Health-related quality-of-life implications of cardiovascular events in individuals with type 2 diabetes mellitus: A subanalysis from the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-TIMI 53 trial. (August 2017)

• Record Type: Journal Article
• Authors: Briggs, Andrew H.; Bhatt, Deepak L.; Scirica, Benjamin M.; Raz, Itamar; Johnston, Karissa M.; Szabo, Shelagh M.; Bergenheim, Klas; Mukherjee, Jayanti; Hirshberg, Boaz; Mosenzon, Ofri
• Is Part Of: Diabetes research and clinical practice. Volume 130(2017)
• Page Start: 24
• Page End: 33
• Publication Date: 2017-08
• Subjects: Health-related quality of life -- Cardiovascular -- Diabetes mellitus; Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2016.12.019
• Languages: English
• ISSNs: 0168-8227

Abstract

Highlights: Few data exist on the quality of life (QOL) impact of complications in diabetes. SAVOR-TIMI 53, a phase IV trial of saxagliptin for diabetes, collected robust QoL data. In SAVOR-TIMI 53, cardiovascular complications were associated with decreased QoL. This was most substantial in the initial post-event period, but persisted over time. Abstract: Background: The impact of cardiovascular complications on health-related quality-of-life (HRQoL) in type 2 diabetes mellitus has not been clearly established. Using EQ5D utility data from SAVOR-TIMI 53, a large phase IV trial of saxagliptin versus placebo, we quantified the impact of cardiovascular and other major events on HRQoL. Methods: EQ5D utilities were recorded annually and following myocardial infarction (MI) or stroke. Utilities among patients experiencing major cardiovascular events were analyzed using linear mixed-effects regression, adjusting for baseline characteristics (including EQ5D utility), and compared to those not experiencing major cardiovascular events. Mean utility decrements with standard errors (SE) were estimated as the difference in utility before and after the event. Findings: The mean EQ5D utility of the sample was 0.776 at all time points, and did not differ by treatment. However, mean baseline and month 12 utilities among those with a major cardiovascular event were 0.751 and 0.714. Mean utilities were 0.691 within 3 months of, 0.691 3–6 months after, and 0.714 6–12 months after, a major cardiovascular event. Cardiovascular event-specific utility decrements were 0.05 (0.007) for major cardiovascular events over the same time periods. Decrements of 0.051 (0.012; myocardial infarction), 0.111 (0.022; stroke), 0.065 (0.014; hospitalization for heart failure) 0.019 (0.024; hospitalization for hypoglycemia) were estimated; all coefficients were statistically significant. Interpretation: Consistent with clinical outcomes reported elsewhere, saxagliptin did not improve HRQoL. Cardiovascular complications were associated with significantly decreased HRQoL, most substantial earlier after the event. Funding: BMS/AZ.