Effect on serum potassium level in patients of diabetic nephropathy on spironolactone and ramipril over follow up period
DOI:
https://doi.org/10.18203/2320-6012.ijrms20195540Keywords:
Albumin creatinine ratio, Angiotensin converting enzyme, Estimated glomerular filtration rat, Glycated haemoglobinAbstract
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.
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References
Adler AI, Stevens RJ, Manley SE, Bilous RW, Cull CA, Holman RR, et al. Development and progression of nephropathy in type 2 diabetes: The United Kingdom Prospective Diabetes Study. Kidney Int. 2003 Jan 1;63(1):225-32.
Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes: prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12.
Schjoedt KJ, Andersen S, Rossing P, Tarnow L, Parving HH. Aldosterone escape during blockade of the renin-angiotensin-aldosterone system in diabetic nephropathy is associated with enhanced decline in glomerular filtration rate. Diabetol. 2004 Nov 1;47(11):1936-9.
Sato A, Hayashi K, Naruse M, Saruta T. Effectiveness of aldosterone blockade in patients with diabetic nephropathy. Hypertension. 2003 Jan 1;41(1):64-8.
Greene EL, Kren S, Hostetter TH. Role of aldosterone in the remnant kidney model in the rat. J Clini Invest. 1996 Aug 15;98(4):1063-8.
Chrysostomou A, Becker G. Spironolactone in addition to ACE inhibition to reduce proteinuria in patients with chronic renal disease. New Engl J Med. 2001 Sep 20;345(12):925-6.
Rachmani R, Slavachevsky I, Amit M, Levi Z, Kedar Y, Berla M, et al. The effect of spironolactone, cilazapril and their combination on albuminuria in patients with hypertension and diabetic nephropathy is independent of blood pressure reduction: a randomized controlled study. Diabe Med. 2004 May;21(5):471-5.
Rossing K, Schjoedt KJ, Smidt UM, Boomsma F, Parving HH. Beneficial effects of adding spironolactone to recommended antihypertensive treatment in diabetic nephropathy: a randomized, double-masked, cross-over study. Diabe care. 2005 Sep 1;28(9):2106-12.
Bianchi S, Bigazzi R, Campese VM. Antagonists of aldosterone and proteinuria in patients with CKD: an uncontrolled pilot study. Am J kidney Dis. 2005 Jul 1;46(1):45-51.
Rossing K, Christensen PK, Jensen BR, Parving HH. Dual blockade of the renin-angiotensin system in diabetic nephropathy: a randomized double-blind crossover study. Diabecare. 2002 Jan 1;25(1):95-100.
Makhlough A, Kashi Z, Akha O, Zaboli E, Yazdani J. Effect of spironolactone on diabetic nephropathy compared to combination of spironolactone and losartan. Nephrourol Mon. 2014 Jan;6(1):e12148.