Empagliflozin
The medicine inside Jardiance. It is an SGLT2 inhibitor. EMPEROR-Reduced tested it in adults with heart failure and an ejection fraction of 40% or less, and EMPEROR-Preserved tested it above 40%. In both trials fewer people taking empagliflozin than placebo died from cardiovascular causes or were admitted to hospital for heart failure. In the second trial the effect was mainly due to fewer hospital admissions. Genital tract infections were reported more often with empagliflozin.
- Drug
- In this atlas
Overview
Technical summary
RxNorm ingredient 1545653. FDA classes in RxClass: Sodium-Glucose Transporter 2 Inhibitors (mechanism of action) and Sodium-Glucose Cotransporter 2 Inhibitor (established pharmacologic class). EMPEROR-Reduced (NCT03057977) and EMPEROR-Preserved (NCT03057951) were sponsored by Boehringer Ingelheim. Other trials of the same substance sit in other areas of the atlas.
About this drug
- Level
- Substance
- Mechanism
- The FDA mechanism-of-action class for empagliflozin in RxClass is Sodium-Glucose Transporter 2 Inhibitors.
Claims and evidence
Context Adults with chronic heart failure and an ejection fraction above 40%, on usual therapy (EMPEROR-Preserved)
- Recipient
- Adult
- Population
- Patients with class II to IV heart failure and an ejection fraction of more than 40%, who were taking usual therapy. The registry gives a minimum age of 18 years. The abstract says the effects appeared consistent in people with and without diabetes. The trial includes people with mildly reduced as well as preserved ejection fraction.
- Care setting
- Not stated in the abstract. The registry record is not read for setting.
- Geography
- Multinational: the registry lists many countries across several continents.
- Life stage
- Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
- Follow-up
- Median 26.2 months (abstract).
Eligibility: 3 inclusion criteria; 1 exclusion criterion
- Included
- Heart failure of class II to IV
- Ejection fraction of more than 40%
- Taking usual therapy for heart failure (abstract)
- Excluded
- Exclusion criteria were not read; the abstract does not list them
In EMPEROR-Preserved, adults with class II to IV heart failure and an ejection fraction of more than 40% took empagliflozin 10 mg once daily or placebo, in addition to usual therapy. Over a median of 26.2 months, the primary outcome, cardiovascular death or hospitalization for heart failure, occurred in 415 of 2997 people (13.8%) taking empagliflozin and 511 of 2991 (17.1%) taking placebo (hazard ratio 0.79, 95% CI 0.69 to 0.90). The authors say this effect was mainly related to a lower risk of hospitalization for heart failure with empagliflozin. Separately, the total number of hospitalizations for heart failure was 407 with empagliflozin and 541 with placebo (hazard ratio 0.73, 95% CI 0.61 to 0.88); these are counts of events and not of people. The effects appeared consistent in people with or without diabetes. Uncomplicated genital and urinary tract infections and low blood pressure were reported more often with empagliflozin.
Applies to Adult- Patients with class II to IV heart failure and an ejection fraction of more than 40%, who were taking usual therapy. The registry gives a minimum age of 18 years. The abstract says the effects appeared consistent in people with and without diabetes. The trial includes people with mildly reduced as well as preserved ejection fraction.
- Not stated in the abstract. The registry record is not read for setting.
- Multinational: the registry lists many countries across several continents.
- Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
- Certainty method
- Not assessed
- Limitations
- One double-blind trial funded by Boehringer Ingelheim and Eli Lilly. The numbers come from the PubMed abstract; the full text, tables and registry results were not read. The abstract does not give the separate counts for cardiovascular death, so the claim does not say whether death alone differed. The trial enrolled people with an ejection fraction above 40%, a wider band than the preserved range NHLBI describes. No certainty rating was assessed.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (8)
-
Supports Empagliflozin in Heart Failure with a Preserved Ejection Fraction
- Locator
- Abstract, RESULTS, sentence 1
- How it applies
- Primary outcome counts and hazard ratio. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6aa150f130383577608a2ceaeb9d3d7329eda3f870a9438e7b8407f7c2904970- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Empagliflozin in Heart Failure with a Preserved Ejection Fraction
- Locator
- Abstract, RESULTS, sentence 2
- How it applies
- The effect was mainly related to fewer heart-failure hospitalizations. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6aa150f130383577608a2ceaeb9d3d7329eda3f870a9438e7b8407f7c2904970- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Empagliflozin in Heart Failure with a Preserved Ejection Fraction
- Locator
- Abstract, RESULTS, sentence 3
- How it applies
- Consistency with or without diabetes. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6aa150f130383577608a2ceaeb9d3d7329eda3f870a9438e7b8407f7c2904970- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Empagliflozin in Heart Failure with a Preserved Ejection Fraction
- Locator
- Abstract, RESULTS, sentence 4
- How it applies
- Total hospitalizations for heart failure. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6aa150f130383577608a2ceaeb9d3d7329eda3f870a9438e7b8407f7c2904970- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Empagliflozin in Heart Failure with a Preserved Ejection Fraction
- Locator
- Abstract, RESULTS, sentence 5
- How it applies
- Infections and low blood pressure. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6aa150f130383577608a2ceaeb9d3d7329eda3f870a9438e7b8407f7c2904970- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Empagliflozin in Heart Failure with a Preserved Ejection Fraction
- Locator
- Abstract, METHODS, sentence 1
- How it applies
- Who was randomized, the dose and the background therapy. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6aa150f130383577608a2ceaeb9d3d7329eda3f870a9438e7b8407f7c2904970- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Empagliflozin in Heart Failure with a Preserved Ejection Fraction
- Locator
- Abstract, METHODS, sentence 2
- How it applies
- How the primary outcome was defined. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6aa150f130383577608a2ceaeb9d3d7329eda3f870a9438e7b8407f7c2904970- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Empagliflozin in Heart Failure with a Preserved Ejection Fraction
- Locator
- Abstract, CONCLUSIONS, sentence 2
- How it applies
- Funding statement and registry number. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6aa150f130383577608a2ceaeb9d3d7329eda3f870a9438e7b8407f7c2904970- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
Context Adults with chronic heart failure and an ejection fraction of 40% or less, on recommended therapy (EMPEROR-Reduced)
- Recipient
- Adult
- Population
- Patients with class II, III or IV heart failure and an ejection fraction of 40% or less, who were taking recommended therapy. The registry gives a minimum age of 18 years. The abstract says the effect on the primary outcome was consistent in people with and without diabetes.
- Care setting
- Not stated in the abstract. The registry record is not read for setting.
- Geography
- Multinational: the registry lists many countries across several continents.
- Life stage
- Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
- Follow-up
- Median 16 months (abstract).
Eligibility: 3 inclusion criteria; 1 exclusion criterion
- Included
- Heart failure of class II, III or IV (the abstract does not say the class scale is NYHA)
- Ejection fraction of 40% or less
- Taking recommended therapy for heart failure (abstract)
- Excluded
- Exclusion criteria were not read; the abstract does not list them
In EMPEROR-Reduced, adults with class II, III or IV heart failure and an ejection fraction of 40% or less took empagliflozin 10 mg once daily or placebo, in addition to recommended therapy. Over a median of 16 months, the primary outcome, cardiovascular death or hospitalization for worsening heart failure, occurred in 361 of 1863 people (19.4%) taking empagliflozin and 462 of 1867 (24.7%) taking placebo (hazard ratio 0.75, 95% CI 0.65 to 0.86). The authors report that the effect was consistent in people with and without diabetes. The total number of hospitalizations for heart failure was lower with empagliflozin (hazard ratio 0.70, 95% CI 0.58 to 0.85), and the yearly decline in estimated glomerular filtration rate was slower, at -0.55 against -2.28 ml per minute per 1.73 m2 of body surface area per year. Uncomplicated genital tract infection was reported more often with empagliflozin.
Applies to Adult- Patients with class II, III or IV heart failure and an ejection fraction of 40% or less, who were taking recommended therapy. The registry gives a minimum age of 18 years. The abstract says the effect on the primary outcome was consistent in people with and without diabetes.
