ArticleEndocrinology, diabetes & metabolism2020
The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care.
Article in Endocrinology, diabetes & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Healthcare resource utilization in patients treated with empagliflozin in East Asia.Journal of diabetes investigation · 2022Pooled it
- Diabetic cardiomyopathy: a comprehensive review of diagnosis, management, and future directions.Diabetology & metabolic syndrome · 2025Review
- Empagliflozin versus DPP4i or GLP-1RA for the risk of nephrolithiasis in patients with type 2 diabetes: Research letter from the EMPRISE cohort study.Diabetes, obesity & metabolism · 2025Article
- A Scalable Approach to Assess the Safety of Recently Marketed Systemic Treatments for Atopic Dermatitis in Clinical Practice: First Analysis Cycle of a Sequential Monitoring System.The Journal of investigative dermatology · 2025Article
- Real-world evidence: state-of-the-art and future perspectives.Journal of comparative effectiveness research · 2025Review
- Health Care Utilization and Costs Associated With Empagliflozin in Older Adults With Type 2 Diabetes.Diabetes care · 2024Article
- Empagliflozin and Risk of Incident Gout: Analysis from the EMPagliflozin Comparative Effectiveness and SafEty (EMPRISE) Cohort Study.Journal of general internal medicine · 2024Article
- Article
- Cardiorenal effectiveness of empagliflozin vs. glucagon-like peptide-1 receptor agonists: final-year results from the EMPRISE study.Cardiovascular diabetology · 2024Article
- Development and Validation of a Claims-Based Model to Predict Categories of Obesity.American journal of epidemiology · 2024Article
- Empagliflozin Use Is Associated With Lower Risk of All-Cause Mortality, Hospitalization for Heart Failure, and End-Stage Renal Disease Compared to DPP-4i in Nordic Type 2 Diabetes Patients: Results From the EMPRISE (Empagliflozin Comparative Effectiveness and Safety) Study.Journal of diabetes research · 2024Article
- Machine Learning Algorithm Predicts Mortality Risk in Intensive Care Unit for Patients with Traumatic Brain Injury.Diagnostics (Basel, Switzerland) · 2023Article
- A Novel Chronic Kidney Disease Phenotyping Algorithm Using Combined Electronic Health Record and Claims Data.Clinical epidemiology · 2023Article
- Empagliflozin reduces cardiorenal events, healthcare resource use and mortality in Sweden compared to dipeptidyl peptidase-4 inhibitors: Real world evidence from the Nordic EMPRISE study.Diabetes, obesity & metabolism · 2023Article
- Anti-Diabetic Therapy, Heart Failure and Oxidative Stress: An Update.Journal of clinical medicine · 2022Review
- Validation of obesity-related diagnosis codes in claims data.Diabetes, obesity & metabolism · 2021Article
- Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: Results from the EMPRISE East Asia study.Endocrinology, diabetes & metabolism · 2021Article
- The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care.Endocrinology, diabetes & metabolism · 2020Article
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundThe EMPA-REG OUTCOME trial showed that empagliflozin reduced the risk of cardiovascular death and hospitalization for heart failure (HHF) in diabetic patients with cardiovascular disease. EMPRISE is a study programme on the effectiveness, safety and healthcare utilization of empagliflozin in routine care, leveraging real-world data from two commercial and one federal US data sources from 2014 to 2019.
objectivesTo describe rationale and design of EMPRISE, assess ability to minimize confounding and evaluate the time to reach sufficient statistical power for a key study outcome, HHF, using baseline information from the first year of EMPRISE.
methodsIn 3 claims data sets, we identified a 1:1 propensity score (PS)-matched cohort of diabetic patients ≥18 years initiating empagliflozin or a dipeptidyl peptidase-4 inhibitor (DPP4i), resulting in 6643 total pairs. The PS model included >140 baseline covariates. We measured covariate balance via standardized differences (SD) and postmatching c-statistic. We computed the incidence rate (IR) of HHF, predicted exposure accrual over time and calculated expected power.
resultsAfter PS matching, patient characteristics were balanced with SD <0.1 and c-statistic between 0.54 and 0.59. The population IR of HHF was 4.4 per 1000 person-years using a specific HHF definition and 14.8 using a broader HHF definition. In our projection, 80%-powered analyses would require a minimum of 169 HHF events, expected to accumulate by year 3 (specific definition) or year 2 (broader definition).
conclusionBaseline information from EMPRISE provided evidence of solid confounding control and adequate exposure accrual with expected powered analyses for the primary outcomes.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.