(Statins) and Fixed-dose Combination Products Containing a Statin

Final Report Update 5 Drug Effectiveness Review Project
In WOSCOPS, 132 pravastatin 40 mg reduced coronary events by 31%, or 1 for every 44
patients (men only) treated (absolute risk, 5.5% compared with 7.9%) whereas in
AFCAPS/TexCAPS, lovastatin reduced the incidence of new cardiovascular events by 37%, or 1
for every 49 subjects (men and women) treated (absolute risk, 6.8% compared with 10.9%).
WOSCOPS used a stricter definition of coronary events, defined as the occurrence of nonfatal
myocardial infarction or coronary heart disease death, than AFCAPS, which included incidence
of unstable angina in their primary outcome, so the relative risk reductions and numbers-neededto-treat
were not directly comparable.
In WOSCOPS, but not AFCAPS/TexCAPS, pravastatin therapy reduced coronary disease
deaths by 33% (95% CI, 1 to 55) and all-cause mortality by 22% (95% CI, 0 to 40), a result that
nearly reached statistical significance (P=0.051). The absolute risks of coronary disease death
were 1.3% for subjects in the pravastatin group and 1.9% in the placebo group; number needed
to treat, 163. In AFCAPS/TexCAPS, the absolute risks of fatal coronary disease events were 3.3
per 1000 subjects in the lovastatin group and 4.5 per 1000 subjects in the placebo group (P=NS).
There was no difference in all-cause mortality in AFCAPS/TexCAPS.
The different mortality results should not be taken as evidence that pravastatin and
lovastatin would differ if used in subjects at similar risk. Compared with AFCAPS/TexCAPS,
WOSCOPS recruited subjects who had about 4 times as high a risk of dying from coronary
disease in the first place. The reduction in coronary heart disease deaths was actually comparable
in the 2 studies, however in AFCAPS/TexCAPS, it did not reach statistical significance due to
the lower number of events.
In JUPITER, 81 a large multicenter, international trial, 17 802 relatively healthy adults
with lipid levels below current treatment thresholds who also had elevated C-reactive protein and
who had never used lipid lowering therapy, were randomized to rosuvastatin 20 mg or placebo.
The trial was initially designed to continue until 520 primary endpoints were documented but
was stopped early for benefit. After a median follow-up of 1.9 years, rosuvastatin 20 mg lowered
the risk for the occurrence of a first major cardiovascular event by 44% (hazard ratio, 0.56; 95%
CI, 0.46 to 0.69; P3 times the upper limit of normal (0.3% compared with 0.2%; P=0.34) but
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