Phentermine Resin Complex

— Presentations spotlight VIVUS’s 13-year track record of leadership with QSYMIA® (phentermine andtopiramate extended-release capsules CIV) in the treatment of obesity and overweight CAMPBELL, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced that Santosh T. Varghese, MD, President VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC, will deliver an oral presentation on advancing obesity management with QSYMIA® (phentermine and topiramate extended-release capsules CIV) at the 2025 International Congress on Obesity and MEtabolic Syndrome (ICOMES), taking place September 4 – 6, 2025 in Seoul, Korea. Additionally, findings from the QUEEN’s study, which was recently published in Diabetes Obesity and Metabolism, will be presented by Sangmo Hong, MD, Hanyang University, Guri Hospital, South Korea. “Over the past 13 years, we have seen firsthand how impactful QSYMIA has been for patients in achieving and maintaining healthy weight goals in the United States,” said Santosh T. Varghese, MD, President of VIVUS Global Pharmaceutical Development and Chief Medical Officer at VIVUS LLC. “Since receiving market approval in the Republic of Korea in 2019 through our partnership with Alvogen, we have been proud to extend this option to patients globally. At VIVUS, we remain committed to making a difference in this critical public health area and providing patients with therapies that can improve their overall wellbeing.” Details of Dr. Varghese’s presentation at ICOMES are as follows: Symposium: (Symposium 12) Oldies But Goodies, Update on Oral Anti-Obesity MedicationTitle: Advancing Obesity Management: Thirteen Years Strong with Once Daily Oral Phentermine/Topiramate ERPresentation Date & Time: 09:00 – 10:30, September 6 (KST)Location: Room 1 (Grand Ballroom 3) 3F, Conrad Seoul Hotel Dr. Hong will share findings from the study, “Evaluation of the efficacy and safety of controlled-release phentermine/topiramate in adults with obesity in Korea: A randomized, double-blind, placebo-controlled, phase 4 trial (QUEEN’s study).” This phase 4, double-blind, placebo-controlled trial tested the weight-loss drug combination phentermine/topiramate controlled release (PHEN/TPM CR) in Korean adults with obesity and found that adding PHEN/TPM CR to lifestyle changes led to significantly greater weight loss (−8.3% vs. −2.3% with placebo). The QUEEN’s study also demonstrated that weight reduction in the PHEN/TPM CR group was accompanied by decreases in visceral fat, which is closely linked to insulin resistance, type 2 diabetes and heart disease, and body fat percentage, as well as improvements in glucose metabolism. QSYMIA, is a once-daily oral medication that has clinically proven weight management results in adults and children ages 12-17 when combined with a healthy diet and regular exercise. QSYMIA is the leading branded oral product for obesity treatment in the United States with more than four million prescriptions. About VIVUSVIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs. For more information about the Company, please visit http://www.vivus.com. About QSYMIAQSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition. The effect of QSYMIA on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of QSYMIA in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. For more information on QSYMIA, please visit