Document 0751
 DOCN  M9470751
 TI    Oral atovaquone compared with intravenous pentamidine for Pneumocystis
       carinii pneumonia in patients with AIDS. Atovaquone Study Group.
 DT    9409
 AU    Dohn MN; Weinberg WG; Torres RA; Follansbee SE; Caldwell PT; Scott JD;
       Gathe JC Jr; Haghighat DP; Sampson JH; Spotkov J; et al;
       Pulmonary/Critical Care Division, University of Cincinnati, OH;
       45267-0564.
 SO    Ann Intern Med. 1994 Aug 1;121(3):174-80. Unique Identifier : AIDSLINE
       MED/94288398
 AB    OBJECTIVE: To test the hypothesis that the therapeutic success rate of
       oral atovaquone is not worse than that of intravenous pentamidine in the
       primary treatment of mild and moderate Pneumocystis carinii pneumonia in
       patients with the acquired immunodeficiency syndrome and to detect
       differences in the toxicity rates of the two treatments. DESIGN:
       Patients were randomly assigned to receive 21 days of open-label therapy
       with either atovaquone, 750 mg orally with meals three times daily, or
       intravenous pentamidine, 3 to 4 mg per kg body weight once daily.
       SETTING: Multicenter study including university and community treatment
       facilities. PATIENTS: Patients with human immunodeficiency virus
       infection and clinical presentations consistent with mild or moderate P.
       carinii pneumonia were eligible. For efficacy and safety analyses,
       patients with histologically confirmed P. carinii pneumonia were
       emphasized. MEASUREMENTS: Patients were monitored by clinical and
       laboratory evaluations for therapeutic efficacy and adverse events
       during the acute treatment phase and for 8 weeks after therapy was
       discontinued. RESULTS: As initial therapy for a histologically confirmed
       episode of P. carinii pneumonia, 56 patients received atovaquone and 53
       received pentamidine. More patients were successfully treated with
       atovaquone (57%) than with pentamidine (40%), a difference of 17% (95%
       CI, -3% to 38%; P = 0.085), but more patients failed to respond to
       atovaquone (29%) than to pentamidine (17%), a difference of 12% (CI, -6%
       to 29%; P = 0.18). Discontinuation of original therapy because of
       treatment-limiting adverse events was more frequent in the pentamidine
       group (36%) than in the atovaquone group (4%) (difference, -32%; CI,
       -48% to -17%; P < 0.001). Nine patients in each treatment group died
       during the study. CONCLUSIONS: Oral atovaquone and intravenous
       pentamidine have similar rates for successful treatment of mild and
       moderate P. carinii pneumonia, but atovaquone has significantly fewer
       treatment-limiting adverse events.
 DE    Adult  Antifungal Agents/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/
       *THERAPEUTIC USE  AIDS-Related Opportunistic Infections/*DRUG THERAPY
       Female  Human  Male  Middle Age  Naphthoquinones/ADMINISTRATION &
       DOSAGE/ADVERSE EFFECTS/  *THERAPEUTIC USE  Pentamidine/THERAPEUTIC USE
       Pneumonia, Pneumocystis carinii/*DRUG THERAPY  Support, Non-U.S. Gov't
       Survival Analysis  Treatment Outcome  CLINICAL TRIAL  JOURNAL ARTICLE
       MULTICENTER STUDY  RANDOMIZED CONTROLLED TRIAL

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