Current medical research and opinion
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Randomized Controlled Trial Multicenter Study Comparative Study
Clinical evaluation of the first oxycodone once daily prolonged release tablet in moderate to severe chronic pain: a randomized, double-blind, multicenter, cross-over, non-inferiority study to investigate efficacy and safety in comparison with an established oxycodone twice daily prolonged release tablet.
The first oxycodone once daily (OOD) has been developed and after successful pharmacokinetic characterization, therapeutic efficacy and safety were compared to an established oxycodone twice daily (OTD: Oxygesic/OxyContin, Mundipharma). ⋯ Despite the small number of patients and short study duration, the results support the conclusion that new OOD is (at least) equivalent to established OTD regarding safety and efficacy.
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Multicenter Study Clinical Trial
An open-label multicenter study to assess the safety of dextromethorphan/quinidine in patients with pseudobulbar affect associated with a range of underlying neurological conditions.
Pseudobulbar affect (PBA) is associated with neurological disorders or injury affecting the brain, and characterized by frequent, uncontrollable episodes of crying and/or laughing that are exaggerated or unrelated to the patient's emotional state. Clinical trials establishing dextromethorphan and quinidine (DM/Q) as PBA treatment were conducted in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). This trial evaluated DM/Q safety in patients with PBA secondary to any neurological condition affecting the brain. ⋯ DM/Q was generally well tolerated over this 52 week trial in patients with PBA associated with a wide range of neurological conditions.
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Comparative Study
A mixed treatment comparison of gabapentin enacarbil, pramipexole, ropinirole and rotigotine in moderate-to-severe restless legs syndrome.
A mixed treatment comparison (MTC) was performed to investigate the relative efficacy and safety of licensed pharmaceuticals for moderate-to-severe restless legs syndrome (RLS). ⋯ This MTC confirmed the superiority of gabapentin enacarbil, pramipexole, ropinirole, and rotigotine above placebo in alleviating RLS symptoms. Compared to ropinirole, rotigotine showed some additional benefit in terms of change in IRLS at Week 12. Choice of RLS drugs requires careful evaluation of effectiveness and safety profiles in clinical practice. Due to lack of head-to-head trials, inconsistency could not be assessed in our analysis. Head-to-head trials on a more homogeneous population are needed to validate the MTC results.
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To assess differences in psychological outcomes as well as risk and protective factors for these outcomes among several USA ethnic groups and identify correlates of these psychological outcomes among adults with diabetes in the second Diabetes Attitudes, Wishes and Needs (DAWN2 * ) study. ⋯ Ethnic groups differ in their psychological outcomes. The risk/protective factors for psychological outcomes differ across ethnic groups and different ethnic groups are more/less sensitive to their influence. These findings can aid the development of strategies to overcome the most prominent and influential psychosocial barriers to optimal diabetes care within each ethnic group.