scholarly journals Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments

2021 ◽  
Vol 14 (7) ◽  
pp. 678
Author(s):  
Giada Crescioli ◽  
Ennio Boscia ◽  
Alessandra Bettiol ◽  
Silvia Pagani ◽  
Giulia Spada ◽  
...  
Keyword(s):  
Adverse Drug Events ◽  
Vitamin K Antagonists ◽  
Multivariate Logistic Regression ◽  
Post Hoc Analysis ◽  
Adverse Event Following Immunization ◽  
Drug Classes ◽  
Increased Risk ◽  
Ed Visits ◽  
Post Hoc ◽  
Reduced Risk

This post hoc analysis of an Italian active pharmacovigilance study describes pharmacological differences of ADEs leading to emergency department (ED) visits and hospitalization in women and men. During the study period (January 2007–December 2018), 61,855 reports of ADEs leading to ED visits were collected. Overall, 30.6% of ADEs resulted in hospitalization (30% in women and 31% in men). Multivariate logistic regression showed that, among women, drug classes significantly associated with an increased risk of hospitalization were heparins (ROR 1.41, CI 1.13–176), antidepressants (ROR 1.12, CI 1.03–1.23) and antidiabetics (ROR 1.13, CI 1.02–1.24). Among men, only vitamin K antagonists (ROR 1.28, CI 1.09–1.50), opioids (ROR 1.30, CI 1.06–1.60) and digitalis glycosides (ROR 1.32, CI 1.09–1.59) were associated with a higher risk of hospitalization. Overall, older age, multiple suspected drugs and the presence of comorbidities were significantly associated with a higher risk of hospitalization. A significantly reduced risk of hospitalization was observed in both women and men experiencing an adverse event following immunization (ROR 0.36, CI 0.27–0.48 and 0.83, 0.42–0.74, respectively) compared to drugs. Results obtained from this real-world analysis highlight important aspects of drug safety between sexes.

scholarly journals Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post-Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments

2021 ◽  
Author(s):  
Giada Crescioli ◽  
Ennio Boscia ◽  
Alessandra Bettiol ◽  
Silvia Pagani ◽  
Giulia Spada ◽  
...  
Keyword(s):  
Adverse Drug Events ◽  
Vitamin K Antagonists ◽  
Multivariate Logistic Regression ◽  
Digitalis Glycosides ◽  
Post Hoc Analysis ◽  
Adverse Event Following Immunization ◽  
Drug Classes ◽  
Increased Risk ◽  
Post Hoc ◽  
Reduced Risk

This post-hoc analysis of an Italian active pharmacovigilance study describes pharmacological differences of ADEs leading to emergency department (ED) visit and hospitalization in women and men. During the study period (January 2007 – December 2018), 61,855 reports of ADE leading to ED visit were collected. Overall, 30.6% of ADEs resulted in hospitalization (30% in women and 31% in men). Multivariate logistic regression showed that, among women, drug classes significantly associated with an increased risk of hospitalization were heparins (ROR 1.41, CI 1.13-176), antidepressants (ROR 1.12, CI 1.03-1.23) and antidiabetics (ROR 1.13, CI 1.02-1.24). Among men only vitamin K antagonists (ROR 1.28, CI 1.09-1.50), opioids (ROR 1.30, CI 1.06-1.60) and digitalis glycosides (ROR 1.32, CI 1.09-1.59) were associated with a higher risk of hospitalization. Overall, older age, multiple suspected drugs and the presence of comorbidi-ties were significantly associated with a higher risk of hospitalization. A significantly reduced risk of hospitalization was observed in both women and men experiencing and adverse event following immunization (ROR 0.36, CI 0.27-0.48 and 0.83, 0.42-0.74, respectively) compared to drugs. Results obtained from this real-world analysis highlight important aspects of drug safety between sexes.

