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Effect size of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder.
Postgrad Med 2011; 123(2):169-76PM

Abstract

OBJECTIVE

To examine duration of efficacy of lisdexamfetamine dimesylate (LDX) in adults with attention-deficit/hyperactivity disorder (ADHD) by effect size in performance and symptom improvement in a simulated adult workplace environment (AWE).

METHODS

Adults (aged 18-55 years) with ADHD enrolled in the AWE study of LDX with open-label dose-optimization and randomized, placebo-controlled, double-blind, 2-way crossover phases. Efficacy measures included the Permanent Product Measure of Performance (PERMP)-Attempted (-A) and PERMP-Correct (-C) scores assessed throughout the day and the ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts. Model-based least-squares (LS) mean effect size was assessed for PERMP and post-hoc ADHD-RS-IV with adult prompts. Remission was defined as an ADHD-RS-IV total scores ≤ 18. Safety assessments included treatment-emergent adverse events (TEAEs) and vital signs.

RESULTS

Least-squares mean (standard error [SE]) effect sizes were 0.9 (0.17) for PERMP-A and 0.8 (0.16) for PERMP-C for all postdose sessions. For PERMP-A, postdose LS mean (SE) effect sizes were 0.5 (0.15), 0.8 (0.16), 0.7 (0.16), 0.7 (0.16), 0.7 (0.16), and 0.6 (0.16) at 2, 4, 8, 10, 12, and 14 hours, respectively. Medium-to-large effect sizes (0.5-0.8) were generally maintained from 2 to 14 hours for all PERMP assessments. Overall LS mean (SE) ADHD-RS-IV total and subscale effect sizes were -1.2 (0.19), -1.2 (0.19), and -1.0 (0.17), respectively. Remission was achieved in 67.6% of participants receiving LDX. Treatment-emergent adverse events (≥ 5% with LDX) during the 4-week dose-optimization phase were decreased appetite, dry mouth, headache, insomnia, upper respiratory tract infection, irritability, nausea, anxiety, and feeling jittery. During the crossover week on LDX, there were no TEAEs ≥ 5%.

CONCLUSIONS

In adults studied in the AWE, medium-to-large model-based effect sizes were maintained from 2 to 14 hours postdose, on a performance-based measure of productivity, suggesting participants experienced improvement in sustained attention throughout the day and into the evening hours. Lisdexamfetamine dimesylate demonstrated a safety profile consistent with long-acting stimulants.

Authors+Show Affiliations

University of California, Irvine, Child Development Center, Irvine, CA 92612, USA. tlwigal@uci.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21474905

Citation

Wigal, Timothy, et al. "Effect Size of Lisdexamfetamine Dimesylate in Adults With Attention-deficit/hyperactivity Disorder." Postgraduate Medicine, vol. 123, no. 2, 2011, pp. 169-76.
Wigal T, Brams M, Gasior M, et al. Effect size of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. Postgrad Med. 2011;123(2):169-76.
Wigal, T., Brams, M., Gasior, M., Gao, J., & Giblin, J. (2011). Effect size of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. Postgraduate Medicine, 123(2), pp. 169-76. doi:10.3810/pgm.2011.03.2275.
Wigal T, et al. Effect Size of Lisdexamfetamine Dimesylate in Adults With Attention-deficit/hyperactivity Disorder. Postgrad Med. 2011;123(2):169-76. PubMed PMID: 21474905.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect size of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. AU - Wigal,Timothy, AU - Brams,Matthew, AU - Gasior,Maria, AU - Gao,Joseph, AU - Giblin,John, PY - 2011/4/9/entrez PY - 2011/4/9/pubmed PY - 2011/6/4/medline SP - 169 EP - 76 JF - Postgraduate medicine JO - Postgrad Med VL - 123 IS - 2 N2 - OBJECTIVE: To examine duration of efficacy of lisdexamfetamine dimesylate (LDX) in adults with attention-deficit/hyperactivity disorder (ADHD) by effect size in performance and symptom improvement in a simulated adult workplace environment (AWE). METHODS: Adults (aged 18-55 years) with ADHD enrolled in the AWE study of LDX with open-label dose-optimization and randomized, placebo-controlled, double-blind, 2-way crossover phases. Efficacy measures included the Permanent Product Measure of Performance (PERMP)-Attempted (-A) and PERMP-Correct (-C) scores assessed throughout the day and the ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts. Model-based least-squares (LS) mean effect size was assessed for PERMP and post-hoc ADHD-RS-IV with adult prompts. Remission was defined as an ADHD-RS-IV total scores ≤ 18. Safety assessments included treatment-emergent adverse events (TEAEs) and vital signs. RESULTS: Least-squares mean (standard error [SE]) effect sizes were 0.9 (0.17) for PERMP-A and 0.8 (0.16) for PERMP-C for all postdose sessions. For PERMP-A, postdose LS mean (SE) effect sizes were 0.5 (0.15), 0.8 (0.16), 0.7 (0.16), 0.7 (0.16), 0.7 (0.16), and 0.6 (0.16) at 2, 4, 8, 10, 12, and 14 hours, respectively. Medium-to-large effect sizes (0.5-0.8) were generally maintained from 2 to 14 hours for all PERMP assessments. Overall LS mean (SE) ADHD-RS-IV total and subscale effect sizes were -1.2 (0.19), -1.2 (0.19), and -1.0 (0.17), respectively. Remission was achieved in 67.6% of participants receiving LDX. Treatment-emergent adverse events (≥ 5% with LDX) during the 4-week dose-optimization phase were decreased appetite, dry mouth, headache, insomnia, upper respiratory tract infection, irritability, nausea, anxiety, and feeling jittery. During the crossover week on LDX, there were no TEAEs ≥ 5%. CONCLUSIONS: In adults studied in the AWE, medium-to-large model-based effect sizes were maintained from 2 to 14 hours postdose, on a performance-based measure of productivity, suggesting participants experienced improvement in sustained attention throughout the day and into the evening hours. Lisdexamfetamine dimesylate demonstrated a safety profile consistent with long-acting stimulants. SN - 1941-9260 UR - https://www.unboundmedicine.com/medline/citation/21474905/Effect_size_of_lisdexamfetamine_dimesylate_in_adults_with_attention_deficit/hyperactivity_disorder_ L2 - http://www.tandfonline.com/doi/full/10.3810/pgm.2011.03.2275 DB - PRIME DP - Unbound Medicine ER -