Vyvanse™ Delivered Significant Improvement in Core ADHD Symptoms
In a clinical study Vyvanse provided a greater than 50% reduction on ADHD Rating Scale.
[1]Efficacy across all doses[1]
- Objective: Determine efficacy and safety for 3 doses of Vyvanse (30 mg,
50 mg, and 70 mg) versus placebo in children aged 6 to 12 (N = 290) whose symptoms
were not adequately controlled with their current ADHD medication or had
not previously been treated for ADHD[1]
- Design:
- Multicenter, randomized, double-blind, parallel-group, forced-dose titration,
4-week study[1]
- Enrolled patients[1]:
- 69% Male
- 53% Caucasian, 24% Black, 17% Hispanic
- 67% of patients were not previously treated with stimulants in the last
12 months
- Following a 1-week washout period, subjects were randomized to one of the
4 treatment arms[1]
- Subjects randomized to Vyvanse 30 mg or placebo received the assigned
dose for 4 weeks
- Subjects randomized to Vyvanse 50 mg or 70 mg received their doses by
forced titration regardless of response to lower Vyvanse doses
- Results: Significant improvement in core ADHD symptoms[1]
- Greater than 50% reduction in ADHD Rating Scale (ADHD-RS) mean total score;
(P < .0001 vs placebo)[1] (Figure 3-1)
IMPORTANT SAFETY INFORMATION
Vyvanse should not be taken by patients who have advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncrasy to sympathomimetic amines; agitated states; glaucoma; a history of drug abuse; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).
Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam, to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.
New psychosis, mania, aggression, growth suppression, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of psychosis, seizures or EEG abnormalities, bipolar disorder, or depression. Growth monitoring is advised during prolonged treatment.
Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic uses or distribution to others and the drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.
The most common adverse events reported in clinical studies of Vyvanse were loss of appetite, insomnia, abdominal pain, and irritability.
