Document 1123
 DOCN  M94A1123
 TI    The effect of the Concorde trial on initiation of didanosine (ddI)
       therapy.
 DT    9412
 AU    Peter A; Rachlis A; Sunnybrook Health Science Centre, Ontario, Canada.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(2):203 (abstract no. PB0824). Unique
       Identifier : AIDSLINE ICA10/94371452
 AB    OBJECTIVE: In April 1993, the results of the MRC/ANRS Concorde trial
       were published in a letter to the editor. This trial found no benefit of
       zidovudine (ZDV) for patients with early asymptomatic disease. In an
       earlier study it was shown that in Ontario, Canada, there was a
       significant decline in initiation of ZDV therapy in asymptomatic and
       symptomatic patients after the release of the Concorde. For patients who
       are intolerant or resistant to ZDV, ddI is used as second-line
       treatment, either as monotherapy or in combination. The objective of the
       current study was to determine if the Concorde findings have had an
       impact on initiation of ddI therapy. METHOD: Antiretrovirals are funded
       and centrally distributed for all Ontario residents with HIV/AIDS.
       Records were drawn from the ddI registry. Enrollment records from 07/92
       to 03/93 were used as the pre-Concorde period and between 04/93 and
       12/93 as post-Concorde (N = 1,735). The adjusted mean number of monthly
       enrollments in the pre and post periods were compared for the sample as
       a whole and for broad disease stage categories. RESULTS: Post-Concorde,
       the mean number of ddI enrollments per month dropped 50%, from 101 to 51
       (t = 4.93, p < .0001). A significant decrease in enrollments was seen in
       both symptomatic and AIDS patients. There was no significant decrease in
       the mean number of asymptomatics enrolled. CONCLUSIONS: The significant
       decline in the use of ddI since release of the Concorde results and the
       earlier examination of ZDV enrollments, imply that Concorde may have
       affected initiation of treatment in persons with symptomatic disease and
       AIDS. Since the Concorde trial only examined the use of ZDV in
       asymptomatics, the ddI findings suggest the results may have been
       generalized to other antiretrovirals and disease stages. Other factors
       that may have influenced the results will be presented.
 DE    Canada  Clinical Trials  Didanosine/*THERAPEUTIC USE  Drug Utilization
       Human  HIV Infections/*DRUG THERAPY  Zidovudine/*THERAPEUTIC USE
       MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).