- Not stated in the abstract. The registry record is not read for setting.
- Multinational: the registry lists many countries across several continents.
- Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
- Certainty method
- Not assessed
- Limitations
- One double-blind trial funded by Boehringer Ingelheim and Eli Lilly. The numbers come from the PubMed abstract; the full text, tables and registry results were not read. The abstract says patients were randomized but gives no age, setting or exclusion criteria, and no counts for infection. Median follow-up was 16 months. No certainty rating was assessed.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (8)
-
Supports Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
- Locator
- Abstract, RESULTS, sentence 1
- How it applies
- Primary outcome counts and hazard ratio. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6519ae8338ccd9e7fb161e306e177ad9a66f171c96ee4da655099894e0ff9ea8- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
- Locator
- Abstract, RESULTS, sentence 2
- How it applies
- Consistency with and without diabetes. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6519ae8338ccd9e7fb161e306e177ad9a66f171c96ee4da655099894e0ff9ea8- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
- Locator
- Abstract, RESULTS, sentence 3
- How it applies
- Total hospitalizations for heart failure. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6519ae8338ccd9e7fb161e306e177ad9a66f171c96ee4da655099894e0ff9ea8- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
- Locator
- Abstract, RESULTS, sentence 4
- How it applies
- Rate of decline in estimated glomerular filtration rate. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6519ae8338ccd9e7fb161e306e177ad9a66f171c96ee4da655099894e0ff9ea8- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
- Locator
- Abstract, RESULTS, sentence 5
- How it applies
- Genital tract infection. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6519ae8338ccd9e7fb161e306e177ad9a66f171c96ee4da655099894e0ff9ea8- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
- Locator
- Abstract, METHODS, sentence 1
- How it applies
- Who was randomized, the dose and the background therapy. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6519ae8338ccd9e7fb161e306e177ad9a66f171c96ee4da655099894e0ff9ea8- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
- Locator
- Abstract, METHODS, sentence 2
- How it applies
- How the primary outcome was defined. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6519ae8338ccd9e7fb161e306e177ad9a66f171c96ee4da655099894e0ff9ea8- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure
- Locator
- Abstract, CONCLUSIONS, sentence 2
- How it applies
- Funding statement and registry number. Abstract of the paper from PubMed; the full text was not read.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
6519ae8338ccd9e7fb161e306e177ad9a66f171c96ee4da655099894e0ff9ea8- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
Context Adults with chronic kidney disease at risk of progression (EMPA-KIDNEY)
- Recipient
- Adult
- Population
- Patients with chronic kidney disease who had an eGFR of at least 20 but less than 45 ml per minute per 1.73 m2, or an eGFR of at least 45 but less than 90 with a urinary albumin-to-creatinine ratio of at least 200. People with and without diabetes were included.
- Care setting
- Multicenter international trial (registry official title). The care setting is not described further in the sources read.
- Geography
- Multinational. The registry lists the sites by country on the study page.
- Life stage
- Adults aged 18 years or older (registry minimum age 18 years)
- Follow-up
- Median follow-up 2.0 years. The trial was stopped early for efficacy at a formal interim analysis.
Eligibility: 2 inclusion criteria; exclusion criteria not stated
- Included
- Chronic kidney disease
- eGFR at least 20 but less than 45 ml per minute per 1.73 m2, or at least 45 but less than 90 with an albumin-to-creatinine ratio of at least 200
- Excluded
- None stated
In EMPA-KIDNEY, 6609 patients with chronic kidney disease at risk of progression were randomly assigned to empagliflozin 10 mg once a day or matching placebo. Over a median of 2.0 years, kidney disease progression or death from cardiovascular causes occurred in 432 of 3304 patients (13.1%) on empagliflozin and 558 of 3305 (16.9%) on placebo (hazard ratio 0.72; 95% CI 0.64 to 0.82; P<0.001). Results were consistent in patients with and without diabetes and across the eGFR ranges studied. Hospitalization from any cause was lower on empagliflozin (hazard ratio 0.86; 95% CI 0.78 to 0.95; P=0.003). There were no significant differences in the composite of hospitalization for heart failure or death from cardiovascular causes (4.0% against 4.6%) or in death from any cause (4.5% against 5.1%). The full text, in the PMC copy, gives the hazard ratio for death from cardiovascular causes alone as 0.84 (95% CI 0.60 to 1.19). Serious adverse events were similar in the two groups.
