{"id":"f0a352f4-1afb-50a6-bc18-3d3cbdb60845","stable_key":"8b3cf083-ea9c-54f5-b42b-bf1fef5b2978:metformin-lactic-acidosis-incidence","predicate":"associated_with","statement":"The crude incidence of lactic acidosis was 3.3 cases per 100,000 person-years among metformin users and 4.8 among sulfonylurea users, and relevant comorbidities known as risk factors were identifiable in all six cases.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"1f555c40-9b03-587f-8a64-3ae7ca13ac41","mechanism_event_label":"The event is very rare, and it was no more common than with the comparison drug.","subject":{"id":"519971b1-5aef-5ad7-8022-840144855cd0","slug":"metformin","display_name":"Metformin","entity_type_key":"drug"},"object":{"id":"3cae207b-dbfd-5818-92aa-ef6137ff568d","slug":"lactic-acidosis-incidence","display_name":"Incidence of lactic acidosis during oral antidiabetes-drug use","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"1f555c40-9b03-587f-8a64-3ae7ca13ac41","stable_key":"8b3cf083-ea9c-54f5-b42b-bf1fef5b2978:metformin-lactic-acidosis-incidence-event","event_type":"observed_intervention","label":"The event is very rare, and it was no more common than with the comparison drug.","description":"The crude incidence of lactic acidosis was 3.3 cases per 100,000 person-years among metformin users and 4.8 among sulfonylurea users, and relevant comorbidities known as risk factors were identifiable in all six cases.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"519971b1-5aef-5ad7-8022-840144855cd0","slug":"metformin","display_name":"Metformin","entity_type_key":"drug"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"3cae207b-dbfd-5818-92aa-ef6137ff568d","slug":"lactic-acidosis-incidence","display_name":"Incidence of lactic acidosis during oral antidiabetes-drug use","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"availability_state","value_text":"biomarker_context","comparator":null,"unit":null,"notes":"Imported condition classification; unverified.","entity":null},{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/metformin-research/18782901.abstract.txt\", \"locator\": \"Indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"1fb3a7b0fff3f288a6d6f3da8e2fea2746e2869eee8e4171fbf6568e48124243\", \"start_char\": 0, \"end_char\": 1676, \"text_sha256\": \"1fb3a7b0fff3f288a6d6f3da8e2fea2746e2869eee8e4171fbf6568e48124243\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Nested case-control analysis in 50,048 people with type 2 diabetes in the UK General Practice Research Database","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Current use of oral antidiabetes drugs","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"A population incidence estimate. Six cases in total is a very small numerator, and comorbidity was present in all of them.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Metformin research collection; topical membership is not evidence of a direct clinical effect, and pharmacological exposure is not dietary intake.","comparator":null,"unit":null,"notes":"","entity":{"slug":"metformin","display_name":"Metformin","entity_type_key":"drug"}},{"dimension":"organism","value_text":"Human","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"The event is very rare, and it was no more common than with the comparison drug.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[metformin-p18782901] Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis. (2008). https://pubmed.ncbi.nlm.nih.gov/18782901/ DOI: 10.2337/dc08-1171","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Whole body","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"trigger_kind","value_text":"biomarker_context","comparator":null,"unit":null,"notes":"Imported condition classification; unverified.","entity":null}],"evidence":[{"id":"1474ae08-464d-585a-a5f7-7f00ac15de1e","evidence_kind":"source_excerpt","locator":"Lines 1451-1462","start_line":1451,"end_line":1462,"excerpt":"### metformin-lactic-acidosis-incidence\nThe crude incidence of lactic acidosis was 3.3 cases per 100,000 person-years among metformin users and 4.8 among sulfonylurea users, and relevant comorbidities known as risk factors were identifiable in all six cases.\nCondition category: biomarker_context\nnutrient_topic: Metformin research collection; topical membership is not evidence of a direct clinical effect, and pharmacological exposure is not dietary intake.\nplain_language: The event is very rare, and it was no more common than with the comparison drug.\norganism: Human\ntissue_or_cell_type: Whole body\nexperimental_model: Nested case-control analysis in 50,048 people with type 2 diabetes in the UK General Practice Research Database\nlimitations: A population incidence estimate. Six cases in total is a very small numerator, and comorbidity was present in all of them.\nexposure: Current use of oral antidiabetes drugs\nevidence_span: {\"source_cache\": \"artifacts/metformin-research/18782901.abstract.txt\", \"locator\": \"Indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"1fb3a7b0fff3f288a6d6f3da8e2fea2746e2869eee8e4171fbf6568e48124243\", \"start_char\": 0, \"end_char\": 1676, \"text_sha256\": \"1fb3a7b0fff3f288a6d6f3da8e2fea2746e2869eee8e4171fbf6568e48124243\"}\n[metformin-p18782901] Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis. (2008). https://pubmed.ncbi.nlm.nih.gov/18782901/ DOI: 10.2337/dc08-1171","model_system":"Nested case-control analysis in 50,048 people with type 2 diabetes in the UK General Practice Research Database","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [metformin-p18782901] Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis. 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