Danazol in the treatment of systemic lupus erythematosus: a qualitative systematic review

To review and summarize published information on the use, effectiveness, and adverse effects of danazol in patients with systemic lupus erythematosus (SLE).

A MEDLINE search from January 1950 to July 2009 was conducted using 2 search strategies retrieving 51 and 62 references, respectively. We also searched 2 standard reference textbooks and bibliographies of the 38 articles selected.

Of the 38 articles selected, there were 19 case series/reports with a total of 153 patients, including 2 prospective trials of 7 and 16 patients, respectively, and 1 randomized controlled trial of 40 patients. Danazol has been used successfully in the treatment of hematologic manifestations of SLE such as thrombocytopenia, Evan's syndrome, autoimmune hemolytic anemia, and a case of red cell aplasia. Thirteen patients responded to danazol after failing splenectomy. There is limited information on the use of danazol in nonhematologic manifestations of SLE. Adverse effects were generally tolerable but high doses may produce undesirable side effects for female patients.

Danazol is a useful drug in the treatment of SLE patients, especially in patients with refractory thrombocytopenia, autoimmune hemolytic anemia, and premenstrual flares, and in some mild nonhematologic manifestations of SLE. It appears to be relatively well tolerated, safe, and efficacious.