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Published online by Cambridge University Press: 15 April 2020
Previously, we reported the clinical efficacy of MPH-LA in adult ADHD evaluated in a 40-week, randomised, double-blind, placebo-controlled, multicentre core study [comprising of dose confirmation (9-week), real-life dose optimisation (5-week) and maintenance of effect phases (6- month)] (Atten Defic Hyperact Disord. 2013;(5):219–220). Here, we report the long-term efficacy from the 26-week extension phase of the same study.
During the extension phase, patients initiated treatment with MPH-LA 20 mg/day (oral, once daily capsules); uptitrated to optimal dose of 40, 60 or 80 mg/day in increments of 20 mg/week. Change in DSM-IV ADHD rating scale (RS) and SDS total scores at the end of study, were evaluated from the baseline of maintenance of effect phase of the core study and the baseline of extension phase.
At the end of the extension phase, the mean change in DSM-IV ADHD RS and SDS total scores from baseline of the maintenance of effect phase was −0.9 and −1.4 points respectively; and from baseline of extension phase was −7.2 and −4.8 respectively (Table). No new or unexpected safety concerns were observed during the extension phase.
MPH-LA continued to maintain clinical efficacy in adult ADHD patients over long-term.
Table DSM-IV ADHD RS, SDS total scores and change from baseline at the end of extension phase
DSM-IV ADHD RS N= 298 (Mean ± SD) | SDS N= 298 (Mean ± SD) | |
Week 26 Extension phase* (LOCF) | 12.0 ± 7.78 | 8.0 ± 5.46 |
Maintenance of effect phase (baseline) | 12.9 ± 6.714 | 9.3 ± 5.78 |
Mean Change from maintenance of effect phase baseline | −0.9 ± 7.78 | −1.4 ± 5.50 |
Extension phase (baseline) | 19.2 ± 12.00 | 12.8 ± 7.28 |
Mean Change from extension phase baseline | −7.2 ± 11.00 | −4.8 ± 6.88 |
LOCF: Last observation carried forward applied for each patient with data in extension period. If no post-baseline was available, it was considered as missing.
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