Posted on 03/08/2024 6:13:51 PM PST by nickcarraway
— New indication for patients with obesity or overweight and a history of cardiovascular disease by , Senior Staff Writer, MedPage Today
The FDA approved semaglutide (Wegovy)opens in a new tab or window to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight, the agency announced on Friday.
A GLP-1 receptor agonist, semaglutide should be used in conjunction with a reduced calorie diet and increased physical activity, according to the FDA.
"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," John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity at FDA's Center for Drug Evaluation and Research, said in a statement. "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," Sharretts added.
Underpinning the approval was the 17,600-patient SELECT trialopens in a new tab or window, which included patients with overweight and obesity (with or without diabetes) as well as pre-existing cardiovascular disease.
The phase III study showed that semaglutide significantly reduced the composite of cardiovascular death, heart attack, and stroke by 20% (HR 0.80, 95% CI 0.72-0.90). In the 3-year study, where both groups received standard-of-care medical treatment, these major adverse cardiac events occurred in 6.5% of patients on semaglutide and 8% of those on placebo.
"Semaglutide 2.4 mg is the first weight management therapy proven in a rigorous randomized trial to reduce the risk of cardiovascular events, which establishes overweight or obesity as a modifiable risk factor for cardiovascular disease," said study investigator A. Michael Lincoff, MD, of the Cleveland Clinic, when the data were presented at the American Heart Association annual meetingopens in a new tab or window last year.
FDA noted that the GLP-1 receptor agonist should not be used with other agents in the class, or with other semaglutide-containing products.
Wegovy was first approvedopens in a new tab or window in June 2021 for chronic weight management in adults with obesity (BMI of 30 or greater) or for adults with overweight (BMI 27 or greater) with at least one weight-related condition. This indication was later expanded to include childrenopens in a new tab or window with obesity ages 12 and up. Semaglutide is also approved for type 2 diabetes as an injectable (Ozempicopens in a new tab or window) and oral drug (Rybelsus)opens in a new tab or window.
Consistent with the GLP-1 agonist class, common side effects with semaglutide include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with diabetes, flatulence, and gastroesophageal reflux disease.
Other warnings and precautions in the labeling include pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy, increased heart rate, and suicidal behavior or thinking.
"The prescribing information for Wegovy contains a boxed warning to inform healthcare professionals and patients about the risk of thyroid C-cell tumors," the agency noted. "Because of this risk, Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2."
Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.
I doubt very much the drug itself reduces risks. I suggest that the drug inhibits impulses and actions that increase risk. At least that’s what I told my cardiologist when he suggested it can help.
As long as I can maintain my Oreo and Twinkie diet with reduced activity, I’m all in on these drugs helping me.
Demand is already off the charts.A few years ago a doctor at a major Boston hospital recommended it to me for diabetes. She described it as “a miracle drug” (her exact words). In 20 years working at a world famous hospital I never heard a physician or surgeon use the word “miracle” until then.
I agree. But it seems like a wonder drug for addiction.
Glucagon Like Peptide (GLP-1) agonist. Shrinks your stomach. Kicks your pancreas into overdrive. Some how effects your satiety in your brain, how satisfied you are, and makes you not hungry. I mean 3 days with no solid food and you realize you haven’t even wanted to eat. The best diet is the one where you dont eat anythting. This is that diet. But it has some side effects. Gut cramps so bad. Knock the wind out of you for a half hour. I stopped using all my GLP-1 agonists in December and I still get a gut punch about 2 times a week. It could just go away and I won’t miss it.
Another issue: People lose muscle as well as fat.
But...for the diabetic/severely overweight who will NOT change how they eat, it might be helpful.
I went from 185 to 160 in short order. Yes you lose just as much muscle as fat and I noticed it in my body. Everyone else thinks I look good and can tell I’ve lost weight, but I know I am weaker because of it.
It definitely will change the way folks eat only not how they think. Once your stomach get shrunken down to 1/4 of its normal size, You cannot eat anything more than a very small portion of anything, chips, ice cream, steak, or you are gonna be throwing up harder than you have ever thrown up in your life. Your portions have to get smaller or you will vomit your guts out because thats all the bigger your stomach is now.
One of the other main side effects is diarrhea. Thank God I didnt experience any of that. I am sure it would be somehow in the extreme.
Not a big fan. NOT RECOMMENDED!
Physical 2 days ago. 162lbs. I aint dead yet!
Eating food fit for human consumption instead of engineered addictive Frankenfoods would fix this, without the need for toxic Pharma concoctions.
Friend was just on it for about 5 months and stopped due to pancreatitis. Now five months later he has been diagnosed with pancreatic cancer. Strange thing is aside from the pain no other symptoms , no weight loss , jaundice, bloating , and its still working fine as he goes to the bathroom regular and no insulin issues etc. Personally staying far away from it.
I’m on it. I plan to die soon.
Hey, that’s a form of a diet, right?
Yep - it’s likely that reducing calories and increasing activity does more for one than the drug - and with less side effects...
The day isn't over.
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