Lipid-Modifying Therapies and Risk of Pancreatitis: A Meta-analysis
Open accessAbstract
CONTEXT: Statin therapy has been associated with pancreatitis in observational studies. Although lipid guidelines recommend fibrate therapy to reduce pancreatitis risk in persons with hypertriglyceridemia, fibrates may lead to the development of gallstones, a risk factor for pancreatitis. OBJECTIVE: To investigate associations between statin or fibrate therapy and incident pancreatitis in large randomized trials. DATA SOURCES: Relevant trials were identified in literature searches of MEDLINE, EMBASE, and Web of Science (January 1, 1994, for statin trials and January 1, 1972, for fibrate trials, through June 9, 2012). Published pancreatitis data were tabulated where available (6 trials). Unpublished data were obtained from investigators (22 trials). STUDY SELECTION: We included randomized controlled cardiovascular end-point trials investigating effects of statin therapy or fibrate therapy. Studies with more than 1000 participants followed up for more than 1 year were included. DATA EXTRACTION: Trial-specific data described numbers of participants developing pancreatitis and change in triglyceride levels at 1 year. Trial-specific risk ratios (RRs) were calculated and combined using random-effects model meta-analysis. Between-study heterogeneity was assessed using the I2 statistic. RESULTS: In 16 placebo- and standard care-controlled statin trials with 113,800 participants conducted over a weighted mean follow-up of 4.1 (SD, 1.5) years, 309 participants developed pancreatitis (134 assigned to statin, 175 assigned to control) (RR, 0.77 [95% CI, 0.62-0.97; P = .03; I2 = 0%]). In 5 dose-comparison statin trials with 39,614 participants conducted over 4.8 (SD, 1.7) years, 156 participants developed pancreatitis (70 assigned to intensive dose, 86 assigned to moderate dose) (RR, 0.82 [95% CI, 0.59-1.12; P = .21; I2 = 0%]). Combined results for all 21 statin trials provided RR 0.79 (95% CI, 0.65-0.95; P = .01; I2 = 0%). In 7 fibrate trials with 40,162 participants conducted over 5.3 (SD, 0.5) years, 144 participants developed pancreatitis (84 assigned to fibrate therapy, 60 assigned to placebo) (RR, 1.39 [95% CI, 1.00-1.95; P = .053; I2 = 0%]). CONCLUSION: In a pooled analysis of randomized trial data, use of statin therapy was associated with a lower risk of pancreatitis in patients with normal or mildly elevated triglyceride levels.
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The magnitude of fibrate effects on lipids is highly dependent on baseline lipid levels.
“The magnitude of effect is highly dependent on the baseline lipid levels [305].”
From 2019 ESC/EAS guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk (2019) · cites this paper as [305]
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“Additionally, a recent meta-analysis on lipid-modifying therapies and risk of pancreatitis reported no association between fi brate therapy and pancreatitis [86].”
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Toxic‐metabolic Risk Factors in Pediatric Pancreatitis
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“A meta-analysis has shown that use of statin therapy was associated with a reduced risk of acute pancreatitis in patients with normal or mildly elevated serum triglyceride concentrations [32].”
BackgroundLow‐event‐rate meta‐analyses of clinical trials: implementing good practices
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Peroxisome proliferator-activated receptor α as a novel therapeutic target for schizophrenia
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Hypertriglyceridaemia: an update
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“way, posing the question of possible variation in results among trials.(22)”
ResultPharmacologic management and prevention of acute pancreatitis
Machicado, J. D., & Papachristou, G. I. (2019) · Current Opinion in Gastroenterology · doi:10.1097/mog.0000000000000563 · Cited by 33 · see citing works
“However, a case–control study and a meta-analysis of large RCTs with cardiovascular endpoints suggested that statins were associated with a lower risk of developing acute pancreatitis [62,63].”
ResultA Reappraisal of the Risks and Benefits of Treating to Target with Cholesterol Lowering Drugs
Alla, V. M., Agrawal, V., DeNazareth, A., Mohiuddin, S., Ravilla, S., & Rendell, M. (2013) · Drugs · doi:10.1007/s40265-013-0072-9 · Cited by 32 · see citing works
“The Lipid Research Clinics study of the effect of cholestyramine in hypercholesterolemic patients was the first to show a positive benefit of lipid lowering on cardiovascular mortality [4, 303].”
