Sotagliflozin

Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape. LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Chronic Heart Failure Market Report According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023. Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period. As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases. Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum. Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient. Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors, Farxiga is the leading prescribed SGLT2 inhibitor globally by volume Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others. In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU. In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024. In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines. AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025. Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report Chronic Heart Failure Overview Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development. The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities. Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications. Chronic Heart Failure Epidemiology Segmentation The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Heart Failure Gender-specific Cases of Heart Failure Ejection Fraction-specific Cases of Heart Failure New York Heart Association (NYHA) Class-specific Cases of Heart Failure Type-specific Cases of Heart Failure Age-specific Cases of Heart Failure Chronic Heart Failure Treatment Market Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition. Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly. However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position. SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments. To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management Chronic Heart Failure Pipeline Therapies and Key Companies Omecamtiv Mecarbil: Cytokinetics KERENDIA (finerenone): Bayer Tirzepatide (LY3298176): Eli Lilly and Company CardiAMP Cell Therapy: BioCardia Ziltivekimab (NN6018): Novo Nordisk REVASCOR (rexlemestrocel-L): Mesoblast Levosimendan (TNX-103): Tenax Therapeutics Semaglutide: Novo Nordisk Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca Mitiperstat (AZD4831): AstraZeneca Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb Lenrispodun (ITI - 214): Intra-Cellular Therapies CRD-740: Cardurion Pharmaceuticals HU6: Rivus Pharmaceuticals Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials Chronic Heart Failure Market Dynamics The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory. Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM. However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure. Scope of the Chronic Heart Failure Market Report Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends Table of Contents Related Reports Chronic Heart Failure Epidemiology Forecast Chronic Heart Failure Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic heart failure epidemiology trends. Chronic Heart Failure Pipeline Chronic Heart Failure Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHF companies, including Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Ionis Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, among others. Acute Coronary Syndrome Market Acute Coronary Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ACS companies, including Novartis, Boehringer Idorsia Pharmaceuticals, Viatris, Recardio, AstraZeneca, Faraday Pharmaceuticals, DalCor Pharmaceuticals, Roche, Jiangsu Vcare PharmaTech, CeleCor Therapeutics, Novo Nordisk, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, CellProthera, BioCardia, Kancera, Amgen, Arrowhead Pharmaceuticals, Abcentra , among others. Acute Coronary Syndrome Pipeline Acute Coronary Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute coronary syndrome companies, including Janssen Research & Development, LLC, DalCor Pharmaceuticals, Hyloris Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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点击“蓝字”关注我们 年终盘点微专辑 扫描二维码 可查看更多内容 糖尿病肾脏病（DKD）作为终末期肾病（ESRD）的首要病因，严重影响患者的生存质量，给全球带来沉重负担。聚焦2024年糖尿病肾脏病领域临床研究，精彩纷呈。本文中，天津医科大学朱宪彝纪念医院陈莉明教授盘点和梳理了2024年度JCR 1区发表的相关临床研究，以飨读者。 SGLT2/1双重抑制剂相关研究 01 索格列净与T2DM合并CKD患者肾脏结局、肾功能和白蛋白尿：SCORED研究的二次分析 发表刊物Clin J Am Soc Nephol SCORED研究是一项多中心、随机对照临床试验，在10 584例2型糖尿病（T2DM）合并慢性肾脏病（CKD）患者中评估钠-葡萄糖共转运蛋白（SGLT）2/1双重抑制剂索格列净（Sotagliflozin）的心肾结局。本研究利用SCORED研究的估算肾小球滤过率（eGFR）数据进行探索性分析，以评价索格列净对预设肾脏复合终点及额外心肾复合终点的影响。依据实验室数据和病例报告表数据，识别出223个事件。结果显示，索格列净可降低eGFR持续下降>50%、eGFR<15 ml/min/1.73m2、透析或肾脏移植复合事件的风险，索格列净组和安慰剂组分别发生87个（1.6%）和136个（2.6%）事件（HR 0.62，95%CI：0.48~0.82，P<0.001）。同时，索格列净降低了心肾复合终点（定义为上述肾脏复合终点+心血管死亡或肾脏死亡）风险，索格列净组和安慰剂组分别发生239个（4.5%）和306个（5.7%）事件（HR 0.77，95%CI：0.65~0.91，P=0.0023）。SCORED研究的二次分析证实，索格列净可降低T2DM合并CKD患者肾脏和心肾复合终点的风险。 图1. 肾脏复合终点累积发生率 GLP-1RA相关研究 02 司美格鲁肽对T2DM患者CKD的影响：FLOW研究 发表刊物N Engl J Med T2DM合并CKD患者发生肾衰竭、心血管事件和死亡的风险很高，FLOW研究旨在评价胰高糖素样肽-1受体激动剂（GLP-1RA）司美格鲁肽1.0 mg每周一次皮下注射治疗在T2DM合并CKD患者中预防肾衰竭、肾功能严重受损以及肾性死亡或心血管死亡的疗效和安全性。本研究将T2DM合并CKD患者[eGFR 50~75 ml/min/1.73m2和尿白蛋白肌酐比值（UACR）>300~<5000 mg/g，或eGFR 25~<50 ml/min/1.73m2和UACR>100~<5000 mg/g]以1:1比例随机分配接受每周一次1.0 mg司美格鲁肽或安慰剂治疗。主要终点为首发肾脏复合事件（eGFR自基线持续降低≥50%、持续性eGFR<15 ml/min/1.73m2、起始长期肾脏替代治疗、肾脏相关或心血管原因死亡）。 3533例受试者中，中位随访3.4年。与安慰剂组相比，司美格鲁肽组的主要终点事件风险降低24%（HR 0.76，95%CI：0.66~0.88，P=0.0003），主要终点的肾脏特异性复合终点（HR 0.79，95%CI：0.66~0.94）和心血管原因死亡（HR 0.71，95%CI：0.56~0.89）的结果相似。