期刊
JOURNAL OF ATTENTION DISORDERS
卷 24, 期 3, 页码 402-413出版社
SAGE PUBLICATIONS INC
DOI: 10.1177/1087054717696771
关键词
triple-bead mixed amphetamine salts; efficacy; safety and tolerability
资金
- Shire Development LLC (Lexington, MA)
- Shire
Objective: Evaluate the efficacy and tolerability of triple-bead mixed amphetamine salts (MAS) in ADHD. Method: Adults with ADHD Rating Scale IV (ADHD-RS-IV) total scores >= 32 were randomized to 6 weeks of triple-bead MAS (25, 50, or 75 mg) or placebo. The primary endpoint was ADHD-RS-IV total score change from baseline at end of study (EOS). Results: Least squares mean (95% confidence interval [CI]) treatment differences for ADHD-RS-IV total score changes from baseline to EOS significantly favored triple-bead MAS (all doses combined: -10.6 [-13.2, -8.0]; p < .0001); there were no significant differences between triple-bead MAS dosages. The most frequently reported TEAEs with triple-bead MAS (all doses combined) included insomnia, decreased appetite, and dry mouth. Mean +/- SD pulse and systolic blood pressure increases at EOS were 3.5 +/- 10.33 bpm and 0.3 +/- 10.48 mmHg with triple-bead MAS (all doses combined). Conclusion: Triple-bead MAS significantly reduced adult ADHD symptoms; the safety profile was consistent with previous triple-bead MAS studies.
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