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 0.81
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
6 support 0 contradict 0 tested null 3 mixed · 9 sources, 6 independent groups · 2 superseded — pooled inside a review, counted once
What the evidence shows
Bempedoic acid modestly and reversibly raises serum uric acid by inhibiting renal urate transport, and gout incidence rises with it: pooled as a pre-specified safety endpoint across seven trials in 17,497 patients, the odds ratio was 1.55, with hyperuricaemia roughly doubled across 17 trials. Absolute event numbers are low and the effect is manageable.
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 KK, Bays HE, Catapano AL, Lalwani ND, Bloedon LT, Sterling LR, Robinson PL, Ballantyne CM, CLEAR Harmony Trial 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, Tomlinson B 2025 · Expert opinion on drug safety | 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 L, Biolo M, Marodin G, Portinari C, Simioni P, Ferri N 2026 · Nutr Metab Cardiovasc Dis | mechanism | supports | moderate | Review (NMCD 'data synthesis' format), not evidence: summarises that urate rise 'is due to the inhibition by bempedoic acid of organic anion transporters 2 and 3' and that 'The increased levels of uric acid were associated with higher incidence of gout'. No data of its own. Review — zero weight. |
| Bays HE, Bloedon LT, Lin G, Powell HA, Louie MJ, Nicholls SJ, Lincoff AM, Nissen SE 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 O, D'Ascenzo F, Iannaccone M, Bertaina M, Leone A, Borzillo I, Ravetti E, Solano A, Pagliassotto I, Nebiolo M, Bruno F, Giacobbe F, Muscoli S, Monticone S, Brizzi MF, Biondi Zoccai G, De Ferrari GM 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 F, Giugliano RP 2023 · JAMA Cardiol | mechanism | supports | moderate | Narrative review (title: 'A Narrative Review') re-describing CLEAR Outcomes: 'Rates of gout and cholelithiasis were higher with bempedoic acid, and small increases in serum creatinine, uric acid, and hepatic-enzyme levels were also observed.' No own data. Review — zero weight; CLEAR trials carry the vote. |
| 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 A, Carubbi F, Campanozzi E, Bellisario F, Schoones JW, Mariani FM, Di Ruscio E, Altieri P, Ferri C 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, Begic Z, Radman I, Zlopasa F, Mateljic J, Zec I, Titlic M, Sliskovic AM, Pecin I, Reiner Z, Mercep I 2025 · Biomedicines | 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 AC, Leiter LA, Stroes ESG, Baum SJ, Hanselman JC, Bloedon LT, Lalwani ND, Patel PM, Zhao X, Duell PB 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, Tsai DH, Hsieh MH, Vairaperumal T, Lai EC, Liu PY 2026 · Communications medicine | 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 N, Syed AA, Ismail SM, Ashraf MT, Khan MK, Sohail A 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 SNS, Goyal A, Venkata VS, Panchal V, Sivasubramanian BP, Du DT, Jakulla RS, Pamulapati H, Afaq MA, Owens S, Dalia T 2024 · J Cardiol | observational | supports | moderate | This review reports that bempedoic acid can cause up to four times higher risk of gout in people with a previous gout diagnosis or high serum uric acid levels, and that increased blood urea nitrogen and serum creatinine have also been reported. The other adverse events it lists are muscle pain (4.7%), anemia (3.4%) and raised liver aminotransferases (0.3%). The abstract gives no figure for how much bempedoic acid raises uric acid itself. |
| Albosta M, Grant JK, Michos ED 2023 · Heart international | 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 A, Bhandari M, Vishwakarma P, Singh A, Perrone MA, Sethi R 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 SE, Lincoff AM, Brennan D, Ray KK, Mason D, Kastelein JJP, Thompson PD, Libby P, Cho L, Plutzky J, Bays HE, Moriarty PM, Menon V, Grobbee DE, Louie MJ, Chen CF, Li N, Bloedon L, Robinson P, Horner M, Sasiela WJ, McCluskey J, Davey D, Fajardo-Campos P, Petrovic P, Fedacko J, Zmuda W, Lukyanov Y, Nicholls SJ, CLEAR Outcomes Investigators 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. |
Disagree, or know a study we missed?
We grade by evidence, not opinions. The way to weigh in is to point us to a study we haven't cited (check the evidence table above first), or to flag a problem with one we have. Every submission is reviewed; if it holds up, the grade updates and shows in Science Changes Its Mind.
Opens a short form. You'll sign in with Google so submissions are tied to a real account — we don't display your identity, and we only accept a link we can verify (PubMed, DOI, ClinicalTrials.gov).
Educational only, not medical advice. Grades and scores reflect published evidence weighted by study design and quality; see the methodology.