Metabolic & Cardiometabolic
bempedoic acid increases uric acid and gout risk
In plain terms: Does bempedoic acid raise serum uric acid and increase gout risk?
Strong support Metabolic & Cardiometabolic
Part of: 💊 bempedoic acid
RefutedContestedStrong support
consensus score 0.82
Yes — it modestly and reversibly raises serum uric acid (via OAT2/OAT3 inhibition of renal urate excretion) and increases gout incidence roughly 1.5-3 fold, concentrated in those with prior gout or high baseline urate; absolute risk remains low.
📅 Last reviewed: 2026-07-15 ⓘ
Evidence ladder
How far up the ladder this claim has climbed. A high consensus on a low rung means "consistent so far," not "proven in people."
Top evidence so far: All trials, pooled (Meta-analysis)
MechanismIn-vitroAnimalObservationalRCTMeta-analysis
How the studies fall
8 support 0 contradict 0 tested null 3 mixed · 11 sources, 8 independent groups · 2 superseded — pooled inside a review, counted once
The evidence (19)
| Source | Grade | Stance | Quality | Finding |
|---|---|---|---|---|
| Gómez-Barrado JJ et al 2025 · Preprints.org | observational | mixed | moderate | Prospective real-world study, n=118 CCS patients on bempedoic acid 180mg/day added to intensive LLT: uric acid increased by 0.96 mg/dL over >=8 weeks, with no gout events observed. |
| d10-5281-zenodo-17710926 2025 · Zenodo (CERN European Organization for Nuclear Research) | observational | supports | low | States bempedoic acid use is associated with an increased risk of developing gout, likely due to elevated serum uric acid levels as evidenced in various studies. |
| Ray 2019 · N Engl J Med | RCT | supports | high | CLEAR Harmony (n=2230, 52 wk, on max-tolerated statin): 'the incidence of adverse events leading to discontinuation of the regimen was higher in the bempedoic acid group than in the placebo group (162 patients [10.9%] vs. 53 [7.1%]), as was the incidence of gout (18 patients [1.2%] vs. 2 [0.3%]).' Gout is the uric-acid-relevant signal; no serum uric acid values, hyperuricemia AE rate, or significance test for gout are reported in the available (abstract-only) text. ↩ SUPERSEDED — pooled in the review above, counted once |
| Zeng W et al 2025 · study_type: observational | observational | supports | low | Safety review of statin alternatives states bempedoic acid is associated with a small increase in plasma uric acid and slightly increased frequency of gout episodes in susceptible subjects. |
| Bonanni 2026 · Nutr Metab Cardiovasc Dis | mechanism | supports | moderate | Mechanism: bempedoic acid inhibits renal OAT2/OAT3, reducing urate excretion; the uric-acid rise is minor and reversible. |
| Bays 2024 · J Clin Lipidol | RCT | supports | moderate | CLEAR Outcomes safety analysis: confirms higher gout and uric-acid elevation rates, but absolute event numbers low and rarely treatment-limiting. |
| De Filippo 2023 · Cardiovasc Diabetol | meta-analysis | supports | high | Gout was a pre-specified safety endpoint, pooled directly across 7 trials / 17,497 patients: OR 1.55 (95% CI 1.27-1.90, I2 = 0% - no heterogeneity) vs placebo; the authors conclude 'The present data confirm that BA is associated with a significant increase of gout.' SCOPE CAVEAT: serum uric acid was never itself a pooled endpoint. The uric-acid limb of this claim rests only on the authors' mechanistic reading - 'This effect is attributed to a competition between uric acid and the glucuronide metabolite for the same renal transporter' - and they report the risk concentrates in patients with pre-existing gout. Other safety endpoints in the same analysis were null or favourable (muscle-related AEs OR 1.00, 0.92-1.09; myalgia OR 0.86, 0.75-0.98; new-onset diabetes OR 0.94, 0.82-1.06; serious AEs OR 1.03, 0.96-1.11), so gout is the isolated harm signal, not one of a cluster. 'Funding None' / 'Competing interests None declared'; over 70% of the pooled sample is CLEAR OUTCOMES (Nissen 2023), so this is not independent of a Nissen-2023 appraisal on the same claim. |
| Duarte Lau 2023 · JAMA Cardiol | mechanism | supports | moderate | Narrative review of ACLY inhibition notes elevated uric acid as an on-target/transporter-mediated class effect of bempedoic acid. |
| Venkatraman, Das, Eerike, Cherian, Bagepally 2023 · Eur J Clin Pharmacol 2023;79(11):1453-1463 | meta-analysis | supports | moderate | SR + random-effects MA of 17 RCTs (n = 21,131): 'there was a significant increase in the risk of hyperuricemia [RR, 2.05 (95% CI: 1.81 to 2.33), p < 0.001] following bempedoic acid treatment.' Roughly doubled hyperuricemia risk, tempered by the authors: 'The number needed to harm was large for all safety outcomes. The GRADE of evidence was moderate for all outcomes.' GOUT as a distinct endpoint is not reported in the available abstract, so this vote rests on the uric-acid half of the claim only. |
| Alunno 2023 · Front Cardiovasc Med | RCT | mixed | moderate | Systematic review: gout signal real but inconsistent across RCTs — significant in only 1 study; baseline urate/gout history poorly reported; risk likely concentrated in predisposed patients. |
| Strikic D et al 2025 · study_type: observational | observational | supports | low | Narrative review states that adverse effects such as increased uric acid and gout have been reported with bempedoic acid, requiring careful patient selection and monitoring. |
| Gomez-Barrado JJ et al 2025 · Research Square | observational | mixed | moderate | Prospective real-world study, n=118/125 CCS patients (same cohort as related preprint): uric acid rose by 0.96 mg/dL, but no gout occurred; renal function changes were small. |
| Goldberg 2019 · JAMA | RCT | supports | moderate | CLEAR Wisdom: hyperuricemia 4.2% vs 1.9% placebo among common adverse events. ↩ SUPERSEDED — pooled in the review above, counted once |
| Su PH et al 2026 · study_type: observational | observational | mixed | moderate | Retrospective cohort, 7676 propensity-matched pairs (bempedoic acid vs ezetimibe): incident hyperuricemia (UA>7.0mg/dL) HR 1.94 (95% CI 1.58-2.37) at 12 months. Anti-gout therapy initiation did not differ between groups (HR 1.06, 95% CI 0.8 |
| Uddin 2023 · Curr Probl Cardiol | meta-analysis | supports | high | 7 RCTs (n=17,816): gout RR 1.55 (1.26-1.90) and hyperuricemia RR 1.94 (1.73-2.18) vs placebo, both highly significant. |
| Yarrarapu 2024 · J Cardiol | observational | supports | moderate | Review: up to ~4x higher gout risk in patients with prior gout diagnosis or high baseline serum uric acid; recommends baseline urate monitoring. |
| Albosta M et al 2023 · study_type: observational | observational | supports | moderate | Review of CLEAR Outcomes trial data states bempedoic acid was associated with increases in uric acid levels and cholelithiasis, though numerically fewer myalgia/new-onset-diabetes events. |
| Pradhan 2023 · J Cardiovasc Dev Dis | observational | supports | moderate | Review: uric acid rises ~4x more often and acute gout ~3x more often vs placebo, via competitive renal transport at OAT2. |
| Nissen 2023 · N Engl J Med | RCT | supports | high | CLEAR Outcomes: gout 3.1% vs 2.1% (placebo) and higher hyperuricemia/uric-acid elevation in the bempedoic acid arm. |
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