On the CGI-I scale , the analysis revealed that MPH was more effective than ATX and GXR .
For any adverse events , RBX ( 89 % ) was the safest alternative .
Network meta- analysis offered a broader overview on the available treatments for ADHD , especially for safety issues , and contributes towards evidence gathering and clinical practice decisions .
The aim of this study is to gather evidence of head-to-head double-blind r and omized-controlled trials on the efficacy and safety of available treatments for attention deficit hyperactivity disorder ( ADHD ) in children and adolescents .
Efficacy and Safety of Lisdexamfetamine Dimesylate and Atomoxetine in the Treatment of Attention-Deficit/Hyperactivity Disorder: a Head-to-Head, Randomized, Double-Blind, Phase IIIb Study
Objectives The aim of this study was to compare the efficacy and safety of the prodrug psychostimulant lisdexamfetamine dimesylate ( LDX ) and the non-stimulant noradrenergic compound atomoxetine ( ATX ) in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) who had previously responded inadequately to methylpheni date ( MPH ) . Methods This 9-week , head-to-head , r and omized , double-blind , active-controlled study ( SPD489 - 317 ; Clinical Trials.gov NCT01106430 ) enrolled patients ( aged 6–17 years ) with at least moderately symptomatic ADHD and an inadequate response to previous MPH therapy . Patients were r and omized ( 1:1 ) to an optimized daily dose of LDX ( 30 , 50 or 70 mg ) or ATX ( patients < 70 kg , 0.5–1.2 mg/kg with total daily dose not to exceed 1.4 mg/kg ; patients ≥70 kg , 40 , 80 or 100 mg ) . The primary efficacy outcome was time ( days ) to first clinical response . Clinical response was defined as a Clinical Global Impressions-Improvement ( CGI-I ) score of 1 ( very much improved ) or 2 ( much improved ) . Secondary efficacy outcomes included the proportion of responders at each study visit and the change from baseline in ADHD Rating Scale ( ADHD-RS-IV ) and CGI-Severity scores . Tolerability and safety were assessed by monitoring treatment-emergent adverse events ( TEAEs ) , height and weight , vital signs and electrocardiogram parameters . Endpoint was defined as the last post-baseline , on-treatment visit with a valid assessment . Results Of 267 patients r and omized ( LDX , n = 133 ; ATX , n = 134 ) , 200 ( 74.9 % ) completed the study . The median time to first clinical response [ 95 % confidence interval ( CI ) ] was significantly shorter for patients receiving LDX [ 12.0 days ( 8.0–16.0 ) ] than for those receiving ATX [ 21.0 days ( 15.0–23.0 ) ] ( p = 0.001 ) . By week 9 , 81.7 % ( 95 % CI 75.0–88.5 ) of patients receiving LDX had responded to treatment compared with 63.6 % ( 95 % CI 55.4–71.8 ) of those receiving ATX ( p = 0.001 ) . Also by week 9 , the difference between LDX and ATX in least-squares mean change from baseline ( 95 % CI ) was significant in favour of LDX for the ADHD-RS-IV total score [ −6.5 ( −9.3 to −3.6 ) ; p < 0.001 ; effect size 0.56 ] , inattentiveness subscale score [ −3.4 ( −4.9 to −1.8 ) ; p < 0.001 ; effect size 0.53 ] and the hyperactivity/impulsivity subscale score [ −3.2 ( −4.6 to −1.7 ) ; p < 0.001 ; effect size 0.53 ] . TEAEs were reported by 71.9 and 70.9 % of patients receiving LDX and ATX , respectively . At endpoint , both treatments were associated with mean ( st and ard deviation ) increases in systolic blood pressure [ LDX , + 0.7 mmHg ( 9.08 ) ; ATX , + 0.6 mmHg ( 7.96 ) ] , diastolic blood pressure [ LDX , + 0.1 mmHg ( 8.33 ) ; ATX , + 1.3 mmHg ( 8.24 ) ] and pulse rate [ LDX , + 3.6 bpm ( 10.49 ) ; ATX , + 3.7 bpm ( 10.75 ) ] , and decreases in weight [ LDX , −1.30 kg ( 1.806 ) ; ATX , −0.15 kg ( 1.434 ) ] . Conclusions LDX was associated with a faster and more robust treatment response than ATX in children and adolescents with at least moderately symptomatic ADHD who had previously responded inadequately to MPH . Both treatments displayed safety profiles consistent with findings from previous clinical trials
On the CGI-I scale , the analysis revealed that MPH was more effective than ATX and GXR .
For any adverse events , RBX ( 89 % ) was the safest alternative .
Network meta- analysis offered a broader overview on the available treatments for ADHD , especially for safety issues , and contributes towards evidence gathering and clinical practice decisions .
The aim of this study is to gather evidence of head-to-head double-blind r and omized-controlled trials on the efficacy and safety of available treatments for attention deficit hyperactivity disorder ( ADHD ) in children and adolescents .