185-OR: Efficacy and Safety of Bempedoic Acid in Patients with Diabetes, Prediabetes, and Normoglycemia: Analysis of Pooled Patient-Level Data from Four Phase 3 Clinical Trials
Bibliographic record
Abstract
Background: Current guidelines support aggressive LDL-C lowering in patients with diabetes. We assessed the efficacy and safety of BA, a first-in-class ATP-citrate lyase inhibitor, by baseline glycemic status (diabetes, prediabetes, or normoglycemia) in patients with hypercholesterolemia. Methods: Four phase 3 trials randomized 3623 patients on stable lipid-lowering therapy to receive BA 180 mg or placebo (PBO) once daily for 12 to 52 weeks. Studies were grouped into 2 pools by enrollment criteria (52-weeks in patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia vs. 12- or 24- weeks in patients with statin intolerance). Primary efficacy endpoint was percent change from baseline to week 12 in LDL-C. Results: In both pools, BA significantly lowered LDL-C compared with PBO, regardless of baseline glycemic status (all P<.001; Table). Significant reductions with BA vs. PBO were seen in total cholesterol, non-HDL-C, apolipoprotein B, and hsCRP (all P<.01). The safety profile of BA was similar to PBO and did not vary by glycemic status. BA did not worsen measures of glycemic control or increase occurrence of new-onset diabetes mellitus compared with PBO. Conclusion: BA significantly lowered LDL-C and had a safety profile comparable to PBO, regardless of baseline glycemic status. Disclosure L.A. Leiter: Advisory Panel; Self; Abbott, Amgen, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier. Research Support; Self; Amgen, AstraZeneca, Kowa Pharmaceuticals America, Inc., Medicines Company. Speaker’s Bureau; Self; Amgen, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Medscape, Merck & Co., Inc., Novo Nordisk Inc., Sanofi, Servier. M. Banach: Advisory Panel; Self; Esperion Therapeutics, Inc., Novo Nordisk Inc. Research Support; Self; Resverlogix Corp. Speaker’s Bureau; Self; Amgen, Sanofi. A.L. Catapano: Other Relationship; Self; Akcea Therapeutics, Amgen, Daiichi Sankyo, Esperion Therapeutics, Inc., Kowa Company, Ltd., Menarini Group, Mylan, Novartis, Ionis Pharmaceuticals, Medco, MSD, Recordati, Astrazeneca, Aegerion, Amryt, Eli Lilly, Genzyme, Regeneron Pharmaceuticals, Sanofi. P. Duell: Consultant; Self; Akcea Therapeutics, AstraZeneca, Esperion Therapeutics, Inc. Other Relationship; Self; Regeneron Pharmaceuticals, REGENXBIO Inc., Retrophin, Inc. A. Gotto: Board Member; Self; Esperion Therapeutics, Inc. Consultant; Self; Amarin Corporation, Kowa Company, Ltd. Other Relationship; Self; Ionis Pharmaceuticals, Inc. U. Laufs: Advisory Panel; Self; Esperion Therapeutics, Inc. G. Mancini: Advisory Panel; Self; Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Boehringer Ingelheim (Canada) Ltd., Esperion Therapeutics, Inc., HLS Therapeutics, Inc., Sanofi. K.K. Ray: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Esperion Therapeutics, Inc., Novo Nordisk Inc., Sanofi. J.C. Hanselman: Employee; Self; Esperion Therapeutics, Inc. Stock/Shareholder; Self; Esperion Therapeutics, Inc. A. Feng: Employee; Self; Esperion Therapeutics, Inc. H. Bays: Advisory Panel; Self; Esperion Therapeutics, Inc. Consultant; Self; Kowa Company, Ltd. Research Support; Self; Abbott, Acasti, Akcea, Amarin Corporation, Amgen, AstraZeneca, Dr. Reddy’s Laboratories, Esperion Therapeutics, Inc., Gan & Lee Pharmaceuticals, Ionis Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Johnson & Johnson, LIB, Lilly Diabetes, Matinas BioPharma, Medicines Company, MedImmune, Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Regeneron Pharmaceuticals, Sanofi.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".