Epidemiology of first and recurrent venous thromboembolism in patients with active cancer

2017 ◽  
Vol 117 (01) ◽  
pp. 57-65 ◽  
Author(s):  
Anja Katholing ◽  
Stephan Rietbrock ◽  
Luke Bamber ◽  
Carlos Martinez ◽  
Alexander T. Cohen
Keyword(s):  
Venous Thromboembolism ◽  
Confidence Interval ◽  
Incidence Rate ◽  
Incidence Rates ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Source Population ◽  
Recurrence Rates ◽  
Recurrent Vte ◽  
Active Cancer

SummaryPopulation studies on the incidence of venous thromboembolism (VTE) in patients with active cancer are limited. An observational cohort study was undertaken to estimate the incidence of first and recurrent VTE. The source population consisted of all patients in the UK Clinical Practice Research Datalink, with additional information on hospitalisation and cause of death, between 2001 and 2011. A cancer-related clinical diagnosis or therapy within the 90 days before or after a VTE constituted an active-cancer-associated VTE. Incidence rates of first VTE among patients with active cancer and incidence rates of recurrent VTE during the 10-year observational period after a first VTE event were estimated. Incidence rates of all-cause mortality and age- and gender-specific mortality were also calculated. There were 6,592 active-cancer-associated VTEs with a total of 112,738 cancer-associated person-years of observation. The incidence rate of first VTE in patients with active cancer was 5.8 (95 % confidence interval 5.7–6.0) per 100 person-years. A first VTE recurrence was observed in 591 patients. The overall incidence rate for recurrence was 9.6 (95 % confidence interval 8.8–10.4) per 100 person-years, with a peak at 22.1 in the first six months. Recurrence rates were similar after initial pulmonary embolism and after initial deep-vein thrombosis. The mortality risk after VTE was considerable, with 64.5 % mortality after one year and 88.1 % after 10 years. VTE in patients with active cancer is common and associated with high recurrence and mortality rates. Efforts are needed to prevent VTE and reduce recurrence, especially in the first year after VTE diagnosis.Supplementary Material to this article is available online at www.thrombosis-online.com.

Epidemiology of first and recurrent venous thromboembolism: A population-based cohort study in patients without active cancer

2014 ◽  
Vol 112 (08) ◽  
pp. 255-263 ◽  
Author(s):  
Alexander T. Cohen ◽  
Luke Bamber ◽  
Stephan Rietbrock ◽  
Carlos Martinez
Keyword(s):  
Cohort Study ◽  
Venous Thromboembolism ◽  
The Elderly ◽  
Population Based ◽  
Incidence Rates ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Recurrence Rates ◽  
Recurrent Vte ◽  
Active Cancer

SummaryContemporary data from population studies on the incidence and complications of venous thromboembolism (VTE) are limited. An observational cohort study was undertaken to estimate the incidence of first and recurrent VTE. The cohort was identified from all patients in the UK Clinical Practice Research Datalink (CPRD) with additional linked information on hospitalisation and cause of death. Between 2001 and 2011, patients with first VTE were identified and the subset without active cancer-related VTE observed for up to 10 years for recurrent VTE. The 10-year cumulative incidence rates (CIR) were derived with adjustment for mortality as a competing risk event. A total of 35,373 first VTE events (12,073 provoked, 16,708 unprovoked and 6592 active cancer-associated VTE) among 26.9 million person-years of observation were identified. The overall incidence rate (IR) of VTE was 131.5 (95% CI, 130.2–132.9) per 100,000 person-years and 107.0 (95% CI, 105.8–108.2) after excluding cancer-associated VTE. DVT was more common in the young and PE was more common in the elderly. VTE recurrence occurred in 3671 (CIR 25.2%). The IR for recurrence peaked in the first six months at around 11 per 100 person years. It levelled out after three years and then remained at around 2 per 100 person years from year 4–10 of follow-up. The IRs for recurrences were particularly high in young men. In conclusion, VTE is common and associated with high recurrence rates. Effort is required to prevent VTE and to reduce recurrences.

