Rectal indomethacin or intravenous gabexate mesylate as prophylaxis for acute pancreatitis post-endoscopic retrograde cholangiopancreatography.

OBJECTIVE: We aimed to evaluate the results in our case series of AP ERCP over the last three years. The prophylaxis for acute pancreatitis (AP) post-endoscopic retrograde cholangiopancreatography (ERCP) consists of rectal indomethacin, but some studies are not concordant. PATIENTS AND METHODS: We compared 241 ERCP performed from January 2014 to February 2015 with intravenous gabexate mesylate (Group A), with the 387 ERCP performed from March 2015 to December 2016 with rectal indomethacin (Group B) as prophylaxis for AP post-ERCP. RESULTS: There were 8 (3.31%) AP post-ERCP in Group A vs. 4 (1.03%) in Group B. CONCLUSIONS: Rectal indomethacin shows a better statistically significant performance than intravenous gabexate mesylate in the prophylaxis of AP post-ERCP, besides being cheaper.

Effect and cost of treatment for acute pancreatitis with or without gabexate mesylate: a propensity score analysis using a nationwide administrative database.

OBJECTIVES: Despite a lack of evidence, gabexate mesylate (GM) is routinely used for the treatment of acute pancreatitis (AP) in some countries. The present study examined the effect and cost of GM for AP treatment using the Japanese Diagnosis Procedure Combination database. METHODS: We performed a propensity score analysis to compare inhospital mortality, length of stay (LOS), and total costs between patients with AP treated with GM and those without GM in 2010. RESULTS: We identified 2483 patients treated with GM and 890 patients without GM. Overall, 77% of the patients treated with GM were nonsevere AP cases. The propensity-matched 707 pairs showed no significant difference between GM users and nonusers in inhospital mortality or median length of stay in nonsevere AP (1.0% vs 1.2%, P = 0.789; 10 vs 10 days, P = 0.160) and severe AP (8.4% vs 5.0%, P = 0.438; 12 vs 14 days, P = 0.487) cases. Total costs were significantly different between the GM users and the nonusers in nonsevere AP cases (US$4982 vs US$4373, P < 0.001), but not in severe AP cases ($6605 vs $6490, P = 0.764). CONCLUSIONS: Using GM for nonsevere AP cannot be justified because of higher costs without significant effects. Gabexate mesylate use is also not justifiable for severe AP because it does not reduce mortality or length of stay.

Frequency of post-ERCP pancreatitis in a single tertiary referral centre without and with routine prophylaxis with gabexate: a 6-year survey and cost-effectiveness analysis.

BACKGROUND AND STUDY AIMS: Several drugs have been used for the prevention of post-ERCP pancreatitis with conflicting results and no data referring to the routine use of a pharmacological prophylaxis have been published up to now. Aim of the study was to evaluate the frequency of post-ERCP pancreatitis and costs in a series of consecutive patients who have undergone ERCP procedures before and after the introduction of a routine prophylaxis with gabexate in all cases. PATIENTS AND METHODS: Data from 1312 patients who underwent ERCP procedures without gabexate prophylaxis and from 1149 consecutive patients with 1g i.v. gabexate, were retrospectively evaluated during a 6-year period. Patients were also subdivided in standard- and high-risk subjects, on the basis of patient- and technique-related risk factors: 984 subjects (39.9%) had one or more conditions that placed them at high risk for post-ERCP pancreatitis. RESULTS: Post-ERCP pancreatitis was reported in 76 out of 2461 patients (3.1%). The frequency of pancreatitis appeared significantly reduced in the gabexate period in comparison with before gabexate in overall cases (2.2% versus 3.9%; p=0.019); however, the reduction was significant only for high-risk patients (3.8% versus 7.3%; p=0.001). Severe hyperamylasaemia at 4-6h and 24h after the procedure was also significantly reduced only in high-risk patients (p=0.001). Routine prophylaxis with gabexate appeared cost-effective in high-risk patients. CONCLUSIONS: Routine gabexate prophylaxis was associated with a significant reduction of post-ERCP pancreatitis rate, severe hyperamylasaemia and hospitalisation-related costs only in high-risk patients. However, gabexate appeared unable to reduce the incidence of severe pancreatitis.

Gabexate mesilate and acute pancreatitis: an experience of evidence based drug information for improving rational drug use.

INTRODUCTION: Gabexate mesylate is a drug marketed only in Italy and Japan and it is considered an essential drug in the treatment of acute pancreatitis. A periodic revision and evaluation of drug utilization in our hospital demonstrated that the dosages and indications of Gabexate mesilate (GM) did not follow those settled by the National Health System and by our Hospital Formulary. We therefore promoted and conducted a program of drug information and meetings with the physicians in order to improve the correct utilisation of GM and identify potential problems. METHODS: GM prescriptions in 1999 were analysed for indications and dosages. Scheduled meetings with the medical staff were successively started in order to debate current therapies and treatments of acute pancreatitis using the criteria of evidence-based medicine (EBM). Follow-up was done in 2000, 2001 and 2002 to evaluate the efficacy of our intervention. RESULTS: The hospital board and 20 physicians were involved in this program of evidence-based drug information. The follow-up and the monitoring of GM prescriptions showed a reduction in the utilisation of GM in the subsequent period. CONCLUSIONS: GM is one of the most expensive drugs in our hospital, but its benefits are not very evident. Moreover, the international guidelines and literature ascribe to GM only a marginal role in the treatment of acute pancreatitis. Evidence-based medicine strengthens clinical experience with the evidence from the literature and underlines that essential drugs are used worldwide.