-
Frontiers in Pharmacology 2023
PubMed: 37869753
DOI: 10.3389/fphar.2023.1242014 -
Frontiers in Immunology 2023
Topics: Vaccines
PubMed: 37662921
DOI: 10.3389/fimmu.2023.1212148 -
Frontiers in Neuroscience 2023
PubMed: 37483343
DOI: 10.3389/fnins.2023.1247681 -
Therapeutic Advances in Drug Safety 2024
PubMed: 38737826
DOI: 10.1177/20420986241249905 -
Frontiers in Pharmacology 2024Atorvastatin is a commonly prescribed medication for the prevention of cardiovascular diseases. Recent observational studies have suggested a potential association...
BACKGROUND
Atorvastatin is a commonly prescribed medication for the prevention of cardiovascular diseases. Recent observational studies have suggested a potential association between atorvastatin use and the occurrence of Erectile Dysfunction (ED). In this study, we aimed to explore the relationship between atorvastatin and ED using real-world data from the FAERS database and employed Mendelian randomization to assess causality.
METHODS
To evaluate the disproportionality of atorvastatin in relation to ED, we conducted several pharmacovigilance analyses, including odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence propagation neural network (BCPNN), and gamma-Poisson contractile apparatus (GPS). Additionally, we employed Mendelian randomization to investigate the causal relationship between atorvastatin and ED.
RESULTS
Pharmacovigilance disproportionality analysis revealed a significant association between atorvastatin and ED, as indicated by the following results: ROR [3.707078559, 95% CI (3.33250349, 4.123756054)], PRR [3.702969038, χ2 (669.2853829)], IC [1.870490139, IC025 (1.702813857)], and EBGM [3.656567867, EBGM05 (3.28709656)]. Furthermore, the two-sample Mendelian randomization analysis provided evidence supporting a causal relationship between atorvastatin use and ED, with an inverse variance weighted estimate of β = 3.17 (OR = 23.91, = 0.02 < 0.05).
CONCLUSION
Based on comprehensive analyses incorporating pharmacovigilance and Mendelian randomization, our findings suggest that atorvastatin use is associated with an increased risk of ED and indicate a causal relationship. These results emphasize the importance of considering potential adverse effects, such as ED, when prescribing atorvastatin for cardiovascular disease prevention. Further research and clinical monitoring are warranted to better understand the underlying mechanisms and develop appropriate strategies to mitigate this side effect.
PubMed: 38741592
DOI: 10.3389/fphar.2024.1382924 -
BMJ Open Sep 2023The slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the... (Review)
Review
OBJECTIVES
The slow progress of pharmacovigilance (PV) in low-income and middle-income countries (LMIC) raises questions about core challenges on the growth of PV, and the appropriateness of strategies used so far to develop PV. Therefore, this scoping review aims to describe strategies and interventions to strengthen PV in LMIC and to propose recommendations for future investments in PV capacity building.
INCLUSION CRITERIA
Publications included were primary studies, articles, policy and guideline papers, describing interventions to strengthen PV in LMIC.
METHODS
The review was conducted following the Joanna Briggs Institute (JBI) guidelines on conducting scoping reviews. Literature searches were performed in MEDLINE, EMBASE, Web of Science, PDQ-evidence, CINAHL and other relevant websites from January 1990 to January 2021. Two reviewers independently screened titles, abstracts and full texts. One reviewer performed data extraction and descriptive analysis, which were reviewed by two other reviewers.
RESULTS
10 922 unique titles were screened and 152 were eligible for full text review. Of these, 57 and an additional 13 reports from grey literature fulfilled eligibility criteria for inclusion in the review. These were grouped into two categories: (1) Interventions aimed at increasing PV knowledge and adverse drug reactions (ADR) reporting (45 papers), primarily education of healthcare professionals (HCP), alone or in combination with other interventions such as mobile and electronic reporting and (2) Interventions aimed at strengthening various components of the national PV system (25 papers), describing strategies or mixed interventions implemented at the national level, targeting different components of the national PV system.
CONCLUSIONS
Results of this review suggest that educating HCP on ADR reporting is the most common approach to build PV capacity in LMIC. Though important, education alone is insufficient and should ideally be organised within the holistic framework of strengthening national PV systems, with a focus on also building capacity for advanced activities such as signal detection.
Topics: Humans; Developing Countries; Pharmacovigilance; Educational Status; Academies and Institutes; Capacity Building; Drug-Related Side Effects and Adverse Reactions
PubMed: 37709326
DOI: 10.1136/bmjopen-2022-071079 -
ERJ Open Research Nov 2023The ATP-sensitive potassium channels and their regulatory subunits, sulfonylurea receptor 1 (SUR1/Kir6.2) and SUR2/Kir6.1, contribute to the pathophysiology of pulmonary... (Review)
Review
The ATP-sensitive potassium channels and their regulatory subunits, sulfonylurea receptor 1 (SUR1/Kir6.2) and SUR2/Kir6.1, contribute to the pathophysiology of pulmonary hypertension (PH). Loss-of-function pathogenic variants in the gene, which encodes for SUR1, have been associated with heritable pulmonary arterial hypertension. Conversely, activation of SUR1 and SUR2 leads to the relaxation of pulmonary arteries and reduces cell proliferation and migration. Diazoxide, a SUR1 activator, has been shown to alleviate experimental PH, suggesting its potential as a therapeutic option. However, there are paradoxical reports of diazoxide-induced PH in infants. This review explores the role of SUR1/2 in the pathophysiology of PH and the contradictory effects of diazoxide on the pulmonary vascular bed. Additionally, we conducted a comprehensive literature review of cases of diazoxide-associated PH and analysed data from the World Health Organization pharmacovigilance database (VigiBase). Significant disproportionality signals link diazoxide to PH, while no other SUR activators have been connected with pulmonary vascular disease. Diazoxide-associated PH seems to be dose-dependent and potentially related to acute effects on the pulmonary vascular bed. Further research is required to decipher the differing pulmonary vascular consequences of diazoxide in different age populations and experimental models.
