Overview: comprehensive and carefully constructed strategies are required when conducting searches for adverse effects data

Golder, Su; Peryer, Guy; Loke, Yoon K.

doi:10.1016/j.jclinepi.2019.05.019

Cited by 6 publications

(5 citation statements)

References 37 publications

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“…The search terms applied were frail older adults, heart failure-specific medications, and ADRs or ADEs. Validated filters for ADRs and ADEs were adapted from Golder et al [ 15 ] (Electronic Supplementary Material [ESM] Table S1). The search was validated using the Peer Review of Electronic Search Strategies (PRESS) checklist [ 16 ] (ESM Table S2).…”

Section: Methodsmentioning

confidence: 99%

The Prevalence of Adverse Drug Reactions and Adverse Drug Events from Heart Failure Medications in Frail Older Adults: A Systematic Review

et al. 2022

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Introduction Frailty is highly prevalent in heart failure populations and a major risk factor for adverse drug reactions (ADRs) and adverse drug events (ADEs). This review aimed to describe the prevalence, causality and severity of ADRs or ADEs from heart failure medications among frail compared with non-frail older adults. Methods A systematic search of CENTRAL, MEDLINE, Embase, Ageline, CINAHL, International Pharmaceutical Abstracts, PsychInfo, Scopus, registries and citations prior to 18 May 2021 was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 checklist. Risk of bias and quality of evidence were assessed. Eligible studies included randomised controlled trials (RCTs) and observational studies of people diagnosed with heart failure, aged ≥ 65 years, with frailty defined by an objective measurement, and reported ADRs/ADEs from/with heart failure medications. Results Two reviewers screened 2419 articles; interrater reliability kappa = 0.88. Three observational studies (n = 2596), a secondary analysis of two RCTs (n = 2098) and two cohort studies (n = 498) were included in a narrative synthesis. Frail patients in randomised trials of sacubitril/valsartan, aliskiren, or enalapril had twice the risk of mortality (hazard ratio [HR] 2.09, 1.62-2.71) and hospitalisations (HR 1.82, 1.37-2.41) compared with robust patients, which may reflect responsiveness to medications and/or factors unrelated to medication use. Hospitalisations from falls, tiredness and nausea were probably attributable to digoxin and possibly preventable according to the Naranjo and Hallas scales, respectively. Conclusion The potential harms from heart failure medications in frail older people are poorly studied and understood. Clinical trials and pharmacovigilance studies should include frailty as a covariate to inform medication optimisation for this vulnerable and growing population. Registration Prospero registration number: CRD 42021253762.

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Section: Methodsmentioning

confidence: 99%

The Prevalence of Adverse Drug Reactions and Adverse Drug Events from Heart Failure Medications in Frail Older Adults: A Systematic Review

et al. 2022

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“…Eine standardisierte Methode zur Entwicklung von Literatursuchen zu möglichen arzneimittelbedingten vermeidbaren Risiken ist nicht etabliert, Empfehlungen sind dafür aber beschrieben [17]. Unter Berücksichtigung publizierter Hinweise zur Evidenzsuche zu Arzneimittelinteraktionen wird strukturiert für jedes potenzielle Risiko nach publizierter Evidenz gesucht [18,19].…”

Section: Detektion Von Risikosignalen Und Priorisierungunclassified

Entwicklung von Empfehlungen zum Management von Arzneimitteltherapie bei Multimorbidität

Grandt

Gamstätter

Fölsch

2020

Dtsch Med Wochenschr

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ZusammenfassungDie Anwendung aller Leitlinien für jede Erkrankung eines Patienten mit Multimorbidität kann zu ungeeigneten Arzneimittelkombinationen und vermeidbaren Risiken führen. In einer Fachgesellschaften-übergreifenden, repräsentativen Arbeitsgruppe werden derartige therapeutische Konflikte identifiziert und Empfehlungen zum Management entwickelt, konsentiert und als S2k-Leitlinie formal Konsensus-basiert publiziert. Die Rationale für die Entwicklung der Empfehlungen, ihre Zielsetzung und die angewandte Methodik werden nachfolgend dargestellt. Die Struktur der Empfehlungen sowie ihre Erprobung, Fortschreibung und Aktualisierung werden erläutert.

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“…Assessing AEs is challenging for multiple reasons; AEs are not always pre-specified, the range of potential reactions can be broad, reporting can be erratic, and terminology is often inconsistent ( Golder et al, 2016 , 2019 ) and includes side effects, toxic effects, adverse effects, treatment-emergent AEs (TEAEs), adverse drug reactions, complications and harms, all of which are used interchangeably ( Peryer et al, 2021 ). This is further complicated by the highly variable and context-dependent subjective effects elicited by psychedelics ( Breeksema et al, 2020 ; Carbonaro et al, 2016 ).…”

Section: Introductionmentioning

confidence: 99%

Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review

et al. 2022

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Introduction: Small-scale clinical studies with psychedelic drugs have shown promising results for the treatment of several mental disorders. Before psychedelics become registered medicines, it is important to know the full range of adverse events (AEs) for making balanced treatment decisions. Objective: To systematically review the presence of AEs during and after administration of serotonergic psychedelics and 3,4-methyenedioxymethamphetamine (MDMA) in clinical studies. Methods: We systematically searched PubMed, PsycINFO, Embase, and ClinicalTrials.gov for clinical trials with psychedelics since 2000 describing the results of quantitative and qualitative studies. Results: We included 44 articles (34 quantitative + 10 qualitative), describing treatments with MDMA and serotonergic psychedelics (psilocybin, lysergic acid diethylamide, and ayahuasca) in 598 unique patients. In many studies, AEs were not systematically assessed. Despite this limitation, treatments seemed to be overall well tolerated. Nausea, headaches, and anxiety were commonly reported acute AEs across diagnoses and compounds. Late AEs included headaches (psilocybin, MDMA), fatigue, low mood, and anxiety (MDMA). One serious AE occurred during MDMA administration (increase in premature ventricular contractions requiring brief hospitalization); no other AEs required medical intervention. Qualitative studies suggested that psychologically challenging experiences may also be therapeutically beneficial. Except for ayahuasca, a large proportion of patients had prior experience with psychedelic drugs before entering studies. Conclusions: AEs are poorly defined in the context of psychedelic treatments and are probably underreported in the literature due to study design (lack of systematic assessment of AEs) and sample selection. Acute challenging experiences may be therapeutically meaningful, but a better understanding of AEs in the context of psychedelic treatments requires systematic and detailed reporting.

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Overview: comprehensive and carefully constructed strategies are required when conducting searches for adverse effects data

Cited by 6 publications

References 37 publications

The Prevalence of Adverse Drug Reactions and Adverse Drug Events from Heart Failure Medications in Frail Older Adults: A Systematic Review

The Prevalence of Adverse Drug Reactions and Adverse Drug Events from Heart Failure Medications in Frail Older Adults: A Systematic Review

Entwicklung von Empfehlungen zum Management von Arzneimitteltherapie bei Multimorbidität

Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review

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