ADVERSE EVENTS (AEs)
The following table summarizes the AEs observed in the two placebo-controlled clinical trials.
|
ADVERSE EVENTS
|
VISIT AT 12 MONTHS
|
VISIT AT 24 MONTHS
|
|
UDCA
n (%)
|
Placebo
n (%)
|
UDCA
n (%)
|
Placebo
n (%)
|
|
Diarrhea
|
---
|
---
|
1 (1.32)
|
---
|
|
Elevated creatinine
|
---
|
---
|
1 (1.32)
|
---
|
|
Elevated blood glucose
|
1 (1.18)
|
---
|
1 (1.32)
|
---
|
|
Leukopenia
|
---
|
---
|
2 (2.63)
|
---
|
|
Peptic ulcer
|
---
|
---
|
1 (1.32)
|
---
|
|
Skin rash
|
---
|
---
|
2 (2.63)
|
---
|
Note: Those AEs occurring at the same or higher incidence in the placebo as in the UDCA group have been deleted from this table (this includes diarrhea and thrombocytopenia at 12 months, nausea/ vomiting, fever and other toxicity).
UDCA = Ursodeoxycholic acid = Ursodiol
In a randomized, cross-over study in sixty PBC patients, four patients (6.7%) experienced one serious adverse event each (diabetes mellitus, cyst and breast neoplasm (experienced by two patients)). No deaths occurred in the study. Forty-three patients (43, 71.7%) experienced at least one treatment-emergent adverse event (TEAEs) during the study. The most common (>5%) TEAEs were asthenia (11.7%), dyspepsia (10%), peripheral edema (8.3%), hypertension (8.3%), nausea (8.3%), GI disorders (5%), chest pain (5%), and pruritus (5%). Seven patients (11.6%) reported nine events that were judged as possibly or probably related to study medication. These nine TEAEs included abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients) and anorexia and esophagitis (1 patient each). One patient on the BID regimen (total dose 1000 mg) withdrew due to nausea. All of these nine TEAEs except esophagitis were observed with the BID regimen at a total daily dose of 1000 mg or greater.
|
