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Psychiatry (Edgmont (Pa. : Township)) Apr 2010In this article, we provide information on patient-reported side effects from a cross-section of real-world patients. Specifically, data on side effects were tabulated...
In this article, we provide information on patient-reported side effects from a cross-section of real-world patients. Specifically, data on side effects were tabulated for patients taking one of the following attention deficit hyperactivity disorder medications: amphetamine and dextroamphetamine; atomoxetine; dexmethylphenidate; isdexamfetamine; and methylphenidate. Forty-eight percent of the approximately 325 patients surveyed reported having experienced a side effect as a result of taking an attention deficit hyperactivity disorder medication. Most common side effects mentioned included loss of appetite, sleep problems, and mood disturbances. Only 21 percent of side effects were considered very bothersome or extremely bothersome. Regardless of how bothersome the side effects were, only 20 percent of patients mentioned the side effects to their prescribing physicians.
PubMed: 20508803
DOI: No ID Found -
Journal of Central Nervous System... 2010To review the literature on the safety and efficacy of methylphenidate, OROS-methylphenidate, methylphenidate ER, and dexmethylphenidate in adults with...
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. In addition, reference citations from publications identified were reviewed.
STUDY SELECTION AND DATA EXTRACTION
Double-blinded, placebo-controlled clinical trials, as well as crossover and open-label trials found using the search criteria listed above were included for review. Case reports were not included in this review.
DATA SYNTHESIS
Attention-deficit/hyperactivity disorder (ADHD) is a psychiatric condition that is commonly seen in children and adolescents, that persists into adulthood for about 50% of patients. Methylphenidate and dexmethylphenidate are often prescribed to treat the symptoms associated with ADHD. The literature validating the safety and efficacy of methylphenidate and dexmethylphenidate in children and adolescents with ADHD is substantial. However, the literature specifically addressing the safety and efficacy of these medications in the adult population is less extensive and prescribing is often anecdotal based on child and adolescent data. Understanding the literature regarding methylphenidate and dexmethylphenidate and its effects in adults can enhance evidence-based medicine (EBM) and improve treatment outcomes.
CONCLUSION
Methylphenidate and dexmethylphenidate are safe and effective medications to treat the symptoms of ADHD in adults. Based on the literature, increased doses are associated with better treatment response with moderate safety concerns. The different dosage forms available enable individualization of treatment.
PubMed: 23861628
DOI: 10.4137/jcnsd.s4178 -
Drugs 2010Throughout this decade, there has been significant research into pharmacotherapies for attention-deficit hyperactivity disorder (ADHD). This article considers the...
Throughout this decade, there has been significant research into pharmacotherapies for attention-deficit hyperactivity disorder (ADHD). This article considers the efficacy and safety of five of the more novel long-acting pharmacological treatments recently approved by the FDA for marketing in the US for paediatric ADHD, along with an alpha(2)-adrenoceptor agonist in preparation. Reviewed treatments include the non-stimulant atomoxetine, three novel extended-release (XR) stimulant preparations: dexmethylphenidate, lisdexamfetamine dimesylate and the methylphenidate transdermal system (TDS), and the recently approved XR alpha(2)-adrenoceptor agonist, guanfacine. Dexmethylphenidate XR is a stimulant treatment in a single isomer form, and has an efficacy and tolerability similar to two doses of immediate-release (IR) dexmethylphenidate when taken 4 hours apart, but is dosed at half of the usual d,l-methylphenidate dose. Dexmethylphenidate XR utilizes a beaded bimodal release, with 50% initially released and another 50% released 4 hours later to provide benefit lasting up to 10-12 hours. Lisdexamfetamine was the first stimulant treatment approved as a prodrug, whereby the single isomer d-amfetamine remains pharmacologically inactive until activated by cleaving the lysine. Its efficacy and tolerability are generally consistent with that of XR mixed amfetamine salts, with this activation method and more consistent absorption generally resulting in up to an 11- to 13-hour benefit. The methylphenidate TDS patch utilizes skin absorption to provide predictable and uniform delivery of methylphenidate when worn for 9 hours/day. The efficacy and tolerability of the methylphenidate TDS patch is generally consistent with that of osmotic-controlled release oral system (OROS) methylphenidate, providing benefit for about 11-12 hours. Because of their formulation, lisdexamfetamine and methylphenidate each have an onset of effect at about 2 hours after administration. An adjustable wear time for the methylphenidate TDS patch accommodates related adverse effects, but its disadvantages are frequent skin irritation and the need to remember to take the patch off. Atomoxetine is the first non-stimulant treatment approved by the FDA and employs weight-based dosing up to 1.4 mg/kg/day. Benefit is generally observed within 2-8 weeks of initiation and is considered to have a lesser therapeutic effect than that of stimulants. A recent parallel-group controlled study found that atomoxetine (up to 1.8 mg/kg/day) and OROS methylphenidate both improved ADHD symptoms, although subjects receiving OROS methylphenidate had a significantly better response. Interestingly, treatment-naive children had a similar beneficial response to atomoxetine as those receiving OROS methylphenidate. Subsequent crossover treatment revealed a subgroup of youths who did not respond well to OROS methylphenidate but did respond to atomoxetine. Also identified was a larger than expected subgroup who did not respond well to either active treatment, confirming the need to continue the pursuit of novel treatments. As of September of 2009, guanfacine in XR form is the first alpha(2)-adrenoceptor agonist to gain approval to treat ADHD, approved for the treatment of 6- to 17-year olds. A second alpha(2)-adrenoceptor agonist, clonidine, is in development as a potential XR treatment for paediatric ADHD. IR clonidine has a fast onset and short half-life, with its use historically limited by somnolence. Although early formulations did not improve inattention well, recent evidence suggests that clonidine XR may have potential use as monotherapy or in extending benefit when taken with a stimulant. Guanfacine has a more specific neuronal action and a longer action than that of clonidine. The approved dosing of guanfacine XR 1 to 4 mg daily generally provides symptom benefit lasting 8-14 hours, and up to 24 hours in some children and adolescents receiving a higher dose. Such recent developments and ongoing study of additional potential pharmacological interventions may lead to additional future treatment options for children with ADHD.
Topics: Administration, Oral; Adolescent; Atomoxetine Hydrochloride; Attention Deficit Disorder with Hyperactivity; Child; Clonidine; Dexmethylphenidate Hydrochloride; Dextroamphetamine; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Approval; Drug Therapy, Combination; Half-Life; Health Care Costs; Humans; Lisdexamfetamine Dimesylate; Methylphenidate; Pediatrics; Prodrugs; Propylamines; Psychiatric Status Rating Scales; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 20030423
DOI: 10.2165/11530540-000000000-00000 -
CNS Drugs Dec 2009Dexmethylphenidate extended release (XR) [Focalin XR] is a CNS stimulant indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients aged... (Review)
Review
Dexmethylphenidate extended release (XR) [Focalin XR] is a CNS stimulant indicated for the treatment of attention-deficit hyperactivity disorder (ADHD) in patients aged > or = 6 years. Dexmethylphenidate contains the d-threo-enantiomer of methylphenidate. Dexmethylphenidate XR capsules have a bimodal release profile, which mimics two doses of dexmethylphenidate immediate release (IR) given 4 hours apart, and allows once-daily administration. Once-daily dexmethylphenidate XR was effective and generally well tolerated in the treatment of ADHD in children, adolescents and adults in placebo-controlled trials. Improvements in ADHD symptoms were significantly greater for dexmethylphenidate XR versus placebo throughout the day, from as early as 0.5 hours after drug administration up to 11-12 hours after administration. Furthermore, dexmethylphenidate XR showed greater efficacy than osmotic release oral system (OROS) methylphenidate over the first half of the laboratory classroom day in crossover trials; however, assessments late in the day (10-12 hours post-dose) favoured OROS methylphenidate. The once-daily administration regimen with dexmethylphenidate XR avoids the need for a midday dose to be administered at school; administration options are extended in that the contents of the dexmethylphenidate XR capsule can be sprinkled on apple sauce for patients unable to swallow the capsule whole. Although dexmethylphenidate XR is a controlled substance in the US, this formulation appears to have a low risk of abuse or misuse. Thus, dexmethylphenidate XR extends the range of first-line pharmacological treatment options for children, adolescents or adults with ADHD, particularly for patients who require a rapid onset and prolonged duration of action, including children who require a reduction in ADHD symptoms throughout the school day.
