Treatment of Crohn's Disease with 6-Mercaptopurine: A Long-Term, Randomized, Double-Blind Study

Daniel H. Present, Burton I. Korelitz, Nathaniel Wisch, Joseph L. Glass, David B. Sachar, Bernard S. Pasternack, Daniel H. Present

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972 Scopus citations

Abstract

To test the effectiveness of 6-mercaptopurine (6-MP) in the treatment of Crohn's disease, we entered 83 chronically ill patients into a two-year double-blind study comparing 6-MP with placebo. Crossover data showed that improvement occurred In 26 of 39 courses of 6-MP (67 per cent) as compared with three of 39 courses of placebo (8 per cent) (P<0.0001). Non-crossover data likewise confirmed the superiority of 6-MP. The drug was more effective than placebo in closing fistulas (31 vs. 6 per cent) and in permitting discontinuation or reduction of steroid dosage (75 vs. 36 per cent) (P<0.001). The onset of response to 6-MP was often delayed, with 32 per cent of patients taking longer than three months to respond, and 19 per cent taking longer than four months. Adverse side effects to 6-MP occurred in 10 percent of patients and were uniformly reversible. We conclude that 6-MP is an effective and useful agent in the management of Crohn's disease. (N Engl J Med. 1980; 302:981–7.) THE natural history of Crohn's disease is highly variable and unpredictable. Because of the high postoperative recurrence rate, surgical resection is indicated only for severe complications or for prolonged debilitation. Medical treatment is therefore required. Unfortunately, only a few drugs are demonstrably effective, and their benefits are limited. Influenced by early reports of favorable responses to immunosuppressive drugs in Crohn's disease1 2 3 and ulcerative colitis,4,5 we undertook a long-term, randomized, double-blind crossover study of 6-mercaptopurine (6-MP) compared with placebo in patients chronically ill with Crohn's disease. Methods Case Selection Cases were drawn from approximately 700 patients with Crohn's disease who were.

Original languageEnglish
Pages (from-to)981-987
Number of pages7
JournalNew England Journal of Medicine
Volume302
Issue number18
DOIs
StatePublished - 1 May 1980
Externally publishedYes

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