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Xinyue Liu, Paul Kubilis, Regina Bussing, Almut G Winterstein
PURPOSE: The purposes of the study were to develop a refill pattern method to identify polypharmacy in pharmacy billing records and to compare the method with traditional days' supply overlap algorithms. METHODS: This method is characterized by the assessment of prescription refill pattern. Concomitant therapy is assumed when two drugs are dispensed repeatedly during the active days' supply of each other. We tested the refill pattern method in a simplified scenario in which two drugs (methylphenidate/dexmethylphenidate and atomoxetine) for attention deficit/hyperactivity disorder (ADHD) were considered...
August 16, 2016: Pharmacoepidemiology and Drug Safety
Kennerly S Patrick, Arthur B Straughn
The postulate that twice the milligram/kilogram dose of dl-methylphenidate (dl-MPH) would result in equal exposure to d-MPH compared with half that milligram/kilogram dose of the chiral switch product dexmethylphenidate (d-MPH) was tested. Using a randomized, crossover study design, 12 men and 12 women received either immediate-release (IR) dl-MPH (0.3 mg/kg) or IR d-MPH (0.15 mg/kg). Relative bioavailability comparisons included partial area under the plasma concentration-time curves (pAUC0-3 h) for d-MPH...
March 2016: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Narong Maneeton, Benchalak Maneeton, Pakapan Woottiluk, Sirijit Suttajit, Surinporn Likhitsathian, Chawanun Charnsil, Manit Srisurapanont
BACKGROUND: The efficacy of dexmethylphenidate (d-MPH) has been proven in the treatment of children and adolescents with attention-deficit hyperactivity disorder (ADHD). OBJECTIVE: The aim of this systematic review is to determine the efficacy, acceptability, and tolerability of d-MPH in child and adolescent ADHD. METHODS: The searches of SCOPUS, MEDLINE, CINAHL, and Cochrane Controlled Trials Register were performed in February 2015. All randomized controlled trials of d-MPH versus placebo that were performed in children and adolescents with ADHD up to 18 years of age were included in the study...
2015: Neuropsychiatric Disease and Treatment
Jan Buitelaar, Philip Asherson, Cesar Soutullo, Michael Colla, David H Adams, Yoko Tanaka, Virginia S Haynes, Rodrigo Escobar, Himanshu Upadhyaya
The attention-deficit/hyperactivity disorder (ADHD) treatment literature has been focused on onset-of-effect and short-term effect size, with little exploration of ADHD symptoms upon medication discontinuation. The objective of this narrative review and analysis was to better understand the relapse of ADHD symptoms upon discontinuation of medication treatment in children, adolescents, and adults with ADHD who have responded to medication treatment and to explore differences among different medications in maintaining treatment response...
October 2015: European Neuropsychopharmacology: the Journal of the European College of Neuropsychopharmacology
Kennerly S Patrick, Arthur B Straughn, Owen T Reeves, Hilary Bernstein, Robert Malcolm
The potentiation of positive subjective responses to immediate-release dexmethylphenidate (d-MPH) or dl-methylphenidate (dl-MPH) by ethanol was investigated over the time course of maximal drug exposure after a single dose. In a 4-way, randomized, crossover study design, 12 men and 12 women normal volunteers received d-MPH (0.15 mg/kg) or dl-MPH (0.3 mg/kg) with or without ethanol (0.6 g/kg). Serial visual analog scales were used as surrogates for drug abuse liability ("high," "good," "like," "stimulated," and "any drug effect")...
August 2015: Journal of Clinical Psychopharmacology
Kennerly S Patrick, Timothy R Corbin, Cristina E Murphy
We review the pharmaceutical science of ethylphenidate (EPH) in the contexts of drug discovery, drug interactions, biomarker for dl-methylphenidate (MPH)-ethanol exposure, potentiation of dl-MPH abuse liability, contemporary "designer drug," pertinence to the newer transdermal and chiral switch MPH formulations, as well as problematic internal standard. d-EPH selectively targets the dopamine transporter, whereas d-MPH exhibits equipotent actions at dopamine and norepinephrine transporters. This selectivity carries implications for the advancement of tailored attention-deficit/hyperactivity disorder (ADHD) pharmacotherapy in the era of genome-based diagnostics...
December 2014: Journal of Pharmaceutical Sciences
J A Santisteban, M A Stein, L Bergmame, R Gruber
OBJECTIVE: We sought to determine the dose-response effects of extended-release (ER) dexmethylphenidate (d-MPH) and ER mixed amphetamine salts (MAS) on objective measures of sleep. METHODS: This was an 8-week, double-blind, placebo-controlled, randomized, two period, crossover study of youth with attention-deficit hyperactivity disorder (ADHD) as confirmed by the Kiddie Schedule for Affective Disorders for School-Age Children-Present and Lifetime version (K-SADS-PL)...
