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Clinical question
Are statins similar regarding adverse drug reactions?
Bottom line
The United States Federal Drug Administration (FDA), Health Canada, and
European regulators have recently issued advisories to physicians regarding
higher doses of rosuvastatin. These data -- though inherently limited by
their voluntary nature and the possibility of reporting bias -- lend
credence to concerns that rosuvastatin is less safe than other statins. It
is also the only statin for which we do not have patient-oriented outcome
data.
Reference
Alsheikh-Ali AA, Ambrose MS, Kuvin JT, Karas RH. The safety of rosuvastatin
as used in common clinical practice: a postmarketing analysis. Circulation
2005;111:3051-57.
Study design: Other
Setting: Population-based
Synopsis
The authors searched 2 FDA databases for adverse event reports by health
professionals and patients for several statins. The number of reports per
million patients were calculated for a 1-year period during which the
following 4 statins were simultaneously available: rosuvastatin (Crestor),
simvastatin (Zocor), pravastatin (Pravachol), and atorvastatin (Lipitor).
That rate was also calculated for the first year that each statin was
available; for this calculation, data for cerivastatin (Baychol), a statin
removed from the market for safety reasons, were also included. Results were
reported for a variety of individual adverse events (rhabdomyolysis,
proteinuria, nephropathy, and renal failure) and for a composite of more
serious adverse events (fatal, life-threatening, or requiring
hospitalization). Composite adverse event reports were approximately 2 to 8
times more common with rosuvastatin than with the other 3 currently
available statins during the composite observation period, as well as during
the first postmarketing year (the corresponding rate for cerivastatin was 3
times higher yet than that for rosuvastatin). The same was true of serious
adverse event reports and each of the individual reports during the
composite observation period, although more serious adverse events were seen
during the first postmarketing year for simvastatin than rosuvastatin. This
may be because simvastatin was given with a fibrate much more often than
rosuvastatin (18.4% vs 7.6%; P < .01). Particularly worrisome is the fact
that 62% of the adverse events with rosuvastatin occurred at a dose of 10 mg
or lower.
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