Adverse Safety Research Articles

Adverse events in women giving birth in a labor ward: a retrospective record review study

BackgroundChildbirth could negatively affect the woman’s health through adverse events. To prevent adverse events and increase patient safety it is important to detect and learn from them. The aim of the study was to describe adverse events, including the preventability and severity of harm during planned vaginal births, in women giving birth in the labor ward.MethodsThe study had a descriptive design with a retrospective birth record review to assess the preventability of adverse events using the Swedish version of the Global Trigger Tool. The setting was a labor ward in Sweden with low-risk and risk childbirths. Descriptive statistics, Pearson’s Chi-square test and Student’s t-test were used.ResultsA total of 38 adverse events (12.2%) were identified in 311 reviewed birth records. Of these, 28 (73.7%) were assessed as preventable. Third- or fourth-degree lacerations and distended urinary bladder were most prevalent together with anesthesia-related adverse events. The majority of the adverse events were classified into the harm categories of ‘prolonged hospital care’ (63.2%) and ‘temporary harm’ (31.6%). No permanent harm were identified, but over two-thirds of the adverse events were assessed as preventable.ConclusionsThis first study using Global Trigger Tool in a labor ward in Sweden identified a higher incidence of adverse events than previous studies in obstetric care. No permanent patient harm was found, but over two-thirds of the adverse events were assessed as preventable. The results draw particular attention to 3rd-or 4th-degree lacerations, distended urinary bladder and anesthesia-related adverse events. The feedback on identified adverse events should be used for systematic quality improvement and clinical recommendations how to prevent adverse events must be implemented.

Joint modelling of multivariate longitudinal clinical laboratory safety outcomes, concomitant medication and clinical adverse events: application to artemisinin-based treatment during pregnancy clinical trial

BackgroundIn drug trials, clinical adverse events (AEs), concomitant medication and laboratory safety outcomes are repeatedly collected to support drug safety evidence. Despite the potential correlation of these outcomes, they are typically analysed separately, potentially leading to misinformation and inefficient estimates due to partial assessment of safety data. Using joint modelling, we investigated whether clinical AEs vary by treatment and how laboratory outcomes (alanine amino-transferase, total bilirubin) and concomitant medication are associated with clinical AEs over time following artemisinin-based antimalarial therapy.MethodsWe used data from a trial of artemisinin-based treatments for malaria during pregnancy that randomized 870 women to receive artemether–lumefantrine (AL), amodiaquine–artesunate (ASAQ) and dihydroartemisinin–piperaquine (DHAPQ). We fitted a joint model containing four sub-models from four outcomes: longitudinal sub-model for alanine aminotransferase, longitudinal sub-model for total bilirubin, Poisson sub-model for concomitant medication and Poisson sub-model for clinical AEs. Since the clinical AEs was our primary outcome, the longitudinal sub-models and concomitant medication sub-model were linked to the clinical AEs sub-model via current value and random effects association structures respectively. We fitted a conventional Poisson model for clinical AEs to assess if the effect of treatment on clinical AEs (i.e. incidence rate ratio (IRR)) estimates differed between the conventional Poisson and the joint models, where AL was reference treatment.ResultsOut of the 870 women, 564 (65%) experienced at least one AE. Using joint model, AEs were associated with the concomitant medication (log IRR 1.7487; 95% CI: 1.5471, 1.9503; p < 0.001) but not the total bilirubin (log IRR: -0.0288; 95% CI: − 0.5045, 0.4469; p = 0.906) and alanine aminotransferase (log IRR: 0.1153; 95% CI: − 0.0889, 0.3194; p = 0.269). The Poisson model underestimated the effects of treatment on AE incidence such that log IRR for ASAQ was 0.2118 (95% CI: 0.0082, 0.4154; p = 0.041) for joint model compared to 0.1838 (95% CI: 0.0574, 0.3102; p = 0.004) for Poisson model.ConclusionWe demonstrated that although the AEs did not vary across the treatments, the joint model yielded efficient AE incidence estimates compared to the Poisson model. The joint model showed a positive relationship between the AEs and concomitant medication but not with laboratory outcomes.Trial registrationClinicalTrials.gov: NCT00852423

