da-8159 and Pancreatitis

Acute pancreatitis is a common complication of endoscopic retrograde cholangiopancreatography (ERCP). Combination therapy w ith ora l udenafil and aceclofenac may reduce the occurrence of post-ERCP pancreatitis by targeting different pathophysiological mechanisms. We investigated whether combining udenafil and aceclofenac reduced the rates of post-ERCP pancreatitis.. A prospective, randomized, double-blind, placebo-controlled, multicenter study was conducted in four academic medical centers. Between January 2012 and June 2013, a total of 216 patients who underwent ERCP were analyzed for the occurrence of post-ERCP pancreatitis. Patients were determined to be at high risk for pancreatitis based on validated patient and procedure-related risk factors.. Demographic features, indications for ERCP, and therapeutic procedures were similar in each group. There were no significant differences in the rate (15.8% [17/107] vs. 16.5% [18/109], p = 0.901) and severity of post-ERCP pancreatitis between the udenafil/aceclofenac and placebo groups. One patient in each group developed severe pancreatitis. Multivariate analyses indicated that suspected dysfunction of the sphincter of Oddi and endoscopic papillary balloon dilation without sphincterotomy were associated with post-ERCP pancreatitis.. Combination therapy with udenafil and aceclofenac is not effective for the prevention of post-ERCP pancreatitis.

Topics: Acute Disease; Administration, Oral; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Cholangiopancreatography, Endoscopic Retrograde; Diclofenac; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Multivariate Analysis; Pancreatitis; Phosphodiesterase 5 Inhibitors; Prospective Studies; Pyrimidines; Republic of Korea; Risk Factors; Sulfonamides; Treatment Outcome; Young Adult

Udenafil, a phosphodiesterase-5 inhibitor, may decrease sphincter of Oddi tone and allow efficient cannulation.. To determine whether prophylactic udenafil reduces the rates of occurrence of post-ERCP pancreatitis.. Prospective, randomized, double-blind, placebo-controlled, multicenter study.. Three academic medical centers.. From November 2008 to November 2010, a total of 278 patients who underwent ERCP were analyzed.. ERCP.. Rate of post-ERCP pancreatitis.. Demographic features, indications for ERCP, and therapeutic procedures were similar in each group. The overall rate of pancreatitis was 7.9% (22/278). There was no significant difference in the rate (8.0% [11/137] vs 7.8% [11/141], P = .944) and severity of post-ERCP pancreatitis between the udenafil and placebo groups. Severe pancreatitis developed in 1 patient in the placebo group. On both univariate and multivariate analyses, age 40 years or younger, suspected sphincter of Oddi dysfunction, complete pancreatic duct opacification, and failed cannulation were associated with post-ERCP pancreatitis. Only mild udenafil-related complications occurred, including flushing (n = 3) and headache (n = 3).. Unselected patient group, overestimation of the rate of pancreatitis in the placebo group.. Udenafil was not effective for prevention of post-ERCP pancreatitis in this study. (. KCT0000021.).

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Cholangiopancreatography, Endoscopic Retrograde; Double-Blind Method; Humans; Logistic Models; Middle Aged; Multivariate Analysis; Pancreatitis; Phosphodiesterase 5 Inhibitors; Pyrimidines; Risk Factors; Severity of Illness Index; Sphincter of Oddi Dysfunction; Sulfonamides; Young Adult