Table 3.
Tolerability and safety of lurasidone treatment (safety population)
| Placebo (N = 49) | Lurasidone 20 mg/day (N = 49) | Lurasidone 60 mg/day (N = 51) | |
|---|---|---|---|
| A. Treatment-emergent adverse events (incidence ≥5 % a ), n (%) | |||
| Any adverse event | 28 (57) | 35 (71) | 38 (75) |
| Vomiting | 2 (4) | 4 (8) | 14 (28) |
| Somnolence | 2 (4) | 3 (6) | 9 (18) |
| Nasopharyngitis | 0 (0) | 5 (10) | 3 (6) |
| Akathisia | 0 (0) | 3 (6) | 3 (6) |
| Fatigue | 1 (2) | 1 (2) | 4 (8) |
| Weight increased | 1 (2) | 1 (2) | 4 (8) |
| Cough | 2 (4) | 2 (4) | 3 (6) |
| Sedation | 1 (2) | 3 (6) | 1 (2) |
| Constipation | 1 (2) | 0 (0) | 3 (6) |
| Nausea | 0 (0) | 2 (4) | 3 (6) |
| B. Change in weight, BMI, and fasting laboratory parameters (week 6 b ) | |||
| Weight, kg | |||
| LS mean (SE) change | +0.4 (0.2) | +0.5 (0.2) | +1.2 (0.2)d |
| Mean (SD) change in percentile | −0.9 (6.6) | +0.8 (5.4) | +2.7 (6.5) |
| LS mean (SE) z-score change | −0.02 (0.03) | +0.02 (0.03) | +0.09 (0.03) |
| BMI (kg/m2) | |||
| LS mean (SE) change | −0.0 (0.1) | −0.04 (0.1) | +0.4 (0.1) |
| Mean (SD) change in percentile | −1.1 (7.6) | +0.3 (6.5) | +3.3 (9.5) |
| LS mean (SE) z-score change | −0.02 (0.04) | −0.02 (0.04) | +0.1 (0.04) |
| Waist circumference, cm, mean (SD) change | +0.5 (3.0) | +0.2 (1.6) | +1.1 (2.6) |
| Cholesterol (mg/dL, median change)c | −5.0 | +6.0 | +7.5 |
| Triglycerides (mg/dL, median change)c | −4.0 | +1.0 | +15.0 |
| Glucose (mg/dL, median change)c | −5.0 | −1.0 | −1.0 |
| HbA1c (%, mean (SD) change) | +0.0 (0.3) | +0.1 (0.2) | +0.1 (0.4) |
| Prolactin (ng/mL, mean (SD) change) | −0.1 (5.9) | −0.2 (9.0) | +2.3 (13.9) |
BMI body mass index, HbA1c glycosylated hemoglobin
aAdverse events shown where incidence on lurasidone > placebo
bEndpoint data, except for weight and BMI, which were analyzed by MMRM
cFasting subjects: placebo (n = 36); lurasidone 20 mg/day (n = 37); lurasidone 60 mg/day (n = 45)
d p value (vs. placebo): 0.015