Topics: Adolescent; Adult; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Clinical Trials as Topic; Delayed-Action Preparations; Dexmethylphenidate Hydrochloride; Dose-Response Relationship, Drug; Drug Interactions; Humans; Methylphenidate; Psychiatric Status Rating Scales; Severity of Illness Index
PubMed: 19958043
DOI: 10.2165/11201140-000000000-00000 -
Journal of Pain and Symptom Management Nov 2009Cancer and its treatment can induce subjective and objective evidence of diminished functional capacity encompassing physical fatigue and cognitive impairment.... (Randomized Controlled Trial)
Randomized Controlled Trial
Cancer and its treatment can induce subjective and objective evidence of diminished functional capacity encompassing physical fatigue and cognitive impairment. Dexmethylphenidate (D-MPH; the D-isomer of methylphenidate) was evaluated for treatment of chemotherapy-related fatigue and cognitive impairment. A randomized, double-blind, placebo-controlled, parallel-group study evaluated the potential therapeutic effect and safety of D-MPH in the treatment of patients with chemotherapy-related fatigue. Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-F) total score at Week 8 was the primary outcome measure. One hundred fifty-four patients (predominantly with breast and ovarian cancers) were randomized and treated. Compared with placebo, D-MPH-treated subjects demonstrated a significant improvement in fatigue symptoms at Week 8 in the FACIT-F (P=0.02) and the Clinical Global Impression-Severity scores (P=0.02), without clinically relevant changes in hemoglobin levels. Cognitive function was not significantly improved. There was a higher rate of study drug-related adverse events (AEs) (48 of 76 [63%] vs. 22 of 78 [28%]) and a higher discontinuation rate because of AEs (8 of 76 [11%] vs. 1 of 78 [1.3%]) in D-MPH-treated subjects compared with placebo-treated subjects. The most commonly reported AEs independent of study drug relationship in D-MPH-treated subjects were headache, nausea, and dry mouth, and in placebo-treated subjects were headache, diarrhea, and insomnia. D-MPH produced significant improvement in fatigue in subjects previously treated with cytotoxic chemotherapy. Further studies with D-MPH or other agents to explore treatment response in chemotherapy-associated fatigue should be considered.
Topics: Adolescent; Adult; Aged; Antineoplastic Agents; Central Nervous System Stimulants; Dexmethylphenidate Hydrochloride; Double-Blind Method; Fatigue; Female; Humans; Male; Methylphenidate; Middle Aged; Neoplasms; Neuropsychological Tests; Sample Size; Young Adult
PubMed: 19896571
DOI: 10.1016/j.jpainsymman.2009.03.011 -
Expert Opinion on Pharmacotherapy Nov 2009Dexmethylphenidate is a single-isomer stimulant medication approved for the treatment of attention deficit hyperactivity disorder (ADHD). Single-isomer drugs have the...
BACKGROUND
Dexmethylphenidate is a single-isomer stimulant medication approved for the treatment of attention deficit hyperactivity disorder (ADHD). Single-isomer drugs have the potential for decreased undesired effects and improved therapeutic efficacy. Stimulant medications have been the mainstay treatments for ADHD for fifty years, and ability to reduce their adverse effects would be useful in promoting patient compliance with treatment.
