Association Between Healthy Behaviors and Health Care Resource Use With Subsequent Positive Airway Pressure Therapy Adherence in OSA.

Background: The healthy adherer effect has gained increasing attention as a potential source of bias in observational studies examining the association of positive airway pressure (PAP) adherence with health outcomes in OSA.

Research Question: Is adherence to PAP associated with healthy behaviors and health care resource use prior to device prescription?

Study Design And Methods: Data from the Institut de Recherche en Santé Respiratoire (IRSR) des Pays de la Loire Sleep Cohort were linked to health administrative data to identify proxies of heathy behaviors, including adherence to cardiovascular (CV) drugs (medical possession ratio), cancer screening tests, influenza vaccination, alcohol and smoking consumption, and drowsiness-related road accidents during the 2 years preceding PAP onset in patients with OSA. Multivariable regression analyses were conducted to evaluate the association of heathy behaviors with subsequent PAP adherence.

Real-World Treatment Patterns Among French Patients With Metastatic Castration-Resistant Prostate Cancer Under Abiraterone or Enzalutamide.

Purpose: Using large French retrospective study cohort of chemotherapy-naïve metastatic castration-resistant prostate cancer patients (mCRPC; n = 10,308) comparing survival between patients who initiated abiraterone (ABI; 64%) and those initiating enzalutamide (ENZ; 36%), the present objective was to describe treatment patterns in the 2 years following initiation.

Method: Using the national health data system (SNDS) from 2014 to 2018, we first explored the number of treatment lines, and secondly, patterns of patient management using state sequence analysis; cluster analyses were performed on the 0 to 12 month and 13 to 24 month periods. Age, Charlson score, and duration of androgen deprivation therapy (ADT) were obtained for each cluster in the first year of follow-up.

Clinical use of low-dose parenteral anticoagulation, incidence of major bleeding and mortality: a multi-centre cohort study using the French national health data system.

Purpose: Low-dose parenteral anticoagulation has demonstrated its efficacy for venous thromboembolism prophylaxis in randomized trials. However, current practice is not widely documented. In ambulatory settings, we aimed to provide an overview of the clinical use of low-dose parenteral anticoagulation in France and to assess the incidence of major bleeding and death rates.

Prescribing Trends for Valproate Among Pregnant Women: A Cross-sectional Study in 2013 and 2016 Using the French Health Insurance Database.

Background And Objective: To describe the prescribing trends for sodium valproate (VPA) and alternative drugs during and around pregnancy, comparing 2016 (after the recommendations on valproate for women were reinforced by the European Medicines Agency [EMA]) with 2013 (before the recommendations).

Methods: Using the French National Health Insurance Database, a cross-sectional study was carried out in 2013 and in 2016, including women who became pregnant and had at least 1 reimbursement claim for VPA in the 2 years prior to pregnancy or during pregnancy. Exposure to VPA and its alternatives was then measured for each quarter, in the 2 years before pregnancy (preconception), during pregnancy, and in the year after pregnancy (postpartum).

The Association Between Antibiotic Use and Outcome Among Metastatic Melanoma Patients Receiving Immunotherapy.

Background: Several observational studies have reported a decreased response to immune checkpoint inhibitors (ICI) following antibiotic use. ICI activity has been hypothesized to be impaired by antibiotic-induced gut dysbiosis.

Methods: Patients with advanced melanoma receiving an anti-PD-1 antibody as a first-line therapy between 2015 and 2017 in France were selected using the French Health Insurance database.

Effectiveness of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers on total and cardiovascular mortality and morbidity in primary prevention: A nationwide study based on French Health Insurance Data (SNDS).

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) both inhibit the renin-angiotensin system (RAS) but have different sites of action. Whether clinically meaningful differences exist is still debated. The authors set up a population-based nationwide retrospective cohort study with at least 5 years of follow-up based on the comprehensive French Health Insurance Database linked to the French hospital discharge database.

Impact of recommendations on sodium valproate prescription among women with epilepsy: An interrupted time-series study.

Background: The European Medicines Agency (EMA) has developed risk minimization measures (RMMs) to reduce the use of the teratogenic drug, sodium valproate (VPA). The objective was to assess the impact of these RMMs among females with epilepsy in France.

Methods: We used data from the French National Health Insurance Database (SNDS), including 114,936 females aged under 50, with a reimbursement claim for an antiepileptic drug from January 2011 to December 2017, and identified as people with epilepsy.

