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Yahoo
4 days ago
- Health
- Yahoo
New Real-World Study by Columbia Data Analytics Confirms Semaglutide Significantly Reduces Kidney Disease Risk in Patients with Type 2 Diabetes
NEW YORK & ISTANBUL, June 16, 2025--(BUSINESS WIRE)--A groundbreaking study led by researchers from Columbia Data Analytics, Bogazici University and the City University of New York (CUNY) College of Technology, has demonstrated that semaglutide, a GLP-1 receptor agonist, significantly reduces the risk of major kidney disease events among patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) in real-world clinical practice. Key findings: 26% Reduction in Major Kidney Events: Compared with standard care, semaglutide treatment was associated with a 26% reduction in the risk of major kidney disease events, including kidney failure and substantial loss of kidney function. This effect is consistent with, and slightly exceeds, the 24% risk reduction observed in the landmark FLOW clinical trial. Robust Real-World Evidence: Creating 896,257 external control arm semaglutide users and a comparator group from the Kythera Labs database (2019–2024), the study provides the largest real-world evaluation of semaglutide's renoprotective effects to date. Broad Patient Representation: The real-world cohort included a more diverse, representative patient population than typical clinical trials, enhancing the generalizability of the findings. Consistent Results Across Sensitivity Analyses: The study's conclusions remained robust across multiple sensitivity analyses, further supporting the reliability of the results. The researchers constructed an external control arm using real-world data and applied rigorous statistical methods, including propensity score matching and Cox regression, to ensure comparability with the FLOW trial population. The primary outcome was a composite of kidney failure onset and a sustained 50% reduction in estimated glomerular filtration rate. "These results provide compelling real-world evidence for the use of semaglutide in reducing the risk of kidney failure and progression in patients with type 2 diabetes and CKD," said lead author Dr. Onur Baser. "The findings support broader adoption of semaglutide as a renoprotective therapy and may inform clinical guidelines, payer coverage decisions, and health policy." Although reliance on diagnosis codes and the inability to confirm medication adherence are limitations typical of observational research, the large sample size, advanced statistical adjustments, and consistency with clinical trial data strengthen the findings' validity. About the Study Authors: Onur Baser, PhD (Bogazici University, City University of New York [CUNY] College of Technology) and Yuanqing Lu, MS (Columbia Data Analytics) Data Source: Kythera Labs, 2019–2024 Presented at: ISPOR 2025, Montréal, Québec, Canada Funding: No external funding Conflicts of Interest: None declared Citation: Baser O, Lu Y. External control arm with real world data to assess the effect of semaglutide on chronic kidney disease risk among patients with type 2 diabetes. Expert Opinion on Pharmacotherapy. Accepted June 6, 2025. View source version on Contacts Elizabeth Vivierlizv@
Yahoo
5 days ago
- Health
- Yahoo
New Real-World Study by Columbia Data Analytics Confirms Semaglutide Significantly Reduces Kidney Disease Risk in Patients with Type 2 Diabetes
NEW YORK & ISTANBUL, June 16, 2025--(BUSINESS WIRE)--A groundbreaking study led by researchers from Columbia Data Analytics, Bogazici University and the City University of New York (CUNY) College of Technology, has demonstrated that semaglutide, a GLP-1 receptor agonist, significantly reduces the risk of major kidney disease events among patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) in real-world clinical practice. Key findings: 26% Reduction in Major Kidney Events: Compared with standard care, semaglutide treatment was associated with a 26% reduction in the risk of major kidney disease events, including kidney failure and substantial loss of kidney function. This effect is consistent with, and slightly exceeds, the 24% risk reduction observed in the landmark FLOW clinical trial. Robust Real-World Evidence: Creating 896,257 external control arm semaglutide users and a comparator group from the Kythera Labs database (2019–2024), the study provides the largest real-world evaluation of semaglutide's renoprotective effects to date. Broad Patient Representation: The real-world cohort included a more diverse, representative patient population than typical clinical trials, enhancing the generalizability of the findings. Consistent Results Across Sensitivity Analyses: The study's conclusions remained robust across multiple sensitivity analyses, further supporting the reliability of the results. The researchers constructed an external control arm using