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Preventing microalbuminuria with benazepril, valsartan, and benazepril-valsartan combination therapy in diabetic patients with high-normal albuminuria: A prospective, randomized, open-label, blinded endpoint (PROBE) study.
PLOS Medicine ( IF 10.5 ) Pub Date : 2021-07-14 , DOI: 10.1371/journal.pmed.1003691
Piero Ruggenenti 1, 2 , Monica Cortinovis 1 , Aneliya Parvanova 1 , Matias Trillini 1 , Ilian P Iliev 1 , Antonio C Bossi 3 , Antonio Belviso 4 , Maria C Aparicio 1 , Roberto Trevisan 5 , Stefano Rota 2 , Annalisa Perna 1 , Tobia Peracchi 1 , Nadia Rubis 1 , Davide Martinetti 1 , Silvia Prandini 1 , Flavio Gaspari 1 , Fabiola Carrara 1 , Salvatore De Cosmo 6 , Giancarlo Tonolo 7 , Ruggero Mangili 8 , Giuseppe Remuzzi 1 ,
Affiliation  

BACKGROUND Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) prevent microalbuminuria in normoalbuminuric type 2 diabetic patients. We assessed whether combined therapy with the 2 medications may prevent microalbuminuria better than ACE inhibitor or ARB monotherapy. METHODS AND FINDINGS VARIETY was a prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluating whether, at similar blood pressure (BP) control, combined therapy with benazepril (10 mg/day) and valsartan (160 mg/day) would prevent microalbuminuria more effectively than benazepril (20 mg/day) or valsartan (320 mg/day) monotherapy in 612 type 2 diabetic patients with high-normal albuminuria included between July 2007 and April 2013 by the Istituto di Ricerche Farmacologiche Mario Negri IRCCS and 8 diabetology or nephrology units in Italy. Time to progression to microalbuminuria was the primary outcome. Analyses were intention to treat. Baseline characteristics were similar among groups. During a median [interquartile range, IQR] follow-up of 66 [42 to 83] months, 53 patients (27.0%) on combination therapy, 57 (28.1%) on benazepril, and 64 (31.8%) on valsartan reached microalbuminuria. Using an accelerated failure time model, the estimated acceleration factors were 1.410 (95% CI: 0.806 to 2.467, P = 0.229) for benazepril compared to combination therapy, 0.799 (95% CI: 0.422 to 1.514, P = 0.492) for benazepril compared to valsartan, and 1.665 (95% CI: 1.007 to 2.746, P = 0.047) for valsartan compared to combination therapy. Between-group differences in estimated acceleration factors were nonsignificant after adjustment for predefined confounders. BP control was similar across groups. All treatments were safe and tolerated well, with a slight excess of hyperkalemia and hypotension in the combination therapy group. The main study limitation was the lower than expected albuminuria at inclusion. CONCLUSIONS Risk/benefit profile of study treatments was similar. Dual renin-angiotensin system (RAS) blockade is not recommended as compared to benazepril or valsartan monotherapy for prevention of microalbuminuria in normoalbuminuric type 2 diabetic patients. TRIAL REGISTRATION EudraCT 2006-005954-62; ClinicalTrials.gov NCT00503152.

中文翻译:

使用贝那普利、缬沙坦和贝那普利 - 缬沙坦联合治疗预防高蛋白尿的糖尿病患者出现微量白蛋白尿:一项前瞻性、随机、开放标签、盲法终点 (PROBE) 研究。

背景血管紧张素转换酶(ACE)抑制剂和血管紧张素受体阻滞剂(ARB)可预防正常白蛋白尿的2型糖尿病患者的微量白蛋白尿。我们评估了与 2 种药物联合治疗是否可以比 ACEI 或 ARB 单药治疗更好地预防微量白蛋白尿。方法和发现 VARIETY 是一项前瞻性、随机、开放标签、盲法终点 (PROBE) 试验,评估在相似的血压 (BP) 控制下,在 612 例高正常值的 2 型糖尿病患者中,贝那普利(10 毫克/天)和缬沙坦(160 毫克/天)联合治疗比贝那普利(20 毫克/天)或缬沙坦(320 毫克/天)单药治疗更有效地预防微量白蛋白尿2007 年 7 月至 2013 年 4 月期间,Istituto di Ricerche Farmacologiche Mario Negri IRCCS 和意大利的 8 个糖尿病或肾脏病学单位包括了蛋白尿。进展为微量白蛋白尿的时间是主要结果。分析是意向治疗。各组之间的基线特征相似。在中位 [四分位距,IQR] 66 [42 至 83] 个月的随访期间,联合治疗组 53 名患者 (27.0%)、贝那普利组 57 名 (28.1%) 和缬沙坦组 64 名 (31.8%) 患者出现微量白蛋白尿。使用加速失效时间模型,估计加速因子为 1.410(95% CI:0.806 到 2。467,P = 0.229)贝那普利与联合治疗相比,贝那普利与缬沙坦相比为 0.799(95% CI:0.422 至 1.514,P = 0.492),1.665(95% CI:1.007 至 P = 2.70)缬沙坦与联合治疗相比。调整预定义的混杂因素后,估计加速因素的组间差异不显着。各组的血压控制相似。所有治疗均安全且耐受性良好,联合治疗组的高钾血症和低血压略高。主要研究限制是纳入时的蛋白尿低于预期。结论 研究治疗的风险/收益概况是相似的。与贝那普利或缬沙坦单药治疗相比,不推荐使用双肾素-血管紧张素系统 (RAS) 阻断剂来预防正常白蛋白尿的 2 型糖尿病患者的微量白蛋白尿。试验注册 EudraCT 2006-005954-62;ClinicalTrials.gov NCT00503152。
更新日期:2021-07-14
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