Pravastatin Fenofibrate

In addition to these newer agents, there are currently three fibrate-based combinations with HMG-CoA reductase inhibitors in clinical trials. In phase III, Sciele has fenofibrate/pravastatin combination and AstraZeneca and Abbott have rosuvastatin/choline fenofibrate (ABT335), while in phase II, Life Cycle Pharma have atorvastatin / fenofibrate. 

Raimondeau J, Le Marec H, Chevallier JC, Bouhour JB. Myolyse biologique survenue a Toc-casion d un relais therapeutique fenofibrate-pravastatine. Presse Med (1992) 21, 663—4. 

Abbreviations AM, amlodipine AT, atorvastatin DS, diclofenac sodium EZ, ezetimibe FB, fenofibrate HAT, hydroxy atorvastatin IS, internal standard o-HAT, ortfio-hydroxy atorvastatin p-HAT, para-hydroxy atorvastatin HPLC-ESI-MS, high-performance liquid chromatography with electrospray tandem mass spectrometry LV, lovastatin NA, nicotinic acid NB, novobiocin FV, pravastatin RV, rosuastatin SV, simvastatin RT, roxethromycin UPLC, ultra performance liquid chromatography. 

A single-dose study in 23 healthy subjects found that the eoneurrent use of pravastatin 40 mg and fenofibrate 201 mg had no effeet on the pharmaeokinetics of either drug, but a moderate increase in the formation of a non-toxic pravastatin metabolite was seen. This was not thought to be clin-ieally important. In a multiple-dose study pravastatin 40 mg daily was given to 23 healthy subjects with fenofibrate 160 mg daily. Fenofibrate increased the maximum levels and AUC of pravastatin by about 40% and 30%, respectively. Similar increases were seen for the main pravastatin metabolite. The combination was well tolerated, and the inereases were eonsidered to be modest." However, a case report describes a patient taking fenofibrate 300 mg daily, who developed rhabdomyolysis after starting pravastatin 10 mg daily. ... 

Gustavson LE, Schweitzer SM, Koehne-Voss S, Achari R, Chira TO, EssUnger H-U, Yanni-celli HD. The effects of multiple doses of fenofibrate on the pharmacokinetics of pravastatin and its 3a-hydro) isomeric metabolite. J Clin Pharmacol (2005) 45, 947-53. 

Pan WJ, Gustavson LE, Achari R, et al. Lack of a clinically significant pharmacokinetic interaction between fenofibrate and pravastatin in healthy volunteers. J Clin Pharmacol 2000 40 316-323. 

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