Pancreatitis Uncommon Among Tigecycline-Treated Patients

SAN DIEGO, CA High exposure to other medications known to cause pancreatitis occurred prior to and concomitantly in tigecycline and comparator cases and non-cases of pancreatitis, according to a study presented at IDWeek2012.

Pancreatitis is a known but infrequent side effect of tetracyclines that has also been described with tigecycline, a glycylcycline antibiotic related to tetracyclines.

Paul McGovern, MD, from Pfizer Inc., Collegeville, PA identified hospitalized subjects who developed pancreatitis in Phase 3 and 4 tigecycline trials. Risk factors, comprising medical history, procedures, and concomitant medicines known to cause pancreatitis via the Badalov classification scheme were noted. Incidence of overall pancreatitis was computed with a 95% CI. Nine of 3,788 tigecycline-treated patients (0.24%; 95% CI 0.11–0.45) and ten of 3,646 comparator-treated patients (0.27%; 95% CI 0.13–0.5) developed pancreatitis.

The mean duration of therapy was ten days in each group. Two tigecycline-treated patients had necrotizing pancreatitis regarded as associated with a prior episode of necrotizing pancreatitis or to an endoscopic retrograde cholangiopancreatogram.

Of the nine tigecycline-treated patients who developed pancreatitis, seven (77.8%) received medications known to cause pancreatitis prior to the use of tigecycline, nine (100%) received concomitant medications known to cause pancreatitis with the use of tigecycline, and six (66.7%) received concomitant but not prior medications known to cause pancreatitis in relation to the use of tigecycline.

Of the ten comparator-treated patients who developed pancreatitis, seven (70%) received medications known to cause pancreatitis prior to the use of comparator, eight (80%) received concomitant medications known to cause pancreatitis with the use of comparator, and seven (70%) received concomitant but not prior medications known to cause pancreatitis in relation to the use of comparator.

Of the 3,779 tigecycline-treated patients who did not develop pancreatitis, 2,694 (71.3%) received medications known to cause pancreatitis prior to the use of tigecycline, 2,910 (77%) received concomitant medications known to cause pancreatitis with the use of tigecycline, and 1,759 (46.5%) received concomitant but not prior medications known to cause pancreatitis in relation to the use of tigecycline.

Of the 3,636 comparator-treated patients who did not develop pancreatitis, 2,547 (70%) received medications known to cause pancreatitis prior to the use of comparator, 2,823 (77.6%) received concomitant medications known to cause pancreatitis with the use of comparator, and 1,686 (46.4%) received concomitant but not prior medications known to cause pancreatitis in relation to the use of comparator.