scholarly journals Influenza vaccination and risk for cardiovascular events: a nationwide self-controlled case series study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Abhijit Sen ◽  
Inger Johanne Bakken ◽  
Ragna Elise Støre Govatsmark ◽  
Torunn Varmdal ◽  
Kaare Harald Bønaa ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Influenza Vaccination ◽  
Lower Risk ◽  
Cardiovascular Events ◽  
Case Series ◽  
Baseline Risk ◽  
Inverse Association ◽  
Relative Risks ◽  
Case Series Study ◽  
Cardiovascular Medications

Abstract Background US and European guidelines diverge on whether to vaccinate adults who are not at high risk for cardiovascular events against influenza. Here, we investigated the associations between influenza vaccination and risk for acute myocardial infarction, stroke and pulmonary embolism during the 2009 pandemic in Norway, when vaccination was recommended to all adults. Methods Using national registers, we studied all vaccinated Norwegian individuals who suffered AMI, stroke, or pulmonary embolism from May 1, 2009 through September 30, 2010. We defined higher-risk individuals as those using anti-diabetic, anti-obesity, anti-thrombotic, pulmonary or cardiovascular medications (i.e. individuals to whom vaccination was routinely recommended); all other individuals were regarded as having lower-risk. We estimated incidence rate ratios with 95% CI using conditional Poisson regression in the pre-defined risk periods up to 180 days following vaccination compared to an unexposed time-period, with adjustment for season or daily temperature. Results Overall, we observed lower risk for cardiovascular events following influenza vaccination. When stratified by baseline risk, we observed lower risk across all three outcomes in association with vaccination among higher-risk individuals. In this subgroup, relative risks were 0.72 (0.59–0.88) for AMI, 0.77 (0.59–0.99) for stroke, and 0.73 (0.45–1.19) for pulmonary embolism in the period 1–14 days following vaccination when compared to the background period. These associations remained essentially the same up to 180 days after vaccination. In contrast, the corresponding relative risks among subjects not using medications were 4.19 (2.69–6.52), 1.73 (0.91–3.31) and 2.35 (0.78–7.06). Conclusion In this nationwide study, influenza vaccination was associated with overall cardiovascular benefit. This benefit was concentrated among those at higher cardiovascular risk as defined by medication use. In contrast, our results demonstrate no comparable inverse association with thrombosis-related cardiovascular events following vaccination among those free of cardiovascular medications at baseline. These results may inform the risk–benefit balance for universal influenza vaccination.

Retrospective Case Series Study of Hypomethylating Therapy in IPSS Lower-Risk Myelodysplastic Syndrome

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1992-1992
Author(s):  
Han-Seung Park ◽  
Je-Hwan Lee ◽  
Yoo-Jin Kim ◽  
Sang Kyun Sohn ◽  
Sung-Soo Yoon ◽  
...  
Keyword(s):  
High Risk ◽  
Survival Data ◽  
Lower Risk ◽  
Conflicts Of Interest ◽  
Case Series ◽  
Retrospective Case ◽  
Retrospective Case Series ◽  
Case Series Study ◽  
Prognostic Indices ◽  
Series Study

Abstract Introduction: The IPSS has been widely used for risk stratification in myelodysplastic syndromes (MDS), and patients with IPSS low and intermediate-1 scores are designated as having lower-risk (LR) MDS. Despite its utility, the outcomes of patients with LR disease defined by IPSS are variable and a subset of patients experience inferior than expected outcomes. Treatment with hypomethylating agents is the standard of care in higher-risk MDS, but there have been little data for hypomethylating therapy in LR MDS. We retrospectively collected and analyzed the data related to hypomethylating therapy in IPSS LR MDS from 12 Korean institutes. Patients and Methods: A total of 610 patients, who were treated with azacitidine or decitabine for IPSS LR MDS, were included in this retrospective case series study. All patients received azacitidine (7-day) or decitabine (5-day). Both regimens were repeated every 4 weeks. The overall response rate (ORR) included rates for complete response (CR), partial response (PR), marrow CR (mCR), and stable disease (SD) with hematologic improvements (HI). For 139 patients who underwent allogeneic hematopoietic cell transplantation (HCT), all survival data were censored at the time of HCT. Results: Median age was 63 (19-84) years. IPSS category was low in 44 and intermediate-1 in 566. The patients were reclassified with other scoring systems including revised IPSS (R-IPSS), WPSS, and LR-PSS, and between 21.8% and 37.7% of patients were identified as having high or very high risk features by the other prognostic indices. Patients received azacitidine (n=436) or decitabine (n=174) for a median of 5 (1-46) courses. ORR was 51.3% (CR 78, PR 12, mCR with HI 27, mCR without HI 20, and SD with HI 176). 294 patients (48.2%) showed any HI. Median OS was 2.35 years and patients with HI had significantly longer OS than those without HI (P=0.001). Our case series patients were well stratified in terms of OS by R-IPSS (P=0.001), WPSS (P<0.001), and LR-PSS (P<0.001). Conclusion: IPSS LR MDS included a broad range of prognostic implications. Hypomethylating therapy brought varying degrees of response in about half of the patients with IPSS LR MDS. The patients who had high risk features with other prognostic indices showed poor OS and allogeneic HCT should be considered during the course of hypomethylating therapy in these patients. Disclosures No relevant conflicts of interest to declare.

