{ "release_id": "f6f6f1b6f50379ed", "id": "cardio:empagliflozin", "owner": "cardio", "kind": "drug", "slug": "empagliflozin", "name": "Empagliflozin", "aliases": [], "atlases": [ "cardio" ], "summary_plain": "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.", "summary_technical": "RxNorm ingredient 1545653. US drug-label 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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "rxnorm", "value": "1545653", "normalized_value": "1545653", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "cardio": { "system": [ "heart" ], "condition-area": [ "heart-failure", "diabetes-and-metabolic-disease", "kidney-connections" ] } }, "payload": { "level": "substance", "mechanism": "The US drug-label mechanism-of-action class for empagliflozin in RxClass is Sodium-Glucose Transporter 2 Inhibitors." }, "content_digest": "8f8b2c5b77b4e83e144b8298d55ff4ef5efd4c82c57509c85370bcf84e15a20a", "review": { "content_digest": "8f8b2c5b77b4e83e144b8298d55ff4ef5efd4c82c57509c85370bcf84e15a20a", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-empa-kidney-effect", "owner": "cardio", "subject_entity_id": "cardio:empagliflozin", "category": "effect", "statement": "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.", "context": { "id": "cardio:ctx-empa-kidney-adults-ckd-at-risk-of-progression", "label": "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_note": "Adults aged 18 years or older (registry minimum age 18 years)", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Median follow-up 2.0 years. The trial was stopped early for efficacy at a formal interim analysis.", "eligibility": { "inclusion": [ "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" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-14", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 2", "applicability_note": "Primary outcome events by arm, hazard ratio and p-value.", "snapshot": { "id": "cardio:pubmed-36331190-2026-10-14", "retrieved_at": "2026-10-14T18:18:49Z", "content_hash": "d32e700391c241bb3cecba3ed4ca1bc4de49fe9f28d7c1f87c7ee4f84b6e0545", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pmc-pmc7614055", "source_type": "publication", "title": "Empagliflozin in Patients with Chronic Kidney Disease", "canonical_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7614055/", "identifiers": [ { "scheme": "pmcid", "value": "PMC7614055", "normalized_value": "PMC7614055", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "36331190", "normalized_value": "36331190", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "doi", "value": "10.1056/NEJMoa2204233", "normalized_value": "10.1056/nejmoa2204233", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": null, "publisher": "The New England journal of medicine", "edition": "PMC Open Access subset full-text XML, from NCBI E-utilities. 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The raw file is committed at research/snapshots/ch-pmc-PMC7614055.xml.", "public_text": "quote" } } ], "review": { "content_digest": "f8aec744c9d500f0ae992f6c74a664d84095239d2bc48f5749001699bcb5be5a", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-empa-kidney-effect.json" }, { "release_id": "f6f6f1b6f50379ed", "id": "cardio:claim-empa-reg-outcome-primary-effect", "owner": "cardio", "subject_entity_id": "cardio:empagliflozin", "category": "effect", "statement": "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.", "context": { "id": "cardio:ctx-empa-reg-adults-type-2-diabetes-high-cv-risk", "label": "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_note": "Adults aged 18 years or older (registry minimum age 18 years)", "life_stage_terms": null, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Median observation time 3.1 years in 7020 treated patients.", "eligibility": { "inclusion": [ "Type 2 diabetes", "High cardiovascular risk" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The two empagliflozin doses were analysed together against placebo. 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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. 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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.", "context": { "id": "cardio:ctx-emperor-reduced-hfref-adults", "label": "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_note": "Adults, 18 years and over (registry minimum age). 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