National Centre for Healthcare Research and Pharmacoepidemiology, at the University of Milano-Bicocca Milan, Milan, Italy.
Unit of Biostatistics, Epidemiology and Public Health, Laboratory of Healthcare Research and Pharmacoepidemiology, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Via Bicocca degli Arcimboldi, 8, Edificio U7, 20126, Milan, Italy.
Adv Ther. 2021 Oct;38(10):5270-5285. doi: 10.1007/s12325-021-01892-7. Epub 2021 Sep 3.
Although several studies have shown that a simplified cardiovascular drug treatment leads to better treatment adherence, limited and conflicting findings have been reported on the separate or single-pill combination of the now recommended association between a statin and ezetimibe. We addressed this issue in a large cohort of patients newly treated with statins to whom ezetimibe was additionally administered, either separately or as a single-pill combination.
A total of 256,012 patients (age 40-80 years) from the Lombardy Region (Italy) newly treated with statins during 2011-2013 were followed until 2018 to identify those to whom ezetimibe was added. The 2881 and 5351 patients who started a two-pill or a single-pill combination, respectively, of statin and ezetimibe were identified and matched for propensity score. Adherence to drug therapy at 1 year was measured as the ratio between the number of days in which the drug was available and the days of follow-up (the proportion of days covered; PDC). Patients who had a PDC > 75% or < 25% were, respectively, defined as highly and poorly adherent to drug therapy. Analysis was extended to the association between adherence and the risk of fatal/non-fatal cardiovascular events.
Compared to those prescribed a two-pill combination, those prescribed a single-pill combination had an 87% (75-99%) greater odds of being highly adherent and a 79% (72-84%) lower odds of being poorly adherent to treatment. These advantages were manifest in all strata of age, sex, and clinical profile. The risk of cardiovascular outcomes decreased by 55% in patients with high adherence compared to those with low adherence.
Patients who were prescribed a single-pill combination of statin/ezetimibe more frequently exhibit a good adherence and less frequently bad adherence to treatment than those prescribed a two-pill combination of these drugs.
尽管有几项研究表明简化心血管药物治疗可提高治疗依从性，但对于目前推荐的他汀类药物和依折麦布联合应用的单独或单一药丸联合应用，其结果存在局限性和争议。我们在一个新接受他汀类药物治疗的大患者队列中解决了这个问题，并在这些患者中另外添加了依折麦布，单独添加或作为单一药丸联合添加。
我们对 2011 年至 2013 年期间在意大利伦巴第地区（意大利）新接受他汀类药物治疗的 256012 例患者进行了随访，直到 2018 年，以确定那些添加了依折麦布的患者。分别确定了开始使用他汀类药物和依折麦布两丸或单丸组合的 2881 例和 5351 例患者，并根据倾向评分进行匹配。通过将可用药物天数与随访天数（覆盖率天数；PDC）进行比较，测量药物治疗的依从性在 1 年时的比例。PDC>75%或<25%的患者分别被定义为对药物治疗高度和低度依从。分析扩展到了依从性与致命/非致命心血管事件风险之间的关系。
与服用两丸联合用药的患者相比，服用单丸联合用药的患者对药物治疗高度依从的可能性高 87%（75-99%），而低度依从的可能性低 79%（72-84%）。这些优势在所有年龄、性别和临床特征的分层中都表现出来。与低依从率患者相比，高依从率患者的心血管结局风险降低了 55%。
与服用两种药物的两丸联合用药的患者相比，服用他汀类药物/依折麦布单丸联合用药的患者更频繁地表现出良好的治疗依从性，而不太频繁地出现治疗依从性差的情况。