司美格鲁肽组eGFR年均下降斜率较慢，为1.16 ml/min/1.73m2（P<0.001），主要心血管事件风险降低18%（HR 0.82，95%CI：0.68~0.98，P=0.029），全因死亡风险降低20%（HR 0.80，95%CI：0.67~0.95，P=0.01）。司美格鲁肽组报告严重不良事件的受试者比例低于安慰剂组（49.6% vs. 53.8%）。FLOW研究证实，司美格鲁肽治疗可降低T2DM合并CKD患者出现临床重要肾脏终点、主要心血管事件和全因死亡的风险。 图2. 首发主要肾脏事件和首发肾脏特异性复合事件发生率 03 司美格鲁肽对T2DM患者DKD一级预防的影响：SUSTAIN 6随机对照试验的事后分析 发表刊物Diabetes Obes Metab 众所周知，识别DKD高危人群并及时干预是预防DKD的关键。本研究采用已开发的DKD风险分类模型，评估司美格鲁肽或安慰剂对DKD一级预防的效果。受试者为SUSTAIN 6研究中基线无DKD的T2DM患者，接受0.5 mg或1.0 mg司美格鲁肽或安慰剂治疗，根据基线DKD风险进行分组，风险计算采用一个已验证的模型，主要事后分析结局是司美格鲁肽或安慰剂对发生DKD（UACR≥30 mg/g和/或eGFR<60 ml/min/1.73m²）患者比例的影响，其他事后分析结局包括随时间变化的DKD风险评分、UACR和eGFR的变化。 结果显示，1139例受试者中，28.7%发展为DKD；更多的DKD高危受试者（952/1139）发展为DKD。与安慰剂相比，司美格鲁肽显著降低总体（OR 0.56，95%CI：0.42~0.74，P<0.0001）和DKD高危人群中发生DKD的风险（OR 0.51，95%CI：0.38~0.69，P<0.0001），显著延缓DKD进展，司美格鲁肽的有益作用主要由UACR变化驱动。本研究表明，司美格鲁肽可能对T2DM患者DKD的一级预防有益。 图3. 治疗结束时，总体研究人群中DKD风险评分随时间的变化 GLP-1R/GCGR双重激动剂相关研究 04 GLP-1/GCG双受体激动剂对DKD患者肾脏结局的影响：一项2b期随机对照临床试验 发表刊物Kidney Int Cotadutide是胰高糖素样肽-1受体（GLP-1R）和胰高糖素受体（GCGR）双重激动剂，可改善T2DM合并CKD患者的肾功能。在这项为期26周的2b期研究中，T2DM合并CKD患者（eGFR>20~<90 ml/min/1.73m2，UACR>50 mg/g）按照1:1:1:1:1比例随机分配至标准治疗加皮下注射Cotadutide分别100 μg、300 μg或600 μg，或安慰剂每日（双盲），或司美格鲁肽1 mg，每周一次（开放标签）。主要终点是UACR从基线到第14周结束的绝对变化以及与安慰剂相比的百分比变化。248例随机分组的T2DM患者平均年龄为67.1岁，平均eGFR为55.3 ml/min/1.73m2，UACR为205.5 mg/g，46.8%的患者同时接受SGLT2抑制剂治疗。从基线到第14周结束时，Cotadutide呈剂量依赖性地降低UACR，300 μg组（-43.9%，95%CI：-54.7 ~ -30.6）和600 μg组（-49.9%，95%CI：-59.3 ~ -38.4）的UACR下降相较安慰剂组的差异达到显著性；且效果持续至第26周。Cotadutide 600 μg组的安全性和耐受性与司美格鲁肽组相当。本研究表明，在T2DM合并CKD患者中，Cotadutide可显著降低UACR，具有可接受的耐受性。 图4. 双受体激动剂Cotadutide治疗后UACR的改变 联合用药相关研究 05 SGLT2i和GLP-1RA联合治疗对T2DM患者eGFR下降的影响：RECAP研究事后分析 发表刊物Front pharmacol 在RECAP研究事后分析中，共纳入643例T2DM患者（GLP-1RA先导组，n=331；SGLT2i先导组，n=312），观察两组患者每年eGFR下降的差异。SGLT2i先导组中，联合GLP-1RA后，每年eGFR下降显著减少（先前：-3.5±9.4 ml/min/1.73m2/年，之后：-0.4±6.3 ml/min/1.73m2/年，P<0.001）；而GLP-1RA先导组，在开始SGLT2i后，eGFR下降趋势减缓，但未达统计学显著差异（先前：-2.0±10.9 ml/min/1.73m2/年，之后：-1.8±5.4 ml/min/1.73m2/年，P=0.83）。SGLT2i治疗患者加入GLP-1RA后，能够观察到每年eGFR下降减缓，由此可见SGLT2i和GLP-1RA联合治疗的肾脏益处，如每年eGFR下降，可能受到先前药物的影响。 图5. SGLT2i先导组和GLP-1RA先导组联合治疗前后eGFR的变化 06 SGLT2i、GLP-1RA和ns-MRA联合治疗T2DM合并蛋白尿患者的终生心血管、肾脏和生存获益 发表刊物Circulation SGLT2i、GLP-1RA以及非甾体类盐皮质激素受体拮抗剂（ns-MRA）非奈利酮均能单独减少T2DM合并蛋白尿患者的心血管、肾脏和死亡终点。然而，这些药物联合治疗的终生益处尚不清楚。 本研究利用2项SGLT2i试验（CANVAS和CREDENCE）、2项ns-MRA试验（FIDELIO-DKD和FIGARO-DKD）以及8项GLP-1RA试验数据，以评估与常规治疗（肾素-血管紧张素系统阻断和传统风险因素控制）相比，三药联合治疗对心血管、肾脏和死亡结局的相对影响。作者采用精算方法，通过将估算的联合治疗效果应用于CANVAS和CREDENCE中接受常规治疗的受试者，在蛋白尿至少中度增加（UACR≥30 mg/g）的T2DM患者中评估联合SGLT2i、GLP-1RA和ns-MRA治疗的绝对风险降低。 与传统治疗相比，SGLT2i、GLP-1RA和ns-MRA联合治疗的主要心血管不良事件（MACE，非致死性心肌梗死、非致死性卒中或心血管死亡）风险降低35%（HR 0.65，95%CI：0.55~0.76），相应的3年内估计绝对风险降低为4.4%（95%CI：3.0~5.7），需要治疗人数为23例（95%CI：18~33）。