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  • 2022Journal Article Research Paper
    [["dc.bibliographiccitation.artnumber","20420986211072383"],["dc.bibliographiccitation.journal","Therapeutic Advances in Drug Safety"],["dc.bibliographiccitation.volume","13"],["dc.contributor.author","Doni, Katharina"],["dc.contributor.author","Bühn, Stefanie"],["dc.contributor.author","Weise, Alina"],["dc.contributor.author","Mann, Nina-Kristin"],["dc.contributor.author","Hess, Simone"],["dc.contributor.author","Sönnichsen, Andreas"],["dc.contributor.author","Pieper, Dawid"],["dc.contributor.author","Thürmann, Petra"],["dc.contributor.author","Mathes, Tim"],["dc.date.accessioned","2022-02-24T14:58:47Z"],["dc.date.available","2022-02-24T14:58:47Z"],["dc.date.issued","2022"],["dc.description.abstract","Registration: PROSPERO: CRD42020210645 Introduction: We aimed to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older patients with type 2 diabetes with inadequate glycaemic control. Methods: We included randomized controlled trials (RCTs) in older (⩾65 years) patients with type 2 diabetes. The intervention group was randomized to treatment with any DPP-4 inhibitors. A systematic search in MEDLINE and Embase was performed in December 2020. For assessing the risk of bias, RoB 2 tool was applied. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We pooled outcomes using random effects meta-analyses. Results: We identified 16 RCTs that included 19,317 patients with a mean age of greater than 70 years. The mean HbA1c level ranged between 7.1 and 10.0 g/dl. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly [risk ratio (RR) 1.04; 95% confidence interval (CI) 0.89–1.21]. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia (RR 1.08; 95% CI 1.01–1.16), but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas (RR 0.88; 95% CI 0.75–1.04). DPP-4 inhibitors probably reduce the risk for hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis. Conclusion: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase hypoglycaemia risk. Second-line therapy in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case second-line treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas."],["dc.identifier.doi","10.1177/20420986211072383"],["dc.identifier.pmid","35111291"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/102555"],["dc.language.iso","en"],["dc.relation.issn","2042-0986"],["dc.rights","CC BY 4.0"],["dc.title","Safety of dipeptidyl peptidase-4 inhibitors in older adults with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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  • 2022Journal Article Research Paper
    [["dc.bibliographiccitation.artnumber","234"],["dc.bibliographiccitation.issue","1"],["dc.bibliographiccitation.journal","BMC Medical Research Methodology"],["dc.bibliographiccitation.volume","22"],["dc.contributor.author","Mathes, Tim"],["dc.contributor.author","Mann, Nina-Kristin"],["dc.contributor.author","Thürmann, Petra"],["dc.contributor.author","Sönnichsen, Andreas"],["dc.contributor.author","Pieper, Dawid"],["dc.date.accessioned","2022-09-01T09:50:54Z"],["dc.date.available","2022-09-01T09:50:54Z"],["dc.date.issued","2022"],["dc.date.updated","2022-09-04T03:12:21Z"],["dc.description.abstract","Abstract\r\n \r\n Background\r\n Systematic reviews that synthesize safety outcomes pose challenges (e.g. rare events), which raise questions for grading the strength of the body of evidence. This is maybe one reason why in many potentially inappropriate medication (PIM) lists the recommendations are not based on formalized systems for assessing the quality of the body of evidence such as GRADE.\r\n In this contribution, we describe specifications and suggest adaptions of the GRADE system for grading the quality of evidence on safety outcomes, which were developed in the context of preparing a PIM-list, namely PRISCUS.\r\n \r\n \r\n Methods\r\n We systematically assessed each of the five GRADE domains for rating-down (study limitations, imprecision, inconsistency, indirectness, publication bias) and the criteria for rating-up, considering if special considerations or revisions of the original approach were indicated. The result was gathered in a written document and discussed in a group-meeting of five members with various background until consensus. Subsequently, we performed a proof-of-concept application using a convenience sample of systematic reviews and applied the approach to systematic reviews on 19 different clinical questions.\r\n \r\n \r\n Results\r\n We describe specifications and suggest adaptions for the criteria “study limitations”, imprecision, “publication bias” and “rating-up for large effect”. In addition, we suggest a new criterion to account for data from subgroup-analyses. The proof-of-concept application did not reveal a need for further revision and thus we used the approach for the systematic reviews that were prepared for the PRISCUS-list.\r\n We assessed 51 outcomes. Each of the proposed adaptions was applied. There were neither an excessive number of low and very low ratings, nor an excessive number of high ratings, but the different methodological quality of the safety outcomes appeared to be well reflected.\r\n \r\n \r\n Conclusion\r\n The suggestions appear to have the potential to overcome some of the challenges when grading the methodological quality of harms and thus may be helpful for producers of evidence syntheses considering safety."],["dc.identifier.citation","BMC Medical Research Methodology. 2022 Aug 30;22(1):234"],["dc.identifier.doi","10.1186/s12874-022-01715-5"],["dc.identifier.pii","1715"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/113832"],["dc.language.iso","en"],["dc.notes.intern","DOI-Import GROB-597"],["dc.relation.eissn","1471-2288"],["dc.rights","CC BY 4.0"],["dc.rights.holder","The Author(s)"],["dc.rights.uri","https://creativecommons.org/licenses/by/4.0"],["dc.subject","Evidence synthesizes"],["dc.subject","systematic reviews"],["dc.subject","potentially inadequate medications"],["dc.subject","PIM-List"],["dc.subject","GRADE"],["dc.subject","Level of Evidence"],["dc.subject","safety"],["dc.subject","harms"],["dc.title","Assessing the quality of evidence on safety: specifications for application and suggestions for adaptions of the GRADE-criteria in the context of preparing a list of potentially inappropriate medications for older adults"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.subtype","original_ja"],["dc.type.version","published_version"],["dspace.entity.type","Publication"]]
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