OBJECTIVE
To review the literature on the safety and efficacy of dexmethylphenidate.
METHODS
MedLine, PubMed search of dexmethylphenidate research.
RESULTS/CONCLUSIONS
Dexmethylphenidate is a safe and effective treatment for ADHD. Its overall safety and tolerability profile is similar to other members of the psychostimulant class.
Topics: Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Dexmethylphenidate Hydrochloride; Humans; Methylphenidate
PubMed: 19874250
DOI: 10.1517/14656560903386284 -
Journal of Child and Adolescent... Aug 2009This 5-week, multicenter, double-blind, placebo-controlled, parallel-group investigation is the first fixed-dose study to evaluate efficacy and tolerability of three... (Comparative Study)
Comparative Study Randomized Controlled Trial
OBJECTIVE
This 5-week, multicenter, double-blind, placebo-controlled, parallel-group investigation is the first fixed-dose study to evaluate efficacy and tolerability of three doses of (10, 20, or 30 mg, once daily [o.d.]) dexmethylphenidate hydrochloride (HCl) extended-release (d-MPH XR; Focalin XR) across multiple settings to treat pediatric attention-deficit/hyperactivity disorder (ADHD).
RESULTS
ADHD pediatric outpatients (n = 253) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition, criteria were randomized (1:1:1:1) to receive d-MPH XR (10, 20, or 30 mg o.d.) or placebo. Treatment with d-MPH XR significantly (p < 0.001) reduced the mean score (change from baseline) on Conners'-ADHD/DSM-IV Scales (CADS) as assessed by the teacher CADS-T (dose [mean];10 mg [18], 20 mg [16.9], 30 mg [20.7]) and parents, CADS-P (dose [mean];10 mg [15.8]; 20 mg [17.8]; 30 mg [20.5]) compared to placebo (mean CADS-T [5.7]; CADS-P [4.6]). A significant (p < 0.001) proportion of patients in the three d-MPH XR treatment groups showed improvement on the clinician-rated, Clinical Global Impressions-Improvement (CGI-I) scales (10 mg [73.8%]; 20 mg [71.2%]; 30 mg [77.2 %]) and severity ratings (CGI-S) compared to the placebo group (CGI-I, 22.2%). Adverse events were mild to moderate in severity and similar to previous observations for this class of neurostimulants.
CONCLUSION
All three doses of d-MPH XR (10, 20, or 30 mg o.d), were significantly more effective than placebo in improving ADHD symptoms as confirmed by the teacher, parent and clinician. Additionally, d-MPH XR was well tolerated and demonstrated a consistent safety profile.
Topics: Attention Deficit Disorder with Hyperactivity; Capsules; Child; Delayed-Action Preparations; Dexmethylphenidate Hydrochloride; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Methylphenidate; Nervous System Diseases; Skin Diseases
PubMed: 19702487
DOI: 10.1089/cap.2009.0007 -
The Journal of Clinical Psychiatry May 2009The U.S. Food and Drug Administration has approved 3 medications, atomoxetine and the extended-release formulations of amphetamine salts and dexmethylphenidate, for the...
The U.S. Food and Drug Administration has approved 3 medications, atomoxetine and the extended-release formulations of amphetamine salts and dexmethylphenidate, for the treatment of adult attention-deficit hyperactivity disorder (ADHD). Different formulations of the same drugs, as well as other agents and cognitive-behavioral therapy, have been tested to determine efficacy in ADHD alone and in ADHD with comorbid substance use disorders, mood disorders, and anxiety disorders. A deficit in research exists in regard to these comorbidities in adults with ADHD.
