{ "release_id": "5dcd9b263fe17744", "id": "cardio:dapagliflozin", "owner": "cardio", "kind": "drug", "slug": "dapagliflozin", "name": "Dapagliflozin", "aliases": [], "atlases": [ "cardio" ], "summary_plain": "The medicine inside Farxiga. It is an SGLT2 inhibitor. DAPA-HF tested it in adults with heart failure and an ejection fraction of 40% or less, and DELIVER tested it above 40%. In both trials fewer people taking dapagliflozin than placebo had worsening heart failure or died from cardiovascular causes, although in DELIVER cardiovascular death on its own did not show a clear difference.", "summary_technical": "RxNorm ingredient 1488564. US drug-label classes in RxClass: Sodium-Glucose Transporter 2 Inhibitors (mechanism of action) and Sodium-Glucose Cotransporter 2 Inhibitor (established pharmacologic class). DAPA-HF (NCT03036124) and DELIVER (NCT03619213) were sponsored by AstraZeneca. 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": "1488564", "normalized_value": "1488564", "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 dapagliflozin in RxClass is Sodium-Glucose Transporter 2 Inhibitors." }, "content_digest": "8e3a86da55881b012f00eddf352d4c00137b06a4682e73988027b66b2c0174ab", "review": { "content_digest": "8e3a86da55881b012f00eddf352d4c00137b06a4682e73988027b66b2c0174ab", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "5dcd9b263fe17744", "id": "cardio:claim-dapa-ckd-kidney-effect", "owner": "cardio", "subject_entity_id": "cardio:dapagliflozin", "category": "effect", "statement": "In DAPA-CKD, 4304 participants with chronic kidney disease, with or without type 2 diabetes, were randomly assigned to dapagliflozin 10 mg once a day or placebo. The independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, the primary outcome (a sustained eGFR decline of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes) occurred in 197 of 2152 participants (9.2%) on dapagliflozin and 312 of 2152 (14.5%) on placebo (hazard ratio 0.61; 95% CI 0.51 to 0.72; P<0.001; number needed to treat to prevent one primary event 19, 95% CI 15 to 27). The kidney composite had a hazard ratio of 0.56 (0.45 to 0.68) and cardiovascular death or heart-failure hospitalization 0.71 (0.55 to 0.92). Death occurred in 101 participants (4.7%) against 146 (6.8%) (hazard ratio 0.69; 0.53 to 0.88). Effects were similar in participants with and without type 2 diabetes, and the known safety profile of dapagliflozin was confirmed.", "context": { "id": "cardio:ctx-dapa-ckd-adults-ckd-with-or-without-type-2-diabetes", "label": "Adults with chronic kidney disease, with or without type 2 diabetes (DAPA-CKD)", "recipient": "adult", "population": "Participants with chronic kidney disease, an eGFR of 25 to 75 ml per minute per 1.73 m2 and a urinary albumin-to-creatinine ratio of 200 to 5000. People with and without type 2 diabetes were included.", "care_setting": "Multicenter trial. 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 2.4 years. The independent data monitoring committee recommended stopping the trial because of efficacy.", "eligibility": { "inclusion": [ "Chronic kidney disease", "eGFR 25 to 75 ml per minute per 1.73 m2", "Urinary albumin-to-creatinine ratio 200 to 5000" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The trial was stopped on the monitoring committee recommendation for efficacy. The abstract does not list adverse event numbers. Funded by AstraZeneca (named in the abstract). Only the PubMed abstract was read. The claim is about dapagliflozin as tested in this one trial; it does not pool the other dapagliflozin 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 number needed to treat.", "snapshot": { "id": "cardio:pubmed-32970396-2026-10-14", "retrieved_at": "2026-10-14T18:18:49Z", "content_hash": "00f73eca914196ec04ee4fa8f586078dda46e50024778d0c2b75d9542ebd2fd3", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa2024816", "source_type": "publication", "title": "Dapagliflozin in Patients with Chronic Kidney Disease", "canonical_url": "https://doi.org/10.1056/NEJMoa2024816", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa2024816", "normalized_value": "10.1056/nejmoa2024816", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "32970396", "normalized_value": "32970396", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2020-10-08", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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The full text and the version of record were not fetched.", "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.", "public_text": "quote" } } ], "review": { "content_digest": "0a78784ab46fa8d973052b83870c633ab997ae7dc00cf64a95f600979d868ed2", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-dapa-ckd-kidney-effect.json" }, { "release_id": "5dcd9b263fe17744", "id": "cardio:claim-dapa-hf-primary-effect", "owner": "cardio", "subject_entity_id": "cardio:dapagliflozin", "category": "effect", "statement": "In DAPA-HF, adults with class II, III or IV heart failure and an ejection fraction of 40% or less took dapagliflozin 10 mg once daily or placebo, in addition to recommended therapy. Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 people (16.3%) taking dapagliflozin and 502 of 2371 (21.2%) taking placebo (hazard ratio 0.74, 95% CI 0.65 to 0.85). The primary outcome was worsening heart failure, meaning a hospitalization or an urgent visit that led to intravenous heart-failure treatment, or death from cardiovascular causes. Death from cardiovascular causes occurred in 227 people (9.6%) and 273 (11.5%) respectively (hazard ratio 0.82, 95% CI 0.69 to 0.98), and death from any cause in 276 (11.6%) and 329 (13.9%) (hazard ratio 0.83, 95% CI 0.71 to 0.97). The authors report that findings in people with diabetes were similar to those in people without it, and that adverse events related to volume depletion, kidney dysfunction and low blood sugar did not differ between the groups.", "context": { "id": "cardio:ctx-dapa-hf-hfref-adults", "label": "Adults with chronic heart failure and an ejection fraction of 40% or less, with or without diabetes, on recommended therapy (DAPA-HF)", "recipient": "adult", "population": "Patients with New York Heart Association class II, III or IV heart failure and an ejection fraction of 40% or less, who were taking recommended heart-failure therapy. The registry gives a minimum age of 18 years (its maximum age field reads 130 years). The abstract says findings were similar 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 20 countries, including the United States, Canada, Brazil, China, India, Japan, Russia and several European countries.", "life_stage_note": "Adults, 18 years and over (registry minimum age). The abstract gives no mean age.", "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 18.2 months (abstract). The registry gives the primary outcome time frame as up to 27.8 months.", "eligibility": { "inclusion": [ "Heart failure of NYHA class II, III or IV", "Ejection fraction of 40% or less", "Taking recommended heart-failure therapy (abstract)" ], "exclusion": [ "Exclusion criteria were not read; the abstract does not list them" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "One placebo-controlled trial funded by AstraZeneca, which is also the registry lead sponsor. The numbers come from the PubMed abstract; the full text, supplementary tables and the registry results section were not read, so no subgroup counts are given and the abstract gives no counts for the adverse events it mentions. Median follow-up was 18.2 months, so the claim says nothing about longer use. Entry age, setting and exclusion criteria were not read. No certainty rating was assessed.", "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 1", "applicability_note": "Primary outcome counts and hazard ratio. 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Abstract of the paper from PubMed; the full text was not read.", "snapshot": { "id": "cardio:pubmed-31535829-2026-10-14", "retrieved_at": "2026-10-14T18:18:44Z", "content_hash": "d86f142d100d12573e1bc9993fbf40729a81ab213219aa50b1d716709bcb2b4c", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1911303", "source_type": "publication", "title": "Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction", "canonical_url": "https://doi.org/10.1056/NEJMoa1911303", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1911303", "normalized_value": "10.1056/nejmoa1911303", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "31535829", "normalized_value": "31535829", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-11-21", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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Abstract of the paper from PubMed; the full text was not read.", "snapshot": { "id": "cardio:pubmed-31535829-2026-10-14", "retrieved_at": "2026-10-14T18:18:44Z", "content_hash": "d86f142d100d12573e1bc9993fbf40729a81ab213219aa50b1d716709bcb2b4c", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1911303", "source_type": "publication", "title": "Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction", "canonical_url": "https://doi.org/10.1056/NEJMoa1911303", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1911303", "normalized_value": "10.1056/nejmoa1911303", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "31535829", "normalized_value": "31535829", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-11-21", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.", "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.", "public_text": "quote" } } ], "review": { "content_digest": "c42deb3300cb5d8842f7a92a819133f4ed931809bdedd9ac10589408707bd7fa", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-dapa-hf-primary-effect.json" }, { "release_id": "5dcd9b263fe17744", "id": "cardio:claim-declare-timi-58-effect", "owner": "cardio", "subject_entity_id": "cardio:dapagliflozin", "category": "effect", "statement": "In DECLARE-TIMI 58, patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease took dapagliflozin or placebo. The paper evaluated 17,160 patients, 10,186 of them without atherosclerotic cardiovascular disease, for a median of 4.2 years. Dapagliflozin met the prespecified noninferiority criterion for the primary safety outcome of major adverse cardiovascular events (upper boundary of the 95% CI below 1.3). It did not lower the rate of major adverse cardiovascular events: 8.8% on dapagliflozin and 9.4% on placebo (hazard ratio 0.93; 95% CI 0.84 to 1.03; P=0.17). It did lower the rate of cardiovascular death or hospitalization for heart failure (4.9% against 5.8%; hazard ratio 0.83; 95% CI 0.73 to 0.95), which reflected fewer hospitalizations for heart failure (hazard ratio 0.73; 0.61 to 0.88); there was no difference in cardiovascular death (0.98; 0.82 to 1.17). A renal event occurred in 4.3% against 5.6% (hazard ratio 0.76; 0.67 to 0.87), and death from any cause in 6.2% against 6.6% (0.93; 0.82 to 1.04). Diabetic ketoacidosis was more common on dapagliflozin (0.3% against 0.1%; P=0.02), as were genital infections that led to stopping the medicine or were serious (0.9% against 0.1%; P<0.001).", "context": { "id": "cardio:ctx-declare-adults-type-2-diabetes-ascvd-or-risk", "label": "Adults with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease (DECLARE-TIMI 58)", "recipient": "adult", "population": "Patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease; 10,186 of the 17,160 evaluated did not have atherosclerotic cardiovascular disease. The registry gives a minimum age of 40 years.", "care_setting": "Multicenter trial. 