Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy

Tehran University of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Diabetic Nephropathies

Treatments: Drug: Pentoxifylline; Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT03006952

931133003

Details and patient eligibility

About

This study was designed to assess the efficacy of adding pentoxifylline to losartan in comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy. also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein

Full description

Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes patients with nephropathy that might relate to its effect on N terminal brain natriuretic peptide (NT-pro BNP) and C-reactive protein.

Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used in type 2 diabetes patients with nephropathy for treatment of diabetes complications.

NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2 diabetes.

Enrollment: 59 patients

Sex: All

Ages: 38 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age>30 and age<70, urinary albumin excretion (UAE) ≥150 mg/24 h

Exclusion criteria

• any infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage, acute myocardial infarction, uncontrolled hypertension, pregnancy, unable to follow up, hyperthyroidism, baseline serum potassium concentrations ≥5.5 meq/L, glomerular filtration rate (GFR)<30mL/min/1.73 m and intolerance of pentoxifylline

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

pentoxifylline & losartan

Active Comparator group

Description:

pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.

Treatment:

Drug: Losartan

Drug: Pentoxifylline

Losartan

Active Comparator group

Description:

losartan arm took 100mg losartan daily for 12 weeks.

Treatment:

Drug: Losartan