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| |  ACG: Mixed Results Seen in Meta-analysis of Budesonide to Treat Crohn's Disease By Cameron Johnston Special to DG News LAS VEGAS, NV -- October 23, 2001 -- Patients with moderate and severe Crohn's disease have less likelihood of their disease going into remission, but also have less chance of developing gastrointestinal adverse reactions when treated with budesonide rather than conventional corticosteroids such as prednisone, a meta-analysis reports. According to Dr. Sunanda Kane, who conducted a meta-analysis of 12 studies that used budesonide to treat Crohn's disease, the drug has a higher probability of inducing remission than either placebo (RR = 1.82) or mesalamine (RR = 1.73). But, it still has a lower probability than other steroids (RR = 0.87). Dr. Kane is with the department of gastroenterology at University of Chicago medical school, Chicago, Illinois, United States, and presented her findings in a podium presentation yesterday at the annual meeting of the American College of Gastroenterology. The meta-analysis involved patients who had taken conventional steroids, mesalamine, 5-ASA or budesonide to treat their disease. The benefit of budesonide in terms of lower risk of GI adverse events was also evaluated. It was found that the relative risk reduction was 0.65 of having a steroid related adverse event. "That means you can tell your patients that they will have 35 percent less chance of steroid related adverse reaction if they are treated with budesonide," she said in her podium presentation. Interestingly, she said, the meta-analysis found that while budesonide was less effective at inducing remission than conventional steroids, it was more effective among those patients who had mild and moderate disease, with Crohn's Disease Activity Index of = 300. Active Crohn's disease is regarded as a CDAI score of >220. Ultimately, Dr. Kane said that while budesonide was not as efficacious as steroids at inducing, or maintaining remission, it was steroid-sparing and had a better side effect profile. However she added, that none of the studies involved in the meta-analysis considered the effect that steroids, including budesonide, had on bone turn-over or the patient's risk of developing osteoporosis or osteopenia. This was mainly because the risks of corticosteroid use for something like Crohn's disease were not well understood when some of these trials were being planned. Dr. Kane also pointed out that no formal dose-ranging studies have been conducted with budesonide but it is known that 9 mg/day is not more effective than 12 mg/day. Therefore, there would be no advantage to increasing the dose of budesonide to achieve greater efficacy while at the same time, keeping the pharmacokinetic levels of the drug below toxic levels so as to minimize the risk of adverse events.
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