scholarly journals Adverse effects of Z-drugs for sleep disturbance in people living with dementia: a population-based cohort study

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Kathryn Richardson ◽  
Yoon K. Loke ◽  
Chris Fox ◽  
Ian Maidment ◽  
Robert Howard ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Adverse Events ◽  
Confidence Interval ◽  
Ischaemic Stroke ◽  
Sleep Disturbance ◽  
Cox Regression ◽  
Population Based ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Health Related

Abstract Background Sleep disturbance is common in dementia and often treated with Z-drugs (zopiclone, zaleplon, and zolpidem). While some observational studies suggest that Z-drugs are associated with adverse events such as falls and fracture risks in older people, this has not been studied in dementia. Methods We used data from 27,090 patients diagnosed with dementia between January 2000 and March 2016 from the Clinical Practice Research Datalink linked to Hospital Episodes Statistics data in England. We compared adverse events for 3532 patients newly prescribed Z-drugs by time-varying dosage to (1) 1833 non-sedative-users with sleep disturbance; (2) 10,214 non-sedative-users with proximal GP consultation matched on age, sex, and antipsychotic use; and (3) 5172 patients newly prescribed benzodiazepines. We defined higher dose Z-drugs and benzodiazepines as prescriptions equivalent to ≥ 7.5 mg zopiclone or > 5 mg diazepam daily. Cox regression was used to estimate hazard ratios (HRs) for incident fracture, hip fracture, fall, mortality, acute bacterial infection, ischaemic stroke/transient ischaemic attack, and venous thromboembolism over a 2-year follow-up, adjusted for demographic- and health-related covariates. Results The mean (SD) age of patients was 83 (7.7) years, and 16,802 (62%) were women. Of 3532 patients prescribed Z-drugs, 584 (17%) were initiated at higher doses. For patients prescribed higher dose Z-drugs relative to non-users with sleep disturbance, the HRs (95% confidence interval) for fractures, hip fractures, falls, and ischaemic stroke were 1.67 (1.13–2.46), 1.96 (1.16–3.31), 1.33 (1.06–1.66), and 1.88 (1.14–3.10), respectively. We observed similar associations when compared to non-sedative-users with proximal GP consultation. Minimal or inconsistent excess risks were observed at ≤ 3.75 mg zopiclone or equivalent daily, and for mortality, infection, and venous thromboembolism. We observed no differences in adverse events for Z-drugs compared to benzodiazepines, except lower mortality rates with Z-drugs (HR [95% confidence interval] of 0.73 [0.64–0.83]). Conclusions Higher dose Z-drug use in dementia is associated with increased fracture and stroke risks, similar or greater to that for higher dose benzodiazepines. Higher dose Z-drugs should be avoided, if possible, in people living with dementia, and non-pharmacological alternatives preferentially considered. Prescriptions for higher dose Z-drugs in dementia should be regularly reviewed. Trial registration ENCePP e-register of studies, EUPAS18006

Subgroup Analysis of Patients with Cancer in Xalia - a Non-Interventional Study of Rivaroxaban in Routine Treatment of Deep Vein Thrombosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1438-1438 ◽  
Author(s):  
Alexander G G Turpie ◽  
Lorenzo G Mantovani ◽  
Sylvia Haas ◽  
Reinhold Kreutz ◽  
Danja Monje ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Research Funding ◽  
Incidence Rates ◽  
Vein Thrombosis ◽  
All Cause Mortality ◽  
Recurrent Vte ◽  
Deep Vein ◽  
Active Cancer