Applies to Adult- Patients with chronic kidney disease who had an eGFR of at least 20 but less than 45 ml per minute per 1.73 m2, or an eGFR of at least 45 but less than 90 with a urinary albumin-to-creatinine ratio of at least 200. People with and without diabetes were included.
- Multicenter international trial (registry official title). The care setting is not described further in the sources read.
- Multinational. The registry lists the sites by country on the study page.
- Adults aged 18 years or older (registry minimum age 18 years)
- Certainty method
- Not assessed
- Limitations
- The trial was stopped early for efficacy at a formal interim analysis, according to the PMC full text. The PMC copy is a CC BY-ND article, quoted briefly. Funded by Boehringer Ingelheim, Eli Lilly and others (named in the abstract). The claim is about empagliflozin as tested in this one trial; it does not pool the other empagliflozin trials, which sit in other claims.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (7)
-
Supports Empagliflozin in Patients with Chronic Kidney Disease
- Locator
- Abstract, RESULTS, sentence 2
- How it applies
- Primary outcome events by arm, hazard ratio and p-value.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
d32e700391c241bb3cecba3ed4ca1bc4de49fe9f28d7c1f87c7ee4f84b6e0545- Reuse basis
- PMC Open Access subset article under https://creativecommons.org/licenses/by-nd/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/ch-pmc-PMC7614055.xml.
-
Supports Empagliflozin in Patients with Chronic Kidney Disease
- Locator
- Abstract, RESULTS, sentence 3; Abstract, RESULTS, sentence 4; Abstract, RESULTS, sentence 5
- How it applies
- Consistency by diabetes status, hospitalization, other outcomes and safety.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
d32e700391c241bb3cecba3ed4ca1bc4de49fe9f28d7c1f87c7ee4f84b6e0545- Reuse basis
- PMC Open Access subset article under https://creativecommons.org/licenses/by-nd/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/ch-pmc-PMC7614055.xml.
-
Supports Empagliflozin in Patients with Chronic Kidney Disease
- Locator
- Results, Primary and Secondary Outcomes, para 3, sentence 1
- How it applies
- Hazard ratios for the two parts of the primary outcome, from the PMC full text.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
d236f12892360025a5d23cc760b2ac15ce6062270fa6f373d91499a0408e2bd0- Reuse basis
- PMC Open Access subset article under https://creativecommons.org/licenses/by-nd/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/ch-pmc-PMC7614055.xml.
-
Supports Empagliflozin in Patients with Chronic Kidney Disease
- Locator
- Abstract, CONCLUSIONS, sentence 1
- How it applies
- The authors conclusion.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
d32e700391c241bb3cecba3ed4ca1bc4de49fe9f28d7c1f87c7ee4f84b6e0545- Reuse basis
- PMC Open Access subset article under https://creativecommons.org/licenses/by-nd/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/ch-pmc-PMC7614055.xml.
-
Background Empagliflozin in Patients with Chronic Kidney Disease
- Locator
- Results, Recruitment and Follow-Up, para 2, sentence 1
- How it applies
- The interim analysis at which the trial was stopped early for efficacy.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
d236f12892360025a5d23cc760b2ac15ce6062270fa6f373d91499a0408e2bd0- Reuse basis
- PMC Open Access subset article under https://creativecommons.org/licenses/by-nd/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/ch-pmc-PMC7614055.xml.
-
Background Empagliflozin in Patients with Chronic Kidney Disease
- Locator
- Abstract, METHODS, sentence 2; Abstract, METHODS, sentence 3
- How it applies
- Dose and primary outcome definition.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
d32e700391c241bb3cecba3ed4ca1bc4de49fe9f28d7c1f87c7ee4f84b6e0545- Reuse basis
- PMC Open Access subset article under https://creativecommons.org/licenses/by-nd/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/ch-pmc-PMC7614055.xml.
