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Lisdexamfetamine dimesylate

Maria Gasior, James Hudson, Javier Quintero, M Celeste Ferreira-Cornwell, Jana Radewonuk, Susan L McElroy
BACKGROUND: A 12-month, open-label extension study assessed the long-term safety and tolerability of lisdexamfetamine dimesylate (LDX) in adults with binge eating disorder (BED). METHODS: Adults (aged 18-55 y) with BED who completed 1 of 3 antecedent studies were enrolled in a 52-week, open-label extension study (dose optimization, 4 weeks [initial titration dose, 30-mg LDX; target doses, 50- or 70-mg LDX]; dose maintenance, 48 weeks). Safety evaluations included the occurrence of treatment-emergent adverse events (TEAEs), vital sign and weight assessments, and Columbia-Suicide Severity Rating Scale responses...
June 2017: Journal of Clinical Psychopharmacology
Alain Joseph, Rajeev Ayyagari, Meng Xie, Sean Cai, Jipan Xie, Michael Huss, Vanja Sikirica
This study compared the clinical efficacy and safety of attention-deficit/hyperactivity disorder (ADHD) pharmacotherapy in children and adolescents 6-17 years of age. A systematic literature review was conducted to identify randomized controlled trials (RCTs) of pharmacologic monotherapies among children and adolescents with ADHD. A Bayesian network meta-analysis was conducted to compare change in symptoms using the ADHD Rating Scale Version IV (ADHD-RS-IV), Clinical Global Impression-Improvement (CGI-I) response, all-cause discontinuation, and adverse event-related discontinuation...
March 3, 2017: European Child & Adolescent Psychiatry
Christopher L Norkus, Iain Keir, Charlotte Means
A 5-month-old intact female domestic shorthaired cat had mydriasis, agitation, and increased locomotion after ingestion of lisdexamfetamine, 10.3 mg/kg body weight (BW). Despite treatment with IV fluids, IV acepromazine, oral cyproheptadine and intravenous lipid emulsion the patient's clinical signs worsened. Dexmedetomidine administered at 2 μg/kg BW and continued at 0.5 μg/kg BW per hour rapidly controlled the patient's signs. An episode of vomiting and hematuria developed. Follow-up 5 days after discharge revealed that the cat appeared normal...
March 2017: Canadian Veterinary Journal. la Revue Vétérinaire Canadienne
Evelina A Zimovetz, Alain Joseph, Rajeev Ayyagari, Josephine A Mauskopf
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurobehavioral disorder in children that may persist into adulthood. Lisdexamfetamine dimesylate (LDX) is approved in many countries for ADHD treatment in children, adolescents, and adults. OBJECTIVES: Estimate the cost-effectiveness of LDX as a first- or second-line treatment for adults with ADHD from the United Kingdom (UK) National Health Service (NHS) perspective compared with methylphenidate extended release (MPH-ER) and atomoxetine (ATX)...
January 16, 2017: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
Ying Li, Jie Gao, Shu He, Yan Zhang, Qiwei Wang
Attention deficit hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders. We carried out this comparison of multiple treatments based on sufficient data in attempt to evaluate the efficacy and safety of ADHD medication for children and adolescents. PubMed, Embase and the Cochrane Database were used to search for relevant articles. Changes in the ADHD Rating Scale (ADHD-RS) scores and the Conners' Parent Rating Scale-Revised (CPRS) scores were used as outcomes for efficacy. Withdrawals due to all-cause, adverse effects and lack of efficacy were defined as primary outcomes evaluating the safety of such medications...
October 13, 2016: Molecular Neurobiology
James Ermer, Mary Corcoran, Kenneth Lasseter, Patrick T Martin
BACKGROUND: This open-label, crossover study examined lisdexamfetamine dimesylate (LDX) and D-amphetamine pharmacokinetics in healthy adults after administration of an intact LDX capsule or after the capsule was emptied into orange juice or yogurt and the contents consumed. METHODS: Healthy adult volunteers (N = 30) were administered a 70-mg LDX capsule or the contents of a 70-mg capsule mixed with yogurt or orange juice using a 3-way crossover design. Blood samples were collected serially for up to 96 hours after dose...
December 2016: Therapeutic Drug Monitoring
Anna I Guerdjikova, Nicole Mori, Thomas J Blom, Paul E Keck, Stephanie L Williams, Jeffrey A Welge, Susan L McElroy
OBJECTIVE: To evaluate lisdexamfetamine dimesylate (LDX) in the treatment of binge eating disorder (BED). METHOD: Fifty participants with BED received LDX (20-70 mg/day) (n = 25) or placebo (n = 25) for up to 12 weeks in a single-center, randomized, double-blind, and flexible-dose trial. The primary outcome measure was binge eating (BE) days/week. RESULTS: In the primary longitudinal analysis, compared with placebo, LDX was not associated with a significantly greater rate of reduction in BE days/week, as well as BE episodes/week, and scores on the Clinical Global Impression-Severity or Yale-Brown Obsessive-Compulsive Scale modified for binge eating scales...
