Appeal No. 2006-1304 Page 6
Application No. 10/214,058
Jukema prefaces its conclusions with two caveats: “Whether all CCBs or only
some of these drugs are capable of extending the antiatherosclerotic effect of
pravastatin is not yet known,” and “[t]he REGRESS trial was not designed to study the
effect of CCB administration. In this regard, it is a retrospective analysis and therefore
no definite conclusions can be drawn concerning the beneficial effect of adding a CCB
to lipid-lowering therapy.” Page 429, right-hand column.
Jukema concludes that, “[r]ecognizing these limitations, it may be stated that this
is the first report to provide substantial evidence that CCBs may have a beneficial effect
on the evolution of coronary atherosclerosis in patients treated with lipid-lowering
therapy. Our results appear to warrant a prospective randomized trial to determine in a
more definitive manner the merits of this combination in the prevention of progression of
coronary atherosclerosis.” Id.
We recognize that Jukema attaches some conditions to the conclusions it draws
from the data of the REGRESS study. Research papers published in peer-reviewed
scientific journals are often cautious about drawing conclusions that go beyond the
specific data presented. See, e.g., Bakker-Arkema:5
Atorvastatin . . . appears to be unique in the magnitude of the associated
decrease in VLDL-C. . . . This well-tolerated drug, therefore, may provide
single-agent therapy for some of the most difficult problems faced in
clinical lipidemiology. . . . Specific explanations for the differences in
efficacy are under study. However, at this time, atorvastatin appears to
offer greater efficacy in the reduction of triglycerides, LDL, and VLDL
levels than other reductase inhibitors with similar safety profiles.
5 Bakker-Arkema et al., “Efficacy and safety of a new HMG-CoA reductase inhibitor, atorvastatin, in
patients with hypertriglyceridemia,” Journal of the American Medical Association, Vol. 275, pp. 128-133
(1996).
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