Tag Archive for: CVD

Cost vs. Benefit for Saturated Fat

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In Tuesday’s Memo, I suggested that I don’t like speaking in absolutes when it comes to health recommendations; I’ve seen too many exceptions. What about our Michigan cardiologist? Was he correct? Yes and no, but mostly no.

He implied in the interview that the source of saturated fat is animal products. That isn’t true. In fact, someone could be a vegan and still over-consume saturated fats from using vegetable oils. Palm oil, vegetable oil, even almonds and other nuts that contain monounsaturated and polyunsaturated oils also contain saturated fats. My point is that even without any animal products such as cheese or milk, you can still get a lot of saturated fat in a vegan diet.

He was also overstating the positive effects of lowering saturated fat intake. I read the abstract; it said that it would take 56 people lowering their saturated fat intake for two years to prevent a single cardiac event. Further, the review did not show any reduction in mortality. To me, it raised a lot of questions that may have been answered but not reported.

Should we lower our saturated fat intake? Probably, but it’s going to take a lot more answers to swing the cost to benefit ratio in favor of giving up animal products for the potential benefits we may get.

What are you prepared to do today?

        Dr. Chet

Reference: Cochrane Library. https://doi.org/10.1002/14651858.CD011737.pub2

“Give Up Meat or Else!”

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“Animal Foods Conclusively Cause Heart Disease!” was the title in my news feed that attracted my attention. I had to check it out, because I’m not a fan of absolute statements in the health field; too often, some facts have to be ignored to make definitive statements such as that true. Was this any different?

A cardiologist from Michigan was interviewed in response to a recently published paper in the Cochrane Review. The review updated the information related to saturated fat intake and the rate of cardiovascular disease and mortality. After reading the paper, that’s the response the doctor gave to an interviewer from the Plant Based News. He suggested that the review conclusively shows that reducing saturated fat intake will result in a 21% decrease in CVD events. The implication is that most saturated fat comes from animal products: if we really buckle down and reduce our saturated fat consumption more, we can reduce events even further.

He makes the connection between animal products and saturated fat. But is that correct? It would mean that vegans, who consume no animal products, are protected from cardiovascular disease. Is that true? I’ll let you know on Thursday

What are you prepared to do today?

        Dr. Chet

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.

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