Endothelial function, blood pressure control, and risk modification: impact of irbesartan alone or in combination

Figures & data

Table 1 The Irbesartan Microalbuminuria type 2 Diabetes in Hypertensive Patients II study

Title	IRMA II (The Irbesartan MicroAlbuminuria type 2 Diabetes in Hypertensive Patients Study)
Study	Randomized, multicenter, placebo-controlled study
Design	Three parallel groups of patients receiving irbesartan 150 mg/day, 300 mg/day, or placebo
Target BP	<135/85 mmHg after three months
Patients (n)	590
Patient characteristics	Type 2 diabetes Hypertension Microalbuminuria
Primary endpoint	Onset of diabetic nephropathy in patients with type 2 diabetes Definition of diabetic nephropathy: urinary albumin excretion rate in an overnight specimen >200 μg/min and 30% of the baseline rate on at least two consecutive visits
Secondary endpoints	Changes in level of albuminuria Changes in creatinine clearance Restoration of normoalbuminuria Urinary albumin excretion rate in an overnight specimen 20 μg/min
Median follow-up treatment	2.0 years
Treatment dosages	Irbesartan 150 mg/day (195 patients) Irbesartan 300 mg/day (194 patients) Placebo (201 patients)
Results (primary endpoint)	Nephropathy prevalence 14.9% placebo group 7.9% irbesartan 150 mg/day^a 5.2% irbesartan 300 mg/day^Table Footnoteb,Table Footnotec Irbesartan 300 mg/day reduced the progression of diabetic nephropathy by 70%.
Results (secondary endpoints)	Urinary albumin excretion rate significantly decreased with irbesartan versus placebo (–38% in the irbesartan group)^d Decline in creatinine clearance did not significantly differ between groups Average blood pressure –144/83 mmHg placebo –143/83 mmHg irbesartan 150 mg/day –141/83 mmHg irbesartan 300 mg/day^e
Conclusions	Significant reduction of progression from microalbuminuria to nephropathy in diabetic patients treated with irbesartan, independently of BP control renoprotection independent of blood pressure reduction

a P = 0.08;

b P < 0.001;

c P < 0.001 for comparison between placebo and irbesartan 300 mg/day;

d P < 0.001 for irbesartan compared with placebo;

e P = 0.004 for the comparison of systolic blood pressure between the combined irbesartan groups and the placebo group.

Table 2 The IDNT study

Title	IDNT (Irbesartan Diabetic Nephropathy Trial)
Study	Prospective randomized, multicenter, double-blind placebo-controlled study
Design	Groups were compared with regard to the time to the primary composite endpoint
Target BP	135/85 mmHg or less in all groups
Patients (n)	1.715
Patient characteristics	Type 2 diabetes Nephropathy due to type 2 diabetes
Primary endpoint	Comparison between irbesartan and amlodipine efficacy in protection against the progression of nephropathy due to type 2 diabetes, independently of BP reduction
Secondary endpoints	Overall mortality in the two treatment groups Rates of cardiovascular events in the two treatment groups
Treatments	Irbesartan 300 mg/day Amlodipine 10 mg/day
Results (primary endpoint)	Irbesartan reduction of composite primary end-point 20% lower versus placebo and 23% versus amlodipine^Table Footnotea,Table Footnoteb Relative risk of doubling of serum creatinine concentration 33% lower with irbesartan versus placebo and 37% versus amlodipine^Table Footnotec,Table Footnoted Relative risk of end-stage renal disease was 23% lower in irbesartan group than in both other groups^e
Results (secondary endpoints)	No significant differences in the rate of death from any cause and in the cardiovascular composite endpoint
Conclusions	Significant reduction of progression from microalbuminuria to nephropathy in diabetic patients treated with irbesartan Renoprotection independent of blood pressure reduction

a P = 0.02 for irbesartan versus placebo;

b P = 0.006 for irbesartan vs amlodipine;

c P = 0.003 for irbesartan versus placebo;

d P < 0.001 for irbesartan versus amlodipine;

e P = 0.07 for both comparisons.