Table 3 Change From Double-blind Baseline in Safety Parameters After 12-months of Treatment With Lurasidone or Risperidone, Followed by 6-months of Open-label Treatment With Lurasidone (OC analysis)
Parameter | LUR-LUR | RIS-LUR |
|---|---|---|
Weight, kg | n = 109a | n = 66a |
DB Baseline mean (SD) | 81.1 (18.25) | 82.9 (18.65) |
Mean change to OL Baseline (after 12-mo DB Tx) | −1.1 | + 2.4 |
Mean change from OL Baseline to Month 6-OL | −0.6 | −2.9 |
≥ 7% weight increase from DB Baseline, % | 12.8 | 13.6 |
≥ 7% weight decrease from DB Baseline, % | 28.4 | 18.2 |
≥ 7% weight increase from OL Baseline, % | 1.8 | 3.0 |
≥ 7% weight decrease from OL Baseline, % | 6.4 | 19.7 |
Body mass index, kg/m2 | n = 109 | n = 66 |
DB Baseline mean (SD) | 27.7 (5.3) | 28.8 (5.6) |
Mean change to OL Baseline (after 12-mo DB Tx) | −0.55 | + 2.1 |
Mean change from OL Baseline to Month 6-OL | −0.2 | −1.0 |
Waist circumference, cm | n = 104 | n = 62 |
DB Baseline mean (SD) | 93.8 (14.1) | 97.5 (14.3) |
Mean change to OL Baseline (after 12-mo DB Tx) | −0.4 | + 2.8 |
Mean change from OL Baseline to Month 6-OL | −0.9 | −1.6 |
Total cholesterol, mg/dL | n = 108 | n = 64 |
DB Baseline mean (SD) | 196.4 (45.4) | 188.0 (49.0) |
Median change to OL Baseline (after 12-mo DB Tx) | −8.5 | −9.0 |
Median change from OL Baseline to Month 6-OL | −4.0 | + 4.5 |
Triglycerides, mg/dL | n = 108 | n = 64 |
DB Baseline mean (SD) | 127.5 (57.7) | 125.5 (88.8) |
Median change to OL Baseline (after 12-mo DB Tx) | −13.0 | + 1.0 |
Median change from OL Baseline to Month 6-OL | −4.5 | −5.5 |
Glucose, mg/dL | n = 105 | n = 63 |
DB Baseline mean (SD) | 95.1 (14.5) | 94.6 (13.7) |
Median change to OL Baseline (after 12-mo DB Tx) | −1.0 | + 3.0 |
Median change from OL Baseline to Month 6-OL | 0.0 | −3.0 |
Hemoglobin A1c, % | n = 103 | n = 63 |
DB Baseline mean (SD) | 5.7 (0.4) | 5.6 (0.4) |
Median change to OL Baseline (after 12-mo DB Tx) | 0.0 | 0.0 |
Median change from OL Baseline to Month 6-OL | 0.0 | 0.0 |
Bone alkaline phosphatase, mcg/L | n = 106 | n = 61 |
DB Baseline mean (SD) | 13.6 (5.2) | 13.9 (4.3) |
Median change to OL Baseline (after 12-mo DB Tx) | −0.9 | − 0.3 |
Median change from OL Baseline to Month 6-OL | + 1.5 | 0 |
N-telopeptide (urine), nmol BCE/mmol creatinine | n = 104 | n = 62 |
DB Baseline mean (SD) | 41.2 (120.3) | 37.0 (35.8) |
Median change to OL Baseline (after 12-mo DB Tx) | + 1.5 | −4.0 |
Median change from OL Baseline to Month 6-OL | −1.0 | + 0.5 |
Osteocalcin, ng/mL | n = 104 | n = 61 |
DB Baseline mean (SD) | 5.25 (3.38) | 5.70 (4.36) |
Median change to OL Baseline (after 12-mo DB Tx) | −0.85 | −1.0 |
Median change from OL Baseline to Month 6-OL | 0 | 0 |
Parathyroid hormone, pg/mL | n = 105 | n = 61 |
DB Baseline mean (SD) | 38.6 (17.4) | 43.2 (27.8) |
Median change to OL Baseline (after 12-mo DB Tx) | 0 | −2.0 |
Median change from OL Baseline to Month 6-OL | + 2.0 | + 4.0 |
Prolactin, ng/mL, males | n = 84 | n = 43 |
DB Baseline mean (SD) | 7.7 (6.7) | 10.2 (6.5) |
Median change to OL Baseline (after 12-mo DB Tx) | −0.6 | + 12.8 |
Median change from OL Baseline to Month 6-OL | + 0.15 | −11.2 |
Prolactin, ng/mL, females | n = 24 | n = 21 |
DB Baseline mean (SD) | 20.0 (24.7) | 18.6 (40.8) |
Median change to OL Baseline (after 12-mo DB Tx) | −0.75 | + 35.2 |
Median change from OL Baseline to Month 6-OL | + 1.3 | −30.8 |
Testosterone, total, ng/dL, males | n = 84 | n = 42 |
DB Baseline mean (SD) | 498.1 (198.4) | 481.3 (231.5) |
Median change to OL Baseline (after 12-mo DB Tx) | + 24.9 | −103.0 |
Median change from OL Baseline to Month 6-OL | −23.5 | + 43.5 |
Testosterone, free, pg/mL, males | n = 84 | n = 40 |
DB Baseline mean (SD) | 10.3 (5.5) | 9.6 (6.2) |
Median change to OL Baseline (after 12-mo DB Tx) | −0.015 | −1.405 |
Median change from OL Baseline to Month 6-OL | −1.06 | −0.095 |