Results from the largest prospective controlled ulcerative colitis (UC) trial conducted to date, called the QD dosing investigation for efficacy IN UC maintenance (QDIEM), found that once-daily dosing of Asacol(R) (mesalamine) delayed-release 400 mg tablets at 1.6-2.4 g/day was comparable to twice-daily dosing for the maintenance of remission in patients with UC.
The study, which met its primary endpoint of non-inferiority, found that 90.5 per cent of patients taking Asacol once-daily remained in remission at six months compared to 91.8 per cent of patients taking Asacol twice-daily. These findings were announced at the American College of Gastroenterology (ACG) Annual Scientific Meeting in San Diego, California.
At 12 months, approximately 85 per cent of patients maintained remission irrespective of whether they took Asacol once- or twice-daily. The number of serious adverse events and withdrawals due to adverse events were similar for patients in the once-daily and twice-daily Asacol dosing regimens.
"While Asacol is currently indicated for divided dosing, it is encouraging to see that in this study, when Asacol was taken once-daily, the results were comparable to when it was taken twice-daily," said Dr. Pierre Paré, Director of Clinical Research in Gastroenterology, Centre Hospitalier Affilie Universitaire de Québec. "UC is a chronic condition, so it is extremely important that patients take their medication as prescribed, and work together with their physician to determine how to best manage their symptoms and maintain disease remission."