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Table 5 Changes in Clinical Laboratory and Safety Parameters (Safety Population)

From: The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis

  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)
  1. HDL High-density lipoprotein, LDL Low-density lipoprotein, QTcB QT interval corrected for heart rate using the Bazett formula, QTcF QT interval corrected for heart rate using the Fridericia formula
  2. aN1 is the subset of patients who met baseline criteria and had ≥1 nonmissing postbaseline value during open-label treatment; n is the subset of N1 who met the criteria during the open-label treatment period
  3. bNormotensive: systolic blood pressure < 120 mmHg and diastolic blood pressure < 80 mmHg; stage I hypertension: systolic blood pressure 140–159 mmHg or diastolic blood pressure 90–99 mmHg; Stage II hypertension: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg