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The American Journal of Managed Care Mar 2014A "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...
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. From publicly available US Food and Drug Administration (FDA) approval documents, we extracted the characteristics of the pivotal premarket trials for the single enantiomers. Specifically, we evaluated whether the single enantiomer was directly compared with the precursor racemic drug and whether there was evidence of superior efficacy. We used quarterly drug expenditure data from each state Medicaid program to chart trends in use of, and spending on, the single-enantiomer products and their racemic precursors during the study period.
RESULTS
From 2001 to 2011, the FDA approved 9 single-enantiomer products: dexlansoprazole, levoleucovorin, levocetirizine, armodafinil, arformoterol, eszopiclone, escitalopram, dexmethylphenidate, and esomeprazole. Of those 9 drugs, 3 had at least 1 pre-approval randomized trial that included the racemic precursor as a direct comparator, but there was no evidence of superiority of the single enantiomer over the racemic at comparable doses. Between 2001 and 2011, US Medicaid programs spent approximately $6.3 billion on these 9 single-enantiomer drugs.
CONCLUSIONS
Recently approved single-enantiomer drugs showed no evidence of superior efficacy over the older racemic precursors in the pivotal trials leading to their approval, and in a majority of cases, they were not directly compared.
Topics: Antidotes; Azabicyclo Compounds; Benzhydryl Compounds; Bronchodilator Agents; Central Nervous System Stimulants; Cetirizine; Dexlansoprazole; Dexmethylphenidate Hydrochloride; Drug Approval; Drug Prescriptions; Drugs, Generic; Esomeprazole; Eszopiclone; Ethanolamines; Formoterol Fumarate; Histamine H1 Antagonists, Non-Sedating; Humans; Hypnotics and Sedatives; Levoleucovorin; Medicaid; Modafinil; Patents as Topic; Piperazines; Proton Pump Inhibitors; Retrospective Studies; Stereoisomerism; United States; United States Food and Drug Administration; Wakefulness-Promoting Agents
PubMed: 24773330
DOI: No ID Found -
Journal of Medical Economics Nov 2013To compare treatment persistence in attention-deficit/hyperactivity disorder (ADHD) of patients initiated on lisdexamfetamine (LDX) vs other ADHD medications.
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). Furthermore, patients were classified into seven mutually exclusive treatment groups, based on their index treatment: LDX, atomoxetine (ATX), osmotic-release methylphenidate hydrochloride long-acting (OROS MPH), other methylphenidate/dexmethylphenidate short-acting (MPH SA) and long-acting (MPH LA), and amphetamine/dextroamphetamine short acting (AMPH SA) and long-acting (AMPH LA). Treatment persistence, analyzed through discontinuation (interruption of the index treatment for ≥30 consecutive days), was compared between treatment groups using multivariate Cox proportional hazards. Patients were followed until first treatment discontinuation or up to 12 months after the initiation of the index treatment, whichever occurred first.
RESULTS
Among children and adolescents, LDX patients had a significantly lower discontinuation rate compared to other treatment groups (range hazard ratios [HRs]; 1.04-2.26; all p < 0.05), except when compared to treatment-naïve patients on ATX and OROS MPH, where no statistically significant differences were found and where LDX had a higher risk of discontinuation, respectively. Among adults, LDX patients had a significantly lower discontinuation rate compared to patients in other treatment groups (range HR; 1.14-1.86; all p < 0.05), except for the comparison with AMPH LA patients, where differences were not statistically significant.
LIMITATIONS
This study did not control for ADHD severity.
CONCLUSION
LDX-treated patients were associated with higher persistence compared to patients initiated on other ADHD medications, except for the comparisons with OROS MPH and ATX treated patients in treatment-naïve children and adolescents and AMPH LA-treated patients in adults.
Topics: Adolescent; Adult; Age Factors; Amphetamines; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Comorbidity; Dextroamphetamine; Drug Combinations; Female; Humans; Insurance Claim Review; Lisdexamfetamine Dimesylate; Male; Medication Adherence; Retrospective Studies; United States; Young Adult
PubMed: 24004347
DOI: 10.3111/13696998.2013.839947 -
Journal of Medical Economics Oct 2013To compare therapy augmentation and deviation rates from the recommended once-daily dosing regimen in Attention Deficit Hyperactivity Disorder (ADHD) patients initiated...
Comparison of therapy augmentation and deviation rates from the recommended once-daily dosing regimen between LDX and commonly prescribed long-acting stimulants for the treatment of ADHD in youth and adults.