Association Between Potentially Inappropriate Medications and 30-Day Post–Hospital Discharge Outcomes in US Veterans

2021 ◽  
pp. 106002802110320
Author(s):  
Heather G. Allore ◽  
Danijela Gnjidic ◽  
Melissa Skanderson ◽  
Ling Han
Keyword(s):  
Hospital Discharge ◽  
Adverse Drug Events ◽  
Primary Care Clinic ◽  
Care Utilization ◽  
Potentially Inappropriate Medications ◽  
Care Hospital ◽  
Care Clinic ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
Reduced Risk

Background Potentially inappropriate medication (PIMs) use is common in older inpatients and it may lead to increased risk of adverse drug events. Objectives To examine prevalence of PIMs at hospital discharge and its contribution to health care utilization and mortality within 30-days of hospital discharge. Methods This was a prospective cohort of 117 570 veterans aged ≥65 years and hospitalized in 2013. PIMs at discharge were categorized into central nervous system acting (CNS) and non-CNS. Outcomes within 30-days of hospital discharge were: (1) time to first acute care hospital readmission, and all-cause mortality, (2) an emergency room visit, and (3) ≥3 primary care clinic visits. Results The cohort’s mean age was 74.3 years (SD 8.1), with 51.3% exposed to CNS and 62.8% to non-CNS PIMs. Use of CNS and non-CNS PIMs, respectively, was associated with a reduced risk of readmission, with an adjusted hazard ratio (aHR) of 0.93 (95% CI = 0.89-0.96) for ≥2 (vs 0) CNS PIMs and an aHR of 0.85 (95% CI = 0.82-0.88) for ≥2 (vs 0) non-CNS PIMs. Use of CNS PIMs (≥2 vs 0) was associated with increased risk of mortality (aHR = 1.37 [95% CI = 1.25-1.51]), whereas non-CNS PIMs use was associated with a reduced risk of mortality (aHR = 0.75 [95% CI = 0.69-0.82]). Conclusion and Relevance PIMs were highly common in this veteran cohort, and the association with outcomes differed by PIMs. Thus, it is important to consider whether PIMs are CNS acting to optimize short-term posthospitalization outcomes.

scholarly journals The “Gender Factor” in Wearing-Off among Patients with Parkinson’s Disease: A Post Hoc Analysis of DEEP Study

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Delia Colombo ◽  
Giovanni Abbruzzese ◽  
Angelo Antonini ◽  
Paolo Barone ◽  
Gilberto Bellia ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cross Sectional Study ◽  
Motor Symptom ◽  
Cross Sectional ◽  
Post Hoc Analysis ◽  
Increased Risk ◽  
Wearing Off ◽  
Gender Factor ◽  
Post Hoc

Background. The early detection of wearing-off in Parkinson disease (DEEP) observational study demonstrated that women with Parkinson’s disease (PD) carry an increased risk (80.1%) for wearing-off (WO). This post hoc analysis of DEEP study evaluates gender differences on WO and associated phenomena.Methods. Patients on dopaminergic treatment for ≥1 year were included in this multicenter observational cross-sectional study. In a single visit, WO was diagnosed based on neurologist assessment as well as the use of the 19-item wearing-off questionnaire (WOQ-19); WO was defined for scores ≥2. Post hoc analyses were conducted to investigate gender difference for demographic and clinical features with respect to WO.Results. Of 617 patients enrolled, 236 were women and 381 were men. Prevalence of WO was higher among women, according to both neurologists’ judgment (61.9% versus 53.8%,P=0.045) and the WOQ-19 analysis (72.5% versus 64.0%,P=0.034). In patients with WO (WOQ-19), women experienced ≥1 motor symptom in 72.5% versus 64.0% in men and ≥1 nonmotor symptom in 44.5% versus 36.7%, in men.Conclusions. Our results suggest WO as more common among women, for both motor and nonmotor symptoms. Prospective studies are warranted to investigate this potential gender-effect.

scholarly journals Peak Thrombin and D-Dimer Levels in Subjects with Severe Hemophilia Receiving Acute Treatment for Bleeding Episodes Experienced during Prophylactic Marstacimab Treatment

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 33-34
Author(s):  
Satyaprakash Nayak ◽  
Sangeeta Raje ◽  
John Teeter ◽  
Lutz Harnisch ◽  
Steven Arkin
Keyword(s):  
Bleeding Episode ◽  
Phase 2 ◽  
Bleeding Events ◽  
Post Hoc Analysis ◽  
On Demand ◽  
Increased Risk ◽  
Phase 2 Study ◽  
Bleeding Episodes ◽  
Post Hoc ◽  
D Dimer