Abstract Background: XALIA is a prospective, non-interventional study of rivaroxaban in the treatment of acute deep vein thrombosis. The overall XALIA results showed that rivaroxaban was associated with similarly low rates of major bleeding and symptomatic recurrent venous thromboembolism (VTE) as standard anticoagulation. A subset of patients in XALIA had active cancer at the time of enrolment into the study. Purpose: To describe the demographics, clinical characteristics, treatment strategies and outcomes of patients in XALIA with cancer and VTE. The primary outcomes were major bleeding, recurrent VTE and all-cause mortality. Methods: Patients with deep vein thrombosis with or without concomitant pulmonary embolism aged ≥18 years who had active cancer and were scheduled to receive ≥3 months of anticoagulation with rivaroxaban or standard therapy were eligible. Therapy type, dose and duration were at the physician's discretion. For the purpose of this substudy, we defined the following treatment cohorts: rivaroxaban cohort (patients treated with rivaroxaban alone or who received heparin/fondaparinux for ≤48 hours before switching to rivaroxaban); early switchers cohort (patients treated with rivaroxaban who received heparin/fondaparinux for >48 hours-14 days and/or a vitamin K antagonist [VKA] for 1-14 days before changing to rivaroxaban); standard anticoagulation cohort (patients treated with heparin/fondaparinux and a VKA or a VKA only); and heparin/fondaparinux cohort (patients treated with heparin/fondaparinux alone). Results: Of 5136 patients in XALIA who received study medication, 587 (11.4%) had active cancer at baseline. Of these, 146 (24.9%) received rivaroxaban, 30 (5.1%) were early switchers, 167 (28.4%) received standard anticoagulation (of which 26 [4.4%] received a VKA only) and 244 (41.6%) received heparin/fondaparinux only, of whom 223 (38.0%) received low molecular weight heparin and the remainder other heparins or fondaparinux. Demographics are shown in Table 1. The most common type of active cancer at baseline in all cohorts was genitourinary, with the exception of the heparin/fondaparinux cohort where gastrointestinal cancer was the most common type (Table 2). The incidence rates for the primary outcomes for each cohort are shown in Figure 1. The rates of major bleeding were highest in the standard anticoagulation cohort (n=8 [4.8%]) and lowest in the early switchers (no major bleeding events occurred). The rates of recurrent VTE were similar in the in the rivaroxaban, early switcher and standard anticoagulation cohorts (n=5 [3.4%], n=1 [3.3%] and n=6 [3.6%], respectively) and were highest in the heparin/fondaparinux cohort (n=12 [4.9%]). All-cause mortality was highest in the heparin/fondaparinux cohort (n=61 [25.0%]) and lowest in the early switchers (no deaths occurred). Conclusions: In the real-world XALIA study, 38.0% of patients with cancer received treatment with low molecular weight heparin, which was in line with guidelines. The remaining patients received rivaroxaban, standard anticoagulation or were early switchers. For the three primary outcomes, the lowest incidence rates were observed in the early switcher cohort. The highest rates were in the standard anticoagulation cohort for major bleeding and the heparin/fondaparinux cohort for recurrent VTE and all-cause mortality; rates for all three primary outcomes were low in the rivaroxaban cohort, suggesting that rivaroxaban may be a safe and effective treatment option for patients with VTE and active cancer. Figure 1 Primary outcomes in patients with active cancer at baseline by treatment group. VTE, venous thromboembolism. Figure 1. Primary outcomes in patients with active cancer at baseline by treatment group. / VTE, venous thromboembolism. Disclosures Turpie: Janssen Research & Development, LLC: Consultancy, Honoraria; Bayer Pharma AG: Consultancy, Honoraria. Mantovani:Janssen-Cilag Ltd: Research Funding; Boehringer Ingelheim: Research Funding; Daiichi Sankyo: Consultancy; Bayer Pharma AG: Consultancy; Pfizer Inc: Research Funding. Haas:Sanofi SA: Consultancy; Pfizer Inc: Consultancy; Daiichi Sankyo: Consultancy; Bristol-Myers Squibb: Consultancy; Bayer Pharma AG: Consultancy; Aspen Pharmacare: Consultancy. Kreutz:Bayer Pharma AG: Honoraria; Servier Laboratories Ltd: Consultancy; Lundbeck Ltd: Consultancy; Daiichi Sankyo: Consultancy; Berlin-Chemie Menarini: Consultancy; Bayer Pharma AG: Consultancy; Bristol-Myers Squibb: Honoraria; Daiichi Sankyo: Honoraria. Monje:Bayer Pharma AG: Employment. Schneider:Bayer Pharma AG: Employment. van Eickels:Bayer Pharma AG: Employment. Gebel:Bayer Pharma AG: Employment. Ageno:Boehringer Ingelheim: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Bayer Pharmaceuticals: Research Funding; Daiichi Sankyo: Consultancy, Honoraria; Bayer Pharma AG: Consultancy, Honoraria.

