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Browsing by Subject "valmisteyhteenveto"

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  • Peltoniemi, Jonne (2020)
    Erenumab (Aimovig®) is a first-in-class calcitonin gene-related peptide (CGRP) inhibitor approved for the preventive treatment of migraine by the FDA in May 2018 and by European Commission (EC) in July 2018. It is a human monoclonal antibody (mAb) binding to the CGRP receptor, antagonizing the effect of CGRP. The marketing authorization of Aimovig® was based on two phase II and two phase III clinical trials. In all trials, erenumab with doses 70 mg/mL and 140 mg/mL was found to have a significantly superior effect compared to placebo, with a similar safety profile between all groups. These conclusions are mainly in line with studies conducted post marketing authorization. However, questions about the optimal dose, and the frequency and types of adverse events in larger patient populations remain to be studied. A European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC) are required by the European Commission for each human medicine with a marketing authorization within the European Union. The SmPC is produced by the applicant and it should contain all relevant information of the medicinal product as distilled during the assessment process. The SmPC can thus be viewed as a kind of summarized version of the EPAR. The aim of this study was to investigate the post-marketing efficacy and safety information of erenumab from three perspectives: 1) the EPAR was compared with recent systematic reviews and meta-analyses assessing the efficacy and safety of erenumab, 2) all existing literature on the efficacy and safety of erenumab on different subgroups of migraine patients was assessed and summarized, and 3) the efficacy and safety information of the EPAR was compared to those of the SmPC, to resolve whether important information is missing. This review found several points regarding the efficacy and safety of erenumab. First, the status of erenumab was further established as a safe and effective treatment for the prevention of migraine. Second, meta-analyses (n=3) with more extensive cohorts compared to those of the EPAR and SmPC, present a further case for the superiority of the 140 mg dose compared to the 70 mg dose. The difference in dose effect is addressed in the EPAR but its assessment may be based on limited information. Third, different subgroups seem to respond differently to erenumab treatment. This aspect should be further investigated by head-to-head studies. Lastly, the safety information of the SmPC seems insufficient due to lack of mention of upper respiratory infections. This adverse event was among the most common in all of the four clinical trials and has since been observed in a real-world study. Based on these findings, neither the EPAR nor the SmPC of erenumab seem to be fully up to date and information related to the dose and upper respiratory infections as a risk should be reconsidered.
  • Engström, Isanora (2023)
    The long-term use of antidepressants has increased significantly worldwide in recent decades. Deprescribing and the expertise related to it is an important part of the individual drug treatment optimization, the management of long-term diseases, the avoidance of adverse drug effects and the improvement of treatment outcomes. The aim of this thesis was to examine the information found in the statutory Summary of Product Characteristics (SmPC) and other key information sources for healthcare professionals about antidepressant deprescribing. A qualitative content analysis was conducted on SmPC (n=15) of the antidepressants (escitalopram, mirtazapine, sertraline, citalopram, venlafaxine) selected for the study, three national depression treatment guidelines (Suomalainen Lääkäriseura Duodecim: Depressio Käypä hoito -suositus, American Psychological Association APA: Practice Guideline for the Treatment of Patients with Major Depressive Disorder, United States and National Institute for Health and Care Excellence NICE: Depression in Adults: Treatment and Management, United Kingdom) and one decision supporting deprescribing tool (MedStopper). The content, quantity, and quality of information about antidepressant deprescribing varied between the information sources included in the study. However, the information found in the SmPC and the MedStopper -tool was mostly in line with the information found in the clinical practice guidelines included in the study. Most general information about antidepressant deprescribing or measures that can be used to guide deprescribing was found in the clinical practice guidelines. In all examined sources, antidepressants were recommended to be discontinued in a controlled manner by gradually reducing the dose. However, the recommended duration of the dose reduction varied in different information sources. A detailed dose reduction program was not found in most of the information sources. A detailed dose reduction program was found in only one clinical practice guideline (NICE) and the MedStopper -tool. The continuation of antidepressant treatment after remission and the timing of stopping the medication was discussed in only two clinical practice guidelines (APA and Käypä hoito). However, instructions for action if severe or intolerable discontinuation symptoms appears were found in almost all information sources. Only the clinical practice guidelines mentioned the recurrence of depression as a possible harm when stopping the medication and instructed how to act in the event of a possible relapse. Benefits related to antidepressant discontinuation was not mentioned in any of the examined information sources and only one clinical practice guideline (NICE) discussed barriers related to stopping antidepressants. The information found in individual information sources was insufficient and provided little support for healthcare professionals to guide deprescribing. Current key sources of information for healthcare professionals provide limited information and relatively imprecise guidance on antidepressant deprescribing and how to support the antidepressant discontinuation process. Better randomized clinical trials are needed to develop clearer and more extensive evidence-based guidelines for healthcare professionals on antidepressant deprescribing and to prevent unnecessary long-term antidepressant treatment and patient exposure to possible adverse drug effects.