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. 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 (≥18 years old), and previously treated adults. Furthermore, patients were classified into four mutually exclusive treatment groups, based on index medication: lisdexamfetamine (LDX), osmotic release methylphenidate hydrochloride long-acting (OROS MPH), other methylphenidate/dexmethylphenidate long-acting (MPH LA), and amphetamine/dextroamphetamine long-acting (AMPH LA). The average daily consumption was measured as the quantity of index medication supplied in the 12-month study period divided by the total number of days of supply. Therapy augmentation was defined as the use of another ADHD medication concomitantly with the index medication for ≥28 consecutive days. Therapy augmentation and deviation rates from the recommended once-daily dosing regimen were compared between treatment groups using multivariate logistic regression models.
RESULTS
Compared to the other treatment groups, LDX patients were less likely to augment with another ADHD medication (range odds ratios [OR]; 1.28-3.30) and to deviate from the recommended once-daily dosing regimen (range OR; 1.73-4.55), except for previously treated adult patients, where therapy augmentation differences were not statistically significant when compared to OROS MPH and MPH LA patients.
LIMITATION
This study did not control for ADHD severity.
CONCLUSION
Overall, compared to LDX-treated patients, patients initiated on other ADHD medications were equally or more likely to have a therapy augmentation and more likely to deviate from the recommended once-daily dosing regimen.
Topics: Adolescent; Adult; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Delayed-Action Preparations; Dextroamphetamine; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Insurance Claim Review; Lisdexamfetamine Dimesylate; Male; Retrospective Studies; United States; Young Adult
PubMed: 23937642
DOI: 10.3111/13696998.2013.832258 -
Journal of Medical Economics Jul 2013To assess treatment adherence in attention deficit/hyperactivity disorder (ADHD) patients initiated on Lisdexamfetamine (LDX) vs other FDA-approved stimulants and... (Comparative Study)
Comparative Study
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. Furthermore, based on their index medication, patients were classified into seven mutually exclusive treatment groups: LDX, atomoxetine (ATX), osmotic release methylphenidate hydrochloride long acting (OROS MPH), other methylphenidate/dexmethylphenidate long acting (MPH LA) and short acting (MPH SA), and amphetamine/dextroamphetamine short acting (AMPH SA) and long acting (AMPH LA). Treatment adherence (proportion of days covered by the index medication ≥0.8) over a 12-month period was compared across treatment groups using multivariate logistic regression models.
RESULTS
In children and adolescents, LDX patients were more likely to be adherent compared to patients in each of the other treatment groups, except in treatment-naïve patients where LDX patients had a similar likelihood (p = 0.6925) and were less likely (p = 0.0004) to be adherent compared to ATX and OROS MPH patients, respectively. In adults, the LDX treatment group was also more likely to be adherent compared to each of the other treatment groups, except compared to AMPH LA, where statistically insignificant differences were observed (previously treated: p = 0.6471, treatment-naïve: p = 0.0733).
LIMITATIONS
ADHD severity information was not available in the database. Accordingly, this study did not control for ADHD severity.
CONCLUSION
Overall, LDX-treated patients demonstrated a better treatment adherence compared to patients initiated on other ADHD medications, except for AMPH LA in adult and OROS MPH and ATX in treatment-naïve children and adolescents.
Topics: Adolescent; Adult; Age Distribution; Attention Deficit Disorder with Hyperactivity; Child; Dextroamphetamine; Family Health; Female; Humans; Insurance Claim Review; Lisdexamfetamine Dimesylate; Longitudinal Studies; Male; Medication Adherence; Retrospective Studies; Sex Distribution; United States
PubMed: 23621503
DOI: 10.3111/13696998.2013.800524 -
Drugs in R&D Mar 2013α2-Adrenoceptor agonists are used adjunctively to psychostimulants in treating attention-deficit/hyperactivity disorder (ADHD) when psychostimulants alone do not... (Randomized Controlled Trial)
Randomized Controlled Trial
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.
STUDY DESIGN
This was an open-label, randomized, three-period crossover, drug-drug interaction study.
SETTING
The study was conducted at a single clinical research center.
PARTICIPANTS
Thirty-eight healthy adults were randomized in this study.
INTERVENTIONS
Subjects were administered single oral doses of GXR (Intuniv(®); Shire Development LLC, Wayne, PA, USA) 4 mg, MPH (Concerta(®); McNeil Pediatrics, Titusville, NJ, USA) 36 mg, or GXR and MPH combined.
MAIN OUTCOME MEASURES
Guanfacine, dexmethylphenidate (d-MPH), and l-methylphenidate (l-MPH) levels were measured with blood samples collected predose and up to 72 h postdose. Safety evaluations included treatment-emergent adverse events (TEAEs), vital signs, and electrocardiograms (ECGs).