Population-scale identification of differential adverse events before and during a pandemic

Adverse patient safety events, unintended injuries resulting from medical therapy, were associated with 110,000 deaths in the United States in 2019. A nationwide pandemic (such as COVID-19) further challenges the ability of healthcare systems to ensure safe medication use and the pandemic’s effects on safety events remain poorly understood. Here, we investigate drug safety events across demographic groups before and during a pandemic using a dataset of 1,425,371 reports involving 2,821 drugs and 7,761 adverse events. Among 64 adverse events identified by our analyses, we find 54 increased in frequency during the pandemic, despite a 4.4% decrease in the total number of reports. Out of 53 adverse events with a pre-pandemic gender gap, 33 have seen their gap increase with the pandemic onset. We find that the number of adverse events with an increased reporting ratio is higher in adults (by 16.8%) than in older patients. Our findings have implications for safe medication use and preventable healthcare inequality in public health emergencies.

Reducing Severe Tracheal Intubation Events Through an Individualized Airway Bundle.

Neonatal tracheal intubation (TI) is a high-risk procedure associated with adverse safety events. In our newborn and infant ICU, we measure adverse tracheal intubation-associated events (TIAEs) as part of our participation in National Emergency Airway Registry for Neonates, a neonatal airway registry. We aimed to decrease overall TIAEs by 10% in 12 months. A quality improvement team developed an individualized approach to intubation using an Airway Bundle (AB) for patients at risk for TI. Plan-do-study-act cycles included AB creation, simulation, unit roll out, interprofessional education, team competitions, and adjusting AB location. Outcome measure was monthly rate of TIAEs (overall and severe). Process measures were AB initiation, AB use at intubation, video laryngoscope (VL) use, and paralytic use. Balancing measure was inadvertent administration of TI premedication. We used statistical process control charts. Data collection from November 2016 to August 2020 included 1182 intubations. Monthly intubations ranged from 12 to 41. Initial overall TIAE rate was 0.093 per intubation encounter, increased to 0.172, and then decreased to 0.089. System stability improved over time. Severe TIAE rate decreased from 0.047 to 0.016 in June 2019. AB initiation improved from 70% to 90%, and AB use at intubation improved from 18% to 55%. VL use improved from 86% to 97%. Paralytic use was 83% and did not change. The balancing measure of inadvertent TI medication administration occurred once. We demonstrated a significant decrease in the rate of severe TIAEs through the implementation of an AB. Next steps include increasing use of AB at intubation.

Intent to Vaccinate SARS-CoV-2 Infected Children in US Households: A Survey.

A paucity of data exists evaluating a guardian’s intent to vaccinate their child against COVID-19 in the United States. We administered 102 first (April–November 2020) and 45 second (December–January 2020–2021) surveys to guardians of children (<18 years) who had a laboratory-confirmed diagnosis of COVID-19 and assessed their intent to give a COVID-19 vaccine to their child, when one becomes available. The first and second surveys of the same cohort of guardians were conducted before and following the press releases detailing the adult Pfizer-BioNTech and Moderna Phase 3 results. Both surveys included an intent-to-vaccinate question using the subjective language of “if a safe and effective vaccine” became available, and a second question was added to second surveys using the objective language of “would prevent 19 of 20 people from getting disease”. When using subjective language, 24 of 45 (53%) guardians endorsed vaccine administration for their children in the first survey, which decreased to 21 (46%) in the second survey. When adding objective language, acceptance of vaccination increased to 31 (69%, p = 0.03). Common reasons for declining vaccination were concerns about adverse effects and/or vaccine safety. Providing additional facts on vaccine efficacy increased vaccine acceptance. Evidence-based strategies are needed to increase pediatric COVID-19 vaccine uptake.

