scholarly journals Use of the Bacterial Lysate OM-85 in the Paediatric Population in Italy: A Retrospective Cohort Study

2021 ◽  
Vol 18 (13) ◽  
pp. 6871
Author(s):  
Anna Cantarutti ◽  
Elisa Barbieri ◽  
Antonio Scamarcia ◽  
Luigi Cantarutti ◽  
Cristina Canova ◽  
...  
Keyword(s):  
General Practice Research Database ◽  
Paediatric Population ◽  
Practice Research ◽  
Research Database ◽  
Bacterial Lysate ◽  
One Year ◽  
Tract Infections ◽  
The Impact ◽  
Post Period

Background: In Italy, the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®) is registered for the prophylaxis of recurrent respiratory tract infections (RTIs) in adults and children above one year of age, but there are limited data on its use in the paediatric population. We aim to estimate the impact of OM-85 treatment on RTIs and antibiotic prescriptions in children. Methods: This study included children aged 1 to 14 years enrolled in Pedianet, a paediatric general practice research database, from January 2007 to June 2017, having at least one prescription of OM-85. Children with less than 12 months of follow-up before (PRE period) and after (POST period) the OM-85 prescription were excluded. The frequency of antibiotic prescriptions and the frequency of RTI episodes in the PRE and POST periods were compared through the post-hoc test. Subgroup analysis was performed in children with recurrent RTIs. Results: 1091 children received 1382 OM-85 prescriptions for a total follow-up of 619,525.5 person-years. Overall, antibiotic prescriptions decreased from a mean of 2.8 (SD (standard deviation) 2.7) prescriptions in the PRE period to a mean of 2.2 (SD 2.6) prescriptions in the POST period (p < 0.0001). RTIs decreased from a mean of 3.4 (SD 2.9) episodes in the PRE period to a mean of 2.5 (SD 2.6) episodes in the POST period (p < 0.0001). No change in antibiotic class was noted, and co-amoxiclav remained the preferred therapy in 28% of cases, followed by amoxicillin. These results were confirmed among children with recurrent RTIs. Conclusions: OM-85 is effective in preventing both antibiotic prescriptions and RTIs in children.

Incidence of Vascular Outcomes in Patients with Atrial Fibrillation,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4223-4223
Author(s):  
Arlene M Gallagher ◽  
Tarita Murray-Thomas ◽  
Andreas Clemens ◽  
Ackermann Diana ◽  
Dorothee B Bartels
Keyword(s):  
Atrial Fibrillation ◽  
Cohort Study ◽  
Vitamin K Antagonists ◽  
General Practice Research Database ◽  
Practice Research ◽  
Admission Diagnosis ◽  
Research Database ◽  
Vascular Events ◽  
Chads2 Score

Abstract Abstract 4223 Objective: To describe the characteristics of patients with recently diagnosed atrial fibrillation (AF) and to estimate the incidence of vascular outcomes in patients with AF. Methods: A cohort study in newly diagnosed AF patients (2005–2010) without heart valve replacement/problems was performed in the General Practice Research Database (GPRD), UK. Linked data to the Hospital Episode Statistics (HES) and death certificates from the Office of National Surveillance (ONS) were included. Current vitamin K antagonists (VKA) treatment was defined as a valid prescription/INR measurement during the last 28 days, recent as a treatment period from 28 to 90 days after the last prescription/INR measurement, and past treatment as more than 90 days after last treatment/INR measurement. No treatment was the time between diagnosis of AF and first prescription/INR measurement, or the whole follow-up for patients that have never been treated. Vascular outcomes – first ever recorded – were assessed as primary hospital admission diagnosis recorded in HES, i.e. myocardial infarction (MI), stroke, and systemic peripheral arterial embolism (SPAE). Results: Data from 16,513 AF patients could be linked; 48% were female, the mean age (std) was 74 (12) years, the median duration of follow-up was 1.7 years (range 0–5). According to CHADS2 score 21% were at low risk, 65% at moderate and 14% at high risk for stroke. Overall 55.8% of the patients had at least one period of VKA use. Overall, 1,151 vascular events were recorded (403 MIs, 716 strokes, 68 SPAE). The incidence (per 100 patient years (95% CIs)) of vascular events was 3.8 (3.5 – 4.0), 1.3 (1.2 – 1.4) for MI, 2.3 (2.1 – 2.5) for stroke and 0.2 (0.2 – 0.3) for SPAE. Stratification by period of VKA use resulted in incidences for current, recent, past and non users for MI of 0.7 (0.6 – 0.9), 0.7 (0.4 – 1.2), 1.1 (0.8 – 1.5), 1.9 (1.7 – 2.1), for stroke of 0.9 (0.8 – 1.1), 2.2 (1.6 – 2.9), 2.4 (1.9 – 2.9), 3.4 (3.1 – 3.7), and for SPAE of 0.2 (0.2 – 0.3), 0.2 (0.1 – 0.3), 0.3 (0.1 – 0.6), 0.2 (0.1 – 0.3), 0.2 (0.2 – 0.3). Conclusion: In this cohort study, a trend towards lower incidences of vascular events, specifically stroke and MI, was detected during VKA use compared to past/no use. No causal conclusions can be drawn from these crude incidence estimates, but the trends are in line with the clinical expectations of anticoagulation in AF patients. Disclosures: Clemens: Boehringer Ingelheim Pharma GmbH & Co. KG: Employment. Diana:Boehringer Ingelheim GmbH: Employment. Bartels:Boehringer Ingelheim GmbH: Employment.