对于开始联合治疗的50岁患者，估计MACE无事件生存期为21.1年，而传统治疗组为17.9年（增加3.2年，95%CI：2.1~4.3）。预计的无心力衰竭住院（3.2年，95%CI：2.4~4.0）、无CKD进展（5.5年，95%CI：4.0~6.7）、无心血管死亡（2.2年，95%CI：1.2~3.0）和无全因死亡（2.4年，95%CI：1.4~3.4）的生存期均增加。因此，在蛋白尿至少中度增加的T2DM患者中，SGLT2i、GLP-1RA和ns-MRA联合治疗可能在无心肾事件生存期以及总体生存期方面带来益处。 图6. 三药联合组与常规治疗组的无肾脏事件生存率 07 在FLOW试验中，司美格鲁肽联合或不联合SGLT2i对T2DM合并CKD受试者的影响 发表刊物Nat Med 将FLOW试验中纳入的T2DM合并CKD患者根据基线SGLT2i使用情况（使用组n=550，未使用组n=2983）进行分层，并随机分至司美格鲁肽组或安慰剂组。主要终点为肾衰竭、eGFR降低≥50%、肾脏死亡或心血管死亡的复合终点。与安慰剂组相比，所有接受司美格鲁肽治疗的受试者主要终点风险降低24%（95%CI：34%~12%）。在基线使用SGLT2i的受试者中，司美格鲁肽组与安慰剂组的主要终点事件发生比例分别为41/277和38/273（HR 1.07，95%CI：0.69~1.67，P=0.755）；在基线未使用SGLT2i的受试者中，司美格鲁肽组与安慰剂组的主要终点发生比例分别为290/1490和372/1493（HR 0.73，95%CI：0.63~0.85，P<0.001；P交互作用=0.109）。在SGLT2i亚组和无SGLT2i亚组中，司美格鲁肽对总体eGFR斜率（ml/min/1.73m2/年）的治疗差异分别为0.75（95%CI：-0.01~1.5）和1.25（95%CI：0.91~1.58）（P交互作用=0.237）。可见，司美格鲁肽在减少肾脏终点方面的获益在基线使用或未使用SGLT2i的受试者中一致。 图7. 司美格鲁肽联合与不联合SGLT2i对T2DM合并CKD患者的影响 中药相关研究 08 T2DM合并CKD患者加用黄芪治疗：一项多中心、评估员盲法、随机对照试验 发表刊物Phytomedicine 本研究为随机、评估者盲法、标准护理对照、多中心临床试验，旨在评价黄芪对大量蛋白尿的T2DM合并CKD患者肾功能下降的有效性。研究从香港7个公立门诊诊所和社区纳入118例eGFR 30~90 ml/min/1.73m2和UACR 300~5000 mg/g的患者，将其随机分至加用口服黄芪颗粒（相当于15 g/d生药）或继续标准治疗48周。主要终点是意向治疗人群的eGFR变化斜率和UACR。黄芪组的eGFR下降斜率估计差异为4.6 ml/min/1.73m2/年（95%CI：1.5~7.6，P=0.003），下降速度更慢。对于UACR，估计的组间变化斜率差异不显著（1.14，95%CI：0.85~1.52，P=0.392）。31例黄芪治疗患者和41例标准治疗患者发生不良事件。黄芪治疗组患者第48周末收缩压降低7.9 mmHg（95%CI：-12.9 ~ -2.8，P=0.003）。这提示，T2DM合并CKD患者加用黄芪治疗，在标准治疗的基础上能够进一步稳定肾功能。 图8. 加用黄芪组和标准治疗组的eGFR和UACR改变 参考文献 （上下滑动可查看） 1. 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Influence of the combination of SGLT2 inhibitors and GLP-1 receptor agonists on eGFR decline in type 2 diabetes: post-hoc analysis of RECAP study. Front Pharmacol. 2024; 15: 1358573. DOI: 10.3389/fphar.2024.1358573. 6. Neuen BL, et al. Estimated Lifetime Cardiovascular, Kidney, and Mortality Benefits of Combination Treatment With SGLT2 Inhibitors, GLP-1 Receptor Agonists, and Nonsteroidal MRA Compared With Conventional Care in Patients With Type 2 Diabetes and Albuminuria. Circulation. 2024; 149(6): 450-462. DOI: 10.1161/circulationaha.123.067584. 7. Mann JFE, et al. Effects of semaglutide with and without concomitant SGLT2 inhibitor use in participants with type 2 diabetes and chronic kidney disease in the FLOW trial. Nat Med. 2024; 30(10): 2849-2856. DOI: 10.1038/s41591-024-03133-0. 8. Chan KW, et al. Add-on astragalus in type 2 diabetes and chronic kidney disease: A multi-center, assessor-blind, randomized controlled trial. Phytomedicine. 2024; 130: 155457. DOI: 10.1016/j.phymed.2024.155457. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。 最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！ （来源：《国际糖尿病》编辑部） 版权声明 版权属《国际糖尿病》所有。欢迎个人转发分享。其他任何媒体、网站未经授权，禁止转载。