Appeal No. 1997-1842
Application 08/068,878
11. Lepor et al. 1989 reported the results of a two-month dose-titration study of
terazosin in the treatment of BPH. Twenty-two normotensive patients with moderate
symptoms of BPH were initially given 1 mg/day of terazosin (HYTRIN®). The dose
was subsequently increased to 5 mg/day over an interval of one month. The 5 mg/day
dose was continued for another month. Twenty-two patients continued the two month
study. The remainder of the patients did not complete the study because of adverse
drug reactions and poor compliance. Page, 393, column 1, lines 2, 13, 14, 38-49;
page 393, column 2, lines 23-31.
12. Lepor et al. 1989 showed that after two months, the peak and mean urinary
flow rates increased 63% and 61%, respectively, and the mean obstructive and irritative
symptom scores deceased 62% and 33%, respectively. Lepor et al. 1989 disclosed
that the observed changes from the baseline urinary flow rates and symptom scores
were statistically and clinically significant. Page 393, column 2, lines 32-38; and Table
5.
13. Lepor et al. 1989 disclosed that terazosin was well tolerated in the
normotensive patients, and that adverse drug reactions were all mild and readily
reversible. Page 393, column 2, lines 46-49; page 396, column 1, lines 39-41; and
Table 7.
14. Lepor et al. 1989 concluded that their study indicated that terazosin is safe
and effective for the treatment of symptomatic BPH. Page 396, column 2, lines 9-13.
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