Comparative Effectiveness of Pitavastatin Versus Atorvastatin on Lipid Profile and Blood Sugar in Patients of Diabetic Dyslipidemia: An Open-Label Comparative Study.

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.