美國聯邦食品暨藥物管理局 (FDA) 4日核准一款糖尿病藥物Wegovy在美國販售,稱此藥可協助肥胖症患者進行長期減重;根據該藥物研究報告指出,使用Wegovy的試驗者平均減重15%,大約是34磅(15.3公斤)。 研究報告顯示,服用該藥物的受測者可在14個月內維持體重下滑,直到體重變化趨於穩定;至於服用安慰劑的對照組,受測者體重平均只減少2.5%,不超過六磅。 協助該藥物研究報告、路易維爾代謝與動脈粥狀硬化研究中心(Louisville Metabolic and Atherosclerosis Research Center)醫學主任貝斯(Harold Bays)表示:「市面上目前有的藥物只能幫助減重大約5%至10%,有時候甚至不到。」 全美罹患肥胖症的成人人口超過1億人,占比約三分之一;一般人若減重5%就能大幅改善行動力、高血壓、高血糖和膽固醇指數等健康問題;但貝斯表示,對肥胖症的患者來說,只減重5%是不夠的。 貝斯強調,比起一些初期用於治療肥胖症的藥物,Wegovy更加安全;Wegovy最常見的副作用包括腸胃不適、噁心、腹瀉和嘔吐,但這些症狀都會慢慢消退,但仍有5%的試驗者最終停止使用。 Wegovy對罹患特定甲狀腺瘤的患者具有潛在風險,因此不建議家族有甲狀腺瘤或內分泌瘤病史的人使用;此外,該藥物也會增加憂鬱症和胰臟發炎的風險。 Wegovy由丹麥藥廠諾和諾德(Novo Nordisk)研發,是一種用來抑制食慾的腸道激素,比另一款糖尿病用藥semaglutide的劑量還高;糖尿病患者每周使用一次Wegovy,並搭配飲食調整和運動達到減重的效果。 諾和諾德還未公布Wegovy的定價,但據稱和另一款減肥藥Saxenda的價格不相上下;Saxenda為每日注射,如果使用者沒有保險,一個月的費用在1300美元以上。(約39000元新台幣) 休士頓衛理公會醫院集團(Houston Methodist Hospitals)糖尿病首席醫師薩度(Archana Sadhu)表示,Wegovy的成效將取決於定價,因為有時候健保並不給付減肥藥物,定價太高恐怕使需要的人無法獲得。 以上文章內容摘自世界新聞網。www.worldjournal.com/wj/story/121617/5512354 提醒大家,此藥品在台灣尚未通過TFDA核准。 以下是美國FDA發表的新聞稿: (該新聞稿網址: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014) FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014 Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. This under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014. The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater. “Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, M.D., deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.” Approximately 70% of American adults have obesity or overweight. Having obesity or overweight is a serious health issue associated with some leading causes of death, including heart disease, stroke and diabetes, and is linked to an increased risk of certain types of cancer. Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adult patients with obesity or overweight. Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The medication dose must be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects. Wegovy should not be used in combination with other semaglutide-containing products, other GLP-1 receptor agonists, or other products intended for weight loss, including prescription drugs, over-the-counter drugs, or herbal products. Wegovy has not been studied in patients with a history of pancreatitis. Wegovy’s safety and efficacy were studied in four 68-week trials. Three were randomized, double-blind, placebo-controlled trials (including 16 weeks of dose increases) and one was a double-blind, placebo-controlled, randomized withdrawal trial in which patients receiving Wegovy either continued with the treatment or switched to a placebo. More than 2,600 patients received Wegovy for up to 68 weeks in these four studies and more than 1,500 patients received placebo. The largest placebo-controlled trial enrolled adults without diabetes. The average age at the start of the trial was 46 years and 74% of patients were female. The average body weight was 231 pounds (105 kg) and average BMI was 38 kg/m2. Individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo. Another trial enrolled adults with type 2 diabetes. The average age was 55 years and 51% were female. The average body weight was 220 pounds (100 kg) and average BMI was 36 kg/m2. In this trial, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo. The most common side effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycemia (low blood sugar) in patients with type 2 diabetes, flatulence (gas buildup), gastroenteritis (an intestinal infection) and gastroesophageal reflux disease (a type of digestive disorder). The prescribing information for Wegovy contains a boxed warning to inform healthcare professionals and patients about the potential risk of thyroid C-cell tumors. 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 (MEN 2). Wegovy should not be used in patients with a history of severe allergic reactions to semaglutide or any of the other components of Wegovy. Patients should stop Wegovy immediately and seek medical help if a severe allergic reaction is suspected. Wegovy also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy (damage to the eye's retina), increased heart rate and suicidal behavior or thinking. Patients should discuss with their healthcare professional if they have symptoms of pancreatitis or gallstones. If Wegovy is used with insulin or a substance that causes insulin secretion, patients should speak to their health care provider about potentially lowering the dose of insulin or the insulin-inducing drug to reduce the risk of low blood sugar. Healthcare providers should monitor patients with kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts. The FDA granted the approval to Novo Nordisk. Semaglutide 1 mg injection (Ozempic) was first approved as a treatment for type 2 diabetes in 2017. Related Information NIH: Overweight & Obesity Statistics ### The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 有關該藥品的詳細說明,僅供專業醫療人員閱覽,恕不對外開放。 此文合乎著作權法第50條規定:「以中央或地方機關或公法人之名義公開發表之著作,在合理範圍內,得重製、公開播送或公開傳輸。」
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