| Content Provider |
World Health Organization (WHO)-Global Index Medicus |
| Author |
Zakko, Salam F. Gordon, Glenn L. Murthy, Uma Sedghi, Shahriar Pruitt, Ronald Barrett, Andrew C. Bortey, Enoch Paterson, Craig Forbes, William P. Lichtenstein, Gary R. |
| Description |
Country affiliation: United States Author Affiliation: Zakko SF ( a Connecticut Gastroenterology Institute , Bristol Hospital , Bristol , Connecticut , USA.); Gordon GL ( b Center for Digestive and Liver Diseases, Inc ., Mexico , Missouri , USA.); Murthy U ( c Department of Medicine , Syracuse VA Medical Center , Syracuse , New York , USA.); Sedghi S ( d Gastroenterology Associates of Central Georgia, LLC , Macon , Georgia , USA.); Pruitt R ( e Nashville Medical Research Institute and The Maria Nathanson Center at Saint Thomas Hospital , Nashville , Tennessee , USA.); Barrett AC ( f Salix, a Division of Valeant Pharmaceuticals North America LLC , Bridgewater , NJ , USA.); Bortey E ( f Salix, a Division of Valeant Pharmaceuticals North America LLC , Bridgewater , NJ , USA.); Paterson C ( f Salix, a Division of Valeant Pharmaceuticals North America LLC , Bridgewater , NJ , USA.); Forbes WP ( f Salix, a Division of Valeant Pharmaceuticals North America LLC , Bridgewater , NJ , USA.); Lichtenstein GR ( g Department of Medicine , University of Pennsylvania School of Medicine , Philadelphia , Pennsylvania , USA.) |
| Abstract |
OBJECTIVES: A capsule formulation of mesalamine granules (MG) was developed for once-daily dosing and better compliance. The study aim was to evaluate MG efficacy and tolerability in maintaining ulcerative colitis (UC) remission. METHODS: Pooled analysis of 2 identical phase 3, randomized, double-blind trials of once-daily MG 1.5 g or placebo for up to 6 months. The primary endpoint was percentage of patients remaining relapse-free at month 6 versus placebo. Relapse was defined as revised Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, UC flare, or UC-related adverse event (AE). RESULTS: Data were pooled for patients receiving MG (n = 373) and placebo (n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4%) than placebo (62.4%; P < 0.001) and across subgroups based on select demographic and baseline characteristics (P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG (P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9% and 7.6%), diarrhea (7.9% and 7.0%), and abdominal pain (6.3% and 6.5%). CONCLUSION: Once-daily MG was more efficacious than and as well tolerated as placebo in maintaining UC remission. ClinicalTrials.gov identifiers: NCT00744016 and NCT00767728. |
| File Format |
HTM / HTML |
| ISSN |
00325481 |
| Issue Number |
3 |
| Volume Number |
128 |
| e-ISSN |
19419260 |
| Journal |
Postgraduate Medicine |
| Language |
English |
| Publisher |
Taylor & Francis |
| Publisher Date |
2016-01-01 |
| Publisher Place |
Great Britain (UK) |
| Access Restriction |
One Nation One Subscription (ONOS) |
| Subject Keyword |
Discipline medicine Anti-inflammatory Agents, Non-steroidal Administration & Dosage Colitis, Ulcerative Drug Therapy Mesalamine Adult Capsules Double-blind Method Humans Maintenance Chemotherapy Methods Middle Aged Prognosis Treatment Outcome Clinical Trial, Phase Iii Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't |
| Content Type |
Text |
| Resource Type |
Article |
| Subject |
Medicine |
