No Cardiovascular Benefit on Niacin, Fenofibrate Combinations with Statins

 In FDA

The FDA has withdrawn approvals for the use of niacin or fenofibrate in combination with statins for the treatment of high cholesterol. The FDA also withdrew approval of the indications related to the adjunctive therapy to a statin with niacin extended-release tablets (Niaspan) or fenofibrate delayed-release capsules (Trilipix). This decision directly impacts two medications, Advicor and Simcor, both contain niacin with a statin (lovastatin and simvastatin, respectively) and they are no longer on the market.

The FDA made this decision based on several large trials including AIM-HIGH, ACCORD and HPS2-THRIVE, which collectively showed no benefits of adjunctive therapy to statins for the reduction in the risk of cardiovascular events. According to the studies, further reduction of LDL cholesterol did not translate to the reduction of cardiovascular events. In the absence of benefits, serious adverse events such as myopathy were statistically significantly higher in patients taking niacin with statin.

Niacin and fenofibrate are still available individually on the market. While niacin is also available over-the-counter, patients medications should be reviewed and patients should be educated on efficacy concerns about combination therapy as the benefits of the drugs no longer outweigh the risks.

Preventive care, referring to medical interventions with anticipated long-term benefits, is often inappropriately continued near the end of life. Majority of patients, who were on cholesterol-lowering medications prior to starting hospice, remained on the therapy. This is a great opportunity for hospice care providers and patients to discuss the appropriateness of continuing preventive care as part of an important conversation about prognosis. As patients are often worried about the risks associated with discontinuation, recent studies have shown that the discontinuation of statin therapy in the setting of advanced illness is actually safe and may be associated with benefits. These benefits include improved quality of life, reduced pill burden and reduction in medication costs.

Our pharmacists have developed a patient-directed letter to help you communicate with your patients regarding the discontinuation of cholesterol-lowering drugs. This letter can be found in the clinical resources section of the Client Resources page.

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