|
Table 8.5.2.1.1 Proportions of Patients
Having Potentially Clinically Significant Changes in Serum Chemistry
Variables in Protocols 203 and 205 |
||||||
|
Serum
Chemistry Variables |
Bupropion
sustained-release |
Placebo |
||||
|
Total
Patients |
Abnormal |
Total
Patients |
Abnormal |
|||
|
# |
# |
% |
# |
# |
% |
|
|
Total
Bilirubin - High |
693 |
1 |
0.1% |
235 |
0 |
0% |
|
Alkaline
Phosphatase |
693 |
0 |
0% |
235 |
0 |
0% |
|
ALT
(SPGT) – High |
692 |
2 |
0.3% |
235 |
1 |
0.4% |
|
AST
(SGOT) – High |
692 |
2 |
0.3% |
235 |
0 |
0% |
|
Creatinine
- High |
693 |
2 |
0.3% |
235 |
0 |
0% |
|
Creatinine
– Low |
693 |
1 |
0.1% |
235 |
0 |
0% |
|
Glucose
– High |
692 |
4 |
0.6% |
234 |
0 |
0% |
|
Glucose
– Low |
692 |
3 |
0.4% |
235 |
0 |
0% |
|
Albumin |
693 |
0 |
0% |
235 |
0 |
0% |
|
Sodium |
693 |
0 |
0% |
235 |
0 |
0% |
|
Potassium
– Low |
693 |
1 |
0.1% |
235 |
0 |
0% |
|
Potassium
– High |
693 |
0 |
0% |
235 |
0 |
0% |
|
Bicarbonate
– Low |
691 |
2 |
0.3% |
2324 |
3 |
1.3% |
The
number of patients exceeding the bounds of normal laboratory values was not
large enough to draw any significant statistical inferences about different effects
of drug versus placebo in causing extreme laboratory values. Mean changes from baseline to last visit in
serum chemistry parameters were compared by the sponsor across treatment groups
with Wilcoxon rank sum analysis (Table 8.5.2.1.2). Although there were some statistically differences, none were
felt to be clinically important for the group as a whole. One patient (205-2004) with a prior history
of elevated creatinine levels had a creatinine level of 1.9 mg/dL and
urinalysis protein value of 3+ at screening.
After five weeks of 200 mg mg/d bupropion sustained-release, serum
creatinine level was 2.1 mg/dL and urine protein was unchanged. The patient was then discontinued from
protocol 205 because of the increase in creatinine. No other patients were discontinued due to abnormal serum
chemistries.
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