Tag Archive for: statin

Will the Polypill Reduce Second Heart Attacks?

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One of the issues with prevention is having people stick to a plan, even after an event as serious as a heart attack. Lifestyle changes are challenging to stick with, but so is something as simple as taking medications. Remember, this isn’t to prevent a heart attack; it’s to prevent a second one. That’s serious.

The concept of a polypill has been around for close to 15 years. The idea was to put medications together in one pill as a preventive that would reduce the risk of getting cardiovascular disease. For a long time, that idea never went anywhere, but recently researchers decided to resurrect the concept. This time, the objective was to monitor subjects with recent heart attacks. Would there be a difference in the rate of secondary events between subjects who took the polypill and those who took the same medications as individual pills? The medications used were aspirin, ace-inhibitor, and a statin. After three years of follow-up, the subjects in the polypill experienced significantly fewer secondary events, 9.5% versus 12.7%.

Can you figure out why the subjects who took the polypill did better than the subjects who took the same medications individually? I’ll tell you the secret to disease prevention on Saturday.

What are you prepared to do today?

        Dr. Chet

Reference: NEJM. 2022. DOI: 10.1056/NEJMoa2208275

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.

The Bottom Line on the 2018 Cholesterol Guidelines

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In Thursday’s Memo, I talked about the 2018 Cholesterol Guidelines and evidence-based medicine, focusing on the physician side of the treatment discussion. But I believe that’s not the most important part of the discussion; I think the critical part is the patient side. Here’s why.

The Cholesterol Guidelines focus on lifestyle changes first: a healthier diet, exercise, quitting smoking, and weight loss. That’s supposed to be the initial part of the potential treatment plan—lifestyle first. In other words, what will the patients do for themselves before the discussion leads to medications, especially statins?

The guidelines aggressively focus on the use of statins and other medications to get the LDL-cholesterol to desirable levels, so we have a dilemma during the discussion of a treatment plan. Do the physicians assume, based on experience, that the patients won’t do what they’re supposed to do to lower their risk of CVD and immediately prescribe medications? Or do the patients take the lifestyle route seriously and do what’s necessary to change their health?

To be blunt, we patients haven’t done our part. We lose weight and gain it back. We start to eat healthier and don’t sustain it. We start to exercise, but we let life get in the way and stop, or we push too hard and get injured and stop, or the weather turns colder or hotter and we stop. When we agree to change our health habits and then don’t follow through, we make our health issues worse—they’re still in there eating away at our lifespan and not being treated.

Don’t make promises you know you won’t keep; notice I didn’t say can’t keep, I said won’t keep. If you know in your heart you’ll never change your diet or keep up with exercise, the best thing you can do for your health is don’t delay: start taking the meds and start taking care of the problem.

Although I disagree with it, I get why physicians jump to meds. There’s only one way to change that: we have to prove them wrong when they assume we won’t stick to a healthier lifestyle.

The Bottom Line

The 2018 Cholesterol Guidelines put the responsibility for lowering the risk of CVD without medications in our hands—the patients. Work out a timeline with some concrete goals for each lifestyle area with your physician. It won’t be easy: regular exercise for life, eating better from now on, quitting smoking, plus getting to a normal weight and staying there will all take time and consistent effort. That’s okay because even if your risk of CVD is high, it doesn’t mean you drop dead tomorrow. Even if you fall into an at-risk scenario, I know you can do it. There are many tools to help you keep at it: an app, a workout buddy, a Facebook group, and more.

Instead of looking at your health challenge as an obstacle, look at it as an opportunity for better health. If you say you don’t want to take medications, this is your chance to prove whether you really mean it. I can’t guarantee you’ll never need the meds, but you can work your way down to a smaller dosage with fewer side effects.

It all depends on your answer to one question: what are you prepared to do today?

Dr. Chet

 

Reference: www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000000625.