COVID-19 Vaccine Update: We are now offering walk-in appointments at the Wellness & Walk-In Care Center at the Garden State Plaza for those ages 12 and older who live, work, or go to school in NJ. We are also offering walk-ins at our Paramus Vaccination Center, but appointments are highly encouraged.
Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes
The primary scientific aim of the PROMINENT study is to assess whether treatment with the SPPARM-α, K-877 (pemafibrate), will prevent MI, ischemic stroke, unstable angina requiring unplanned revascularization, and CV death in participants with T2D who have elevated TGs and HDL-C levels and are at high risk for future CV events. Participants will be on moderate- to high-intensity statin therapy (atorvastatin ≥ 40 mg/day, rosuvastatin ≥ 20 mg/day, simvastatin ≥ 40 mg/day, or pitavastatin 4 mg/day) or meet LDL-C criteria (by chart review) within 12 months prior to enrollment.
Specifically, the primary objective of the study is to determine whether pemafibrate administered at a dose of 0.2 mg twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:
- Nonfatal MI
- Nonfatal ischemic stroke
- Hospitalization for unstable angina requiring unplanned coronary revascularization, or
- CV death
- Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
- HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
- Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% [48 mmol/mol]), elevated plasma glucose (fasting ≥ 126 mg/dL [7.0 mmol/L], 2-hour ≥ 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes