de Vries F M, Voorham J, Hak E, Denig P
a a Department of Clinical Pharmacy and Pharmacology , University of Groningen, University Medical Center Groningen , Groningen , The Netherlands.
b b Department of Pharmacy , Unit of PharmacoEpidemiology and PharmacoEconomics, University of Groningen , Groningen , The Netherlands.
Curr Med Res Opin. 2015 Dec;31(12):2197-206. doi: 10.1185/03007995.2015.1092126. Epub 2015 Oct 19.
To determine the association between adherence, dose and low-density lipoprotein (LDL) cholesterol response in patients with type 2 diabetes initiating statin treatment.
This cohort study was performed using data for 2007-2012 from the Groningen Initiative to Analyse Type 2 Diabetes Treatment (GIANTT) database. The association between adherence to a standard-dose statin and LDL cholesterol response was assessed using linear regression, adjusting for covariates. The effect of low-dose versus standard-dose was assessed in a propensity-score matched cohort. Adherence rates, defined as the proportion of days covered (PDC), were estimated between statin initiation and LDL outcome measurement.
LDL cholesterol level at follow-up.
The effect of adherence on LDL cholesterol response, measured in 2160 patients, was dependent on the baseline LDL cholesterol level. For patients with a baseline LDL cholesterol of 3.7 mmol/l and an adherence rate of 80%, a 40% reduction in LDL cholesterol was predicted. In the matched sample of 1144 patients, the treatment dose showed a difference in impact on the outcome for adherence rates higher than 50%. It was estimated that a patient with a baseline LDL cholesterol of 3.7 mmol/l will need an adherence rate of at least 76% on low-dose and 63% on standard-dose treatment to reach the LDL cholesterol target of 2.5 mmol/l.
Adherence was measured as the PDC, which is known to overestimate actual adherence. Also, we were not able to adjust for lifestyle factors.
We determined the concurrent effect of treatment adherence and dose on LDL cholesterol outcomes. Given the adherence levels seen in clinical practice, diabetes patients initiating statin treatment are at high risk of not reaching the recommended cholesterol target, especially when they start on a low-dose statin.
确定2型糖尿病患者开始他汀类药物治疗时,依从性、剂量与低密度脂蛋白(LDL)胆固醇反应之间的关联。
本队列研究使用了格罗宁根2型糖尿病治疗分析倡议(GIANTT)数据库2007 - 2012年的数据。采用线性回归评估标准剂量他汀类药物的依从性与LDL胆固醇反应之间的关联,并对协变量进行校正。在倾向评分匹配队列中评估低剂量与标准剂量的效果。依从率定义为覆盖天数比例(PDC),在他汀类药物开始治疗至LDL结果测量期间进行估算。
随访时的LDL胆固醇水平。
在2160例患者中测量发现,依从性对LDL胆固醇反应的影响取决于基线LDL胆固醇水平。对于基线LDL胆固醇为3.7 mmol/l且依从率为80%的患者,预计LDL胆固醇降低40%。在1144例匹配样本患者中,治疗剂量对依从率高于50%的结局影响存在差异。据估计,基线LDL胆固醇为3.7 mmol/l的患者,低剂量治疗时依从率至少需达到76%,标准剂量治疗时需达到63%,才能实现LDL胆固醇目标值2.5 mmol/l。
依从性以PDC衡量,已知该方法会高估实际依从性。此外,我们无法对生活方式因素进行校正。
我们确定了治疗依从性和剂量对LDL胆固醇结局的共同影响。鉴于临床实践中的依从性水平,开始他汀类药物治疗的糖尿病患者未达到推荐胆固醇目标的风险很高,尤其是在开始使用低剂量他汀类药物时。