What is the most important information I should know about Wegovy®?
Wegovy® may cause serious side effects, including:
Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people Do not use Wegovy® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Do not use Wegovy® if:
you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy®
Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you:
have or have had problems with your pancreas or kidneys have type 2 diabetes and a history of diabetic retinopathy have or have had depression, suicidal thoughts, or mental health issues are pregnant or plan to become pregnant. Wegovy® may harm your unborn baby. You should stop using Wegovy® 2 months before you plan to become pregnant are breastfeeding or plan to breastfeed. It is not known if Wegovy® passes into your breast milk
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
What are the possible side effects of Wegovy®?
Wegovy® may cause serious side effects, including:
inflammation of your pancreas (pancreatitis). Stop using Wegovy® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back gallbladder problems. Wegovy® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration serious allergic reactions. Stop using Wegovy® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy® increased heart rate. Wegovy® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you
The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.
2023年11月11日，诺和诺德在AHA会议上公布司美格鲁肽2.4mg剂量心血管获益三期临床SELECT最新数据，数据同步发表在新英格兰医学期刊（NEJM）上。
SELECT入组17604例有既往心血管疾病肥胖/超重患者，随机分配接受司美格鲁肽或安慰剂治疗。司美格鲁肽组569例心血管死亡或非致病性stroke事件，对照组701例，心血管风险降低20%。
NEJM文章发布了更详细的数据分析。
患者基线数据如下。
心血管获益从研究开始很快就显现，因此认为心血管获益不仅仅是因为体重减轻的附带劫夺。心血管风险整体降低15%，心血管死亡风险降低15%，心衰复合终点风险降低18%，全因死亡风险降低19%。
支持性次要终点数据，非致命心梗风险降低28%，心衰住院或急诊率降低21%等。
今年可谓司美格鲁肽的爆发之年，减肥药供不应求一再扩大产能，CKD疗效优异提前终止三期临床，心血管获益大规模三期临床大获成功等。
总结诺和诺德基于对代谢疾病深刻理解，聚焦司美格鲁肽的多适应症开发，围绕肝脏、脑、肠道、胰脏，逐一将多个大适应症收入囊中。今年前三季度，司美格鲁肽大卖120亿美元，预计全年超过200亿美元。此次MACE三期临床的成功，意味着司美格鲁肽坐实心血管获益效果，为其长期增长再添助力。
Important Safety Information
What is the most important information I should know about Wegovy®?Wegovy® may cause serious side effects, including:
Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people Do not use Wegovy® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)Do not use Wegovy® if:
you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy®Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you:
have or have had problems with your pancreas or kidneys have type 2 diabetes and a history of diabetic retinopathy have or have had depression, suicidal thoughts, or mental health issues are pregnant or plan to become pregnant. Wegovy® may harm your unborn baby. You should stop using Wegovy® 2 months before you plan to become pregnant are breastfeeding or plan to breastfeed. It is not known if Wegovy® passes into your breast milkTell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
What are the possible side effects of Wegovy®?Wegovy® may cause serious side effects, including:
inflammation of your pancreas (pancreatitis). Stop using Wegovy® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back gallbladder problems. Wegovy® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration serious allergic reactions. Stop using Wegovy® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy® increased heart rate. Wegovy® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry youThe most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.
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