scholarly journals Risk of Immune Thrombocytopenia Induced By Influenza Vaccine. a Nationwide Population-Based Study in France

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1086-1086
Author(s):  
Margaux Lafaurie ◽  
Bérangère Baricault ◽  
Maryse Lapeyre-Mestre ◽  
Laurent Sailler ◽  
Agnès Sommet ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Research Funding ◽  
Case Series ◽  
Population Based ◽  
Case Control ◽  
Population Based Study ◽  
Case Series Study ◽  
Increased Risk ◽  
Series Study

Introduction: Epidemiological studies suggest a risk of immune thrombocytopenia (ITP) following viral infections, particularly influenza. Conversely, an increased risk of ITP following vaccination has been proven for some vaccines like Measles-Mumps-Rubella vaccine. However, the risk of ITP induced by influenza vaccine is debated. Two case-controls studies has been conducted, with contradictory results: in the Berlin Case-Control Surveillance Study, an increased risk has been found (odds ratio - OR: 3.8 [95% confidence interval - CI: 1.5- 9.1]. Conversely, the French PGRx study suggested the absence of risk of ITP after influenza vaccination [OR: 0.9; 95% CI: 0.4-2.1]. These studies were limited by the number of ITP patients included (169 and 198, respectively) and other limitations. Therefore, we aimed to assess the risk of ITP induced by influenza vaccine in a nationwide cohort in France. Methods: We conducted a population-based study in France within the FAITH cohort (NCT03429660). This cohort is built within the National Health Database that links sociodemographic, hospital and out-hospital data. The FAITH cohort includes all adult patients with incident ITP in France since 2009. Patients are identified using a validated algorithm combining diagnosis codes and drug exposures (with very high positive predictive values). We included in the present study all patients with incident primary ITP aged ≥65 years at ITP diagnosis (indication of influenza vaccination in the general population in France) between July 2009 and June 2015. We assessed the link between influenza vaccine and ITP onset using two designs: a case-control and a self-controlled case series designs. In the case-control design, ITP cases were matched with four controls from the general population for age, sex and place of residency. Index dates for controls were similar to index dates of their matched cases. Cases and controls were compared for exposure to influenza vaccine in the 6 weeks before the index date using conditional logistic regression models adjusted for exposure to other drugs known as inducers of ITP. In the self-controlled case series study, only vaccinated ITP cases were included. The analysis compared the incidence of ITP within periods of risk (6 weeks following vaccination) to the incidence of ITP within other periods of time. We further excluded the 2 weeks prior to vaccine dispensing from the analysis to address selective survival bias (healthy vaccinee effect). Incidence rate ratios (IRRs) adjusted for seasonality were calculated. Results: We included 3,142 incident primary ITP patients aged ≥65 years matched with 12,528 controls in the case-control study. Overall, 147 cases (4.7%) and 579 controls (4.6%) were vaccinated with influenza vaccine during the 6 weeks prior to the index date (adjusted OR: 0.99; 95% CI: 0.80-1.23]). In the self-controlled case series study, 1,875 vaccinated ITP cases were included. Among them, 146 (7.8%) patients were diagnosed for ITP during one of the risk periods following vaccination. The adjusted IRR was 0.96 [95 CI%: 0.80-1.17]. Conclusion: This nationwide population-based study using two different designs showed no increased risk of ITP after influenza vaccination. Disclosures Moulis: Novartis pharma: Research Funding, Speakers Bureau; Amgen pharma: Research Funding, Speakers Bureau; CSL Behring: Research Funding.

scholarly journals Cardiovascular and metabolic risk of antipsychotics in children and young adults: a multinational self-controlled case series study

2021 ◽  
Vol 30 ◽  
Author(s):  
Kenneth K. C. Man ◽  
Shih-Chieh Shao ◽  
Yu-Chuan Chang ◽  
Mei-Hung Chi ◽  
Han Eol Jeong ◽  
...  
Keyword(s):  
Young Adults ◽  
Cardiovascular Events ◽  
Case Series ◽  
Real World Evidence ◽  
Case Series Study ◽  
Increased Risk ◽  
Children And Young Adults ◽  
Exposure Windows ◽  
The Uk

