te discontinuation of risperidone.
Data from an 8-week double-blind, placebo-controlled study with PERSERIS in adult subjects with schizophrenia are presented in TABLE 1.
Table 1. Changes in Fasting Glucose from Baseline to End of Study (EOS) and Postbaseline Abnormal Values of Glucose > 126 mg/dL in an 8-Week Double-Blind, Placebo-Controlled Study in Adult Subjects with Schizophrenia
† The “n”s in the Serum Glucose mean row are the number of subjects with data at baseline and EOS visits.
‡ Data shown as number of subjects with at least one postbaseline value as denominator and number of subjects satisfying the predefined criterion as numerator.
PERSERIS
90 mg PERSERIS
120 mg Placebo
n = 98 n = 106 n = 96
Serum Glucose, mg/dL, mean†
Mean Change from Baseline to EOS 5.7 6.3 -0.9
Glucose, > 126 mg/dL
Proportion of Subjects with Postbaseline Abnormal Values‡ 12/104 (11.5%) 14/111 (12.6%) 8/109 (7.3%)
Similar changes from baseline in serum glucose were observed in subjects receiving PERSERIS during an open-label, 12-month long-term safety study. Additionally, the mean HbA1c increased from 5.6 to 5.7% over the 12 months.
Dyslipidemia
Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
Data from an 8-week double-blind, placebo-controlled study with PERSERIS in adult subjects with schizophrenia are presented in TABLE 2.
Table 2. Changes in Cholesterol from Baseline to End of Study (EOS) and Postbaseline Abnormal Values of Cholesterol ≥ 300 mg/dL in an 8-Week Double-Blind, Placebo-Controlled Study in Adult Subjects with Schizophrenia
† The “n”s in the Cholesterol mean row are the number of subjects with data at baseline and EOS visits.
‡ Data shown as number of subjects with at least one postbaseline value as denominator and number of subjects satisfying the predefined criterion as numerator.
PERSERIS
90 mg PERSERIS
120 mg Placebo
Cholesterol, mg/dL, mean † n = 98 n = 106 n = 96
Mean Change from Baseline to EOS -0.5 -0.5 1.1
Cholesterol, ≥ 300 mg/dL
Proportion of Subjects with Postbaseline Abnormal Values‡ 2/104 (1.9%) 2/111 (1.8%) 2/109 (1.8%)
Weight Gain
Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.
Data from an 8-week double-blind, placebo-controlled study with PERSERIS in adult subjects with schizophrenia are presented in TABLE 3.
Table 3. Changes in Body Weight from Baseline to End of Study (EOS) and ≥ 7% Increase from Baseline in an 8-Week Double-Blind, Placebo-Controlled Study in Adult Subjects with Schizophrenia
† The “n”s in the Weight Change mean row are the number of subjects with data at baseline and end of study visits.
‡ Data shown as number of subjects with at least one postbaseline value as denominator and number of subjects satisfying the predefined criterion as numerator.
PERSERIS
90 mg PERSERIS
120 mg Placebo
Weight † n = 105 n = 112 n = 107
Mean Change from Baseline to EOS, kg 4.4 5.3 2.6
Weight Gain
≥ 7% Increa |
