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November 1, 2004New England Journal of MedicineOpen Access

Preventing Microalbuminuria in Type 2 Diabetes

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Why the study?

Do angiotensin-converting-enzyme inhibitors and non-dihydropyridine calcium-channel blockers, alone or in combination, prevent microalbuminuria in subjects with hypertension, type 2 diabetes mellitus, and normal urinary albumin excretion?

Population

1204 subjects with hypertension, type 2 diabetes mellitus, and normal urinary albumin excretion

Comparison

Trandolapril plus verapamil, trandolapril alone… vs Placebo for at least three years, with a target…

Design

RCT, randomly assigned, double-blind

Follow-up

at least three years

Authors

PRPiero RuggenentiMario Negri Institute for Pharmacological ResearchAFAnna FassiLjubljana University Medical CentreSBSimona BrunoAzienda Ospedaliero Universitaria Ospedali Riuniti

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Implication

Supports ACEI use, alone or combined, to delay microalbuminuria in hypertensive type 2 diabetes; confirms early renoprotection in normoalbuminuric patients.

Structured PICO

Do angiotensin-converting-enzyme inhibitors and non-dihydropyridine calcium-channel blockers, alone or in combination, prevent microalbuminuria in subjects with hypertension, type 2 diabetes mellitus, and normal urinary albumin excretion?

P
Population
1204 subjects with hypertension, type 2 diabetes mellitus, and normal urinary albumin excretion
I
Intervention
Trandolapril (2 mg per day) plus verapamil (sustained-release formulation, 180 mg per day), trandolapril alone (2 mg per day), or verapamil alone (sustained-release formulation, 240 mg per day) for at least three years, with a target blood pressure of 120/80 mm Hg
C
Comparator
Placebo for at least three years, with a target blood pressure of 120/80 mm Hg
O
Outcome
Development of persistent microalbuminuria (overnight albumin excretion, >=20 microg per minute at two consecutive visits)surrogate

In hypertensive patients with type 2 diabetes and normoalbuminuria, trandolapril alone or combined with verapamil significantly delayed the onset of microalbuminuria compared to placebo.

Cite This Study

Ruggenenti et al. (2004) studied this question.

synapsesocial.com/papers/6a7c9998e98c86b2617ccd3bhttps://doi.org/10.1056/nejmoa042167

Topics

Hypertension management
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Also Consider

Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Long-term renoprotective effect of angiotensin-converting enzyme inhibition in non-insulin-dependent diabetes mellitus. A 7-year follow-up study1996 · 489 citations
  2. 2Albuminuria and Vascular Damage — The Vicious Twins2003 · 83 citations
  3. 3Renoprotective Effect of the Angiotensin-Receptor Antagonist Irbesartan in Patients with Nephropathy Due to Type 2 Diabetes2001 · 6,047 citations
  4. 4The diagnosis of renal involvement in non-insulin-dependent diabetes mellitus1997 · 21 citations