Tags

Type your tag names separated by a space and hit enter

Pharmacoepidemiology safety study of fibrate and statin concomitant therapy.
Am J Cardiol 2010; 106(11):1594-601AJ

Abstract

Combinations of statins and fibrates may be increasingly prescribed to achieve lipid goals in high-risk patients and those with other cardiovascular risk factors, such as mixed dyslipidemia. The purpose of this retrospective cohort study was to compare rates of hospitalization for specific diagnoses in a cohort of new users of statins or fibrates, using claims data from a large United States health insurer. New users of statin, fibrate, or statin-fibrate therapy from 2004 to 2007 were identified; followed for hospitalization with rhabdomyolysis, renal impairment, hepatic injury, or pancreatitis; and confirmed by medical record review. Incidence rates (IRs) were compared across categories of fibrate or statin use, with adjusted IR ratios estimated using Poisson regression. A total of 584,784 patients initiated statins or fibrates. The IR of rhabdomyolysis in statins was 3.30 per 100,000 patient-years; the adjusted IR ratio for statin-fenofibrate combinations compared to statins alone was 3.75 (95% confidence interval 1.23 to 11.40). The IRs of renal impairment and pancreatitis in statins were 108.87 per 100,000 patient-years and 45.76 per 100,000 patient-years, respectively; the adjusted IR ratios for statin-fenofibrate combinations compared to statins alone were 1.47 (95% confidence interval 1.12 to 1.93) and 2.87 (95% confidence interval 2.05 to 4.02), respectively. The IR of hepatic injury with statins was 8.57 per 100,000 patient-years, with no risk difference between exposure groups. In conclusion, the risk for rhabdomyolysis was low, although higher in patients newly treated with statin-fibrate concurrent therapy than those treated with either as monotherapy. The risk for pancreatitis was higher in patients treated with fenofibrate, whether in combination with statins or alone.

Authors+Show Affiliations

Epidemiology, i3 Drug Safety, Waltham, Massachusetts, USA. cheryl.enger@i3drugsafety.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21094360

Citation

Enger, Cheryl, et al. "Pharmacoepidemiology Safety Study of Fibrate and Statin Concomitant Therapy." The American Journal of Cardiology, vol. 106, no. 11, 2010, pp. 1594-601.
Enger C, Gately R, Ming EE, et al. Pharmacoepidemiology safety study of fibrate and statin concomitant therapy. Am J Cardiol. 2010;106(11):1594-601.
Enger, C., Gately, R., Ming, E. E., Niemcryk, S. J., Williams, L., & McAfee, A. T. (2010). Pharmacoepidemiology safety study of fibrate and statin concomitant therapy. The American Journal of Cardiology, 106(11), pp. 1594-601. doi:10.1016/j.amjcard.2010.07.041.
Enger C, et al. Pharmacoepidemiology Safety Study of Fibrate and Statin Concomitant Therapy. Am J Cardiol. 2010 Dec 1;106(11):1594-601. PubMed PMID: 21094360.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacoepidemiology safety study of fibrate and statin concomitant therapy. AU - Enger,Cheryl, AU - Gately,Robert, AU - Ming,Eileen E, AU - Niemcryk,Steve J, AU - Williams,Laura, AU - McAfee,Andrew T, Y1 - 2010/10/14/ PY - 2010/04/16/received PY - 2010/07/17/revised PY - 2010/07/17/accepted PY - 2010/11/25/entrez PY - 2010/11/26/pubmed PY - 2011/1/21/medline SP - 1594 EP - 601 JF - The American journal of cardiology JO - Am. J. Cardiol. VL - 106 IS - 11 N2 - Combinations of statins and fibrates may be increasingly prescribed to achieve lipid goals in high-risk patients and those with other cardiovascular risk factors, such as mixed dyslipidemia. The purpose of this retrospective cohort study was to compare rates of hospitalization for specific diagnoses in a cohort of new users of statins or fibrates, using claims data from a large United States health insurer. New users of statin, fibrate, or statin-fibrate therapy from 2004 to 2007 were identified; followed for hospitalization with rhabdomyolysis, renal impairment, hepatic injury, or pancreatitis; and confirmed by medical record review. Incidence rates (IRs) were compared across categories of fibrate or statin use, with adjusted IR ratios estimated using Poisson regression. A total of 584,784 patients initiated statins or fibrates. The IR of rhabdomyolysis in statins was 3.30 per 100,000 patient-years; the adjusted IR ratio for statin-fenofibrate combinations compared to statins alone was 3.75 (95% confidence interval 1.23 to 11.40). The IRs of renal impairment and pancreatitis in statins were 108.87 per 100,000 patient-years and 45.76 per 100,000 patient-years, respectively; the adjusted IR ratios for statin-fenofibrate combinations compared to statins alone were 1.47 (95% confidence interval 1.12 to 1.93) and 2.87 (95% confidence interval 2.05 to 4.02), respectively. The IR of hepatic injury with statins was 8.57 per 100,000 patient-years, with no risk difference between exposure groups. In conclusion, the risk for rhabdomyolysis was low, although higher in patients newly treated with statin-fibrate concurrent therapy than those treated with either as monotherapy. The risk for pancreatitis was higher in patients treated with fenofibrate, whether in combination with statins or alone. SN - 1879-1913 UR - https://www.unboundmedicine.com/medline/citation/21094360/Pharmacoepidemiology_safety_study_of_fibrate_and_statin_concomitant_therapy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9149(10)01511-0 DB - PRIME DP - Unbound Medicine ER -