-
Background Empagliflozin in Patients with Chronic Kidney Disease
- Locator
- Abstract, CONCLUSIONS, sentence 2
- How it applies
- Funding line.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
d32e700391c241bb3cecba3ed4ca1bc4de49fe9f28d7c1f87c7ee4f84b6e0545- Reuse basis
- PMC Open Access subset article under https://creativecommons.org/licenses/by-nd/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/ch-pmc-PMC7614055.xml.
Context Adults with type 2 diabetes at high cardiovascular risk (EMPA-REG OUTCOME)
- Recipient
- Adult
- Population
- Patients with type 2 diabetes at high cardiovascular risk. The registry gives a minimum age of 18 years.
- Care setting
- Multicenter, international trial (registry official title). The care setting is not described further in the sources read.
- Geography
- Multinational. The registry lists the sites by country on the study page.
- Life stage
- Adults aged 18 years or older (registry minimum age 18 years)
- Follow-up
- Median observation time 3.1 years in 7020 treated patients.
Eligibility: 2 inclusion criteria; exclusion criteria not stated
- Included
- Type 2 diabetes
- High cardiovascular risk
- Excluded
- None stated
In EMPA-REG OUTCOME, patients with type 2 diabetes at high cardiovascular risk were randomly assigned to 10 mg or 25 mg of empagliflozin or placebo once a day, added to standard care; 7020 patients were treated, with a median observation time of 3.1 years. The primary outcome (death from cardiovascular causes, nonfatal heart attack or nonfatal stroke) occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and 282 of 2333 (12.1%) on placebo (hazard ratio 0.86; 95.02% CI 0.74 to 0.99; P=0.04 for superiority). Rates of heart attack and stroke did not differ significantly, but rates were lower on empagliflozin for death from cardiovascular causes (3.7% against 5.9%; a 38% relative reduction), hospitalization for heart failure (2.7% against 4.1%; 35%) and death from any cause (5.7% against 8.3%; 32%). There was no significant difference in the key secondary outcome (P=0.08). Genital infection was more frequent on empagliflozin.
Applies to Adult- Patients with type 2 diabetes at high cardiovascular risk. The registry gives a minimum age of 18 years.
- Multicenter, international trial (registry official title). The care setting is not described further in the sources read.
- Multinational. The registry lists the sites by country on the study page.
- Adults aged 18 years or older (registry minimum age 18 years)
- Certainty method
- Not assessed
- Limitations
- The two empagliflozin doses were analysed together against placebo. The abstract gives the percentages for cardiovascular death, heart-failure hospitalization and all-cause death with relative reductions, not hazard ratios, and this record repeats them as printed. Funded by Boehringer Ingelheim and Eli Lilly (named in the abstract). Only the PubMed abstract was read. The claim is about empagliflozin as tested in this one trial; it does not pool the other empagliflozin trials, which sit in other claims.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (6)
-
Supports Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
- Locator
- Abstract, RESULTS, sentence 2
- How it applies
- Primary outcome counts, hazard ratio and p-value.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
ad466a06bafa965b18544969f77821c62c52332106e45d4cb24d3e04468f50c1- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
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Supports Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
- Locator
- Abstract, RESULTS, sentence 3; Abstract, RESULTS, sentence 4
- How it applies
- Components of the outcome and the key secondary outcome.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
ad466a06bafa965b18544969f77821c62c52332106e45d4cb24d3e04468f50c1- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
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Supports Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
- Locator
- Abstract, RESULTS, sentence 1; Abstract, RESULTS, sentence 5
- How it applies
- Number treated, observation time and genital infection.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
ad466a06bafa965b18544969f77821c62c52332106e45d4cb24d3e04468f50c1- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
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Supports Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
- Locator
- Abstract, CONCLUSIONS, sentence 1
- How it applies
- The authors conclusion.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
ad466a06bafa965b18544969f77821c62c52332106e45d4cb24d3e04468f50c1- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
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Background Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
- Locator
- Abstract, METHODS, sentence 1; Abstract, METHODS, sentence 2; Abstract, METHODS, sentence 3
- How it applies
- Doses, primary outcome and key secondary outcome.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
ad466a06bafa965b18544969f77821c62c52332106e45d4cb24d3e04468f50c1- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
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Background Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
- Locator
- Abstract, CONCLUSIONS, sentence 2
- How it applies
- Funding line.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
ad466a06bafa965b18544969f77821c62c52332106e45d4cb24d3e04468f50c1- Reuse basis
- PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
Clinical links
Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.
