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Vyvanse (Lisdexamfetamine Dimesylate) - Summary

 
 



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 USE 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.

 

VYVANSE SUMMARY

Vyvanse™ (lisdexamfetamine dimesylate) C-II Rx Only

Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S)-1-methyl-2-phenylethyl]hexanamide dimethanesulfonate.

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).


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NEWS HIGHLIGHTS

Media Articles Related to Vyvanse (Lisdexamfetamine)

Published data shows long-term efficacy of Elvanse® (lisdexamfetamine dimesylate) in children and adolescents with ADHD
Source: ADHD News From Medical News Today [2014.06.30]
A new paper published in the Journal of the American Association of Children and Adolescent Psychiatry (JAACAP) shows long-term efficacy of lisdexamfetamine dimesylate (LDX) in children and...

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Published Studies Related to Vyvanse (Lisdexamfetamine)

Dose response effects of lisdexamfetamine dimesylate treatment in adults with ADHD: an exploratory study. [2012]
CONCLUSION: For LDX doses between 30 and 70 mg/d, the dose-response efficacy

Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. [2011.11.04]
ABSTRACT: BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral psychiatric disorder that afflicts children, with a reported prevalence of 2.4% to 19.8% worldwide. Stimulants (methylphenidate [MPH] and amphetamine) are considered first-line ADHD pharmacotherapy. MPH is a catecholamine reuptake inhibitor, whereas amphetamines have additional presynaptic activity. Although MPH and amphetamine can effectively manage ADHD symptoms in most pediatric patients, many still fail to respond optimally to either. After administration, the prodrug stimulant lisdexamfetamine dimesylate (LDX) is converted to l-lysine and therapeutically active d-amphetamine in the blood. The objective of this study was to evaluate the clinical efficacy of LDX in children with ADHD who remained symptomatic (ie, nonremitters; ADHD Rating Scale IV [ADHD-RS-IV] total score > 18) on MPH therapy prior to enrollment in a 4-week placebo-controlled LDX trial, compared with the overall population... CONCLUSION: In this analysis, children with significant clinical ADHD symptoms despite MPH treatment improved during treatment with LDX and experienced similar improvements in their symptoms as the overall study population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00556296.

Prediction of placebo response in 2 clinical trials of lisdexamfetamine dimesylate for the treatment of ADHD. [2011.10]
CONCLUSIONS: In both children and adults, baseline symptom severity was the most consistent predictor of remission with placebo while the temporal profile of response reliably differentiated placebo from medication responders. Placebo effects are most likely to be minimized in shorter trials enrolling more severely impaired subjects. The impact of medical and psychiatric comorbidities on placebo response merits further investigation. TRIAL REGISTRATION: clinicaltrials.gov identifiers NCT00556296 and NCT00334880. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

Effect of lisdexamfetamine dimesylate on sleep in children with ADHD. [2011.08]
CONCLUSIONS: In this pilot sleep study in children with ADHD, LDX did not appear to contribute to any sleep disturbances as measured by both objective and subjective sleep parameters. The sample used in this study was small, and the multifarious nature of findings in this study warranted that the study conclusions be interpreted cautiously and that further study is required focusing on the influence of LDX on sleep in larger samples of ADHD children.

Long-term treatment outcomes with lisdexamfetamine dimesylate for adults with attention-deficit/hyperactivity disorder stratified by baseline severity. [2011.06]
CONCLUSIONS: Some aspects of these analyses (e.g., open-label design without placebo control, inclusion and exclusion criteria of the demographic profile of participants, and the post hoc nature of the statistical analysis) limit interpretation. However, long-term LDX treatment demonstrated increased degree of symptom improvement with greater baseline symptom severity. Rates of clinical response and symptomatic remission tended to be greater for those with greater baseline severity. LDX demonstrated a safety profile consistent with long-acting stimulant use.

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Clinical Trials Related to Vyvanse (Lisdexamfetamine)

Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD [Completed]
Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.

A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With ADHD [Completed]
The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

An In Depth Cardiovascular Study of Lisdexamfetamine (LDX; Vyvanse) in Healthy and Treated Hypertensive Adults With Attention Deficit Hyperactivity Disorder (ADHD) [Recruiting]
The purpose of this research study is to learn about the effects of a medication called Vyvanse on the heart (cardiovascular system). The U. S. Food and Drug Administration (FDA) has approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). People who have ADHD have trouble paying attention, organizing, and planning; these symptoms can cause problems at work, socially and at home.

Vyvanse (also known as Lisdexamfetamine) is an amphetamine (a stimulant). Amphetamines increase alertness and activity. They are considered safe and effective for treating ADHD in children. Less is known about the safety and effectiveness of stimulants when they are used to treat adults with ADHD. There have been some reports of sudden death in children and adults treated with stimulants. There is no definite evidence that the deaths were related to the use of stimulants. However, the deaths have raised questions about the effects that stimulants might have on such things as blood pressure and heart rate.