Introduction: Marstacimab is a fully humanized monoclonal immunoglobulin G1 that targets the shared K2 domains of tissue factor pathway inhibitor (TFPI)α and (TFPI)β and is currently in phase 3 development. The intended indication is routine prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B (with or without inhibitors). Factor replacement or bypass treatment for bleeding events may lead to increased levels of peak thrombin and D-dimer associated with an increased risk of thrombosis . In this post hoc analysis of data from a phase 2 study in patients with hemophilia with and without bleeding episodes, receiving prophylactic marstacimab treatment, peak thrombin and D-dimer levels were investigated to assess the changes in these biomarker levels observed after bleeding episodes. Methods: Individual subject data from the phase 2 study (clinicaltrials.gov identifier: NCT02974855)were used for this analysis. Biomarker data for healthy volunteers who received single doses of marstacimab in a phase 1 dose escalation study (clinicaltrials.gov identifier: NCT02531815) were used as control data, as these subjects represent an intact and uncompromised coagulation system. Study subjects in the phase 2 study received subcutaneous (SC) marstacimab at doses of (1) 150 mg once weekly (QW), with a loading dose of 300 mg, (2) 300 mg QW, and (3) 450 mg QW. All subjects with bleeding episodes were identified, along with on-demand treatment administered for each bleeding episode. Treatments permitted for bleeding episodes included activated coagulation factor VIIa, factor VIII, or factor IX; use of activated prothrombin complex concentrate was prohibited. D-dimer and peak thrombin data collected within 3 days after each bleeding episode were used for this analysis. Time profiles of peak thrombin and D-dimer levels were analyzed to assess the effect of bleed treatment. Biomarker profiles were compared between subjects with and without bleeding episodes, as well as with the data from healthy volunteers (n=41). Results: A total of 15 bleeding episodes were reported in 8 of 26 subjects during the study (excluding screening and follow-up). No subject participating in the study showed any relevant increases in D-dimer levels after receiving on-demand treatment for a bleeding episode while receiving regular prophylaxis with marstacimab, compared with levels seen in subjects who did not experience a bleeding episode. Based on the peak thrombin data (see Figure), 150 nM was observed as the upper limit for 18 of 26 subjects who did not experience any bleeding episodes, which was approximately 50% of the 300 nM observed in healthy volunteer controls treated with 450 mg intravenous marstacimab. Transient increases in peak thrombin of >150 nM were observed at several time points in 3 of 8 subjects who experienced bleeding episodes. The highest peak thrombin level reported was approximately 211 nM in one subject receiving marstacimab 300 mg SC QW and factor VIII concentrate on demand during the study. Conclusions: No transient increases in D-dimer could be attributed to the administration of bleeding episode treatment. The transient increases in peak thrombin levels following on-demand treatment for bleeding episodes did not exceed peak thrombin levels seen in subjects without bleeding events or the levels seen in healthy volunteer controls receiving single doses of marstacimab. Based on peak thrombin and D-dimer levels observed in this post hoc analysis, there does not appear to be any indication of an increased risk of thrombosis post administration of acute on-demand bleeding episode treatment while on prophylactic marstacimab therapy at the doses studied. Disclosures Nayak: Pfizer Inc.: Current Employment, Other. Raje:Pfizer Inc.: Current Employment, Other. Teeter:Pfizer Inc.: Current Employment. Harnisch:Pfizer Inc.: Current Employment, Other. Arkin:Pfizer: Current Employment, Current equity holder in publicly-traded company, Other: own stock/options in the company.

scholarly journals A higher non-severe hypoglycaemia rate is associated with an increased risk of subsequent severe hypoglycaemia and major adverse cardiovascular events in individuals with type 2 diabetes in the LEADER study

Diabetologia ◽  
2021 ◽  
Author(s):  
Simon R. Heller ◽  
Milan S. Geybels ◽  
Ahmed Iqbal ◽  
Lei Liu ◽  
Lily Wagner ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Events ◽  
Severe Hypoglycaemia ◽  
Cardiovascular Death ◽  
Cardiovascular Outcomes ◽  
Post Hoc Analysis ◽  
Increased Risk ◽  
All Cause Mortality ◽  
Post Hoc

