Cariprazine 1.5–3 mg/d n = 170 | Cariprazine 4.5–6 mg/d n = 361 | Cariprazine 9 mg/d n = 148 | Cariprazine Overall N = 679 | |
---|---|---|---|---|
Metabolic parameters, mean change (SD) | ||||
Total cholesterol, mg/dL | −2.5 (33.0) | −6.1 (29.1) | −6.4 (33.4) | −5.3 (31.1) |
Fasting LDL cholesterol, mg/dL | −1.1 (27.9) | −3.9 (25.1) | −4.9 (28.0) | −3.5 (26.4) |
HDL cholesterol, mg/dL | −0.9 (10.9) | −1.0 (11.8) | −0.3 (10.5) | −0.8 (11.3) |
Fasting triglycerides, mg/dL | 4.4 (114.4) | 2.2 (78.5) | −4.4 (74.8) | 1.2 (87.2) |
Fasting glucose, mg/dL | 5.0 (23.6) | 3.6 (23.9) | 6.3 (20.9) | 4.5 (23.2) |
Clinically relevant shifts in lipid levels and glucose, n/N1a (%) | ||||
Total cholesterol, normal/borderline (<240 mg/dL) to high (≥240 mg/dL) | 6/143 (4.2) | 11/328 (3.4) | 6/132 (4.5) | 23/603 (3.8) |
Fasting LDL cholesterol, normal/borderline (<160 mg/dL) to high (≥160 mg/dL) | 4/126 (3.2) | 5/325 (1.5) | 7/133 (5.3) | 16/584 (2.7) |
HDL cholesterol, normal (≥40 mg/dL) to low (<40 mg/dL) | 13/120 (10.8) | 45/280 (16.1) | 10/107 (9.3) | 68/507 (13.4) |
Fasting triglycerides, normal/borderline (<200 mg/dL) to high (≥200 mg/dL) | 10/119 (8.4) | 24/301 (8.0) | 13/119 (10.9) | 47/539 (8.7) |
Fasting glucose, normal (<100 mg/dL) to high (≥126 mg/dL) | 3/117 (2.6) | 11/270 (4.1) | 5/110 (4.5) | 19/497 (3.8) |
Body weight | ||||
Body weight change, kg, mean (SD) | 2.38 (4.96) | 1.61 (5.43) | 0.64 (5.76) | 1.58 (5.42) |
≥ 7% increase from baseline, n/N1a (%) | 47/161 (29.2) | 101/360 (28.1) | 34/148 (23.0) | 182/669 (27.2) |
≥ 7% decrease from baseline, n/N1a (%) | 12/161 (7.5) | 37/360 (10.3) | 24/148 (16.2) | 73/669 (10.9) |
Clinical laboratory parameters, mean change (SD) | ||||
Prolactin, ng/mL | −13.6 (26.4) | −17.1 (47.6) | −13.3 (29.3) | −15.4 (39.6) |
Alanine aminotransferase, U/L | 6.0 (44.6) | 0.9 (20.8) | 2.0 (16.5) | 2.4 (27.8) |
Aspartate aminotransferase, U/L | 1.8 (23.6) | 0.1 (12.7) | 0.1 (9.4) | 0.5 (15.5) |
Alkaline phosphatase, U/L | −0.6 (13.2) | −4.4 (32.7) | −1.4 (16.5) | −2.8 (26.1) |
Total bilirubin, mg/dL | 0.01 (0.27) | 0.03 (0.30) | 0.02 (0.24) | 0.02 (0.28) |
Creatine phosphokinase, U/L | −12.5 (218.2) | 23.5 (290.6) | 40.2 (239.0) | 18.5 (264.0) |
Cardiovascular parameters, mean change (SD) | ||||
Systolic blood pressure, mmHg | 0.6 (11.6) | 1.0 (11.1) | 0.9 (11.8) | 0.9 (11.3) |
Diastolic blood pressure, mmHg | 0.9 (8.6) | 0.0 (8.5) | 1.3 (8.9) | 0.5 (8.6) |
Pulse, bpm | −2.0 (12.4) | −1.7 (12.0) | −2.7 (11.4) | −2.0 (12.0) |
Electrocardiogram | ||||
Ventricular heart rate, bpm | −2.0 (14.3) | 0.0 (14.7) | −1.7 (13.5) | −0.9 (14.3) |
QRS interval, msec | 0.9 (6.5) | 0.8 (8.2) | −0.8 (7.4) | 0.5 (7.7) |
PR interval, msec | −2.3 (14.3) | −0.1 (15.1) | −0.4 (15.0) | −0.7 (14.9) |
QT interval, msec | 4.3 (26.7) | −1.5 (30.5) | 0.6 (28.1) | 0.4 (29.1) |
QTcB interval, msec | −1.3 (22.4) | −1.5 (22.1) | −3.7 (21.0) | −1.9 (21.9) |
QTcF interval, msec | 0.7 (16.2) | −1.5 (18.0) | −2.2 (17.1) | −1.1 (17.4) |
Shift from normotensive to Stage I or Stage II hypertension, n (%)b | 2/63 (3.2) | 3/122 (2.5) | 4/46 (8.7) | 9/231 (3.9) |