Table 1.
Characteristics of patients receiving ESA therapy before and after the March 2007FDA black box warning
| Entire study period | Base period | Follow up | P-value* | |
|---|---|---|---|---|
| Number of patients months |
13,748,238 |
6,702,212 |
7,046,026 |
|
| |
% |
% |
% |
|
| Age (Year) |
|
|
|
<.0001 |
| 18–44 |
13.5 |
13.6 |
13.4 |
|
| 45–64 |
37.9 |
37.1 |
38.6 |
|
| ≥65 |
48.6 |
49.3 |
48.0 |
|
| Race |
|
|
|
0.329 |
| White |
54.6 |
54.6 |
54.6 |
|
| Non-white |
45.4 |
45.4 |
45.4 |
|
| Gender |
|
|
|
<.0001 |
| Male |
53.7 |
53.4 |
53.9 |
|
| Female |
46.3 |
46.6 |
46.1 |
|
| Duration of dialysis |
|
|
|
<.0001 |
| <12 months |
20.3 |
21.2 |
19.5 |
|
| 12– < 36 months |
29.5 |
29.9 |
29.2 |
|
| ≥36 months |
50.1 |
48.9 |
51.3 |
|
| Diabetes co-morbidity |
|
|
|
<.0001 |
| Diabetic |
44.3 |
44.0 |
44.6 |
|
| Non-diabetic |
55.7 |
56.0 |
55.4 |
|
| Facility profit status |
|
|
|
<.0001 |
| For-profit |
81.2 |
80.5 |
82.0 |
|
| Non-profit |
18.8 |
19.5 |
18.0 |
|
| Facility chain status |
|
|
|
<.0001 |
| Chain 1 (FP) |
27.0 |
26.9 |
27.0 |
|
| Chain 2 (FP) |
30.4 |
26.8 |
33.9 |
|
| Chain 3 (NP) |
4.0 |
4.1 |
3.9 |
|
| Medium chain |
10.8 |
13.0 |
8.8 |
|
| Small/non chains |
17.8 |
18.7 |
16.9 |
|
| Hospital-based (NP) |
10.0 |
10.6 |
9.5 |
|
| Hematocrit value# |
|
|
|
<.0001 |
| <30% |
8.4 |
7.4 |
9.4 |
|
| 30– < 36% |
45.7 |
41.6 |
49.8 |
|
| ≥36% | 45.9 | 51.0 | 40.8 |
Notes: FP For-profit, NP Nonprofit.
Base period from September 2004 to February 2007. Followup MArch 2007 to August 2009.
FDA black box warning was issuedin March 2007.
#Patients months with missing hematocrit values are not included (when dose is withheld).
*P-value for Pearson’s chi-square test based on the difference between pre and post FDA warning period.