Intensive glucose, blood pressure, or lipid control had no significant negative impact on health utility or quality-adjusted life years in the ACCORD Trial [abstract 134-OR]
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ACCORD study is a multicenter randomized trial to compare cardiovascular disease (CVD) outcomes in 10,251 high-CVD risk participants with type 2 diabetes receiving intensive or standard glucose, blood pressure (BP), and lipid control strategies. Here we report the impact of the ACCORD interventions on health-related quality of life (HRQOL), measured by Health Utilities Index Mark 3(HUI-3) and the Feeling Thermometer (FT) and quality adjusted life years (QALY)s, calculated as the product of survival time and HUI or FT score. HUI-3 and FT were measured at the baseline and repeated at 12, 36, 48 month visit, and the end of the study. We analyzed the change in HUI-3 and FT measures as a function of follow-up time, and of which glucose, BP, and lipid treatment strategies the patient was randomly assigned to. Tests of significance were done using general linear models for repeated measures. Differences in QALYs by treatment strategy were assessed using analysis of variance model. During a mean follow up of 5 years (range 3.4 to 8.5 years), no difference could be detected between groups in HUI and FT scores at the baseline and the end of the study (P values for testing all group difference were greater than 0.10). No significant difference was detected in total QALYs calculated using either HUI-3 scores or FT scores (P values for testing all group difference were greater than 0.20). These results indicate that intensive glucose, BP, and lipid control as implemented in the ACCORD trial in subjects with established type 2 diabetes did not significantly alter patient-reported measures of health utility or QALYs. While, no adverse effect of intensive glucose, BP, or lipid control were observed on measures of HRQOL or QALYs in the ACCORD Trial, the resources needed for implementing the interventions in relation to benefits as measured by other clinical outcomes should be taken into consideration for policy formulation.