Randomized trial evaluates health-related quality of life improvements in adults after 2 years of tirzepatide or intensified conventional care treatment.
Introduction and Objective: Tirzepatide (TZP), a GIP/GLP-1 RA, showed superior glycemic control, weight and waist circumference reduction at 2 years vs intensified conventional care (ICC) in adults on metformin treatment in the SURPASS-EARLY trial. We evaluated the HRQoL of adults receiving TZP or ICC in this study. Methods: Adults with T2D, inadequately controlled with diet, exercise, and metformin were randomized (1:1) to QW TZP 15 mg or maximum tolerated dose (MTD) or ICC for 2 years. Changes from baseline to Weeks 56 and 104 were assessed for the IWQOL-Lite-CT, SF-36v2 acute form, APPADL, and IW-SP. Results: Overall, 794 participants with mean age 53.5 years, duration of T2D 2.6 years, HbA1c 7.8%, and BMI 35.4 kg/m2 were randomized. Participants in the TZP 15 mg or MTD group had improved IQWOL-Lite-CT total, SF-36v2 PCS, APPADL total, and IW-SP total scores vs baseline, and vs participants in the ICC group, at Weeks 56 and 104 (all p<0.05; Table). A significant improvement in SF-36v2 MCS score was seen in the TZP 15 mg or MTD group vs baseline (p<0.05) but not vs the ICC group at Week 56. Conclusion: In alignment with the overall results of SURPASS-EARLY, TZP treatment significantly improved overall physical and psychosocial functioning and health, as well as weight-related QoL - specifically the ability to perform daily activities and self-perception - compared with ICC in the trial. Disclosure K.S. Boye: Employee; Current; Lilly. Stock/Shareholder; Current; Lilly. P. Sharma: None. A. Choudhury: Employee; Current; Eli Lilly and Company. E. Gomez: Employee; Current; Eli Lilly and Company. S.E. Williamson: Consultant; Current; Eli Lilly and Company. V. Thieu: None. Funding Eli Lilly and Company (no reference number)
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