BackgroundHypertriglyceridemic Pancreatitis Treated with Insulin Therapy: A Comparative Review of 34 Cases
Inayat, F., Zafar, F., Baig, A. S., Chaudhry, N. A., Aslam, A., Khan, Z. H., & Iqbal, M. J. (2018) · Cureus · doi:10.7759/cureus.3501 · Cited by 28 · see citing works
“The hypolipidemic medications like gemfibrozil and fenofibrate lower serum triglyceride levels and reduce the recurrence risk of HTGP [36-37].”
BackgroundProtocol for analyses of adverse event data from randomized controlled trials of statin therapy
Reith, C. A., Blackwell, L. S., Emberson, J., Mihaylova, B., Armitage, J., Fulcher, J., KEECH, A. C., Simes, R. J., Baigent, C., & Collins, R. (2016) · American Heart Journal · doi:10.1016/j.ahj.2016.01.016 · Cited by 26 · see citing works
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“Pancreatitis can essentially be divided into two types: chronic pancreatitis (CP) and acute pancreatitis (AP) [Preiss et al., 2012].”
BackgroundRhodes, K. S., Weintraub, M., Marchlewicz, E. H., Rubenfire, M., & Brook, R. D. (2015) · Journal of Clinical Lipidology · doi:10.1016/j.jacl.2015.03.012 · Cited by 25 · see citing works
“Interestingly, the health benefits of treating severe hypertriglyceridemia remain uncertain as highlighted by a recent editorial(25) and by a meta-analysis of drug therapy.(26) Given the numerous additional factors involved in developing pancreatitis (eg, alcohol), and the unclear absolute risks associated with severe…”
BackgroundUse of statins and the risk of acute pancreatitis: a population-based case-control study
Kuoppala, J., Pulkkinen, J., Kastarinen, H., Kiviniemi, V. V., Jyrkkä, J., Enlund, H., Happonen, P., & Paajanen, H. (2015) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.3858 · Cited by 24 · see citing works
“Age at index date (years) 18–64 2877 (66) 13 774 (69) ≥ 65 1499 (34) 6085 (31) Sex Male 2578 (59) 11 791 (59) Female 1798 (41) 8068 (41) Medications Statins 826 (19) 2589 (13) Fibrates 43 (1) 52 (0) ACE inhibitors 985 (23) 2458 (12) Comorbidities Gallstone disease 337 (8) 224 (1) Alcohol-related disease 530 (12) 369 (…”
Gornik, I., Gašparović, V., Gubarev, N., Haxiu, A., & Vucelic, B. N. (2013) · Pancreatology · doi:10.1016/j.pan.2013.03.008 · Cited by 24 · see citing works
“A recent review and a meta-analysis lower risk of pancreatitis in patients on statin therapy [27,28]which couldbe due to effects on gallstones, but also other effects of statins.”
BackgroundStatins for the Prevention of Acute Pancreatitis
de‐Madaria, E. (2017) · The American Journal of Gastroenterology · doi:10.1038/ajg.2017.396 · Cited by 23 · see citing works
Characteristics, Physiopathology and Management of Dyslipidemias in Pregnancy: A Narrative Review
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“For this reason, statins may reduce the risk of pancreatitis [203].”
BackgroundPancréatites d’origine médicamenteuse. Revue des notifications spontanées en France
Chebane, L., Bagheri, H., Hillaire‐Buys, D., Geniaux, H., Yahioui, N., Laroche, M., Cottin, J., Spreux, A., Mosquet, B., Pécriaux, C., et al. (2015) · La Revue de Médecine Interne · doi:10.1016/j.revmed.2015.04.012 · Cited by 19 · see citing works
Hypertriglyceridemia and acute pancreatitis: clinical and basic research—a narrative review
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“[75] The meta-analysis of 5 studies found that the combined risk ratio for AP in favor of statins was 0.8 (95% CI, 0.7–1.0, P = .01).”
