Efficacy and safety of routine blood pressure lowering in older patients with diabetes: results from the ADVANCE trial.
OBJECTIVE
The efficacy and safety of blood pressure lowering in elderly patients have not been sufficiently investigated in patients with diabetes. Using data from the Action in Diabetes and Vascular disease: preterAx and diamicroN-MR Controlled Evaluation study, we assessed the efficacy and safety of routine blood pressure lowering to prevent major clinical outcomes in elderly patients with type 2 diabetes.


METHODS
Eleven thousand one hundred and forty patients aged at least 55 years with type 2 diabetes (mean 66+/-6 years) were randomly assigned to perindopril-indapamide or placebo. The primary endpoint was a composite of major macrovascular and microvascular disease. The effects of active treatment on outcomes were estimated in subgroups according to age: below 65, 65-74 and at least 75 years.


RESULTS
During a mean 4.3-year follow-up, 1799 (16.1%) patients experienced a major event. Active treatment produced similar relative risk reductions for the primary outcome, major macrovascular disease, death and renal events across age groups (all P heterogeneity >0.3). Over 5 years, active treatment was estimated to prevent one primary outcome in every 21, 71 and 118 patients of at least 75, 65-74 and below 65 years, respectively. Similar patterns of benefits were observed for secondary outcomes. There were no differences in the tolerability between randomized allocations across age groups (all P heterogeneity >0.6)


CONCLUSIONS
Routine administration of perindopril-indapamide lowers blood pressure safely and reduces the risk of major clinical outcomes in patients of at least 75 years with type 2 diabetes. The greater absolute benefits in older patients in this age group were not offset by an increased risk of side effects.
Ninomiya
Toshiharu
T
The George Institute for International Health, University of Sydney, New South Wales, Australia.
Zoungas
Sophia
S
Neal
Bruce
B
Woodward
Mark
M
Patel
Anushka
A
Perkovic
Vlado
V
Cass
Alan
A
Cooper
Mark
M
Grobbee
Diederick
D
Hamet
Pavel
P
Harrap
Stephen
S
Liu
Lisheng
L
Mancia
Giuseppe
G
Mogensen
Carl-Erik
CE
Poulter
Neil
N
Rodgers
Anthony
A
Williams
Bryan
B
MacMahon
Stephen
S
Chalmers
John
J
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007190:Indapamide / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020913:Perindopril / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos
D000959:Antihypertensive Agents; D010919:Placebos; D007190:Indapamide; D020913:Perindopril