PMID- 16733834
OWN - NLM
STAT- MEDLINE
DCOM- 20061127
LR  - 20161124
IS  - 1053-8569 (Print)
IS  - 1053-8569 (Linking)
VI  - 15
IP  - 7
DP  - 2006 Jul
TI  - Rosuvastatin safety: a comprehensive, international pharmacoepidemiology 
      programme.
PG  - 454-61
AB  - 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.
CI  - Copyright (c) 2006 John Wiley & Sons, Ltd.
FAU - Johansson, Saga
AU  - Johansson S
AD  - AstraZeneca R&D Molndal, Sweden. Saga.Johansson@astrazeneca.com
FAU - Ming, Eileen E
AU  - Ming EE
FAU - Wallander, Mari-Ann
AU  - Wallander MA
FAU - Rodriguez, Luis A Garcia
AU  - Rodriguez LA
FAU - Herings, Ron M C
AU  - Herings RM
FAU - Goettsch, Wim G
AU  - Goettsch WG
FAU - Gonzalez-Perez, Antonio
AU  - Gonzalez-Perez A
FAU - McAfee, Andrew T
AU  - McAfee AT
FAU - Walker, Alexander M
AU  - Walker AM
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Fluorobenzenes)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
SB  - IM
MH  - Canada
MH  - Databases as Topic
MH  - Fluorobenzenes/*adverse effects
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects
MH  - Netherlands
MH  - Pharmacoepidemiology
MH  - Pyrimidines/*adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Rosuvastatin Calcium
MH  - Safety
MH  - Sulfonamides/*adverse effects
MH  - United Kingdom
MH  - United States
EDAT- 2006/05/31 09:00
MHDA- 2006/12/09 09:00
CRDT- 2006/05/31 09:00
PHST- 2006/05/31 09:00 [pubmed]
PHST- 2006/12/09 09:00 [medline]
PHST- 2006/05/31 09:00 [entrez]
AID - 10.1002/pds.1260 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2006 Jul;15(7):454-61. doi: 10.1002/pds.1260.