Evolution of antithrombotic therapy for patients with atrial fibrillation: The prospective global GLORIA-AF registry program.

Objective: To assess baseline characteristics and antithrombotic treatment (ATT) prescription patterns in patients enrolled in the third phase of the GLORIA-AF Registry Program, evaluate predictors of treatment prescription, and compare results with phase II.

Methods: GLORIA-AF is a large, global, prospective registry program, enrolling patients with newly diagnosed nonvalvular atrial fibrillation (AF) at risk of stroke. Patients receiving dabigatran were followed for two years in phase II, and all patients were followed for 3 years in phase III.

Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry.

Background: Prospectively collected, routine clinical practice-based data on antithrombotic therapy in non-valvular atrial fibrillation (AF) patients are important for assessing real-world comparative outcomes. The objective was to compare the safety and effectiveness of dabigatran versus vitamin K antagonists (VKAs) in patients with newly diagnosed AF.

Methods And Results: GLORIA-AF is a large, prospective, global registry program.

STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies.

In alignment with the International Council of Harmonization’s strategic goals, a public-private consortium has developed a structured template for planning and reporting on the implementation of real world evidence (RWE) studies of the safety and effectiveness of treatments. The template serves as a guiding tool for designing and conducting reproducible RWE studies; set clear expectations for transparent communication of RWE methods; reduce misinterpretation of prose that lacks specificity; allow reviewers to quickly orient and find key information; and facilitate reproducibility, validity assessment, and evidence synthesis. The template is intended for use with studies of the effectiveness and safety of medical products and is compatible with multiple study designs, data sources, reporting guidelines, checklists, and bias assessment tools.

Incorporating patient generated health data into pharmacoepidemiological research.

Epidemiology and pharmacoepidemiology frequently employ Real-World Data (RWD) from healthcare teams to inform research. These data sources usually include signs, symptoms, tests, and treatments, but may lack important information such as the patient's diet or adherence or quality of life. By harnessing digital tools a new fount of evidence, Patient (or Citizen/Person) Generated Health Data (PGHD), is becoming more readily available.

Persistence with Anticoagulation for Atrial Fibrillation: Report from the GLORIA-AF Phase III 1-Year Follow-up.

Background: We aimed to assess the extent to which drug persistence is better with non-vitamin K antagonist oral anticoagulants (NOACs) than vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients and to estimate the difference in therapy persistence depending on NOAC dosing regimen (once daily (QD) vs. twice daily (BID)).

Methods: Consecutive patients were followed for 1 year in phase III of the GLORIA-AF registry.

Characterizing Health Outcomes in Idiopathic Pulmonary Fibrosis using US Health Claims Data.

Background: Idiopathic pulmonary fibrosis (IPF) is a life-threatening interstitial lung disease (ILD). Characterizing health outcomes of IPF patients is challenging due to disease rarity.

Objective: This study aimed to identify the burden of disease in patients newly diagnosed with IPF.

Safety and Effectiveness of Dabigatran and Other Direct Oral Anticoagulants Compared With Warfarin in Patients With Atrial Fibrillation.

The study objective was to evaluate the safety and effectiveness of dabigatran and other direct oral anticoagulants (DOACs) compared with warfarin among patients with nonvalvular atrial fibrillation using a prospective monitoring program. We implemented a cohort design with propensity score matching to compare initiators of DOACs and warfarin between 2010 and 2015 in two US healthcare databases. Proportional hazards regression was used to estimate hazard ratios (HRs) for stroke and major bleeding.

Safety and effectiveness of dabigatran at 2 years: Final outcomes from Phase II of the GLORIA-AF registry program.

GLORIA-AF is a large, ongoing, prospective, global registry program run in 3 phases, assessing long-term safety and effectiveness of dabigatran etexilate (dabigatran) in patients with newly diagnosed atrial fibrillation (AF) in clinical practice. This report provides the final analysis of 2-year clinical outcomes of the full cohort of 4873 patients prescribed dabigatran and followed for a mean of 18.0 +/- 9.

Antithrombotic treatment for newly diagnosed atrial fibrillation in relation to patient age: the GLORIA-AF registry programme.

Aims: To assess antithrombotic therapy choices in relation to patient age in a large, global registry on atrial fibrillation (AF).

Methods And Results: Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) is an international programme involving patients with newly diagnosed AF and ≥1 risk factors for stroke. We used Phase II data (from November 2011 through December 2014), which commenced immediately following first non-vitamin K antagonist oral anticoagulants (NOACs) approval in participating countries.

Choosing Among Common Data Models for Real-World Data Analyses Fit for Making Decisions About the Effectiveness of Medical Products.

Many real-world data analyses use common data models (CDMs) to standardize terminologies for medication use, medical events and procedures, data structures, and interpretations of data to facilitate analyses across data sources. For decision makers, key aspects that influence the choice of a CDM may include (i) adaptability to a specific question; (ii) transparency to reproduce findings, assess validity, and instill confidence in findings; and (iii) ease and speed of use. Organizing CDMs preserve the original information from a data source and have maximum adaptability.

Evaluating utilization patterns of oral anticoagulants in routine care.

Unlabelled: Essentials Unlike warfarin, treatment with DOACs do not require regular plasma level monitoring. We compared persistence of patients treated with DOACs compared to warfarin. Persistence at 12 months was higher for all DOACs compared to warfarin.

Cardiovascular safety of linagliptin compared with other oral glucose-lowering agents in patients with type 2 diabetes: A sequential monitoring programme in routine care.

Aim: To evaluate the safety of linagliptin versus other glucose-lowering medications in a multi-year monitoring programme using insurance claims data.

Methods: In two commercial US claims databases, we identified three pairwise 1:1 propensity-score (PS)-matched cohorts of patients with type 2 diabetes (T2D) aged ≥18 years initiating linagliptin or a comparator (other dipeptidyl peptidase-4 [DPP-4] inhibitors [n = 31 492 pairs], pioglitazone [n = 23 316 pairs], or second-generation sulphonylureas [n = 19 731 pairs]) between May 2011 and December 2015. The primary endpoint was the risk of a composite cardiovascular (CV) outcome (hospitalization for myocardial infarction, stroke, unstable angina, or coronary revascularization).

Sequential Monitoring of the Comparative Effectiveness and Safety of Dabigatran in Routine Care.

Background The increasing availability of electronic healthcare data enables ongoing monitoring of the effectiveness and safety of newly marketed medications. We sought to demonstrate a 5-year prospective monitoring system of dabigatran for stroke prevention that may expedite discovery and allow ongoing evidence development. Methods and Results Between 2011 and 2015, we conducted 9 sequential analyses of dabigatran versus warfarin users in a sequential cohort design in 2 US claims databases.

Preferential prescribing of linagliptin in type 2 diabetes patients in an expanded post-marketing surveillance study in Japan.

Aims/introduction: To evaluate linagliptin prescribing in type 2 diabetes mellitus patients with different comorbidities, an expanded Japanese post-marketing surveillance also collected baseline data for patients initiating other glucose-lowering drugs.

Materials And Methods: Patients initiating linagliptin monotherapy were enrolled, then the next patient starting monotherapy with another glucose-lowering drug was enrolled (2012-2014). Baseline data were collected and analyzed by the Medical Dictionary for Regulatory Activities system organ class.

Measuring prevalence and incidence of chronic conditions in claims and electronic health record databases.

Background: Health care databases are natural sources for estimating prevalence and incidence of chronic conditions, but substantial variation in estimates limits their interpretability and utility. We evaluated the effects of design choices when estimating prevalence and incidence in claims and electronic health record databases.

Methods: Prevalence and incidence for five chronic diseases at increasing levels of expected frequencies, from cystic fibrosis to COPD, were estimated in the Clinical Practice Research Datalink (CPRD) and MarketScan databases from 2011 to 2014.

Claims Data Studies of Direct Oral Anticoagulants Can Achieve Balance in Important Clinical Parameters Only Observable in Electronic Health Records.

Claims databases provide information on the effects of direct oral anticoagulants (DOACs) as used in routine care but may not contain important data on clinical characteristics, which may be captured in electronic health records (EHRs). Within a US claims database, we identified patients initiating a DOAC or warfarin between October 2010 and December 2014. Propensity score (PS) matching, 1:1, was used to balance 78 claims-defined baseline characteristics.

Real world management of pregestational diabetes not achieving glycemic control for many patients in the UK.

