Tags

Type your tag names separated by a space and hit enter

Use of multiple international healthcare databases for the detection of rare drug-associated outcomes: a pharmacoepidemiological programme comparing rosuvastatin with other marketed statins.
Pharmacoepidemiol Drug Saf. 2010 Dec; 19(12):1218-24.PD

Abstract

BACKGROUND

Statins (inhibitors of 3-hydroxy-3-methyl-glutaryl-CoA reductase) are associated with rare but serious adverse events involving the muscle, kidney and liver. To compare the safety profile of rosuvastatin with other marketed statins, four pharmacoepidemiological studies were conducted using different national healthcare databases. These studies used a coordinated methodology to facilitate future meta-analysis.

OBJECTIVE

To achieve enhanced estimates of rosuvastatin safety relative to other statins, by performing a meta-analysis of four rosuvastatin safety studies.

METHODS

Outcomes were identified using computerised codes, and validated using hospital records or questionnaires. Incidence estimates were based on current statin exposure. Incidence estimates for hospitalised myopathy, rhabdomyolysis, acute renal failure and acute liver injury among users of rosuvastatin and users of other statins were pooled across studies using a weighted average corresponding to the Mantel-Haenszel estimate of the common relative risk.

RESULTS

More than 29,900 person-years were accrued for rosuvastatin use and more than 166,900 person-years were accrued for other statin use. Relative to other statins, rosuvastatin was not associated with significant differences in the incidence of hospitalised myopathy (+0.5 cases per 10,000 person-years; 95%CI: -0.6 to 1.6), rhabdomyolysis (+0.7 cases per 10,000 person-years; 95%CI: -0.3 to 1.6), acute renal failure (-0.2 cases per 10,000 person-years; 95%CI: -2.9 to 2.5) or acute liver injury (-0.8 cases per 10,000 person-years; 95%CI: -1.8 to 0.2).

CONCLUSION

In this large sample (∼ 200,000 person-years), no significant difference in the risk of myopathy, rhabdomyolysis, acute liver injury or acute renal failure was seen between rosuvastatin and other statins.

Authors+Show Affiliations

Spanish Centre for Pharmacoepidemiologic Research (CEIFE), Madrid, Spain. lagarcia@ceife.esNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20922707

Citation

García Rodríguez, Luis A., et al. "Use of Multiple International Healthcare Databases for the Detection of Rare Drug-associated Outcomes: a Pharmacoepidemiological Programme Comparing Rosuvastatin With Other Marketed Statins." Pharmacoepidemiology and Drug Safety, vol. 19, no. 12, 2010, pp. 1218-24.
García Rodríguez LA, Herings R, Johansson S. Use of multiple international healthcare databases for the detection of rare drug-associated outcomes: a pharmacoepidemiological programme comparing rosuvastatin with other marketed statins. Pharmacoepidemiol Drug Saf. 2010;19(12):1218-24.
García Rodríguez, L. A., Herings, R., & Johansson, S. (2010). Use of multiple international healthcare databases for the detection of rare drug-associated outcomes: a pharmacoepidemiological programme comparing rosuvastatin with other marketed statins. Pharmacoepidemiology and Drug Safety, 19(12), 1218-24. https://doi.org/10.1002/pds.2032
García Rodríguez LA, Herings R, Johansson S. Use of Multiple International Healthcare Databases for the Detection of Rare Drug-associated Outcomes: a Pharmacoepidemiological Programme Comparing Rosuvastatin With Other Marketed Statins. Pharmacoepidemiol Drug Saf. 2010;19(12):1218-24. PubMed PMID: 20922707.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Use of multiple international healthcare databases for the detection of rare drug-associated outcomes: a pharmacoepidemiological programme comparing rosuvastatin with other marketed statins. AU - García Rodríguez,Luis A, AU - Herings,Ron, AU - Johansson,Saga, Y1 - 2010/10/04/ PY - 2010/02/18/received PY - 2010/06/29/revised PY - 2010/07/12/accepted PY - 2010/10/6/entrez PY - 2010/10/6/pubmed PY - 2011/3/16/medline SP - 1218 EP - 24 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 19 IS - 12 N2 - BACKGROUND: Statins (inhibitors of 3-hydroxy-3-methyl-glutaryl-CoA reductase) are associated with rare but serious adverse events involving the muscle, kidney and liver. To compare the safety profile of rosuvastatin with other marketed statins, four pharmacoepidemiological studies were conducted using different national healthcare databases. These studies used a coordinated methodology to facilitate future meta-analysis. OBJECTIVE: To achieve enhanced estimates of rosuvastatin safety relative to other statins, by performing a meta-analysis of four rosuvastatin safety studies. METHODS: Outcomes were identified using computerised codes, and validated using hospital records or questionnaires. Incidence estimates were based on current statin exposure. Incidence estimates for hospitalised myopathy, rhabdomyolysis, acute renal failure and acute liver injury among users of rosuvastatin and users of other statins were pooled across studies using a weighted average corresponding to the Mantel-Haenszel estimate of the common relative risk. RESULTS: More than 29,900 person-years were accrued for rosuvastatin use and more than 166,900 person-years were accrued for other statin use. Relative to other statins, rosuvastatin was not associated with significant differences in the incidence of hospitalised myopathy (+0.5 cases per 10,000 person-years; 95%CI: -0.6 to 1.6), rhabdomyolysis (+0.7 cases per 10,000 person-years; 95%CI: -0.3 to 1.6), acute renal failure (-0.2 cases per 10,000 person-years; 95%CI: -2.9 to 2.5) or acute liver injury (-0.8 cases per 10,000 person-years; 95%CI: -1.8 to 0.2). CONCLUSION: In this large sample (∼ 200,000 person-years), no significant difference in the risk of myopathy, rhabdomyolysis, acute liver injury or acute renal failure was seen between rosuvastatin and other statins. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/20922707/Use_of_multiple_international_healthcare_databases_for_the_detection_of_rare_drug_associated_outcomes:_a_pharmacoepidemiological_programme_comparing_rosuvastatin_with_other_marketed_statins_ L2 - https://doi.org/10.1002/pds.2032 DB - PRIME DP - Unbound Medicine ER -