Abstract Aims/hypothesis Hypoglycaemia is a common side effect of insulin and some other antihyperglycaemic agents used to treat diabetes. Severe hypoglycaemia has been associated with adverse cardiovascular events in trials of intensive glycaemic control in type 2 diabetes. The relationship between non-severe hypoglycaemic episodes (NSHEs) and severe hypoglycaemia in type 2 diabetes has been documented. However, an association between more frequent NSHEs and cardiovascular events has not been verified. This post hoc analysis of the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial aimed to confirm whether there is an association between NSHEs and severe hypoglycaemic episodes in individuals with type 2 diabetes. In addition, the possible association between NSHEs and major adverse cardiac events (MACE), cardiovascular death and all-cause mortality was investigated. Methods LEADER was a double-blind, multicentre, placebo-controlled trial that found that liraglutide significantly reduced the risk of MACE compared with the placebo. In this post hoc analysis, we explored, in all LEADER participants, whether the annual rate of NSHEs (defined as self-measured plasma glucose <3.1 mmol/l [56 mg/dl]) was associated with time to first severe hypoglycaemic episode (defined as an episode requiring the assistance of another person), time to first MACE, time to cardiovascular death and time to all-cause mortality. Participants with <2 NSHEs per year were used as reference for HR estimates. Cox regression with a time-varying covariate was used. Results We demonstrate that there is an association between NSHEs (2–11 NSHEs per year and ≥12 NSHEs per year) and severe hypoglycaemic episodes (unadjusted HRs 1.98 [95% CI 1.43, 2.75] and 5.01 [95% CI 2.84, 8.84], respectively), which was consistent when baseline characteristics were accounted for. Additionally, while no association was found between participants with 2–11 NSHEs per year and adverse cardiovascular outcomes, higher rates of NSHEs (≥12 episodes per year) were associated with higher risk of MACE (HR 1.50 [95% CI 1.01, 2.23]), cardiovascular death (HR 2.08 [95% CI 1.17, 3.70]) and overall death (HR 1.80 [95% CI 1.11, 2.92]). Conclusions/interpretation The analysis of data from the LEADER trial demonstrated that higher rates of NSHEs were associated with both a higher risk of severe hypoglycaemia and adverse cardiovascular outcomes in individuals with type 2 diabetes. Therefore, irrespective of the cause of this association, it is important that individuals with high rates of hypoglycaemia are identified so that the potentially increased risk of cardiovascular events can be managed and steps can be taken to reduce NSHEs. Trial registration ClinicalTrials.gov (NCT01179048). Graphical abstract

scholarly journals Serum MMP-9: a novel biomarker for prediction of clinical relapse in patients with quiescent Crohn’s disease, a post hoc analysis

2019 ◽  
Vol 12 ◽  
pp. 175628481988159 ◽  
Author(s):  
Doron Yablecovitch ◽  
Uri Kopylov ◽  
Adi Lahat ◽  
Michal M. Amitai ◽  
Eyal Klang ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Intestinal Inflammation ◽  
Area Under The Curve ◽  
Fecal Calprotectin ◽  
Clinical Relapse ◽  
Post Hoc Analysis ◽  
Reactive Protein ◽  
Increased Risk ◽  
Post Hoc

Background: Matrix metalloproteinase-9 (MMP-9) is a novel marker of intestinal inflammation. The aim of this study was to assess if serum MMP-9 levels predict clinical flare in patients with quiescent Crohn’s disease (CD). Methods: This study was a post hoc analysis of a prospective observational study in which quiescent CD patients were included and followed until clinical relapse or the end of a 2-year follow-up period. Serial C-reactive protein (CRP) and fecal calprotectin (FC) levels were measured, and the patients underwent repeated capsule endoscopies (CEs) every 6 months. Small bowel inflammation was quantified by Lewis score (LS) for CE. A baseline magnetic resonance enterography was also performed, and MaRIA score was calculated. Serum MMP-9 levels in baseline blood samples were quantified by ELISA. Results: Out of 58 eligible enrolled patients, 16 had a flare. Higher levels of baseline MMP-9 were found in patients who developed subsequent symptomatic flare compared with patients who did not [median 661 ng/ml, 25–75 interquartile range (IQR; 478.2–1441.3) versus 525.5 ng/ ml (339–662.7), respectively, p = 0.01]. Patients with serum MMP-9 levels of 945 ng/ ml or higher were at increased risk for relapse within 24 months [area under the curve (AUC) of 0.72 [95% confidence interval (CI): 0.56–0.88]; hazard ratio 8.1 (95% CI 3.0–21.9, p < 0.001)]. Serum MMP-9 concentrations showed weak and moderate correlation to baseline LS and FC, respectively ( r = 0.31, p = 0.02; r = 0.46, p < 0.001). No correlation was found between serum MMP-9 to CRP and MaRIA score. Conclusions: Serum MMP-9 may be a promising biomarker for prediction of clinical flare in CD patients with quiescent disease.