September 2016: Human Psychopharmacology
Evelina A Zimovetz, Stephen M Beard, Paul Hodgkins, Matthias Bischof, Josephine A Mauskopf, Juliana Setyawan
BACKGROUND: An economic analysis from the perspective of the UK National Health Service (NHS) evaluated the cost effectiveness of lisdexamfetamine dimesylate (LDX) compared with atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder who have had an inadequate response to methylphenidate. METHODS: A 1-year decision-analytic model was constructed, with the health outcomes "response", "nonresponse", and "unable to tolerate". Clinical data were taken from a head-to-head, randomized controlled trial in inadequate responders to methylphenidate...
October 2016: CNS Drugs
Cynthia Richards, Roger S McIntyre, Richard Weisler, Angelo Sambunaris, Olga Brawman-Mintzer, Joseph Gao, Brooke Geibel, Matthew Dauphin, Manisha Madhoo
BACKGROUND: The efficacy, safety, and tolerability of lisdexamfetamine dimesylate (LDX) augmentation of antidepressant monotherapy in adults with major depressive disorder (MDD) from two phase 3 studies are reported. METHODS: Across study 1 (placebo, n=201; LDX, n=201) and study 2 (placebo, n=213; LDX, n=211), most participants (placebo and LDX) in the safety analysis set were female (study 1: 66.2% and 64.2%; study 2: 67.1% and 66.8%); mean±SD ages were 41.8±12...
December 2016: Journal of Affective Disorders
Kelly E Wood, Matthew D Krasowski
INTRODUCTION: Stimulant medications are approved to treat attention deficit hyperactivity disorder (ADHD) in children over the age of 6 years. Fatal ingestion of stimulants by children has been reported, although most ingestions do not result in severe toxicity. Lisdexamfetamine dimesylate, a once daily long-acting stimulant, is a prodrug requiring conversion to its active form, dextroamphetamine, in the bloodstream. Based on its unique pharmacokinetics, peak levels of d-amphetamine are delayed...
December 2016: Journal of Medical Toxicology: Official Journal of the American College of Medical Toxicology
Anna I Guerdjikova, Nicole Mori, Leah S Casuto, Susan L McElroy
Binge eating disorder (BED) is the most common eating disorder and an important public health problem. It is characterized by recurrent episodes of excessive food consumption accompanied by a sense of loss of control over the binge eating behavior without the inappropriate compensatory weight loss behaviors of bulimia nervosa. BED affects both sexes and all age groups and is associated with medical and psychiatric comorbidities. Until recently, self-help and psychotherapy were the primary treatment options for patients with BED...
2016: Neuropsychiatric Disease and Treatment
Vanisha Patel, Ashwin Subramani Krishna, Cassandra Lefevre, Mildred Kaagaza, Michael Wittkamp
OBJECTIVE: Attention deficit hyperactivity disorder (ADHD) is an increasingly common diagnosis of childhood that manifests with symptoms that affect cognitive, academic, behavioral, emotional, and social functioning. There are a multitude of pharmaceutical therapies to choose from when managing this condition, and though many studies on the safety and efficacy of these medications have been published, adverse effects still occur. CASE: This case discusses a previously healthy 8-year-old boy who had been prescribed 20-mg lisdexamfetamine dimesylate for ADHD however mistakenly took his brother's 36-mg methylphenidate extended-release tablets, resulting in hyperhidrosis, excessive thirst, polydipsia, and combative behavior that began within 3 hours of ingestion...
April 26, 2016: Pediatric Emergency Care
Alain Joseph, Martin Cloutier, Annie Guérin, Roy Nitulescu, Vanja Sikirica
PURPOSE: To compare treatment adherence, discontinuation, add-on, and daily average consumption (DACON) among adults with attention-deficit/hyperactivity disorder receiving second-line lisdexamfetamine dimesylate (LDX) or atomoxetine (ATX), following methylphenidate. PATIENTS AND METHODS: A retrospective cohort study using US commercial claims databases (Q2/2009-Q3/2013). RESULTS: At month 12, the LDX cohort (N=2,718) had a higher adherence level (proportion of days covered: 0...