Comparing User Perceptions of Surgical Environments: Simulations in a High-Fidelity Physical Mock-Up Versus a Postoccupancy Evaluation.

The purpose of this study was to compare perceptions and behaviors of end users participating in simulations in a high-fidelity physical mock-up of an operating room (OR) prototype with the perceptions and behaviors of end users in the built out ORs postoccupancy. Simulation-based evaluations of high-fidelity physical mock-ups of proposed layouts are increasingly being conducted during the facility design process to understand impacts on workflow and potential adverse patient safety outcomes. Nevertheless, it is unclear to what extent user experiences in these simulated healthcare spaces are similar to those in built and occupied healthcare environments. Using interviews, surveys, and observations, this study compared user evaluations in a high-fidelity physical mock-up of an OR with user evaluations of the built and occupied OR postoccupancy. Workflow disruptions were also analyzed using video recordings for a simulated pediatric surgery and five pediatric surgeries in the actual OR. This study found that user perceptions and behavior in the two types of environments were mostly similar with regard to perceived support for the location of surgeon workstation, perceived space and task performance, perceived access to storage locations, boom setup, and OR cleanability. Participant's ratings differed for supportiveness of the mobile Circulating Nurse (CN) workstation, maneuvering booms, and environmental disruptions. Simulation-based evaluations are extremely beneficial during the design process and can provide valuable input to design teams as well as clinical teams about workflow and safety issues that allow design issues to be addressed before construction.

A Review of Reported Adverse Events in MRI-Safe and MRI-Conditional Cochlear Implants.

This study looks to examine how the development of diametric magnet cochlear implant devices (CIDs) has affected observed magnetic resonance imaging (MRI)-related adverse events and MRI safety measures. A search of the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was conducted using the product code "MCM" for "Cochlear implants." Reports were included for analysis if they involved MRI in recipients of cochlear implantation. Included reports were stratified into two cohorts by year: 2010 to 2014 and 2015 to 2020, reflecting the FDA approval of diametric magnet cochlear implants in 2015. Extracted event variables included implant manufacturer, adherence to MRI protocol, patient injuries, and device malfunctions. The product code search query yielded a total of 27,305 reports, from which 584 reports were included for analysis. From 2010 to 2014, there were 109 adverse events and 30 pre-MRI explantations. Implant displacement was the most common device malfunction (n = 69, 87.3%), and pain was the most common patient injury (n = 16, 53.3%). From 2015 to 2020, there were 566 adverse events and 62 pre-MRI explantations. The most common device malfunction was implant displacement (n = 365, 94.6%) and pain was the most common patient injury (n = 114, 63.3%). Only 64/114 (56.1%) reports after 2015 reported adherence to the recommended MRI protocol. No adverse events occurred in patients with synchrony diametric-magnet CIDs. Despite the advent of FDA-approved MRI-safe diametric magnet devices, implanted patients are still experiencing injury, explantation, and device malfunction, and providers are reporting poor compliance with MRI safety protocols.

An Overview about Safety Surveillance of Adverse Drug Reactions and Pharmacovigilance in India

One pathway for more actively monitoring Adverse Drug Reactions (ADRs) and, as a result, improving patient care safety is a structured Adverse Drug Reaction Surveillance network. Multiple methods for testing and recording the efficacy of drugs in clinical use are important for avoiding or reducing patient injury and strengthening public health. This entails establishing a well-structured Pharmacovigilance programme in clinical practise. Once a prescription has been published into the "true world," pharmacovigilance is an important method of monitoring medication-related issues. Pharmacovigilance and other drug-related problems should be familiar to those whose life is impacted by prescription procedures in some way. In modern times, pharmacovigilance has gained prominence as a technology critical to sound clinical practise and public health science. Since ADRs have such a detrimental influence on patients' wellbeing and inflict too much financial strain, it's critical to carefully monitor each medication for any potential adverse effects in animal models (preclinical studies) and clinical trials until releasing it. Pharmacovigilance aims to serve a significant part in combating the dangers faced by an ever-growing number of drugs, each of which is vulnerable to unpredictably negative side effects. When adverse effects and toxicity occur, they must be recorded, analysed and the importance of the results correctly communicated to those who may understand the evidence. By ensuring that prescription drugs of high consistency, purity and effectiveness are used rationally, the risk of injury will be minimised. In this study it will briefly explore adverse drug reaction safety control and pharmacovigilance in India.