scholarly journals The Prognostic Value of Brain Dysfunction in Critically Ill Patients with and without Sepsis: A Post Hoc Analysis of the ICON Audit

2021 ◽  
Vol 11 (5) ◽  
pp. 530
Author(s):  
Ilaria Crippa ◽  
Fabio Taccone ◽  
Xavier Wittebole ◽  
Ignacio Martin-Loeches ◽  
Mary Schroeder ◽  
...  
Keyword(s):  
Hospital Mortality ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Brain Function ◽  
Brain Dysfunction ◽  
Hospital Death ◽  
Post Hoc Analysis ◽  
Increased Risk ◽  
Brain Failure ◽  
Post Hoc

Brain dysfunction is associated with poor outcome in critically ill patients. In a post hoc analysis of the Intensive Care over Nations (ICON) database, we investigated the effect of brain dysfunction on hospital mortality in critically ill patients. Brain failure was defined as a neurological sequential organ failure assessment (nSOFA) score of 3–4, based on the assumed Glasgow Coma Scale (GCS) score. Multivariable analyses were performed to assess the independent roles of nSOFA and change in nSOFA from admission to day 3 (ΔnSOFA) for predicting hospital mortality. Data from 7192 (2096 septic and 5096 non-septic) patients were analyzed. Septic patients were more likely than non-septic patients to have brain failure on admission (434/2095 (21%) vs. 617/4665 (13%), p < 0.001) and during the ICU stay (625/2063 (30%) vs. 736/4665 (16%), p < 0.001). The presence of sepsis (RR 1.66 (1.31–2.09)), brain failure (RR 4.85 (3.33–7.07)), and both together (RR 5.61 (3.93–8.00)) were associated with an increased risk of in-hospital death, but nSOFA was not. In the 3280 (46%) patients in whom ΔnSOFA was available, sepsis (RR 2.42 (1.62–3.60)), brain function deterioration (RR 6.97 (3.71–13.08)), and the two together (RR 10.24 (5.93–17.67)) were associated with an increased risk of in-hospital death, whereas improvement in brain function was not.

scholarly journals Contrast-induced acute renal injury: multi-factor analysis to establish risks and associations

2020 ◽  
Vol 7 (11) ◽  
pp. 1695
Author(s):  
Jacob Joseph ◽  
Ashish Indani ◽  
Poonam Bhutada ◽  
Saji Jose
Keyword(s):  
Heart Failure ◽  
Contrast Media ◽  
Kidney Injury ◽  
Coronary Intervention ◽  
Morbidity Rate ◽  
Ethical Guidelines ◽  
Mortality And Morbidity ◽  
Post Hoc Analysis ◽  
Increased Risk ◽  
Post Hoc

Background: Contrast-induced acute kidney Injury (CIAKI) also called nephropathy is one of the recurrent complications with very high mortality and morbidity rate amongst the patients undergoing percutaneous coronary intervention (PCI). The purpose of this research was to validate the incidence, risk factors, and correlation of various comorbidities with CIAKI.Methods: The study was conducted on 308 patients who had undergone PCI procedures. All patients were recruited following all ethical guidelines. All patients were treated as per the hospital protocol. All patients were followed up for 7 days post PCI. Out of 308 patients, 35 developed CIKAI while remaining was classified as control for post-hoc analysis comparison. Evaluation of the patients was done using Mehran’s risk score, ODD analysis and RADHIKa method.Results: The incidence of CIAKI was found in 35 (11.37%) out of 308 patients. No patients required dialysis within 1 week of the procedure. The use of the ionization optimized contrast medium (IOCM) is linked with the reduction of +CIAKI. The obvious relationship between the volume of contrast media, MRS, and CIAKI was reestablished. Post-hoc analysis of CIAKI and non-CIAKI revealed that the CIAKI is closely linked with heart failure as a risk factor. Congestive heart failure (CHF) increases the risk of CIAKI and that results in an increased risk of heart failure.Conclusion: In conclusion, the pre-existing multiple co-morbidities, volume, and ionization value of the contrast media were found to be directly associated with CIAKI.

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