2016: Patient Preference and Adherence
James E Frampton
Lisdexamfetamine dimesylate (lisdexamfetamine) is a long-acting amfetamine prodrug with a convenient once-daily oral regimen that offers the potential for improved adherence and reduced abuse compared with short-acting preparations of amfetamines. Lisdexamfetamine (as Elvanse Adult(®); Tyvense Adult™) has been approved for use in adults with attention-deficit hyperactivity disorder (ADHD) under the EU decentralization procedure, with the first approvals in the UK, Sweden and Denmark. This approval reflects the results of three short-term trials in adults with ADHD in which fixed- or flexible-dose lisdexamfetamine produced significantly greater improvements than placebo in ADHD symptoms, overall functioning, executive functioning (including in patients with significant pre-existing impairment) and quality of life...
April 2016: CNS Drugs
James C Ermer, Michael Pennick, Glen Frick
Lisdexamfetamine dimesylate (LDX) is a long-acting d-amphetamine prodrug used to treat attention-deficit/hyperactivity disorder (ADHD) in children, adolescents and adults. LDX is hydrolysed in the blood to yield d-amphetamine, and the pharmacokinetic profile of d-amphetamine following oral administration of LDX has a lower maximum plasma concentration (Cmax), extended time to Cmax (Tmax) and lower inter- and intra-individual variability in exposure compared with the pharmacokinetic profile of an equivalent dose of immediate-release (IR) d-amphetamine...
May 2016: Clinical Drug Investigation
James Ermer, Mary Corcoran, Kenneth Lasseter, Thomas Marbury, Brian Yan, Patrick T Martin
BACKGROUND: Lisdexamfetamine (LDX) and D-amphetamine pharmacokinetics were assessed in individuals with normal and impaired renal function after a single LDX dose; LDX and D-amphetamine dialyzability was also examined. METHODS: Adults (N = 40; 8/group) were enrolled in 1 of 5 renal function groups [normal function, mild impairment, moderate impairment, severe impairment/end-stage renal disease (ESRD) not requiring hemodialysis, and ESRD requiring hemodialysis] as estimated by glomerular filtration rate (GFR)...
August 2016: Therapeutic Drug Monitoring
Tamás Ágh, Manjiri Pawaskar, Balázs Nagy, Jean Lachaine, Zoltán Vokó
BACKGROUND: Lisdexamfetamine dimesylate (LDX) demonstrated efficacy in terms of reduced binge eating days per week in adults with binge eating disorder (BED) in two randomized clinical trials (RCTs). OBJECTIVE: The objective of this study was to evaluate the cost effectiveness of LDX versus no pharmacotherapy (NPT) in adults with BED from a USA healthcare payer's perspective. STUDY DESIGN AND METHODS: A decision-analytic Markov cohort model was developed using 1-week cycles and a 52-week time horizon...
April 2016: Clinical Drug Investigation
Guilherme A Eger, Vinícius V Ferreira, Camila R Batista, Henrique Bonde, Daniela D de Lima, Angela T S Wyse, Júlia N da Cruz, André F Rodrigues, Débora D Dal Magro, José G P da Cruz
The present study aims to directly investigate the behavioral and antioxidant effects of simvastatin in a model of bipolar mania induced by lisdexamfetamine dimesylate. Wistar rats were treated for 30 days with simvastatin. On the 24th day after the start of treatment, each rat was administered lisdexamfetamine dimesylate for 7 days. The results suggest that simvastatin combined with lisdexamfetamine dimesylate induced a significant increased locomotion and lisdexamfetamine dimesylate administration causes an oxidative imbalance determined by an increment in lipid peroxidation, protein oxidation and alterations in the activities of antioxidant enzymes in brain areas; moreover, in the presence of simvastatin, most of these effects were prevented...
March 2016: Anais da Academia Brasileira de Ciências
Beatrice Bortolato, Kamilla W Miskowiak, Cristiano A Köhler, Michael Maes, Brisa S Fernandes, Michael Berk, André F Carvalho
BACKGROUND: Cognitive dysfunction in major depressive disorder (MDD) encompasses several domains, including but not limited to executive function, verbal memory, and attention. Furthermore, cognitive dysfunction is a frequent residual manifestation in depression and may persist during the remitted phase. Cognitive deficits may also impede functional recovery, including workforce performance, in patients with MDD. The overarching aims of this opinion article are to critically evaluate the effects of available antidepressants as well as novel therapeutic targets on neurocognitive dysfunction in MDD...
January 22, 2016: BMC Medicine
Jean Lachaine, Vanja Sikirica, Karine Mathurin
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a common psychiatric disorder in children, with worldwide prevalence of ADHD varying from 5.9 to 7.1 %, depending on the reporter. In case of inadequate response to stimulants, combination therapy of stimulants and an adjunctive medication may improve the control of ADHD symptoms, reduce the dose-limiting adverse events, and help control comorbidities. To date, the only medication to be used for adjunctive therapy to psychostimulants is guanfacine extended release (GXR)...
2016: BMC Psychiatry
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