Evidence map›Paper›PMID 31295358›Full record

ArticleDiabetic medicine : a journal of the British Diabetic Association2019

Cost-effectiveness analysis of empagliflozin treatment in people with Type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial.

A Kansal, O S Reifsnider, I Proskorovsky, Y Zheng, E Pfarr, J T George, P Kandaswamy, A Ruffolo

Registry-linked trialAbstract read
In one paragraph

Article in Diabetic medicine : a journal of the British Diabetic Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01131676 (A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773), which is not on this map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01131676 phase3completednot on this map

A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

TypeinterventionalSponsorBoehringer IngelheimRan2010 to 2015Enrolled7,064ConditionsDiabetes Mellitus, Type 2ArmsBI 10773 low dose, Placebo BI 10773 high dose, BI 10773 high dose, Placebo BI 10773 low dose
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
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  8. Modeling Chronic Kidney Disease in Type 2 Diabetes Mellitus: A Systematic Literature Review of Models, Data Sources, and Derivation Cohorts.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
    Review
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  18. Cost-Effectiveness Analysis of Linagliptin in Japan Based on Results from the Asian Subpopulation in the CARMELINADiabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

A KansalEvidera, Bethesda, MD, USA.
O S ReifsniderEvidera, Bethesda, MD, USA.
I ProskorovskyEvidera, Bethesda, MD, USA.
Y ZhengEvidera, Bethesda, MD, USA.
E PfarrBoehringer Ingelheim International, Ingelheim am Rhein, Germany.
J T GeorgeBoehringer Ingelheim Ltd, Bracknell, UK.
P KandaswamyBoehringer Ingelheim International, Ingelheim am Rhein, Germany.
A RuffoloBoehringer Ingelheim International, Ingelheim am Rhein, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimIn the EMPA-REG OUTCOME trial, empagliflozin therapy reduced cardiovascular death by 38% compared with placebo when added to standard of care. Using the trial results, we created a discrete-event simulation model to assess lifetime health economic outcomes in people with Type 2 diabetes and established cardiovascular disease.

methodsTime-dependent survival regression analysis was performed on data from EMPA-REG OUTCOME for 10 cardiovascular and renal events (e.g. stroke, heart failure hospitalization, macroalbuminuria, cardiovascular mortality) to capture event rates over time, and interaction between events. Model performance was assessed by comparing predicted and observed outcomes at 3 years. Costs in the United Kingdom (UK) and health utilities were obtained from published literature. Outcomes included cumulative event rates, life-years, costs and quality-adjusted life-years (QALYs).

resultsThe model predicted an 18% relative increase (by 2.1 life-years) in survival for empagliflozin (14.0 life-years) vs. standard of care (11.9 life-years), attributable to direct treatment effect on cardiovascular mortality, and to indirect effect via reductions in other events. Participants treated with empagliflozin may experience improved quality of life (1.0 QALY) and higher costs (£3737/participant), yielding an incremental cost-effectiveness ratio (ICER) of £4083/QALY. Sensitivity analyses confirmed the robustness of these results to changes in input parameters.

conclusionsBased on extrapolation of EMPA-REG OUTCOME trial data using a participant-level simulation model, empagliflozin in addition to standard of care is projected to be highly cost-effective using UK healthcare costs. The impact in other countries will vary due to differences in drug pricing and accrual of other costs. (Clinical Trial Registry No: NCT01131676).

Indexed as

Benzhydryl CompoundsCost-Benefit AnalysisDiabetes Mellitus, Type 2Diabetic AngiopathiesFemaleGlucosidesHumansMaleMiddle AgedModels, EconomicPatient SimulationSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsempagliflozinGlucosidesSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID31295358
PMCPMC6851686

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LicenceCC BY-NC
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Registered trials

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.