uu.seUppsala University Publications
Change search
ReferencesLink to record
Permanent link

Direct link
Rosuvastatin safety: a comprehensive, international pharmacoepidemiology programme
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology.
Show others and affiliations
2006 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 15, no 7, 454-461 p.Article in journal (Refereed) Published
Abstract [en]

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 pharmacoepidentiology 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 50000 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 pharmacoepiderniology programme.

Place, publisher, year, edition, pages
2006. Vol. 15, no 7, 454-461 p.
Keyword [en]
pharmacoepidemiology, rosuvastatin, statin, safety
National Category
Pharmaceutical Sciences Medical and Health Sciences
URN: urn:nbn:se:uu:diva-83623DOI: 10.1002/pds.1260ISI: 000239289200003PubMedID: 16733834OAI: oai:DiVA.org:uu-83623DiVA: diva2:111531
Available from: 2006-11-07 Created: 2006-11-07 Last updated: 2011-08-15Bibliographically approved

Open Access in DiVA

No full text

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Wallander, Mari-Ann
By organisation
Family Medicine and Clinical Epidemiology
In the same journal
Pharmacoepidemiology and Drug Safety
Pharmaceutical SciencesMedical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar

Altmetric score

Total: 170 hits
ReferencesLink to record
Permanent link

Direct link