Adverse Effects and Safety of Etirinotecan Pegol, a Novel Topoisomerase Inhibitor, in Cancer Treatment: A Systematic Review

Background: Due to the increasing prevalence of cancer and the inadequacy of current therapies, the development of novel antitumor pharmaceutics with higher efficacies and lower adverse effects is considered a fundamental tenet of contemporary cancer management. Poly-Ethylene-Glycol (PEG) attachment is a novel pharmaceutical technology to improve the efficacy and safety of chemotherapies. Etirinotecan Pegol (EP), also known as NKTR-102, is the PEGylated form of Irinotecan (CPT-11), which causes cancer cell apoptosis by inhibiting the topoisomerase I enzyme. Objectives: The present study reviews and evaluates various reports of the EP’s anti-tumor activity in various cancers. Data Sources: Studies were identified using the Scopus database, with no exclusions. The search terms included Etirinotecan Pegol and NKTR-102, which yielded 125 articles (66 and 59 articles, respectively). In addition, the clinicaltrials.gov website was used to find ongoing studies, which resulted in the addition of two studies. Study Eligibility Criteria: Subsequently, we excluded studies that were published in languages other than English, duplicate articles, and studies with no data. Results: This systematic review clarifies that EP possesses numerous advantages over many other medications, such as safety, efficacy, increased half-life, increased health-related quality of life, increased overall survival, increased progression-free survival, and decreasing the adverse events in the treatment of various cancers. Conclusion: Therefore, Etirinotecan Pegol may represent a major contribution to the treatment of various cancers in the future.

Induction of SARS-CoV-2-Specific IgG and IgA in Serum and Milk with Different SARS-CoV-2 Vaccines in Breastfeeding Women: A Cross-Sectional Study in Northern Spain.

Breastfeeding mothers were excluded from the clinical trials conducted for vaccines against SARS-CoV-2. Since the start of the vaccination, some doubts have arisen regarding its compatibility with breastfeeding. The aim of this study was to analyse the presence of anti-SARS-CoV-2 antibodies in breast milk and serum (IgG and IgA) of vaccinated breastfeeding women. The main variables of the observational study were: adverse related events after vaccination and determination of the presence of IgG and IgA isotypes antibodies in serum and in breast milk of vaccinated women against the SARS-CoV-2 antigens. Results: 110 breastfeeding mothers were included; 70 women (63.6%) were vaccinated with two doses of BNT162b2, 20 women (18.2%) with two doses of mRNA-1273, and 20 women (18.2%) with a single dose of ChAdOx1-S. Regarding adverse reactions and vaccine safety, 38 women had no adverse reactions; 20 (18.2%) had general malaise or adenopathies; 10 (9.1%) had a headache; and 7 (6.4%) had fever. When analysing IgG antibodies, significantly higher levels of antibodies were found in serum and breast milk from mothers vaccinated with BNT162b2 or mRNA-1273 vs. ChAdOx1-S (p < 0.001 and p = 0.001, respectively). Analysing IgA antibodies, significant differences were found when comparing mean values in serum from mothers vaccinated with BNT162b2 or mRNA-1273 vs. ChAdOx1-S (0.12, 0.16, and 0.02, respectively; p < 0.001) and breast milk of mothers vaccinated when comparing BNT16b2 vs. ChAdOx1-S. All vaccinated breastfeeding mothers had serum anti-S1 IgG antibodies in response to vaccination against SARS-CoV-2, regardless of the commercial vaccine administered. Conclusions: the anti-SARS-CoV-2 vaccines were well tolerated by the mothers and the breastfed infant. In addition, breastfeeding mothers offer their infants IgA and IgG isotype antibodies directed against SARS-CoV-2 protein S in breast milk.

