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Table 3 Change in laboratory parameters from double-blind acute phase baseline

From: Long-term use of lurasidone in patients with bipolar disorder: safety and effectiveness over 2 years of treatment

 

Baseline means

Median change (from double-blind acute phase baseline)

6-week double-blind N = 122

6-month extension N = 120–122

Current study N = 98–103

Month 12 (OC)

Month 24 (OC)

n

Median

n

Median

Total cholesterol, mg/dL

195.5

188.7

197.9

111

+5.0

54

−3.0

LDL cholesterol, mg/dL

116.8

110.2

117.5

108

−4.5

53

−10.0

HDL cholesterol, mg/dL

50.5

50.4

50.3

112

1.0

54

−1.0

Triglycerides, mg/dL

151.5

151.0

157.6

111

+10.0

54

+26.0

Glucose, mg/dL

91.1

93.1

93.7

112

+2.5

54

+3.5

HbA1c, %

5.3

5.3

5.4

112

0.0

53

−0.1

Prolactin, ng/mL

10.9

13.1

13.7

112

+0.8

54

+0.6

Prolactin, males

10.1 (N = 64)

9.5 (N = 64)

8.3 (N = 52)

59

−0.2

27

+0.2

Prolactin, females

11.7 (N = 58)

17.3 (N = 57)

19.3 (N = 51)

53

+1.4

27

+0.6

  1. Month 12 = 6 months of Extension + 6 months of Maintenance treatment; Month 24 = 6 months of Extension + 18 months of Continuation treatment (patients randomized to lurasidone in the initial double-blind acute treatment study had an additional 6 weeks of exposure to lurasidone)
  2. HbA1c glycosylated hemoglobin, LDL low-density lipoprotein, HDL high-density lipoprotein, OC observed case analysis