| Abstract
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OBJECTIVES: The purpose of this study was to assess the impact
on cardiovascular and adverse events of attaining low-density
lipoprotein cholesterol (LDL-C) levels <50 mg/dl with rosuvastatin
in apparently healthy adults in the JUPITER (Justification for
the Use of Statins in Prevention: an Intervention Trial Evaluating
Rosuvastatin) trial.
BACKGROUND: The safety and magnitude of cardiovascular risk reduction
conferred by treatment to LDL-C levels below current recommended
targets remain uncertain.
METHODS: A cohort of 17,802 apparently healthy men and women with
high-sensitivity C-reactive protein =2 mg/l and LDL-C <130
mg/dl were randomly allocated to rosuvastatin 20 mg daily or placebo,
and followed up for all-cause mortality, major cardiovascular
events, and adverse events. In a post-hoc analysis, participants
allocated to rosuvastatin were categorized as to whether or not
they had a follow-up LDL-C level <50 mg/dl.
RESULTS: During a median follow-up of 2 years (range up to 5 years),
rates of the primary trial endpoint were 1.18, 0.86, and 0.44
per 100 person-years in the placebo group (n = 8,150) and rosuvastatin
groups without LDL-C <50 mg/dl (n = 4,000) or with LDL-C <50
mg/dl (n = 4,154), respectively (fully-adjusted hazard ratio:
0.76; 95% confidence interval: 0.57 to 1.00 for subjects with
no LDL-C <50 mg/dl vs. placebo and 0.35, 95% confidence interval:
0.25 to 0.49 for subjects attaining LDL-C <50 mg/dl; p for
trend <0.0001). For all-cause mortality, corresponding event
rates were 0.67, 0.65, and 0.39 (p for trend = 0.004). Rates of
myalgia, muscle weakness, neuropsychiatric conditions, cancer,
and diabetes mellitus were not significantly different among rosuvastatin-allocated
participants with and without LDL-C <50 mg/dl.
CONCLUSIONS: Among adults with LDL-C <130 mg/dl and high-sensitivity
C-reactive protein =2 mg/l, rosuvastatin-allocated participants
attaining LDL-C <50 mg/dl had a lower risk of cardiovascular
events without a systematic increase in reported adverse events.
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