Appeal No. 2006-1304 Page 5
Application No. 10/214,058
Jukema discloses that, out of the 885 patients in the REGRESS trial (page 426,
under “Results”), 536 were taking CCBs (id., under “Calcium Channel Blocker
Comedication Results.”). That is, roughly 60% of the patients in both the placebo and
pravastatin groups were also taking a CCB.
Jukema discloses that “with respect to MOD [minimum obstruction diameter; see
page 426, left-hand column], patients in the pravastatin group had on average 0.05 mm
. . . less progression if cotreated with CCBs compared to no CCB cotreatment. . . . With
respect to new lesion formation, in the pravastatin group, there were 50% . . . fewer
patients with new lesions if cotreated with CCBs compared with no CCB cotreatment.”
Page 427, paragraph bridging the columns.
Jukema also separately analyzes the data relating to patients taking a
dihydropyridine CCB (nifedipine, amlodipine, or “another dihydropyridine CCB”) and
those taking a nondihydropyridine CCB (diltiazem or verapamil) (page 426, under
“Calcium Channel Blocker Comedication Results.”). Jukema reports that a “beneficial
effect of CCB treatment together with pravastatin therapy was evident” for both types of
CCBs “regarding the effect on MOD and percent of patients with new lesions. . . . No
beneficial effect was found for either type of CCB treatment on 2-year event-free
survival. If there was any effect on event-free survival, it was in favor of no CCB
treatment; however, this was not statistically significant.” Page 428, paragraph bridging
the columns.4
4 Jukema also notes that “any trend to more clinical events in the CCB groups can be largely explained by
the higher number of unscheduled CABG [coronary artery bypass graft surgery; page 426, left-hand
column] procedures in the nondihydropyridine CCB group.” Page 428, right-hand column.
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