Table 5.
Effect of ACEI/ARB blockade on diabetic (DM) nephropathy
| Trial acronym (year of publication) | Population | Patient no. | Comparators | Mean follow-up duration (years) | Major results |
|---|---|---|---|---|---|
| ACEI | |||||
| Viberti et al., 1994 | Normotensive, insulin-dependent DM with microalbuminuria | 92 | Captopril (50 mg twice daily) versus placebo | 2 | Captopril was associated with significant reduction in albumin excretion compared to placebo (P < 0.01) |
| The Microalbuminuria Captopril Study Group, 1996 | Normotensive insulin-dependent DM with microalbuminuria | 253 | Captopril (50 mg twice daily) versus placebo | 2 | Progression to overt albuminuria over 24 months was significantly reduced by captopril by 69% (P = 0.004) |
| Captopril Study, 1993 Lewis et al., 1993 | Insulin-dependent DM with overt proteinuria and creatinine ≤ 2.5 mg·L−1 (220 µmol·L−1) | 409 | Captopril (25 mg thrice daily) versus placebo | 3 | Captopril reduced the risk of doubling of the serum creatinine by 48% (P = 0.007) |
| Hebert et al., 1994 | DM with nephritic-range proteinuria | 108 | Captopril (25 mg thrice daily) versus placebo | 3 | Captopril was associated with higher remission of nephrotic-range proteinuria compared to placebo (6.7 vs. 1.5%; P = 0.005). |
| Ravid et al., 1994 | Normotensive, type II DM with microalbuminuria and normal renal function | 94 | Enalapril 10 mg daily versus placebo | 5 | Enalapril prevented decline of kidney function (13% decline in the placebo group and remained stable in the enalapril group; P < 0.05) |
| MICRO-HOPE (2000) Heart Outcomes Prevention Evaluation Study Investigators, 2000 | DM patients in the HOPE study | 3577 | Ramipril 10 mg daily versus placebo | 4.5 | Ramipril lowered the risk of the combined primary outcome by 25% (P = 0.0004), myocardial infarction by 22% (P = 0.01), stroke by 33% (P = 0.0074), cardiovascular death by 37% (P = 0.0001), total mortality by 24% (P = 0.004), revascularisation by 17% (P = 0.031) and overt nephropathy by 24% (P = 0.036) |
| ARB | |||||
| IDNT (2001) Lewis et al., 2001 | Hypertensive, type II DM with nephropathy | 1715 | Irbesartan (300 mg daily) versus amlodipine (10 m daily) versus placebo | 2.6 | Irbesartan was associated 23% (P = 0.02) and 20% (P = 0.006) reduction in combined end points (doubling of the plasma creatinine, development of end-stage renal disease or death from any cause) compared with amlodipine and placebo, respectively |
| Parving et al., 2001a | Hypertensive, type II DM with microalbuminuria | 590 | Irbesartan (150 or 300 mg daily) versus placebo | 2 | Irbesartan 300 mg daily reduced the risk of DM nephropathy compared with placebo (HR 0.30, 95% CI 0.14–0.61, P < 0.001) while 150 mg daily was associated with a statistically insignificant risk reduction of 39% (P = 0.081) |
| RENAAL (2001) Brenner et al., 2001 | Type II DM with nephropathy | 1517 | Losartan (50–100 mg daily) versus placebo | 3.4 | Losartan reduced doubling of the plasma creatinine by 25% (P = 0.006) and end-stage renal disease by 28% (P = 0.002) |
| DETAIL (2004) Barnett et al., 2004 | Type II DM with nephropathy | 250 | Telmisartan (80 mg daily) versus enalapril (20 mg daily) | 5 | Telmisartan and enalapril were associated with similar decline in GFR |