1,720,958 research outputs found
Diabetes drugs and the incidence of solid cancers: a survey of the current evidence
No full textThe evaluation of the relationship between the use of antidiabetic drug and the occurrence of cancer is extremely challenging, both from the clinical and pharmacoepidemiological standpoint. This narrative review described the current evidence supporting a relationship between the use of antidiabetic drugs and the incidence of solid cancers. Areas covered: Data from pharmacoepidemiological studies on cancer incidence were presented for the main antidiabetic drugs and drug classes, including human insulin and insulin analogues, metformin, sulfonylureas, glinides, alpha-glucosidase inhibitors, thiazolidinediones, incretin mimetics, and sodium glucose co-transporter 2 inhibitors. The relationship between the use of antidiabetics and the incidence of solid cancer was described in strata by any cancer and by organ-specific cancer and by drug and by drug classes. Information supporting biological evidence and putative mechanisms were also provided. Expert opinion: The history of exploration of the relationship between antidiabetic drugs and the risk of solid cancers has showed several issues. Unrecognized biases and misinterpretations of study results have had important consequences that delayed the identification of actual risk and benefits of the use of antidiabetic drugs associated with cancer occurrence or progression. The lesson learned from the past should address the future research in this area, since in the majority of cases findings are controversial and confirmatory studies are warranted
Potential Direct Costs of Adverse Drug Events and Possible Cost Savings Achievable by their Prevention in Tuscany, Italy: A Model-Based Analysis
No full textIntroduction: Adverse drug events (ADEs) may represent an important item of expenditure for healthcare systems and their prevention could be associated with a relevant cost saving.
Objective: The objective of this study was to simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost savings related to avoidable ADEs.
Methods: A systematic review was performed, according to the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) and Meta-analysis Of Observational Studies in Epidemiology (MOOSE) statements, on observational studies published from 2006 to 2016 in MEDLINE and EMBASE, focusing on direct costs of ADEs in the inpatient setting from high-income countries. The mean probability of preventable ADEs was estimated over the included studies. The mean ADE cost was calculated by means of Monte Carlo simulation. We then extrapolated the spontaneous reports of ADEs in Tuscany, Italy in 2016 from the Italian National Pharmacovigilance Network (Rete Nazionale di Farmacovigilanza), and we assumed the same costs and preventability probability for these as obtained in the systematic review. Finally, we simulated the possible costs of ADEs and preventable ADEs in Tuscany. Three sensitivity analyses were also performed to test the robustness of the results.
Results: Of 11,936 articles initially selected, 12 observational studies were included. The estimated mean [± standard deviation (SD)] ADE cost was €2471.46 (± €1214.13). The mean (± SD) probability of preventable ADEs was 45% (± 21). The Tuscan expenditure for ADEs was €3,406,280.63 per million inhabitants (95% confidence interval (CI) 1,732,910.44-5,079,664.61) and the potential cost saving was €1,532,760.25 per million inhabitants (95% CI 779,776.1-2,285,750.60). Sensitivity analyses confirmed the robustness of the results.
Conclusions: The present simulation showed that ADEs could have a relevant economic impact on the Tuscan healthcare system. In this setting, the prevention of ADEs would result in important cost savings. These results could be likely extended to other healthcare systems
A Model-Based Analysis on Direct Costs of Adverse Drug Events and Related Cost-Savings Achievable by their Prevention in Tuscany, Italy
No full textBackground/Introduction: Adverse drug events (ADEs) may represent an important cost item for healthcare systems, since the recall, repair or rework of faults from ADEs and their management are costly and time consuming [1–3]. Their prevention could result in a relevant cost-saving.
Objective/Aim: To simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost-savings related to avoidable ADEs.
Methods: A systematic review was performed, according to PRISMA [4] and MOOSE [5] statements, on observational studies published from 2006 to 2016 in Medline and EMBASE, focusing on direct costs of ADEs in the inpatient setting from high-income Countries. All the included studies were assessed for their methodological quality through the Newcastle–
Ottawa Scale. The mean probability of preventable ADEs was estimated over the included studies. The mean ADE cost was calculated by means of Monte Carlo simulation. Then, we extrapolated the Tuscan spontaneous reports of inpatient ADEs in 2016 from the Italian Pharmacovigilance database, and we assumed for Tuscan ADEs the same costs and preventability
probability obtained in the systematic review. Finally, we simulated the possible costs of ADEs and the potential cost-savings by using the estimated preventable ADEs in Tuscany. Three sensitivity analyses were performed also to test the robustness of the results [6].
