Skip Navigation
Department of Health and Human Services www.hhs.gov
 
Slide Tray
0 slides

Return to Slide Library

Slides

Add Presentation to Slide Tray Presentation:

First- and Second-Generation Antipsychotics for Children and Young Adults

Slide: 35 of 43

Adverse Effects: Second-Generation Antipsychotics Versus Placebo (2 of 2)

The risks and severity of the key adverse effects of extrapyramidal symptoms (EPS), somnolence, and prolactin levels were examined for the second-generation antipsychotics (SGAs) in pediatric use.

Extrapyramidal Symptoms

  • During treatment with aripiprazole, the risk of EPS is 4.2 times that of the placebo group (statistically valid range from 2.4-fold to 7.2-fold). With this elevation in risk, when compared with the placebo group, one in four patients will exhibit EPS. The strength of evidence for this finding is moderate.
  • The risk of EPS with olanzapine was not reported. Quetiapine demonstrated no statistically significant difference from placebo. The strength of evidence for this finding is low.
  • The risk of EPS is elevated 2.7-fold with risperidone (statistically valid range from 1.4-fold to 4.9-fold). With this elevation of risk, when compared with the placebo group, 1 in every 15 patients will develop EPS. The strength of evidence for this finding is moderate.
  • The risk of EPS is elevated 10.3-fold with ziprasidone when compared with placebo (statistically valid range from 1.4-fold to 75-fold). With this elevation of risk, when compared with the placebo group, one in every nine patients will develop EPS. The strength of evidence for this finding is low.

Somnolence

  • The risk of somnolence is elevated 2.7-fold during treatment with aripiprazole when compared with placebo (statistically valid range from 1.1-fold to 6.5-fold). With this elevation of risk, when compared with the placebo group, 1 in every10 patients will exhibit somnolence. The strength of evidence for this finding is low.
  • The risk of somnolence during treatment with olanzapine is not statistically significantly different from placebo. The strength of evidence for this finding is low.
  • The risk of somnolence is elevated 3.4-fold during treatment with quetiapine when compared with placebo (statistically valid range from 2.0-fold to 5.8-fold). With this elevation of risk, when compared with the placebo group, one in every four patients will exhibit somnolence. The strength of evidence for this finding is low.
  • The risk of somnolence is elevated 2.9-fold during treatment with risperidone when compared with placebo (statistically valid range from 1.5-fold to 5.5-fold). With this elevation of risk, when compared with the placebo group, one in every four patients will exhibit somnolence. The strength of evidence for this finding is moderate.
  •  The risk of somnolence is elevated 3.0-fold during treatment with ziprasidone, when compared with placebo (statistically valid range from 1.7-fold to 5.2-fold). With this elevation of risk, when compared with the placebo group, one in every seven patients will exhibit somnolence. The strength of evidence for this finding is moderate.

 Prolactin Levels

  • Prolactin levels are 4.1 ng/mL lower than in the placebo group during treatment with aripiprazole (statistically valid range from 1.8 ng/mL lower to 6.3 ng/mL lower). The strength of evidence for this finding is moderate.
  • During treatment with olanzapine, prolactin levels are 11.5 ng/mL higher than in the placebo group (statistically valid range from 8.8 ng/mL higher to 14.1 ng/mL higher). The strength of evidence for this finding is moderate.
  • No statistically significant difference was found between prolactin levels during treatment with quetiapine when compared with the placebo group. The strength of evidence for this finding is low.
  • During treatment with risperidone, prolactin levels are 22.6 ng/mL higher than in the placebo group (statistically valid range from 10.7 ng/mL higher to 34.5 ng/mL higher). The strength of evidence for this finding is low.
  • The evidence about ziprasidone effects on prolactin levels is insufficient to permit conclusions.