Pregnancy in women with multiple sclerosis in France from 2010 to 2015: Incidence, outcomes, and exposure to disease-modifying therapies.

Background: Multiple sclerosis (MS) is usually diagnosed between 20-40 years old, when women often plan to have children.

Objective: Our objectives were to estimate pregnancy incidence rates in women with multiple sclerosis (MS), and to describe the use of disease-modifying therapies (DMTs) before conception and during pregnancy, and pregnancy outcomes.

Methods: This retrospective cohort study included all 15- to 49-year-old women with MS in the French national health insurance database over 2010-2015.

Hospitalization for adverse events under abiraterone or enzalutamide exposure in real-world setting: A French population-based study on prostate cancer patients.

Aims: Safety profiles of abiraterone and enzalutamide rely mainly on Phase III clinical trials. Our objective was to estimate the incidence rate ratio (IRR) for certain adverse events leading in real life to hospitalization (atrial fibrillation, acute heart failure, ischaemic heart disease, acute kidney injury [AKI], ischaemic stroke, torsade de pointe/QT interval prolongation, hepatitis and seizure), comparing abiraterone to enzalutamide. We also set out to discuss previously identified safety signals.

Patients with Metastatic Melanoma Receiving Anticancer Drugs: Changes in Overall Survival, 2010-2017.

Immune checkpoint inhibitors and targeted therapies have profoundly altered the management of several cancers over the past decade. Metastatic melanoma has been at the forefront of these changes. We provide here a nationwide overview and an assessment of changes in survival in France.

Teriflunomide-exposed pregnancies in a French cohort of patients with multiple sclerosis.

Objective: To describe pregnancies exposed to teriflunomide (TERIF) in women with multiple sclerosis (MS) in France over the period 2014-2016.

Methods: All 15- to 49-year-old women with MS in the national health insurance database were included. Pregnancies that had started between August 2014 and March 2016 were identified from their outcomes.

Overall Survival Among Chemotherapy-Naive Patients With Castration-Resistant Prostate Cancer Under Abiraterone Versus Enzalutamide: A Direct Comparison Based on a 2014-2018 French Population Study (the SPEAR Cohort).

Abiraterone acetate (ABI) and enzalutamide (ENZ) are considered to be clinically relevant comparators among chemotherapy-naive patients with castration-resistant prostate cancer. No clinical trials comparing overall survival with ABI versus ENZ in a head-to-head approach have been published so far. A few observational studies with low power suggested a potential benefit of ENZ.

Association Between Early Severe Cardiovascular Events and the Initiation of Treatment With the Anti-Interleukin 12/23p40 Antibody Ustekinumab.

Importance: Ustekinumab, a monoclonal antibody targeting interleukin 12/23p40 (IL-12/23p40), is effective in the treatment of moderate to severe psoriasis, psoriatic arthritis, and Crohn disease. In 2011, a meta-analysis of randomized clinical trials reported a potential risk of severe cardiovascular events (SCEs) within the first few months after the initiation of anti-IL-12/23p40 antibodies.

Objective: To assess whether the initiation of ustekinumab treatment is associated with increased risk of SCEs.

Risk of systemic infections in adults with atopic dermatitis: A nationwide cohort study.

Background: Atopic dermatitis (AD) has been linked to systemic infections in adulthood, but large-scale studies are few, and potential associations are unclear.

Objective: To examine whether adults with AD have increased risk of developing systemic infections leading to hospital-based management.

Methods: Nationwide register-based cohort study including all Danish adults from 1995 through 2017.

French administrative health care database (SNDS): The value of its enrichment.

SNIIRAM/SNDS, the French administrative health care database, covers around 99% of the population. Its main limitation is the absence of clinical information and biological results. This report exposes the value of SNIIRAM/SNDS enrichment by external databases, and the linkage issues.

Safety of Oral Propranolol for Infantile Hemangioma.

Objectives: The safety of oral propranolol for infantile hemangioma has not yet been studied at population level since the pediatric use marketing authorization was obtained in Europe.

Methods: A survey of a nationwide, claim-based observational cohort of children <3 years old, with at least 1 delivery of oral propranolol between July 2014 and June 2016, was performed by using the database of the French National Health Insurance system. Standardized morbidity ratios (SMRs) were calculated by using, from the same database, a representative random sample of nonexposed subjects.