Rate Of Serious Events Research Articles

Adverse events following Measles-Mumps-Rubella and varicella immunization: A safety profile analysis and comparison of different vaccination schedules based on the Italian Pharmacovigilance Network in the Veneto Region

ObjectiveThe vaccines for measles, mumps, rubella and varicella (MMR and V) have been mandatory in Italy since 2017. Two different vaccination strategies are suggested for the first dose: trivalent MMR and a separate V vaccine or the tetravalent MMRV vaccine. Our aim is to compare the safety profile of MMRV and MMR-V vaccines through the passive adverse event reporting system in the Veneto region and to perform a case-by-case review of a few conditions of interest (febrile and afebrile seizures, ataxia, encephalitis, Guillain-Barré Syndrome, thrombocytopenia, neutropenia and Henoch-Schönlein Purpura). Age and sex differences were also explored. MethodsWe identified all reports following MMRV or MMR-V vaccination in the Veneto Region and received into the National Pharmacovigilance Network between 2007 and April 30, 2022. Results9,510 reports were retrieved, of which 5,662 (59.5 %) were related to MMRV and 3,848 (40.5 %) to MMR-V. No safety signals were detected supporting the evidence that MMRV and MMR-V vaccinations have a good safety profile. The reporting rate (RR) for serious events between 2007 and 2022 resulted in 13.67 per 10,000 administered doses for MMRV and 10.90 for MMR-V. ConclusionPassive surveillance data show a significantly higher rate of serious events for males 0–2 years old, both overall and stratified per vaccination strategy. Further studies are needed to confirm this observation. The analyses suggest that retrieved differences do not have a significant impact on the overall safety of both formulations.

What is the clinical benefit of left main coronary artery treatment by percutaneous coronary intervention?

Abstract Funding Acknowledgements Type of funding sources: None. Introduction The treatment of choice of left main coronary artery (LMCA) disease has been subject to intense debate and investigation in the last decade. More recent studies showed benefit of percutaneous coronary intervention (PCI) in patients with less complex coronary anatomy. Although it is not the standard treatment, the use of this technique has been increasing. Objectives Characterize the patient population undergoing LMCA PCI and analyze its clinical benefit. Also, try to identify patient profiles according to the composite outcome (angor, heart failure symptoms (HF), myocardial infarction (MI) or death) in short and medium term (30 days (D) and 180D). Methods Observational and retrospective study of patients submitted to LMCA PCI, between 1 January 2019 and 31 December 2020. A descriptive analysis was carried out. Chi-Square test was used for categorical variables and the T-Student test for numerical variables, with a significance level of 95%. CHIAD algorithm was applied to identify patient profiles – composite outcome was the dependent variable (fixed 15 parent nodes and 5 children nodes). For statistical analysis, SPSS 24.0 was used. Results N120 patients, mean age of 70,4 years (standard deviation of 10.8), 76% were male. 81.7% had multivessel disease, with LMCA-anterior descendig artery injury being the most frequent (31.7%). The average LVEF was 49%. The complication rate was 15.8%, most vessel dissections. The most serious complications (cardio-respiratory arrest and cardiogenic shock) occurred in 0.8% of cases. The composite outcome occurred in 25,2% (30D) and 13,3% (180D), regardless of past medical history and number/type of vessels affected. The presence of angor was 9.9% (30D) and 1.3% (180D); HF symptoms in 13.5% (30D) and 4.8% (180D); MI in 2.7% (30D) and 1.2% (180D) and mortality in 2.7% (30D) and 2.4% (180D). In a logic of dependence and profiles, patients with LVEF [45-55%] (95.6%-p=0.003) who treated the lesions in first intention (AdHoc) (100%-p=0.009) presented fewer occurrences at 30D. Patients with occurrences at 30D (65.2%-p=0.001) or without PV of LVEF (66.7%-p = 0.016) and dyslipidemia (53.8%-p = 0.027) were those with most occurrences at 180D. Conclusion This analysis highlights the experience of the angiography laboratory. The majority of patients experienced evident clinical improvement and recovered in shortand medium term. The rate of serious events was low. The analysis suggests that the greatest benefit were found in the profile of patients with LVEF [45-55%] with an AdHoc approach.

What is the clinical benefit of coronary chronic total occlusions treatment by percutaneous coronary intervention?

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Coronary chronic total occlusions (CTO) are relatively common findings in the context of coronary angiography. The indication for revascularization of this type of lesions remains controversial. The recommendations of international cardiology societies consider the treatment of CTO by percutaneous coronary intervention (PCI) in selected patients, but this technique is not yet widely used in this context. Objectives Characterize the patient population undergoing CTO PCI and analyze its clinical benefit. Also, try to identify patient profiles according to the composite outcome (angor, heart failure symptoms (HF), myocardial infarction (MI) or death) in short and medium term (30 days (D) and 180D). Methods Observational and retrospective study with descriptive and comparative analysis of patients submitted to CTO PCI, between 1 January 2019 and 31 December 2020. A descriptive analysis was carried out. Chi-Square test was used for categorical variables and the T-Student test for numerical variables, with a significance level of 95%. CHIAD algorithm was applied to identify patient profiles, whose dependent variable was the presence or absence of the composite outcome (fixed 15 parent nodes- 5 children nodes). For statistical analysis, SPSS 24.0 was used. Results N177 patients were identified, with a mean age of 65.4 years (standard deviation of 11.1), 51% were female. The most frequent location of CTO was the right coronary in 41.2%. The composite outcome occurred in 23% (30D) and 16% (180D) of patients, regardless of past medical history. Angor was present in 9.4% (30D) and 5.3% (180D); HF symptoms in 12.3% (30D) and 5.3% (180D); MI in 2% (180D) mortality in 1.8% (30D) and 4.7% (180D). The complication rate was 5.1%, mostly cardio-respiratory arrest (2.5%) and vessel dissection (1.7%). In a logic of dependence and profiles, patients with LVEF>36% (80.1%-p=0.017), without HF symptoms (82.9%-p=0.007) and non-smokers/ ex-smokers (87.6%-p=0.043), were those with the greatest benefit at 30D. Patients with a history of NSTEMI (24.5%-p=0.018) and CKD (37.5%-p=0.048) were those with most occurrences presented at 180D. Conclusion This analysis highlights the experience of the angiography laboratory. In this pool, the majority of patients experienced evident clinical improvement and recovered in short and medium term. The rate of serious events during and after the procedure was low. This analysis suggests that the greatest benefit were found in patients with LVEF>36%, who didn´t develop post-procedure HF symptoms and in non-smokers/ex-smokers.

Initial Cholinesterase Inhibitor Therapy Dose and Serious Events in Older Women and Men.

To examine dose-related prescribing and short-term serious events associated with initiation of cholinesterase inhibitor (ChEI) therapy. Retrospective, population-based cohort study. Ontario, Canada. Women (n=47,829) and men (n=32,503) aged 66 and older who initiated a ChEI between April 1, 2010, and June 30, 2016. All-cause serious events (emergency department (ED) visits, inpatient hospitalizations, death) within 30 days of ChEI initiation. Multivariable Cox proportional hazards models were used to estimate adjusted rates of serious events. Overall, 4.8% of older adults were dispensed a lower-than-recommended ChEI starting dose, 87.9% a recommended dose, and 7.3% a higher-than-recommended starting dose. Eight thousand six hundred seventy-one (10.8%) individuals experienced a serious event within 30 days of initiating therapy, primarily ED visits (8,540, 10.6%). Relative to those initiated on a recommended starting dose, those initiated on a higher dose had a significantly increased rate of serious events (women adjusted hazard ratio (aHR) 1.50, 95% confidence interval (CI) =1.38-1.63; men aHR 1.31, 95% CI=1.19-1.45). Similar patterns were found for ED visits and inpatient hospitalizations but not death. The relative effect of higher-than-recommended starting dose dispensed vs. recommended starting dose dispensed was greater in women than it was in men: the number needed to harm was 22 (95% confidence interval (CI)=18-29) for women and 36 (95% CI= 26-61) for men. Serious events immediately after initiation of ChEIs were associated with starting ChEI dose. This association was stronger in women.