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 40 years or older (registry minimum age 40 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 4.2 years.", "eligibility": { "inclusion": [ "Type 2 diabetes", "Atherosclerotic cardiovascular disease, or risk factors for it" ], "exclusion": [] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "The primary efficacy outcome for major adverse cardiovascular events was null, so the benefit shown is for the second primary efficacy outcome, driven by heart-failure hospitalization. The registry counts 17,190 enrolled and the abstract 17,160 evaluated; this atlas does not reconcile them. Funded by AstraZeneca (named in the abstract). Only the PubMed abstract was read. The claim is about dapagliflozin as tested in this one trial; it does not pool the other dapagliflozin 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; Abstract, RESULTS, sentence 3", "applicability_note": "Primary safety and efficacy results, including the null major adverse cardiovascular event result.", "snapshot": { "id": "cardio:pubmed-30415602-2026-10-14", "retrieved_at": "2026-10-14T18:18:49Z", "content_hash": "f5bb215bfcaad135a312fbef8dc48eda491d7ce2465dbbf106f0593bea2fe0ba", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "cardio:pubmed-10-1056-nejmoa1812389", "source_type": "publication", "title": "Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes", "canonical_url": "https://doi.org/10.1056/NEJMoa1812389", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa1812389", "normalized_value": "10.1056/nejmoa1812389", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "30415602", "normalized_value": "30415602", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2019-01-24", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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The full text and the version of record were not fetched.", "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.", "public_text": "quote" } } ], "review": { "content_digest": "0631919e5bfc1f2982840687700385af6b218209009fea09bddcb83f4df57690", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/cardio--claim-declare-timi-58-effect.json" }, { "release_id": "5dcd9b263fe17744", "id": "cardio:claim-deliver-primary-effect", "owner": "cardio", "subject_entity_id": "cardio:dapagliflozin", "category": "effect", "statement": "In DELIVER, adults with heart failure and a left ventricular ejection fraction of more than 40% took dapagliflozin 10 mg once daily or matching placebo, in addition to usual therapy. Over a median of 2.3 years, the primary outcome, worsening heart failure (an unplanned hospitalization or an urgent visit for heart failure) or cardiovascular death, occurred in 512 of 3131 people (16.4%) taking dapagliflozin and 610 of 3132 (19.5%) taking placebo (hazard ratio 0.82, 95% CI 0.73 to 0.92). Worsening heart failure alone occurred in 368 people (11.8%) and 455 (14.5%) respectively (hazard ratio 0.79, 95% CI 0.69 to 0.91). Cardiovascular death alone occurred in 231 people (7.4%) and 261 (8.3%) (hazard ratio 0.88, 95% CI 0.74 to 1.05); the confidence interval includes 1, so the abstract does not show a difference in cardiovascular death on its own. The authors report that results were similar in people with an ejection fraction of 60% or more and those below 60%, and in prespecified subgroups including patients with or without diabetes, and that the incidence of adverse events was similar in the two groups.", "context": { "id": "cardio:ctx-deliver-hf-ef-over-40-adults", "label": "Adults with heart failure and an ejection fraction above 40%, mildly reduced or preserved, on usual therapy (DELIVER)", "recipient": "adult", "population": "Patients with heart failure and a left ventricular ejection fraction of more than 40%, who were taking usual therapy. The registry gives a minimum age of 40 years. The abstract says results were similar in people with an ejection fraction of 60% or more and those below 60%, and in subgroups including patients with or 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, 40 years and over (registry minimum age).", "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 2.3 years (abstract).", "eligibility": { "inclusion": [ "Heart failure", "Left ventricular ejection fraction of more than 40%", "Taking usual therapy for heart failure (abstract)" ], "exclusion": [ "Exclusion criteria were not read; the abstract does not list them" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "One placebo-controlled trial funded by AstraZeneca. The numbers come from the PubMed abstract; the full text, tables and registry results were not read. Worsening heart failure alone had a hazard ratio of 0.79 (0.69 to 0.91); cardiovascular death alone had 0.88 (0.74 to 1.05), an interval that includes 1. The abstract title says mildly reduced or preserved ejection fraction, while the registry condition says preserved. No certainty rating was assessed.", "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 1", "applicability_note": "Primary outcome counts and hazard ratio. 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