did it and I’ll send you a coupon code good for 30% off the Optimal Performance Program; Member and Insider discounts apply. I’ll take you at your word, no selfies and no videos. After all, the only person you would be cheating is yourself and your risk of heart disease. I know age doesn’t matter; one of my readers in his 80s can already do this challenge. All it takes is a little sweat equity. Check with your doctor and get started.

What are you prepared to do today?

        Dr. Chet

Reference: doi:10.1001/jamanetworkopen.2018.8341.

Push-Ups and CVD

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On Tuesday, I asked you to see how many push-ups you can do before you can’t do any more (if you’re fit enough with no real orthopedic issues). How did you do? I have torn biceps in both arms, but I managed to eke out 21. But you may be wondering why I asked you to do push-ups.

A study published in JAMA Online periodically tested a group of 1,500 firefighters between 21 and 66 in 2000 to 2007. They were given several tests including maximal exercise capacity, height, weight, blood pressure, blood glucose, and the number of push-ups they could do. They were tracked for 10 years.

Researchers divided the results into quintiles based on the number of push-ups. They found that as the number of push-ups increased, the rate of CVD decreased. While not all comparisons were statistically different, there was a definite pattern of benefit.

That wasn’t the only data that proved to be interesting in the study. I’ll finish it on Saturday, along with a challenge.

What are you prepared to do today?

        Dr. Chet

Reference: doi:10.1001/jamanetworkopen.2018.8341.