Anidulafungin compared with fluconazole for treatment of candidemia and other forms of invasive candidiasis caused by Candida albicans: a multivariate analysis of factors associated with improved outcome

Table 2 Reasons for failure of and withdrawal from study medication.

	Anidulafungin	Fluconazole
Observed failure^a	4	13
Clinical success and microbiologic failure^b	0	1
Clinical failure and microbiologic success	1	4
Clinical failure and microbiologic failure^b	3	7
Clinically indeterminate and microbiologic failure^b	0	1
Indeterminate response^c	10	10
Withdrawal from study medication	12	21
Due to adverse event^d	7	7
Due to withdrawal of consent	2	1
At investigator's discretion	1	3
Worsening clinical status	2	9
Death within 24 hours of end of IV study treatment^b	4	7
Receipt of < 3 doses of study medication	1	1

^a Observed failure was defined as treatment failure declared by the investigator to be clinical failure, microbiologic failure (i.e. positive findings on culture), or both. In these patients mean time to failure was 16.8 days for anidulafungin and 8.9 days for fluconazole.
^b Among those in whom microbiologic failure occurred, two of three patients in the anidulafungin group and eight of nine in the fluconazole group had persistent infection. The other two patients in whom microbiologic failure occurred had superinfections.
^c For the primary efficacy analysis, indeterminate response was treated as failure of global response. Patients could be considered to have an indeterminate response for more than one reason.
^d In the anidulafungin group, adverse events leading to discontinuation included sepsis (2), renal failure (1), elevated liver enzymes (1), multisystem organ failure (1), cardiac failure (1), and hypoglycemia (1). In the fluconazole group, adverse events leading to discontinuation included renal failure (3), elevated liver enzymes (2), cancer (1), and multisystem organ failure (1).

ISSN: 1471-2334