Another new star in the field of hypoglycemia-Simeglutide "Indications for Weight Loss" was officially approved!

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On June 4, 2021, the US FDA official website announced that semaglutide (semaglutide, trade name Wegovy) injection (2.
4 mg, once a week) was officially approved for chronic weight management in obese or overweight adults
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Approved indications are: suitable for patients with body mass index (BMI) ≥27kg/m^2 and at least one weight-related disease (such as hypertension, type 2 diabetes or high cholesterol) or BMI≥30kg/m^2
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This is the first drug approved by the FDA for weight management in chronic obese or overweight adults since 2014
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Obesity is sweeping the world.
According to the World Health Organization (WHO), nearly 2 billion people are overweight or obese in the world.
From 1975 to 2016, the global obesity rate has nearly tripled.
Every year, overweight or obesity causes 2.
8 million deaths
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As far as China is concerned, the flow regulation research shows that the incidence of obesity in China has increased from 4.
2% in 1993 to 15.
7% in 2015, and the overall incidence of abdominal obesity has increased from 20.
2% to 46.
9%
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It needs to be clearly pointed out that obesity is a disease that not only causes inconvenience in life and decreased exercise capacity, but also has a greater harm in greatly increasing the risk of metabolic diseases and cardiovascular and cerebrovascular diseases
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In addition, studies have shown that obesity is associated with increased risk of dozens of cancers and decreased prognosis and survival rates
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The most effective way to lose weight is exercise + diet, but most people who lose weight find it difficult to stick to it.
Therefore, many people hope to achieve rapid weight loss through drugs.
However, the current weight loss drug market is either ineffective or negative.
Obviously
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 Smeglutide-the new star for the treatment of type 2 diabetes officially cross-border weight loss field.
Human glucagon-like peptide 1 (GLP-1) is a brain-gut peptide secreted by endocrine cells of the human ileum.
It is released from the intestine after a meal.
Released into the bloodstream, it can reduce hunger and increase satiety
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Simeglutide was initially approved for the treatment of type 2 diabetes.
The mechanism is that it can mimic the effects of GLP-1, reduce hunger, reduce diet, and reduce calorie intake, so it has an outstanding effect in weight loss
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 "The effect of weight loss is comparable to surgery.
" In four 68-week trials (STEP 1, STEP 2, STEP 3, STEP 4), researchers have explored the safety and effectiveness of smegaglutide for weight loss from different aspects.
Three of them are randomized, double-blind, placebo-controlled trials, and the other is a double-blind, placebo-controlled, randomized withdrawal trial
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A total of more than 2,600 patients received 68 weeks of drug treatment, and more than 1,500 patients received placebo treatment
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Among them, STEP1, 3, and 4 studies have shown that the application of smeglutide treatment for 68 weeks can reduce the weight of subjects by 15%-18%, and the safety is good
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The results of these studies are the main basis for the FDA to approve the drug's weight loss indications
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 Regarding the weight loss effect of such drugs, some experts describe: "The weight loss effect that can only be achieved by surgery before human beings is achieved through drugs for the first time
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" What issues should be paid attention to in drug dosage and combination medication? The FDA notice pointed out that the dosage of the drug should be gradually increased to 2.
4 mg per week during 16-20 weeks to reduce gastrointestinal side effects
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In terms of combination drugs, it should not be used in combination with other products containing smegaglutide, other GLP-1 receptor agonists or other products for weight loss (including prescription drugs, over-the-counter drugs or herbal products)
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 How safe is the drug? 1.
Common adverse reactions The most common adverse reactions of these drugs are nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, indigestion, dizziness, bloating, belching, hypoglycemia in patients with type 2 diabetes, gastrointestinal Flatulence (gas accumulation), gastroenteritis and gastroesophageal reflux disease
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Medication warnings include pancreatitis, gallbladder problems (including gallstones), hypoglycemia, acute kidney injury, diabetic retinopathy (damage to the retina of the eye), increased heart rate, and suicidal behavior
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 2.
Black box warning The prescription information of this type of drug contains a black box warning about "potential risk of thyroid c-cell tumor"
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 3.
The following patients are contraindicated in patients with personal or family history of medullary thyroid cancer, or patients with rare multiple endocrine neoplasia syndrome type 2 (MEN 2), such drugs are contraindicated
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People who are severely allergic to smeglutide or any component of the drug should stop immediately and seek medical help if a severe allergic reaction is suspected
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Reference materials: [1]https:// NEWS RELEASE.
FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014[EB/OL].
https:// 2021-6-4.