Sanmukhani J, Shah V
Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat- 364001, India.
J Postgrad Med. 2010 Jul-Sep;56(3):196-200. doi: 10.4103/0022-3859.68649.
Coronary heart disease (CHD) is the leading cause of death in India resulting in loss of young Indians. Statins have proved to reduce the CHD mortality in various clinical trials. The aim of the study is to find the cost-effectiveness ratio (CER) for each major coronary event averted and a coronary death avoided by use of statins in different clinical settings based on the data from the major clinical trials on statins.
Using electronic database and as per our inclusion and exclusion criteria we selected the West of Scotland Coronary Prevention Study (WOSCOPS), the Air Force Coronary Atherosclerosis Prevention Study (AFCAPS) and the Anglo-Scandinavian Cardiac Outcomes Trial--Lipid Lowering Arm (ASCOT-LLA) study for primary prevention; the Cholesterol and Recurrent Events Trial (CARE), the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) Study and the Scandinavian Simvastatin Survival Study (4S) for secondary prevention and two studies, the Heart Protection Study (HPS) and the Pravastatin in elderly individuals at risk of vascular disease (PROSPER) study for high-risk patients. The results of these studies were used for cost-effectiveness analysis of statins in different patient groups.
Absolute risk reduction, Number Needed to Benefit (NNTB), NNTB/year for total sample and in subgroups of males, females and age >65 was derived. CER for branded and generic versions was calculated by using the prices of statins listed in Indian Drug Review Triple i.
Cost-effectiveness ratio (CER) in primary prevention studies i.e., the WOSCOPS, the AFCAPS and the ASCOT-LLA was Rs. 25.8 lacs, Rs. 23.8 lacs and Rs. 7.9 lacs per major coronary event averted respectively. CER in secondary prevention studies i.e., the CARE and the LIPID was approximately Rs. 20 lacs per major coronary event averted while it was Rs. 52.4 lacs and Rs. 37 lacs per coronary heart disease (CHD) death avoided. CER from the 4S was Rs. 6.9 lacs per major coronary event and Rs. 16.9 lacs per CHD death averted. CER in the HPS and the PROSPER study was Rs. 17.9 lacs and Rs. 27.1 lacs per major coronary event avoided in high-risk patients.
Cost associated with the use of statins is higher in primary prevention as compared to secondary prevention. More studies are needed to confirm the cost-effectiveness of statins to make any decision for health policy.
冠心病（CHD）是印度的主要死因，导致众多年轻印度人丧生。他汀类药物已在多项临床试验中证明可降低冠心病死亡率。本研究旨在根据他汀类药物的主要临床试验数据，找出在不同临床环境中使用他汀类药物避免每种主要冠状动脉事件和避免冠状动脉死亡的成本效益比（CER）。
利用电子数据库，并根据我们的纳入和排除标准，我们选择了苏格兰西部冠心病预防研究（WOSCOPS）、空军冠状动脉粥样硬化预防研究（AFCAPS）和盎格鲁-斯堪的纳维亚心脏结局试验——降脂组（ASCOT-LLA）进行一级预防；胆固醇与再发事件试验（CARE）、普伐他汀长期干预缺血性疾病研究（LIPID）和斯堪的纳维亚辛伐他汀生存研究（4S）进行二级预防，以及两项针对高危患者的研究，即心脏保护研究（HPS）和普伐他汀用于有血管疾病风险的老年人研究（PROSPER）。这些研究的结果用于他汀类药物在不同患者群体中的成本效益分析。
得出总样本以及男性、女性和年龄>65岁亚组的绝对风险降低、需治疗获益人数（NNTB）、每年NNTB。通过使用《印度药物评论Triple i》中列出的他汀类药物价格，计算品牌药和仿制药的CER。
一级预防研究即WOSCOPS、AFCAPS和ASCOT-LLA中，避免每种主要冠状动脉事件的成本效益比（CER）分别为258万卢比、238万卢比和79万卢比。二级预防研究即CARE和LIPID中，避免每种主要冠状动脉事件的CER约为200万卢比，而避免每例冠心病（CHD）死亡的CER分别为524万卢比和370万卢比。4S研究中，避免每种主要冠状动脉事件的CER为69万卢比，避免每例CHD死亡的CER为169万卢比。HPS和PROSPER研究中，高危患者避免每种主要冠状动脉事件的CER分别为179万卢比和271万卢比。
与二级预防相比，一级预防中使用他汀类药物的成本更高。需要更多研究来证实他汀类药物的成本效益，以便为卫生政策做出任何决策。
