Dr. Rockey explained,
1. The study met its primary endpoint: significantly fewer patients in the
active arm experienced HE events -- 21% vs. 36% (p = 0.021).
2. Compared to placebo, patients randomized to GPB also had significantly
fewer total HE events (35 vs. 57 p=0.035), significantly lower ammonia
values (46 vs. 58 umol/L p=0.036), and significantly fewer symptomatic days
(13 vs. 27; p=0.015).
3. There were non-statistically significant trends in favor of fewer HE-
hospitalizations and fewer total HE-hospital days.
4. Safety appeared satisfactory (76% and 79% of subjects in the placebo and
GPB groups, respectively, reported AEs) and the adverse event profile was
consistent with that expected for the study population.
5. Ammonia was significantly lower on GPB (45.7 vs. 58.15 umol/L, p = 0.036)
and correlated with the likelihood of HE events whether measured at
baseline or during the study (p < 0.01)
The study enrolled 178 total patients, of whom 59 were on Rifaximin at
baseline, including 29 in the placebo arm and 30 in the active arm. Among
the 119 patients not on Rifaximin at baseline, there was a highly
statistically significant reduction among GPB treated patients in both the
percentage of patients with events (10% vs 32%; p=0.003) as well as the
total number of HE events (7 vs. 31; p<0.001). Among patients on Rifaximin
at baseline, there was no difference in the number of patients with events
or total events. Ammonia was similarly lowered on GPB among patients taking
(67 vs. 91 umol/L; p=0.13) or not taking (36 vs. 43 umol/L; p=0.08),
although the differences were not statistically significant due to the
smaller sample size. Patients on Rifaximin at baseline had higher ammonia
levels than those not on Rifaximin.