PARADIGM-HF Trial: Angiotensin Neprilysin Inhibition vs Enalapril Heart Failure
PICOTS for the Trial:
- P = Adults with class II - IV heart failure and EF < 40% on standard therapy
- I = Angiotensin-neprilysin inhibition(LCZ696) at doses of 200 mg twice a day
- C = Enalapril 10 mg twice daily
- O = CV related mortality, all-cause mortality, and hospitalizations for heart failure
- T = Over a period a median of 27 months
- S = Outpatient
- What is PICOTS? It is an acronym similar to PICO used in evidenced-based medicine and represents the following: (P) for patient population, (I) for the intervention of interest, (C) for comparative intervention, (O) for the outcome, (T) for the timing of the intervention, and (S) for the setting. EBM Consult uses PICOTS because it is more complete and appropriate. Every study has a PICO or PICOTS and appropriate application of this content should be compared to the PICO or PICOTS being asked by the clinician.
- This was a prospective, randomized, multicenter, double-blinded clinical trial of 8,442 patients with class II, III, or IV heart failure and with an EF ≤ 40% who received either the angiotensin-neprilysin inhibitor (LCX696 at 200 mg twice daily) vs. enalapril.
- The trial was stopped early (median follow up of 27 months) due to overwhelming benefit in those receiving angiotensin-neprilysin inhibition in reducing risk of death and hospitalization for heart failure.
PARADIGM-HF Trial Summary