By Ed Susman
SAN DIEGO -- May 22, 2008 -- Treatment of mild to moderate active ulcerative proctitis can be simplified without increasing adverse effects or diminishing efficacy, researchers reported here at Digestive Diseases Week 2008 (DDW).
Both the mesalamine 1-g suppository once daily and the mesalamine 0.5-g suppository 3 times daily were very well accepted, "but patients preferred to take suppositories once daily," said investigator Tilo Andus, MD, Chief of Internal Medicine, Krankenhaus Bad Cannstatt, Stuttgart, Germany.
Dr. Andus and collaborators in Germany, Russia, Ukraine, and Israel recruited 408 patients for the trial; 403 patients were in the intention-to-treat cohort and 354 patients were evaluated as per-protocol patients.
Remission was defined as a score of <4 on the Disease Activity Index (DAI).
Average age was 42 years; 55% of patients were women. Mean duration of disease was 2.2 years for the 201 patients in the once-daily treatment group and 3.6 years in the 3-times-daily group, but some patients had the disease for as long as 36 and 31 years, respectively.
No differences in rates of remission were observed between the intention-to-treat population and the per-protocol population, and between the once-daily group and the 3-times-daily group.
"Rectal mesalamine treatment induced a prompt cessation of clinical symptoms," Dr. Andus said in his poster presentation on May 20. He found no significant differences in efficacy, safety, or tolerability between the 2 treatment arms.
In the primary outcome measure, remission rates were 87.9% and 90.7% with once-daily and 3-times-daily treatment in the per-protocol population, which reached statistical significance (P = .00027 for equivalence).
In the intention-to-treat population, 84% and 84.7% of patients achieved remission in the once-daily and 3-times-daily groups, which also reached statistical significance (P = .00008).
Outcomes were similar between the treatment groups in the secondary measures of clinical remission, endoscopic remission, mucosal healing, histological improvement, therapeutic success, and therapeutic benefit.
Funding for this study was provided by Dr. Falk Pharma.
[Presentation title: A Novel High Dose 1 g Mesalamine Suppository (Salofalk) Is as Efficacious as 500 Mg TID Suppositories in Mild to Moderate Active Ulcerative Proctitis: A Multicenter, Randomized Trial. Abstract T1137]
E-Mail this DGDispatch to a colleague
