Ozempic : Wonder Drug for Heart Disease, Too?

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First it it was the wonder drug for Diabetes, then Obesity and now it’s Heart Disease. Semaglutide (the active ingredient in Ozempic and Wegovy) seems to have no limit to its talents. Yet, it helps to read the fine print and analyses from scientists not affiliated with the clinical trials.

MAIN POINTS

  • The recent SELECT trial claimed that Semaglutide reduced cardiovascular events by 20%;
  • The trial was funded by Novo Nordisk and all investigators were affiliates;
  • The absolute reduction in cardiovascular events due the drug was closer to 1%;
  • Lifestyle factors have made far greater impact on heart disease risk – for more than 3 decades.

Read on to get the full details or skip directly to the way of eating that reduces the risk of heart disease – as well as other chronic diseases like cancer and dementia – and also loses weight. Based on the old science and the new, it’s called the MMM! Anti-diet and you can read more about it here.

What The Trial Did & Didn’t Say

Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial.’ That’s what Novo Nordisk, makers of Ozempic (for diabetes) and Wegovy (for weight loss) said in the trial summary. (By the way, Semaglutide is a class of drug called a GLP-1 receptor agonist. It’s not the only one but is the best known.)

As is often the case when bold clinical trial claims are made, the warm feelings go cold when the data is put under the microscope, especially by people not involved in the trial.

Here is some of what’s been found:

  1. The SELECT trial protocol was designed by Novo Nordisk, and the trial was funded by that company and the full trial data are the property of Novo Nordisk and can remain confidential. Nothing unique here but each of the 20 investigators also has financial affiliations with Novo Nordisk (conflicts of interest) and four of them are employees of the company.

  2. The COI (Conflicts Of Interest) statement of just two investigators, Donna Ryan and John Deanfield, takes up about half a page (see bottom of press release). Even so, the New England Journal Of Medicine (NEJM), one of the oldest and most revered medical journals, was happy to publish the trial. (As you’ll see here, these days, 80% of clinical trials are industry-sponsored and journal editors don’t check trial details like they used to.)

  3. As its endpoint, the SELECT trial was using what are called MACE ( (Major Adverse Cardiovascular Events), which is far from precise. That’s because some MACE are subjective, for instance, the need for hospitalization or the need to insert stents. That means the term MACE includes ‘soft targets’ like these and ‘hard targets’ like heart attacks, strokes and deaths, without revealing how many of each.

  4. The 20% claimed reduction in heart disease deaths was relative (compared to the placebo group) rather than absolute (measured per 100 trialists) which inflates the result significantly (see how these numbers are calculated and used). If the absolute number is used instead, the reduction is closer to 1%, or almost nothing.

  5. ‘The trial was said to be ‘double blind’ which means that neither trial nor placebo group knew who was in which group. Yet, rapid weight loss is the hallmark of Semaglutide (which is why there are worldwide shortages of both Ozempic and Wegovy, as both are being taken ‘off-script’ for weight loss). In just a few weeks, it would have been obvious which participants were in which group, rendering the terms ‘double blind’, ‘trial’ and ‘placebo’ somewhat irrelevant;

  6. Semaglutide is an experimental drug, although its maker insists that it’s been prescribed for 7 years. That’s true but that’s in the dose for diabetes (Ozempic); the weight loss dose (Wegovy) has 240% more Semaglutide than Ozempic; not a trivial difference. As Paraselsus said back in the 1500s, the difference between a benign and harmful substance is just in the dose. Time will tell with Semaglutide.

SELECT Under the Microscope

Independent nutrition and obesity researcher Dr Zoe Harcombe put the SELECT trial under her exacting microscope. This is the summary of what she found:  

  1. ‘Deaths were not significantly different between the groups (narrative of main paper and Table 2).
  2. The supplementary appendix (Figure S5) reported that many sub group analyses failed to achieve statistical significance for the main outcome i.e., there were no differences in heart events (deaths, heart attacks and strokes) in many sub groups.
  3. There were no significant results for women.
  4. There were no significant results for those under 55 or aged 75 or over.
  5. There were no significant results for those with a BMI above 35.
  6. There were no significant results for strokes or peripheral arterial disease (PAD).
  7. There were no significant results for North American or other territories (only Europe/Asia had significant results).
  8. There were no significant results for Hispanic or Latino people.’

Ignorance or Amnesia?

Michael Lincoff is the SELECT trial’s lead author, and the Vice Chair for Research in Cardiovascular Medicine at the Cleveland Clinic. According to him, the back story for the SELECT trial is the forecast that more than half the world will be overweight or obese by 2035. He adds that obesity is clearly associated with an increased risk of cardiovascular complications, which others have also concluded.

