Tewari Jay, Qidwai Khalid Ahmad, Roy Shubhajeet, Rana Anadika, Kumar Satish, Sonkar Satyendra Kumar, Tewari Ajoy, Atam Virendra
Gandhi Memorial and Associated Hospitals, King George's Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003 India.
Department of Medicine, Gandhi Ward, King George's Medical University, Lucknow, India.
J Diabetes Metab Disord. 2024 Dec 16;24(1):7. doi: 10.1007/s40200-024-01538-9. eCollection 2025 Jun.
Type 2 diabetes mellitus and hypertension frequently coexist, increasing the risk of cardiovascular and renal complications. Urinary Albumin Creatinine Ratio (UACR) serves as a crucial predictor of these outcomes. While renin-angiotensin system inhibitors are often initial therapy, evidence suggests a potential role for Azelnidipine, a non-dihydropyridine calcium channel blocker, in reducing UACR, especially in cases of persistent proteinuria despite optimal therapy. However, conflicting results from existing studies necessitate a comprehensive systematic review and meta-analysis to clarify Azelnidipine's (AZL) efficacy in reducing UACR in people with type 2 diabetes mellitus and hypertension.
This meta-analysis, following Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, included randomized controlled trials (RCTs) published until January 15, 2024. Studies involving individuals with type 2 diabetes mellitus and hypertension were included, comparing AZL or AZL-containing regimens with other antihypertensive agents. The primary outcome was changes in UACR, with secondary outcomes including alterations in Glycated Hemoglobin (HbA1c), systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), and estimated glomerular filtration rate (eGFR).
Six RCTs involving 731 participants were included. Meta-analysis revealed a significant reduction in UACR in the AZL group compared to controls (Mean Difference (MD) = -47.96; 95% Confidence Interval (CI): -79.56, -16.37; = 0.003). AZL also significantly decreased HR (MD = -3.70; 95% CI: -6.66, -0.74; = 0.01), while no significant changes were observed in HbA1c, SBP, DBP, or eGFR. Sensitivity analyses demonstrated the nuanced impacts of individual studies on results, highlighting the importance of careful interpretation.
This meta-analysis confirms AZL's efficacy in reducing UACR and HR in people with type 2 diabetes mellitus and hypertension.
2型糖尿病和高血压常并存，增加了心血管和肾脏并发症的风险。尿白蛋白肌酐比值（UACR）是这些结局的关键预测指标。虽然肾素-血管紧张素系统抑制剂常作为初始治疗药物，但有证据表明，非二氢吡啶类钙通道阻滞剂阿折地平在降低UACR方面可能发挥作用，尤其是在尽管进行了最佳治疗仍存在持续性蛋白尿的情况下。然而，现有研究结果相互矛盾，因此有必要进行全面的系统评价和荟萃分析，以阐明阿折地平（AZL）在降低2型糖尿病和高血压患者UACR方面的疗效。
本荟萃分析遵循Cochrane协作网及系统评价和荟萃分析的首选报告项目（PRISMA）指南，纳入截至2024年1月15日发表的随机对照试验（RCT）。纳入涉及2型糖尿病和高血压患者的研究，比较阿折地平或含阿折地平的治疗方案与其他抗高血压药物。主要结局是UACR的变化，次要结局包括糖化血红蛋白（HbA1c）、收缩压和舒张压（SBP和DBP）、心率（HR）以及估算肾小球滤过率（eGFR）的改变。
纳入了6项涉及731名参与者的RCT。荟萃分析显示，与对照组相比，阿折地平组的UACR显著降低（平均差值（MD）=-47.96；95%置信区间（CI）：-79.56，-16.37；P=0.003）。阿折地平还显著降低了心率（MD=-3.70；95%CI：-6.66，-0.74；P=0.01），而HbA1c、SBP、DBP或eGFR未观察到显著变化。敏感性分析显示了个别研究对结果的细微影响，突出了谨慎解读的重要性。
本荟萃分析证实了阿折地平在降低2型糖尿病和高血压患者UACR及心率方面的疗效。
