*In a descriptive, retrospective analysis of 186,670 patients with ASCVD with index LDL-C >70 mg/dL (mean index LDL-C of 108 mg/dL). Baseline statin intensity: Among the 75,523 patients with ASCVD treated at baseline, 12.18% were on low statin intensity, 58.4% were on moderate statin intensity, 20.6% were on high statin intensity, and 8.8% were treated with other lipid-lowering agents. Patients were identified between January 1, 2012 and August 31, 2014, using the IQVIA US ambulatory electronic medical record database. Treatment exposure to statin and/or ezetimibe was based on observation of a valid prescription recorded in the EMR database, which does not guarantee that the patient filled the prescription or used the medication.
†Data from the placebo arm of the FOURIER trial. CV event compromises, MI, stroke, or CV death.
‡A retrospective cohort study of 16,344 patients 19 years of age or older with a history of major ASCVD events using data from the MarketScan database. 5,919 patients had symptomatic PAD as their history of a major ASCVD event. Patients were followed from January 1, 2016 through December 31, 2017 for recurrent ASCVD events. Major ASCVD events included recent ACS, history other than a recent ACS, history of ischemic stroke, and symptomatic PAD.
ACS, acute coronary syndrome; AU, Agatston units; CABG, coronary artery bypass graft; CAC, coronary artery calcium; IS, ischemic stroke; MI, myocardial infarction; PAD, peripheral arterial disease; PCI, percutaneous coronary intervention; TIA, transient ischemic attack.
Contraindications: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.
Adverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.
Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.
Repatha® is indicated: