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The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care.

ABSTRACT: Background:The 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. Objectives:To 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. Methods:In 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. Results:After 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). Conclusion:Baseline information from EMPRISE provided evidence of solid confounding control and adequate exposure accrual with expected powered analyses for the primary outcomes.

SUBMITTER: Patorno E

PROVIDER: S-EPMC6947693 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care.

Patorno Elisabetta E Najafzadeh Mehdi M Pawar Ajinkya A Franklin Jessica M JM Déruaz-Luyet Anouk A Brodovicz Kimberly G KG Santiago Ortiz Adrian J AJ Bessette Lily G LG Kulldorff Martin M Schneeweiss Sebastian S

Endocrinology, diabetes & metabolism 20191126 1

<h4>Background</h4>The 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.<h4>Objectives</h4>To describe rationale and design of EMPRISE, assess abilit ...[more]

PMID: 31922030

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Project description:IntroductionThere is an epidemic of opioid use related to adverse events and deaths in the USA. The rates of chronic pain, mental illness and substance use disorder are higher at the Veterans Health Administration (VHA) compared with the general US population. The 2016 Comprehensive Addiction and Recovery Act requires the VHA to improve opioid therapy strategies in treating patients and to ensure responsible prescribing practices. The Stratification Tool for Opioid Risk Mitigation (STORM) is a web-based dashboard that prioritises review of VHA patients receiving opioids based on their risk. The VHA Partnered Evidence-based Policy Resource Center is coordinating a multiyear evaluation of STORM and aspects of the VHA policy that mandate case review of patients identified by STORM as very high risk.Methods and analysisThis stepped-wedge cluster randomised controlled trial will test two hypotheses: (1) VHA medical centres randomised to facilitation for not meeting the targeted case review rate will achieve lower opioid-related serious adverse events (SAEs), relative to facilities not randomised to facilitation and (2) Patients whose cases are required to be reviewed will have a lower rate of opioid-related SAEs compared with comparable risk patients whose cases are not required to be reviewed. Patients who receive an opioid prescription at VHA medical centres will be followed for a minimum of 3 months after their first opioid prescription. Follow-up will continue until the last day of the project or death. The data will be analysed using an intention-to-treat approach with patient-month-level Cox proportional hazards models for both interventions.Ethics and disseminationEvaluation of the randomised roll-out was approved by the VA Boston Healthcare System Institutional Review Board (IRB) and Research & Development Committees (Protocol # 3069). Findings will be published in peer-reviewed journals and presentations at national conference meetings.Trial registration numberISRCTN16012111.

Project description:BackgroundSodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce blood glucose, blood pressure, and body weight in patients with type 2 diabetes (T2D). However, the comparative long-term effectiveness and safety of SGLT2i among similar drugs, administered at different doses, have not been assessed. In this study, we compared the long-term effectiveness and safety of SGLT2i (dapagliflozin versus empagliflozin) as add-on therapy to hypoglycemic agents in T2D patients.MethodsThis study was a single-center, 3-year, retrospective, observational study. For all patients in the study, drugs were evaluated for safety by documenting adverse drug reactions. The primary effectiveness was evaluated as the difference between hemoglobin A1c (HbA1c) values obtained at baseline and those obtained after 36 months of treatment. The proportion of participants with HbA1c levels <7.0% and <6.5% was also analyzed.ResultsIn total, 680 patients were enrolled in this study. Using propensity score matching, 234 patients each from the dapagliflozin and empagliflozin groups were selected based on patient characteristics. After 36 months of treatment, clinical parameters (including HbA1c, fasting plasma glucose, alanine aminotransferase, triglyceride levels, body weight, and systolic blood pressure) decreased significantly in these groups. The changes from the baseline for the physiological values and clinical parameters did not vary among the different dose groups of SGLT2i. The incidence of adverse drug reactions was approximately 7-8%. All patients with observed serious adverse reactions were hospitalized for urinary tract infections.ConclusionOur study showed that the long-term continuous use of either dapagliflozin or empagliflozin as add-on therapy to hypoglycemic drugs for T2D patients is synergistically effective for lowering blood glucose, reducing body weight, and stabilizing blood pressure. Additionally, there was no significant difference in efficacy between dapagliflozin and empagliflozin, even with the administration of different doses of these agents.

Project description:ObjectiveTo evaluate mammography screening quality on the Island of Jersey over a 25-year period from Jan 1990 to end March 2015 from females invited between ages 50 to 75 using a 2 yearly screening interval. Jersey had a population of only around 67,000 at onset, rising to around 100,000 at the end of the 25 years.MethodsAn analysis was performed of key routinely collected measures that are important to determining if a screening programme is on course to reduce breast cancer mortality such as uptake, recall rates, screen detected cancer and interval cancer rates. Further supporting indicators including grade, stage and comparative deaths from breast cancer in screen detected and not screen detected females were also assessed.ResultsOver the 25-year period 19,768 females were invited to screening and 16,866 attended, giving an uptake of 85.2%. There were 501 screen detected cancers of which 400 were invasive, and 101 DCIS. 125 interval cancers presented outside screening over the 25 years. The annual recall rate over the last 20 years was <6% for prevalent round and 4% for incident round screening. Based on the standardized detection ratio (SDR) and uptake, the estimated reduction in mortality from breast cancer was calculated as 40.2%.ConclusionsRecommended population sizes for breast units range from a quarter to half a million people. For very small units like Jersey serving smaller populations, rigorous quality control is essential to maintain credibility. Despite the small size of the programme evidence shows a similar detection rate to the UK NHS Breast screening programme was achieved. In small programmes careful monitoring of rates of uptake, recall, cancer detection and interval rates are required over adequate time periods together with supporting information to show that small units can achieve national standards and detection rates necessary to reduce breast cancer mortality.Advances in knowledgeRunning a small breast cancer screening programme is challenging for quality control. The impact on mortality can be predicted for small screening programmes despite their size. 10-year group survival in screen detected invasive breast cancer >90%. Interval cancers are more advanced than screen detected invasive cancers, so high suspicion is still required in breast symptoms after "normal" screen result. Mortality in lapsed/ceased attenders suggest that extending age range could be beneficial.

Project description:BackgroundThe effectiveness of an intervention in clinical practice is often reduced compared to the efficacy demonstrated in a randomised controlled trial (RCT). In this comparative effectiveness study, the RCT-proven efficacy of a diabetes education programme for type 1 diabetic patients (PRIMAS) was compared to the effectiveness observed in an implementation trial (IT) under routine care conditions.Methods75 patients with type 1 diabetes received PRIMAS through an RCT, whereas 179 patients were observed in an implementation trial. Baseline characteristics and treatment outcomes at the 6-month follow-up (improvement of HbA1c, hypoglycaemia problems, and diabetes-related distress) were compared.ResultsAt baseline, the type 1 diabetic patients in the RCT had a significant longer diabetes duration (18.7 ± 12.3 vs. 13.8 ± 12.7 yrs., p = .005), lower self-efficacy scores (21.9 ± 4.7 vs. 23.7 ± 6.1, p = .02) and a greater number of diabetes complications (0.8 ± 1.3 vs. 0.4 ± 0.9, p = .02). After 6 months, PRIMAS achieved comparable effects under RCT and implementation trial conditions, as demonstrated by improvement in HbA1c (-0.36% ± 1.1 vs. -0.37 ± 1.2; Δ -0.01, 95% CI -0.33 to 0.31) and hypoglycaemia unawareness (-0.5 ± 1.4 vs. -0.3 ± 1.4; Δ 0.18, 95% CI -0.21 to 0.57). The likelihood of clinical improvement did not depend on the trial setting (RCT vs. IT: OR 1.18, 95% CI 0.60 to 2.33). The participants with worse glycaemic control (OR 1.40, 95% CI 1.02 to 1.92), hypoglycaemia problems (OR 2.13, 95% CI 1.53 to 2.97) or elevated diabetes distress (OR 1.40, 95% CI 1.03 to 1.89) had a better chance of clinical improvement.ConclusionsThe effectiveness of PRIMAS under routine care conditions was comparable to the efficacy demonstrated in the RCT. Clinical improvement was independent of the setting in which PRIMAS was evaluated. The PRIMAS education programme for type 1 diabetes can be delivered under conditions of routine care without a loss of effectiveness, compared to its original evaluation in an RCT.

Dataset Information

The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care.

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The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care.

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