Department of Pharmacy Practice & Pharmacy Administration, Philadelphia College of Pharmacy, University of Sciences in Philadelphia, Philadelphia, PA 19104, USA.
Curr Med Res Opin. 2010 Jan;26(1):121-8. doi: 10.1185/03007990903426811.
The availability of generic simvastatin has changed the relative cost structure within the statin marketplace and has been associated with third-party payer changes to formularies and statin utilization policies. The current study examines simvastatin therapy modification patterns and associated low-density lipoprotein cholesterol (LDL-C) goal attainment rates.
This retrospective, observational study utilized administrative claims linked to laboratory result data from a national health plan. Patients newly initiated on generic simvastatin from January 2007 to March 2008 were identified. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) risk categories and goal LDL-C targets were assigned. Simvastatin dose titrations and switches to other statins were described, as were changes in LDL-C values and NCEP ATP III goal attainment rates both before and after therapy modifications.
Of the 1654 patients newly initiated on simvastatin, 84% had no simvastatin therapy modification in the >1-year follow-up period. For patients with no therapy modification, 54.4% did not achieve their LDL-C NCEP ATP III goal at their first lipid panel and goal attainment was strongly associated with the level of cardiovascular risk (goal attainment rate = 75.1%, 51.7%, and 28.6% for low-, moderate- and high-risk categories, respectively). Of patients not achieving NCEP ATP III LDL-C goals (n = 885), 85.4% had no therapy modification. Goal was achieved after therapy modification in 36% (dose titration) and 42% (switchers); high-risk patients goal attainment rates were 23% and 38%, respectively.
LIMITATIONS of the study include the observational design, use of an administrative claims database to assess cardiovascular risk, relatively short follow-up time (slightly more than 1 year) and the lack of assessment of adherence to therapy.
This study found that the majority of patients initiated on generic simvastatin stayed on their initial starting dose regardless of NCEP ATP III goal attainment status. The findings of low rates of therapy modification irrespective of baseline CV risk and associated low rates of goal attainment, especially in high risk patients treated with simvastatin, indicate an opportunity to encourage clinical decision making based on the needs of the individual patient.
辛伐他汀仿制药的出现改变了他汀类药物市场的相对成本结构，并导致第三方支付方改变了处方集和他汀类药物使用政策。本研究考察了辛伐他汀治疗调整模式及其与低密度脂蛋白胆固醇（LDL-C）目标达标率的关系。
这是一项回顾性观察性研究，利用全国健康计划的行政索赔数据与实验室结果数据进行关联。2007 年 1 月至 2008 年 3 月期间，新开始使用辛伐他汀的仿制药的患者被识别出来。根据国家胆固醇教育计划成人治疗专家组第三版（NCEP ATP III）风险类别和目标 LDL-C 目标进行了分配。描述了辛伐他汀剂量滴定和转换为其他他汀类药物的情况，以及治疗调整前后 LDL-C 值和 NCEP ATP III 目标达标率的变化。
在新开始使用辛伐他汀的 1654 名患者中，84%在超过 1 年的随访期间没有进行辛伐他汀治疗调整。对于没有治疗调整的患者，54.4%在第一次血脂检查时未达到 LDL-C NCEP ATP III 目标，目标达标率与心血管风险水平密切相关（低风险、中风险和高风险类别的目标达标率分别为 75.1%、51.7%和 28.6%）。在未达到 NCEP ATP III LDL-C 目标的 885 名患者中，85.4%没有进行治疗调整。在 36%（剂量滴定）和 42%（转换者）的患者中，在治疗调整后目标得到了实现；高风险患者的目标达标率分别为 23%和 38%。
本研究的局限性包括观察性设计、使用行政索赔数据库评估心血管风险、随访时间相对较短（略超过 1 年）以及缺乏对治疗依从性的评估。
本研究发现，大多数开始使用辛伐他汀仿制药的患者，无论 NCEP ATP III 目标达标情况如何，都坚持使用初始起始剂量。无论基线 CV 风险如何，治疗调整率均较低，目标达标率也较低，特别是在接受辛伐他汀治疗的高风险患者中，这表明有机会根据患者的个体需求鼓励临床决策。