September 2014: CNS Drugs
David Sugrue, Robin Bogner, Megan J Ehret
PURPOSE: Current literature on the safety and efficacy of various intermediate- and long-acting preparations of methylphenidate and dexmethylphenidate for pediatric attention-deficit/hyperactivity disorder (ADHD) is reviewed. SUMMARY: The efficacy of methylphenidate in controlling ADHD symptoms is firmly established. Given the drug's relatively short half-life in pediatric patients (about 2.5 hours), a number of intermediate- and long-acting products have been developed; these extended-release methylphenidate products provide the same efficacy as immediate-release (IR) formulations, with the convenience of less frequent dosing...
July 15, 2014: American Journal of Health-system Pharmacy: AJHP
Mark A Stein, Irwin Waldman, Jeffrey Newcorn, Jeffrey Bishop, Rick Kittles, Edwin H Cook
OBJECTIVES: This study seeks to determine if variation in the dopamine transporter gene (SLC6A3/DAT1) moderates the dose-response effects of long-acting dexmethylphenidate (D-MPH) and mixed amphetamine salts (MAS) in children with attention-deficit/hyperactivity disorder (ADHD). METHODS: Fifty-six children and adolescents (mean age=11.7±2.2) participated in a double-blind, two period crossover, dose-response study with a randomized placebo week in each 4 week drug period...
June 2014: Journal of Child and Adolescent Psychopharmacology
Walid F Gellad, Phillip Choi, Margaret Mizah, Chester B Good, Aaron S Kesselheim
OBJECTIVES: A "chiral switch" occurs in the pharmaceutical market when a drug made up of 2 enantiomer forms is replaced with a purified single-enantiomer version, often in the context of a patent expiration. We studied the prevalence of chiral switching in the United States over the past decade, including trends in use of, and expenditures on, these products in Medicaid. STUDY DESIGN: Retrospective analysis. METHODS: We used US Adopted Names prefixes (lev/levo/ar/es/dex/dextro) to identify all single-enantiomer drugs approved from 2001 to 2011...
March 2014: American Journal of Managed Care
Juliana Setyawan, Annie Guérin, Paul Hodgkins, Geneviève Gauthier, Martin Cloutier, Eric Wu, M Haim Erder
OBJECTIVE: To compare treatment persistence in attention-deficit/hyperactivity disorder (ADHD) of patients initiated on lisdexamfetamine (LDX) vs other ADHD medications. METHODS: A large US administrative claims database was used to select ADHD patients who initiated an ADHD medication (index treatment) during/after 2007. Patients were classified, based on age and previous treatment status, as treatment-naïve or previously treated children and adolescents (6-17 years) and treatment-naïve or previously treated adults (18 years and older)...
November 2013: Journal of Medical Economics
Juliana Setyawan, Paul Hodgkins, Annie Guérin, Geneviève Gauthier, Martin Cloutier, Eric Wu, M Haim Erder
OBJECTIVE: To compare therapy augmentation and deviation rates from the recommended once-daily dosing regimen in Attention Deficit Hyperactivity Disorder (ADHD) patients initiated on lisdexamfetamine (LDX) vs other once-daily Food and Drug Administration (FDA) approved stimulants. METHODS: ADHD patients initiated on a long-acting ADHD stimulant medication (index medication) in/after 2007 were selected from a large U.S. administrative claims database. Patients were required to be persistent for ≥90 days and continuously enrolled in their healthcare plan for ≥12 months following treatment initiation date...
October 2013: Journal of Medical Economics
Michael A Sopko, Harjeet Caberwal, Benjamin Chavez
OBJECTIVE: To review the literature on the safety and efficacy of methylphenidate, OROS-methylphenidate, methylphenidate ER, and dexmethylphenidate in adults with Attention-Deficit/Hyperactivity Disorder (ADHD). To analyze the effects of different doses of methylphenidate, it's various formulations, and methylphenidate on efficacy and safety in this population. DATA SOURCES: Literature retrieval was performed through Pubmed/MEDLINE (Up to May 2010) using the terms methylphenidate, dexmethylphenidate, and attention-deficit hyperactivity disorder...
2010: Journal of Central Nervous System Disease
Raul R Silva, Matthew Brams, Kevin McCague, Linda Pestreich, Rafael Muniz
OBJECTIVE: This study aimed to compare the effects of dexmethylphenidate (D-MPH) extended-release (ER) 30 mg and D-MPH-ER 20 mg on attention, behavior, and performance in children with attention-deficit/hyperactivity disorder. METHODS: In a randomized, double-blind, 3-period-by-3-treatment, crossover study, children aged 6 to 12 years with attention-deficit/hyperactivity disorder stabilized on methylphenidate (40-60 mg/d) or D-MPH (20-30 mg/d) received D-MPH-ER 20 mg/d, 30 mg/d, and placebo for 7 days each (final dose of each treatment period administered in a laboratory classroom)...