Contemporary Estimates of the Incidence of Venous Thromboembolism: A Population-Based Cohort Study

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1143-1143
Author(s):  
Vicky Tagalakis ◽  
Valerie Patenaude ◽  
Susan R. Kahn ◽  
Samy Suissa
Keyword(s):  
Venous Thromboembolism ◽  
General Population ◽  
Incidence Rate ◽  
Conflicts Of Interest ◽  
Public Health Problem ◽  
Incidence Rates ◽  
Future Research ◽  
Public Healthcare ◽  
Source Population

Abstract Abstract 1143 Background: Venous thromboembolism (VTE) is a growing public health problem due largely to the aging population and the increasing prevalence of known risk factors such as surgery and cancer-related treatments. As a result, the true burden of VTE is not fully known and more contemporary estimates of incidence are needed. Objectives: We estimated the incidence of a first VTE event in a general population. Methods: This retrospective, observational study used the linked administrative healthcare databases of the province of Québec, Canada, including the province-wide hospitalization database (MED-ÉCHO) and the healthcare services database of RAMQ which oversees all physician reimbursement claims for services provided to Québec residents. From a source population of all RAMQ beneficiaries with a physician visit or a hospitalization associated with an ICD-9-CM or ICD-10-CA diagnosis code for deep vein thrombosis (DVT) or pulmonary embolism (PE) recorded between January 1, 2000 and December 31, 2009 and without a DVT or PE code prior to January 1, 2000, we identified a cohort of Québec residents with definite incident VTE and a cohort with definite or probable incident VTE. We used a priori determined diagnostic algorithms using RAMQ and MED-ÉCHO data to identify definite and probable cases of VTE. Subjects were followed forward in time from first-time VTE occurrence until the earliest of either death or end of study period (December 31, 2009). Incidence rates of first VTE, DVT alone, and PE with or without DVT were calculated by dividing the number of new cases by the total person-years at risk in the population of Québec residents eligible for RAMQ between 2000 and 2009. Age-specific incidence rates and associated 95% confidence intervals (CI) were calculated using achieved age during follow-up, and as a result patients contributed person-time in different age categories while aging during follow-up. Crude and age-adjusted incidence rate ratios (IRR) were reported comparing rates among women and men. Results: From the 245 452 Québec residents between 2000 and 2009 with at least 1 VTE diagnosis in RAMQ or MED-ÉCHO (source population), we identified 67 410 cases with definite VTE and 35 123 cases with probable VTE. The incidence rate of definite VTE was 0.91 per 1000 person-years (95% CI: 0.90–0.91). For DVT alone, the incidence was 0.53 per 1000 person-years (95% CI: 0.52–0.52) and for PE with or without DVT it was 0.38 per 1000 person-years (95% CI: 0.38–0.38). The incidence rates increased with age, and rates in patients 70 years of age and older were more than 4 times higher than rates in patients who were 40–69 years of age (Table 1). The VTE incidence rate was 0.99 per 1000 person-years (95% CI: 0.98–1.00) in women as compared to 0.82 per 1000 person-years (95% CI: 0.81–0.83) in men. The IRR was 1.19 (95% CI: 1.17–1.22) but this sex difference was no longer seen when adjusted for age (IRR 0.98; 95% CI: 0.96–1.01). The corresponding VTE, DVT alone, and PE incidence rates per 1000 person-years for definite or probable VTE were 1.24 (95% CI: 1.23–1.24), 0.79 (95% CI: 0.78–0.79), and 0.45 (95% CI: 0.45–0.46), respectively. Conclusion: Our study provides real-world contemporary estimates of VTE incidence. The risk in the general population is about 0.9 to 1.2 per 1000 person-years and is highest in the elderly. These data may help inform public healthcare planning and future research. Disclosures: No relevant conflicts of interest to declare.

