{"id":"49af0985-0876-5c42-9834-b7d9c56b87d0","stable_key":"8ccb5461-efe2-5d95-9869-950d7cd50575:tadalafil-lowers-prostate-symptom-score","predicate":"reduces","statement":"Tadalafil 5 mg once daily improved the total International Prostate Symptom Score by a mean difference of 2.3 points against placebo in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.","claim_class":"mechanistic","status":"source_derived_draft","evidence_grade":"ungraded","direction":"negative","is_public":true,"mechanism_event_id":"4bc17c13-f039-5478-ad02-68502a4accc8","mechanism_event_label":"Tadalafil 5 mg once daily improved the total International Prostate Symptom Score by a mean difference of 2.3 points against placebo in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.","subject":{"id":"9820ebfe-515d-50cc-9b44-2bd2be220325","slug":"tadalafil","display_name":"Tadalafil","entity_type_key":"drug"},"object":{"id":"30ee06e8-4f70-57ee-954e-670c3165e561","slug":"ipss-total-score","display_name":"Total International Prostate Symptom Score","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"4bc17c13-f039-5478-ad02-68502a4accc8","stable_key":"8ccb5461-efe2-5d95-9869-950d7cd50575:tadalafil-lowers-prostate-symptom-score-event","event_type":"observed_relationship","label":"Tadalafil 5 mg once daily improved the total International Prostate Symptom Score by a mean difference of 2.3 points against placebo in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.","description":"Tadalafil 5 mg once daily improved the total International Prostate Symptom Score by a mean difference of 2.3 points against placebo in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"9820ebfe-515d-50cc-9b44-2bd2be220325","slug":"tadalafil","display_name":"Tadalafil","entity_type_key":"drug"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"30ee06e8-4f70-57ee-954e-670c3165e561","slug":"ipss-total-score","display_name":"Total International Prostate Symptom Score","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"0be8b435-6b8a-592c-bd4c-c0efd9481a97","slug":"pde5-family","display_name":"Phosphodiesterase 5 family","entity_type_key":"protein_family"},"role":"context_participant","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"duration","value_text":"12 weeks","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"evidence_access","value_text":"Primary PubMed abstract and indexed metadata reviewed. Full-text method details not stated here remain unresolved.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"1500 men pooled from four international randomised placebo-controlled studies","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Tadalafil 5 mg once daily against placebo","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"A pooled analysis rather than a single trial. Improvements were significant regardless of baseline symptom severity, age, recent alpha-blocker or PDE5 inhibitor use, total testosterone or predicted prostate volume, so no subgroup was identified in which the effect was absent, and the mechanism in this tissue is not established by the symptom score. PubMed records an erratum for this paper without a resolvable identifier, and the abstract itself carries an inline corrected marker, so it is not known whether the erratum altered these figures.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"organism","value_text":"1500 men pooled from four international randomised placebo-controlled studies","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"Tadalafil 5 mg once daily improved the total International Prostate Symptom Score by a mean difference of 2.3 points against placebo in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia. (2013). https://pubmed.ncbi.nlm.nih.gov/23876588/ DOI: 10.1016/j.urology.2013.05.005","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"route","value_text":"Oral","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue","value_text":"Lower urinary tract symptoms","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"2702fbe0-f2a5-59d7-a969-443171e27091","evidence_kind":"source_excerpt","locator":"Lines 111-120","start_line":111,"end_line":120,"excerpt":"## tadalafil-lowers-prostate-symptom-score\nTadalafil 5 mg once daily improved the total International Prostate Symptom Score by a mean difference of 2.3 points against placebo in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia.\nModel/species: 1500 men pooled from four international randomised placebo-controlled studies\nTissue/system: Lower urinary tract symptoms\nExposure: Tadalafil 5 mg once daily against placebo\nRoute: Oral\nDuration: 12 weeks\nLimits: A pooled analysis rather than a single trial. Improvements were significant regardless of baseline symptom severity, age, recent alpha-blocker or PDE5 inhibitor use, total testosterone or predicted prostate volume, so no subgroup was identified in which the effect was absent, and the mechanism in this tissue is not established by the symptom score. PubMed records an erratum for this paper without a resolvable identifier, and the abstract itself carries an inline corrected marker, so it is not known whether the erratum altered these figures.\nPrimary reference: Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia. (2013). https://pubmed.ncbi.nlm.nih.gov/23876588/ DOI: 10.1016/j.urology.2013.05.005\nAccess: Primary PubMed abstract and indexed metadata reviewed. Full-text method details not stated here remain unresolved.","model_system":"","directness":"reported_statement","verification_status":"source_derived_draft","notes":"","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"cca24ae7-e036-525c-a440-4cc2e38ccb4d","stable_key":"import-8ccb5461-efe2-5d95-9869-950d7cd50575","title":"Tadalafil: PDE5 occupancy, the cGMP route and three measured endpoints (2026-09-22)","document_type":"imported_text","citation_label":"Original AI-assisted curation of seven primary studies resolved by PubMed title search, with every abstract read and all DOIs cross-checked against live PubMed metadata. Two references carry an unresolvable erratum and are recorded as corrected. Study-specific doses, effect sizes and limitations retained. Not publisher full text.","file_path":"","sha256":"3df8ec8f7114f983e8cae9fbc54912d3ac5b5f962454afea9dd8d4438c94cded","revision_id":"510acdea-65ae-57a6-b743-68e031ff1f05","review_status":"unverified_draft","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}