OX40L blockade cellular nanovesicles for autoimmune diseases therapy

Current clinical agents for autoimmunity disorders treatment often cause substantial adverse effects and safety concerns, owing to non-specific immune modulation. Due to the prominent contribution of effector T cells in pathogenesis of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), and preferential location of co-stimulatory receptor-ligand pair OX40-OX40L at the inflamed sites, selectively targeting autoaggressive T cells by blockade OX40-OX40L, might represent an alternative strategy. Herein, we developed a new strategy to antagonize OX40-OX40L interaction by engineering a cell membrane derived nanovesicles (NVs) expressing OX40 receptors (OX40 NVs), and explored their potential for autoimmune disorders therapy. OX40 NVs showed specific binding capability to inflamed HUVECs in vitro, it also possessed distinct arthritic-targeting capacity in RA inflamed joints, and preferential accumulation in IBD inflamed colon. OX40 NVs efficiently suppressed the progression of both RA and IBD diseases through reducing CD4+OX40+ T cells population, and proinflammatory cytokines (i.e., TNF-α and IL-1β), while reinforcing Tregs immune-suppressive effect, with superior therapeutic efficacy than anti-OX40L. Additionally, dexamethasone (DEX) loading can further enhance the potential of OX40 NVs for RA treatment. Owing to their preferential localization to inflamed sites, and potent immune-suppression ability, targeting OX40-OX40L blockade by OX40 NVs for autoimmune therapy is highly promising.

Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52\xa0week open label study

BackgroundThe current study evaluated the long-term (52 week) safety and impact on symptom measures of lurasidone (with or without lithium or valproate) for the treatment of bipolar I disorder in Japanese patients.MethodsBipolar patients for this open-label flexibly dosed lurasidone (20–120 mg/day) study were recruited from those with a recent/current depressive episode who completed an initial 6 week, double-blind, placebo-controlled, lurasidone study (depressed group), and those with a recent/current manic, hypomanic, or mixed episode (non-depressed group) who agreed to enroll directly into the long-term study. Measures of adverse events and safety included treatment-emergent adverse events, vital signs, body weight, ECG, laboratory tests, and measures of suicidality and extrapyramidal symptoms. Symptom measures included Montgomery Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS).ResultsThe most common adverse events associated with lurasidone were akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%). Minimal changes in lipids and measures of glycemic control occurred. Mean change in body weight was + 1.0 kg in the non-depressed group and − 0.8 kg in the depressed group. MADRS total scores declined by a mean (SD) of 2.0 (14.7) points from long-term baseline to endpoint in the depressed group who had received placebo in the prior 6 week trial. The depressed group that had received lurasidone during the prior 6 week study maintained their depressive symptom improvements. For the non-depressed group, YMRS total scores decreased over time.LimitationsNo control group was included, treatment was open-label, and 49.7% of patients completed the 52 week study.ConclusionsLong-term treatment with lurasidone 20–120 mg/day for Japanese patients with bipolar disorder maintained improvements in depressive symptoms for depressed patients who were treated in a prior 6 week trial and led to improvements in manic symptoms among a newly recruited subgroup of patients with a recent/current manic, hypomanic, or mixed episode. Few changes in weight or metabolic parameters were evident.Clinical trial registration: JapicCTI-132319, clinicaltrials.gov—NCT01986114.

Risk assessment of ayahuasca use in a religious context: self-reported risk factors and adverse effects.

