Preadmission GLP-1 Receptor Agonist Plus SGLT2 Inhibitor Use and Early Outcomes After Pneumonia Hospitalization in Adults With Type 2 Diabetes

Официальное название

Preadmission GLP-1 Receptor Agonist Plus SGLT2 Inhibitor Use and Early Outcomes After Pneumonia Hospitalization in Adults With Type 2 Diabetes: A Target Trial Emulation

Обзор

This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare preadmission glucose-lowering treatment strategies in adults with type 2 diabetes hospitalized with pneumonia. Time zero is the date of the index pneumonia admission. The study compares patients with evidence of prescriptions for both a GLP-1 receptor agonist and an SGLT2 inhibitor in the year before admission with patients prescribed a GLP-1 receptor agonist alone, an SGLT2 inhibitor alone, or usual care. Usual care includes metformin, sulfonylureas, or DPP-4 inhibitors without either study class. The primary outcome is a composite of all-cause death, invasive mechanical ventilation, or renal replacement therapy within 30 days of admission, with the individual components and 12-month mortality, major adverse cardiovascular events, and major adverse kidney events also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.

Первичные конечные точки

• Composite outcome (all-cause mortality, invasive mechanical ventilation, or renal replacement therapy) [Срок оценки: Within 30 days after the index pneumonia admission]

Вторичные конечные точки (7)

• All-cause mortality [Срок оценки: Within 30 days after the index pneumonia admission]
• Invasive mechanical ventilation [Срок оценки: Within 30 days after the index pneumonia admission]
• Renal replacement therapy [Срок оценки: Within 30 days after the index pneumonia admission]
• Composite outcome (all-cause mortality, major adverse cardiovascular events, or major adverse kidney events) [Срок оценки: Through 12 months after the index pneumonia admission]
• All-cause mortality [Срок оценки: Through 12 months after the index pneumonia admission]
• Major adverse cardiovascular events [Срок оценки: Through 12 months after the index pneumonia admission]
• Major adverse kidney events [Срок оценки: Through 12 months after the index pneumonia admission]

Критерии участия

Критерии включения

• Adults aged 18 years or older.
• Type 2 diabetes mellitus
• Hospitalization with pneumonia during the study period, serving as the index admission
• Prescription of a GLP-1 receptor agonist, an SGLT2 inhibitor, or usual-care glucose-lowering therapy in the year before the index admission
• No GLP-1 receptor agonist or SGLT2 inhibitor prescription in the 6 months before the first qualifying prescription

Критерии исключения

• Type 1 diabetes mellitus, or other specified diabetes types that are not type 2 diabetes
• Human immunodeficiency virus infection
• Bariatric surgery
• Solid-organ transplantation
• Pneumonia hospitalization, invasive mechanical ventilation, or renal replacement therapy in the year before the index admission
• End-stage kidney disease, dialysis dependence, ventilator dependence, or tracheostomy status
• Metastatic malignancy, lung cancer, or palliative care
• Viral pneumonia, influenza with pneumonia, or COVID-19 around the index admission
• Acute cardiovascular event in the 6 months before the index admission

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• Chung Shan Medical University Hospital — Taichung

Публикации

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Идентификаторы

NCT: NCT07708610 · CS2-26152

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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