Tag Archive for: CVD

Research Update on Prescription Fish Oil

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Let’s begin by taking a look at the prescription fish oil supplement medication. To review, this is a 100%-EPA fish oil that received FDA approval in December of 2019. The amount prescribed for people with high triglycerides is four grams of highly processed fish oil per day. Data from the REDUCE-IT trial suggested that there was a 25% decrease in mortality in the experimental group compared with the control group.

The current trial was called the EVAPORATE trial: Effect of Vascepa on Improving Coronary Atherosclerosis in People with High Triglycerides Taking Statin Therapy. The study began with 80 men and women, ages 30-85, with greater than 20% blockage in at least one of their coronary arteries, elevated triglycerides, and taking statin therapy; 68 subjects completed the 18-month study. The primary endpoint was to see if there was any reduction in plaque buildup in the coronary arteries.

The subjects in the prescription fish oil group saw a 17% decrease in overall arterial plaque; there was a plaque increase in the placebo group. The researchers did not track cardiovascular events or mortality in this study. We’ll take a look at the OTC fish oil supplement study on Saturday as well as determine the clinical significance of each trial.

What are you prepared to do today?

        Dr. Chet

References:
1. European Heart Journal (2020) 00, 1–8 doi:10.1093/eurheartj/ehaa652
2. https://doi.org/10.1016/j.mayocp.2020.08.034

Research Update: Fish Oil and Heart Disease

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The prescription fish oil Vascepa has been approved since December of last year. The fish oil medication was originally intended for those who had a family history of high triglycerides of 500 mg/dl or greater. In the approval process, the recommendation was lowered to those whose triglycerides were at least 150 mg/dl and who were taking a statin medication. But the research hasn’t stopped.

Research on Vascepa as well as over-the-counter (OTC) fish oil supplements continues. From the pharmaceutical perspective, more research on the use of the medication could result in an increase in the potential applications of this pharmaceutical. From the dietary supplement perspective, research may help establish the efficacy of using fish oil dietary supplements instead of the prescription medication

Last week within one day of each other, studies on prescription fish oil and fish oil supplements were published that both demonstrated significant benefits. We’ll review those studies the rest of the week and see if we can find out whether fish oil dietary supplements match up with pharmaceutical fish oil. If you want a preview of the studies, check the references below; they’re both open access.

What are you prepared to do today?

        Dr. Chet

References:
1. European Heart Journal (2020) 00, 1–8 doi:10.1093/eurheartj/ehaa652
2. https://doi.org/10.1016/j.mayocp.2020.08.034

The Health Benefits of Spices

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Continuing our look at the research study on the effect of spices on markers of inflammation, there were some interesting results. The high-fat, high-carbohydrate meal was coconut curry chicken, a cornbread muffin, and a biscuit; that strikes me as an odd meal, but you do what you must for research. The only difference was the spices added to allow for comparative results.

Examining the effect of the 1,000-calorie, high-fat, high-carbohydrate meal, the researchers found an increase in the release of inflammatory hormones above baseline in all subjects. So that’s the first result: inflammation was increased after eating the test meal with no spices added.

Compare that to consumption of the same meal with six grams of spice blend: it significantly reduced IL-1β secretion at four hours after the meal compared with the meal with none of the spice blend. Also, IL-6, IL-8, MCP-1, and TNF-α secretion after the meal containing six grams of the spice blend was below baseline values for each cytokine (inflammatory hormone). These results suggest that spice consumption may reduce inflammation after a high-fat, high-carbohydrate meal for hours after eating. The paper is Open Access, so you can read it yourself at the link in the references.

Those are interesting results, and I’m guessing you really would like to know which spices were used in the study. I’m going to give you that spice blend and put this research in context in Saturday’s memo. But if you haven’t done our little experiment with the teaspoon, half teaspoon, and eighth teaspoon, please do it before then.

What are you prepared to do today?

        Dr. Chet

Reference: J Nutr 2020;150:1600–1609.

Can Spices Make You Healthier?

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I’d like you to do something before you read the rest of this memo. Go to your drawer that contains measuring spoons, and pull out the teaspoon, half teaspoon, and eighth teaspoon. Then measure out salt or sugar for each different volume and put it on a plate. Notice how little there is by the time you get to the eighth teaspoon. Keep that image in your mind for the remainder of the week.

Too often, nutrition research lacks a practical approach; researchers try to drill down into the details before they look at the larger response to any intervention. In other words, examining what people actually eat and cook, then changing something and seeing what happens. I don’t mean exaggerated results such as weight loss, but more subtle effects such as changes in triglycerides, cholesterol, blood sugar, and in this case, markers of inflammation.

This week we’re going to take a look at a recently published paper that took exactly that approach. Researchers selected a group of 12 overweight male subjects with at least one additional risk factor for cardiovascular disease and fed them a high-fat, high-carbohydrate, 1,000-calorie meal. They fed them the same meal on three different days: once without any specific spice blend, second with two grams of a spice blend, and the third time with six grams of the same spice blend. They tested the subjects to see what markers of inflammation were changed after each feeding. I’ll give you the results in Thursday’s memo.

What are you prepared to do today?

        Dr. Chet

Reference: J Nutr 2020;150:1600–1609.

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.