Lincoff goes further to say: ‘Yet there’s been no lifestyle or drug intervention for overweight or obesity that’s been shown to reduce cardiovascular complications.’ This is an astonishing claim in light of 30-year-old trial results that showed the exact opposite: that diet had a major impact on hard targets – heart attacks – not the softer more-encompassing ‘major adverse cardiovascular events’ used in the SELECT trial.

..subjects following the Mediterranean-style diet had a 50% to 70% lower risk of recurrent heart disease.’

Lyon Diet Heart Study

The French Were First

The Lyon Diet Heart Study showed clearly that a modified Mediterranean Diet reduced heart attacks by up to 70%, in a population who had already suffered one or more attacks. And that was an absolute number not a relative one. So, what does that say about the lead author of SELECT and the Chair for Research at one of the most famous heart clinics in the world? Could he be unaware of this iconic heart disease research?

And what about the Keto Diet?

People on low-cab regimes like this can lose similarly vast amounts of weight (30 to 40 kilos) as can people on Semaglutide. Many on the Keto Diet also reverse Metabolic Syndrome and Type 2 Diabetes, both risk factors for heart disease. This diet approach isn’t new and doesn’t have adverse side effects like Semaglutide. It’s really simple, too: just about any diet based on whole foods (cutting out sugar, junk food and ultra-processed foods) will lose weight and improve cardiovascular health. Regular exercise can add to the benefits of diet. This isn’t rocket science.

During the 34 months of the SELECT trial, participants definitely lost weight: the trial group lost an average 9.4% of body weight, yet the MACE results were less remarkable. In the trial group there were 2,941 events versus 3,204 in the placebo group. The difference in cardiac deaths (the ultimate hard target you might say) did not reach statistical significance. No wonder Peter Attia, who helps patients to live healthier for longer, not just live longer, spans, said the results of this trial fall far short of miraculous.’

Attia’s view is this: if obesity is a risk for heart disease then, of course, losing weight will reduce that risk. The sleight of hand is that Novo Nordisk recorded two outcomes – weight loss AND reduced heart disease risk – when there was only one. As Attia said they just: ‘simply counted the one effect twice‘.

...a once-weekly injection that can independently improve glycemic control, reduce body weight, and lower cardiovascular risk would indeed be a miracle drug. But …we’ve simply counted one effect twice.

Dr Peter Attia

A Pill for Every Ill

When it comes to health in the modern day, there seem to be two types of people: those who take control and action, and those who do nothing and, instead, take a drug. The bigger problem is that modern medicine says the latter is just fine: keep eating rubbish and sitting on your butt. If you inject this drug, all will be fine.

You have to wonder how highly-trained, intelligent doctors can convince themselves of this, when you consider the long-term effects of this lifestyle. In fact, even some short-term effects are mighty unpalatable. Who knows what the long-term ones will be.

Serious Adverse Events

Semaglutide comes with side effects from the unpleasant to the life-threatening. Nausea, vomiting and diarrhea are pretty tame compared to blocked intestines or ‘gastroporesis’ which has sparked a spate of law suits against makers of semaglutide-based drugs. When it comes to side effects, 1,461 out of 8,803, or one in six of the semaglutide group, dropped out because they couldn’t tolerate them.

Whether it’s because of side effects, the cost (in countries without government subsidies) or lack of supply (due to the huge demand for weight loss drugs), giving up semaglutide has a serious downside: the weight comes straight back on – but it’s even worse than that. Almost half the weight loss is muscle so, when the weight piles back on, it’s fat because these people have done nothing to build muscle. This is a serious double whammy we’re sure to see play out in years to come.

A Kinder Way

The good news is that diet does work in reducing heart disease risk. We’ve known for 30 years that a Mediterranean Diet can do that – to the tune of 70%. These days we know that, with a few extras, The Med Diet can delay dementia and protect against cancer. It can also lose weight.

Get all the science explained along with shortcuts and recipes to cook scrumptious weight-losing, disease-fighting food in our eBook ‘MMM! Lose Weight The Food Lover’s Way’. See what inside, below.

Lose Weight

MMM! LOSE WEIGHT THE FOOD LOVER’S WAY

Discover The Muscles & Marbles Mediterranean Anti-diet

  

Kim Brebach

Kim Brebach

Hi, I’m Kim Brebach, boomer, information researcher, technical writer and Joiner of Dots at M&M. In my spare time, I review wines and love to cook.

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