Dataset Information

Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: Results from the EMPRISE East Asia study.

ABSTRACT:

Aim

To evaluate the effectiveness of empagliflozin in clinical practice in East Asia in the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) East Asia study.

Materials and methods

Data were obtained from the Medical Data Vision database (Japan), National Health Insurance Service database (South Korea) and National Health Insurance database (Taiwan). Patients aged ? 18 years with type 2 diabetes initiating empagliflozin or a dipeptidyl peptidase-4 (DPP-4) inhibitor were 1:1 propensity score (PS) matched into sequentially built cohorts of new users naïve to both drug classes. This design reduces confounding due to switching treatments, time lag and immortal time biases. Outcomes included hospitalization for heart failure (HHF), end-stage renal disease (ESRD) and all-cause mortality. Hazard ratios (HRs) and 95% CIs were estimated using Cox proportional models, controlling for > 130 baseline characteristics in each data source and pooled by random-effects meta-analysis.

Results

Overall, 28?712 pairs of PS-matched patients were identified with mean follow-up of 5.7-6.8 months. Compared with DPP-4 inhibitors, the risk of HHF was reduced by 18% and all-cause mortality was reduced by 36% with empagliflozin (HR 0.82; 95% CI 0.71-0.94, and HR 0.64; 95% CI 0.50-0.81, respectively). Reductions were consistent across countries, and in patients with and without baseline cardiovascular disease. ESRD was also significantly reduced with empagliflozin versus DPP-4 inhibitors (HR 0.37; 95% CI 0.24-0.58).

Conclusions

Empagliflozin treatment was associated with reduced risk for HHF, all-cause mortality and ESRD compared with DPP-4 inhibitors in routine clinical practice in Japan, South Korea and Taiwan.

SUBMITTER: Seino Y

PROVIDER: S-EPMC7831226 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: Results from the EMPRISE East Asia study.

Seino Yutaka Y Kim Dae Jung DJ Yabe Daisuke D Tan Elise Chia-Hui EC Chung Wook-Jin WJ Ha Kyoung Hwa KH Nangaku Masaomi M Node Koichi K Klement Riho R Yasui Atsutaka A Lei Wei-Yu WY Lee Sunwoo S Kyaw Moe H MH Deruaz-Luyet Anouk A Brodovicz Kimberly G KG H-H Sheu Wayne W

Endocrinology, diabetes & metabolism 20200916 1

<h4>Aim</h4>To evaluate the effectiveness of empagliflozin in clinical practice in East Asia in the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) East Asia study.<h4>Materials and methods</h4>Data were obtained from the Medical Data Vision database (Japan), National Health Insurance Service database (South Korea) and National Health Insurance database (Taiwan). Patients aged ≥ 18 years with type 2 diabetes initiating empagliflozin or a dipeptidyl peptidase-4 (DPP-4) inhibitor were ...[more]

PMID: 33532619

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Project description:ObjectiveTo determine the relative costs and health effects of interventions to combat cardiovascular disease, diabetes, and tobacco related disease in order to guide the allocation of resources in developing countries.DesignCost effectiveness analysis of 123 single or combined prevention and treatment strategies for cardiovascular disease, diabetes, and smoking by means of a lifetime population model.SettingTwo World Health Organization sub-regions of the world: countries in sub-Saharan Africa with very high adult and high child mortality (AfrE) and countries in South East Asia with high adult and high child mortality (SearD).Data sourcesDemographic and epidemiological data were taken from the WHO databases of mortality and global burden of disease. Estimates of intervention coverage, effectiveness, and resource needs were drawn from clinical trials, observational studies, and treatment guidelines. Unit costs were taken from the WHO-CHOICE (Choosing Interventions that are Cost-Effective) price database.Main outcome measuresCost per disability adjusted life year (DALY) averted, expressed in international dollars ($Int) for the year 2005.ResultsMost of the interventions studied were considered highly cost effective, meaning they generate one healthy year of life at a cost of <$Int2000 (which is the gross domestic product per capita of the two regions considered here). Interventions that offer particularly good monetary value, and which could be considered for prioritised implementation or scale up, include demand reduction strategies of the Framework Convention for Tobacco Control (<$Int950 and <$Int200 per DALY averted in AfrE and SearD respectively); combination drug therapy for people with a >25% chance of experiencing a cardiovascular event over the next decade, either alone or together with specific multidrug regimens for the secondary prevention of post-acute ischaemic heart disease and stroke (<$Int150 and <$Int230 per DALY averted in AfrE and SearD respectively); and retinopathy screening and glycaemic control for patients with diabetes (<$Int2100 and <$Int950 per DALY averted in AfrE and SearD respectively).ConclusionThis comparative economic assessment has identified a set of population-wide and individual strategies for prevention and control of cardiovascular disease that are inexpensive and cost effective in low resource settings.

