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Lisdexamfetamine dimesylate

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https://www.readbyqxmd.com/read/28700805/efficacy-of-lisdexamfetamine-in-adults-with-moderate-to-severe-binge-eating-disorder-a-randomized-clinical-trial
#1
James I Hudson, Susan L McElroy, M Celeste Ferreira-Cornwell, Jana Radewonuk, Maria Gasior
Importance: The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. Objective: To assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. Design, Setting, and Participants: A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015...
July 12, 2017: JAMA Psychiatry
https://www.readbyqxmd.com/read/28667569/long-term-safety-and-efficacy-of-lisdexamfetamine-dimesylate-in-children-and-adolescents-with-adhd-a-phase-iv-2-year-open-label-study-in-europe
#2
David R Coghill, Tobias Banaschewski, Peter Nagy, Isabel Hernández Otero, César Soutullo, Brian Yan, Beatriz Caballero, Alessandro Zuddas
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is increasingly recognized as a persistent disorder requiring long-term management. OBJECTIVES: Our objective was to evaluate the 2-year safety and efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents with ADHD. METHODS: Participants (aged 6-17 years) with ADHD received open-label, dose-optimized LDX 30, 50, or 70 mg/day for 104 weeks. Safety monitoring included treatment-emergent adverse events (TEAEs), vital signs, electrocardiography, and growth...
July 2017: CNS Drugs
https://www.readbyqxmd.com/read/28590365/the-efficacy-of-psychostimulants-in-major-depressive-episodes-a-systematic-review-and-meta-analysis
#3
Roger S McIntyre, Yena Lee, Aileen J Zhou, Joshua D Rosenblat, Evyn M Peters, Raymond W Lam, Sidney H Kennedy, Carola Rong, Jeanette M Jerrell
BACKGROUND: Psychostimulants are frequently prescribed off-label for adults with major depressive disorder or bipolar disorder. The frequent and increasing usage of stimulants in mood disorders warrants a careful appraisal of the efficacy of this class of agents. Herein, we aim to estimate the efficacy of psychostimulants in adults with unipolar or bipolar depression. METHODS: The PubMed/Medline database was searched from inception to January 16, 2016 for randomized, placebo-controlled clinical trials investigating the antidepressant efficacy of psychostimulants in the treatment of adults with unipolar or bipolar depression...
August 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28513760/cell-therapy-in-the-treatment-of-bipolar-mania-in-an-animal-model-a-proof-of-concept-study
#4
Bruna M Ascoli, Rafael Colombo, Luiza P Géa, Paula B Terraciano, Sabrina B Pizzato, Fernanda S de Oliveira, Elizabeth Cirne-Lima, Flávio Kapczinski, Adriane R Rosa
Introduction: The rationale of mesenchymal stem cells (MSCs) as a novel therapeutic approach in certain neurodegenerative diseases is based on their ability to promote neurogenesis. Hippocampal atrophy has been related to bipolar disorder (BD) in preclinical, imaging and postmortem studies. Therefore, the development of new strategies to stimulate the neurogenesis process in BD is crucial. Objectives: To investigate the behavioral and neurochemical changes induced by transplantation of MSCs in a model of mania-like behavior induced by lisdexamfetamine dimesylate (LDX)...
May 15, 2017: Trends in Psychiatry and Psychotherapy
https://www.readbyqxmd.com/read/28481434/time-course-of-the-effects-of-lisdexamfetamine-dimesylate-in-two-phase-3-randomized-double-blind-placebo-controlled-trials-in-adults-with-binge-eating-disorder
#5
Susan L McElroy, James I Hudson, Maria Gasior, Barry K Herman, Jana Radewonuk, Denise Wilfley, Joan Busner
OBJECTIVE: This study examined the time course of efficacy-related endpoints for lisdexamfetamine dimesylate (LDX) versus placebo in adults with protocol-defined moderate to severe binge eating disorder (BED). METHODS: In two 12-week, double-blind, placebo-controlled studies, adults meeting DSM-IV-TR BED criteria were randomized 1:1 to receive placebo or dose-optimized LDX (50 or 70 mg). Analyses across visits used mixed-effects models for repeated measures (binge eating days/week, binge eating episodes/week, Yale-Brown Obsessive Compulsive Scale modified for Binge Eating [Y-BOCS-BE] scores, percentage body weight change) and chi-square tests (Clinical Global Impressions-Improvement [CGI-I; from the perspective of BED symptoms] scale dichotomized as improved or not improved)...