RESULTS
Thirty-five subjects completed the study. Analyses of the 90 % confidence intervals (CIs) for the geometric mean ratios of the maximum plasma concentration (Cmax) and area under the concentration-time curve extrapolated to infinity (AUC∞) values for guanfacine and d-MPH following administration of GXR or MPH alone or combined met strict bioequivalence criteria (90 % CIs within the interval of 0.80-1.25). Overall, combining GXR and MPH did not alter the pharmacokinetic parameters of either medication. Sixteen subjects (42.1 %) had at least one TEAE. The most commonly reported TEAEs included headache and dizziness following GXR, MPH, and GXR and MPH combined. Two subjects had clinically significant abnormalities in ECG results following coadministration: both events were mild and resolved the same day.
CONCLUSIONS
In this short-term, open-label study of healthy adults, coadministration of GXR and MPH did not result in significant pharmacokinetic drug-drug interactions. No unique TEAEs were observed with coadministration of GXR and MPH compared with either treatment alone.
Topics: Adrenergic alpha-2 Receptor Agonists; Adult; Central Nervous System Stimulants; Cross-Over Studies; Delayed-Action Preparations; Drug Interactions; Drug Therapy, Combination; Female; Guanfacine; Humans; Male; Methylphenidate; Young Adult
PubMed: 23519656
DOI: 10.1007/s40268-013-0009-5 -
Journal of Managed Care Pharmacy : JMCP 2012Although not indicated for attention-deficit/hyperactivity disorder (ADHD), atypical antipsychotics (AAPs) are commonly prescribed for children with ADHD. The treatment...
Comparative treatment patterns, resource utilization, and costs in stimulant-treated children with ADHD who require subsequent pharmacotherapy with atypical antipsychotics versus non-antipsychotics.
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).
METHODS
Patients with at least one ADHD diagnosis (ICD-9-CM codes 314.00 or 314.01) and at least one stimulant medication claim between January 1, 2005 and December 31, 2009, were identified from a large U.S. commercial medical/pharmacy claims database. Patients were classified into the AAP cohort if they had a claim for an AAP following a stimulant fill or into the non-antipsychotic cohort if they had a claim for a non-antipsychotic medication after a stimulant fill and no AAP claims. The index date was defined as the date of the first fill of the AAP or a randomly selected eligible non-antipsychotic medication. Patients were eligible for inclusion if they were aged 6-12 as of the index date and had at least 18 months of continuous eligibility. Patients were excluded if they had a psychiatric diagnosis for which AAPs were approved by the U.S. Food and Drug Administration (FDA) or commonly used. Patients in the non-antipsychotic group were matched 1:1 to patients in the AAP group using a propensity score generated from a logistic regression that included demographics, treatments, resource utilization, and comorbidities during the 6 months prior to the index date. All outcomes were measured during the 12 months following the index date. Treatment patterns were compared using Kaplan-Meier (KM) estimates and Cox proportional hazards models. Annual resource utilization was compared using McNemar's test and Poisson regression. Costs were estimated from the perspective of U.S. third-party payers and were adjusted to 2010 dollars using the medical component of the Consumer Price Index. Both all-cause and mental health-related costs were examined and compared using Wilcoxon signed-rank tests.
RESULTS
Of the 22,622 patients with ADHD identified to have used AAPs after a stimulant, 15,664 (69%) patients did not have a psychiatric diagnosis for which AAPs were FDA-indicated or commonly used. Among the 84,558 patients using non-antipsychotics after a stimulant, 81,397 (96%) did not have such psychiatric diagnoses. A total of 2,127 children in the AAP cohort and 16,508 children in the non-antipsychotic cohort met all of the study inclusion criteria. After propensity score matching, 1,857 children (358 switchers and 1,499 augmenters) were included in each of the matched cohorts. The baseline characteristics were well balanced between the matched cohorts. In the 12 months post-index date, children treated with AAPs were more likely to experience switching (KM: 17.2% vs. 10.4% at 12 months; HR = 1.75) and augmentation (KM: 43.4% vs. 22.4% at 12 months; HR = 2.62) than the non-antipsychotic group (both P less than 0.001). Rates of discontinuation were similar between groups (KM: 71.8% vs. 71.7% at 12 months; HR = 0.98, P = 0.600). The AAP cohort also had higher mean numbers of hospitalizations, emergency room visits, and outpatient visits (0.08 vs. 0.03, 0.34 vs. 0.25, 14.1 vs. 12.7 per patient, respectively; event rate ratios = 2.61, 1.33, and 1.11, respectively; all P less than 0.001). The AAP group also incurred higher all-cause mean medical, prescription drug, and total health care costs compared with the non-antipsychotic group ($3,090 vs. $2,238; $3,844 vs. $2,509; $6,934 vs. $4,748, respectively; all P less than 0.001). Patients in the AAP group also incurred higher mean total, medical, and drug costs related to mental health ($5,057 vs. $2,859; $1,555 vs. $964; $3,502 vs. $1,895, respectively; all P less than 0.001).