Purpose: Our goal was to describe the management of pregestational diabetes in pregnant women in the United Kingdom.

Methods: We used electronic medical records from The Health Improvement Network database between January 1995 and June 2012 to identify the first pregnancy in women 15 to 45 years of age with pregestational diabetes type 1 or type 2. Information on lifestyle factors, demographic characteristics, prescription of specific antidiabetic medications, and glycemic control measures (HbA1c) was obtained from primary care provider records.

Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry.

Background And Purpose: GLORIA-AF is a large, global, prospective registry program of newly diagnosed atrial fibrillation (AF) patients with ≥1 stroke risk factors. We describe the effectiveness and safety of dabigatran etexilate over 2 years from routine clinical practice in nearly 3000 patients from GLORIA-AF who are newly diagnosed with non-valvular AF and at risk of stroke.

Methods: Consecutive enrollment into phase II of GLORIA-AF was initiated following approval of dabigatran for stroke prevention in non-valvular AF.

Safety of non-insulin glucose-lowering drugs in pregnant women with pre-gestational diabetes: A cohort study.

Aims: To evaluate the association between use of non-insulin antidiabetics in early pregnancy and the risk of miscarriages, stillbirths and major structural malformations.

Materials And Methods: A cohort of 1511 pregnant women with pre-gestational diabetes linked to live births was identified using electronic medical records from The Health Improvement Network (THIN) for the period 1995 to 2012. Information on prescriptions, foetal outcomes and potential confounders was ascertained from both codes and free text in the THIN database.

Claims-based studies of oral glucose-lowering medications can achieve balance in critical clinical variables only observed in electronic health records.

Aim: To evaluate the extent to which balance in unmeasured characteristics of patients with type 2 diabetes (T2DM) was achieved in claims data, by comparing against more detailed information from linked electronic health records (EHR) data.

Methods: Within a large US commercial insurance database and using a cohort design, we identified patients with T2DM initiating linagliptin or a comparator agent within class (ie, another dipeptidyl peptidase-4 inhibitor) or outside class (ie, pioglitazone or a sulphonylurea) between May 2011 and December 2012. We focused on comparators used at a similar stage of diabetes to linagliptin.

Preferential prescribing and utilization trends of diabetes medications among patients with renal impairment: Emerging role of linagliptin and other dipeptidyl peptidase 4 inhibitors.

Objectives: Although many newer diabetes medications have become available in the last decade, most have not been widely studied in populations with chronic kidney disease under routine care. Linagliptin, a recently marketed dipeptidyl peptidase 4 (DPP-4) inhibitor, is the only agent in the U.S.

Prevalence and incidence of urinary tract and genital infections among patients with and without type 2 diabetes.

Objective: Epidemiological data on genitourinary infections (GUIs) comparing patients with and without type 2 diabetes (T2DM) is scant. We aimed to estimate the incidence of urinary tract infections (UTIs), genital infections (GIs), or any GUI in total and stratified by history of GUI and sex.

Research Design And Methods: We identified 39,295 patients in the Kaiser Permanente Northwest health plan with T2DM and an equal number of age and sex matched patients without diabetes.

The Changing Landscape for Stroke Prevention in AF: Findings From the GLORIA-AF Registry Phase 2.

Background: GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non-vitamin K antagonist oral anticoagulant (NOAC), became available.

Objectives: This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1.

Propensity Score Weighting Compared to Matching in a Study of Dabigatran and Warfarin.

Introduction: Comparing medications in observational settings requires differences in patient characteristics to be accounted for. Propensity score (PS) methods can address these differences, but PS weighting approaches may introduce bias.

Methods: Within a cohort study of anticoagulant initiators from October 2010 through to December 2012, PS values for dabigatran relative to warfarin were estimated, and study outcomes (stroke or major bleeding) among the cohort were identified.

The Use of Telmisartan and the Incidence of Cancer.

Background: A meta-analysis reported an 8% increased risk of cancer with the use of angiotensin receptor blockers (ARBs), but subsequent meta-analyses and observational studies did not confirm this risk. However, telmisartan comprised 85% of the data in the original meta-analysis. Thus, the objective of this study was to determine whether the use of telmisartan, compared with other ARBs, is associated with an increased risk of cancer.