extremely low power associated with this test makes it difficult to draw broad conclusions regarding the relative safety of bupropion sustained-release versus placebo in this regard.  No patient withdrew from clinical trials because of abnormal urinalysis results.

8.5.3                       Vital Signs and Weight

Appendix 8.5.3.1 gives the criteria for determining potentially clinically significant changes in vital signs, and Appendix 8.5.3.2 displays the proportions of patients in protocols 203 and 205 exceeding these criteria at least once.  Here the denominator is the number who did not meet the particular criteria at baseline.  When proportions of bupropion sustained-release and placebo patients meeting criteria for vital sign changes were compared (using Yates chi-square or 2-tailed Fisher’s Exact test, as appropriate), weight parameters were the only factors found to differ between the groups.  There was a trend for placebo patients to have exhibited weight gain at least one during the study (p=0.094), while significantly more bupropion sustained-release patients exhibited weight loss (182/680 vs. 33/231) at least once during the study (p=0.001).  The power to detect differences in rates of hypertension, tachycardia, and bradycardia between drug- and placebo-treated patients was likely inadequate.

No patient treated with bupropion sustained-release had to discontinue the drug because of changes in vital signs or weight.  Although there were some statistically significant effects of drug vs. placebo at different time points in protocols 203 and 205, none of these mean changes were of significant clinical meaning.  Table 8.5.3 displays those vital signs that were statistically differently affected by bupropion sustained-release than by placebo at each week of the trials.  (The p values indicated were not corrected for multiple-time-points testing.)  The most consistent change in vital signs associated with bupropion sustained-release was weight loss.  In protocol 203, the mean weight change at discontinuation for the placebo, bupropion sustained-release 150 mg, and bupropion sustained-release 300 mg groups was a decrease of 0.4, 1.2, and 2.3 pounds, respectively.  In protocol 205, the mean weight change at discontinuation for the placebo, bupropion sustained-release 100 mg, bupropion sustained release 200 mg, bupropion sustained-release 300 mg, and bupropion sustained-release 400 mg groups was an increase of 0.6 pounds for placebo, and a decrease of 0.8, 1.3, and 2.8 pounds for the remaining groups, respectively.

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