Abstract
Purpose Due to economic consideration, Indonesia's formulary restrictions are at odds with the treatment guidelines of the American Diabetes Association (ADA) and the Eighth Joint National Committee (JNC 8). ADA and JNC 8 equally recommend the prescription of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) for hypertensive patients with type 2 diabetes mellitus (T2DM) with overt proteinuria (urine albumin to creatinine ratio (UACR) ≥ 300 mg/g creatinine). However, since 1 April 2018, Indonesian formulary restricted telmisartan and valsartan only for T2DM patients with declined renal function as shown by eGFR value. There is no compelling evidence in favor of ACEI over ARB or vice versa except for data supporting the early use of both drugs in patients with overt proteinuria. However, ARB is a choice if ACEI's side effects, that is, coughing, occurs. Therefore, it necessitates a detailed evaluation of the effects of ACEIs and ARBs on albuminuria and their side effect, hyperkalemia, specific to Indonesian T2DM patients. Methods This cross-sectional study involved 134 T2DM patients whose treatment was restricted to either ACEIs (n = 57) or ARBs (n = 77) for at least two months before the study during May–October 2018. Patients with known end-stage renal disease and those receiving dialysis were excluded. UACR and blood potassium levels were compared between the two study groups. Also, the risk factors of albuminuria and hyperkalemia were estimated using multivariate analysis. Results T2DM patients in the ACEI and ARB groups had similar characteristics except for a higher body mass index (p=0.008), lower glomerular filtration rate (p=0.04), and a longer duration of prior treatment (p < 0.001) in the ARB group. This study showed no differences between the ACEI and ARB groups in the proportion of cases with albuminuria (p=0.97) and hyperkalemia (p=0.86), even after adjustment for confounders. In addition, uncontrolled diastolic blood pressure was a significant factor associated with albuminuria (OR: 4.897, 95% CI: 1.026–23.366; p=0.046), whereas a female was 70.1% less likely to develop hyperkalemia than a male (OR: 0.299, 95% CI: 0.102–0.877; p=0.028). Conclusion This cross-sectional study demonstrated that ACEIs and ARBs have a similar effect on albuminuria and hyperkalemia in Indonesian hypertensive T2DM patients, even after correction for potentially confounding variables.
Highlights
Chronic hyperglycemia in diabetes mellitus is associated with various complications, including retinopathy, neuropathy, and nephropathy
Based on American Diabetes Association ADA guidelines (2018), angiotensin-converting enzyme inhibitor (ACEI) and angiotensin II receptor blocker (ARB) are the only two drug classes recommended for hypertensive type 2 diabetes mellitus (T2DM) patients with albuminuria, to slow down the development of chronic kidney disease [4]
ARBs were reported to reduce proteinuria and blood pressure in diabetic patients with nephropathy and hypertension [6]. e renoprotective effects of ACEIs or ARBs in diabetic patients are reflected in decreased progression of macroalbuminuria and increased occurrence of normoalbuminuria and microalbuminuria [7]. e different mechanisms of action of the two classes of therapeutics might result in different renoprotective effects [8]
Summary
Chronic hyperglycemia in diabetes mellitus is associated with various complications, including retinopathy, neuropathy, and nephropathy. Based on American Diabetes Association ADA guidelines (2018), ACEIs and ARBs are the only two drug classes recommended for hypertensive type 2 diabetes mellitus (T2DM) patients with albuminuria, to slow down the development of chronic kidney disease [4]. ARBs were reported to reduce proteinuria and blood pressure in diabetic patients with nephropathy and hypertension [6]. A study by Helmidanora et al showed that diabetic hypertensive patients receiving either ACEIs or ARBs as antihypertensive monotherapy did not show different renoprotective effects, as evaluated by qualitative measurements of the severity proteinuria levels [13]. American Diabetes Association (ADA) and Eighth Joint National Committee (JNC 8) recommend the prescription of ACEI or ARB for hypertensive patients with T2DM with overt proteinuria (UACR ≥ 300 mg/g creatinine) [4]. Covariates were analyzed using chi-square tests, and variables with p < 0.25 and the variables considered relevant in the literature were analyzed by multivariate analysis. e selected variables were analyzed by the binary logistic regression backward likelihood ratio method, and the tests with p values < 0.05 were regarded as statistically significant
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