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Drug Class To Be Reviewed

Statins (HMG-CoA Reductase Inhibitors)

Instructions

  • Students must pick a maximum of three statins to place on their institution’s closed formulary

  • Refer to the Formulary Review Reference List to complete this activity. Groups may only use the articles on this list to satisfy the clinical trial data listed in the criteria below.

  • Complete all sections of the Formulary Review Recommendation Form.

  • Deliver a 5-minute presentation to the class that summarizes the group’s recommendations and provides justification for each agent selected.

Criteria

The three agents together must be able to achieve all of the following:

  • Meet the 2019 AHA/ACC cholesterol guideline criteria for high-intensity, moderate-intensity, and low-intensity regimens

  • Include at least one agent that can lower baseline LDL levels by at least 60% [either with the maximum dose of one of the statins as monotherapy, or through combination with ezetimibe (assuming that the ezetimibe will provide a maximum of 25% additional LDL reduction after the maximal reduction achieved by the statin)]

  • Include at least one agent that is eliminated through a pathway other than P450 3A4

  • Include at least one agent that can be used safely in patients taking transplant medications (eg, cyclosporine, tacrolimus) and HIV antiretroviral regimens (eg, protease inhibitors)

  • Have a published randomized controlled trial (RCT) conducted over at least 1 year and enrolling at least 1000 patients (overall or in subgroup analysis) with statistically significant benefits in each of the following situations:

    • Secondary prevention of ASCVD in patients with stable CAD (ie, stable angina or at least 1 month since ACS/MI)

    • Secondary prevention of ASCVD during the acute hospitalization of patients with ACS

    • Secondary prevention of TIA/stroke in patients with recent history of TIA/stroke

    • Secondary prevention of ASCVD in patients with PAD

    • Primary prevention of ASCVD in patients with T2DM and at least one additional ASCVD risk factor

    • Primary prevention of ASCVD in patients with multiple ASCVD risk factors

    • Primary or secondary prevention of ASCVD in the elderly (>65 years of age)

    • Primary or secondary prevention of ASCVD in patients with CKD with or without hemodialysis

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