Low-dose ramipril reduces microalbuminuria in type 1 diabetic patients without hypertension results of a randomized controlled trial - Results of a randomized controlled trial

被引：85

作者：

O'Hare, JP ^{[1
]}

Bilous, R ^{[1
]}

Mitchell, T ^{[1
]}

O'Callaghan, CJ ^{[1
]}

Viberti, GC ^{[1
]}

Willoughby, R ^{[1
]}

Riley, J ^{[1
]}

Robinson, AM ^{[1
]}

Reckless, JP ^{[1
]}

Havard, F ^{[1
]}

Sampson, M ^{[1
]}

Lloyd, A ^{[1
]}

Williams, T ^{[1
]}

Vora, J ^{[1
]}

Chattington, P ^{[1
]}

Hampson, K ^{[1
]}

Ibrahim, H ^{[1
]}

Borthwick, L ^{[1
]}

Willoughby, R ^{[1
]}

Viberti, G ^{[1
]}

Russell, C ^{[1
]}

Barnes, D ^{[1
]}

Macklin, A ^{[1
]}

Murphy, E ^{[1
]}

Stephens, E ^{[1
]}

Vincent, J ^{[1
]}

Tindall, H ^{[1
]}

Simpson, H ^{[1
]}

Knowles, E ^{[1
]}

Cunningham, B ^{[1
]}

Simpson, E ^{[1
]}

Bilous, R ^{[1
]}

Bilous, M ^{[1
]}

Mitchell, T ^{[1
]}

O'Halloran, D ^{[1
]}

Nugent, S ^{[1
]}

Hadden, D ^{[1
]}

Fetherstone, M ^{[1
]}

McCarton, D ^{[1
]}

McGurk, C ^{[1
]}

Johnston, C ^{[1
]}

Burton, J ^{[1
]}

Harris, C ^{[1
]}

Hempstead, H ^{[1
]}

Baksi, A ^{[1
]}

Bartlett, J ^{[1
]}

Heaton, C ^{[1
]}

Brown, K ^{[1
]}

Arora, A ^{[1
]}

Burke, J ^{[1
]}

机构：

[1] Univ Warwick, Sch Biol Sci, Sir Quentin Hazel Inst Mol Med, Coventry CV4 7AL, W Midlands, England

来源：

DIABETES CARE | 2000年 / 23卷 / 12期

关键词：

D O I：

10.2337/diacare.23.12.1823

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

OBJECTIVE - To assess if low (1.25 mg) and/or standard (5 mg) doses of the ACE inhibitor ramipril could prevent progression of microalbuminuria (incipient diabetic nephropathy) in normotensive type 1 diabetic patients. RESEARCH DESIGN AND METHODS - This study, using a multicenter randomized placebo-controlled double-blind parallel group, was conducted over 2 years in 28 outpatient diabetic clinics in the U.K. and Ireland. We screened 334 type 1 diabetic patients with suspected microalbuminuria and normal blood pressure; of these, 140 patients 18-65 years of age with a diagnosis of type 1 diabetes and persistent microalbuminuria, defined as urinary albumin excretion rate (AER) of 20-200 mug/min, were enrolled in the study. RESULTS - The proportion of patients progressing to macroalbuminuria was reduced in the ramipril groups but did not reach statistical significance over 2 years. AER was significantly lower at year 2 in the combined ramipril-treated patients versus placebo (P = 0.013). More patients on ramipril regressed to normoalbuminuria (<20 <mu>g/min), with 11% for 1.25 mg ramipril, 20% for 5 mg ramipril, and 4% for placebo (P = 0.053). Blood pressure was significantly reduced to a similar extent with both 1.25 and 5 mg ramipril. Supine systolic blood pressure increased from 130 to 134 mmHg in the placebo group and fell in the 1.25 mg ramipril group (from 132 to 129 mmHg) and in the 5 mg ramipril group (from 134 to 130 mmHg) (P = 0.003, compared with placebo). No statistically significant changes were observed in glomerular filtration rate (GFR) between the placebo- and ramipril-treated groups during the 2-year period. CONCLUSIONS - Microalbuminuria is reduced significantly by ramipril treatment in type 1 diabetic patients without hypertension. Although the magnitude of the response was greater, there is no significant difference between responses to 1.25 or 5 mg ramipril. Small but highly significant reductions in systolic and mean arterial pressures occur in ramipril-treated patients. GFR is stable at this stage of the evolution of diabetic nephropathy and is unaffected by ramipril treatment for 2 years.

