Dr. Ahmed On March 8th, 2024, the FDA approved Wegovy for preventing cardiovascular diseases in obese and overweight individuals without Diabetes.
The FDA approval was based on the SELECT Clinical Trial conducted and published in NEJM in 2023.
Here are the important key points of the Study:
Title: Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes [Ref]
Total number of patients enrolled: 17609 (8803 in the Wegovy group and 8801 in the Placebo group)
Patients’ Selection:
- Overweight or Obese with a BMI of 27 kg/m2 or more
- Age: 45 years or more
- Preexisting cardiovascular disease: Yes
- Diabetes: No
Treatment Period: 34.2 +/- 13.7 months
Follow up: 39.8 +/- 9.4 months
Primary Outcome: A composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke
Results: Primary Outcome occurred in 569 of the 8803 patients (6.5%) in the semaglutide group and 701 of the 8801 patients (8.0%) in the placebo group (hazard ratio, 0.80; 95% confidence interval, 0.72 to 0.90; P<0.001).
Adverse events: Side effects resulting in permanent discontinuation of the treatment occurred in 1461 patients (16.6%) in the semaglutide group and 718 patients (8.2%) in the placebo group (P<0.001).
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Highlights of FDA News Release: Dated 8th March, 2024
- The 2.4 mg injection of semaglutide, Wegovy, has received FDA approval as a mode of treatment for lowering the risks of CVD in adults who are obese or overweight and have been diagnosed with heart disease.
- This drug was previously used for weight loss but now it can be utilised to reduce chances of major heart-related events like strokes or MI.
- However, they have also recommended its use alongside a low-calorie diet and more physical activity.
- Over 17,000 subjects were involved in a study that led to the approval of semaglutide and none of them had diabetes but they were at risk for it.
- Conclusively, subjects receiving semaglutide experienced a 20% decrease in heart conditions compared to the placebo. Nevertheless, people did face some GIT side effects.
“Wegovy Reduces Major Cardiovascular Events by 20%”
Semaglutide belongs to the GLP-1 receptor agonists class of drugs and it contains the potential of mimicking the nature of a natural hormone in the human body.
These GLP-1 hormones serve to normalize and regulate blood sugar levels and appetite.
After the receptors are activated, semaglutide takes charge and promotes weight loss by controlling blood sugar.
For these reasons, semaglutide was approved for extreme weight management in adults. FDA officially announced it in July 2021. Since then, this drug has been repeatedly used to manage obesity and overweight issues in patients.
However, since science is consistently advancing, the use of semaglutide has gone beyond just weight management.
Obesity or weight gain has been labeled as a risk factor for several issues like dyslipidemia, insulin resistance, and diabetes, which all turn out to be a risk factor for CVDs. [ref]
On 8th March 2024, the FDA announced that the Wegovy injection had been approved for lowering risks of cardiovascular death, stroke, and heart attack in overweight or obese adults with CVD. [ref]
John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research has stated that
“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,”
which shows the efficiency of this drug in treating multiple conditions.
Furthermore, he added
“This patient population has a higher risk of cardiovascular death, heart attack, and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
while addressing the Wegovy SELECT trial.
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The SELECT Trial: The Basis of Wegovy FDA Approval for Preventing Heart Diseases:
The SELECT clinical trial included 17,605 participants aged 45 or above. The subjects were overweight but not diabetic and split into two groups.
One group received semaglutide and the other received a placebo. The research lasted 3 years and the results were promising.
Results showed that those who took semaglutide had fewer heart-related problems like heart attacks and strokes compared to those who took the placebo.
6.5% of semaglutide subjects had cardiovascular events compared to 8.0% in the placebo group.
However, subjects from the semaglutide group faced more side effects which led to them leaving the trial in the middle.
In the SELECT trial, semaglutide results tell us that giving Wegovy once a week is better than a placebo at lowering the risk of heart-related issues in overweight people with heart disease who do not have diabetes.
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How Does Obesity Affect the Heart?
First of all, carrying excess weight strains the heart and increases the effort required for it to pump blood throughout the body.
This can cause high blood pressure, which is a significant risk factor for CHD.
Furthermore, obesity is always coupled with unhealthy lifestyle habits. This includes both poor dietary patterns and bad physical activity.
Then these conditions lead to high cholesterol and diabetes which are risk factors for CHD.
Furthermore, excess body fat, particularly around the waist, can trigger inflammation in the body.
Chronic inflammation can damage the arteries, causing plaque to build up, narrowing them, and restricting blood flow to the heart.
The narrowing of the arteries, known as atherosclerosis, is a characteristic of CHD.
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Wegovy is not a “Miracle” Drug, a Healthy Lifestyle is!
Medications do miracles (often for Pharma companies and rarely for the patients).
A healthy lifestyle including aerobic exercise and a low-calorie diet with lots of fiber is probably superior to Wegovy.
When you adopt a healthy lifestyle you cut your chances of developing CVD by multiple times. Start eating a low-fat, high-fiber diet with fresh fruits, veggies, and whole grains.
Restrict salt intake to less than 6g daily to maintain a healthy blood pressure. Moreover, avoid foods rich in saturated fats and never indulge in junk foods.
Eating healthy and exercising regularly helps you stay fit and lowers the chances of high blood pressure.
Try activities like walking, swimming, or dancing to make your heart stronger, improve blood flow, and lower bad cholesterol.
Importantly, quitting smoking reduces the risk of atherosclerosis, a major cause of cardiovascular disease.
Lastly, maintain good blood pressure by practicing healthy habits. Take meds if you need them for this.
Try achieving a 135/85 mmHg BP and consult your physician if your condition is deteriorating immediately.
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