BackgroundInfluentialMark, P. B., Winocour, P. H., & Day, C. (2017) · British Journal of Diabetes · doi:10.15277/bjd.2017.125 · Cited by 18 · see citing works
Feingold, K. R. (2017) · Europe PMC (PubMed Central) · Cited by 18 · see citing works
Lipid levels and risk of acute pancreatitis using bidirectional Mendelian randomization
Wang, B., Dron, J. S., Wang, Y., Choi, S. H., Huffman, J. E., Cho, K., Wilson, P. W. F., Natarajan, P., & Peloso, G. M. (2024) · Scientific Reports · doi:10.1038/s41598-024-56946-x · Cited by 17 · see citing works
“Previous meta-analysis of randomized clinical trials showed that the use of statin therapy was associated with a lower risk of pancreatitis in patients with normal or mildly elevated TG levels 18 .”
MethodRydén, L., estable, G. D. T. D. L. S. E. D. C. S. D. Y. T. D. L. C. I., Grant, P. J., Anker, S. D., Berne, C., Cosentino, F., Danchin, N., Deaton, C., Escaned, J., Hammes, H. P., et al. (2014) · Revista Española de Cardiología · doi:10.1016/j.recesp.2013.10.015 · Cited by 17 · see citing works
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Effect of statin on life prognosis in Japanese patients undergoing hemodialysis
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“First, MR relies on three rigorous assumptions, that is genetic instruments should be strongly related to the exposure, share no common cause with the outcome, and be independent of the outcome given the exposure [7 ].”
Villarino, N., Signaevskaia, L., van Niekerk, J., Medal, R., Kim, H., Lahmy, R., Scully, K. M., Pinkerton, A. B., Kim, S. W., Lowy, A. M., et al. (2017) · Oncotarget · doi:10.18632/oncotarget.18587 · Cited by 16 · see citing works
“Interestingly, a large meta-analysis of 16 placebo and standard care–controlled statin trials with 113,800 participants reported that statins are protective against pancreatitis, which is a significant risk factor for PDA [37].”
BackgroundAssociation of Statin Usage and the Development of Diabetes Mellitus after Acute Pancreatitis
Thiruvengadam, N. R., Schaubel, D. E., Forde, K. A., Lee, P., Saumoy, M., & Kochman, M. L. (2022) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2022.05.017 · Cited by 15 · see citing works
Statin Use in Patients With Acute Pancreatitis and Symptomatic Gallstone Disease
Pulkkinen, J., Kastarinen, H., Kiviniemi, V. V., Jyrkkä, J., Juvonen, P., Räty, S., & Paajanen, H. (2014) · Pancreas · doi:10.1097/mpa.0000000000000068 · Cited by 15 · see citing works
“In contrast to previously referred observational evidence, it has also been suggested that statins have protective effects on pancreas.(12) According to a recent meta-analysis, there were no indications that there is increased risk of pancreatitis in statin treatment.”
BackgroundResultFibrates and niacin: is there a place for them in clinical practice?
Wierzbicki, A. S., & Viljoen, A. (2014) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656566.2014.972365 · Cited by 14 · see citing works
“No data exists on combination therapy in lipid-induced pancreatitis though recent evidence suggests that statins may reduce pancreatitis through their anti-inflammatory effect [59] reinforcing the clinical tendency to combine fibrate and statins in the treatment of severe hypertriglyceridaemia [11,12].”
BackgroundBenefits and limitations of statin use in primary cardiovascular prevention: recent advances
Strandberg, T. E. (2022) · Polskie Archiwum Medycyny Wewnętrznej · doi:10.20452/pamw.16258 · Cited by 13 · see citing works
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Statins and their role in acute pancreatitis: Case report and literature review
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Sezgın, O., Ozdogan, O. C., Yaraş, S., Uçbılek, E., & Altıntaşž, E. (2018) · The Turkish Journal of Gastroenterology · doi:10.5152/tjg.2018.18292 · Cited by 13 · see citing works
Kumar, B. G. V., Prasad, K., Singh, D., & Sethy, P. C. (2022) · Journal of Family Medicine and Primary Care · doi:10.4103/jfmpc.jfmpc_1426_21 · Cited by 12 · see citing works
“According to a recent meta‐analysis, statin use was linked to a reduced risk of pancreatitis in patients with mild to moderately increased TG levels.[46] Alipogene tiparvovec, Pemafibrate, Pradigastats, Volanesorsen and Evinacumab are some novel anti‐HTG drugs currently in phase 2‐3 clinical trials.”
BackgroundAssociation of Statins With Decreased Acute Pancreatitis Severity
Lee, P. J., Modha, K., Chua, T. Y., Chak, A., Jang, D., López, R., Gougol, A., Papachristou, G. I., & Stevens, T. (2017) · Journal of Clinical Gastroenterology · doi:10.1097/mcg.0000000000000956 · Cited by 12 · see citing works
Triglycerides Revisited to the Serial
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Do Triglyceride-Rich Lipoproteins Equal Low-Density Lipoproteins in Risk of ASCVD?
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“Statins, which lower triglycerides by up to 20%, decrease risk of pancreatitis [57].”
BackgroundQureshi, T. M., Khan, A., Javaid, H., Tabash, A., Hussein, M. S., & Othman, M. O. (2021) · The American Journal of the Medical Sciences · doi:10.1016/j.amjms.2021.01.005 · Cited by 11 · see citing works
Facciorusso, A., Buccino, V. R., Prete, V. D., Antonino, M., Contaldo, A., & Muscatiello, N. (2019) · Hepatobiliary & pancreatic diseases international · doi:10.1016/j.hbpd.2019.10.001 · Cited by 10 · see citing works
Effect of Pemafibrate on Serum Creatinine in Patients with Chronic Kidney Disease
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Statin intake can decrease acute pancreatitis severit
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Regular Statin Use and Incidence of Postendoscopic Retrograde Cholangiopancreatography Pancreatitis
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“7) Periamupullary diverticulum 81 (25) 454 (20) 0.”
Idiopathic chronic pancreatitis: Beyond antioxidants
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“Recently, ameta-analysis regarding lipid-modifying therapy and the risk of AP revealed that statin therapy was beneficial for lowering the incidence of AP in patients with normal or mildly elevated triglyceride (TG) levels [5].”
BackgroundEASD, E. (2013) · Kardiologia Polska · doi:10.5603/kp.2013.0289 · Cited by 8 · see citing works
The past, present and future of lipidlowering therapy
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Statin consumption and risk of post-endoscopic retrograde cholangiopancreatography pancreatitis
Martínez-Moneo, E., Cárdenas‐Jaén, K., Laso, A. B. F., Millastre‐Bocos, J., Gallego, A. T., Martín-Arriero, S., Alfaro-Almajano, E., García‐Rayado, G., & de‐Madaria, E. (2020) · Pancreatology · doi:10.1016/j.pan.2020.05.002 · Cited by 7 · see citing works
- Authors
- Preiss, D., Tikkanen, M. J., Welsh, P., Ford, I., Lovato, L. C., Elam, M. B., LaRosa, J. C., DeMicco, D. A., Colhoun, H. M., Goldenberg, I., Murphy, M. J., MacDonald, T. M., Pedersen, T. R., Keech, A. C., Ridker, P. M., Kjekshus, J., Sattar, N., & McMurray, J. J. V.
- Affiliations
- University of Glasgow (GB)
- University of Helsinki (FI)
- Wake Forest University Health Sciences (US)
- Memphis VA Medical Center (US)
- SUNY Downstate Health Sciences University (US)
- Pfizer (United States) (US)
- University of Dundee (GB)
- Sheba Medical Center (IL)
- Oslo University Hospital (NO)
- The University of Sydney (AU)
- Brigham and Women's Hospital (US)
- Corresponding author
- Preiss, David
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2012-08-22
- Volume
- 308
- Issue
- 8
- Pages
- 804
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2125871101
- Cited by
- 181
- References
- 70
- Citations by year
- 2026: 9 · 2025: 5 · 2024: 13 · 2023: 13 · 2022: 16 · 2021: 10 · 2020: 10 · 2019: 10 · 2018: 13 · 2017: 17 · 2016: 15 · 2015: 16 · 2014: 15 · 2013: 14 · 2012: 5
- FWCI
- 3.09
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion)
- Research Bank (Australian Catholic University) (submittedVersion)
- Discovery Research Portal (University of Dundee) (submittedVersion)
- Funders
- British Heart Foundation (FS/10/005/28147)
- Topics
- Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
- Keywords
- pancreatitis, statin therapy, fibrate therapy, lipid therapy, hypertriglyceridemia, gallstones, triglyceride levels, randomized controlled trials, drug safety, dose comparison, drug-induced pancreatitis
- MeSH terms
- Humans, Hyperlipidemias, Pancreatitis, Risk, Triglycerides, Hypertriglyceridemia, Incidence, Randomized Controlled Trials as Topic, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Gallstones, Fibric Acids
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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