Lodotra: Modified-Release Prednisone for Rheumatoid Arthritis
Lodotra is a modified-release form of prednisone. When compared to standard immediate-release prednisone, rheumatoid arthritis patients were found to experience less morning stiffness. Night-time levels of inflammatory cytokines such as IL-6 are elevated in rheumatoid arthritis, causing extreme pain and joint stiffness after waking. It has been previously established that morning stiffness can be helped with prednisone administered at 2 a.m. but that's terrribly inconvenient for most people. Lodotra is an oral medication that releases prednisone from the tablet core about 4 hours after it is taken. Taking Lodotra at 10 p.m. would result in release of the medication at 2 a.m. -- more effective in treating morning stiffness associated with rheumatoid arthritis, researchers claim.
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According to the January 19th issue of The Lancet, 288 patients with active rheumatoid arthritis were evaluated in a 12-week study that compared modified-release with immediate-release prednisone.
- After 12 weeks, patients taking the modified-release prednisone experienced 44 minutes less morning stiffness than at the beginning of the study -- 29.2 minutes less than those taking the standard version.
- A 12-month study reported at the 2007 Annual Meeting of the American College of Rheumatology also yielded positive results with patients having 50 percent less morning stiffness.
Lodotra successfully completed Phase III trials in Europe in 2006 and marketing approval was requested in 15 European countries. In the United States, Lodotra is in development. A second phase III study planned for the second quarter of 2008 will include about 300 patients in the United States and Europe.
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