Current medical research and opinion
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Multicenter Study Controlled Clinical Trial
Infliximab efficacy in rheumatoid arthritis after an inadequate response to etanercept or adalimumab: results of a target-driven active switch study.
Evaluate efficacy of infliximab with response-driven dosing in patients with active RA. ⋯ Given the relatively short duration of study follow-up, these safety findings require confirmation in a longer-term study.
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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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Randomized Controlled Trial
An analysis of TRITON-TIMI 38, based on the 12 month recommended length of therapy in the European label for prasugrel.
In TRITON-TIMI 38, patients with acute coronary syndromes were treated with prasugrel or clopidogrel, with aspirin, for a median of 14.5 (maximum of 15) months. Based on this trial, the EU label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroke/transient ischemic attack (TIA). Furthermore, the EU label recommends the 10 mg maintenance dose (MD) for patients with body weight ≥60 kg and age <75 years. A lower MD of 5 mg is recommended for those with body weight <60 kg; although generally not recommended, 5 mg can be prescribed to patients ≥75 years after individual risk-benefit evaluation. This paper presents the one-year outcome data for this '10 mg indicated cohort'. ⋯ Although restricted to 365 days of follow-up, this analysis encapsulates 1366 of 1424 (95.9%) of all primary endpoint events and 244 of 257 (94.9%) of all first non-CABG TIMI major bleeds reported in the pivotal manuscript. Furthermore, the 10 mg indicated cohort was not a pre-specified subgroup in the study protocol, but due to European labeling restrictions, results for all outcomes in this cohort are presented through 12 months.
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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.
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Observational Study
Management of severe chronic pain with tapentadol prolonged release - long-term data from pain specialists.
Clinical trials have documented the efficacy and good tolerability of tapentadol prolonged released (PR) for severe chronic pain. This study investigated routine long-term administration by pain specialists. ⋯ The study lacks a control group; assessment under routine practice conditions, however, reflects daily practice clinical management conditions.