Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid

Summary

The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals with atorvastatin 10mg monotherapy.

Timeline

Start

2013-07

Primary completion

2014-06

Completion

2014-07

Publications

• Results Goldberg AC, Bays HE, Ballantyne CM, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia. Am J Cardiol. 2009 Feb 15;103(4):515-22. doi: 10.1016/j.amjcard.2008.10.025. Epub 2008 Dec 26.
• Results Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66. doi: 10.1016/j.ahj.2010.06.045.
• Results Mohiuddin SM, Pepine CJ, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study. Am Heart J. 2009 Jan;157(1):195-203. doi: 10.1016/j.ahj.2008.08.027. Epub 2008 Nov 20.
• Results Kishikawa R, M-Horiuti T, Togawa A, Kondoh Y, Janzy PD, Goldblum RM, Kotoh E, Shimoda T, Shoji S, Nishima S, Brooks EG. [Juniper pollen monitoring by Burkard sampler in Galveston, Texas, USA and Japanese cedar pollen counting in Fukuoka, Japan -- introduction of Pan American Aerobiology Association protocol counting technique]. Arerugi. 2004 Jun;53(6):582-8. Japanese.
• Results Jones PH, Davidson MH, Kashyap ML, Kelly MT, Buttler SM, Setze CM, Sleep DJ, Stolzenbach JC. Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study. Atherosclerosis. 2009 May;204(1):208-15. doi: 10.1016/j.atherosclerosis.2008.09.027. Epub 2008 Oct 5.
• Results Filippatos TD. A review of time courses and predictors of lipid changes with fenofibric acid-statin combination. Cardiovasc Drugs Ther. 2012 Jun;26(3):245-55. doi: 10.1007/s10557-012-6394-0.
• Results Chatley P, Badyal DK, Calton R, Khosla PP. Combination therapy of low-dose atorvastatin and fenofibrate in mixed hyperlipidemia. Methods Find Exp Clin Pharmacol. 2007 Apr;29(3):217-21. doi: 10.1358/mf.2007.29.3.1075363.
• Results Davidson MH, Rooney MW, Drucker J, Eugene Griffin H, Oosman S, Beckert M; LCP-AtorFen Investigators. Efficacy and tolerability of atorvastatin/fenofibrate fixed-dose combination tablet compared with atorvastatin and fenofibrate monotherapies in patients with dyslipidemia: a 12-week, multicenter, double-blind, randomized, parallel-group study. Clin Ther. 2009 Dec;31(12):2824-38. doi: 10.1016/j.clinthera.2009.12.007.
• Results Shah HD, Parikh KH, Chag MC, Shah UG, Baxi HA, Chandarana AH, Naik AM, Shah JN, Iyer S, Shah KJ, Goyal RK. Beneficial effects of the addition of fenofibrate to statin therapy in patients with acute coronary syndrome after percutaneous coronary interventions. Exp Clin Cardiol. 2007 Summer;12(2):91-6.
• Results Farnier M, Ducobu J, Bryniarski L. Efficacy and safety of adding fenofibrate 160 mg in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy. Am J Cardiol. 2010 Sep 15;106(6):787-92. doi: 10.1016/j.amjcard.2010.05.005. Epub 2010 Aug 2.

Drugs

Indications