Variation in the Association between Antineoplastic Therapies and Venous Thromboembolism in Patients with Active Cancer

2020 ◽  
Vol 120 (05) ◽  
pp. 847-856 ◽  
Author(s):  
Michela Giustozzi ◽  
Antonio Curcio ◽  
Bob Weijs ◽  
Thalia S. Field ◽  
Saulius Sudikas ◽  
...  
Keyword(s):  
Risk Factors ◽  
Radiation Therapy ◽  
Venous Thromboembolism ◽  
Cause Of Death ◽  
Cancer Diagnosis ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Cancer Type ◽  
Increased Risk ◽  
Active Cancer

Abstract Background Venous thromboembolism (VTE) is a major cause of death in cancer patients. Although patients with cancer have numerous risk factors for VTE, the relative contribution of cancer treatments is unclear. Objective The objective of this study is to evaluate the association between cancer therapies and the risk of VTE. Methods From UK Clinical Practice Research Datalink, data on patients with first cancer diagnosis between 2008 and 2016 were extracted along with information on hospitalization, treatments, and cause of death. Primary outcome was active cancer-associated VTE. To establish the independent effects of risk factors, adjusted subhazard ratios (adj-SHR) were calculated using Fine and Gray regression analysis accounting for death as competing risk. Results Among 67,801 patients with a first cancer diagnosis, active cancer-associated VTE occurred in 1,473 (2.2%). During a median observation time of 1.2 years, chemotherapy, surgery, hormonal therapy, radiation therapy, and immunotherapy were given to 71.1, 37.2, 17.2, 17.5, and 1.4% of patients with VTE, respectively. The active cancers associated with the highest risk of VTE—as assessed by incidence rates—included pancreatic cancer, brain cancer, and metastatic cancer. Chemotherapy was associated with an increased risk of VTE (adj-SHR: 3.17, 95% confidence interval [CI]: 2.76–3.65) while immunotherapy with a not significant reduced risk (adj-SHR: 0.67, 95% CI: 0.30–1.52). There was no association between VTE and radiation therapy (adj-SHR: 0.91, 95% CI: 0.65–1.27) and hormonal therapies. Conclusion VTE risk varies with cancer type. Chemotherapy was associated with an increased VTE risk, whereas with radiation and immunotherapy therapy, an association was not confirmed.

scholarly journals Epidemiology of eating disorders in primary care in children and young people: a Clinical Practice Research Datalink study in England

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e026691
Author(s):  
Sophie Wood ◽  
Amanda Marchant ◽  
Mark Allsopp ◽  
Kathleen Wilkinson ◽  
Jackie Bethel ◽  
...  
Keyword(s):  
Primary Care ◽  
Eating Disorders ◽  
Clinical Practice ◽  
Incidence Rate ◽  
Secondary Care ◽  
Service Use ◽  
Incidence Rates ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Deprived Areas

ObjectivesExamination of current temporal trends and clinical management patterns of eating disorders (ED) in primary care is lacking. We aimed to calculate annual incidence rates of EDs in primary care by age, sex and deprivation. We also explored the care received through referrals, psychotropic prescriptions and associated secondary care service use.Participants and settingsA retrospective electronic cohort study was conducted using the Clinical Practice Research Datalink in those aged 11–24 years between 2004 and 2014 in England (n=1 135 038).ResultsA total of 4775 individuals with a first ever recorded ED diagnosis were identified. The crude incidence rate was 100.1 per 100 000 person years at risk (95% CI 97.2 to 102.9). Incidence rates were highest in females (189.3 per 100 000 person years, 95% CI 183.7 to 195.0, n=4336), 16–20 years of age (141.0 per 100 000 person years, 95% CI 135.4 to 146.9, n=2348) and individuals from the least deprived areas (115.8 per 100 000 person years (95% CI 109.3 to 122.5, n=1203). Incidence rates decreased across the study period (incidence rate ratio (IRR) 0.6, 95% CI 0.5 to 0.8), particularly for individuals with bulimia nervosa (IRR 0.5, 95% CI 0.3 to 0.7) and from the most deprived areas (IRR 0.5, 95% CI 0.4 to 0.7). A total of 17.4% (95% CI 16.3 to 18.5, n=831) of first ever recorded ED cases were referred from primary to secondary care. 27.1% (95% CI 25.9 to 28.4, n=1294) of individuals had an inpatient admission 6 months before or 12 months after an incident ED diagnosis and 53.4% (95% CI 52.0 to 54.9, n=2550) had an outpatient attendance. Antidepressants were the most commonly prescribed psychotropic medication.ConclusionsNew ED presentations in primary care are reducing. Understanding the cause of this decrease (coding behaviours, changes in help-seeking or a genuine reduction in new cases) is important to plan services, allocate resources and deliver effective care.

scholarly journals Minocycline and the risk of acute psychiatric events in adolescence: A self-controlled case series

2019 ◽  
Vol 33 (4) ◽  
pp. 466-471 ◽  
Author(s):  
Ruth Brauer ◽  
Maria Herrero-Zazo ◽  
David J Barlow ◽  
Fiona Gaughran ◽  
David Taylor ◽  
...  
Keyword(s):  
United Kingdom ◽  
Confidence Interval ◽  
Incidence Rate ◽  
Rate Ratio ◽  
Incidence Rate Ratio ◽  
Psychiatric Symptoms ◽  
Case Series ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Psychiatric Referral

Background Minocycline has neurological anti-inflammatory properties and has been hypothesised to have antipsychotic effects. Aim The aim of this study was to investigate, using routinely collected United Kingdom primary health care data, whether adolescent men and women are more or less likely to receive an urgent psychiatric referral during treatment for acne with minocycline compared with periods of non-treatment. Method A self-controlled case series using United Kingdom Clinical Practice Research Datalink to calculate the incidence rate ratio of urgent psychiatric referrals for individuals, comparing periods during which minocycline was prescribed with unexposed periods, adjusted for age. Results We found 167 individuals who were at the time exposed to minocycline for a mean of 99 days and who received an urgent psychiatric referral. There was no difference in psychiatric referral risk during periods of exposure compared with periods of non-exposure: incidence rate ratio first 6 weeks of exposure 1.96, 95% confidence interval 0.82–4.71, p=0.132; incidence rate ratio remaining exposure period=1.97, 95% confidence interval 0.86–4.47, p=0.107. Conclusions We found no evidence in support of a protective effect of minocycline against severe psychiatric symptoms in adolescence.

scholarly journals Opioids and the Risk of Fracture: a Self-Controlled Case Series Study in the Clinical Practice Research Datalink

2021 ◽  
Author(s):  
Emily J Peach ◽  
Fiona A Pearce ◽  
Jack Gibson ◽  
Andrew J Cooper ◽  
Li-Chia Chen ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Incidence Rate ◽  
Rate Ratio ◽  
Incidence Rate Ratio ◽  
Case Series ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Risk Of Fracture ◽  
Adjusted Incidence Rate ◽  
Adjusted Incidence

Abstract Self-controlled study designs can be used to assess the association between exposures and acute outcomes while controlling for important confounders. Using routinely collected health data, a self-controlled case series design was used to investigate the association between opioid use and bone fractures in 2008–2017 among adults registered in the United Kingdom Clinical Practice Research Datalink. The relative incidence of fracture was estimated, comparing periods when exposed and unexposed to opioids, adjusted for time-varying confounders. Of 539,369 people prescribed opioids, 67,622 sustained fractures and were included. The risk of fracture was significantly increased when exposed to opioids, with an adjusted incidence rate ratio of 3.93 (95% confidence interval: 3.82, 4.04). Fracture-risk was greatest in the first week of starting opioids (adjusted incidence rate ratio: 7.81, 95% confidence interval: 7.40, 8.25) and declined with increasing duration of use. Re-starting opioids after a gap in exposure significantly increased fracture-risk (adjusted incidence rate ratio: 5.05, 95% confidence interval: 4.83, 5.29) when compared to non-use. These findings highlight the importance of raising awareness of fractures among patients at opioid initiation and demonstrate the utility of self-controlled methods for pharmacoepidemiologic research.

