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NSAIDs useful for prevention of pancreatitis after ERCP
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Clinical use of rectal NSAIDs were found to be appropriate for pharmacoprevention of pancreatitis following endoscopic retrograde cholangiopancreatography, according to results from a systematic review and meta-analysis.
B. Joseph Elmunzer, MD, from University of Michigan Medical Center and the Medical University of South Carolina, and colleagues performed a systematic literature search for randomized controlled trials and meta-analyses of pancreatitis after ERCP (PEP) pharmacoprevention published through February 2014 to identify pharmacologic agents that are ready for clinical use, those which warrant a high-priority RCT, those which require exploratory studies and those for which additional research is of low-priority.
B. Joseph Elmunzer
Overall, 85 RCTs, including a total of 28,857 patients who received one of 28 pharmacologic agents or placebo, and 28 meta-analyses were included in the review. The researchers determined that rectal NSAIDs (100 mg diclofenac or indomethacin administered immediately before or after ERCP) are appropriate for clinical use in high-risk patients. A meta-analysis of RCTs (n = 912) published between 2003 and 2008 showed rectal NSAIDs safely reduced PEP by 64% (RR = 0.36; 95% CI, 0.22-0.6), and a large multicenter RCT of prophylactic rectal indomethacin showed a 7.7% reduction in absolute risk and a 46% reduction in relative risk for PEP (P = .005). RCTs of low-dose rectal diclofenac, rectal diclofenac plus infusion somatostatin, and indomethacin plus sublingual nitroglycerin also showed benefit. No data showed benefit for nonrectally administered NSAIDs, and “strong consideration” should be given to the use of rectal NSAIDs in low-risk patients due to insufficient data.
The researchers also determined sublingual nitroglycerin, bolus-administered somatostatin and nafamostat should be considered promising agents that warrant confirmatory research, and determined topical epinephrine, aggressive intravenous fluids, gabexate, ulinastatin, secretin and antibiotics require further research “to justify confirmatory RCTs.”
“In summary, only rectal NSAIDs can be recommended for pharmacologic PEP prophylaxis in clinical practice,” the researchers concluded. “Interested investigators should consider the findings of this systematic review when selecting agents and dosing regimens for future RCTs of PEP pharmacoprevention. A systematic and evidence-based approach to study selection as well as a commitment to conducting high-quality clinical trials may improve our research success in this traditionally disappointing area.”
“This systematic review is vitally important because it lends support to the need for cooperative comparative effectiveness studies of outcomes in endoscopy that are lacking in the United States,” Timothy B. Gardner, MD, MS, from Dartmouth-Hitchcock Medical Center in New Hampshire, wrote in an accompanying editorial. “However, it takes several steps to organize and prioritize the direction in which the science of pharmacoprevention for PEP needs to move. If we are to achieve success in delivering higher quality care while reducing PEP cost, it will be by following a blueprint such as that provided in this review.” – by Adam Leitenberger
Disclosure: The researchers and Gardner report no relevant financial disclosures.
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