PENTASA: clinically demonstrated to improve UC patients'
quality of life (QOL)
PENTASA (4 grams/day) significantly reduced clinical symptom severity, thereby improving the functions of everyday living.4
Adapted from Robinson, et al, 1994.4
*P<.02 vs placebo.
Results from an 8-week, double-blind, multicenter study. Patients with distal ulcerative colitis or pancolitis were randomized to receive PENTASA (1, 2, or 4 grams/day) or placebo. QoL parameters were measured using a visual analogue scale, where 0 indicated complete symptom relief and 10 indicated severe symptoms. Patients recorded actual number of trips to the toilet in a diary. Placebo rates for reduction of symptoms were 34% for rectal bleeding, 24% for stool consistency, 8% for abdominal/rectal pain, 27% for urgency, and 10% for trips to the toilet per day. Placebo rates for function improvement were 4% for sexual relationships, 8% for work, 0% for social activities, 8% for hobbies, 6% for outdoor activities, 0% for sleep, and 7% for indoor activities.4
Important Safety Information
- PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
- PENTASA is generally well tolerated. In worldwide clinical trials (N>2100), the most common adverse events were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%). As with other mesalamine products, serious adverse events may occur. PENTASA is contraindicated in patients with a hypersensitivity to salicylates. Caution should be used in patients with impaired hepatic or renal function. Patients with pre-existing renal disease, increased BUN or serum creatinine, or proteinuria should be monitored during PENTASA therapy.