Propranolol for treatment of infantile hemangioma: a systematic evaluation

Objective To systematically review the literature evaluating efficacy and adverse events of propranolol for infantile hemangiomas (IHs). Methods We searched the Cochrane, Medline, Wiley, CNKI and Wanfang Databases for all studies on the response of IHs to propranolol only which were published between June 2008 and May 2013. Results A total of 23 studies were collected, including 14 case reports and 2 follow-up studies which were without random and control; another 6 studies were clinical controlled trials and 1 study was RCT. Total 716 patients were included, and never received other treatments before propranolol. Propranolol was initiated at a mean age of (4.5±0.5) months at a mean dose of 2.1 mg/kg/day and for a mean treatment duration of (9.7±9.2) months. The effective rate for patients with IHs treated with propranolol was 97% (691/716), and patients after treatment completion reported IHs recurred in 8.6% of patients. The adverse effects rate was 31% (223/7167) which most common adverse events were changes in sleep (n=35), gastrointestinal reaction (n=52) and decreased heart rate (n=73), and 5 patients discontinued the treatment because of the serious adverse events. Conclusions This systematic review of 716 patients treated with propranolol for IHs show a high rate of efficacy and a low rate of serious adverse events, and it is a better treatment of infantile hemangioma, but we should pay more attention to the serious adverse events and strictly select indications. Key words: Hemangiomas; Propranolol; Infantile

Reduction of unexpected serious adverse events after introducing medical emergency team.

To assess the clinical benefits of introducing a medical emergency team system for early medical intervention in hospital care. This prospective analysis included all cases of medical emergency team activation during the first year after the introduction of the medical emergency team system at Chiba University Hospital (Chiba, Japan) in February 2011. The rates of in-hospital mortality and unexpected events before and after introduction of the medical emergency team system were compared. The total number of medical emergency team activation calls was 83 (4.9 per 1,000 admissions). The activation of the medical emergency team system was requested most frequently from the general ward (56.6%) and by a physician (57.8%), with the most important reasons for activation being cardiac arrest (37.3%), breathing abnormality (33.7%), and impaired consciousness (32.5%). The most frequent medical interventions by the medical emergency team were intubation (43.3%) and oxygen inhalation (41.0%). Approximately one-half of the patients requiring activation of the medical emergency team system were critically ill and needed subsequent intensive care unit admission. Although no significant difference was observed between the pre- and post- medical emergency team in-hospital mortalities (2.1% versus 2.0%, respectively), the incidence rate of serious events significantly decreased (12.4% versus 6.8%, respectively; P = 0.015). Most patients requiring activation of the medical emergency team system were critically ill and needed emergency treatment at the location of the medical emergency team activation, with subsequent critical care. Although the introduction of the medical emergency team system did not affect the in-hospital mortality rate, it reduced the incidence of unexpected serious adverse events, suggesting that it may be clinically useful.

Older Men with Dementia Are at Greater Risk than Women of Serious Events After Initiating Antipsychotic Therapy

To understand how drug therapy differently affects older women and men. Population-based, retrospective cohort study. Ontario, Canada. Twenty-one thousand five hundred twenty-six older adults (13,760 women, 7,766 men) with dementia newly started on oral atypical antipsychotic therapy between April 1, 2007, and March 1, 2010. Numbers and rates of serious events. Serious events were defined as a hospital admission or death within 30 days of treatment initiation. Unadjusted and adjusted odds ratios of women and men were compared in the full cohort and in strata based on setting of care, age, Charlson Comorbidity Index (CCI), and antipsychotic dose. Of 21,526 older adults with a median age of 84, 1,889 (8.8%) had a serious event (1,044 women, 7.6%; 845 men, 10.9%). Of these, 363 women (2.6%) and 355 men (4.6%) died. Men were more likely than women to be hospitalized or die during the 30-day follow-up period (adjusted odds ratio = 1.47, 95% confidence interval = 1.33-1.62) and consistently more likely to experience a serious event in each stratum. A gradient of risk according to drug dose was found for the development of a serious event in women and men. The risk of developing a serious event shortly after the initiation of antipsychotic therapy was high in women and men with dementia but was consistently higher in older men. This pattern remained the same in strata based on setting of care, age, CCI, and antipsychotic dose.

