Clinical drug investigation
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Multicenter Study Comparative Study
Comparative effectiveness of long-acting risperidone in New Zealand: a report of resource utilization and costs in a 12-month mirror-image analysis.
Schizophrenia affects approximately 1% of the population and is associated with a considerable economic burden to society. The healthcare costs of the disorder are high and are compounded by substantial productivity losses. Failure to adhere to medication regimens, with subsequent relapse and hospitalization, is a key driver of these costs. A long-acting injectable formulation of the second generation antipsychotic risperidone (risperidone long-acting injection [risperidone LAI]) was licensed in New Zealand and received full government funding in October 2005. Second generation antipsychotics may have some efficacy advantages, be associated with fewer adverse effects and could improve adherence. However, the acquisition cost of risperidone LAI is higher than that of first generation antipsychotics and healthcare decision makers need information that allows them to determine whether risperidone LAI represents a cost-effective investment in terms of improved outcomes. ⋯ This study suggests that patients have reduced hospital admissions but longer bed-stay after starting risperidone LAI. Longer admissions were driven by those that discontinued treatment and continuation was associated with improved resource and cost outcomes compared with those who discontinued. These findings have potential implications for payers, providers and patients that require further investigation over a longer time frame.
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low back pain is one of the most common reasons for outpatient consultation in both the primary-care and specialized-care settings. However, few studies have explored the effect of pregabalin in this context. ⋯ compared with usual care, addition of pregabalin to existing therapy for refractory low back pain was associated with a larger reduction in pain severity and lost workday equivalents. The acquisition cost of pregabalin was offset by a higher reduction in the indirect components of cost, resulting in a significant decrease in total costs.
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A non-oncology dose selection phase II trial tests multiple active doses in a controlled fashion, and it not only needs to determine whether the treatment is effective but also to select the 'lowest efficacious' dose if the treatment is indeed efficacious. Few approaches exist in the literature for designing phase II non-oncology dose selection trials, and the standard design with a fixed sample size has been widely used. The objective of this study was to develop a more efficient design for phase II dose selection trials that terminates the trial early for futility and adjusts the sample size and number of doses at interim analyses when appropriate. ⋯ Once a confident answer to either or both of these questions can be obtained, the trial may either be terminated early or some of the lower doses may be dropped to prevent assigning more patients to inferior doses and thus reduce the total sample size needed. Theoretical analyses and simulation studies show that the proposed adaptive design significantly outperforms the standard design with a fixed sample size. The proposed adaptive design should be preferred over the standard design especially in cases where enrolment is slow and efficacy can be measured after a relatively short period of time.