https://QSYMIA.com/ Important Safety Information for QSYMIADo not take QSYMIA if you are pregnant, planning to become pregnant, or become pregnant during QSYMIA treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in QSYMIA. QSYMIA can cause serious side effects, including birth defects (cleft lip/cleft palate), serious eye problems (secondary angle closure glaucoma), visual field defects (independent of elevated intraocular pressure), suicidal thoughts or actions, and severe rash with blisters and peeling skin. QSYMIA may slow the increase in height in children 12 years and older. Common side effects of QSYMIA in adults include numbness or tingling in the hands, arms, feet, or face (paraesthesia), dizziness, changes in the way foods taste or loss of taste (dysgeusia), trouble sleeping (insomnia), constipation, and dry mouth. Common side effects of QSYMIA in children aged 12 years and older include depression, dizziness, joint pain, fever, flu, and ankle sprain. For more information, please read the QSYMIA Medication Guide, Full Prescribing Information, and Risk of Birth Defects with QSYMIA patient brochure. Forward-Looking Statements Important Information and Cautionary Note Regarding Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and/or covered by the “Bespeaks Caution” doctrine applied by the courts under the antifraud provisions of the federal securities laws, and other applicable provisions of the federal securities laws. Such forward-looking statements are based on current expectations, management’s beliefs and certain assumptions made by the Company’s management. These statements may be identified by the use of forward-looking words such as “will,” “shall,” “may,” “believe,” “expect,” “forecast,” “intend,” “anticipate,” “predict,” “should,” “plan,” “likely,” “opportunity,” “estimated,” and “potential,” and/or the negative use of these words or other similar words. All forward-looking statements included in this document are based on our current expectations, and the Company assumes no obligation to update any such forward-looking statements except to the extent otherwise required by law. Forward-looking information about QSYMIA, including its potential benefits, approvals in potential markets outside the U.S. and anticipated product availability, involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied in this press release. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other markets or approved, whether QSYMIA will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of QSYMIA; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments. The above factors, risks and uncertainties are difficult to predict, contain uncertainties that may materially affect actual results and may be beyond the Company’s control. New factors, risks and uncertainties emerge from time to time, and it is not possible for management to predict all such factors, risks and uncertainties. Although the Company believes that the assumptions underlying the forward-looking statements contained herein are reasonable, any of the assumptions could be inaccurate, and therefore any of these statements may prove to be inaccurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by the Company or any other person that the Company’s objectives and plans will be achieved. These forward-looking statements speak only as of the date such statements were made or any earlier date indicated, and the Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in underlying assumptions or otherwise, unless otherwise required by law. Contacts VIVUS LLCT: +1 (650) 934-5200 Media – FINN Partners Glenn Silver glenn.silver@finnpartners.com T: +1 973-818-8198