Objective:Whether for spiritual, recreational, or potential therapeutic use, interest in ayahuasca has grown remarkably. Ayahuasca’s main active substances are N,N‐dimethyltryptamine and certain monoamine oxidase inhibitor β-carbolines. Possible drug interactions are a major concern, and research is lacking in this area. The objective of this study was to evaluate the safety of ritual ayahuasca use regarding adverse effects and risk factors.Methods:In this cross-sectional study, ayahuasca users from a religious institution answered an online questionnaire about its safety. Adverse effects, safety measures, and possible risk factors (psychiatric diagnosis and medications) were investigated.Results:The most frequent adverse effects among the 614 participants were transient gastrointestinal effects (nausea and vomiting). Fifty participants self-reported a psychiatric diagnosis (depression and anxiety were the most prevalent), and these participants experienced adverse effects more frequently. Psychiatric medication use was reported by 31 participants. No indication of increased adverse effects due to drug-drug interactions was found.Conclusion:A minority of participants reported being very negatively affected by persistent adverse effects. Psychiatric medication use while participating in ayahuasca rituals was not associated with increased adverse effects. For the most part, the institution’s practices seem sufficient to prevent exacerbated reactions. Future studies may focus on negatively affected users.

Effect of an extract of Pinus koraiensis leaves, Lycium chinense fruit, and Saururus chinensis (Lour.) Baill. leaves on liver function in excessive drinkers: A randomized, double-blind, placebo-controlled trial

• GGT significantly decreased in the women PLC group compared with the placebo group. • TC, LDL-C, and HDL-C significantly decreased in the PLC group after 12-weeks. • Some item of FSS questionnaire improved in PLC group after 12-weeks. • No adverse event and safety issue for 12-week intake PLC. Chronic alcohol consumption is a major risk factor for alcoholic liver disease. In this study, we examined the effect of an extract of Pinus koraiensis leaves, Lycium chinense fruit, and Saururus chinensis (Lour.) Baill. leaves (PLC) on liver function in Korean. A randomized, double-blind, placebo-controlled study was performed in 50 excessive drinkers. The subjects were randomly assigned to PLC (n = 25, 2,000 mg/day) or placebo (n = 25) groups. Blood liver enzymes, lipid profiles, and antioxidant enzymes were assessed at baseline and 12 weeks. GGT level significantly decreased in women in the test group compared with the placebo group (-2.50 ± 3.54 U/L vs. 3.80 ± 11.23 U/L, P = 0.006). TC (-13.04 ± 25.65 mg/dL, P = 0.020) and LDL-C (-10.33 ± 24.15 mg/dL, P = 0.047) levels reduced in the test group after 12 weeks. Although PLC, appears the possibility of improving liver function in excessive drinkers, however, a larger scale and long-term intervention study should be performed.

Can Clinicians Start Prescribing Inclisiran for Hypercholesterolemia Today? A Review of Clinical Studies for Internal Medicine Physicians and Endocrinologists

The safety profile and efficacy margin of inclisiran as a lipid-lowering drug have been assessed in clinical trials and are underway in subgroups with relevant co-morbidities. This systematic review looks at the clinical trials that have been conducted to comment on its safety and efficacy. The conclusions can serve as a guide for practicing physicians and researchers for following current and future cohorts of patients. PubMed, Cochrane, Embase, Scopus, CINAHL, Web of Science, and Clinicaltrials.gov were searched comprehensively using the terms “Inclisiran”, “ALN-PCSsc”, and “ALN-PCS” using the Boolean operator “OR” with data cut-off date of June 28, 2020. The outcomes of safety and efficacy were collected and charted for the systematic review. In our study, eight clinical trials were included in the final study: the ORION (1,2,7,9-11) trials and two clinical trials (phase 1 randomized clinical trials) done before ORION trials. Favourable efficacy in terms of LDL levels and PSCK9 levels was observed across all eight clinical trials. No severe adverse effects, safety concerns, or fatalities attributable directly to inclisiran were reported. Therefore, our study results suggest a positive efficacy and safety profile of inclisiran as a lipid-lowering drug in clinical trials.

