Department of Medicine, University of Padova, Via Giustiniani 2, 35128, Padua, Italy.
University Hospital of Padova , Padova, Italy.
Cardiovasc Diabetol. 2021 Jul 16;20(1):144. doi: 10.1186/s12933-021-01338-y.
This cross-sectional study aimed to identify actionable factors to improve LDL-cholesterol target achievement and overcome underuse of lipid-lowering treatments in high- or very-high-cardiovascular risk patients.
We evaluated healthcare records of 934,332 subjects from North-Italy, including subjects with available lipid profile and being on statin treatments up to December 2018. A 6-month-period defined adherence with proportion-of-days-covered ≥ 80%. Treatment was classified as high-intensity-statin (HIS) + ezetimibe, HIS-alone, non-HIS (NHIS) + ezetimibe or NHIS alone.
We included 27,374 subjects without and 10,459 with diabetes. Among these, 30% and 36% were on secondary prevention, respectively. Adherence was high (78-100%) and increased with treatment intensity and in secondary prevention. Treatment intensity increased in secondary prevention, but only 42% were on HIS. 2019-guidelines LDL-cholesterol targets were achieved in few patients and more often among those with diabetes (7.4% vs. 10.7%, p < 0.001). Patients in secondary prevention had mean LDL-cholesterol levels aligned slightly above 70 mg/dl (range between 68 and 73 mg/dl and between 73 and 85 mg/dl in patients with and without diabetes, respectively). Moreover, the differences in mean LDL-cholesterol levels observed across patients using treatments with well-stablished different LDL-lowering effect were null or much smaller than expected (HIS vs. NHIS from - 3 to - 11%, p < 0.001, HIS + ezetimibe vs. HIS-from - 4 to + 5% n.s.). These findings, given the observational design of the study, might suggest that a "treat to absolute LDL-cholesterol levels" approach (e.g., targeting LDLc of 70 mg/dl) was mainly used by physicians rather than an approach to also achieve the recommended 50% reduction in LDL-cholesterol levels. Our analyses suggested that female sex, younger age, higher HDL-c, and elevated triglycerides are those factors delaying prescription of statin treatments, both in patients with and without diabetes and in those on secondary prevention.
Among patients on statin treatment and high adherence, only a small proportion of patients achieved LDL-cholesterol targets. Late initiation of high-intensity treatments, particularly among those with misperceived low-risk (e.g., female subjects or those with high HDL-cholesterol), appears as pivotal factors needing to be modified to improve CVD prevention.
本横断面研究旨在确定可采取的措施来提高 LDL-胆固醇目标达标率,并克服高或极高心血管风险患者中降脂治疗使用率不足的问题。
我们评估了来自意大利北部的 934332 名受试者的医疗记录,包括在 2018 年 12 月之前有可用血脂谱且正在接受他汀类药物治疗的受试者。6 个月的治疗依从性定义为比例覆盖天数≥80%。治疗分为高强度他汀类药物(HIS)+依折麦布、HIS 单药、非高强度他汀类药物(NHIS)+依折麦布或 NHIS 单药。
我们纳入了 27374 名无糖尿病和 10459 名有糖尿病的受试者。其中,分别有 30%和 36%处于二级预防。治疗依从性高(78-100%),且随治疗强度和二级预防而增加。二级预防中治疗强度增加,但只有 42%的患者使用 HIS。2019 年指南 LDL-胆固醇目标在少数患者中达到,且在有糖尿病的患者中更为常见(7.4%比 10.7%,p<0.001)。处于二级预防的患者的平均 LDL-胆固醇水平略高于 70mg/dl(无糖尿病患者的范围为 68-73mg/dl,有糖尿病患者的范围为 73-85mg/dl)。此外,在使用具有明确不同 LDL 降低效果的治疗方法的患者中,观察到的平均 LDL-胆固醇水平差异为零或明显小于预期(HIS 与 NHIS 相比为-3 至-11%,p<0.001,HIS+依折麦布与 HIS 相比为-4 至+5%,无统计学意义)。这些发现,鉴于研究的观察性设计,可能表明医生主要采用了“治疗 LDL-胆固醇绝对值”的方法(例如,目标 LDLc 为 70mg/dl),而不是实现 LDL-胆固醇水平降低 50%的推荐方法。我们的分析表明,女性、年轻、较高的高密度脂蛋白胆固醇和升高的甘油三酯是延迟他汀类药物治疗处方的因素,无论患者是否患有糖尿病,也无论患者是否处于二级预防中。
在接受他汀类药物治疗且治疗依从性高的患者中,只有一小部分患者达到了 LDL-胆固醇目标。高强度治疗的起始延迟,尤其是在那些被误认为低风险的患者(例如女性或那些高密度脂蛋白胆固醇较高的患者)中,似乎是需要改变的关键因素,以改善心血管疾病的预防。