Quality of life (QoL) reductions associated with new adverse events in secondary prevention of CVD, UK and US perspectives.
death, anxiety/depression, cancer, nonhemorrhagic stroke, heart failure, diabetes
MYOCARDIAL INFARCTION, OBESE, CARDIOVASCULAR DISEASE, ADVERSE EVENTS, CVD, EVENT, CANCER, ATRIAL FIBRILLATION, ADVERSE EVENT, REGRESSION, EVENTS, HEART FAILURE, DIABETES
Data of the 19 321 REVEAL participants randomized in Europe and North America was used in both analyses from the UK and US perspectives. EQ‐5D utility values for all 19 321 contributing participants were calculated using the UK or US EQ‐5D value sets, respectively. EQ‐5D is a standardized instrument used to measure health‐related QoL across 5 domains (mobility, self‐care, usual activities, pain/discomfort, anxiety/depression). By combining the scores of each dimension, the EQ‐5D generates a health state profile, which can be converted into a single summary index score. The index score represents an individual's overall health status on a scale where 1.0 denotes perfect health, 0.0 represents death, and negative values indicate health states considered worse than death. QoL reductions associated with adverse events, by duration of time between latest adverse event from each category and EQ‐5D QoL measure at the end of the trial (≤1 year, 1–2 years, and >1 or >2 years), were estimated using a linear regression model with adjustments for sociodemographic and clinical characteristics. We were unable to detect QoL reductions associated with myocardial infarction, coronary revascularization (urgent, nonurgent), and incident diabetes, so these events were not included in the model. CVD indicates cardiovascular disease; EQ‐5D, EuroQol‐5 Dimensions; N, number of people who experienced the event in the study before QoL measure at final follow‐up in the study; QoL, quality of life; REVEAL, Randomized Evaluation of the Effects of Anacetrapib Through Lipid Modification; UK, United Kingdom; and US, United States.For nonhemorrhagic stroke, this impact on QoL persisted in all subsequent years. For other adverse events, QoL improved in subsequent years though for most remained lower compared with not experiencing new event. Reductions in QoL were observed in years following heart failure admission (United Kingdom: 1–2 years after year of event: −0.094 [95% CI, −0.123 to −0.064], >2 years: −0.013 [95% CI, −0.040 to 0.013]; United States: 1–2 years after year of event: −0.086 [95% CI, −0.117 to −0.056]; >2 years: −0.032 [95% CI, −0.058 to −0.007]), noncoronary revascularization (United Kingdom: 1–2 years after year of event: −0.041 [95% CI, −0.064 to −0.017], >2 years: 0.000 [95% CI, −0.018 to 0.018]; United States:1–2 years after year of event: −0.048 [95% CI, −0.072 to −0.023]; >2 years: −0.018 [95% CI, −0.035 to −0.001]) and incident cancer (for all years following the year of event United Kingdom: −0.032 [95% CI, −0.044 to −0.019]; United States: −0.036 [95% CI, −0.048 to −0.023]) (Figure We were unable to detect reductions in QoL associated with MI, CRV (urgent or nonurgent), and incident diabetes so these events were not included in the final models. Independent of the occurrence of adverse events, older age, being female, a current smoker, obese, having atrial fibrillation, and reduced kidney function were all associated with lower QoL (Table The impacts of event were similar in scenario analyses of QoL reduction using only UK or North American participant data, though with increased uncertainty due to the smaller number of events (Table 