Current medical research and opinion
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Randomized Controlled Trial Multicenter Study Comparative Study
Effects of vortioxetine on functional capacity across different levels of functional impairment in patients with major depressive disorder: a University of California, San Diego Performance-based Skills Assessment (UPSA) analysis.
Objective: To evaluate the consistency of vortioxetine's effects on functional capacity in adults with major depressive disorder (MDD) and self-reported cognitive symptoms at different levels of functional impairment. Methods: An exploratory analysis of data from a randomized, placebo-controlled, duloxetine-referenced study (NCT01564862) involving 529 patients with moderate to severe MDD treated once-daily with vortioxetine 10/20 mg, duloxetine 60 mg, or placebo for 8 weeks. Analysis of the University of California, San Diego Performance-based Skills Assessment (UPSA) composite scores stratified patients into subgroups by baseline functional impairment and assessed clinically important differences using several cutoffs for change from baseline (CFB) (least-square means) in UPSA composite score. ⋯ Conclusion: The effects of vortioxetine on functional capacity is robust across different level of functional impairment in patients with MDD. The effect on functional capacity was largely independent of the effect on depressive symptoms. Trial Registration: ClinicalTrials.gov identifier: NCT01564862: https://clinicaltrials.gov/ct2/show/NCT01564862; European Clinical Trials Database [EudraCT] Number 2011-005298-22: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005298-22/DE.
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Meta Analysis Comparative Study
Systematic review and network meta-analysis of the efficacy and safety of lidocaine 700 mg medicated plaster vs. pregabalin.
Objective: Neuropathic pain prevalence is estimated between 7% and 10% of the population. International guidelines recommend a variety of drugs at different therapy lines for pain relief. However, side effect profiles, for example, prompted the UK government recently to classify pregabalin and gabapentin as class C drugs. ⋯ In total 111 references pertaining to 43 RCTs were included for data extraction. Bayesian network meta-analysis of several pain outcomes showed no clear difference in efficacy between treatments However, LMP was clearly advantageous in terms of dizziness and any adverse event vs. pregabalin 600 mg/day and discontinuations vs. pregabalin 300 mg/day or 600 mg/day, as well as being associated with improved quality of life (albeit in this case based on weak evidence). Conclusions: LMP was found to be similar to pregabalin in reducing pain in all populations but had a better adverse events profile.
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Aim: Midazolam like other benzodiazepines is supposed to be neurotoxic in small children and to represent a risk factor for the development of delirium. The aim of this study was to evaluate whether a modified analgesia and sedation protocol is feasible and effective to reduce the requirement of midazolam in neonates and young infants after cardiac surgery. Methods: Patients aged 6 months or younger who underwent surgery for congenital heart disease with cardiopulmonary bypass were enrolled and divided into a pre-modification group (January-December 2016) and after adjusting our sedation protocol into a post-modification group (January-December 2018). ⋯ The number of patients receiving midazolam and the cumulative dose of midazolam could be successfully reduced. The sedation scores were still within the desired target range for adequate sedation without any negative side effects. Conclusions: It is feasible and safe to reduce the use of midazolam in infants after cardiac surgery maintaining sedation goals based on a modified nurse-driven analgesia and sedation protocol.
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Objective: To assess the impact of age on the safety and tolerability of ALO-02, an abuse-deterrent opioid formulation consisting of oxycodone hydrochloride and sequestered naltrexone hydrochloride, in patients with chronic pain. Methods: Data from two clinical studies in patients with chronic low back pain or chronic non-cancer pain were analyzed. Patients aged ≥18 years who required continuous around-the-clock opioid analgesia for an extended period were grouped into ≥65 years and <65 years age groups. ⋯ One patient aged ≥65 years experienced an AE of opioid withdrawal. Conclusions: The safety and tolerability of ALO-02 is similar in those aged ≥65 years and those aged <65 years with chronic pain. ClinicalTrials.gov identifiers: NCT01571362, NCT01428583.
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Objective: To assess the 1-year economic burden among patients hospitalized for community-acquired pneumonia (CAP) in the US. Methods: Adult patients hospitalized for CAP between 1/2012 and 12/2016 were identified from the IQVIA hospital charge data master (CDM) linked to the IQVIA Real-World Data Adjudicated Claims - US Database (date of admission = index date). Patients had continuous enrollment 180-days pre- and 360-days post-index, and empiric antimicrobial treatment (monotherapy [EM] or combination therapy [EC]) and chest x-ray on the index date or day after. ⋯ Mean total inpatient cost was significantly higher among EC versus EM patients ($37,106 versus $25,999, p = .0399). Adjusted mean total all-cause cost was $55,391. Conclusions: Patients hospitalized for CAP incurred a significant annual economic burden, driven substantially by the high cost of hospitalizations.