Bupropion immediate-release use was also associated with tremor at a rate more than twice as frequently as placebo. Other adverse experiences reported more frequently by bupropion immediate-release patients than those on placebo included agitation, dry mouth, rash, and excessive sweating.
Dose
Response for Common, Drug-Related Adverse Events
Visual
inspection of rates in Table 8.5.1.1 for the following adverse events (repeated
in Table 8.5.1.2) suggested that the following adverse experiences demonstrated
a dose dependency: Agitation, dry mouth, pharyngitis, rash, sweating, tinnitus,
and tremor.
|
Table 8.5.1.2 Treatment Emergent Adverse Experiences
in Placebo-Controlled Phase 2-3 Trials (Reported by at least 1% of Patients
Treated with Bupropion Sustained-Release with Dose Dependency Apparent) |
|||
|
ADVERSE EXPERIENCE |
Bupropion
sustained-release Dosing Group |
||
|
100-200 mg/d (N=350) |
300-400 mg/d (N=343) |
Placebo (N=235) |
|
|
Agitation |
2.6% |
5.0% |
1.7% |
|
Dry
Mouth |
12.9% |
19.5% |
5.5% |
|
Pharyngitis |
1.7% |
5.2% |
1.7% |
|
Rash |
2.6% |
5.2% |
0.9% |
|
Sweating |
2.9% |
6.1% |
1.3% |
|
Tinnitus |
3.4% |
5.2% |
1.7% |
|
Tremor |
3.7% |
6.1% |
0.4% |
8.5.2
Laboratory Findings
Clinical
laboratory tests were obtained on all patients in the two major
placebo-controlled studies 203 and 205, and the findings for chemistry,
hematology, and urinalysis will be described below.
8.5.2.1
Serum Chemistry
Appendix
8.5.2.1 lists the bounds that the sponsor provided for consideration of
abnormal chemistry values as being of potential clinical significance.
The
following table displays the proportions of patients meeting those criteria in
placebo-controlled trials 203 and 205.
Patients were counted if they exceeded a laboratory value at the point
of discontinuation from the study. The
denominator from which the percentages are calculated is the number of patients
in that dosing group, excluding those who had lab values beyond the bounds
specified before and after the study.
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