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Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography.
Gastroenterology. 2019 05; 156(6):1753-1760.e1.G

Abstract

BACKGROUND & AIMS

Acute pancreatitis is a major adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) decreases the incidence of post-ERCP pancreatitis (PEP). Little is known about the combined effects of sublingual nitrate and NSAIDs. We performed a randomized trial to assess whether the combination of NSAIDs and sublingual nitrate is more effective than NSAIDs alone in preventing PEP.

METHODS

In a prospective superiority trial, eligible patients underwent ERCP at 12 endoscopic units in Japan, from March 2015 through May 2018. Patients were randomly assigned to groups given diclofenac suppositories (50 mg) within 15 minutes after the endoscopic procedure alone (diclofenac-alone group, n = 442) or in combination with sublingual isosorbide dinitrate (5 mg) 5 minutes before the endoscopic procedure (combination group, n = 444). The primary endpoint was the occurrence of PEP.

RESULTS

PEP developed in 25 patients in the combination group (5.6%), and in 42 patients in the diclofenac-alone group (9.5%) (relative risk 0.59; 95% confidence interval 0.37-0.95; P = .03). Moderate to severe pancreatitis developed in 4 patients (0.9%) in the combination group, and 10 patients (2.3%) in the diclofenac-alone group (relative risk 0.12; 95% confidence interval 0.13-1.26; P = .12). There was no serious adverse event related to the additional administration of sublingual nitrate.

CONCLUSIONS

In a randomized controlled trial, we found that prophylaxis with rectal diclofenac and sublingual nitrate significantly reduces the overall incidence of PEP compared with diclofenac suppository alone. ClinicalTrials.gov, no: UMIN 000016274.

Authors+Show Affiliations

Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan. Electronic address: tomotake79@yahoo.co.jp.Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.Department of Internal Medicine, Fukuyama City Hospital, Fukuyama, Japan.Department of Gastroenterology, Iwakuni Clinical Center, Iwakuni, Japan.Department of Gastroenterology, Mitoyo General Hospital, Kanonji, Japan.Department of Internal Medicine, Okayama Saiseikai General Hospital, Okayama, Japan.Department of Gastroenterology, Japanese Red Cross Okayama Hospital, Okayama, Japan.Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.Department of Gastroenterology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan.Department of Internal Medicine, Sumitomo Besshi Hospital, Niihama, Japan.Department of Gastroenterology, Onomichi Municipal Hospital, Onomichi, Japan.Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

30772342

Citation

Tomoda, Takeshi, et al. "Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography." Gastroenterology, vol. 156, no. 6, 2019, pp. 1753-1760.e1.
Tomoda T, Kato H, Ueki T, et al. Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography. Gastroenterology. 2019;156(6):1753-1760.e1.
Tomoda, T., Kato, H., Ueki, T., Akimoto, Y., Hata, H., Fujii, M., Harada, R., Ogawa, T., Wato, M., Takatani, M., Matsubara, M., Kawai, Y., & Okada, H. (2019). Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography. Gastroenterology, 156(6), 1753-e1. https://doi.org/10.1053/j.gastro.2019.01.267
Tomoda T, et al. Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography. Gastroenterology. 2019;156(6):1753-1760.e1. PubMed PMID: 30772342.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography. AU - Tomoda,Takeshi, AU - Kato,Hironari, AU - Ueki,Toru, AU - Akimoto,Yutaka, AU - Hata,Hidenori, AU - Fujii,Masakuni, AU - Harada,Ryo, AU - Ogawa,Tsuneyoshi, AU - Wato,Masaki, AU - Takatani,Masahiro, AU - Matsubara,Minoru, AU - Kawai,Yoshinari, AU - Okada,Hiroyuki, Y1 - 2019/02/14/ PY - 2018/09/11/received PY - 2019/01/23/revised PY - 2019/01/30/accepted PY - 2019/2/18/pubmed PY - 2019/5/14/medline PY - 2019/2/18/entrez KW - Drug KW - Inflammation KW - Pancreas KW - Smooth-Muscle Relaxant SP - 1753 EP - 1760.e1 JF - Gastroenterology JO - Gastroenterology VL - 156 IS - 6 N2 - BACKGROUND & AIMS: Acute pancreatitis is a major adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) decreases the incidence of post-ERCP pancreatitis (PEP). Little is known about the combined effects of sublingual nitrate and NSAIDs. We performed a randomized trial to assess whether the combination of NSAIDs and sublingual nitrate is more effective than NSAIDs alone in preventing PEP. METHODS: In a prospective superiority trial, eligible patients underwent ERCP at 12 endoscopic units in Japan, from March 2015 through May 2018. Patients were randomly assigned to groups given diclofenac suppositories (50 mg) within 15 minutes after the endoscopic procedure alone (diclofenac-alone group, n = 442) or in combination with sublingual isosorbide dinitrate (5 mg) 5 minutes before the endoscopic procedure (combination group, n = 444). The primary endpoint was the occurrence of PEP. RESULTS: PEP developed in 25 patients in the combination group (5.6%), and in 42 patients in the diclofenac-alone group (9.5%) (relative risk 0.59; 95% confidence interval 0.37-0.95; P = .03). Moderate to severe pancreatitis developed in 4 patients (0.9%) in the combination group, and 10 patients (2.3%) in the diclofenac-alone group (relative risk 0.12; 95% confidence interval 0.13-1.26; P = .12). There was no serious adverse event related to the additional administration of sublingual nitrate. CONCLUSIONS: In a randomized controlled trial, we found that prophylaxis with rectal diclofenac and sublingual nitrate significantly reduces the overall incidence of PEP compared with diclofenac suppository alone. ClinicalTrials.gov, no: UMIN 000016274. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/30772342/Combination_of_Diclofenac_and_Sublingual_Nitrates_Is_Superior_to_Diclofenac_Alone_in_Preventing_Pancreatitis_After_Endoscopic_Retrograde_Cholangiopancreatography_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(19)30376-2 DB - PRIME DP - Unbound Medicine ER -