Thromboembolic Events among Adult Patients with Idiopathic Thrombocytopenic Purpura in the United Kingdom General Practice Research Database.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3401-3401
Author(s):  
Ameet Sarpatwari ◽  
Dimitri Bennett ◽  
John W Logie ◽  
Amit Shukla ◽  
Kathleen J Beach ◽  
...  
Keyword(s):  
General Practice ◽  
United Kingdom ◽  
General Practice Research Database ◽  
Adult Patients ◽  
Practice Research ◽  
Research Database ◽  
Thromboembolic Events ◽  
Thrombocytopenic Purpura ◽  
The United Kingdom

Abstract Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease characterised by elevated peripheral platelet destruction and inadequate platelet production. Little published epidemiological data exists concerning the risk of thromboembolic events (TE) among adult patients with ITP. The objective of our investigation was to estimate the risk of TE among adult patients with and without ITP in the United Kingdom (UK) General Practice Research Database (GPRD), which contains patient data from 6.4 million patients from more than 480 representative medical practices across the UK. Using read [2871C] or Oxford Medical Information System (OXMIS) [D3130000, D313012, 42P2.11, D313.12] codes to define cases, incidence rates (IRs) per 10,000 patient-years of observation (PYO) with 95% confidence intervals (CIs) were estimated. Hazard ratios (HRs) of venous, arterial, and combined (venous and arterial) TE were modelled using Cox proportional hazards regression adjusting for history of prior TE, hypertension, splenectomy status, oral corticosteroids and intravenous immunoglobulin exposure. 840 adults (≥ 18 years) with codes for ITP first referenced between January 1, 1992 and September 30, 2005 and having at least one year pre-diagnosis and three months of post-diagnosis medical history were matched with 3,360 non-ITP patients by age, gender, primary care practice and pre-study follow-up time. Over a median 52 months of follow-up (range: 3–182 months), the cumulative incidence of TE among thromboembolic-free patients at baseline was higher within the ITP cohort [47 (6.7%) v. 172 (5.7%)]. As shown in the table below, the IRs of venous, arterial, and combined TE were additionally elevated among patients with ITP. Outcome Incidence Rate/10,000 PYO 95% CI Adult Patients with ITP Adult Patients without ITP Venous TE 70.83 (46.67–103.05) 47.53 (37.39–59.58) Arterial TE 82.02 (55.73–116.42) 71.50 (58.87–86.04) Combined TE 134.74 (99–179.18) 116.32 (99.59–135.06) Adjusted HRs of 1.58 (95% CI, 0.98–2.53), 1.02 (95% CI, 0.65–1.59), and 1.17 (95% CI, 0.82–1.66) were found for venous, arterial, and combined TE respectively. Further event categorisation revealed elevated HRs for each venous thromboembolic subtype [deep vein thrombosis 1.49 (95% CI, 0.62–3.61), pulmonary embolism 3.52 (95% CI, 1.23–10.04), and other TE 1.17 (95% CI, 0.64– 2.16)]. This study provides evidence of an increased risk in venous TE in adult patients with ITP relative to the general adult non-ITP population.

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