Table 4.
Study 3201 Change from Baseline for Serum Urate by Sex and SLC2A9 Variant rs7442295 Genotype Subgroups (μmol/L).
| Visit | Genotype | Sex | Iloperidone LS Mean Change (SE), n | Placebo LS Mean Change (SE), n | LS Mean Difference (95% CI) | p-value |
|---|---|---|---|---|---|---|
| Day 28 | AA | F | 25.48 (9.16), 34 | −2.37 (9.06), 34 | 27.85 (2.93, 52.76) | 0.0286 |
| Day 28 | AA | M | 28.89 (8.7), 39 | −6.62 (8.58), 40 | 35.52 (12.82, 58.22) | 0.0023 |
| Day 28 | AG | F | 0.06 (10.14), 27 | 7.96 (9.87), 29 | −7.9 (−34.82, 19.03) | 0.5641 |
| Day 28 | AG | M | 53.41 (10.84), 24 | 12.62 (8.7), 39 | 40.79 (14.61, 66.96) | 0.0024 |
| Day 28 | GG | F | −0.19 (19.49), 7 | −3.27 (20.1), 7 | 3.08 (−50.97, 57.13) | 0.9107 |
| Day 28 | GG | M | 65.61 (15.42), 11 | −37.35 (23.02), 5 | 102.96 (48.93, 156.99) | 0.0002 |
Results of ANCOVA model of change from Baseline to either Day 28 or EOS evaluations for serum urate in Study 3201 (Bipolar Mania). LS mean change from Baseline to Day 28 shown for each genotype and sex, with standard error (SE) and n observed cases. LS means difference shown with 95% CI. Abbreviations: ANCOVA = Analysis of Covariance. CI = Confidence Interval. LS = Least Squares. Baseline is defined as the latest non-missing observation across all the visits in the Screening Phase before the first dose of study medication. LS means, CIs, and p-values are based on ANCOVA model with main effects of treatment group, pooled site, sex, genetic group and baseline, interaction effects of treatment group, genetic group, and sex as a covariate. P-value represents the difference between iloperidone and placebo groups.