real-world data and applied rigorous statistical methods, including propensity score matching and Cox regression, to ensure comparability with the FLOW trial population. The primary outcome was a composite of kidney failure onset and a sustained 50% reduction in estimated glomerular filtration rate. "These results provide compelling real-world evidence for the use of semaglutide in reducing the risk of kidney failure and progression in patients with type 2 diabetes and CKD," said lead author Dr. Onur Baser. "The findings support broader adoption of semaglutide as a renoprotective therapy and may inform clinical guidelines, payer coverage decisions, and health policy." Although reliance on diagnosis codes and the inability to confirm medication adherence are limitations typical of observational research, the large sample size, advanced statistical adjustments, and consistency with clinical trial data strengthen the findings' validity. About the Study Authors: Onur Baser, PhD (Bogazici University, City University of New York [CUNY] College of Technology) and Yuanqing Lu, MS (Columbia Data Analytics) Data Source: Kythera Labs, 2019–2024 Presented at: ISPOR 2025, Montréal, Québec, Canada Funding: No external funding Conflicts of Interest: None declared Citation: Baser O, Lu Y. External control arm with real world data to assess the effect of semaglutide on chronic kidney disease risk among patients with type 2 diabetes. Expert Opinion on Pharmacotherapy. Accepted June 6, 2025. View source version on Contacts Elizabeth Vivierlizv@
Business Wire
5 days ago
- Health
- Business Wire
New Real-World Study by Columbia Data Analytics Confirms Semaglutide Significantly Reduces Kidney Disease Risk in Patients with Type 2 Diabetes
NEW YORK & ISTANBUL--(BUSINESS WIRE)--A groundbreaking study led by researchers from Columbia Data Analytics, Bogazici University and the City University of New York (CUNY) College of Technology, has demonstrated that semaglutide, a GLP-1 receptor agonist, significantly reduces the risk of major kidney disease events among patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) in real-world clinical practice. Creating 896,257 external control arm semaglutide users and a comparator group from the Kythera Labs database (2019–2024), the study provides the largest real-world evaluation of semaglutide's renoprotective effects to date. Share Key findings: 26% Reduction in Major Kidney Events: Compared with standard care, semaglutide treatment was associated with a 26% reduction in the risk of major kidney disease events, including kidney failure and substantial loss of kidney function. This effect is consistent with, and slightly exceeds, the 24% risk reduction observed in the landmark FLOW clinical trial. Robust Real-World Evidence: Creating 896,257 external control arm semaglutide users and a comparator group from the Kythera Labs database (2019–2024), the study provides the largest real-world evaluation of semaglutide's renoprotective effects to date. Broad Patient Representation: The real-world cohort included a more diverse, representative patient population than typical clinical trials, enhancing the generalizability of the findings. Consistent Results Across Sensitivity Analyses: The study's conclusions remained robust across multiple sensitivity analyses, further supporting the reliability of the results. The researchers constructed an external control arm using real-world data and applied rigorous statistical methods, including propensity score matching and Cox regression, to ensure comparability with the FLOW trial population. The primary outcome was a composite of kidney failure onset and a sustained 50% reduction in estimated glomerular filtration rate. 'These results provide compelling real-world evidence for the use of semaglutide in reducing the risk of kidney failure and progression in patients with type 2 diabetes and CKD,' said lead author Dr. Onur Baser. 'The findings support broader adoption of semaglutide as a renoprotective therapy and may inform clinical guidelines, payer coverage decisions, and health policy.' Although reliance on diagnosis codes and the inability to confirm medication adherence are limitations typical of observational research, the large sample size, advanced statistical adjustments, and consistency with clinical trial data strengthen the findings' validity. About the Study Authors: Onur Baser, PhD (Bogazici University, City University of New York [CUNY] College of Technology) and Yuanqing Lu, MS (Columbia Data Analytics) Data Source: Kythera Labs, 2019–2024 Presented at: ISPOR 2025, Montréal, Québec, Canada Funding: No external funding Conflicts of Interest: None declared Citation: Baser O, Lu Y. External control arm with real world data to assess the effect of semaglutide on chronic kidney disease risk among patients with type 2 diabetes. Expert Opinion on Pharmacotherapy.