CONCLUSIONS
Stimulant-treated children with ADHD who switched to or augmented with AAPs versus non-antipsychotics had significantly greater rates of subsequent augmentation and health care resource utilization as well as higher total health care costs. Further research and/or drug utilization reviews may be warranted to fully evaluate the clinical and economic outcomes of pediatric ADHD patients who are receiving AAPs.
Topics: Adolescent; Antipsychotic Agents; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Child, Preschool; Drug Costs; Female; Health Care Costs; Health Resources; Humans; Insurance Claim Review; Male; Managed Care Programs; Practice Patterns, Physicians'; Retrospective Studies; Sex Distribution
PubMed: 23206211
DOI: 10.18553/jmcp.2012.18.9.676 -
Drug Metabolism and Disposition: the... Jan 2013Enantioselective hydrolysis of oral racemic methylphenidate (dl-MPH) by carboxylesterase 1 (CES1) limits the absolute bioavailability of the pharmacologically active... (Comparative Study)
Comparative Study
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. Twenty-four healthy volunteers received dl-MPH (0.3 mg/kg) or d-MPH (0.15 mg/kg), with or without ethanol (0.6 g/kg). During the absorption phase of dl-MPH, concomitant ethanol significantly elevated d-MPH plasma concentrations (44-99%; P < 0.005). Furthermore, immediately following the ethanol drink the subjective effects of "high," "good," "like," "stimulated," and overall "effect" were significantly potentiated (P ≤ 0.01). Plasma l-EPH concentrations exceeded those of l-MPH. Ethanol combined with pure d-MPH did not elevate plasma d-MPH concentrations during the absorption phase, and the ethanol-induced potentiation of subjective effects was delayed relative to dl-MPH-ethanol. These findings are consistent with l-MPH competitively inhibiting presystemic CES1 metabolism of d-MPH. Ethanol increased the d-MPH area under the curve (AUC)(0-inf) by 21% following dl-MPH (P < 0.001) and 14% for d-MPH (P = 0.001). In men receiving d-MPH-ethanol, the d-MPH absorption partial AUC(0.5-2 hours) was 2.1 times greater and the time to maximum concentration (T(max)) occurred 1.1 hours earlier than in women, consistent with an increased rate of d-MPH absorption reducing hepatic extraction. More rapid absorption of d-MPH carries implications for increased abuse liability.
Topics: Adult; Area Under Curve; Carboxylesterase; Dexmethylphenidate Hydrochloride; Esterification; Ethanol; Female; Hemodynamics; Humans; Male; Methylphenidate; Stereoisomerism; Young Adult
PubMed: 23104969
DOI: 10.1124/dmd.112.048595 -
Journal of Child and Adolescent... Dec 2011To compare the dose effects of long-acting extended-release dexmethylphenidate (ER d-MPH) and ER mixed amphetamine salts (ER MAS) on attention-deficit/hyperactivity... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To compare the dose effects of long-acting extended-release dexmethylphenidate (ER d-MPH) and ER mixed amphetamine salts (ER MAS) on attention-deficit/hyperactivity disorder (ADHD) symptom dimensions, global and specific impairments, and common adverse events associated with stimulants.
METHODS
Fifty-six children and adolescents with ADHD participated in an 8-week, double-blind, crossover study comparing ER d-MPH (10, 20, 25-30 mg) and ER MAS (10, 20, 25-30) with a week of randomized placebo within each drug period. Efficacy was assessed with the ADHD Rating Scale-IV (ADHD-RS-IV), whereas global and specific domains of impairment were assessed with the Clinical Global Impressions Severity and Improvement Scales and the parent-completed Weiss Functional Impairment Scale, respectively. Insomnia and decreased appetite, common stimulant-related adverse events, were measured with the parent-completed Stimulant Side Effects Rating Scale.
RESULTS
Both ER d-MPH and ER MAS were associated with significant reductions in ADHD symptoms. Improvement in Total ADHD and Hyperactivity/Impulsivity symptoms were strongly associated with increasing dose, whereas improvements in Inattentive symptoms were only moderately associated with dose. About 80% demonstrated reliable change on ADHD-RS-IV at the highest dose level of ER MAS compared with 79% when receiving ER d-MPH. Decreased appetite and insomnia were more common at higher dose levels for both stimulants. Approximately 43% of the responders were preferential responders to only one of the stimulant formulations.
