Abstract
Background and Aims
Microalbuminuria is one of the early presentations of diabetic kidney disease that may progress to macroalbuminuria, progressive loss of glomerular filtration rate and eventually end stage renal disease. Early recognition and management of microalbuminuria can avert irreversible complications. Antihypertensive medications and antihyperlipidemic medications are medications that have been used to control diabetic nephropathy, but the reports of some side effects limited the usage of some of these drugs in diabetic patients. Pentoxifylline is an anti-inflammatory medication that have been experienced for clinical trials in diabetic patients with diabetic kidney disease. Effect of Pentoxifylline on albuminuria has been evaluated in several studies with different outcomes where a significant decrease in albuminuria in the Pentoxifylline group compared with placebo was the final conclusion. The aim of our study is the assessment of the value of Pentoxifylline addition in diabetic patients.
Method
Of 90 patients aged between 20 and 55 years old with a history of diabetes mellites type II for more than 5 years with normal serum creatinine and had a spot urinary albumin/creatinine ratio of > 300 mg/g on two consecutive measurements with HBA1C < 7% and lacking any history of glomerular disease, immunological, malignant nor cardiovascular disease in the previous 6 months nor using pentoxifylline for the past 3 month attending Ain Shams University clinics in Egypt from October 2017 to September 2018, 61 patients were eligible and randomly assigned in prospective, randomized, parallel-group, non-blind study after obtaining written informed consent from studied patients into 2 groups either the Pentoxifylline group (n = 30) receiving 400 mg thrice daily for 6 months or Ramipril group (n = 31) receiving 2.5 mg once daily on the same schedule. Blood samples and single first morning void urine samples were collected before breakfast after an 8–12 hours overnight fast. Plasma glucose, HbA1c, serum Creatinine, AST, ALT, and urinary protein / Creatinine levels were measured. All biochemical analyses were performed. Participants were followed up after 1, 3 and 6 months during the treatment period to evaluate the outcome
Results
Highly Statistically significant differences were noted as regard the reduction of the proteinuria levels at the same measurement points in both groups where the mean ranges of proteinuria in group 1 were found to be 2.2±1, 1.8±0.7, 1.4±0.6 mg\g at the start of the study, 3 and 6 month later respectively while in group 2 the mean range was found to be 2.6±1.2, 2±0.8, 1.6±0.7 mg\g with marked reduction of 20.6% after 3 month and 37.6% after 6 month from the start of the trial in group 1 in contrast to 20.7% and 40.2% respectively in group 2, also the effect of both drugs on the level of HbA1c has been studied in both group, in group 1 there was no reduction in the level of HbA1c after 6 month of drug administration in contrary to group 2 which showed a reduction of 4% where these results were found to be statistically significant in group 2 only. we also found statistically significant differences in both groups as regard the decline in eGFR throughout the trial duration which was 4% in group 1 and 6% in group 2.
Conclusion
We concluded that Pentoxifylline has a promising role as an antiproteinuric agent in comparison with ACEI from our statistical analysis of the study data with a more decline in eGFR throughout the trial duration in the study population using ACEI in comparison to Pentoxifylline. Due to restrictions of the study design these observations need further confirmation by prospective studies.
Figure (1)
showing comparison between both groups as regard the level of proteinuria and its reduction rate over 6 months
Figure (2)
showing eGFR levels at 0, 6 months in both groups
Figure (3)
showing comparison between both groups as regard HbA1C at baseline and after 6 months.
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