Pravastatin + Fenofibrate

  • Pravastatin and Fenofibrate is a fixed dose combination developed for the treatment of mixed dyslipidemia.
  • The combination affects positively all parameters of dyslipidemia : LDL, HDL and TG and proposes an ideal safety profile.
  • Our Pravastatin/fenofibrate 40/160mg fixed dose combination is proposed in hard gelatin capsules filled with an innovative semi-solid matrix that improves patient compliance to treatment. This product has been registered throughout Europe via the centralized procedure of the EMA.
  • Clinical Trials : full clinical development. On going real life clinical study.

Publications :

  • Farnier M, Retterstøl K, Steinmetz A, Császár A. Comparative efficacy and safety of fenofibrate/pravastatin plus ezetimibe triple therapy and simvastatin/ezetimibe dual therapy in type 2 diabetic patients with mixed hyperlipidaemia and cardiovascular disease. Diab Vasc Dis Res. 2012 Jul;9(3):205-15. doi: 10.1177/1479164111430715. Epub 2012 Jan 6.
  • Farnier M. Pravastatin and fenofibrate in combination (Pravafenix(®)) for the treatment of high-risk patients with mixed hyperlipidemia. Expert Rev Cardiovasc Ther. 2012 May;10(5):565-75. doi: 10.1586/erc.12.37. Review. Erratum in: Expert Rev Cardiovasc Ther. 2013 Feb;11(2):253-4.
  • Farnier M, Marcereuil D, De Niet S, Ducobu J, Steinmetz A, Retterstøl K, Bryniarski L, Császár A, Vanderbist F. Safety of a fixed-dose combination of fenofibrate/pravastatin 160 mg/40 mg in patients with mixed hyperlipidaemia: a pooled analysis from a database of clinical trials. Clin Drug Investig. 2012 Apr 1;32(4):281-91. doi: 10.2165/11630820-000000000-00000.
  • Farnier M, Ducobu J, Bryniarski L. Long-term safety and efficacy of fenofibrate/pravastatin combination therapy in high risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy. Curr Med Res Opin. 2011 Nov;27(11):2165-73. doi: 10.1185/03007995.2011.626398. Epub 2011 Oct 5.
  • Farnier M, Steinmetz A, Retterstøl K, Császár A. Fixed-dose combination fenofibrate/pravastatin 160/40 mg versus simvastatin 20 mg monotherapy in adults with type 2 diabetes and mixed hyperlipidemia uncontrolled with simvastatin 20 mg: a double-blind, randomized comparative study. Clin Ther. 2011 Jan;33(1):1-12. doi: 10.1016/j.clinthera.2011.02.006.
  • 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.
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