Add-on sublingual nitrate improves diclofenac for preventing post-ECRP pancreatitis
Prophylaxis with rectal diclofenac together with sublingual nitrate reduces the incidence of postendoscopic retrograde cholangiopancreatography (post-ECRP) pancreatitis (PEP) more than with diclofenac alone, a recent trial has found.
The study included patients who were scheduled to receive ERCP who were randomized to either the combination group (diclofenac with sublingual nitrate tablet; n=444; median age, 68 years; 64.4 percent male) or diclofenac-alone group (n=442; median age, 68 years; 64.7 percent male). The main study outcome was the incidence of PEP.
A total of 67 patients (7.6 percent) developed PEP over the study duration. This rate was higher in patients who received diclofenac alone (9.5 percent; n=42) than in those who were given the combination intervention (5.6 percent; n=25). The resulting difference in risk was statistically significant (relative risk, 0.59; 95 percent CI, 0.37–0.95; p=0.03).
A similar pattern was observed for moderate or severe PEP. The corresponding incidence rates in the combination and diclofenac-alone groups were 0.9 percent (n=4) and 2.3 percent (n=10). However, the resulting difference in risk failed to reach significance (relative risk, 0.12; 0.13–1.26; p=0.12).
Trends were also largely reflected in the subgroup of high-risk patients. The PEP incidence rate was 8.3 percent (n=24) in the combination treatment group and 13 percent (n=39) in the diclofenac-alone group. The risk difference was only of borderline significance (relative risk, 0.64; 0.39–1.03; p=0.08).