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
|
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 |
Changes in GFR
UAE
SCr
BP
The rates of clinical events (ESKD, MI, stroke, CHF)
Rate of death from all causes
Rate of adverse events
|
Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |