ADVERSE REACTIONS
LIALDA tablets have been evaluated in 655 ulcerative colitis patients in controlled and open-label trials.
In two 8-week placebo-controlled clinical trials involving 535 ulcerative colitis patients, 356 received 2.4g/day or 4.8g/day LIALDA tablets and 179 received placebo. More treatment emergent adverse events occurred in the placebo group (119) than in each of the LIALDA treatment groups (109 in 2.4g/day, 92 in 4.8g/day). A lower percentage of LIALDA patients discontinued therapy due to adverse events compared to placebo (2.2% vs 7.3%). The most frequent adverse event leading to discontinuation from LIALDA therapy was exacerbation of ulcerative colitis (0.8%).
The majority of adverse events in the double blind, placebo-controlled trials were mild or moderate in severity. The percentage of patients with severe adverse events was higher in the placebo group (6.1% in placebo; 1.1% in 2.4g/day; 2.2% in 4.8g/day). The most common severe adverse events were gastrointestinal disorders which were mainly symptoms associated with ulcerative colitis. Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with LIALDA in patients experiencing this event.
Overall, the percentage of patients who experienced any adverse event was similar across treatment groups. Treatment related adverse events occurring in LIALDA or placebo groups at a frequency of at least 1% in two Phase 3, 8-week, double blind, placebo-controlled trials are listed in Table 3. The most common treatment related adverse events with LIALDA 2.4g/day and 4.8g/day were headache (5.6% and 3.4%, respectively) and flatulence (4% and 2.8%, respectively).
Table 3. Treatment Related Adverse Events in Two Phase 3 Trials Experienced by at Least 1% of the LIALDA Group and at a Rate Greater than Placebo
Event | LIALDA
2.4g/day
(n = 177) | LIALDA
4.8g/day
(n = 179) | Placebo
(n = 179) |
|---|
| Headache | 10 (5.6%) | 6 (3.4%) | 1 (0.6%) |
| Flatulence | 7 (4%) | 5 (2.8%) | 5 (2.8%) |
| Increased alanine aminotransferase | 1 (0.6%) | 2 (1.1%) | 0 |
| Alopecia | 0 | 2 (1.1%) | 0 |
| Pruritis | 1 (0.6%) | 2 (1.1%) | 0 |
The following treatment-related adverse events, presented by body system, were reported infrequently (less than 1%) by LIALDA -treated ulcerative colitis patients in controlled trials.
Cardiovascular and Vascular: tachycardia, hypertension, hypotension
Dermatological: acne, prurigo, rash, urticaria
Gastrointestinal Disorders: abdominal distention, diarrhea, pancreatitis, rectal polyp, vomiting
Hematologic: decreased platelet count
Hepatobiliary Disorders: elevated total bilirubin
Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain
Nervous System Disorders: somnolence, tremor
Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain
General Disorders and Administrative Site Disorders: asthenia, face edema, fatigue, pyrexia
Special Senses: ear pain
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