P6271The effect of semaglutide once weekly on MACE and blood pressure by race and ethnicity: SUSTAIN 6 post hoc analysis (2019)

Abstract Background In SUSTAIN 6, subcutaneous semaglutide once weekly added to standard of care significantly reduced major adverse cardiovascular events (MACE: non-fatal myocardial infarction, non-fatal stroke or death) vs placebo over 2 years in T2D subjects. Purpose Assess the effect of semaglutide vs placebo on MACE and blood pressure (BP) by race and ethnicity in a post hoc analysis of SUSTAIN 6. Methods Subjects were randomised to semaglutide 0.5 mg, 1.0 mg or volume-matched placebo. Data for the two semaglutide-dose groups were pooled and compared to the pooled placebo groups. Time-to-event data were analysed with a Cox proportional hazards model. Changes from baseline to week 104 were analysed using analysis of covariance. The interaction between treatment and subgroup was added to the models. Results Overall, 3,297 patients received treatment. Subgroups included Caucasian, Asian, Black/African American, Other (race), and Hispanic, non-Hispanic (ethnicity). Mean baseline characteristics were similar across subgroups (age 64.7 years, HbA1c 8.7%, diabetes duration 14.2 years). Time to composite MACE and individual components were improved with semaglutide across all subgroups. Semaglutide affected BP similarly across race and ethnicity, except for systolic BP in Black/African American subjects (Table). Race Ethnicity Caucasian Asian Black/African American Other Interaction p-value Hispanic Non-Hispanic Interaction p-value Semaglutide (n) 1,384 121 108 35 256 1,392 Placebo (n) 1,352 152 113 32 254 1,395 MACE and individual outcomes MACE HR [95% CI] 0.76 [0.58; 1.00] 0.58 [0.25; 1.34] 0.72 [0.23; 2.28] 0.46 [0.08; 2.50] 0.8793 0.67 [0.33; 1.36] 0.74 [0.57; 0.96] 0.7978 CV death HR [95% CI] 0.98 [0.63; 1.50] 0.32 [0.04; 2.85] 1.01 [0.06; 16.20] n/a† 0.8089 0.79 [0.31; 2.00] 1.00 [0.63; 1.59] 0.6521 Non-fatal MI HR [95% CI] 0.69 [0.45; 1.07] 0.97 [0.36; 2.60] 1.37 [0.31; 6.12] 0.31 [0.03; 3.00] 0.6637 0.65 [0.18; 2.31] 0.74 [0.50; 1.10] 0.8562 Non-fatal stroke HR [95% CI] 0.70 [0.42; 1.16] 0.31 [0.04; 2.77] n/a‡ n/a‡ 0.9176 0.73 [0.16; 3.27] 0.60 [0.36; 0.99] 0.7995 Blood pressure at week 104 Systolic BP* ETD (mmHg) [95% CI] −1.92 [−3.09; −0.74] −4.98 [−8.61; 1.35] 4.47 [0.15; 8.79] −11.02 [−18.45; −3.60] 0.0008 −3.22 [−5.93; −0.51] −1.81 [−2.98; −0.64] 0.3489 Diastolic BP* ETD (mmHg) [95% CI] 0.36 [−0.32; 1.04] −1.31 [−3.43; 0.80] −0.07 [−2.56; 2.43] −3.41 [−7.73; 0.92] 0.1871 −0.18 [−1.75; 1.39] 0.16 [−0.52; 0.83] 0.6981 *Treatment difference between semaglutide and placebo (pooled 0.5 and 1.0 mg values for each treatment group) at week 104. †No events in the placebo group; ‡No events in the semaglutide group. BP, blood pressure; CI, confidence interval; ETD, estimated treatment difference; HR, hazard ratio; MACE, major adverse cardiovascular event; MI, myocardial infarction. Conclusion Overall there was no evidence of a differential effect of semaglutide on risk reduction in MACE and its components and on BP across race and ethnicity subgroups in this post hoc analysis. Acknowledgement/Funding Novo Nordisk A/S