The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) observational follow-up study: benefits of RAS blockade with olmesartan treatment are sustained after study discontinuation.
BACKGROUND
The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study showed that 40 mg Olmesartan medoxomil (OM) versus placebo delayed microalbuminuria onset in patients with type 2 diabetes and normoalbuminuria.


RESULTS
One thousand seven hundred and fifty-eight ROADMAP patients (placebo arm: 877; OM arm: 881) participated in the observational follow up (OFU) with an average of 3.3 years. They received standard medical care and micro- and macrovascular events were documented. During observational follow-up 62.9% and 60.1% in the former OM and placebo group, respectively, received treatment with a RAS blocking agent. During the OFU period the systolic blood pressure (SBP) increased to mean values of 135 mm Hg in both groups. Patients who had developed microalbuminuria during ROADMAP had a higher incidence of cardio- and cerebrovascular events (OR 1.77, CI 1.03 to 3.03, P=0.039) during the OFU period compared with patients in whom this was not the case. Diabetic retinopathy was significantly reduced in the former OM group (8 [0.9%] versus 23 [2.6%], OR: 0.34, CI 0.15 to 0.78, P=0.011) and the rate of microalbuminuria was numerically reduced. Congestive heart failure requiring hospitalization (3 [0.3%] versus 12 [1.4%], OR: 0.23, CI 0.06 to 0.85, P=0.027) was reduced and there was a trend of reduced cardio-/cerebrovascular events (OM versus Pb: 73 [8.3%] versus 86 [9.8%] patients). Seven (0.8%) deaths (including 2 CV events) were reported in former placebo patients versus 3 (0.3%) (non-CV events) in former OM patients.


CONCLUSIONS
Development of microalbuminuria is a valid marker for future CV events. RAS blockade with Olmesartan might cause sustained reduction (legacy effect) of micro- and macrovascular events.
Jan
J
Menne
Eberhard
E
Ritz
Luis M
LM
Ruilope
Christos
C
Chatzikyrkou
Giancarlo
G
Viberti
Hermann
H
Haller
D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000419:Albuminuria / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000503:physiopathology; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D003928:Diabetic Nephropathies / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D005500:Follow-Up Studies; D007093:Imidazoles / Q000627:therapeutic use; D007668:Kidney / Q000187:drug effects / Q000378:metabolism / Q000503:physiopathology; D016015:Logistic Models; D016017:Odds Ratio; D000068557:Olmesartan Medoxomil; D016016:Proportional Hazards Models; D012084:Renin-Angiotensin System / Q000187:drug effects; D018570:Risk Assessment; D012307:Risk Factors; D013777:Tetrazoles / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic
D047228:Angiotensin II Type 1 Receptor Blockers; D007093:Imidazoles; D000068557:Olmesartan Medoxomil; D013777:Tetrazoles