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Clinical Therapeutics

Randomized, Double-Blind, Multicenter Study of Caspofungin versus Amphotericin B for Treatment of Oropharyngeal and Esophageal Candidiases

Eduardo G. Arathoon, Eduardo Gotuzzo, L. Miguel Noriega, Rayanne S. Berman, Mark J. DiNubile, Carole A. Sable
Eduardo G. Arathoon
1Hospital General San Juan de Dios, Guatemala City, Guatemala
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Eduardo Gotuzzo
2Hospital Cayetano Heredia, Lima, Peru
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L. Miguel Noriega
3Sotero del Rio Hospital, Santiago, Chile
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Rayanne S. Berman
4Merck Research Laboratories, West Point, Pennsylvania
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Mark J. DiNubile
4Merck Research Laboratories, West Point, Pennsylvania
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  • For correspondence: mark_dinubile@merck.com
Carole A. Sable
4Merck Research Laboratories, West Point, Pennsylvania
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DOI: 10.1128/AAC.46.2.451-457.2002
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  • FIG. 1.
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    FIG. 1.

    Combined favorable response rates in the caspofungin and amphotericin groups. Patients presenting with either esophageal or oropharyngeal candidiasis were treated with caspofungin (35, 50, and 70 mg) or amphotericin (0.5 mg/kg) daily for 7 to 14 days. Patients were evaluated 3 to 4 days after discontinuation of therapy. Numbers within the columns represent the total number of patients in each group included in the MITT analysis. Error bars represent the 95% confidence intervals.

  • FIG. 2.
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    FIG. 2.

    Combined favorable response rates to caspofungin and amphotericin therapy by baseline CD4 lymphocyte count. CD4 cell counts were measured at screening. Numbers within the columns represent the total number of patients in each group. Error bars represent the 95% confidence intervals. The confidence interval was not calculated for the caspofungin 70-mg dose group having >50 CD4 cells/mm3 because the sample size was only seven patients.

  • FIG. 3.
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    FIG. 3.

    Resolution of esophageal plaques caused by infection with C. albicans in two patients treated with caspofungin. Favorable endoscopic responses are illustrated for two representative patients with high-grade esophagitis 3 to 4 days after the conclusion of caspofungin therapy.

Tables

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  • TABLE 1.

    Baseline patient characteristics by treatment group

    CharacteristicValue for patients exhibiting characteristicaTotal patients (n = 140)
    Caspofungin acetate, 35 mg (n = 34)Caspofungin acetate, 50 mg (n = 34)Caspofungin acetate, 70 mg (n = 37)Amphotericin B, 0.5 mg/kg (n = 35)
    Stratumb
        Esophageal (± oropharyngeal)21 (61.8)20 (58.8)24 (64.9)23 (65.7)88 (62.9)
        Oropharyngeal (exclusively)13 (38.2)14 (41.2)13 (35.1)12 (34.3)52 (37.1)
    Substratumc
        Unresponsive to fluconazole6 (17.6)3 (8.8)7 (18.9)5 (14.3)21 (15.0)
        Responsive to fluconazoled28 (82.4)31 (91.2)30 (81.1)30 (85.7)119 (85.0)
    Stratum-substratume
        12 (5.9)1 (2.9)2 (5.4)1 (2.9)6 (4.3)
        211 (32.4)13 (38.2)11 (29.7)11 (31.4)46 (32.9)
        34 (11.8)2 (5.9)5 (13.5)4 (11.4)15 (10.7)
        417 (50.0)18 (52.9)19 (51.4)19 (54.3)73 (52.1)
    HIV infection
        Positive32 (94.1)33 (97.1)37 (100.0)35 (100.0)137 (97.9)
        Negative2 (5.9)1 (2.9)0 (0.0)0 (0.0)3 (2.1)
    Baseline esophageal grade
        1/21 (2.9)2 (5.9)2 (5.4)3 (8.6)8 (5.7)
        14 (11.8)0 (0.0)2 (5.4)1 (2.9)7 (5.0)
        23 (8.8)5 (14.7)7 (18.9)3 (8.6)18 (12.9)
        310 (29.4)11 (32.4)9 (24.3)12 (34.3)42 (30.0)
        42 (5.9)2 (5.9)4 (10.8)4 (11.4)12 (8.6)
    Baseline oropharyngeal grade
        16 (17.6)6 (17.6)2 (5.4)4 (11.4)18 (12.9)
        23 (8.8)8 (23.5)7 (18.9)4 (11.4)22 (15.7)
        34 (11.8)0 (0.0)4 (10.8)4 (11.4)12 (8.6)
    CD4 countf
        No. of patients31323634133
        Mean109.272.651.959.472.2
        SD198.199.8102.465.9124.9
        Median48.034.021.529.030.0
        Range2-8790-4050-5610-2600-879
    • ↵ a Results are presented as number (percent) unless otherwise indicated.

    • ↵ b Primary site of infection.

    • ↵ c Prior response to fluconazole.

    • ↵ d Includes patients not previously exposed to fluconazole or other azole antifungal agents.

    • ↵ e Stratum-substratum categories: 1, oropharyngeal candidiasis alone and unresponsive to fluconazole; 2, oropharyngeal candidiasis alone and responsive to or not previously exposed to fluconazole; 3, esophageal candidiasis (with or without oropharyngeal candidiasis) and unresponsive to fluconazole; 4, esophageal candidiasis (with or without oropharyngeal candidiasis) and responsive or not previously exposed to fluconazole.

    • ↵ f CD4 count tabulations include only those patients with HIV infection. Mean, standard deviation, median, and range are given as number of cells per cubic millimeter.

  • TABLE 2.

    Summary of adverse experiences

    Treatment groupNo. (%) of patients experiencing adverse event
    ClinicalLaboratory
    Drug relatedaSerious and drug relatedaTherapy stopped due to a serious drug-relateda clinical adverse eventDied from any causeDrug relatedaSerious and drug relatedaTherapy stopped due to a serious drug-relateda laboratory adverse event
    Caspofungin acetate, 35 mg (n = 34)17 (50)b0 (0)0 (0)3 (9)16 (48)0 (0)0 (0)
    Caspofungin acetate, 50 mg (n = 34)12 (35)b0 (0)0 (0)1 (3)15 (44)c0 (0)0 (0)
    Caspofungin acetate, 70 mg (n = 37)17 (46)b0 (0)0 (0)3 (8)13 (35)b0 (0)0 (0)
    Amphotericin B, 0.5 mg/kg (n = 35)34 (97)3 (9)1 (3)5 (14)25 (71)1 (3)0 (0)
    All patients (n = 140)d80 (57)3 (2)1 (1)12 (9)69 (50)1 (1)0 (0)
    • ↵ a Determined by the investigator to be possibly, probably, or definitely drug related.

    • ↵ b P ≤ 0.01 versus amphotericin B.

    • ↵ c P ≤ 0.05 versus amphotericin B.

    • ↵ d Only 33 of the 34 patients in the caspofungin, 35 mg, group had follow-up laboratory results and were included in the tabulation of laboratory adverse events.

  • TABLE 3.

    Selecteda drug-relatedb clinical adverse experiences

    SymptomCaspofungin acetatecAmphotericin B, 0.5 mg/kg (n = 35)
    35 mg (n = 34)50 mg (n = 34)70 mg (n = 37)
    n (%)n (%)n (%)n (%)
    Chills1 (2.9)**1 (2.9)**1 (2.7)**28 (80.0)
    Fever7 (20.6)**4 (11.8)**6 (16.2)**25 (71.4)
    Phlebitis3 (8.8)1 (2.9)2 (5.4)5 (14.3)
    Diarrhea1 (2.9)0 (0.0)1 (2.7)5 (14.3)
    Nausea3 (8.8)*1 (2.9)**1 (2.7)**11 (31.4)
    Vomiting0 (0.0)**0 (0.0)**1 (2.7)*8 (22.9)
    Rash3 (8.8)0 (0.0)0 (0.0)1 (2.9)
    Headache4 (11.8)2 (5.9)2 (5.4)*8 (22.9)
    • ↵ a Specific adverse events occurring in ≥7.5% of patients in any treatment group.

    • ↵ b Determined by the investigator to be possibly, probably, or definitely drug related.

    • ↵ c ∗, P ≤ 0.05 versus amphotericin B; ∗∗, P ≤ 0.01 versus amphotericin B.

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Randomized, Double-Blind, Multicenter Study of Caspofungin versus Amphotericin B for Treatment of Oropharyngeal and Esophageal Candidiases
Eduardo G. Arathoon, Eduardo Gotuzzo, L. Miguel Noriega, Rayanne S. Berman, Mark J. DiNubile, Carole A. Sable
Antimicrobial Agents and Chemotherapy Feb 2002, 46 (2) 451-457; DOI: 10.1128/AAC.46.2.451-457.2002

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Randomized, Double-Blind, Multicenter Study of Caspofungin versus Amphotericin B for Treatment of Oropharyngeal and Esophageal Candidiases
Eduardo G. Arathoon, Eduardo Gotuzzo, L. Miguel Noriega, Rayanne S. Berman, Mark J. DiNubile, Carole A. Sable
Antimicrobial Agents and Chemotherapy Feb 2002, 46 (2) 451-457; DOI: 10.1128/AAC.46.2.451-457.2002
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KEYWORDS

amphotericin B
Anti-Bacterial Agents
antifungal agents
candidiasis
Esophageal Diseases
peptides
Peptides, Cyclic

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