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Background: The Acarbose Cardiovascular Evaluation (ACE) trial (ISRCTN91899513) evaluated the alpha‐glucosidase inhibitor acarbose, compared with placebo, in 6522 patients with coronary heart disease and impaired glucose tolerance in China and showed a reduced incidence of diabetes. We assessed the within‐trial medical resource use and costs, and quality‐adjusted life years (QALYs). Methods: Resource use data were collected prospectively within the ACE trial. Hospitalizations, medications, and outpatient visits were valued using Chinese unit costs. Medication use was measured in drug days, with cardiovascular and diabetes drugs summed across the trial by participant. Health‐related quality of life was captured using the EuroQol‐5 Dimension‐3 Level questionnaire. Regression analyses were used to compare resource use, costs, and QALYs, accounting for regional variation. Costs and QALYs were discounted at 3% yearly. Results: Hospitalizations were 6% higher in the acarbose arm during the trial (rate ratio 1.06, p =.009), but there were no significant differences in total inpatient days (rate ratio 1.04, p =.30). Total costs per participant, including study drug, were significantly higher for acarbose (¥ [Yuan] 56 480, £6213), compared with placebo (¥48 079, £5289; mean ratio 1.18, p < 0.001). QALYs reported by participants in the acarbose arm (3.96 QALYs) were marginally higher than in the placebo arm (3.95 QALYs), but the difference was not statistically significant (0.01 QALYs; p =.58). Conclusions: Acarbose, compared with placebo, participants cost more due to study drug costs and reported no statistically significant difference in QALYs. These higher within‐trial costs could potentially be offset in future by savings from the acarbose‐related lower incidence of diabetes. [ABSTRACT FROM AUTHOR]

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., (© 2022 The Authors. Journal of Diabetes published by Ruijin Hospital, Shanghai JiaoTong University School of Medicine and John Wiley & Sons Australia, Ltd.)