May 8, 2017: International Journal of Eating Disorders
https://www.readbyqxmd.com/read/28383364/a-phase-3-multicenter-open-label-12-month-extension-safety-and-tolerability-trial-of-lisdexamfetamine-dimesylate-in-adults-with-binge-eating-disorder
#6
MULTICENTER STUDY
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
https://www.readbyqxmd.com/read/28258319/comparative-efficacy-and-safety-of-attention-deficit-hyperactivity-disorder-pharmacotherapies-including-guanfacine-extended-release-a-mixed-treatment-comparison
#7
REVIEW
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...
August 2017: European Child & Adolescent Psychiatry
https://www.readbyqxmd.com/read/28246413/dexmedetomidine-to-control-signs-associated-with-lisdexamfetamine-dimesylate-toxidrome-in-a-cat
#8
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
https://www.readbyqxmd.com/read/28093662/a-cost-effectiveness-analysis-of-lisdexamfetamine-dimesylate-in-the-treatment-of-adults-with-attention-deficit-hyperactivity-disorder-in-the-uk
#9
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
https://www.readbyqxmd.com/read/27738872/an-evaluation-on-the-efficacy-and-safety-of-treatments-for-attention-deficit-hyperactivity-disorder-in-children-and-adolescents-a-comparison-of-multiple-treatments
#10
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
https://www.readbyqxmd.com/read/27661399/relative-bioavailabilities-of-lisdexamfetamine-dimesylate-and-d-amphetamine-in-healthy-adults-in-an-open-label-randomized-crossover-study-after-mixing-lisdexamfetamine-dimesylate-with-food-or-drink
#11
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
https://www.readbyqxmd.com/read/27650406/lisdexamfetamine-dimesylate-in-binge-eating-disorder-a-placebo-controlled-trial
#12
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
https://www.readbyqxmd.com/read/27530525/a-cost-utility-analysis-of-lisdexamfetamine-versus-atomoxetine-in-the-treatment-of-children-and-adolescents-with-attention-deficit-hyperactivity-disorder-and-inadequate-response-to-methylphenidate
#13
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
https://www.readbyqxmd.com/read/27474961/lisdexamfetamine-dimesylate-augmentation-for-adults-with-major-depressive-disorder-and-inadequate-response-to-antidepressant-monotherapy-results-from-2-phase-3-multicenter-randomized-double-blind-placebo-controlled-studies
#14
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
https://www.readbyqxmd.com/read/27277955/an-infant-with-a-prolonged-sympathomimetic-toxidrome-after-lisdexamfetamine-dimesylate-ingestion
#15
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
https://www.readbyqxmd.com/read/27143885/novel-pharmacologic-treatment-in-acute-binge-eating-disorder-role-of-lisdexamfetamine
#16
REVIEW
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
https://www.readbyqxmd.com/read/27115479/methylphenidate-overdose-causing-secondary-polydipsia-and-severe-hyponatremia-in-an-8-year-old-boy
#17
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
https://www.readbyqxmd.com/read/27069357/treatment-outcomes-after-methylphenidate-in-adults-with-attention-deficit-hyperactivity-disorder-treated-with-lisdexamfetamine-dimesylate-or-atomoxetine
#18
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
https://www.readbyqxmd.com/read/27048350/lisdexamfetamine-a-review-in-adhd-in-adults
#19
REVIEW
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
https://www.readbyqxmd.com/read/27021968/lisdexamfetamine-dimesylate-prodrug-delivery-amphetamine-exposure-and-duration-of-efficacy
#20
REVIEW
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
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