Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study.
Safety and efficacy of a once daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design. ⋯ Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response. Pregabalin CR was well tolerated in most patients. Generalizability may be limited by study duration and selective population.
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Randomized Controlled Trial
Safety profile of semagacestat, a gamma-secretase inhibitor: IDENTITY trial findings.
Semagacestat, a γ-secretase inhibitor, demonstrated an unfavorable risk-benefit profile in a Phase 3 study of patients with Alzheimer's disease (IDENTITY trials), and clinical development was halted. To assist in future development of γ-secretase inhibitors, we report detailed safety findings from the IDENTITY study, with emphasis on those that might be mechanistically linked to γ-secretase inhibition. ⋯ Many of these safety findings can be attributed to γ-secretase inhibition, and may be valuable to researchers developing γ-secretase inhibitors.
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Randomized Controlled Trial Multicenter Study
Impact of fatigue on outcome of selective serotonin reuptake inhibitor treatment: secondary analysis of STAR*D.
To explore relationships between baseline and changes in fatigue during treatment with outcomes in patients with major depressive disorder (MDD) receiving citalopram monotherapy. ⋯ Lower baseline fatigue and remission of fatigue during antidepressant treatment in patients with MDD are associated with higher rates of remission of depressive symptoms and better function and quality of life. Study limitations include use of the STAR*D Level 1 sample (citalopram as only antidepressant), use of a proxy measure of energy/fatigue (item 14 from the QIDS-SR16), and the secondary post-hoc analysis design.
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Observational Study
Tapentadol at medium to high doses in patients previously receiving strong opioids for the management of cancer pain.
The aim of this study was to assess the efficacy and tolerability of tapentadol (TP) for a period of 4 weeks in patients who were already treated by opioids. ⋯ In our sample, TP used in doses of 350-450 mg/day was well tolerated and effective in opioid tolerant patients with cancer pain and could be considered as a flexible drug to be used for the management of moderate to severe cancer pain. Like most studies in patients with cancer pain, it was limited by its open-label, uncontrolled design, the number of patients lost in follow-up, and discontinuation of the treatment for several reasons. Further studies in a large number of patients should confirm these preliminary results.
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Opioid analgesics are commonly and increasingly prescribed by physicians for the management of chronic pain. However, strong evidence supports the need for strategies that reduce opioid use. The objective of this review is to outline limitations associated with opioid use and discuss therapeutic techniques that can be adopted to optimize the use of opioids in the management of chronic nonmalignant pain. ⋯ Appropriate patient selection through identification of risk factors, urine drug testing, and access to prescription monitoring programs has been shown to effectively improve care. Structured opioid therapy in a multimodal platform, including use of a low initial dose, prescription of alternative non-opioid analgesics including non-steroidal anti-inflammatory drugs and acetaminophen, as well as development of written care agreements to individualize and guide therapy has also been shown to improve patient outcomes. Implementation of opioid allocation strategies has the potential to encourage appropriate opioid use and improve patient care.