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The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy.
Pharmacoepidemiol Drug Saf. 2006 Jul; 15(7):444-53.PD

Abstract

PURPOSE

The purpose of this study was to compare incidence rates of hospitalization associated with rhabdomyolysis, myopathy, renal, or hepatic dysfunction, and of in-hospital death, between initiators of rosuvastatin and other statins.

METHODS

This was a matched cohort study of statin initiators from the administrative database of a large health insurer in the US, during the first 6 months of rosuvastatin availability with up to 18 months of follow-up. All outcome events were verified by medical record review. Incidence rates, risk ratios, and associated 95% confidence intervals were estimated.

RESULTS

From an initial pool of 12,217, 11,249 eligible rosuvastatin initiators were matched to 37,282 initiators of other statins. The incidence rate (IR) per 1000 person-years for rhabdomyolysis was 0.10 [0.00, 0.55] for rosuvastatin initiators (n = 1) and 0.06 [0.01, 0.22] for other statin initiators (n = 2), for a hazard ratio (HR) of 1.98 [0.18, 21.90]. The IR for myopathy was 0.20 [0.02, 0.71] for rosuvastatin initiators (n = 2) and 0.00 [0.00, 0.09] for other statin initiators (n = 0). The IR for renal dysfunction was 1.18 [0.61, 2.06] for rosuvastatin initiators (n = 12) and 1.26 [0.91, 1.71] for other statin initiators (n = 42), for a HR of 0.90 [0.47, 1.73]. The IR for hepatic dysfunction was 0.20 (0.02, 0.71) for rosuvastatin initiators (n = 2) and 0.24 (0.10, 0.47) for other statin initiators (n = 8), for a HR of 0.87 (0.18, 4.14).

CONCLUSIONS

This study found no difference between rosuvastatin and the other statins in the incidence of hospitalizations associated with renal or hepatic events, or death. The absolute incidence rates of rhabdomyolysis and myopathy were reassuringly low among all statin initiators but remain too small for firm conclusions to be drawn on any difference between the statins.

Authors+Show Affiliations

i3 Drug Safety, Newton, MA 02466, USA. andrew.mcafee@i3drugsafety.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16761308

Citation

McAfee, Andrew T., et al. "The Comparative Safety of Rosuvastatin: a Retrospective Matched Cohort Study in Over 48,000 Initiators of Statin Therapy." Pharmacoepidemiology and Drug Safety, vol. 15, no. 7, 2006, pp. 444-53.
McAfee AT, Ming EE, Seeger JD, et al. The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy. Pharmacoepidemiol Drug Saf. 2006;15(7):444-53.
McAfee, A. T., Ming, E. E., Seeger, J. D., Quinn, S. G., Ng, E. W., Danielson, J. D., Cutone, J. A., Fox, J. C., & Walker, A. M. (2006). The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy. Pharmacoepidemiology and Drug Safety, 15(7), 444-53.
McAfee AT, et al. The Comparative Safety of Rosuvastatin: a Retrospective Matched Cohort Study in Over 48,000 Initiators of Statin Therapy. Pharmacoepidemiol Drug Saf. 2006;15(7):444-53. PubMed PMID: 16761308.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The comparative safety of rosuvastatin: a retrospective matched cohort study in over 48,000 initiators of statin therapy. AU - McAfee,Andrew T, AU - Ming,Eileen E, AU - Seeger,John D, AU - Quinn,Sherry G, AU - Ng,Eva W, AU - Danielson,Jared D, AU - Cutone,Jennifer A, AU - Fox,Jonathan C, AU - Walker,Alexander M, PY - 2006/6/9/pubmed PY - 2006/12/9/medline PY - 2006/6/9/entrez SP - 444 EP - 53 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 15 IS - 7 N2 - PURPOSE: The purpose of this study was to compare incidence rates of hospitalization associated with rhabdomyolysis, myopathy, renal, or hepatic dysfunction, and of in-hospital death, between initiators of rosuvastatin and other statins. METHODS: This was a matched cohort study of statin initiators from the administrative database of a large health insurer in the US, during the first 6 months of rosuvastatin availability with up to 18 months of follow-up. All outcome events were verified by medical record review. Incidence rates, risk ratios, and associated 95% confidence intervals were estimated. RESULTS: From an initial pool of 12,217, 11,249 eligible rosuvastatin initiators were matched to 37,282 initiators of other statins. The incidence rate (IR) per 1000 person-years for rhabdomyolysis was 0.10 [0.00, 0.55] for rosuvastatin initiators (n = 1) and 0.06 [0.01, 0.22] for other statin initiators (n = 2), for a hazard ratio (HR) of 1.98 [0.18, 21.90]. The IR for myopathy was 0.20 [0.02, 0.71] for rosuvastatin initiators (n = 2) and 0.00 [0.00, 0.09] for other statin initiators (n = 0). The IR for renal dysfunction was 1.18 [0.61, 2.06] for rosuvastatin initiators (n = 12) and 1.26 [0.91, 1.71] for other statin initiators (n = 42), for a HR of 0.90 [0.47, 1.73]. The IR for hepatic dysfunction was 0.20 (0.02, 0.71) for rosuvastatin initiators (n = 2) and 0.24 (0.10, 0.47) for other statin initiators (n = 8), for a HR of 0.87 (0.18, 4.14). CONCLUSIONS: This study found no difference between rosuvastatin and the other statins in the incidence of hospitalizations associated with renal or hepatic events, or death. The absolute incidence rates of rhabdomyolysis and myopathy were reassuringly low among all statin initiators but remain too small for firm conclusions to be drawn on any difference between the statins. SN - 1053-8569 UR - https://www.unboundmedicine.com/medline/citation/16761308/The_comparative_safety_of_rosuvastatin:_a_retrospective_matched_cohort_study_in_over_48000_initiators_of_statin_therapy_ L2 - https://doi.org/10.1002/pds.1281 DB - PRIME DP - Unbound Medicine ER -