Project description:BackgroundThe EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 diabetes Mellitus Patients) showed that empagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces the risk of hospitalization for heart failure (HHF) by 35%, on top of standard of care in patients with type 2 diabetes mellitus (T2D) and established cardiovascular disease. The EMPRISE (Empagliflozin Comparative Effectiveness and Safety) study aims to assess empagliflozin's effectiveness, safety, and healthcare utilization in routine care from August 2014 through September 2019. In this first interim analysis, we investigated the risk of HHF among T2D patients initiating empagliflozin versus sitagliptin, a dipeptidyl peptidase-4 inhibitor.MethodsWithin 2 commercial and 1 federal (Medicare) claims data sources in the United States, we identified a 1:1 propensity score-matched cohort of T2D patients ≥18 years old initiating empagliflozin or sitagliptin from August 2014 through September 2016. The HHF outcome was defined as a HF discharge diagnosis in the primary position (HHF-specific); a broader definition was based on a HF discharge diagnosis in any position (HHF-broad). Hazard ratios (HRs) and 95% CIs were estimated controlling for over 140 baseline characteristics in each data source and pooled by fixed-effects meta-analysis.ResultsAfter propensity-score matching, we identified 16,443 patient pairs who initiated empagliflozin or sitagliptin. Average age was approximately 59 years, almost 54% of the participants were males, and approximately 25% had records of existing cardiovascular disease. Compared with sitagliptin, the initiation of empagliflozin decreased the risk of HHF-specific by 50% (HR, 0.50; 95% CI, 0.28-0.91), and the risk of HHF-broad by 49% (HR, 0.51;95% CI, 0.39-0.68), over a mean follow-up of 5.3 months. The results were consistent in patients with and without baseline cardiovascular disease, and for empagliflozin at both the 10- and 25-mg daily doses; analyses comparing empagliflozin versus the dipeptidyl peptidase-4 inhibitor class, and comparing sodium-glucose cotransporter-2 inhibitor versus dipeptidyl peptidase-4 inhibitor classes also produced consistent findings.ConclusionsThe first interim analysis from EMPRISE showed that compared with sitagliptin, the initiation of empagliflozin was associated with a decreased risk of HHF among patients with T2D as treated in routine care, with and without a history of cardiovascular disease.Clinical trial registrationURL: https://www.clinicaltrials.gov . Unique identifier: NCT03363464.

Project description:BackgroundSodium-glucose cotransporter 2 inhibitors improve outcomes in patients with heart failure with reduced ejection fraction, but additional information is needed about whether glycemic status influences the magnitude of their benefits on heart failure and renal events.MethodsPatients with Class II-IV heart failure and a left ventricular ejection fraction ?40% were randomized to receive empagliflozin (10 mg daily) or placebo in addition to recommended therapy. We prespecified a comparison of the effect of empagliflozin in patients with and without diabetes.ResultsOf the 3730 patients enrolled, 1856 (50%) had diabetes, 1268 (34%) had prediabetes (hemoglobin A1c [HbA1c] 5.7-6.4%), and 606 (16%) had normoglycemia (HbA1c <5.7%). The risks of the primary outcome (cardiovascular death or hospitalization for heart failure), total hospitalizations for heart failure, and adverse renal outcomes were higher in patients with diabetes, but were similar between patients with prediabetes and normoglycemia. Empagliflozin reduced the risk of the primary outcome in patients with and without diabetes (hazard ratio, 0.72 [95% CI, 0.60-0.87] and 0.78 [95% CI, 0.64-0.97], respectively, P-interaction=0.57). Patients with and without diabetes also did not differ with respect to the effect of empagliflozin on total hospitalizations for heart failure, on the decline in estimated glomerular filtration rate over time, and on the risk of serious adverse renal outcomes. Among these end points, the effects of the drug did not differ in patients with prediabetes or normoglycemia. When analyzed as a continuous variable, baseline HbA1c did not significantly modify the benefits of empagliflozin on the primary outcome (P-interaction=0.40). Empagliflozin did not lower HbA1c in patients with prediabetes or normoglycemia and was not associated with increased risk of hypoglycemia.ConclusionsIn EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction), empagliflozin significantly improved cardiovascular and renal outcomes in patients with heart failure and a reduced ejection fraction, independent of baseline diabetes status and across the continuum of HbA1c. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057977.