Results: Out of 11,936 articles initially selected, 12 observational studies were included. Four studies were performed in North America and eight in Europe. The mean cost reported for a single ADE ranged from 5373 in the American studies, and from €970 to €5461 in the European ones. All the included studies were classified at low risk of bias. The estimated mean ADE cost was €2471.46 (standard deviation (SD): ± €1214.13). The mean probability of preventable ADEs was 45% (SD: ± 21). The simulated Tuscan expenditure for ADEs was €3406,280.63 per million inhabitants [95% confidence interval (CI): €1,732,910.44– €5,079,664.61] and the potential cost-saving was €1,532,760.25 per million inhabitants (95% CI: €779,776.1–€2,285,750.60). The sensitivity analyses confirmed the robustness of our results.
Conclusion: The present simulation showed that the management of inpatient ADEs could have a relevant economic impact on the Tuscan healthcare system and the prevention would result in important cost-savings. These findings could be likely extended to other healthcare systems
Neonatal Adaptation Issues After Maternal Exposure to Prescription Drugs: Withdrawal Syndromes and Residual Pharmacological Effects
No full textExposure to drugs during pregnancy has the potential to harm offspring. Teratogenic effects are the most feared adverse outcomes in newborns; however, a wide spectrum of less known, usually reversible and often acute, neonatal adverse events can also occur due to drug intake by mothers during pregnancy, particularly in close proximity to delivery. This narrative review is aimed at the description of drugs and drug classes for which licit maternal use in the predelivery period has been associated with neonatal non-teratogenic disorders. For each drug class, epidemiology, clinical features, biological mechanism and management of these adverse reactions have been discussed in detail. Although these adverse reactions have been described mainly for substances used illicitly for recreational purposes, several prescription drugs have also been involved; these include mainly psychotropic medications such as opioids, antidepressants, antiepileptics and antipsychotics. These effects can be partly explained by withdrawal syndromes (defined also as 'neonatal abstinence syndrome') caused by the delivery-related discontinuation of the drug disposition from the mother to the fetus, with symptoms that may include feeding disorders, tremors, irritability, hypotonia/hypertonia, vomiting and persistent crying, occurring a few hours to 1 month after delivery. Otherwise, neonatal neurological and behavioral effects can also be caused by a residual pharmacological effect due to an accumulation of the drug in the blood and tissues of the newborn, with various symptoms related to the toxic effects of the specific drug class, usually developing a few hours after birth. With few exceptions, validated protocols for the assessment and management of withdrawal or residual pharmacological effects of these drugs in neonates are often lacking or incomplete. Spontaneous reporting of these adverse reactions seems limited, although it might represent a useful tool for improving our knowledge about drug-induced neonatal syndromes
Muscular Adverse Drug Reactions Associated with Proton Pump Inhibitors: A Disproportionality Analysis Using the Italian National Network of Pharmacovigilance Database
No full textIntroduction: Proton pump inhibitors (PPIs) have been implicated in the occurrence of moderate to severe myopathies in several case reports.
Aim: This study was performed to assess the reporting risk of muscular adverse drug reactions (ADRs) associated with PPIs in the Italian National Network of Pharmacovigilance database.
Methods: A disproportionality analysis (case/non-case) was performed using spontaneous reports collected in the database between July 1983 and May 2016. Reporting odds ratio (ROR) and 95% confidence intervals (CIs) were calculated as a measure of disproportionality. In a secondary and tertiary analysis, we explored the association of PPIs with muscular ADRs after taking into account the masking effect of statins. Moreover, the possibility of an interaction between PPIs and statins, leading to the occurrence of muscular ADRs, was also tested.
Results: The study was carried out on 274,108 reports. The ROR of muscular ADRs for PPIs, adjusted for age and gender, was 1.484 (95% CI 1.204-1.829; p < 0.001), whereas the ROR for rhabdomyolysis was 0.621 (95% CI 0.258-1.499). Similar results were obtained in the secondary analysis. The tertiary analysis, where PPIs were considered regardless of whether their role was suspected or concomitant, showed a potential disproportionate reporting for the combination PPIs-rhabdomyolysis (ROR 1.667, 95% CI 1.173-2.369; p < 0.01). The PPIs-statins combination was not associated with an enhanced ROR of muscular ADRs/rhabdomyolysis compared with statins alone.
Conclusions: This explorative study suggests that the class of PPIs could be involved in reports of muscular ADRs, rather than any other ADR, more frequently than any non-statin drug. Our results must be corroborated by further studies
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
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