Ezetimibe- A Novel Add on Treatment Strategy to Achieve Targeted LDL in Patients with Uncontrolled LDL Levels on High Dose Statin Alone

Abstract

Background: The lowering of low-density lipoprotein cholesterol (LDL-C) is the primary target of therapy in the primary and secondary prevention of cardiovascular events. Statins are the most prescribed lipid-lowering drugs, but many patients fail to achieve the target low-density lipoprotein (LDL) level with statin alone or at higher doses. The add-on therapy of 'Ezetimibe' to statin monotherapy has resulted in a synergistic effect in reducing LDL levels and achievements of lipid targets. Cholesterol comes from two sources. endogenous and exogenous. Rather than inhibiting one source, it is better to inhibit two sources. While statins inhibit endogenous production, Ezetimibe decreases absorption of cholesterol. Indian patients are also observed to have low HDL which is another risk factor for heart diseases. We aimed to assess the efficacy of the combination of atorvastatin plus ezetimibe in Indian patients with dyslipidemia and to see whether it can reduce LDL levels and Improve HDL and triglyceride levels. Objective: (1) To find out LDL reduction by addition of ezetimibe in combination with statin in Indian patients. (2) To find out increase in HDL levels by adding ezetimibe in combination with statin along with the reduction in triglyceride levels in Indian patients. Methods: The retrospective data from EMR of the patients diagnosed with a high level of LDL and satisfying the study's inclusion criteria were collected. The patients at the baseline were given monotherapy. Those who did not achieve the desired LDL were given treatment with Atorvastatin high dose (40 mg and 80 daily) and were allocated to the add-on therapy with Ezetimibe at 10 mg/day after 3 months. The groups (monotherapy and combined therapy) were compared at baseline and subsequent follow-up visits. Data were analyzed using R studio 1.2.1335 and Microsoft Excel. Statistical significance was considered at p<0.05. Results: The LDL level showed a significant decrease after 18 months from baseline till the subsequent follow-up visits. The reduction observed in the serum concentration of LDL was from 167.95 ± 12.85 mg/dL to 91.9 ± 10.39 mg/dL (p < 0.001) in 40 mg group and from 164.76 ± 9.9 mg/dL to 106.71 ± 17.17 mg/dL (p < 0.001) in 80 mg group. Furthermore, the rate of achieving an LDL level <100 mg/dL increased from 0% to 45.28% in the 40 mg group and from 0% to 35.24% in 80 mg group and showed significantly greater improvement (p = 0.001). Conclusion: Compared with high doses of statin, the combination of statin with Ezetimibe not only achieves targeted serum lipid levels, suggesting that combination therapy should be a priority when statin resistance or poor efficacy occurs with the higher dose of statin monotherapy. Keyword: LDL; HDL; Triglycerides; Atorvastatin; Ezetimibe