July 2013: Clinical Neuropharmacology
Juliana Setyawan, Paul Hodgkins, Annie Guérin, Geneviève Gauthier, Martin Cloutier, Eric Q Wu, M Haim Erder
OBJECTIVE: To assess treatment adherence in attention deficit/hyperactivity disorder (ADHD) patients initiated on Lisdexamfetamine (LDX) vs other FDA-approved stimulants and non-stimulant medications. METHODS: ADHD patients initiated on an ADHD medication (index medication) were selected from a large US administrative claims database. Based on age and previous treatment status, patients were classified into treatment-naïve children and adolescents (6-17 years old), previously treated children and adolescents, treatment-naïve adults (over 18 years old), and previously treated adults...
July 2013: Journal of Medical Economics
Benno Roesch, Mary Corcoran, Mary Haffey, Annette Stevenson, Phillip Wang, Jaideep Purkayastha, Patrick Martin, James Ermer
BACKGROUND: α2-Adrenoceptor agonists are used adjunctively to psychostimulants in treating attention-deficit/hyperactivity disorder (ADHD) when psychostimulants alone do not sufficiently reduce symptoms. However, data on the pharmacokinetic profiles and safety of combination treatments in ADHD are needed. OBJECTIVE: The primary objective of this study was to evaluate the pharmacokinetic profiles of guanfacine extended release (GXR) and methylphenidate hydrochloride (MPH) extended release, alone and in combination...
March 2013: Drugs in R&D
Vanja Sikirica, Steven R Pliszka, Keith A Betts, Paul Hodgkins, Tom Samuelson, Jipan Xie, Haim Erder, Ryan Dammerman, Brigitte Robertson, Eric Q Wu
BACKGROUND: Although not indicated for attention-deficit/hyperactivity disorder (ADHD), atypical antipsychotics (AAPs) are commonly prescribed for children with ADHD. The treatment patterns, resource utilization, and costs associated with AAPs relative to non-antipsychotic medications have not been evaluated for children with ADHD.  OBJECTIVE: To compare treatment patterns, resource utilization, and costs to U.S. third party payers between stimulant-treated ADHD children who switch to or augment their stimulant treatment with AAPs (risperidone, aripiprazole, quetiapine, olanzapine, ziprasidone, paliperidone, and clozapine) compared with non-antipsychotic medications (atomoxetine, clonidine immediate-release (IR), guanfacine IR, dexmethylphenidate, mixed amphetamine salts, methylphenidate, lisdexamfetamine, and dextroamphetamine)...
November 2012: Journal of Managed Care Pharmacy: JMCP
Kennerly S Patrick, Arthur B Straughn, Owen T Reeves, Hilary Bernstein, Guinevere H Bell, Erica R Anderson, Robert J Malcolm
Enantioselective hydrolysis of oral racemic methylphenidate (dl-MPH) by carboxylesterase 1 (CES1) limits the absolute bioavailability of the pharmacologically active d-MPH isomer to approximately 30% and that of the inactive l-MPH to only 1-2%. Coadministration of dl-MPH with ethanol results in elevated d-MPH plasma concentrations accompanied by CES1-mediated enantioselective transesterification of l-MPH to l-ethylphenidate (EPH). The present study tested the hypothesis that administration of the pure isomer dexmethylphenidate (d-MPH) will overcome the influence of ethanol on d-MPH absorption by eliminating competitive CES1-mediated presystemic metabolism of l-MPH to l-EPH...
January 2013: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Xavier Castells, Ruth Cunill, Dolors Capellà
BACKGROUND: Attention deficit hyperactivity disorder (ADHD) in adulthood is increasingly diagnosed and treated. Methylphenidate is frequently advocated as a first-line pharmacological treatment. PURPOSE: The aim of our study was to compare all-cause discontinuation rate of methylphenidate and its pharmaceutical presentations with placebo in adults with ADHD. METHODS: This was a systematic review and meta-analysis of randomized controlled trials comparing methylphenidate with placebo in adults with ADHD...
March 2013: European Journal of Clinical Pharmacology
Matthew Brams, John Turnbow, Linda Pestreich, John Giblin, Ann Childress, Kevin McCague, Rafael Muniz
The objective of this study was to evaluate the safety and efficacy of dexmethylphenidate extended-release (d-MPH-ER) 30 versus 20 mg in children with attention-deficit/hyperactivity disorder (ADHD) in a 12-hour laboratory classroom setting. In a randomized, double-blind, 3-period × 3-treatment, crossover study, children aged 6 to 12 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-diagnosed ADHD previously stabilized on MPH (40-60 mg/d) or D-MPH (20-30 mg/day) [corrected] were randomized to receive D-MPH-ER 20 mg/day, 30 mg/day, [corrected] or placebo for 7 days each...
October 2012: Journal of Clinical Psychopharmacology
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