Exciting News: On March 08, 2024, the U.S. Food and Drug Administration (FDA) gave the green light for Wegovy (semaglutide) injection to be used to lower the chances of heart-related death, heart attack, and stroke in adults with heart disease who are obese or overweight. It’s recommended to use Wegovy alongside eating fewer calories and being more active.
Wegovy is now the first medication for weight loss that’s also approved to help prevent life-threatening heart problems in adults with heart disease and obesity or overweight. Heart disease includes problems with the heart and blood vessels. Obesity and being overweight are serious health concerns that raise the chances of early death and various health issues, like heart attacks and strokes.
Study Insights:
- The effectiveness and safety of Wegovy for this new use were tested in a large study involving multiple countries and centers.
- The study was double-blind, meaning neither the participants nor the researchers knew who received the medication or the placebo.
- In the study, more than 17,600 people were randomly chosen to either get Wegovy or a placebo.
- Both groups of participants were also given standard-of-care medical treatment (e.g., controlling blood pressure and cholesterol levels) and advice on living a healthy lifestyle (including diet and physical activity).
- Wegovy greatly lowered the chance of serious heart problems like heart attacks, strokes, and even death from heart issues.
- Out of the people who took Wegovy, 6.5% had major heart issues, while 8% of those who took a placebo experienced the same.
Safety Profile:
Some of the most frequently experienced side effects of Wegovy (semaglutide) include:
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Abdominal (stomach) pain
- Headache
- Fatigue
- Dyspepsia (indigestion)
- Dizziness
- Abdominal distension
- Gas buildup
- Heartburn
- Eructation (belching)
- Low blood sugar in patients with diabetes
Boxed Warnings:
Due to the risk of thyroid C-cell tumors, Wegovy should not be used in people with a history of thyroid cancer or a rare condition called Multiple Endocrine Neoplasia syndrome type 2.
Do not use Wegovy if you’ve had a severe allergic reaction to semaglutide or any ingredients. Stop using Wegovy and get medical help if you suspect a severe allergic reaction.
Conclusion:
The FDA’s approval of the first treatment to reduce the risk of serious heart problems specifically in adults with obesity or overweight represents a significant advancement in cardiovascular care. With its demonstrated efficacy and favorable safety profile, this medication offers new opportunities for improving heart health and reducing cardiovascular risk in this high-risk population. Healthcare providers and patients alike can now explore this promising treatment option with confidence, knowing that it has been rigorously evaluated and approved to address weight-related heart concerns.
Reference:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or
