Health utilities in Chinese patients with coronary heart disease and impaired glucose tolerance (ACE): A longitudinal analysis of a randomized, double-blind, placebo-controlled trial.

BACKGROUND: We estimate health-related quality of life and the impact of four cardiovascular events (myocardial infarction [MI], stroke, congestive heart failure, angina) and gastrointestinal events in 6522 Chinese patients with coronary heart disease (CHD) and impaired glucose tolerance (IGT) participating in the Acarbose Cardiovascular Evaluation (ACE) trial. METHODS: Health-related quality of life was captured using the EuroQol-5 Dimension-3 Level (EQ-5D-3L), with data collected at baseline and throughout the trial. Multilevel mixed-effects linear regression with random effects estimated health-related quality of life over time, capturing variation between hospital sites and individuals, and a fixed-effects linear model estimated the impact of cardiovascular and gastrointestinal events. RESULTS: Patients were followed for a median of 5 years (interquartile range 3.4-6.0). The average baseline EQ-5D score of 0.930 (SD 0.104) remained relatively unchanged over the trial period with no evidence of statistically significant differences in EQ-5D score between randomized treatment groups. The largest decrement in the year of an event was estimated for stroke (-0.107, P < .001), followed by heart failure (-0.039, P = .022), MI (-0.021, P = .047), angina (-0.012, P = .047), and gastrointestinal events (-0.005, P = .430). MI and stroke reduced health-related quality of life beyond the year in which the event occurred (-0.031, P = .006, and -0.067, P < .001, respectively). CONCLUSIONS: Acarbose treatment had no impact on health-related quality of life in ACE trial participants with CHD and IGT. Events such as MI, stroke, heart failure, and angina reduce health-related quality of life around the time they occurred, but only MI and stroke impacted on longer-term health-related quality of life.