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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 Unpublished data were obtained from investigators (22 trials).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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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
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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