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Claim, not a settled fact EMPEROR-Reduced: lower rate of cardiovascular death or hospitalization for worsening heart failure than placebo: Heart failure with reduced ejection fraction (HFrEF)
Applies to Adult- Patients with class II, III or IV heart failure and an ejection fraction of 40% or less, who were taking recommended therapy. The registry gives a minimum age of 18 years. The abstract says the effect on the primary outcome was consistent in people with and without diabetes.
- Not stated in the abstract. The registry record is not read for setting.
- Multinational: the registry lists many countries across several continents.
- Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
In EMPEROR-Reduced, adults with class II, III or IV heart failure and an ejection fraction of 40% or less took empagliflozin 10 mg once daily or placebo, in addition to recommended therapy. Over a median of 16 months, the primary outcome, cardiovascular death or hospitalization for worsening heart failure, occurred in 361 of 1863 people (19.4%) taking empagliflozin and 462 of 1867 (24.7%) taking placebo (hazard ratio 0.75, 95% CI 0.65 to 0.86). The authors report that the effect was consistent in people with and without diabetes. The total number of hospitalizations for heart failure was lower with empagliflozin (hazard ratio 0.70, 95% CI 0.58 to 0.85), and the yearly decline in estimated glomerular filtration rate was slower, at -0.55 against -2.28 ml per minute per 1.73 m2 of body surface area per year. Uncomplicated genital tract infection was reported more often with empagliflozin.Limitations. One double-blind trial funded by Boehringer Ingelheim and Eli Lilly. The numbers come from the PubMed abstract; the full text, tables and registry results were not read. The abstract says patients were randomized but gives no age, setting or exclusion criteria, and no counts for infection. Median follow-up was 16 months. No certainty rating was assessed.
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Claim, not a settled fact EMPEROR-Preserved: lower rate of cardiovascular death or hospitalization for heart failure than placebo: Heart failure with mildly reduced or preserved ejection fraction
Applies to Adult- Patients with class II to IV heart failure and an ejection fraction of more than 40%, who were taking usual therapy. The registry gives a minimum age of 18 years. The abstract says the effects appeared consistent in people with and without diabetes. The trial includes people with mildly reduced as well as preserved ejection fraction.
- Not stated in the abstract. The registry record is not read for setting.
- Multinational: the registry lists many countries across several continents.
- Adults, 18 years and over (registry minimum age). The abstract gives no mean age.
In EMPEROR-Preserved, adults with class II to IV heart failure and an ejection fraction of more than 40% took empagliflozin 10 mg once daily or placebo, in addition to usual therapy. Over a median of 26.2 months, the primary outcome, cardiovascular death or hospitalization for heart failure, occurred in 415 of 2997 people (13.8%) taking empagliflozin and 511 of 2991 (17.1%) taking placebo (hazard ratio 0.79, 95% CI 0.69 to 0.90). The authors say this effect was mainly related to a lower risk of hospitalization for heart failure with empagliflozin. Separately, the total number of hospitalizations for heart failure was 407 with empagliflozin and 541 with placebo (hazard ratio 0.73, 95% CI 0.61 to 0.88); these are counts of events and not of people. The effects appeared consistent in people with or without diabetes. Uncomplicated genital and urinary tract infections and low blood pressure were reported more often with empagliflozin.Limitations. One double-blind trial funded by Boehringer Ingelheim and Eli Lilly. The numbers come from the PubMed abstract; the full text, tables and registry results were not read. The abstract does not give the separate counts for cardiovascular death, so the claim does not say whether death alone differed. The trial enrolled people with an ejection fraction above 40%, a wider band than the preserved range NHLBI describes. No certainty rating was assessed.
