Abstract
Purpose :
To examine the impact of systemic DPP-4 inhibitor use on visual and anatomic outcomes in patients with DME.
Methods :
VISTA and VIVID were two similarly designed phase 3 trials that treated 461 and 404 DME patients, respectively, with IAI 2 mg q4 weeks(2q4), IAI 2 mg q8 weeks following 5 monthly doses (2q8), or laser control with monthly follow-up through week 100. Starting at week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8 following 5 monthly doses. Patients’ systemic medications were recorded at baseline (BL) and each subsequent visit. Based on reported use of a DPP-4 inhibitor at BL, patients were assigned to either (+) DPP-4 or (-) DPP-4 subgroup. Visual and anatomic outcomes at week 100 were evaluated for each subgroup. For patients receiving rescue treatment, data were censored at time of rescue treatment.
Results :
At BL, 10% (n=290), 15% (n=286), and 12% (n=286) of patients in the 2q4, 2q8, and laser control groups, respectively, reported use of a DPP-4 inhibitor. BL BCVA and CRT values were balanced across the (+) and (-) DPP-4 subgroups. In the (+) DPP-4 subgroup, mean change in BCVA at week 100 was +13.4, +9.7, and +1.1 letters in the 2q4, 2q8, and laser control groups, respectively. Corresponding mean change in the (-) DPP-4 subgroup was +11.3, +10.4, +0.7 letters, respectively. At week 100, mean change in CRT in the (+) DPP4 subgroup was -220.7, -195.1, -81.2 mm, in the 2q4, 2q8, and laser control groups, respectively. Corresponding mean change in the (-) DPP-4 subgroup was -198.9, -193.0, -85.2 mm, respectively. At week 100, the proportion of patients with ≥2-step Diabetic Retinopathy Severity Scale score improvement in 2q4, 2q8, and laser control groups was 44%, 40%, and 19%, respectively, in (+) DPP-4 patients. In (-) DPP-4 patients, corresponding proportions were 35%, 36%, and 13%, respectively. The most frequent ocular serious adverse event at week 100 was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and laser control, respectively).
Conclusions :
In VIVID and VISTA, a minority of patients reported taking a DPP-4 inhibitor at BL. DPP-4 inhibitor use at BL did not appear to influence visual and anatomic outcomes in patients with DME treated with IAI or laser control through week 100.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.