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. 2006 Oct 18;2006(4):CD006257. doi: 10.1002/14651858.CD006257
Methods Country: USA 
 Setting/Design: Multicentre 
 Time frame: NS 
 Randomisation method: Central location‐based on permuted blocks 
 Blinding 
 ‐ Participants: Yes 
 ‐ Investigators: Yes 
 ‐ Outcome assessors: No 
 ‐ Data analysis: No 
 Intention‐to‐treat: No 
 Follow‐up period: 5 years 
 Loss to follow‐up: 2
Participants Inclusion criteria
  • Age: 35‐80 years

  • DM: Type 2 treated by diet, diet plus oral hypoglycaemic drugs (for at least 1 year), or insulin preceded by treatment with oral agents (also for at least 1 year). Among those whose diabetes was treated with insulin, the onset of diabetes had to have occurred after the age of 40 and the BMI had to be more than 25 at the time of diagnosis

  • Hypertension: Mild to moderate with a resting BP < 180/95 mm Hg after at least 3 months of ACEi therapy before entry into the study

  • Renal morphology: Normal

  • UAE: Mean of 3 consecutive overnight values between 11 and 999 µg/min with 2 values > 10 μg/min

  • HbA1c: < 12

  • SCr: < 1.6 mg/dL

  • GFR: > 70 mL/min/1.73 m²


Enalapril group
  • Number: 130

  • Age: 60.0 (9.1)

  • Sex (M/F): 95/35


Telmiosartan group
  • Number: 120

  • Age: 61.2 (8.5)

  • Sex (M/F): 87/33


Exclusion criteria
  • Any condition (other than cardiovascular disease) that could restrict long‐term survival and known allergy to study drugs or iohexol

Interventions Enalapril group 
 20 mg/d
Telmiosartan group 
 80 mg/d
Co‐interventions 
 Others antihypertensive agents (except ACEi or AIRA) were allowed after 2 months.
Outcomes
  1. Changes in GFR

  2. UAE

  3. SCr

  4. BP

  5. The rates of clinical events (ESKD, MI, stroke, CHF)

  6. Rate of death from all causes

  7. Rate of adverse events

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate