Related trials
ROADMAP, 2010 - olmesartan vs placebo
Ruilope, 2010 - LCZ696 vs placebo
HIJ-CREATE, 2009 - Candesartan vs usual care
KYOTO HEART Study, 2009 - valsartan vs non ARB strategy
PROPHESS, 2008 - telmisartan vs placebo
ONTARGET (telmisartan alone), 2008 - telmisartan vs ramipril
TRANSCEND, 2008 - telmisartan vs placebo
ONTARGET (association vs telmisartan), 2008 - telmisartan + ramipril vs telmisartan
ONTARGET/Tel+Ram, 2008 - Telmisartan + ramipril vs Ramipril
ONTARGET (association vs ramipril), 2008 - telmisartan + ramipril vs ramipril
ONTARGET/Tel, 2008 - Telmisartan vs Ramipril
Jikei Heart, 2007 - Valsartan vs usual care
ADVANCE, 2007 - perindopril and indapamide vs placebo
VALIDD, 2007 - valsartan vs no valsartan
TROPHY, 2006 - candesartan vs placebo
VALUE, 2004 - valsartan vs amlodipine
DETAIL, 2004 - Telmisartan vs Enalapril
SCOPE, 2003 - candesartan vs placebo
ARCH-J, 2003 - candesartan vs placebo
VALIANT/Val+Cap, 2003 - Valsartan + captopril vs Captopril
Mitrovic et al., 2003 - candesartan vs placebo
CHARM-Alternative, 2003 - candesartan vs placebo
VALIANT/Val, 2003 - Valsartan vs Captopril
CHARM-Added, 2003 - candesartan+ACE inhibitor vs ACE inhibitor only
HEAVEN, 2002 - valsartan vs enalapril
See also:
All miscellaneous clinical trials
All diabetes clinical trials
All clinical trials of anti hypertensive agent
All clinical trials of olmesartan
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Treatments
Studied treatment |
olmesartan at 40 mg/day
|
Control treatment |
placebo
|
Patients
Patients |
patients with diabetes and at least one additional cardiovascular risk factor, but no evidence of renal dysfunction |
Inclusion criteria |
diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL; at least one of the following cardiovascular risk factors: total cholesterol greater than 200 mg/dL or statin treatment, high density lipoprotein (HDL) less than 40 mg/dL, triglycerides greater than 150 mg/dL and less than 400 mg/dL, blood pressure greater than or equal to 130/80 mmHg,body mass index (BMI) greater than 28 kg/m2, waist circumference greater than 102 cm for men and greater than 88 cm for women, smoking of more than 5 cigarettes a day; normoalbuminuria at screening |
Method and design
Randomized effectives |
2232 / 2215 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double-blind |
Follow-up duration |
3.2 y |
Geographic area |
Europe |
Primary endpoint |
microalbuminuria |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Cardiovascular death
15 / 2232
3 / 2215
classic
4,96 [1,44;17,12]
Non fatal stroke
14 / 2232
8 / 2215
classic
1,74 [0,73;4,13]
All cause death
26 / 2232
15 / 2215
classic
1,72 [0,91;3,24]
Non fatal MI
17 / 2232
26 / 2215
0,65 [0,35;1,19]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Cardiovascular death
|
15 / 2232 (0,7%) |
3 / 2215 (0,1%) |
4,96 |
[1,44;17,12] |
|
|
All cause death
|
26 / 2232 (1,2%) |
15 / 2215 (0,7%) |
1,72 |
[0,91;3,24] |
|
|
Non fatal MI
|
17 / 2232 (0,8%) |
26 / 2215 (1,2%) |
0,65 |
[0,35;1,19] |
|
|
Non fatal stroke
|
14 / 2232 (0,6%) |
8 / 2215 (0,4%) |
1,74 |
[0,73;4,13] |
|
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Cardiovascular death |
6,72‰ |
1,35‰ |
5,4‰
|
All cause death |
1,16% |
6,77‰ |
4,9‰
|
Non fatal MI |
7,62‰ |
1,17% |
-4,1‰
|
Non fatal stroke |
6,27‰ |
3,61‰ |
2,7‰
|
Meta-analysis of all similar trials:
angiotensin renin system blockade in diabetes for all type of patients
angiotensin-receptor blockers in diabetes for all type of patients
angiotensin-receptor blockers in miscellaneous for all type of patients
anti hypertensive agent in diabetes for patients with or without hypertension
Reference(s)
-
Ritz E, Viberti GC, Ruilope LM, Rabelink AJ, Izzo JL Jr, Katayama S, Ito S, Mimran A, Menne J, Rump LC, Januszewicz A, Haller H.
Determinants of urinary albumin excretion within the normal range in patients with type 2 diabetes: the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study..
Diabetologia 2010;53:49-57
- 10.1007/s00125-009-1577-3
Pubmed
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Hubmed
| Fulltext
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