Vyvanse 30mg Cap

Description

Vyvanse (Lisdexamfetamine Dimesylate) 30mg Cap

Vyvanse (lisdexamfetamine dimesylate) used to treat the symptoms of (ADHD) and severe binge eating disorder. Vyvanse may be used alone or with other medications. Vyvanse belongs to a class of Stimulants; ADHD Agents. It is not known if Vyvanse is safe and effective in children younger than 6 years of age.

The FDA has approved Shire’s Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for the treatment of moderate to severe binge eating disorder (BED). The approval carries the limitation, however, that Vyvanse is not indicated for weight loss: not only is it a sympathomimetic drug, but its safety and effectiveness as a treatment for obesity have not been established. In addition, the use of other sympathomimetic agents for weight loss has been associated with serious cardiovascular adverse events (AEs).1

BED, which occurs in both women and men, is defined as recurring episodes (once or more per week for at least 3 months) of consuming a large amount of food in a short time. Patients usually report associated lack of control, shame, and guilt. It is the most common eating disorder—more so than anorexia and bulimia combined2—in the United States, with an estimated 2.8 million people affected. Vyvanse was initially approved in 2007 for the treatment of attention-deficit/ hyperactivity disorder.1 It is the first medication approved for the treatment of BED.3

Pharmacology

Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.1

Dosage and Administration

The recommended starting dose is 30 mg once daily. It may be titrated in 20-mg increments at weekly intervals to the target dose of 50 to 70 mg daily. The maximum daily dose is 70 mg. Before beginning treatment with Vyvanse, patients should be evaluated for cardiac disease. The maximum daily dose in patients with severe renal impairment is 50 mg. In patients with end-stage renal disease, the maximum daily dose is 30 mg.1

Clinical Trials

The efficacy of Vyvanse in the treatment of BED was evaluated in two 12-week, randomized, double-blind, multicenter, parallel-group, placebo- controlled, dose-optimization studies in adults aged 18 to 55 years who had moderate to severe BED. The primary efficacy outcome for the 2 studies was the change from baseline in the number of binge days per week.

In both studies, patients using Vyvanse 50 or 70 mg daily had a statistically significant greater reduction from baseline in the mean number of binge days per week. The Vyvanse group also demonstrated greater improvement across key secondary outcomes, including a higher proportion of patients who showed improvement on the Clinical Global Impressions-Improvement ratings scale, a higher proportion of patients with 4-week binge cessation, and a greater reduction in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating total score. Patients with current anorexia or bulimia nervosa, current comorbid psychiatric disorder, and cardiovascular risk factors (other than obesity and smoking) were excluded from the studies.1,2.

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