ABSTRACT
Background: The study was conducted to evaluate the change in serum potassium level over follow up period in patients of diabetic nephropathy on spironolactone (25 mg) and ramipril (5 mg) and compare the results with diabetic nephropathy patients on Spironolactone (25 mg) alone.Methods: A comparative, prospective, non-randomized, non-blinded experimental study was conducted on 56 patients (30-70 yr.) of diagnosed type 2 diabetes mellitus showing proteinuria. Total duration of study was about one year from October 2017 to October 2018. Inclusion criteria followed in study were Age 30-70 years, diagnosed type 2 diabetes mellitus, serum potassium level <5 meq/l, estimated GFR >30 ml/min/1.73m2 and HbA1c <10%. Exclusion criteria were type 1 diabetes mellitus, impaired glucose tolerance secondary to endocrine disease, exocrine pancreatic disease, SBP >180 mmHg DBP >110 mmHg, UTI, hematuria, acute febrile illness, vigorous exercise, short-term pronounced hyperglycemia, obstructive uropathy, confirmed or suspected renal artery disease by USG doppler study, Serum potassium level >5.5 meq/l. Patients were divided in two groups, group A (n= 28, spironolactone 25 mg and ramipril 5 mg) and group B (n=27, spironolactone 25 mg). Subjects were followed over 12 weeks and baseline and 12-week serum potassium being compared. Other baseline base line laboratory investigation such as serum lipid profile, HbA1c, eGFR, fundus examination, ultrasonography (KUB), serum urea, serum creatinine, hemoglobin, were taken at the starting point.Results: Both the group after receiving respective drug were followed for 3-month duration and serum potassium level measured at end of 3 months. Mean values of baseline and follow up serum potassium for group A and group B were 4.24±0.59, 4.07±0.61 and 4.35±0.55, 4.16±0.61 respectively, p value found to be >0.05 at 95% CI.Conclusions: In the study it was concluded that p value found to be >0.05 at 95% C.I denoting that there is no significant difference between mean value of base line and follow up serum potassium value in both group. None of patients in either group had experienced hyperkalaemia over follow up period though serum potassium level were slightly higher in group A, but this difference was statistically not significant. Follow up period of study should be long enough to comment on safety profile of combining spironolactone and ACE inhibitors in diabetic nephropathy patients.
ABSTRACT
Background: The study was conducted to evaluate and compare the protective effects of spironolactone (alone) and its effects along with ACE inhibitor (ramipril) on diabetics (30-70year) in relation to proteinuria and state of diabetic nephropathy.Methods: A comparative, prospective, non-randomized, non-blinded experimental study was conducted on 56 patients (30-70year) of diagnosed type 2 diabetes mellitus showing proteinuria. Total duration of study was about one year from October 2017 to October 2018. Patients were divided in two groups, group A (n=28, spironolactone 25mg and ramipril 5mg) and group B (n=27, spironolactone 25mg). Subjects were followed over 12weeks and baseline and 12-week urine ACR being compared.Results: Both the group after receiving respective drug were followed for 3month duration and response were assessed by measuring urine ACR value at end of 3months. Mean values of baseline and follow up urine ACR for group A and group B were 471.5±465.62, 244.66±237.54 and 474.88±438.94, 268.42±268.16 respectively, P value found to be >0.05 at 95%C.I. It was observed that percentage reduction of urine ACR were 48% and 43.47% in group A and group B respectively.Conclusions: In the study, it was concluded that spironolactone had significant effect over proteinuria reduction over follow up period in patient with diabetic nephropathy though there was no additional statistically significant advantage of addition of spironolactone and ACE inhibitor over proteinuria reduction. Significant reduction of proteinuria occurred in both group A and group B over 12weeks follow up period, 48 % reduction in group A and 43.47% in group B. This difference proved statistically not significant after applying independent t-test.