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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 300 mg daily
|
Control treatment |
amlodipine 10 mg daily
|
Patients
Patients |
hypertensive patients with nephropathy due to type 2 diabetes
|
Inclusion criteria |
age between 30 and 70 years; documented diagnosis of type 2 diabetes mellitus, hypertension (systolic blood pressure of more than 135 mm Hg while sitting, diastolic blood pressure of more than 85 mm Hg while sitting, or documented treatment with antihypertensive agents); proteinuria, with urinary protein excretion of at least 900 mg per 24 hours. Serum creatinine concentration between 1.0 and 3.0 mg per deciliter (88 and 265 �mol per liter) in women and 1.2 and 3.0 mg per deciliter (106 and 265 �mol per liter) in men |
Baseline characteristics |
Glycosylated hemoglobin |
8.2% |
BP (systolic/diastolic) |
158/87 |
Female (%) |
31% |
Age |
59 y |
subgroup |
no |
hypertension (%) |
100% |
|
Method and design
Randomized effectives |
579 / 567 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double blind |
Follow-up duration |
2.6 years |
Number of centre |
210 |
Geographic area |
Worldwide |
Hypothesis |
Superiority |
Primary endpoint |
renal death |
Remarks |
|
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
renal death
189 / 579
233 / 567
0,79 [0,68;0,93]
cardiovascular event (fatal and non fatal)
NA / 579
NA / 567
1,03 [0,81;1,31]
All cause death
NA / 579
NA / 567
1,04 [0,77;1,40]
microvascular events
NA / 579
NA / 567
0,77 [0,63;0,94]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
renal death
|
189 / 579 (32,6%) |
233 / 567 (41,1%) |
0,79 |
[0,68;0,93] |
|
12499 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
12499: Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz IRenoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.N Engl J Med 2001;345:851-60
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
renal death |
32,64% |
41,09% |
-84,5‰
|
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)
-
Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohl MA, Lewis JB, Ritz E, Atkins RC, Rohde R, Raz I.
Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes..
N Engl J Med 2001;345:851-60
Pubmed
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Hubmed
| Fulltext
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