Long-term survival of Icelandic women following acute myocardial infarction

Publisher Copyright: © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.Objective. To evaluate the impact of sex on treatment and survival after acute myocardial infarction (AMI) in Iceland. Methods. A retrospective, nationwide cohort study of patients with STEMI (2008–2018) and NSTEMI (2013–2018) and obstructive coronary artery disease. Patient and procedural information were obtained from a registry and electronic health records. Survival was estimated with Kaplan–Meier method and Cox regression analysis used to identify risk factors for long-term mortality. Excess mortality from the AMI episode was estimated by comparing the survival with age- and sex-matched population in Iceland at 30-day interval. Results. A total of 1345 STEMI-patients (24% women) and 1249 NSTEMI-patients (24% women) were evaluated. Women with STEMI (mean age: 71 ± 11 vs. 67 ± 12) and NSTEMI (mean age: 69 ± 13 vs. 62 ± 12) were older and less likely to have previous cardiovascular disease. There was neither sex difference in the extent of coronary artery disease nor treatment. Although crude one-year post-STEMI survival was lower for women (88.7% vs. 93.4%, p =.006), female sex was not an independent risk factor after adjusting for age and co-morbidities after STEMI and was protective for NSTEMI (HR 0.67, 95% CI: 0.46–0.97). There was excess 30-day mortality in both STEMI and NSTEMI for women compared with sex-, age- and inclusion year-matched Icelandic population, but thereafter the mortality rate was similar. Conclusion. Women and men with AMI in Iceland receive comparable treatment including revascularization and long-term survival appears similar. Prognosis after NSTEMI is better in women, whereas higher early mortality after STEMI may be caused by delays in presentation and diagnosis.Peer reviewe

Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

Last years, more than 46 unique biosimilars were approved by EMA and/or US-FDA following patent expiration of reference products. Biosimilars are not identical like generics, but highly similar versions where demonstrating biosimilarity of quality attributes (QAs) to a reference product is the basis of development and regulatory approval. Information on QAs assessed to establish biosimilarity may not always be publicly available, although this information is imperative to understand better the science behind biosimilars approval. This study aims to identify QA types reported in publications presenting biosimilarity assessments of (intended) biosimilars over time. English full-text publications presenting biosimilarity assessments of QAs for (intended) biosimilars between 2000 and 2019 identified from PubMed and EMBASE. Publication characteristics and QAs classified into: structural (physicochemical properties, primary structure, higher-order structures (HOSs), post-translational modifications (PTMs), and purity and impurities) and functional (biological and immunochemical activities) were extracted from publications. Seventy-nine publications were identified (79% open-access, 75% industry-sponsored, 62% including unapproved biosimilars, and 66% involving antibodies). Reporting frequencies varied for QA types: biological activity (94%), physicochemical properties (81%), PTMs (79%), primary structure (77%) purity and impurities (73%), HOSs (58%), and immunochemical activity (41%). The number of publications increased from 6 (7%) during 2009–2011 to 62 (79%) during 2015–2019. Eighteen (28%) publications reported all QA types relevant to an active-biological-substance. Reporting of most QA types increased over time that most evidenced by immunochemical activity (from 0% to 47%) which occured after EMA monoclona

Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

Publisher's version (útgefin grein)Last years, more than 46 unique biosimilars were approved by EMA and/or US-FDA following patent expiration of reference products. Biosimilars are not identical like generics, but highly similar versions where demonstrating biosimilarity of quality attributes (QAs) to a reference product is the basis of development and regulatory approval. Information on QAs assessed to establish biosimilarity may not always be publicly available, although this information is imperative to understand better the science behind biosimilars approval. This study aims to identify QA types reported in publications presenting biosimilarity assessments of (intended) biosimilars over time. English full-text publications presenting biosimilarity assessments of QAs for (intended) biosimilars between 2000 and 2019 identified from PubMed and EMBASE. Publication characteristics and QAs classified into: structural (physicochemical properties, primary structure, higher-order structures (HOSs), post-translational modifications (PTMs), and purity and impurities) and functional (biological and immunochemical activities) were extracted from publications. Seventy-nine publications were identified (79% open-access, 75% industry-sponsored, 62% including unapproved biosimilars, and 66% involving antibodies). Reporting frequencies varied for QA types: biological activity (94%), physicochemical properties (81%), PTMs (79%), primary structure (77%) purity and impurities (73%), HOSs (58%), and immunochemical activity (41%). The number of publications increased from 6 (7%) during 2009–2011 to 62 (79%) during 2015–2019. Eighteen (28%) publications reported all QA types relevant to an active-biological-substance. Reporting of most QA types increased over time that most evidenced by immunochemical activity (from 0% to 47%) which occured after EMA monoclonal antibody (mAbs) guidline in 2012 and more publications on mAbs later on when compared to earlier period. Biosimilarity assessments of QAs have been published in peer-reviewed publications for about 60% of approved biosimilars. Publishing biosimilarity assessments and reporting QAs over time appears to be affected by regulatory actions that occurred in 2012-2015, including regulatory approval and development of regulatory guidelines for biosimilars. Availability of a complete, publicly accessible and unbiased biosimilarity assessment of QAs, as part of a trusted and transparent regulatory process, will contribute to increased confidence and acceptance of biosimilars in clinical practice.This study was funded by the Saudi Food and Drug Authority(SFDA) through the Saudi Arabian cultural mission (SACM), the Hague,Netherlands as a part of a Doctor of Philosophy (Ph.D.) project for AMA.The SFDA has no role in any aspect of the study, including the pre-paration, review, the approval of the manuscript, nor the decision topublish the manuscript.Peer Reviewe

Associations Between Personality Traits and Adherence to Antidepressants Assessed Through Self-Report, Electronic Monitoring, and Pharmacy Dispensing Data : A Pilot Study

Treatment with antidepressants is often compromised by substantial nonadherence. To understand nonadherence, specific medication-related behaviors and beliefs have been studied, but less is known about broader and temporally stable personality "traits." Furthermore, adherence has often been assessed by a single method. Hence, we investigated associations between the Big Five personality traits and adherence assessed by self-report, electronic drug use monitoring, and dispensing data. Using the Big Five Inventory, we assessed the personality traits "openness," "conscientiousness," "extraversion," "agreeableness," and "neuroticism" of patients treated with antidepressants who were invited through community pharmacies. Self-reported adherence was assessed with the Medication Adherence Rating Scale (score >24), electronic monitoring with medication event monitoring system (MEMS) devices (therapy days missed ≤ 10% and < 4 consecutive days missed), and dispensing data (medication possession ratio ≥ 80%). One hundred four women and 33 men participated (mean age, 51; standard deviation, 14). Paroxetine was most frequently prescribed (N = 53, 38%). Logistic regression analysis revealed that of the personality traits, the third and fourth quartiles of "conscientiousness" were associated with better self-reported adherence (odds ratio, 3.63; 95% confidence interval, 1.34-9.86 and odds ratio, 2.97; 95% confidence interval, 1.09-8.08; P ≤ 0.05). No relationships were found between personality traits and adherence assessed through electronic drug use monitoring or dispensing data. We therefore conclude that adherence to antidepressant therapy seems to be largely unrelated to personality traits

Discontinuation of somatic medication during psychiatric hospitalization

BACKGROUND: Psychiatric hospitalization can increase the risk of discontinuation of pharmacotherapy, which may negatively influence patients' health. OBJECTIVE: To investigate the association between psychiatric hospitalization and discontinuation of somatic medication. METHODS: A retrospective crossover study was performed in patients admitted to a psychiatric hospital (index date), who had got somatic medication dispensed during the 3 months prior to hospitalization. Discontinuation of somatic medication was investigated at the following time points: index date and 3, 6, and 9 months before the index date. Relative risks (RR) with 95% confidence intervals (95% CIs) of discontinuing somatic medication at the index date versus the time points before the index date were estimated using Cox regression. RESULTS: In all, 471 hospitalized patients were included in the study; 38.9% of the patients were discontinuers on the index date. RR for discontinuation of ≥1 somatic medication was 1.88 (95% CI=1.55-2.27) at the index date compared with the other time points and highest for patients<45 years (RR=2.83; 95% CI=1.92-4.18). CONCLUSIONS: Psychiatric hospitalization was associated with an almost doubled risk of discontinuation of somatic medication. Future studies should address the influence of discontinuation of care on patients' health