CONCLUSIONS
Dose level, rather than stimulant class, was strongly related to medication response.
Topics: Adolescent; Amphetamines; Appetite; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Cross-Over Studies; Delayed-Action Preparations; Dexmethylphenidate Hydrochloride; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Methylphenidate; Psychiatric Status Rating Scales; Sleep Initiation and Maintenance Disorders
PubMed: 22136094
DOI: 10.1089/cap.2011.0018 -
Revista Da Associacao Medica Brasileira... 2011Cancer-related fatigue is the most prevalent cancer symptom, reported in 50%-90% of patients and severely impacts quality of life and functional capacity. The condition... (Review)
Review
Cancer-related fatigue is the most prevalent cancer symptom, reported in 50%-90% of patients and severely impacts quality of life and functional capacity. The condition remains underreported and often goes untreated. Guidelines suggest screening for fatigue at the initial visit, when the diagnosis of advanced disease is made, and at each chemotherapy session, as well as the identification of treatable contributing factors such as anemia, hypothyroidism, depression and sleep disorders. Brief assessment tools such as the Brief Fatigue Inventory or the Visual Analog Scale may be appropriate in the initial scoring of fatigue severity, but the initial approach to treatment usually requires a more comprehensive assessment, education, and the determination of an individualized treatment plan. Patients with moderate or severe fatigue may benefit from both pharmacological and non-pharmacological interventions, whereas mild fatigue that does not interfere with quality of life can be treated with non-pharmacological measures alone. Non-pharmacological measures that have shown to be promising include cognitive-behavioral interventions such as energy conservation and activity management (ECAM), exercise and perhaps sleep therapy. Many other modalities may be beneficial and can be used on an individual basis, but there is insufficient evidence to promote any single treatment. Pharmacological therapies that have shown to be promising include the psycho-stimulants methylphenidate and dexmethylphenidate, modafinil (in severely fatigued patients only), and erythropoietin-stimulating agents in patients with chemotherapy-associated anemia and hemoglobin levels < 10 g/dL. Recently, our group reported impressive results with the use of the dry extract of Guarana (Paullinia cupana), with no significant side effects and at low cost, for the treatment of physical and mental cancer-related fatigue.
Topics: Fatigue; Humans; Neoplasms; Quality of Life
PubMed: 21537710
DOI: 10.1590/s0104-42302011000200021 -
The Primary Care Companion For CNS... 2011To review the efficacy, safety, and abuse liability of approved treatments in adults with attention-deficit/hyperactivity disorder (ADHD), with a focus on once-daily...
OBJECTIVE
To review the efficacy, safety, and abuse liability of approved treatments in adults with attention-deficit/hyperactivity disorder (ADHD), with a focus on once-daily medications.
DATA SOURCES
PubMed was searched for relevant studies/reviews in English from 2002 to 2011 on adult ADHD treatments.
STUDY SELECTION
Keywords used in the search were ADHD, adults, and treatment. Limits included only clinical trials, meta-analyses, randomized controlled trials, and reviews including adults (aged ≥ 19 years).
DATA EXTRACTION
Selection criteria returned 471 publications. Retrieved studies were excluded if they primarily focused on children, treatments not indicated for ADHD, or ADHD and comorbid conditions.
DATA SYNTHESIS
An epidemiologic survey revealed that 10.9% of adults identified with ADHD had received treatment during the prior 12 months. Treatments for ADHD in adults include pharmacologic and nonpharmacologic options. US Food and Drug Administration-approved long-acting stimulants and a nonstimulant with proven efficacy and safety profiles have been developed and include osmotic-release oral system methylphenidate hydrochloride (OROS-methylphenidate), extended-release dexmethylphenidate hydrochloride, mixed amphetamine salts extended release (MAS-XR), the nonstimulant atomoxetine hydrochloride, and the prodrug lisdexamfetamine dimesylate. Long-acting stimulants differ in formulation characteristics used to achieve extended release, with OROS-methylphenidate employing an osmotic-release technology, extended-release dexmethylphenidate hydrochloride and MAS-XR using pH-dependent beads, and lisdexamfetamine dimesylate using prodrug technology. These features variably affect pharmacokinetic characteristics, duration of action, and abuse liability. While all long-acting medications have varied pharmacokinetic features, mechanism of action, and duration of effect, all are generally efficacious and safety profiles are similar.
CONCLUSION
Approved long-acting treatments in adults with ADHD were effective in improving symptoms and were generally well tolerated.
PubMed: 22454805
DOI: 10.4088/PCC.11r01168