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See also:
All diabetes clinical trials
All hypertension clinical trials
All clinical trials of anti hypertensive agent
All clinical trials of irbesartan
|
|
Treatments
Studied treatment |
irbesartan, at a dose of either 150 mg daily or 300 mg daily
|
Control treatment |
placebo
|
Remarks |
3 arms trial: irbesartan 150 and 300 mg daily, placebo |
Patients
Patients |
hypertensive patients with type 2 diabetes and microalbuminuria |
Inclusion criteria |
hypertension (at least two of three consecutive measurements
obtained one week apart during the run-in period of a mean systolic
blood pressure of more than 135 mm Hg or a mean diastolic
blood pressure of more than 85 mm Hg, or both); age between 30 and 70 years; persistent microalbuminuria (defined
as an albumin excretion rate of 20 to 200 ìg per minute in
two of three consecutive, sterile, overnight urine samples) and a serum
creatinine concentration of no more than 1.5 mg per deciliter
(133 ìmol per liter) for men and no more than 1.1 mg per deciliter
(97 ìmol per liter) for women |
Exclusion criteria |
nondiabetic kidney
disease; cancer; life-threatening disease with death expected to occur
within two years; indication for angiotensin-converting
enzyme (ACE) inhibitors or angiotensin-IIreceptor antagonists |
Baseline characteristics |
Duration of diabetes |
10 yr |
Glycosylated hemoglobin |
7.1 % |
BP (systolic/diastolic) |
153/90 |
Female (%) |
31.3% |
Age |
58.3 y |
subgroup |
no |
hypertension (%) |
100% |
|
Method and design
Randomized effectives |
389 / 201 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double-blind |
Follow-up duration |
2 years |
Number of centre |
96 |
Geographic area |
Worldwide |
Hypothesis |
Superiority |
Primary endpoint |
diabetic nephropathy |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
microvascular events
NA / 590
NA / 0
0,30 [0,14;0,64]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
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. |
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
anti hypertensive agent in diabetes for type1 and 2 diabetic patients with hypertension
anti hypertensive agent in hypertension for diabetic patients
Reference(s)
-
Parving HH, Lehnert H, Bröchner-Mortensen J, Gomis R, Andersen S, Arner P.
The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes..
N Engl J Med 2001;345:870-8
Pubmed
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Hubmed
| Fulltext
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