The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) Observational Follow-Up Study: Benefits of RAS Blockade With Olmesartan Treatment Are Sustained After Study Discontinuation

TY - JOUR

T1 - The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) Observational Follow-Up Study

T2 - Benefits of RAS Blockade With Olmesartan Treatment Are Sustained After Study Discontinuation

AU - Menne, Jan

AU - Ritz, Eberhard

AU - Ruilope, Luis M.

AU - Chatzikyrkou, Christos

AU - Viberti, Giancarlo

AU - Haller, Hermann

PY - 2014/2

Y1 - 2014/2

N2 - 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.Methods and 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.

AB - 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.Methods and 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.

KW - albuminuria

KW - angiotensin receptor blocker

KW - diabetic nephropathy

KW - proteinuria

KW - GLOMERULAR-FILTRATION-RATE

KW - PROTEINURIA

KW - RISK

KW - METAANALYSIS

KW - CANDESARTAN

KW - PROGRESSION

KW - RETINOPATHY

KW - MELLITUS

KW - TRIALS

KW - INJURY

U2 - 10.1161/JAHA.114.000810

DO - 10.1161/JAHA.114.000810

M3 - Article

SN - 2047-9980

VL - 3

JO - Journal of the American Heart Association

JF - Journal of the American Heart Association

IS - 2

M1 - e000810

ER -