Associated Press
15-05-2025
- Health
- Associated Press
Altis Labs Unveils New AI-Powered External Control Arm Product Offering at ISPOR 2025
AI-matched digital twins for MYSTIC trial participants emulated the control arm and overall survival treatment effects. 'These findings highlight the potential for imaging-based digital twins to serve as robust external comparators in oncology clinical trials'— Dr. Omar Khan MONTREAL, QUEBEC, CANADA, May 15, 2025 / / -- Altis Labs, Inc. ('Altis') will present findings at ISPOR 2025 demonstrating how real-world digital twins (rwDTs) can replicate control arm outcomes in AstraZeneca's randomized controlled Phase 3 MYSTIC trial in metastatic non-small cell lung cancer (mNSCLC). These results support the launch of Altis' new product offering that enables clinical development teams to generate external controls with AI applied to comprehensive real-world imaging + clinical + outcomes data. Altis applied MYSTIC's eligibility criteria to its multimodal real-world data to identify historical patients treated with relevant standard-of-care (SOC) treatment. AI models processed the real-world baseline CT scans and quantified thousands of spatial imaging biomarkers representing total tumor burden, body composition, and other prognostic features. Using baseline imaging characteristics of each MYSTIC subject, 'matching' rwDTs were identified to generate an External Control Arms (ECAs). AstraZeneca independently evaluated the survival outcomes of the ECAs and compared them to the MYSTIC trial arms, concluding that the ECAs successfully emulated the actual control arm and yielded consistent treatment effect estimates. 'CT Imaging – a 3D reconstruction of the entire patient anatomy – is the most comprehensive data modality already being used in clinical care and oncology trials,' said Felix Baldauf-Lenschen, CEO of Altis. 'It's no surprise that AI applied to this rich data alone can match patients' baseline characteristics to emulate efficacy readouts.' 'These findings highlight the potential for imaging-based digital twins to serve as robust external comparators in oncology clinical trials,' said the presenting author, Dr. Omar Khan, a Clinical Assistant Professor in the Cumming School of Medicine at the University of Calgary and Medical Oncologist at the Arthur J.E. Child Comprehensive Cancer Centre. 'This approach is particularly relevant to help enhance single-arm trials, where comparative evidence is often limited.' Altis' ECA: A New Tool for Smarter Evidence Generation The newly launched ECA product enables sponsors to generate external controls using their clinical trial imaging data and Altis' real-world imaging data + associated survival outcomes. Sponsors can use these ECAs in various ways: • Benchmarking efficacy signal in single-arm trials • Augmenting a control arm to increase statistical power in RCTs • Real-world external comparators to inform reimbursement strategy Altis' models are trained on a proprietary dataset of over 200,000 cancer patients with longitudinal imaging, demographic, diagnostic, treatment, and survival outcomes data, enabling robust matching. The full results are featured at ISPOR 2025, Poster MSR147: Evaluating Imaging Artificial Intelligence (AI) Matching Real-World Digital Twins (rwDTs) Into an External Control Arm (ECA) for MYSTIC: A Phase 3 Clinical Trial in Metastatic Non-Small Cell Lung Cancer (mNSCLC). About Altis Labs Altis Labs is the computational imaging company accelerating clinical trials with AI. Altis has trained proprietary AI models on the industry's largest multimodal training database spanning over 200 million longitudinal images linked to clinical, molecular, and outcomes data. Top 20 biopharmas use Altis' AI models to more confidently analyze data from phase 1-4 clinical trials so that they can bring the most effective novel treatments to patients sooner. For more information, visit follow @AltisLabs on social media, or email [email protected]. Felix Baldauf-Lenschen Altis Labs, Inc. email us here Visit us on social media: LinkedIn X 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.
