11 research outputs found

    Implementing the cross-disciplinary subject of palliative medicine (Q13) against the backdrop of recent changes of the legal framework using University Medical School Göttingen as an example

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    Palliative care for patients with advanced and progressive diseases has recently become an integrated and compulsory part of undergraduate training in Germany. Up until now, undergraduate teaching in this cross-disciplinary medical field varied and therefore problems during the implementation process with regard to formal aspects and teaching content are to be expected

    Combination treatment of fingolimod with antidepressants in relapsing–remitting multiple sclerosis patients with depression: a multicentre, open-label study – REGAIN

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    Objectives: Approximately one in two patients with multiple sclerosis (MS) suffer from comorbid depression. The primary objective of this study was to evaluate the safety and tolerability of fingolimod and antidepressant combination in relapsing–remitting MS patients with mild-to-moderate depression. Efficacy outcome variables were quality of life (QoL), fatigue, disability and depression. Methods: Patients received open-label fingolimod 0.5 mg over 2 weeks, followed by fingolimod plus citalopram (40 mg), fluoxetine (40 mg) or venlafaxine (150 mg) over 16 weeks. The antidepressant was selected at the physician’s discretion. Results: In total, 54 patients were recruited at 25 centres across Germany. No new safety signals (including cardiac) emerged compared with previous clinical studies. Adverse events (mostly mild-to-moderate) were reported in 43 patients. A total of three patients had serious adverse events and 10 discontinued the study. QoL (mean [95% confidence interval]) improved by 2.2 (−3.3, −1.2; Patient Reported Indices for MS questionnaire), fatigue by 8.2 (−13.1, −3.3; modified Fatigue Impact Scale) and depression by 6.3 (−8.4, −4.2; Hamilton Depression Scale) points. However, the results must be interpreted cautiously owing to limited patient numbers. Conclusions: Combination of fingolimod with antidepressant medication showed no unexpected safety signals. Patient-reported outcomes (QoL, disability, fatigue and depression) remained stable or improved

    Two studies in one: A propensity-score-matched comparison of fingolimod versus interferons and glatiramer acetate using real-world data from the independent German studies, PANGAEA and PEARL - Fig 3

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    <p><b>Time to (a) 3-month and (b) 6-month confirmed disability progression, and (c) 3-month and (d) 6-month confirmed disability improvement in propensity-score-matched patients from the PANGAEA (fingolimod) and PEARL (BRACE) cohorts.</b> Kaplan–Meier estimate (cumulative distribution function) showing time to cumulative disability progression and time to cumulative disability improvement in propensity-score-matched patients from the PANGAEA (fingolimod) and PEARL (BRACE) cohorts. Not all matched patients had available Expanded Disability Status Scale scores and therefore some individuals could not be included in these analyses. BRACE, <u>B</u>etaseron<sup>®</sup>, <u>R</u>ebif<sup>®</sup>, <u>A</u>vonex<sup>®</sup>, <u>C</u>opaxone<sup>®</sup>, <u>E</u>xtavia<sup>®</sup> (beta interferons or glatiramer acetate); PANGAEA, <u>P</u>ost-<u>a</u>uthorization <u>N</u>on-interventional <u>G</u>erman S<u>a</u>fety Study of Gil<u>e</u>ny<u>a</u><sup>®</sup> in Multiple Sclerosis Patients; PEARL, <u>P</u>rosp<u>e</u>ctive Ph<u>a</u>rmacoeconomic Coho<u>r</u>t Eva<u>l</u>uation.</p

    Baseline demographic and clinical characteristics in the unmatched and propensity-score-matched PANGAEA and PEARL cohorts.

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    <p>Baseline demographic and clinical characteristics in the unmatched and propensity-score-matched PANGAEA and PEARL cohorts.</p

    Unadjusted annualized relapse rates.

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    <p>Unadjusted ARRs in propensity-score-matched patients from the PANGAEA (fingolimod) and PEARL (BRACE) cohorts. Unadjusted ARR ratios were calculated from a negative binomial regression model using PEARL as the reference cohort. ARR, annualized relapse rate; BRACE, <u>B</u>etaseron<sup>®</sup>, <u>R</u>ebif<sup>®</sup>, <u>A</u>vonex<sup>®</sup>, <u>C</u>opaxone<sup>®</sup>, <u>E</u>xtavia<sup>®</sup> (beta interferons or glatiramer acetate); CI, confidence interval; PANGAEA, <u>P</u>ost-<u>a</u>uthorization <u>N</u>on-interventional <u>G</u>erman S<u>a</u>fety Study of Gil<u>e</u>ny<u>a</u><sup>®</sup> in Multiple Sclerosis Patients; PEARL, <u>P</u>rosp<u>e</u>ctive Ph<u>a</u>rmacoeconomic Coho<u>r</u>t Eva<u>l</u>uation.</p
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