Tags

Type your tag names separated by a space and hit enter

Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia.
J Am Coll Cardiol. 2006 Apr 18; 47(8):1584-7.JACC

Abstract

OBJECTIVES

This study sought to determine the long-term safety and efficacy of co-administered fenofibrate (FENO) and ezetimibe (EZE) in patients with mixed hyperlipidemia.

BACKGROUND

Both EZE and FENO offer complementary benefits to the lipid profile of patients with mixed hyperlipidemia.

METHODS

After completing the 12-week randomized, double-blind base study that compared EZE 10 mg, FENO 160 mg, FENO 160 mg plus EZE 10 mg, and placebo in patients with mixed hyperlipidemia, patients continued into a double-blind, 48-week extension phase. Those patients in the FENO plus EZE and FENO groups continued on their respective base study treatment, and patients in the EZE and placebo groups were switched to FENO plus EZE and FENO, respectively.

RESULTS

Of the 587 patients who completed the base study, 576 continued into the extension study (n = 340 in FENO plus EZE and n = 236 in FENO). The FENO plus EZE produced significantly greater reductions in low-density lipoprotein-cholesterol compared with FENO (-22% vs. -9%, respectively; p < 0.001). There were also significantly greater improvements in triglycerides, high-density lipoprotein cholesterol (HDL-C), total cholesterol, non-HDL-C, and apolipoprotein B with FENO plus EZE compared with FENO. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. Overall, FENO plus EZE was well tolerated during the extension study. The proportion of patients with consecutive elevations of alanine aminotransferase/aspartate aminotransferase > or =3 times upper limit of normal were similar between the FENO plus EZE (1.2%) and FENO (1.7%) groups. No cases of creatine phosphokinase elevations > or =10 times upper limit of normal or myopathy were observed in either group.

CONCLUSIONS

Long-term, 48-week co-administration of FENO plus EZE was well tolerated and more efficacious than FENO in patients with mixed hyperlipidemia.

Authors+Show Affiliations

National Clinical Research Inc., Richmond, Virginia 23294, USA. jmckenney@ncrinc.netNo 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)

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

Language

eng

PubMed ID

16630994

Citation

McKenney, James M., et al. "Safety and Efficacy of Long-term Co-administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia." Journal of the American College of Cardiology, vol. 47, no. 8, 2006, pp. 1584-7.
McKenney JM, Farnier M, Lo KW, et al. Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia. J Am Coll Cardiol. 2006;47(8):1584-7.
McKenney, J. M., Farnier, M., Lo, K. W., Bays, H. E., Perevozkaya, I., Carlson, G., Davies, M. J., Mitchel, Y. B., & Gumbiner, B. (2006). Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia. Journal of the American College of Cardiology, 47(8), 1584-7.
McKenney JM, et al. Safety and Efficacy of Long-term Co-administration of Fenofibrate and Ezetimibe in Patients With Mixed Hyperlipidemia. J Am Coll Cardiol. 2006 Apr 18;47(8):1584-7. PubMed PMID: 16630994.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of long-term co-administration of fenofibrate and ezetimibe in patients with mixed hyperlipidemia. AU - McKenney,James M, AU - Farnier,Michel, AU - Lo,Kwok-Wing, AU - Bays,Harold E, AU - Perevozkaya,Inna, AU - Carlson,Gary, AU - Davies,Michael J, AU - Mitchel,Yale B, AU - Gumbiner,Barry, Y1 - 2006/03/30/ PY - 2005/08/08/received PY - 2005/10/31/revised PY - 2005/11/30/accepted PY - 2006/4/25/pubmed PY - 2006/5/18/medline PY - 2006/4/25/entrez SP - 1584 EP - 7 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 47 IS - 8 N2 - OBJECTIVES: This study sought to determine the long-term safety and efficacy of co-administered fenofibrate (FENO) and ezetimibe (EZE) in patients with mixed hyperlipidemia. BACKGROUND: Both EZE and FENO offer complementary benefits to the lipid profile of patients with mixed hyperlipidemia. METHODS: After completing the 12-week randomized, double-blind base study that compared EZE 10 mg, FENO 160 mg, FENO 160 mg plus EZE 10 mg, and placebo in patients with mixed hyperlipidemia, patients continued into a double-blind, 48-week extension phase. Those patients in the FENO plus EZE and FENO groups continued on their respective base study treatment, and patients in the EZE and placebo groups were switched to FENO plus EZE and FENO, respectively. RESULTS: Of the 587 patients who completed the base study, 576 continued into the extension study (n = 340 in FENO plus EZE and n = 236 in FENO). The FENO plus EZE produced significantly greater reductions in low-density lipoprotein-cholesterol compared with FENO (-22% vs. -9%, respectively; p < 0.001). There were also significantly greater improvements in triglycerides, high-density lipoprotein cholesterol (HDL-C), total cholesterol, non-HDL-C, and apolipoprotein B with FENO plus EZE compared with FENO. Changes in apolipoprotein A-I and high-sensitivity C-reactive protein were similar between groups. Overall, FENO plus EZE was well tolerated during the extension study. The proportion of patients with consecutive elevations of alanine aminotransferase/aspartate aminotransferase > or =3 times upper limit of normal were similar between the FENO plus EZE (1.2%) and FENO (1.7%) groups. No cases of creatine phosphokinase elevations > or =10 times upper limit of normal or myopathy were observed in either group. CONCLUSIONS: Long-term, 48-week co-administration of FENO plus EZE was well tolerated and more efficacious than FENO in patients with mixed hyperlipidemia. SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/16630994/Safety_and_efficacy_of_long_term_co_administration_of_fenofibrate_and_ezetimibe_in_patients_with_mixed_hyperlipidemia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(06)00293-2 DB - PRIME DP - Unbound Medicine ER -