scholarly journals Safety and Effectiveness of Apixaban, LMWH, and Warfarin Among Venous Thromboembolism Patients with Active Cancer: A Retrospective Analysis Using Four US Claims Databases

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 326-326 ◽  
Author(s):  
Alexander T Cohen ◽  
Allison Keshishian ◽  
Theodore Lee ◽  
Gail Wygant ◽  
Lisa Rosenblatt ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Board Of Directors ◽  
Lower Risk ◽  
Select Committee ◽  
Advisory Committees ◽  
Recurrent Vte ◽  
High Risk Cancer ◽  
Similar Risk ◽  
Active Cancer

BACKGROUND: Venous thromboembolism (VTE) is the second leading cause of death in cancer patients. The treatment of cancer-associated VTE carries a significantly greater risk of major bleeding (MB) and recurrent VTE compared to that in non-cancer patients. CHEST Guidelines suggest the use of low molecular weight heparin (LMWH) over a vitamin K antagonist (VKA) in patients diagnosed with VTE and cancer. The last decade has seen an emergence of non-VKA anticoagulants (NOACs) for the treatment of VTE. Despite completed and ongoing clinical trials, there is a lack of real-world evidence comparing the effectiveness and safety of LWMH with VKAs and NOACs among VTE patients with active cancer. Therefore, this study evaluates the risk of MB, clinically relevant non-MB (CRNMB), and recurrent VTE (fatal or non-fatal) among VTE patients with active cancer prescribed apixaban, LMWH, or warfarin in routine clinical practice. METHODS: Four US commercial insurance claims databases were used to identify VTE patients with active cancer (defined as cancer diagnosis or cancer treatment [chemotherapy, radiation and cancer-related surgery] within 6 months before or 30 days after VTE diagnosis) who initiated apixaban, LMWH, or warfarin within 30-days following the first VTE event (01SEP2014-31MAR2018). Patients who used LMWH as bridging therapy for warfarin (≤14 days before or after warfarin initiation) were classified as warfarin users. Patients were followed to the earliest of: health plan disenrollment, death, index therapy discontinuation, switch to another anticoagulant, study end, or a maximum of 6 months. Additional analysis using all available follow-up was also conducted. Stabilized inverse probability treatment weighting (IPTW) was used to balance treatment cohorts. Cox proportional hazard models were used to evaluate the risk of MB, CRNMB, and recurrent VTE. RESULTS: After applying all eligibility criteria, 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with mean ages of 65, 64, and 64 years, respectively. After IPTW, all patient characteristics were balanced. The mean follow-up was 105, 88, and 113 days for apixaban, LMWH, and warfarin, respectively. Among the weighted VTE cancer population, 51% of the patients had metastatic cancer and 77% of patients received cancer treatment. Further, 15% of patients had very high-risk cancer (brain, stomach, or pancreas), and 40% patients had high-risk cancer (lung, lymphoma, gynecologic, bladder, testicular, renal cell carcinoma). Apixaban patients had a lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH. Apixaban patients also had a lower risk of recurrent VTE and a similar risk of MB and CRNM bleeding compared to warfarin. Warfarin patients had a similar risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH (Figure). When the entire available follow-up period (mean follow-up was 137, 106, and 166 days for apixaban, LMWH, and warfarin, respectively) was used, the trends were similar to the 6-month analysis for apixaban vs. LMWH and warfarin vs. LMWH. However, apixaban patients were associated with a lower risk of both MB and recurrent VTE compared to warfarin patients. CONCLUSION: VTE patients with active cancer initiating apixaban had significantly lower risk of MB, CRNM bleeding, and recurrent VTE compared to LMWH patients. Apixaban patients also had a lower risk of recurrent VTE compared to warfarin patients. These results may be helpful for clinicians in evaluating different anticoagulation treatments for VTE patients with active cancer. Further studies are needed to evaluate these outcomes between different anticoagulation treatment options. Figure Disclosures Cohen: Lifeblood: Other: advisor to Lifeblood: the thrombosis charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism; ONO: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy; TRN: Consultancy; UK Government Health Select Committee: Other: advised the UK Government Health Select Committee, the all-party working group on thrombosis, the Department of Health, and the NHS, on the prevention of VTE; Temasek Capital: Consultancy; ACI Clinical: Consultancy; Navigant: Consultancy; McKinsey: Consultancy; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy; Aspen: Consultancy, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Boston Scientific: Consultancy; Boehringer-Ingelheim: Consultancy, Speakers Bureau; Daiichi-Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL Behring: Consultancy; GlaxoSmithKline: Consultancy, Speakers Bureau; GLG: Consultancy; Guidepoint Global: Consultancy; Johnson and Johnson: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Leo Pharma: Consultancy; Medscape: Consultancy, Speakers Bureau. Keshishian:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Lee:Pfizer Inc.: Employment, Equity Ownership. Wygant:Bristol-Myers Squibb Company: Employment. Rosenblatt:Bristol-Myers Squibb: Other: Stock Owner ; Bristol-Myers Squibb Company: Employment. Hlavacek:Pfizer Inc.: Employment. Mardekian:Pfizer Inc.: Employment. Wiederkehr:Pfizer Inc.: Employment. Sah:STATinMED Research: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company and Pfizer Inc.. Luo:Pfizer Inc.: Employment.

