Rosuvastatin safety: a comprehensive, international pharmacoepidemiology programme.
Pharmacoepidemiology Drug Safety 2006;15(7):454-61.
ABSTRACT
Results from clinical trials and clinical practice have shown statins
to be generally well tolerated with a low frequency of clinically
relevant side effects. Nevertheless, there are rare occasions when
adverse events (AEs), sometimes serious, may occur. Rosuvastatin is
the newest statin to be approved in the USA and many other countries.
As part of the continued assessment of the benefit-risk profile of
rosuvastatin, AstraZeneca has developed a progressive, comprehensive
pharmacoepidemiology programme to complement safety data obtained from
randomised clinical trials and spontaneous reporting systems, which
have demonstrated that rosuvastatin has a safety profile in line with
comparator statins. This programme comprises nine studies conducted in
recognised centres of excellence assessing over 50,000 patients
treated with rosuvastatin. It consists of three components: patient
characteristics studies (four studies), safety evaluation studies
(four studies); and review of data generated from the
Prescription-Event Monitoring (PEM) study, designed and run by an
independent third party. Patient characteristics studies are designed
to describe the characteristics and drug utilisation patterns of new
users of rosuvastatin compared with new users of other statins in
automated databases. Safety evaluation studies will examine the rates
of specific AEs in different cohorts of statin users and determine
risk factors for these events using data recorded prospectively in
automated databases with case adjudication via medical record review.
The independent PEM study will monitor any significant events recorded
by general practitioners since starting rosuvastatin treatment. This
article is an overview of the rationale and methodology of the
rosuvastatin pharmacoepidemiology programme.