Abstract Aims The risk of antipsychotic-associated cardiovascular and metabolic events may differ among countries, and limited real-world evidence has been available comparing the corresponding risks among children and young adults. We, therefore, evaluated the risks of cardiovascular and metabolic events in children and young adults receiving antipsychotics. Methods We conducted a multinational self-controlled case series (SCCS) study and included patients aged 6–30 years old who had both exposure to antipsychotics and study outcomes from four nationwide databases of Taiwan (2004–2012), Korea (2010–2016), Hong Kong (2001–2014) and the UK (1997–2016) that covers a total of approximately 100 million individuals. We investigated three antipsychotics exposure windows (i.e., 90 days pre-exposure, 1–30 days, 30–90 days and 90 + days of exposure). The outcomes were cardiovascular events (stroke, ischaemic heart disease and acute myocardial infarction), or metabolic events (hypertension, type 2 diabetes mellitus and dyslipidaemia). Results We included a total of 48 515 individuals in the SCCS analysis. We found an increased risk of metabolic events only in the risk window with more than 90-day exposure, with a pooled IRR of 1.29 (95% CI 1.20–1.38). The pooled IRR was 0.98 (0.90–1.06) for 1–30 days and 0.88 (0.76–1.02) for 31–90 days. We found no association in any exposure window for cardiovascular events. The pooled IRR was 1.86 (0.74–4.64) for 1–30 days, 1.35 (0.74–2.47) for 31–90 days and 1.29 (0.98–1.70) for 90 + days. Conclusions Long-term exposure to antipsychotics was associated with an increased risk of metabolic events but did not trigger cardiovascular events in children and young adults.

scholarly journals Influenza vaccination and risk of stroke: Self-controlled case-series study

Vaccine ◽  
2015 ◽  
Vol 33 (41) ◽  
pp. 5458-5463 ◽  
Author(s):  
Zahid Asghar ◽  
Carol Coupland ◽  
Niroshan Siriwardena
Keyword(s):  
Influenza Vaccination ◽  
Case Series ◽  
Case Series Study ◽  
Series Study

Risk of arterial cardiovascular events in patients after pulmonary embolism

Blood ◽  
2009 ◽  
Vol 114 (8) ◽  
pp. 1484-1488 ◽  
Author(s):  
Frederikus A. Klok ◽  
Inge C.M. Mos ◽  
Lisette Broek ◽  
Jouke T. Tamsma ◽  
Frits R. Rosendaal ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thrombosis ◽  
Vitamin K ◽  
Cardiovascular Events ◽  
Vitamin K Antagonists ◽  
Baseline Risk ◽  
Start Date ◽  
Risk Characteristics ◽  
The Moment ◽  
And Control

Abstract Studies have reported inconsistent evidence for an association between venous thrombosis and arterial cardiovascular events. We further studied the association between both diseases by comparing the occurrence of cardiovascular events in patients diagnosed with acute pulmonary embolism (PE) contrasted to patients with comparable baseline risk characteristics (patients in whom PE was clinically suspected but ruled out). Included were 259 patients with provoked PE, 95 patients with unprovoked PE, and 334 control patients without PE. Patients diagnosed with PE were treated with vitamin K antagonists for 6 months. Median follow-up was 4.2 years. Sixty-three arterial cardiovascular events were registered (incidence, 5.1/100 patient-years). Adjusted hazard ratio was not different between patients with all-cause PE and control patients (1.39, 95% confidence interval [CI], 0.83-2.3) but increased for patients with unprovoked PE versus both patients with provoked PE and control patients without PE (2.18; 95% CI, 1.1-4.5; and 2.62; 95% CI, 1.4-4.9, respectively). This effect was confirmed after redefining the study start date to the moment the vitamin K antagonists were discontinued. Our study underlines the association between unprovoked venous thrombosis and arterial cardiovascular events; however, risk differences between patients with provoked PE and patients in whom PE was clinically suspected but ruled out could not be demonstrated.

Benefits of hypomethylating therapy in IPSS lower-risk myelodysplastic syndrome patients: A retrospective multicenter case series study

2017 ◽  
Vol 60 ◽  
pp. 135-144 ◽  
Author(s):  
Je-Hwan Lee ◽  
Yoo-Jin Kim ◽  
Sang Kyun Sohn ◽  
Sung-Soo Yoon ◽  
Hawk Kim ◽  
...  
Keyword(s):  
Myelodysplastic Syndrome ◽  
Lower Risk ◽  
Case Series ◽  
Case Series Study ◽  
Series Study
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