Comparative study between vasopressin, norepinephrine, or a combination of both in patients with blood disease who developed septic shock

Background The administration of arginine vasopressin (AVP) may be effective for hemodynamic support in septic shock. The aim of the present study is to compare the effect of continuous infusions of AVP, norepinephrine, or a AVP/norepinephrine combination for 48 h, when given as a hemodynamic supportive therapy in patients with blood diseases who developed septic shock and to compare the side effects, especially organ dysfunction. Patients and methods The study included 54 patients with different blood diseases who developed septic shock; their mean arterial pressure was less than 60 mmHg or the systolic blood pressure was less than 90 mmHg, although adequate fluids had been administered. Patients were randomly allocated according to the drug infusion into three equal groups, with 18 patients in each group. The first group received AVP at 0.06 IU/min (group 1), the second group received 15 μg/min of norepinephrine (group 2), and AVP was infused at 0.03 IU/min combined with 10 μg/min of norepinephrine in the third group (group 3). For all the groups, norepinephrine could be added to achieve a mean arterial pressure between 65 and 75 mmHg if necessary. The hemodynamic response, laboratory and organ function, AVP level, and norepinephrine requirements as well as adverse events were recorded. Results Blood pressure increased significantly in the three study groups throughout the study period ( P P P =0.20). Plasma AVP levels were low in all groups at the baseline ( P =0.35). These levels did not change in group 2, but increased in group 1 and group 3 at 24 and 48 h after drug infusion ( P =0.001 and 0.001, respectively). Serum lactate levels and base deficit decreased significantly ( P =0.002 and 0.001, respectively), whereas arterial pH increased significantly in the three study groups ( P P =0.45). Patients in group 1 had lower plasma troponin levels than patients in the other two groups ( P =0.001). Platelets decreased in group 1 and group 3, but the decrease was only significant in group 1 ( P =0.001). It showed a nonsignificant change in group 2 ( P >0.05). We did not have to administer norepinephrine to any patient in the three study groups. There was no difference in the rate of serious adverse events between group 1 and group 2 (the rate was 5% in both the groups). One patient in the norepinephrine group had a cardiac arrest, whereas hyponatremia was recorded in group 1; no adverse events were recorded in group 3. Conclusion The present study provides evidence that a continuous infusion of low-dose AVP 0.03 IU/min in combination with 10 μg/min of norepinephrine is effective in septic shock, with less complications, especially renal and liver dysfunction and platelet disorder. These findings indicate that this combination is suitable for use in high-risk hematological patients with septic shock.

New Analysis Questions Antipsychotics' Stroke Risk

New Analysis Questions Antipsychotics' Stroke Risk

Comparative Safety of Two Recombinant Hepatitis B Vaccines in Children: Data from the Vaccine Adverse Event Reporting System (VAERS) and Vaccine Safety Datalink (VSD)

Background: Preliminary review of data from the Vaccine Adverse Event Reporting System (VAERS), 1991–1994, revealed that more serious adverse events were reported in children who received a specific brand of recombinant hepatitis B (HepB) vaccine. Objective: To compare the post-marketing safety experience of the two recombinant HepB vaccines licensed for use in infants and children in the United States. Design: Review of a case series derived from passive surveillance data in the national VAERS. A retrospective cohort study using data from one health maintenance organization participating in Vaccine Safety Datalink (VSD), a computerized record linkage system. Populations Studied: U.S. children, ages birth–10 years for whom adverse events after HepB vaccine were reported to VAERS, 1991–1994. Children, ages birth–6 years, who received HepB vaccine at Kaiser Permanente Medical Care Program, Northern California, 1991–1994. Main Outcome Measures: VAERS reporting rates for each vaccine by manufacturer were calculated from the numbers of reported events occurring within 30 days of HepB vaccination and the number of doses distributed by the manufacturers. VSD event rates for each vaccine were calculated from the numbers of hospitalization or emergency room visits within 30 days of HepB vaccination and the number of vaccine doses administered to the cohort. Results: In VAERS, higher rates of serious events (i.e., life threatening or resulting in hospitalization or permanent disability) were reported in children who received Vaccine A vs. Vaccine B (relative risk [RR]: 3.13–8.18, P < 0.01), particularly by those vaccinated in the private (RR: 7.62–28.58, P < 0.01), but not public sector (RR: 2.12, P = 0.19). Similar types of events were reported in recipients of both vaccines. In contrast, analysis of VSD data showed no significant difference in rates of hospitalization or ER visits in children who received either HepB vaccine (RR: 0.96–1.25, P > 0.05). Conclusions: Our investigation reveals that it is unlikely there is a true difference between rates of serious events temporally associated with the two HepB vaccines in children. This study demonstrates the dual roles played by VAERS and VSD in providing a more complete picture of the post-marketing safety profile of childhood vaccines, and underscores the importance of using other analytic studies to evaluate findings from passive surveillance systems of adverse events.