Associations between personality traits and adherence to antidepressants assessed through self-report, electronic monitoring, and pharmacy dispensing data : A Pilot Study

Treatment with antidepressants is often compromised by substantial nonadherence. To understand nonadherence, specific medication-related behaviors and beliefs have been studied, but less is known about broader and temporally stable personality "traits." Furthermore, adherence has often been assessed by a single method. Hence, we investigated associations between the Big Five personality traits and adherence assessed by self-report, electronic drug use monitoring, and dispensing data. Using the Big Five Inventory, we assessed the personality traits "openness," "conscientiousness," "extraversion," "agreeableness," and "neuroticism" of patients treated with antidepressants who were invited through community pharmacies. Self-reported adherence was assessed with the Medication Adherence Rating Scale (score >24), electronic monitoring with medication event monitoring system (MEMS) devices (therapy days missed ≤ 10% and < 4 consecutive days missed), and dispensing data (medication possession ratio ≥ 80%). One hundred four women and 33 men participated (mean age, 51; standard deviation, 14). Paroxetine was most frequently prescribed (N = 53, 38%). Logistic regression analysis revealed that of the personality traits, the third and fourth quartiles of "conscientiousness" were associated with better self-reported adherence (odds ratio, 3.63; 95% confidence interval, 1.34-9.86 and odds ratio, 2.97; 95% confidence interval, 1.09-8.08; P ≤ 0.05). No relationships were found between personality traits and adherence assessed through electronic drug use monitoring or dispensing data. We therefore conclude that adherence to antidepressant therapy seems to be largely unrelated to personality traits

Medication Discontinuation in Patients After Discharge From a Psychiatric Hospital

Background: Patients discharged from psychiatric hospitals may be at risk for intentional or unintentional discontinuation of their medication. Objective: To describe and assess the discontinuation of, and changes to, psychiatric and/or somatic medication in patients after discharge from psychiatric hospitals. Methods: A retrospective follow-up study was conducted in patients discharged from 4 psychiatric hospitals in The Netherlands between 2006 and 2009. Patients' medication use during the last 2 days of hospitalization was compared with medication dispensed during the 3 months following discharge. Changes in psychiatric and somatic medication were investigated and defined as medication discontinuation, start, or switch. Patients were classified as continuing users, when there were no changes to the medication after discharge. Relative risks with 95% confidence intervals to measure differences in discontinuation were estimated using Cox regression analysis. Results: This study included 1324 patients, 69.8% of whom discontinued medication, and 9.7% switched one or more medications. Nearly half (47.4%) of all patients started a medication other than that dispensed during the last 2 days of hospitalization, and 13.7% of all patients experienced no changes to their medication regimen. Approximately 40% of the patients discontinued one or more medications for chronic conditions. From these, 68% discontinued psychiatric medications and 49.4% discontinued somatic medications. A quarter (25.2%) of the 644 patients discontinued using antipsychotics. More than a quarter (28.4%) of the 292 patients using medications for cardiovascular problems discontinued. Patients using as-needed medication prior to discharge were more likely to discontinue their medication (relative risk = 1.85; 95% confidence interval = 1.55-2.20). Conclusions: Discharge from a psychiatric hospital led to medication discontinuation in approximately 70% of all patients. Approximately 40% of the patients discontinued medications for chronic conditions. Discontinuation of somatic medication was more frequent than discontinuation of psychiatric medication, and risk of discontinuation was lower for patients with depressive and anxiety disorders. Although medication discontinuation can be deliberate it is alarming that a quarter of our patients using antipsychotics and cardiovascular medications discontinued their use, both of which are meant for chronic conditions

Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

Last years, more than 46 unique biosimilars were approved by EMA and/or US-FDA following patent expiration of reference products. Biosimilars are not identical like generics, but highly similar versions where demonstrating biosimilarity of quality attributes (QAs) to a reference product is the basis of development and regulatory approval. Information on QAs assessed to establish biosimilarity may not always be publicly available, although this information is imperative to understand better the science behind biosimilars approval. This study aims to identify QA types reported in publications presenting biosimilarity assessments of (intended) biosimilars over time. English full-text publications presenting biosimilarity assessments of QAs for (intended) biosimilars between 2000 and 2019 identified from PubMed and EMBASE. Publication characteristics and QAs classified into: structural (physicochemical properties, primary structure, higher-order structures (HOSs), post-translational modifications (PTMs), and purity and impurities) and functional (biological and immunochemical activities) were extracted from publications. Seventy-nine publications were identified (79% open-access, 75% industry-sponsored, 62% including unapproved biosimilars, and 66% involving antibodies). Reporting frequencies varied for QA types: biological activity (94%), physicochemical properties (81%), PTMs (79%), primary structure (77%) purity and impurities (73%), HOSs (58%), and immunochemical activity (41%). The number of publications increased from 6 (7%) during 2009-2011 to 62 (79%) during 2015-2019. Eighteen (28%) publications reported all QA types relevant to an active-biological-substance. Reporting of most QA types increased over time that most evidenced by immunochemical activity (from 0% to 47%) which occured after EMA monoclonal antibody (mAbs) guidline in 2012 and more publications on mAbs later on when compared to earlier period. Biosimilarity assessments of QAs have been published in peer-reviewed publications for about 60% of approved biosimilars. Publishing biosimilarity assessments and reporting QAs over time appears to be affected by regulatory actions that occurred in 2012-2015, including regulatory approval and development of regulatory guidelines for biosimilars. Availability of a complete, publicly accessible and unbiased biosimilarity assessment of QAs, as part of a trusted and transparent regulatory process, will contribute to increased confidence and acceptance of biosimilars in clinical practice

Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

Last years, more than 46 unique biosimilars were approved by EMA and/or US-FDA following patent expiration of reference products. Biosimilars are not identical like generics, but highly similar versions where demonstrating biosimilarity of quality attributes (QAs) to a reference product is the basis of development and regulatory approval. Information on QAs assessed to establish biosimilarity may not always be publicly available, although this information is imperative to understand better the science behind biosimilars approval. This study aims to identify QA types reported in publications presenting biosimilarity assessments of (intended) biosimilars over time. English full-text publications presenting biosimilarity assessments of QAs for (intended) biosimilars between 2000 and 2019 identified from PubMed and EMBASE. Publication characteristics and QAs classified into: structural (physicochemical properties, primary structure, higher-order structures (HOSs), post-translational modifications (PTMs), and purity and impurities) and functional (biological and immunochemical activities) were extracted from publications. Seventy-nine publications were identified (79% open-access, 75% industry-sponsored, 62% including unapproved biosimilars, and 66% involving antibodies). Reporting frequencies varied for QA types: biological activity (94%), physicochemical properties (81%), PTMs (79%), primary structure (77%) purity and impurities (73%), HOSs (58%), and immunochemical activity (41%). The number of publications increased from 6 (7%) during 2009-2011 to 62 (79%) during 2015-2019. Eighteen (28%) publications reported all QA types relevant to an active-biological-substance. Reporting of most QA types increased over time that most evidenced by immunochemical activity (from 0% to 47%) which occured after EMA monoclonal antibody (mAbs) guidline in 2012 and more publications on mAbs later on when compared to earlier period. Biosimilarity assessments of QAs have been published in peer-reviewed publications for about 60% of approved biosimilars. Publishing biosimilarity assessments and reporting QAs over time appears to be affected by regulatory actions that occurred in 2012-2015, including regulatory approval and development of regulatory guidelines for biosimilars. Availability of a complete, publicly accessible and unbiased biosimilarity assessment of QAs, as part of a trusted and transparent regulatory process, will contribute to increased confidence and acceptance of biosimilars in clinical practice.status: publishe