Simvastatin Fenofibrate

F4, Famier, M., Bonnefous, F., Debbas, N., and Irvine, A., Comparative efficacy and safety of micronized fenofibrate and simvastatin in patients with primary type Ila or lib hyperlipidemia. Arch. Intern. Med. 154, 441-449 (1994). 

McDonald KB, Garber BG, Perreault MM. Pancreatitis associated with simvastatin plus fenofibrate. Ann Pharmacother 2002 36(2) 275-9. 

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. 

Chen XR, Besson VC, Beziand T, Plotkine M, Marchand-Leroux C (2008b) Combination therapy with fenofibrate, a peroxisome proUferator-activated receptor alpha agonist, and simvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor, on experimental traumatic brain injury. J Pharmacol Exp Ther 326 966-974... 

In a randomised, erossover study 25 healthy subjects were given simvastatin 80 mg daily with fenofibrate 160 mg daily for 7 days. The phaima-cokineties of both drugs and their main metabolites (as assessed in 12 subjeets) were unchanged by concurrent use. All 25 subjects were assessed for safety, and the combination was found to be well tolerated. ... 

Bergman AJ, Murphy G, Burke J, Zhao JJ, Valesky Liu L, Lasseter KC, He W, Prueksar-itanont T, QiuY, Hartford A, Vega JM, Paolini JF. Simvastatin does not have a clinically significant pharmacokinetic interaction widi fenofibrate in humans. J Clin Pharmacol (2004) 44, 1054-62. 

Combination studies In an open extension of a phase III study, in which fenofibrate 135 mg/day was combined with either simvastatin 40 mg/day or rosuvastatin 20 mg/day or atorvastatin 40 mg/day, 287 patients completed the 2-year study [11 ]. There were no cases of rhabdomyolysis and the discontinuation rate due to adverse reactions was 2.9%, with no differences between the three treatments. None of the adverse events was considered serious they generally occurred early during treatment and the most common were myalgia (2.9%), muscle spasms (3.9%), and increased creatine kinase activity (3.5%), the latter being highest with the rosuvastatin combination. 

In dislipilemic coronary patients with claudication, combination therapy with simvastatin 40 mg and ezetimibe (149) 10 mg (trade name of the combination preparation Vytorin) after dinner combined with fenofibrate (Tricor) 160 mg (94) with breakfast brings a significant improvement in walking time to onset of claudication, and time to absolute claudication (see Chapter 1) measured on the treadmill (personal observations). There is also a remarkable improvement of the patient s lipid profile with this combination therapy. 

Wang TD, Chen WJ, Lin JW, et al. Efficacy of fenofibrate and simvastatin on endolthelial function and inflammatory markers in patients with combined hyperlipidemia relations with baseline lipid profiles. Atherosclerosis 2003 170 315-323. 

A 64-year-old woman with type 2 diabetes taking metoprolol aspirin, niacin, warfarin, simvastatin, rosiglitazone, and metformin was given fenofibrate. The HDL cholesterol fell from 1.09 to 0.44 mmol/1. The fenofibrate was withdrawn and the HDL rose to 1.09 mmol/1. 

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