点击“蓝字”关注我们 编者按：近年来，随着全球范围内代谢异常疾病的发病率不断攀升，高血压合并糖尿病作为一种常见的共病状态，其对患者心血管、肾脏及代谢系统的影响日益受到医学界的广泛关注。据我国最新流行病学数据显示，高血压和糖尿病已成为导致心血管疾病、慢性肾脏病（CKD）及不良心血管和肾脏结局的主要风险因素。在此背景下，由中国心血管代谢联盟组织发起，多学科专家联合撰写的《高血压合并糖尿病患者心血管‐肾脏‐代谢综合管理专家共识（2024）》（以下简称“共识”）应运而生，为临床医生提供了科学、规范的综合管理指南。本文将从共识的核心内容出发，为医生读者进行深入解读，以期在临床实践中更好地指导高血压合并糖尿病患者的治疗与管理。 CKM综合征的分期与管理 共识首先介绍了CKM综合征的分期标准，将CKM综合征分为0期至4期，每一期都对应着不同的病理生理状态和疾病风险（表1）。对于高血压合并糖尿病患者而言，其通常处于CKM 2期及以上，管理策略应侧重于积极干预已存在的代谢风险因素和CKD，预防病情向亚临床或临床心血管疾病进展。 早期干预的重要性：共识强调，对于CKM 2期及以上的患者，应尽早启动生活方式干预和必要的药物治疗，以控制血压、血糖和血脂水平，减少代谢风险因素对心血管和肾脏的损害。 个体化治疗原则：针对不同患者的具体情况，共识提出了个体化治疗的原则。例如，对于合并亚临床心血管疾病的患者，应强化预防措施，延缓或防止病情进展；对于已出现临床心血管疾病的患者，则应采取二级预防措施，并根据个体情况制定精准的治疗方案。 血糖、血压和体重管理 01 血糖管理 血糖管理需遵循个体化原则，根据患者年龄、病程、整体健康状况等因素分层管理。对于大多数非妊娠成年患者，糖化血红蛋白（HbA1c）控制目标为< 7.0%（表2），同时结合连续性血糖监测（CGM）和动态葡萄糖图谱（AGP）更直观地反映血糖波动。 生活方式干预是血糖管理的基础，包括糖尿病自我管理教育、个体化营养治疗、规律运动、戒烟及控制体重等。药物治疗方面，优先选择具有心血管获益的药物，如GLP-1受体激动剂（GLP-1RA）和钠-葡萄糖共转运蛋白2抑制剂（SGLT2i）。对于合并动脉粥样硬化性心血管疾病（ASCVD）或高心血管风险的患者，优先使用GLP-1RA和/或SGLT2i；对于合并心力衰竭（HF）的患者，优先推荐使用SGLT2i；对于合并CKD的患者，建议优先考虑具有心肾获益证据的SGLT2i和/或GLP-1 RA。 02 血压管理 大多数非妊娠成年患者的血压控制目标应< 130/80 mmHg，若进一步将收缩压降低至约120 mmHg，可显著降低心血管事件复合终点风险。对于妊娠期糖尿病患者，血压控制目标为≤135/85 mmHg。 生活方式干预包括减少钠盐摄入（目标<5 g/d），增加钾盐摄入，平衡膳食，控制体重，戒烟限酒，合理运动。 降压药物治疗方面，优先推荐肾素-血管紧张素-醛固酮系统（RAAS）阻滞剂，包括血管紧张素转化酶抑制剂/血管紧张素受体拮抗剂（ACEI/ARB）、血管紧张素受体脑啡肽酶抑制剂（ARNI），尤其适用于合并微量白蛋白尿、CKD、左心室肥厚、冠心病及HF的患者。对于诊室血压≥160/100 mmHg或高于目标血压20/10 mmHg的患者，启动2种降压药物联合治疗，优先推荐RAAS阻滞剂与钙通道阻滞剂（CCB）或噻嗪类/噻嗪型利尿剂的联合方案。部分降糖药物（如SGLT2i、GLP-1RA）具有降压效应，可作为综合治疗方案的一部分，例如恒格列净5/10mg治疗24周可降低4.4~6.6mmHg（表3）。需注意的是，SGLT2i、GLP‐1 RA与其他降压药物联用时，应定期监测血压，防止低血压的发生。 03 体重管理 体重管理是改善血糖、血压及代谢紊乱的核心策略之一，需结合个体化原则，综合生活方式、药物和手术等多种干预手段。生活方式干预包括饮食控制和运动干预，建议采用低热量、高纤维的饮食模式，减少高糖、高脂肪食物的摄入，同时控制总热量摄入，每周进行至少150分钟的中等强度有氧运动，并结合适当的抗阻运动。当生活方式干预效果不佳时，可联合药物治疗，如奥利司他、利拉鲁肽、贝那鲁肽、司美格鲁肽、替尔泊肽、安非他酮/纳曲酮、芬特明/托吡酯等。对于生活方式干预效果不佳且符合手术指征的患者，可考虑代谢手术，如袖状胃切除术、胃旁路术等。 合并症/并发症的筛查和治疗 高血压合并糖尿病患者常合并多种并发症，如ASCVD、HF、CKD等。共识针对这些合并症/并发症提出了具体的筛查和治疗策略。通过系统的筛查和个体化的治疗方案，可以有效管理高血压合并糖尿病患者的合并症和并发症，以改善患者的生活质量和预后。 ASCVD的筛查和治疗：共识推荐对于合并糖尿病的患者，无论其年龄和性别如何，均应进行ASCVD的风险评估，推荐使用GLP-1RA或SGLT2i，并根据风险层级调整降脂策略。超高危患者低密度脂蛋白胆固醇（LDL‐C）的目标为1.4 mmol/L以下且较基线降幅超过50%；极高危患者LDL‐C的目标为1.8 mmol/L以下且较基线降幅超过50%。对于他汀联合治疗不达标或不耐受的患者，建议使用前蛋白转化酶枯草溶菌素（PCSK9）抑制剂以降低LDL‐C水平。 HF的筛查和治疗：对于高血压合并糖尿病患者，应定期进行HF的风险筛查，包括心脏超声检测等。对于已确诊HF的患者，应根据GDMT原则进行治疗，包括使用RAAS阻滞剂、β受体阻滞剂、盐皮质激素受体拮抗剂（MRA）和SGLT2i等药物。 CKD的筛查和治疗：共识建议至少每年评估一次尿白蛋白和估算的肾小球滤过率（eGFR），以监测CKD的进展。对于合并CKD的患者，应优先选择具有肾脏获益的药物进行治疗，优先使用RAAS阻滞剂，必要时联合其他药物。在降糖治疗中，推荐使用SGLT2i以延缓肾病进展[适用于eGFR≥20 ml·（min·1.73 m2 ）‐1的患者]。具有心肾获益证据的GLP-1RA也是合适的选择。 其他合并症：代谢相关脂肪性肝病患者可使用吡格列酮等药物；糖尿病视网膜病变患者根据病变程度选择相应治疗，使用RAAS阻滞剂、SGLT2i或非诺贝特降低风险，必要时进行激光光凝术或玻璃体腔注射治疗；阻塞性睡眠呼吸暂停综合征患者则根据具体情况选择无创气道正压通气（NPPV）、口腔矫治器或外科手术等治疗方式。 总结 《高血压合并糖尿病患者心血管-肾脏-代谢综合管理专家共识（2024）》为临床医生提供了宝贵的指导，但在实际应用中仍需不断探索与完善。未来，随着医学研究的深入，可能会有更多新型药物与治疗技术应用于临床，如针对心血管-肾脏-代谢综合征发病机制的靶向药物，有望更精准地治疗这类复杂疾病。同时，人工智能、大数据等技术在疾病管理中的应用也将更加广泛，可实现对患者的远程监测、智能预警与个性化治疗推荐，提高疾病管理效率与质量。临床医生应持续关注医学前沿进展，不断更新知识，将最新研究成果应用于临床实践，为高血压合并糖尿病患者带来更好的治疗效果与生活质量。 参考文献：心血管代谢联盟. 高血压合并糖尿病患者心血管‐肾脏‐代谢综合管理专家共识（2024）. 中华心血管病杂志（网络版）. 2025; 8: e1000185(2025‐03‐21).  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：《国际循环》编辑部）