Wednesday, October 9, 2013

ROADMAP: Did we forget to use this map?

Microalbuminuria is an early predictor of diabetic nephropathy and premature cardiovascular disease( so we think). Some people might argue its a word that needs to be taken away from the medical dictionary. In 2011, NEJM published the ROADMAP trial.  They wanted to show if the use of ARB would delay the onset of microalbuminuria or albuminuria in patients with Type 2 DM. In a randomized trial, over 4000 patients were either in olmesartan arm or placebo for close to 3 years. The primary outcome was the time to the first onset of microalbuminuria. 

Interesting results:
1. The target blood pressure (<130/80 mm Hg) was achieved in nearly 80% of the patients taking olmesartan and 71% taking placebo; 
2. Microalbuminuria developed in 8.2% of the patients in the olmesartan group  and 9.8% in the placebo group 
3. The serum creatinine level doubled in 1% of the patients in each group. 
4. Greater number had fatal cardiovascular events in the treatment arm — 15 patients (0.7%) as compared with 3 patients in the placebo arm (0.1%) (P=0.01), a difference that was attributable in part to a higher rate of death from cardiovascular causes.

This is striking. Causes:- was it hyperkalemia? was it lower blood pressure than we think should be for DMII. This was reviewed by FDA as well. Other renal blogs had mentioned this trial as well.

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