Use of an integrated clinical trial database to evaluate the effect of timing of drotrecogin alfa (activated) treatment in severe sepsis

Table 2 INDEPTH baseline patient characteristics based on time to treatment

Parameter	Time to treatment (h)				Between-treatment p
	Placebo (n = 1,175)		DrotAA (n = 3,216)
	0 – 24 (n = 967)	>24 (n = 208)	0 – 24 (n = 1,882)	>24 (n = 1,334)	0 – 24 h	>24 h
Age, years (mean ± SD)	60.2 ± 16.5	60.5 ± 16.0	58.9 ± 17.8	60.2 ± 15.7	0.05^a	0.82^a
<65 (%)	54.8	57.2	53.8	55.4
65 – 75 (%)	24.7	21.6	25.2	25.0
>75 (%)	20.5	21.2	21.0	16.6
Male sex (%)	56.3	62.0	55.8	60.1	0.83^b	0.60^b
Caucasian ethnicity (%)	80.4	76.4	87.1	90.0	<0.0001^b	<0.0001^b
APACHE II score (mean ± SD)	24.9 ± 7.8	24.1 ± 7.9	23.4 ± 7.6	21.8 ± 7.3	<0.0001^a	<0.0001^a
<25 (%)	52.2	53.8	57.2	64.9
≥25(%)	47.8	46.2	42.8	35.1
Number of ODs (mean ± SD)	2.4 ± 1.1	2.6 ± 1.1	2.5 ± 1.3	2.8 ± 1.1	0.26^a	0.01^a
1 (%)	21.2	17.8	23.0	11.3
≥2(%)	78.8	82.1	77.0	88.7
Time from first OD to start of infusion (mean ± SD)	15.7 ± 6.1	35.8 ± 12.4	15.1 ± 6.2	35.5 ± 7.9	0.01^a	0.75^a
Mechanical ventilation (%)	76.6	85.6	73.9	87.6	0.11^b	0.41^b
Vasopressors (%)	63.8	67.0	67.2	74.6	0.08^b	0.02^b
Recent surgery (%)	32.1	36.5	31.1	40.8	0.41^b	0.50^b

Total numbers of patients do not add up to those in Table 1 because of missing time-to-treatment data (44 had missing data, 23 had time-to-treatment values of more than 72 hours, and 1 had a time-to-treatment value of less than 0). APACHE, Acute Physiology and Chronic Health Evaluation; DrotAA, drotrecogin alfa (activated); INDEPTH, International Integrated Database for the Evaluation of Severe Sepsis and Drotrecogin alfa (activated) Therapy; OD, organ dysfunction. Statistical comparisons are between DrotAA and placebo patients treated in 0 to 24 and more than 24 hours: ^aStudent's t test; ^bχ² test.

ISSN: 1364-8535