{"id":"a3516388-4b51-5732-b68a-af0028eaf876","stable_key":"a9dd23c6-978a-5755-8bd8-f29bd1fe0cda:nia-clin-hps-glycemic-harm","predicate":"combination_increases","statement":"Niacin–laropiprant increased serious diabetes-control disturbances by 3.7 percentage points and new diabetes diagnoses by 1.3 points; gastrointestinal, musculoskeletal, skin, infection and bleeding serious adverse events also increased.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"positive","is_public":true,"mechanism_event_id":"c9d06917-406b-5f8d-98bd-f3d87437978b","mechanism_event_label":"The combination had measurable harms as well as lipid effects.","subject":{"id":"9751fdb6-9b30-586f-b07a-79b8e2cd62dd","slug":"nicotinic-acid","display_name":"Nicotinic acid","entity_type_key":"small_molecule"},"object":{"id":"6a672fe8-b53f-5a0d-9e68-16ab648829a3","slug":"serious-glycemic-adverse-event-incidence","display_name":"Serious glycemic adverse-event incidence","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"c9d06917-406b-5f8d-98bd-f3d87437978b","stable_key":"a9dd23c6-978a-5755-8bd8-f29bd1fe0cda:nia-clin-hps-glycemic-harm-event","event_type":"observed_intervention","label":"The combination had measurable harms as well as lipid effects.","description":"Niacin–laropiprant increased serious diabetes-control disturbances by 3.7 percentage points and new diabetes diagnoses by 1.3 points; gastrointestinal, musculoskeletal, skin, infection and bleeding serious adverse events also increased.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"9ebcef37-189c-5599-b463-108eff6c929a","slug":"laropiprant","display_name":"Laropiprant / MK-0524","entity_type_key":"small_molecule"},"role":"coadministered_drug","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"9751fdb6-9b30-586f-b07a-79b8e2cd62dd","slug":"nicotinic-acid","display_name":"Nicotinic acid","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"6a672fe8-b53f-5a0d-9e68-16ab648829a3","slug":"serious-glycemic-adverse-event-incidence","display_name":"Serious glycemic adverse-event incidence","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"cross_nutrient","value_text":"Laropiprant / MK-0524 (coadministered_drug)","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/niacin-clinical-sources/hps2014.abstract.txt\", \"locator\": \"Indexed primary abstract\", \"file_sha256\": \"9f12db5e258418187e65c3b921cffd01bf3cc0f400d3caa19cb4005c5e6f4f05\", \"start_char\": 0, \"end_char\": 2717, \"text_sha256\": \"9f12db5e258418187e65c3b921cffd01bf3cc0f400d3caa19cb4005c5e6f4f05\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"HPS2-THRIVE randomized trial; 25,673 adults with vascular disease on statin-based therapy","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Extended-release nicotinic acid 2 g plus laropiprant 40 mg daily; median 3.9 years","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Combination regimen; observed harm cannot all be assigned to nicotinic acid alone. Run-in selected participants able to tolerate initial therapy. Outcomes do not address deficiency replacement.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Niacin research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"niacin","display_name":"Niacin (vitamin B3)","entity_type_key":"nutrient_element"}},{"dimension":"organism","value_text":"Homo sapiens","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"The combination had measurable harms as well as lipid effects.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[nia-clin-hps2014] Effects of extended-release niacin with laropiprant in high-risk patients. (2014). https://pubmed.ncbi.nlm.nih.gov/25014686/ DOI: 10.1056/nejmoa1300955","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Major vascular events and adverse events","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"67ebd8ff-4496-5674-ad4c-79c796e0501a","evidence_kind":"source_excerpt","locator":"Lines 1417-1429","start_line":1417,"end_line":1429,"excerpt":"### nia-clin-hps-glycemic-harm\nNiacin–laropiprant increased serious diabetes-control disturbances by 3.7 percentage points and new diabetes diagnoses by 1.3 points; gastrointestinal, musculoskeletal, skin, infection and bleeding serious adverse events also increased.\nCondition category: normal\nnutrient_topic: Niacin research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: The combination had measurable harms as well as lipid effects.\norganism: Homo sapiens\ntissue_or_cell_type: Major vascular events and adverse events\nexperimental_model: HPS2-THRIVE randomized trial; 25,673 adults with vascular disease on statin-based therapy\nlimitations: Combination regimen; observed harm cannot all be assigned to nicotinic acid alone. Run-in selected participants able to tolerate initial therapy. Outcomes do not address deficiency replacement.\nexposure: Extended-release nicotinic acid 2 g plus laropiprant 40 mg daily; median 3.9 years\ncross_nutrient: Laropiprant / MK-0524 (coadministered_drug)\nevidence_span: {\"source_cache\": \"artifacts/niacin-clinical-sources/hps2014.abstract.txt\", \"locator\": \"Indexed primary abstract\", \"file_sha256\": \"9f12db5e258418187e65c3b921cffd01bf3cc0f400d3caa19cb4005c5e6f4f05\", \"start_char\": 0, \"end_char\": 2717, \"text_sha256\": \"9f12db5e258418187e65c3b921cffd01bf3cc0f400d3caa19cb4005c5e6f4f05\"}\n[nia-clin-hps2014] Effects of extended-release niacin with laropiprant in high-risk patients. 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