引用

页码：1823 / 1829

页数：7

共 32 条

[1]

ANDERSEN AR, 1978, DIABETOLOGIA, V14, P363

[2] BENEFICIAL-EFFECTS OF ANGIOTENSIN CONVERTING ENZYME-INHIBITION ON RENAL-FUNCTION IN PATIENTS WITH DIABETIC NEPHROPATHY [J].

BJORCK, S ;

NYBERG, G ;

MULEC, H ;

GRANERUS, G ;

HERLITZ, H ;

AURELL, M .

BMJ-BRITISH MEDICAL JOURNAL, 1986, 293 (6545) :471-474

[3] RENAL PROTECTIVE EFFECT OF ENALAPRIL IN DIABETIC NEPHROPATHY [J].

BJORCK, S ;

MULEC, H ;

JOHNSEN, SA ;

NORDEN, G ;

AURELL, M .

BMJ-BRITISH MEDICAL JOURNAL, 1992, 304 (6823) :339-343

[4]

Bojestig M., 1997, Diabetologia, V40, pA544

[5]

Boner G, 1996, DIABETOLOGIA, V39, P587

[6] IOHEXOL CLEARANCE FOR THE DETERMINATION OF GLOMERULAR-FILTRATION RATE IN CLINICAL-PRACTICE - EVIDENCE FOR A NEW GOLD STANDARD [J].

BROWN, SCW ;

OREILLY, PH .

JOURNAL OF UROLOGY, 1991, 146 (03) :675-679

[7] Randomised placebo-controlled trial of lisinopril in normotensive patients with insulin-dependent diabetes and normoalbuminuria or microalbuminuria [J].

Chaturvedi, N ;

Stevenson, J ;

Fuller, JH ;

Rottiers, R ;

Ferriss, B ;

Karamanos, B ;

Kofinis, A ;

Petrou, C ;

IonescuTirgovisite, C ;

Iosif, C ;

Tamas, G ;

Bibok, G ;

Kerenyi, Z ;

KisGombos, P ;

Toth, J ;

Grealy, G ;

Priem, H ;

Koivisto, V ;

Tuominen, J ;

Kostamo, E ;

IdziorWalus, B ;

Solnica, B ;

GalickaLatalie, D ;

Michel, G ;

Keipes, M ;

Giuliani, A ;

Herode, A ;

Santeusanio, F ;

Bueti, A ;

Bistoni, S ;

Cagini ;

Navalesi, R ;

Penno, G ;

Nannipieri, M ;

Rizzo, L ;

Miccoli, R ;

Ghirlanda, G ;

Cotroneo, P ;

Manto, A ;

Minella, A ;

Saponara, C ;

Ward, J ;

Plater, M ;

Ibrahim, S ;

Ibbotson, S ;

Mody, C ;

Papazoglou, N ;

Manes, C ;

Soulis, K ;

Voukias, M .

LANCET, 1997, 349 (9068) :1787-1792

[8] Pathogenesis, prevention, and treatment of diabetic nephropathy [J].

Cooper, ME .

LANCET, 1998, 352 (9123) :213-219

[9] Effects of lisinopril and nifedipine on the progression to overt albuminuria in IDDM patients with incipient nephropathy and normal blood pressure [J].

Crepaldi, G ;

Carta, Q ;

Deferrari, G ;

Mangili, R ;

Navalesi, R ;

Santeusanio, F ;

Spalluto, A ;

Vanasia, A ;

Villa, GM ;

Nosadini, R .

DIABETES CARE, 1998, 21 (01) :104-110

[10]

Deckert T, 1984, DIAB NEPHROPATHY, V3, P6

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