NDLI: First randomised trial of treatments for pulmonary disease causedby M avium intracellulare,M malmoense, and Mxenopi in HIV negative patients: rifampicin, ethambutol andisoniazid versus rifampicin and ethambutol

Content Provider	PubMed Central
Author	Research, C.
Abstract	BACKGROUND—Thetreatment of pulmonary disease caused by opportunist mycobacteria iscontroversial. It is uncertain whether in vitro sensitivity testingpredicts clinical response in the way it does forMycobacterium tuberculosis. The literaturesuggests that the combination of rifampicin (R) and ethambutol (E) isimportant whereas isoniazid (H) may not be, but to date there have beenno published reports of randomised controlled trials in the treatmentof these conditions. The British Thoracic Society has conducted thefirst such trial, a randomised study of two regimens in HIV negativepatients with pulmonary disease caused by Mavium intracellulare (MAC),M malmoense, and Mxenopi. METHODS—When twopositive cultures were confirmed by the Mycobacterium ReferenceLaboratories for England, Wales and Scotland, the coordinatingphysician invited the patient's physician to enrol the patient.Patients were also recruited from Scandinavia. Randomisation to 2 yearsof treatment with RE or REH was performed from lists held in thecoordinator's office. Clinical, bacteriological, and radiologicalprogress was monitored at set intervals up to 5years. RESULTS—FromOctober 1987 to December 1992, 141 physicians entered 223 patients (106 with M malmoense, 75 with MAC, 42 withM xenopi). At entry the RE and REH groupswere comparable over a range of demographic and clinical features. Foreach species there was no significant difference between RE and REH inthe number of deaths, but when the three species were combined therewere fewer deaths from the mycobacterial disease with RE (1%v 8%, p=0.018, odds ratio 0.10, exact 95%CI 0.00 to 0.76). For M malmoense the failure of treatment/relapse rates did not differ appreciably betweenthe regimens, but for MAC there were fewer failures of treatment/relapses with REH (16% v 41%,p=0.033) With M xenopi there was anon-significant trend in the same direction (5%v 18%, p=0.41) and when all three specieswere combined there was a significant difference in favour of REH (11%v 22%, p=0.033). There was no correlationbetween failure of treatment/relapse and in vitro resistance.M xenopi was associated with the greatest mortality (57% at 5 years), MAC was the most difficult to eradicate, and M malmoense had the most favourableoutlook (42% known to be alive and cured at 5years). CONCLUSIONS—Theresults of susceptibility tests performed by the modal resistancemethod do not correlate with the patient's response to chemotherapy.RE and REH are tolerated better than previous regimens containingsecond or third line anti-mycobacterial drugs. Treatment ofM malmoense with RE for 2 years ispreferable to REH. The addition of H reduces the failure oftreatment/relapse rates for MAC and has a tendency to do so also forM xenopi, but there is a suggestion that REHis associated with higher death rates overall. Better regimens are required.
Related Links	http://dx.doi.org/10.1136/thorax.56.3.167
Starting Page	167
File Format	PDF
ISSN	14683296
e-ISSN	14683296
Journal	Thorax
Issue Number	3
Volume Number	56
Language	English
Publisher	BMJ Group
Publisher Date	2001-03-01
Access Restriction	Open
Rights Holder	BMJ Group
Subject Keyword	Research in Higher Education
Content Type	Text
Resource Type	Article
Subject	Pulmonary and Respiratory Medicine

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