In a study comparing dapagliflozin with placebo over two years, which outcome can be regarded as a surrogate endpoint?

Study for the Board Certified Cardiology Pharmacist Exam. Utilize flashcards and answer multiple-choice questions with detailed explanations. Prepare efficiently for your certification!

In clinical research, surrogate endpoints are biomarkers or other indicators used as substitutes for clinically meaningful endpoints. These endpoints are typically chosen based on the association with the actual clinical outcomes of interest, such as mortality or morbidity.

In the context of comparing dapagliflozin with placebo, changes in NT-proBNP (N-terminal pro b-type Natriuretic Peptide) serve as a surrogate endpoint because they provide insight into cardiac function and heart failure status. NT-proBNP is released in response to ventricular stretch and heart failure; therefore, changes in its levels can indicate the effectiveness of a treatment in improving heart health, potentially leading to a reduction in adverse clinical outcomes over time.

On the other hand, outcomes like cardiovascular death and overall mortality are direct clinical endpoints that reflect the actual health outcomes of patients and are not considered surrogate endpoints. Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) represent patient-reported outcomes related to heart failure symptoms and quality of life, but while useful, these do not serve as objective biomarkers like NT-proBNP in this context. Thus, among the options provided, changes in NT-proBNP are clearly the appropriate surrogate endpoint in this study.

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