Project description:BackgroundSimvastatin, 20mg, plus ezetimibe, 10mg, daily (simvastatin plus ezetimibe) reduced major atherosclerotic events in patients with moderate to severe chronic kidney disease (CKD) in the Study of Heart and Renal Protection (SHARP), but its cost-effectiveness is unknown.Study designCost-effectiveness of simvastatin plus ezetimibe in SHARP, a randomized controlled trial.Setting & population9,270 patients with CKD randomly assigned to simvastatin plus ezetimibe versus placebo; participants in categories by 5-year cardiovascular risk (low, <10%; medium, 10%-<20%; or high, ≥20%) and CKD stage (3, 4, 5 not on dialysis, or on dialysis therapy).Model, perspective, & timelineAssessment during SHARP follow-up from the UK perspective; long-term projections.InterventionSimvastatin plus ezetimibe (2015 UK £1.19 per day) during 4.9 years' median follow-up in SHARP; scenario analyses with high-intensity statin regimens (2015 UK £0.05-£1.06 per day).OutcomesAdditional health care costs per major atherosclerotic event avoided and per quality-adjusted life-year (QALY) gained.ResultsIn SHARP, the proportional reductions per 1mmol/L of low-density lipoprotein (LDL) cholesterol reduction with simvastatin plus ezetimibe in all major atherosclerotic events of 20% (95% CI, 6%-32%) and in the costs of vascular hospital episodes of 17% (95% CI, 4%-28%) were similar across participant categories by cardiovascular risk and CKD stage. The 5-year reduction in major atherosclerotic events per 1,000 participants ranged from 10 in low-risk to 58 in high-risk patients and from 28 in CKD stage 3 to 36 in patients on dialysis therapy. The net cost per major atherosclerotic event avoided with simvastatin plus ezetimibe compared to no LDL-lowering regimen ranged from £157,060 in patients at low risk to £15,230 in those at high risk (£30,500-£39,600 per QALY); and from £47,280 in CKD stage 3 to £28,180 in patients on dialysis therapy (£13,000-£43,300 per QALY). In scenario analyses, generic high-intensity statin regimens were estimated to yield similar benefits at substantially lower cost.LimitationsHigh-intensity statin-alone regimens were not studied in SHARP.ConclusionsSimvastatin plus ezetimibe prevented atherosclerotic events in SHARP, but other less costly statin regimens are likely to be more cost-effective for reducing cardiovascular risk in CKD.

Project description:ObjectiveTo assess the comparative costs and effects of interventions to combat five neuropsychiatric conditions (schizophrenia, bipolar disorder, depression, epilepsy, and heavy alcohol use).DesignCost effectiveness analysis based on an epidemiological model.SettingTwo epidemiologically defined World Health Organization sub-regions of the world: countries in sub-Saharan Africa with very high adult and high child mortality (AfrE); and countries in South East Asia with high adult and high child mortality (SearD).Data sourcesPublished studies, costing databases.Main outcome measuresCost per capita and cost per disability adjusted life year (DALY) averted, expressed in international dollars ($Int) for the year 2005.ResultsAcross 44 assessed intervention strategies for the five neuropsychiatric conditions, cost effectiveness values differed by as much as two orders of magnitude (from $Int100-250 to $Int10,000-25,000 for a year of healthy life gained). In both sub-regions, inpatient based treatment of schizophrenia with newer antipsychotic drugs was the most costly and least cost effective strategy. The most cost effective strategies in the African sub-region related to population based alcohol control, while in the South East Asian sub-region the most cost effective intervention was drug treatment of epilepsy in primary care. The cumulative cost per capita of the most cost effective set of interventions covering all five conditions was estimated at $Int4.90-5.70. This package comprises interventions for epilepsy (older first line antiepileptic drugs); depression (generically produced newer antidepressants and psychosocial treatment); bipolar disorder (mood stabiliser drug lithium); schizophrenia (neuroleptic antipsychotic drugs and psychosocial treatment); and heavy alcohol use (increased taxation and its enforcement, reduced access, and, in the African sub-region, advertising bans and brief advice to heavy drinkers in primary care).ConclusionsReallocation of resources to cost effective intervention strategies would increase health gain, save money and help implement much needed expansion of services for neuropsychiatric conditions in low resource settings.

Dataset Information

Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: Results from the EMPRISE East Asia study.

Aim

Materials and methods

Results

Conclusions

Publications

Cardiovascular and renal effectiveness of empagliflozin in routine care in East Asia: Results from the EMPRISE East Asia study.

Similar Datasets

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