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Claim, not a settled fact EMPA-REG OUTCOME: cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk: Type 2 diabetes
Applies to Adult- Patients with type 2 diabetes at high cardiovascular risk. The registry gives a minimum age of 18 years.
- Multicenter, international trial (registry official title). The care setting is not described further in the sources read.
- Multinational. The registry lists the sites by country on the study page.
- Adults aged 18 years or older (registry minimum age 18 years)
In EMPA-REG OUTCOME, patients with type 2 diabetes at high cardiovascular risk were randomly assigned to 10 mg or 25 mg of empagliflozin or placebo once a day, added to standard care; 7020 patients were treated, with a median observation time of 3.1 years. The primary outcome (death from cardiovascular causes, nonfatal heart attack or nonfatal stroke) occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and 282 of 2333 (12.1%) on placebo (hazard ratio 0.86; 95.02% CI 0.74 to 0.99; P=0.04 for superiority). Rates of heart attack and stroke did not differ significantly, but rates were lower on empagliflozin for death from cardiovascular causes (3.7% against 5.9%; a 38% relative reduction), hospitalization for heart failure (2.7% against 4.1%; 35%) and death from any cause (5.7% against 8.3%; 32%). There was no significant difference in the key secondary outcome (P=0.08). Genital infection was more frequent on empagliflozin.Limitations. The two empagliflozin doses were analysed together against placebo. The abstract gives the percentages for cardiovascular death, heart-failure hospitalization and all-cause death with relative reductions, not hazard ratios, and this record repeats them as printed. Funded by Boehringer Ingelheim and Eli Lilly (named in the abstract). Only the PubMed abstract was read. The claim is about empagliflozin as tested in this one trial; it does not pool the other empagliflozin trials, which sit in other claims.
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Claim, not a settled fact EMPA-KIDNEY: kidney disease progression or cardiovascular death in people with chronic kidney disease at risk of progression: Chronic kidney disease (CKD)
Applies to Adult- Patients with chronic kidney disease who had an eGFR of at least 20 but less than 45 ml per minute per 1.73 m2, or an eGFR of at least 45 but less than 90 with a urinary albumin-to-creatinine ratio of at least 200. People with and without diabetes were included.
- Multicenter international trial (registry official title). The care setting is not described further in the sources read.
- Multinational. The registry lists the sites by country on the study page.
- Adults aged 18 years or older (registry minimum age 18 years)
In EMPA-KIDNEY, 6609 patients with chronic kidney disease at risk of progression were randomly assigned to empagliflozin 10 mg once a day or matching placebo. Over a median of 2.0 years, kidney disease progression or death from cardiovascular causes occurred in 432 of 3304 patients (13.1%) on empagliflozin and 558 of 3305 (16.9%) on placebo (hazard ratio 0.72; 95% CI 0.64 to 0.82; P<0.001). Results were consistent in patients with and without diabetes and across the eGFR ranges studied. Hospitalization from any cause was lower on empagliflozin (hazard ratio 0.86; 95% CI 0.78 to 0.95; P=0.003). There were no significant differences in the composite of hospitalization for heart failure or death from cardiovascular causes (4.0% against 4.6%) or in death from any cause (4.5% against 5.1%). The full text, in the PMC copy, gives the hazard ratio for death from cardiovascular causes alone as 0.84 (95% CI 0.60 to 1.19). Serious adverse events were similar in the two groups.Limitations. The trial was stopped early for efficacy at a formal interim analysis, according to the PMC full text. The PMC copy is a CC BY-ND article, quoted briefly. Funded by Boehringer Ingelheim, Eli Lilly and others (named in the abstract). The claim is about empagliflozin as tested in this one trial; it does not pool the other empagliflozin trials, which sit in other claims.
Record details
- Record id
cardio:empagliflozin- Content hash
95fcde281a340af771a76fbaa4815ae8d653b026fea07f475de602e92ae0e3c5