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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 Unpublished data were obtained from investigators (22 trials).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 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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“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 (…”
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“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 .”
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Effect of statin on life prognosis in Japanese patients undergoing hemodialysis
Ota, Y., Kitamura, M., Muta, K., Yamashita, H., Uramatsu, T., Obata, Y., Harada, T., Funakoshi, S., Mukae, H., & Nishino, T. (2019) · PLoS ONE · doi:10.1371/journal.pone.0224111 · Cited by 16
Yang, G., Mason, A. M., Gill, D., Schooling, C. M., & Burgess, S. (2024) · European Journal of Epidemiology · doi:10.1007/s10654-024-01141-5 · Cited by 17
“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
“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
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
“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 15
“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
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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
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“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
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].”
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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
Effect of Pemafibrate on Serum Creatinine in Patients with Chronic Kidney Disease
Imai, E., & Imai, A. (2022) · JMA Journal · doi:10.31662/jmaj.2021-0212 · Cited by 10
Cárdenas‐Jaén, K., Vaillo-Rocamora, A., Gracia, Á., Garg, P. K., Zapater, P., Papachristou, G. I., Singh, V. K., Wu, B. U., & de‐Madaria, E. (2021) · Frontiers in Medicine · doi:10.3389/fmed.2020.00494 · Cited by 10
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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
Mehta, R. M., Pandol, S. J., & Joshi, P. (2021) · World Journal of Gastroenterology · doi:10.3748/wjg.v27.i43.7423 · Cited by 8
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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 9
The past, present and future of lipidlowering therapy
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Statin consumption and risk of post-endoscopic retrograde cholangiopancreatography pancreatitis
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Metadata
- 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 › Cardiology and Cardiovascular Medicine › 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
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