Agustina Putri S, Yunir Em, Prawiroharjo Pukovisa, Damanik Johanda, Sauriasari Rani
Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia.
Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Int J Hypertens. 2020 Jul 29;2020:5342161. doi: 10.1155/2020/5342161. eCollection 2020.
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.
This cross-sectional study involved 134 T2DM patients whose treatment was restricted to either ACEIs ( = 57) or ARBs ( = 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.
T2DM patients in the ACEI and ARB groups had similar characteristics except for a higher body mass index (=0.008), lower glomerular filtration rate (=0.04), and a longer duration of prior treatment ( < 0.001) in the ARB group. This study showed no differences between the ACEI and ARB groups in the proportion of cases with albuminuria (=0.97) and hyperkalemia (=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; =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; =0.028).
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.
出于经济考虑,印度尼西亚的药品目录限制与美国糖尿病协会(ADA)和美国国立综合癌症网络(NCCN)第8版(JNC 8)的治疗指南不一致。ADA和JNC 8同样推荐为患有明显蛋白尿(尿白蛋白与肌酐比值(UACR)≥300mg/g肌酐)的2型糖尿病(T2DM)高血压患者开具血管紧张素转换酶抑制剂(ACEI)或血管紧张素II受体阻滞剂(ARB)。然而,自2018年4月1日起,印度尼西亚药品目录将替米沙坦和缬沙坦的使用限制为仅用于估算肾小球滤过率(eGFR)值显示肾功能下降的T2DM患者。除了支持在明显蛋白尿患者中早期使用这两种药物的数据外,没有确凿证据表明ACEI优于ARB,反之亦然。但是,如果ACEI出现副作用,即咳嗽,则ARB是一种选择。因此,有必要详细评估ACEI和ARB对印度尼西亚T2DM患者蛋白尿及其副作用高钾血症的影响。
这项横断面研究纳入了134例T2DM患者,在2018年5月至10月的研究前,他们至少接受了两个月的ACEI(n = 57)或ARB(n = 77)治疗。已知患有终末期肾病和接受透析的患者被排除。比较两个研究组之间的UACR和血钾水平。此外,使用多变量分析评估蛋白尿和高钾血症的危险因素。
ACEI组和ARB组的T2DM患者具有相似的特征,除了ARB组的体重指数较高(P = 0.008)、肾小球滤过率较低(P = 0.04)和先前治疗持续时间较长(P < 0.001)。即使在调整混杂因素后,该研究也显示ACEI组和ARB组之间在蛋白尿(P = 0.97)和高钾血症(P = 0.86)病例比例上没有差异。此外,舒张压未得到控制是与蛋白尿相关的重要因素(OR:4.897,95%CI:1.026 - 23.366;P = 0.046),而女性发生高钾血症的可能性比男性低70.1%(OR:0.299,95%CI:0.102 - 0.877;P = 0.028)。
这项横断面研究表明,即使在纠正潜在的混杂变量后,ACEI和ARB对印度尼西亚高血压T2DM患者的蛋白尿和高钾血症具有相似的影响。