Devi Gayatri, Singh Jatinder, Bal Baljinder Pal S, Chaudhary Shilpa
Pharmacology and Therapeutics, Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Faridabad, IND.
Pharmacology and Therapeutics, Government Medical College, Amritsar, Amritsar, IND.
Cureus. 2025 Aug 17;17(8):e90307. doi: 10.7759/cureus.90307. eCollection 2025 Aug.
Introduction Diabetes, a chronic metabolic disorder, is one of the fastest-growing health emergencies. Dyslipidemia associated with diabetes increases the risk of hypertension, kidney disease, and cardiovascular diseases. So, dyslipidemia should be treated aggressively as a part of diabetic care. This study was framed to assess the comparative effectiveness of pitavastatin versus atorvastatin on lipid profiles and glycemic control in patients with type 2 diabetes mellitus (T2DM) and dyslipidemia, as well as their comparative cost-effectiveness. Methods This prospective, parallel, open-label, randomized study was conducted at Guru Nanak Dev Hospital Amritsar, India, between September 2020 to March 2022, which enrolled 84, type 2 diabetes mellitus (T2DM) patients aged 35-70 years with glycated hemoglobin (HbA1c) ≥6.5%, who were already taking a combination of metformin and glimepiride at a daily dosage of 1500-3000 mg and 1-2 mg respectively, for ≥3 months. Patients were randomly recruited at a 1:1 ratio in two groups, A (n=40) and B (n=44), to receive either pitavastatin (4 mg, group A) or atorvastatin (20 mg, group B) for 12 weeks. During the course of the study, 10 patients from group A and 14 patients from group B were excluded. The primary endpoint was a change in lipid profile levels, whereas the secondary endpoints were changes in blood glucose levels and adverse drug reactions. Results: Increment of high-density lipoprotein (HDL) levels in pitavastatin (group A) was significantly more pronounced as compared to the atorvastatin (group B) (16.2 ± 5.0 versus 9.2 ± 4.5, p-value<0.0001), while in decrement of total cholesterol (TC) (17.5 ± 8.9 versus 20.1 ± 6.8%, p-value=0.211), low density lipoprotein (LDL) (25.0 ± 11.3 versus 29.1 ± 9.8%, p-value=0.140), and triglycerides (TGs) (20.8 ± 7.2 versus 18.5 ± 9.4%, p-value=0.281), there was no significant difference between two groups after 12 weeks of study. Regarding blood glucose levels, pitavastatin (group A) causes significant improvement in fasting blood glucose than atorvastatin group (22.7 ± 11.6 versus 15.4 ± 6.4%, p-value=0.004) and also the percent change in HbA1c from zero to 12 weeks was more in pitavastatin group than in atorvastatin group (6.4 ± 1.9 versus 5.4 ± 2.3, p-value=0.09). The cost-effectiveness of pitavastatin and atorvastatin was also compared, taking into account the percentage improvement of each parameter. Conclusion: Pitavastatin was found to be more cost-effective than atorvastatin in reducing fasting blood glucose, HbA1c, and triglyceride levels, and in increasing HDL-cholesterol levels.
引言
糖尿病是一种慢性代谢紊乱疾病，是增长最快的健康紧急情况之一。与糖尿病相关的血脂异常会增加患高血压、肾脏疾病和心血管疾病的风险。因此，血脂异常应作为糖尿病护理的一部分进行积极治疗。本研究旨在评估匹伐他汀与阿托伐他汀对2型糖尿病（T2DM）合并血脂异常患者血脂谱和血糖控制的比较效果，以及它们的比较成本效益。
方法
这项前瞻性、平行、开放标签、随机研究于2020年9月至2022年3月在印度阿姆利则的古鲁·那纳克·德夫医院进行，纳入了84名年龄在35 - 70岁、糖化血红蛋白（HbA1c）≥6.5%的2型糖尿病（T2DM）患者，这些患者已经联合服用二甲双胍和格列美脲，每日剂量分别为1500 - 3000毫克和1 - 2毫克，持续≥3个月。患者按1:1比例随机分为两组，A组（n = 40）和B组（n = 44），分别接受匹伐他汀（4毫克，A组）或阿托伐他汀（20毫克，B组）治疗12周。在研究过程中，A组有10名患者和B组有14名患者被排除。主要终点是血脂谱水平的变化，次要终点是血糖水平的变化和药物不良反应。
与阿托伐他汀（B组）相比，匹伐他汀（A组）的高密度脂蛋白（HDL）水平升高更为显著（16.2±5.0对9.2±4.5，p值<0.0001），而在总胆固醇（TC）降低（17.5±8.9对20.1±6.8%，p值 = 0.211）、低密度脂蛋白（LDL）（25.0±11.3对29.1±9.8%，p值 = 0.140）和甘油三酯（TGs）（20.8±7.2对18.5±9.4%，p值 = 0.281）方面，研究12周后两组之间无显著差异。关于血糖水平，匹伐他汀（A组）比阿托伐他汀组能更显著地改善空腹血糖（22.7±11.6对15.4±6.4%，p值 = 0.004），并且匹伐他汀组从0到12周的HbA1c百分比变化也比阿托伐他汀组更大（6.4±1.9对5.4±2.3，p值 = 0.09）。还比较了匹伐他汀和阿托伐他汀的成本效益，并考虑了每个参数的改善百分比。
在降低空腹血糖、HbA1c和甘油三酯水平以及提高HDL - 胆固醇水平方面，发现匹伐他汀比阿托伐他汀更具成本效益。