National Post
14-05-2025
- Health
- National Post
Komodo Health's Real-World Evidence Platform Drives 31 Patient Journey Research Studies at ISPOR 2025
Article content Comprehensive Patient Journey Data Links Clinical Outcomes to Real-World Impact, Addressing Critical Evidence Gaps in Oncology, Neurology, Cardiovascular, Metabolic, and Rare Diseases Article content Article content MONTREAL — Komodo Health today announced that its healthcare intelligence platform enabled 31 research studies being presented at the 2025 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) global conference. These include three studies led by Komodo researchers and 27 collaborative studies with academic institutions, Life Sciences companies, and healthcare organizations. Article content 'The volume and diversity of research powered by our healthcare insights underscore the growing demand for high-quality real-world data combined with advanced analytical capabilities,' said Arif Nathoo, MD, CEO and Co-Founder, Komodo Health. 'By connecting individual patient journeys to large-scale health outcomes, we're enabling researchers to uncover actionable insights that improve clinical practice, healthcare policy, and patient outcomes.' Article content The ISPOR 2025 research presentations demonstrate the value of Komodo's real-world evidence across a wide range of therapeutic areas, including: Article content Oncology: Salix Pharmaceuticals, Analysis Group, and Bausch Health studied the economic burden of opioid-induced constipation among patients with or without cancer; Cardiovascular disease: Veradigm examined the discordance between apolipoprotein B and low-density lipoprotein cholesterol levels in predicting incident hypertension risk and how it correlates to differential hypertension development patterns between diabetic and non-diabetic populations; Metabolic disorders: Novo Nordisk studied non-invasive diagnostic approaches and earlier interventions for metabolic dysfunction-associated steatohepatitis (MASH); Neurology: Jazz Pharmaceuticals analyzed healthcare resource utilization and costs among individuals with narcolepsy or idiopathic hypersomnia (IH) who are considered at higher risk for negative clinical outcomes associated with sodium (due to underlying cardiovascular, cardiometabolic, or renal conditions); and Rare disease: Chiesi analyzed medical claims data to better understand healthcare resource utilization patterns among Fabry disease patients Article content Three poster presentations by Komodo researchers also showcase methodological advances: Article content Komodo provides a multidimensional view of 330+ million patient journeys by linking de-identified claims data with specialty datasets, including lab results, genomics, and demographic information — through its platform to address fundamental challenges in health economics and outcomes research (HEOR). Whereas HEOR teams have traditionally relied on fragmented, incomplete datasets that provide only narrow snapshots of patients' in-network healthcare experiences, Komodo's platform enables researchers to link disparate datasets without the months typically spent on data cleaning and integration. The option to enhance disease understanding at the patient level with lab, EHR, patient insurance, race and ethnicity, and mortality data enables teams to self-serve cohort feasibility and insights. This ability accelerates study planning timelines by weeks and generates more accurate estimates of treatment patterns, healthcare resource utilization, and costs. Article content 'By closing critical data gaps and providing a patient-centric approach to HEOR, our powerful, all-in-one platform brings clean, connected, and compliant real-world data together,' Nathoo added. 'We eliminate the need for messy integrations, manual data wrangling, and coding cohorts from scratch, which enables HEOR teams to generate evidence faster. The inclusion of race, ethnicity, mortality, and other demographic insights at a near-census level also allows researchers to better model the clinical and financial impacts of new therapies across diverse populations, addressing the reality that disease burden is not borne equally across demographic groups.' Article content Article content Article content Article content Article content Contacts Article content Media Contacts: Rowena Kelley 858.255.1651 media@ Article content Article content Article content