Assessment of COVID-19 vaccine hesitancy among undergraduate medical students of a tertiary care teaching hospital, Surat: a source of profound concern

Background: The discussion around COVID-19 vaccines has been in the limelight ever since the announcement was made for mass vaccination campaign in India. Less is known about undergraduate medical students’ perception and willingness towards getting COVID-19 vaccination. The aim of the study was to assess reasons for the apprehension if present towards taking the COVID-19 vaccines among medical students and to spread awareness about the ongoing issue.Methods: This was a prospective, cross sectional, survey-based study which was conducted at Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India. Questionnaire was distributed among medical students during lectures and exam going students were sent Google form link. Data collection was done from February to March 2021, and 550 students submitted the forms.Results: While 34.9% students had taken the vaccine voluntarily, category I (acceptance group); 18.2% students were initially hesitant to take the vaccine, but later took it, category II (hesitant group); the frequency increased to 46.9% students who are still hesitant and have not taken the vaccine, category III (refusal group). Top reasons for hesitancy were: concern regarding adverse events (69%), safety (60%) and lack of scientific data (27%) provided for the vaccines.Conclusions: This study revealed that there was lack of knowledge and positive attitude towards the COVID-19 vaccines among the non-vaccinated students. This evaluation has guided the importance and the need of targeted educational program to address the knowledge gap.

The Safety and Efficacy of Desmopressin in Patients With Intracranial Hemorrhage and a History of Alcohol Use.

Patients with a history of alcohol use disorder are at an increased risk of hematoma expansion following intracranial hemorrhage (ICH) due to the effects of alcohol on platelet aggregation. Desmopressin (DDAVP) improves platelet aggregation and may decrease hematoma expansion in patients with ICH. However, DDAVP may also increase the risk of hyponatremia and thrombotic events. Evidence is limited regarding the safety and efficacy of DDAVP in alcohol use (AU)-associated ICH. This was a retrospective chart review of adult patients with radiographic evidence of ICH and a confirmed or suspected history of alcohol use upon admission. Patients were categorized into groups based on DDAVP administration. Safety outcomes included hyponatremia (serum sodium <135 mEq/L or decrease in serum sodium of ≥ 5 mEq/L for patients with baseline sodium <135 mEq/L) within 24 hours of ICH and thrombotic events within 7 days of ICH. The primary efficacy outcome was the incidence of hematoma expansion, defined as any expansion of the hemorrhage noted on repeat imaging within 32 hours. In total, 52 patients were included in the safety analysis (27 DDAVP and 25 non-DDAVP). Although hyponatremia was numerically higher in the DDAVP group, there was no significant difference between groups (19.2% vs 4.2%, P = 0.192). Thrombotic complications were similar between the DDAVP and non-DDAVP groups (11.1% vs. 8%, P = 1.0). Thirty-nine patients met criteria for hemostatic efficacy analysis. There was no difference in hematoma expansion between the DDAVP and non-DDAVP groups (23.1% vs 34.6%, P = 0.71) and these findings were consistent after adjusting for differences in baseline characteristics (OR 0.63, 95% CI 0.1-3.3). The administration of DDAVP was not associated with adverse safety events, but did not significantly reduce the incidence of hematoma expansion in patients with AU-associated ICH.