The study will involve measuring your blood pressure both at home and in the office as well as cardiovascular tests at the main campus of MGH. The cardiovascular tests involved in the study are the echocardiograph (ultrasound of the heart) and cardiopulmonary exercise test (also called stress test; subjects exercise on a bicycle while measuring their heart activity and breathing is monitored by cardiologists).

We predict to see changes in blood pressure and heart rate (average increase of heart rate 3-7 bpm, 1-5 mmHg blood pressure) as shown in other clinical studies. We predict that cardiovascular tests, such as the stress test, will show higher resting heart rate and lower heart rate recovery during exercise on LDX in comparison to exercise off LDX. However, we do not expect to see any changes in heart and lung functioning on LDX as compared to off LDX.

Vyvanse Driving Study [Recruiting]
The primary objective of the study is to assess the benefice of Vyvanse on the factors that cause impairments in driving behavior in individuals with ADHD using a driving simulation aimed at examining the factors that cause impairments in driving behavior in individuals with ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages 18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show lower velocity (speed) scores and spend less time driving over the posted speed limit in the driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser likelihood of driving through stop signs and solid red traffic lights without slowing down when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with Vyvanse will exhibit more focused visual attention on details in the visual field when compared to subjects taking a placebo while driving. In addition, young adults with ADHD treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when compared to subjects taking a placebo.

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression [Recruiting]
There have been reports that stimulants may be effective for bipolar depression without triggering mania. This study will examine whether lisdexamfetamine can improve depressive symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is currently approved for attention deficit hyperactivity disorder (ADHD). Participants take the study drug or placebo in addition to a mood stabilizer. The study includes functional magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the medication alters the response to affective stimuli or glutamate, glutamine, or GABA levels. Neuropsychological testing is also included to determine whether the study drug improves memory and attention in this population. The primary hypothesis is that lisdexamfetamine is clinically effective in this population. The secondary hypothesis is that it will result in an increased response to affective stimuli and altered neurotransmitter levels in the anterior cingulate cortex.

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Reports of Suspected Vyvanse (Lisdexamfetamine) Side Effects

Depression (29)Suicidal Ideation (26)Aggression (21)Product Quality Issue (19)Drug Effect Decreased (18)Drug Ineffective (17)Overdose (16)Psychotic Disorder (15)Anger (14)Condition Aggravated (14)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 28 ratings/reviews, Vyvanse has an overall score of 8.25. The effectiveness score is 9.21 and the side effect score is 7.07. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Vyvanse review by 44 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   ADD
Dosage & duration:   70 miligrams (dosage frequency: 1 daily) for the period of 4 months
Other conditions:   none
Other drugs taken:   wellbutrin
  
Reported Results
Benefits:   Helps with concentration and staying focused. Helps to keep me from being hyperactive and fidgety and helps with memory to an extent.
Side effects:   If I am stressed, I seem to be jittery and the benefits are not as prominent.
Comments:   I was diagnosed with ADD three years ago. Have tried several different prescriptions and found the best results from Adderall and Vyvanse.

 

Vyvanse review by 18 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   ADD
Dosage & duration:   30mg taken once in the morning for the period of 4 months
Other conditions:   daydreaming and underperforming socially and accedemically
Other drugs taken:   N/A
  
Reported Results
Benefits:   My mood has noticably improved, I have more energy, experience better sleep and digestion.
Side effects:   a few experiences of nausiea, heavy moodswings on the days I do not take it, decreased appetite, and some negative affect on my short-term memory.
Comments:   I had began taking 20mg of Vyvanse for three months and was surprised to find that such a small dose affected my mood so effectively. When it came to school work though I found that I needed the 30mg to increase my level of focus (and have been on it for a month since). I had not experienced decreased appetite until about a month into taking the 20mg. I find that the greatest benefit of Vyvanse for me is that it tends to stabalize my mood on a daily basis and lessens any bouts of anxiety and depression that i used to face before I was perscribed.

 

Vyvanse review by 37 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   add
Dosage & duration:   30mg taken daily for the period of 2 weeks
Other conditions:   na
Other drugs taken:   na
  
Reported Results
Benefits:   Slight eurphoria and "high" felt good but not what I was trying to treat
Side effects:   aggravated acne, short term memory loss, loss of cognitive abilities
Comments:   Most recently diagnosed with adult add, never tried add medications before. Tried to give it time to work as many people say side effects get better but could not deal with the major facial skin breakouts.

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Page last updated: 2014-06-30

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