PubMed: 37965230
DOI: 10.1183/23120541.00350-2023 -
Dermatology and Therapy May 2024Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for...
INTRODUCTION
Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Although the US prescribing information for brodalumab includes a boxed warning regarding suicidal ideation and behavior, no causal association has been demonstrated. Here, we summarize 5 years of pharmacovigilance data, from August 15, 2017, through August 14, 2022, reported to Ortho Dermatologics by US patients and healthcare providers.
METHODS
Prevalence of the most common adverse events (AEs) listed in the brodalumab package insert (incidence ≥ 1%) and AEs of special interest are described. Brodalumab exposure was estimated as the time from the first to last prescription-dispensing authorization dates. Data were collected from 4744 patients in the USA, with an estimated exposure of 5815 patient-years.
RESULTS
Over 5 years, 11 cases of adjudicated major adverse cardiovascular events were reported (0.23 events/100 patients), a rate lower than that experienced by patients in the international Psoriasis Longitudinal Assessment and Registry. There were 106 serious infections. No serious fungal infections were reported. There were 40 confirmed and 2 suspected COVID-19 cases, with no new COVID-19-related deaths. Of 49 reported malignancies among 42 patients, 3 were deemed possibly related to brodalumab. No completed suicides and no new suicidal attempts were reported.
CONCLUSION
Five-year pharmacovigilance data are consistent with the established safety profile reported in long-term clinical trials and previous pharmacovigilance reports, with no new safety signals.
PubMed: 38724839
DOI: 10.1007/s13555-024-01162-8 -
Clinical Therapeutics Apr 2024This work aims to demystify Knowledge Graphs (KGs) in pharmacovigilance (PV). It complements the scoping review within this issue. By bridging knowledge gaps and... (Review)
Review
PURPOSE
This work aims to demystify Knowledge Graphs (KGs) in pharmacovigilance (PV). It complements the scoping review within this issue. By bridging knowledge gaps and stimulating interest, further engagement with this topic by pharmacovigilance professionals will be facilitated.
METHODS
We elucidate fundamental KGs concepts and terminology, followed by delineating a sequence of implementation steps: use case definition, data type selection, data sourcing, KG construction, KG embedding, and deriving actionable insights. Information technology options and limitations are also explored.
FINDINGS
KGs in pharmacovigilance is a multi-disciplinary field involving information technology, machine learning, biology, and PV. We were able to synthesize the relevant core concepts to create an intuitive exposition of KGs in PV.
IMPLICATIONS
This work demystifies KGs with a pharmacovigilance focus, preparing readers for the accompanying in-depth scoping review. that follows. It lays the groundwork for advancing PV research and practice by emphasizing the importance of engaging with vigilance experts. This approach enhances knowledge sharing and collaboration, contributing to more effective and informed pharmacovigilance efforts and optimal assessment and deployment of KGs in PV.
PubMed: 38670887
DOI: 10.1016/j.clinthera.2024.03.006 -
Human Vaccines & Immunotherapeutics Dec 2023COVID-19 vaccine-related adverse events are mostly minor to moderate, and serious events are rare. Single cases of Raynaud's phenomenon (RP) in temporal proximity to...
COVID-19 vaccine-related adverse events are mostly minor to moderate, and serious events are rare. Single cases of Raynaud's phenomenon (RP) in temporal proximity to COVID-19 vaccination have been reported. Demographic data, medical history, and detailed information regarding vaccination status and RP characteristics were obtained from patients with confirmed RP after COVID-19 vaccination. Fifteen participants reported the initial manifestation of RP, which occurred in 40% after the first, in 33% after the second, and in 27% after the third vaccination. RP development and occurrence of episodes were not linked to any specific vaccine type. New onset of disease was observed in 40% of the vaccinees after BNT162b2, in 33% after mRNA-1273, and in 27% after ChAdOx1 vaccination. Three out of four participants with preexisting RP prior to COVID-19 vaccination reported aggravation in frequency and intensity after immunization. Although COVID-19 vaccination is pivotal in controlling the pandemic, the observed temporal association between vaccine administration and RP occurrence warrants global activities to support pharmacovigilance for the detection of adverse reactions, one of which may include RP.
Topics: Humans; BNT162 Vaccine; COVID-19; COVID-19 Vaccines; Raynaud Disease; Vaccination
PubMed: 37067070
DOI: 10.1080/21645515.2023.2199653