Topics: Adrenergic Uptake Inhibitors; Adult; Amphetamines; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Cognitive Behavioral Therapy; Combined Modality Therapy; Comorbidity; Humans; Substance-Related Disorders
PubMed: 19552859
DOI: 10.4088/jcp.7129br5c -
The Annals of Pharmacotherapy Jun 2009To review recent literature on the different stimulant preparations regarding efficacy and safety in children and adolescents with attention-deficit/hyperactivity... (Review)
Review
OBJECTIVE
To review recent literature on the different stimulant preparations regarding efficacy and safety in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) and describe advantages and disadvantages of the many available dosage formulations.
DATA SOURCES
Literature retrieval was performed through PubMed/MEDLINE (2005-December 2008) using the terms methylphenidate, amphetamines, central nervous system stimulants, and attention-deficit/hyperactivity disorder. In addition, reference citations from publications identified were reviewed and drug manufacturers were contacted for any possible additional references.
STUDY SELECTION AND DATA EXTRACTION
Double-blind clinical trials found using the search criteria listed above were included for review. Open-label studies and studies prior to 2005 were included if no double-blind trials were published for that formulation within the time period reviewed.
DATA SYNTHESIS
The literature reviewed here demonstrates the efficacy and safety of stimulant medications in children and adolescents with ADHD. However, there are 19 different formulations of stimulants, leading to confusion and errors in prescribing and dispensing of these drugs. Knowing and understanding the advantages and disadvantages of the different formulations can lead to individualized treatment. Formulations like Concerta, Focalin-XR, Adderall-XR, and Vyvanse provide the convenience of once-daily dosing. Each of these provides varying amount of stimulants at different times of the day. Vyvanse has a unique delivery system that may lower the risk of patients abusing their medication. Daytrana gives patients more control over their dosing by being able to choose when the patch is removed; it is also a feasible alternative for children who cannot swallow pills. For patients who cannot swallow tablets or capsules, the capsules of Focalin-XR, Adderall-XR, Metadate-CD, and Ritalin-LA can be opened and sprinkled on applesauce.
CONCLUSIONS
Stimulants are effective medications to treat the symptoms of ADHD. The multiple available dosage forms allow for individualization of treatment.
Topics: Adolescent; Amphetamines; Attention Deficit Disorder with Hyperactivity; Central Nervous System Stimulants; Child; Controlled Clinical Trials as Topic; Dexmethylphenidate Hydrochloride; Dosage Forms; Humans; Methylphenidate; Practice Patterns, Physicians'
PubMed: 19470858
DOI: 10.1345/aph.1L523 -
Current Opinion in Pulmonary Medicine Sep 2009Several studies have investigated fatigue among sarcoidosis patients. The purpose of this review is to analyze published data on the assessment, prevalence, etiology,... (Review)
Review
PURPOSE OF REVIEW
Several studies have investigated fatigue among sarcoidosis patients. The purpose of this review is to analyze published data on the assessment, prevalence, etiology, and treatment of sarcoidosis-associated fatigue.
RECENT FINDINGS
Fatigue was identified as a prominent problem in sarcoidosis, and its presence was frequently associated with impaired quality of life, compared with patients without fatigue. Although the studies with good methodological fatigue assessment found no relationship between clinical parameters and fatigue in sarcoidosis patients, the remaining studies reported associations between fatigue and clinical and psychological parameters. No studies were designed to analyze the etiology of fatigue, but some studies showed that prednisone-treated patients reported more fatigue compared with untreated patients. In addition, only one study focused on a treatment for fatigue, dexmethylphenidate hydrochloride. Several instruments to measure fatigue were used, with the Fatigue Assessment Scale most frequently utilized.
SUMMARY
This review illustrates the importance of fatigue as an under-recognized complication of sarcoidosis. It further emphasizes the need for longitudinal prospective studies to better define sarcoidosis fatigue, explore its impact on quality of life, define aggravating or alleviating factors and evaluate new potential treatment strategies.
Topics: Fatigue; Glucocorticoids; Humans; Prognosis; Quality of Life; Sarcoidosis
PubMed: 19458531
DOI: 10.1097/MCP.0b013e32832d0403