Comparative efficacy and safety of oral P2Y12 inhibitors for patients with chronic kidney disease and acute coronary syndrome: a network meta-analysis

BackgroundCurrently, there is a paucity of data concerning the safety and effectiveness of P2Y12 inhibitors in the acute coronary syndrome (ACS) with chronic kidney disease (CKD) population. The aim of this study is to compare the different oral P2Y12 inhibitors in terms of efficacy and safety, focusing exclusively on patients with CKD who were treated for ACS. MethodsWe systematically searched PubMed, CENTRAL, and Web of Science to identify studies that compared different oral P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor) in patients with ACS with CKD. Efficacy outcomes included the major adverse cardiovascular events composite outcome and safety outcomes included major bleedings and major or minor bleedings combined. We performed a frequentist network meta-analysis. ResultsTwelve studies were included in the systematic review, 7 CKD subgroup analyses of RCTs (8878 patients) and 5 observational studies (20175 patients). After the exclusion of studies with conservative management, prasugrel resulted in significant primary endpoint reduction versus clopidogrel (HR 0.80 and 95% CI 0.64 - 0.99), while ticagrelor did not (HR 0.88 and 95% CI 0.73 - 1.06). Major bleedings did not differ between the interventions. Ticagrelor resulted in more major or minor bleedings than clopidogrel (HR 1.21 and 95% CI 1.06 - 1.38), whereas prasugrel did not (HR 1.12 and 95% CI 0.84 - 1.49). ConclusionIn patients with ACS with underlying CKD, who are intended to receive invasive management, there may be a significant reduction of the primary efficacy outcome with prasugrel as compared to clopidogrel but not with ticagrelor as compared to clopidogrel. There probably exists no difference among interventions in the major bleedings. Dedicated RCTs are needed to confirm these results.

Relationship between functional capacity and the occurrence of adverse events during healthcare utilization

Introduction: Adverse events, safety incidents, and medical errors in healthcare can be avoided only by understanding the causes of their occurrence, and by applying the knowledge gained from the analysis of similar previous events. Since it is known that most adverse events do not originate from a single cause, most important is timely identification of numerous contributory states that can give us the opportunity to define a number of possible solutions to correct process errors and deficiencies in the system itself. The aim of this paper is to investigate the association between functional capacity of elderly living with cardiovascular diseases and the occurrence of adverse events during use of health-care services.Methods: Assessment of functional limitations was done using the Groningen Activity Restriction Scale (GARS). The presence of adverse events was evaluated after interviews with subjects and review of medical records. Differences in continuous numerical values between inpatient and outpatient service users were analyzed by the Mann–Whitney U-test. Spearman’s correlation coefficients of the number of actual adverse events with the presence of restrictions in daily activities were calculated. Fisher’s exact test or Fisher-Freeman-Halton test (in cases of table sizes larger than 2 × 2 format) analyzed the differences in category variables.Results: The total number of adverse events was 30 (10.1% of the total number of subjects), while there were 12 actual adverse events (40.0% of the total number of adverse events). No statistically significant correlation was found between the limitations in performing daily activities and the occurrence of actual adverse events (p = 0.173).Conclusion: The research conducted in this paper showed that the functional capacity of the elderly with chronic disease is not exclusively related with the occurrence of adverse events associated with health-care utilization.

European Society of Hypertension position paper on renal denervation 2021.

This ESH Position Paper 2021 with updated proposed recommendations was deemed necessary after the publication of a set of new pivotal sham-controlled randomized clinical trials (RCTs), which provided important information about the efficacy and safety of endovascular device-based renal denervation (RDN) for hypertension treatment. RDN is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity. Five independent, fully completed, sham-controlled RCTs provide conclusive evidence that RDN lowers ambulatory and office blood pressure (BP) to a significantly greater extent than sham treatment. BP-lowering efficacy is evident both in patients with and without concomitant antihypertensive medication. The average decrease of 10 mmHg in office BP is estimated to lower the incidence of cardiovascular events by 25-30%, based on meta-analyses of RCTs using pharmacological treatment. Neither peri-procedural, nor short-term or long-term adverse events or safety signals (available up to 3 years) have been observed. Implementing RDN as an innovative third option in the armamentarium of antihypertensive treatment requires a structured process that ensures the appropriate performance of the endovascular RDN procedure and adequate selection of hypertensive patients. The latter should also incorporate patients' perspective and preference that needs to be respected in a shared decision-making process.