PICOTS for the Trial:

• P = Adults > 50 years, on antidiabetic medications, and had persistent microalbuminuria or proteinuria  
• I = Ramipril 1.25 mg once daily on top of usual treatment
• C =  Placebo on top of usual treatment
• O =  Combined incidence of CVD, non-fatal MI, stroke, heart failure leading to hospital admission, and ESRD
• T = Over a period a median of 6 years
  
• S = Outpatient, primary care clinics
• 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.

Trial Summary:

• This was a prospective, randomized, multicenter, placebo-controlled, double-blinded clinical trial of 4912 patients who were over the age of 50 years, on antidiabetic medications, and had persistent microalbuminuria or proteinuria who received either the angiotensin-neprilysin inhibitor, ramipril at 1.25 mg once a day vs. placebo.
• In patients with type 2 diabetes and albuminuria, low-dose ramipril (1.25 mg qd) had no significant effects on CV or renal outcomes despite a small decrease in BP and a trend toward reduction of albuminuria.
• The lack of significance is most likely due to the rather small dose of ramipril because higher doses (10 mg once a day) were shown to decrease CV events in patients with type 2 diabetes by about 25% in the MICRO HOPE trial.