Budgetary impact on a U.S. health plan adopting abiraterone acetate plus prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
To study the efficacy and tolerability of atomoxetine in high-functioning boys with autism spectrum disorders (ASD) and comorbid attention deficit/hyperactivity disorder (AD/HD).
At two years, one patient presented a crisis and two patients continued to display paroxysmal activity in the electroencephalogram.
This randomized, double-blind, placebo- and active-controlled, parallel-group, multicentre study evaluated three dosages of bavisant (1 mg/day, 3 mg/day or 10 mg/day) and two active controls in adults with ADHD. The study consisted of a screening phase of up to 14 days, a 42-day double-blind treatment phase and a 7-day post-treatment follow-up phase. Efficacy and safety assessments were performed.
Efficacy and P300 data from 58 children with ADHD enrolled in a double-blind crossover study using atomoxetine and methylphenidate were analyzed. Robust response was defined as 60% decrease from baseline in the ADHD rating scale. Response was alternately defined as greater than 50% decrease.
Here, we evaluate a report of a head-to-head study of the prodrug stimulant lisdexamfetamine dimesylate (LDX) and the non-stimulant atomoxetine hydrochloride (ATX) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). An inadequate response to previous methylphenidate (MPH) treatment was a notable inclusion criterion. The primary efficacy outcome of a more rapid clinical response to LDX than to ATX was predictable from the known properties of the two drugs. However, secondary efficacy outcomes indicated that LDX was significantly more effective than ATX in relieving investigator-rated symptoms of ADHD, with an effect size of 0.56. Safety and tolerability profiles were consistent with the known properties of LDX and ATX. Despite some issues with the study design, the conclusion that LDX is more effective than ATX over the short term appears robust. In addition, the magnitude of improvement with both treatments indicated that previous MPH treatment is not a factor affecting the potential for patients to benefit from LDX or ATX. The results may help to inform clinical practice in Europe, where LDX is approved for treating children and adolescents with ADHD and a previous inadequate response to MPH, and in other regions where generic MPH formulations are typically the first-line therapeutic option.
A total of 40 children - with a mean age of 8.6 plus or minus 2.3 years and a median age of 11 years; ranged from 8 to 14 years - with attention deficit/hyperactivity disorder - with six girls and 34 boys - were included in the study. We recorded the mean systolic and diastolic blood pressure, heart rate, corrected QT interval, QT dispersion, and left ventricular systolic functions at baseline and 5 weeks after atomoxetine therapy.
A total of 262 patients was treated with atomoxetine. The mean dose for the respective visit intervals ranged between 1.15 and 1.17 mg/kg per day. Quality of life as reflected by the degree of perceived difficulties improved over time. Change in GIPD scores was greatest within the first 2 weeks. The course of the mean GIPD total scores over time showed a similar pattern among the three different rater perspectives. However, patients perceived the degree of difficulties as significantly less compared to parents and physicians. Agreement of ratings was highest between physicians and parents.
The current study sought to determine the effects of pharmacological manipulation of the dopamine, noradrenaline and serotonin neurotransmitter systems on key behavioural and event-related potential correlates of error processing.
Comorbid ODD does not influence the rate of relapse of patients with ADHD during longer-term treatment with atomoxetine. Atomoxetine protects against the relapse of ADHD symptoms regardless of the presence or absence of comorbid ODD.
In total, 65 papers met the inclusion criteria. The results suggest that MPH and DEX are effective at reducing hyperactivity and improving QoL (as determined by Clinical Global Impression) in children, although the reliability of the MPH study results is not known and there were only a small number of DEX studies. There was consistent evidence that ATX was superior to placebo for hyperactivity and Clinical Global Impression. Studies on ATX more often reported the study methodology well, and the results were likely to be reliable. Very few studies made direct head-to-head comparisons between the drugs or examined a non-drug intervention in combination with MPH, DEX or ATX. Adequate and informative data regarding the potential adverse effects of the drugs were also lacking. The results of the economic evaluation clearly identified an optimal treatment strategy of DEX first-line, followed by IR-MPH for treatment failures, followed by ATX for repeat treatment failures. Where DEX is unsuitable as a first-line therapy, the optimal strategy is IR-MPH first-line, followed by DEX and then ATX. For patients contraindicated to stimulants, ATX is preferred to no treatment. For patients in whom a midday dose of medication is unworkable, ER-MPH is preferred to ATX, and ER-MPH12 appears more cost-effective than ER-MPH8. As identified in the clinical effectiveness review, the reporting of studies was poor, therefore this should be borne in mind when interpreting the model results.