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Summaries for Patients are a service provided by Annals to help patients better understand the complicated and often mystifying language of modern medicine.
SUMMARIES FOR PATIENTS
Comparison of the Drugs Fluconazole or Itraconazole To Treat Coccidioidomycosis Infection
7 November 2000 | Volume 133 Issue 9 | Page S-6
Summaries for Patients are presented for informational purposes only. These summaries are not a substitute for advice from your own medical provider. If you have questions about this material, or need medical advice about your own health or situation, please contact your physician.
The summary below is from the full report titled "Comparison of Oral Fluconazole and Itraconazole for Progressive, Nonmeningeal Coccidioidomycosis. A Randomized, Double-Blind Trial." It is in the 7 November 2000 issue of Annals of Internal Medicine (volume 133, pages 676-686). The authors are JN Galgiani, A Catanzaro, GA Cloud, RH Johnson, PL Williams, LF Mirels, F Nassar, JE Lutz, DA Stevens, PK Sharkey, VR Singh, RA Larsen, KL Delgado, C Flanigan, and MG Rinaldi for the National Institute of Allergy and Infectious Diseases–Mycoses Study Group.
What is the problem and what is known about it so far?
Coccidioidomycosis is an infection due to a fungus (Coccidioides immitis) found in Arizona, central California, and other southwestern U.S. states and in parts of Central and South America. Of every three people who get this infection, only one becomes ill. Illness most often involves the lungs but can also involve the skin, lymph nodes, joints, and bone. In people with abnormal immune systems, coccidioidomycosis can also cause meningitis, which is an infection of the lining that covers the brain and spinal cord. Fluconazole and itraconazole are drugs taken by mouth that are used to treat coccidioidomycosis illness. Both of these drugs have been shown to be useful in treating this infection. However, no studies had compared the two drugs to see if one is better than the other.
Why did the researchers do this particular study?
To determine whether fluconazole or itraconazole is better for the treatment of patients with coccidioidomycosis.
Who was studied?
The study included 191 patients with coccidioidomycosis involving the lung, skin, joints, or bone. Patients could not be in the study if they had meningitis.
How was the study done?
The researchers assigned patients at random to receive treatment for 12 months with fluconazole (400 milligrams a day) and a pill that looked like itraconazole but contained no active ingredient (a placebo) or with itraconazole (200 milligrams twice a day) and a placebo pill that looked like fluconazole. The placebo prevented both the patients and the researchers from knowing which medicine the patient was taking until the end of the study. The researchers examined study patients at the beginning of the study and again after 4, 8, and 12 months to determine the severity of the infection. They used a previously established scoring system to define how bad the infection was at each point in time.
What did the researchers find?
Overall, 47 of the 94 patients who took fluconazole (50%) improved compared with 61 of the 97 patients who took itraconazole (63%). Statistical analysis showed that these results did not indicate that one of these medicines was more effective than the other. However, among patients with bone infections, those receiving itraconazole seemed to have improved more than those receiving fluconazole.
What were the limitations of the study?
This study was too small to show small differences in outcomes between fluconazole and itraconazole.
What are the implications of the study?
Fluconazole and itraconazole appear to be equally effective in treating coccidioidomycosis. Patients with bone involvement may do somewhat better when treated with itraconazole than with fluconazole.
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