Effects of valsartan compared to amlodipine on preventing type 2 diabetes in high-risk hypertensive patients: the VALUE trial.
BACKGROUND
Type 2 diabetes is emerging as a major health problem, which tends to cluster with hypertension in individuals at high risk of cardiovascular disease.


OBJECTIVE
To test for the first time the hypothesis that treatment of hypertensive patients at high cardiovascular risk with the angiotensin-receptor blocker (ARB) valsartan prevents new-onset type 2 diabetes compared with the metabolically neutral calcium-channel antagonist (CCA) amlodipine.


METHODS
Pre-specified analysis in the VALUE trial. Follow-up averaged 4.2 years. The risk of developing new diabetes was calculated as an odds ratio (OR) with 95% confidence intervals (CI) for different definitions of diabetes.


METHODS
A sample of 9995 high-risk, non-diabetic hypertensive patients.


METHODS
Valsartan or amlodipine with or without add-on medication [hydrochlorothiazide (HCTZ) and other add-ons, excluding other ARBs, angiotensin-converting enzyme (ACE) inhibitors, CCAs].


METHODS
New diabetes defined as an adverse event, new blood-glucose-lowering drugs and/or fasting glucose > 7.0 mmol/l.


RESULTS
New diabetes was reported in 580 (11.5%) patients on valsartan and in 718 (14.5%) patients on amlodipine (OR 0.77, 95% CI 0.69-0.87, P < 0.0001). Using stricter criteria (without adverse event reports) new diabetes was detected in 495 (9.8%) patients on valsartan and in 586 (11.8%) on amlodipine (OR 0.82, 95% CI 0.72-0.93, P = 0.0015).


CONCLUSIONS
Compared with amlodipine, valsartan reduces the risk of developing diabetes mellitus in high-risk hypertensive patients.
Kjeldsen
Sverre E
SE
Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Julius
Stevo
S
Mancia
Giuseppe
G
McInnes
Gordon T
GT
Hua
Tsushung
T
Weber
Michael A
MA
Coca
Antonio
A
Ekman
Steffan
S
Girerd
Xavier
X
Jamerson
Kenneth
K
Larochelle
Pierre
P
MacDonald
Thomas M
TM
Schmieder
Roland E
RE
Schork
M Anthony
MA
Stolt
Pelle
P
Viskoper
Reuven
R
Widimský
Jiri
J
Zanchetti
Alberto
A
D000368:Aged; D017311:Amlodipine / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D013777:Tetrazoles / Q000627:therapeutic use*; D014633:Valine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000068756:Valsartan
D000959:Antihypertensive Agents; D013777:Tetrazoles; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine