This site is intended for US healthcare professionals only
This site is intended for US healthcare professionals only
This site is intended for US healthcare professionals only
This site is intended for US healthcare professionals only
Duration of efficacy of Vyvanse was assessed in a multicenter, randomized, double-blind, placebo-controlled, crossover, modified analog classroom study to simulate a workplace environment.1,2
During a 4-week, open-label, dose-optimization phase, subjects were titrated to an optimal dose of Vyvanse 30, 50, or 70 mg/day in the morning. They were then randomized in the double-blind crossover phase to receive Vyvanse (optimized dose) followed by placebo, or placebo followed by Vyvanse, each for 1 week. During the double-blind phase, efficacy assessments occurred at the end of each week using PERMP.*1,2
Primary Endpoint: Average of the PERMP total scores from all postdose sessions measured, from 2 to 14 hours1,2
Key Secondary Endpoint: Duration of efficacy as measured by PERMP total score at 2, 4, 8, 10, 12, and 14 hours postdose1,2
DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.
*PERMP=Permanent Product Measure of Performance, an objective, validated, skill-adjusted math test that measures attention in ADHD. The PERMP total score comprises the sum of the number of math problems attempted and the number of math problems answered correctly. Higher scores indicate less severe symptoms. PERMP is not a test of the ability to learn math.1,2
ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV.
Primary Endpoint: Adults with ADHD taking Vyvanse† had a least squares (LS) mean PERMP total score across all postdose assessments (from 2 to 14 hours) of 312.9 vs 289.5 for adults taking placebo, with a difference of 23.4 (P<.0001). Predose scores were: Vyvanse=260; placebo=263.2.1,3,4
n=104.
†Average of all doses tested.
‡At 2-hour timepoint: P=.0017 for Vyvanse vs placebo.
§At all other postdose timepoints assessed: P<.0001 for Vyvanse vs placebo.
Safety and efficacy of Vyvanse 30, 50, and 70 mg/day were compared with placebo in a randomized, double-blind, parallel-group, placebo-controlled, 4-week study with forced-dose titration.1,2
Primary Endpoint: Change from baseline in ADHD-RS-IV* total score at endpoint†1
*ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV, with Adult Prompts, an investigator-rated measure of the core symptoms of ADHD.
†Endpoint was defined as the last post-randomization treatment week for which a valid score was obtained
DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.
‡P<.0001 for Vyvanse vs placebo at endpoint.
§Average of all doses tested.
Maintenance of symptom control with Vyvanse (lisdexamfetamine dimesylate) was assessed in a Phase 4, multicenter, double-blind, placebo-controlled, randomized withdrawal study.1,2
Efficacy was assessed based on the ADHD-RS-IV with adult prompts and CGI-S at study entry (baseline), and weekly thereafter during the open-label and randomized withdrawal phases.2
Primary Endpoint: The proportion of patients with treatment failure (relapse) during the 6-week, randomized withdrawal phase. Treatment failure was defined as ≥50% increase (worsening) in ADHD-RS-IV total score and a ≥2-point increase in CGI-S score compared to scores at entry of the randomized withdrawal phase. Patients who met the relapse criteria were immediately withdrawn from the study.1,2
DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.
ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale Version IV, an investigator-rated measure of the core symptoms of ADHD.
CGI-S=Clinical Global Impression Severity, a scale which assesses the clinician's impression of the patient's current illness state and ranges from 1 (not at all ill) to 7 (extremely ill).
*At endpoint of the 6-week, randomized withdrawal phase.
Hypothetical patient portrayal.
Individual results may vary.
Vyvanse has once-daily dosing and only Vyvanse (lisdexamfetamine dimesylate) has 5 administration options, so you can tailor treatment to meet the needs of your patients with ADHD.1
Hypothetical patient portrayal
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US-LIS-1285v1.0 10/22