3.6.2.0 Statin and Fi­brate

Com­bi­na­tion ther­a­py (statin and fibrate) is as­so­ci­at­ed with an in­creased risk for ab­nor­mal transam­i­nase lev­els, myosi­tis, and rhab­domy­ol­y­sis. The risk of rhab­domy­ol­y­sis is more com­mon with high­er doses of statins and renal insufficien­cy and ap­pears to be high­er when statins are com­bined with gemfibrozil (com­pared with fenofibrate) (101).

In the AC­CORD study, in pa­tients with type 2 di­a­betes who were at high risk for ASCVD, the com­bi­na­tion of fenofibrate and sim­vas­tatin did not re­duce the rate of fatal car­dio­vas­cu­lar events, non­fa­tal MI, or non­fa­tal stroke as com­pared with sim­vas­tatin alone. Pre­specified sub­group anal­y­ses sug­gest­ed het­ero­gene­ity in treat­ment ef­fects with pos­si­ble benefit for men with both a triglyc­eride level ≥204 mg/dL (2.3 mmol/‍L) and an HDL choles­terol level ≤34 mg/dL (0.9 mmol/‍L) (102). A prospec­tive trial of a newer fibrate in this specific pop­u­la­tion of pa­tients is on­go­ing (103).