Sitagliptin

来自慕尼黑工业大学等机构的科学家们通过研究发现，抗肥胖药物司美格鲁肽（semaglutide）和替西帕肽（tirzepatide）不仅能有效减轻体重，还能显著降低心力衰竭患者住院或死亡的风险。 在当今快节奏的生活里，肥胖和 2 型糖尿病早已成为席卷全球的 “健康杀手”——世界卫生组织（WHO）数据显示，全球约 4.63 亿成年人受糖尿病困扰，其中 90% 以上是 2 型糖尿病；与此同时，全球 13% 的成年人存在肥胖问题。更可怕的是，这两种疾病还会 “联手” 推高心力衰竭（心衰）风险，而心衰正是全球住院的主要原因之一，尤其是在肥胖和 2 型糖尿病患者中，心衰发病率更是显著高于普通人群。 近日，慕尼黑工业大学等机构的研究团队在《JAMA》发表重磅研究，给这类患者带来了突破性好消息：常用于减肥的药物司美格鲁肽（semaglutide） 和替西帕肽（tirzepatide） ，不仅能帮人减重，还能大幅降低射血分数保留的心力衰竭（HFpEF）患者的住院或死亡风险，近 10 万名患者的医疗数据更是为这一结论提供了迄今为止最有力的证据支持。 心力衰竭并非单一疾病，而是一种复杂的临床综合征，核心问题是心脏无法有效泵血满足身体需求，主要分为两种类型：射血分数降低的心力衰竭（HFrEF，心脏收缩功能下降）和射血分数保留的心力衰竭（HFpEF，心脏舒张功能异常）。其中 HFpEF 在肥胖和 2 型糖尿病患者中尤为常见，全球受其影响的人群超过 3000 万。虽然 HFpEF 患者的心脏泵血分数看似正常，但心肌会变得僵硬，无法正常舒张充盈血液，长此以往会导致心脏功能逐渐恶化。令人棘手的是，目前针对 HFpEF 的有效治疗方案少之又少，寻找新疗法已成为临床亟待解决的难题。 为了验证司美格鲁肽和替西帕肽对 HFpEF 的疗效，研究团队设计了五组队列研究，分析了 2018 年至 2024 年美国国家医疗索赔数据，覆盖近 10 万名患者。研究首先复刻了两项经典试验——STEP-HFpEF（验证司美格鲁肽）和 SUMMIT（验证替西帕肽）的设计，确保结果的一致性；随后扩大入选标准，纳入更多临床中常规接受治疗的患者，甚至还进行了两种药物的 “头对头” 比较。研究的核心终点是 “心力衰竭住院或全因死亡” 的复合指标，这也是评估心衰治疗效果最关键的指标之一。 结果令人惊喜：与安慰剂（西格列汀，一种常用降糖药）相比，司美格鲁肽能使 HFpEF 患者的主要终点风险降低 42%（风险比 HR=0.58，95% 置信区间 CI=0.51-0.65），替西帕肽的效果更显著，风险直接下降 58%（HR=0.42，CI=0.31-0.57）。不过在两种药物的直接对比中，替西帕肽并未展现出显著优势（HR=0.86，CI=0.70-1.06），说明两者在护心效果上旗鼓相当。更让人放心的是，研究还进行了负向对照、次要终点分析、亚组分析和敏感性分析，所有结果均一致，且未发现两种药物存在显著增加的安全性风险，这意味着它们在带来护心益处的同时，不会额外增加健康隐患。 这项研究的亮点不仅在于 “规模大”，更在于对临床实践的直接指导意义。以往的小型临床试验虽已暗示这两种药物可能对心衰有益，但此次近 10 万患者的真实世界数据，不仅验证了早期试验的结论，还证明它们在更广泛的患者群体中同样有效——无论是不同年龄、性别，还是是否合并其他基础疾病的 HFpEF 患者，都能从这两种药物中获益。研究人员表示，这些结果为用减肥药物治疗 HFpEF 提供了坚实的证据基础，尤其对肥胖和 2 型糖尿病相关的 HFpEF 患者来说，这两种药物带来的保护作用明确且可靠。 更值得关注的是，这项研究还凸显了 “数据驱动药物审批” 的重要性。与传统临床试验相比，基于大规模真实世界医疗数据的研究，能更全面地反映药物在实际临床场景中的效果和安全性，避免了传统试验中 “严格入选标准” 带来的局限性，让研究结论更贴近日常医疗实践。对于全球数千万 HFpEF 患者而言，这一发现无疑打开了新的治疗大门——未来，医生或许可以更放心地用这些既能减重又能护心的药物，为患者制定 “一举两得” 的治疗方案，既改善代谢问题，又守护心脏健康。（生物谷Bioon.com） 参考文献： Nils Krüger, MD1,2,3,4; Sebastian Schneeweiss, MD, ScD1,2; Kenshiro Fuse, MD, MPH1,2et al. Semaglutide and Tirzepatide in Patients With Heart Failure With Preserved Ejection Fraction, JAMA (2025). DOI:10.1001/jama.2025.14092

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.