scholarly journals Epidemiology and current treatment patterns of treatment-resistant depression in Scotland: a CPRD study

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S334-S334
Author(s):  
Timothy Ming ◽  
Tom Denee ◽  
Gemma Scott ◽  
Joachim Morrens ◽  
Christopher Weatherburn
Keyword(s):  
Clinical Practice ◽  
Incidence Rates ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Treatment Resistant Depression ◽  
Augmentation Therapy ◽  
Treatment Resistant ◽  
First Line ◽  
Resistant Depression

AimsTo assess the incidence and treatments currently used in clinical practice for the treatment of treatment-resistant depression (TRD) in Scotland.BackgroundPatients with major depressive disorder (MDD) who have not responded to at least two successive antidepressant (AD) treatments in a single episode are described as having Treatment-Resistant Depression (TRD). Epidemiological data on TRD in Scotland is lacking. Furthermore, there is no data to our knowledge on therapies prescribed in Scottish clinical practice to treat TRD.MethodA retrospective, longitudinal cohort study was conducted using Clinical Practice Research Datalink (CPRD) medical records. Adult patients were indexed on AD prescription, requiring MDD diagnosis within 90 days, from Jan 2011-May 2018 with 360-day baseline and 180-day minimum follow-up periods. Failure of ≥2 adequate oral AD regimens following indexing constituted TRD classification. Incidence rates of MDD and TRD (within the MDD cohort) and treatment lines following TRD classification were derived.ResultThe analysis included 20,059 patients with MDD (mean age 44 years, 63% female, median follow-up 59 months); 1,374 (6.8%) were classified as TRD. Median time-to-TRD classification was 25 months. The incidence rate of MDD was 15.9 per 1,000 patient-years and for TRD was 14.7 per 1,000 MDD-patient-years. For all first four post-TRD treatment lines, SSRI monotherapy was the most commonly prescribed therapy, followed by combination (dual/triple) therapy and augmentation therapy (at least one oral AD supplemented with lithium, an antipsychotic or an anticonvulsant therapy). At first-line of TRD treatment, 1,050 (76.4%) patients received monotherapy AD, 212 (15.4%) received combination AD therapy and 112 (8.2%) received augmentation therapy. The most common monotherapy treatments at first-line TRD were sertraline (15.6%), mirtazapine (13.8%), fluoxetine (12.2%) and venlafaxine (11.6%). Among combination therapies, mirtazapine, venlafaxine, sertraline and amitriptyline were frequently used. Among the TRD and MDD cohort, no somatic treatments were coded in CPRD, although the use of these treatments was likely underestimated.ConclusionMonotherapy AD treatment was the most common therapy type for all four post-TRD treatment lines. These data support the need for new treatments that can achieve and maintain therapeutic response, and avoid continuous cycling through similar AD therapies.This study was sponsored by Janssen Cilag Ltd.

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