Low‐density lipoprotein cholesterol lowering in real‐world patients treated with evolocumab

Abstract

Background Low‐density lipoprotein cholesterol (LDL‐C) is a risk factor for atherosclerotic cardiovascular disease (ASCVD). There are limited real‐world data on LDL‐C lowering with evolocumab in United States clinical practice. Hypothesis We assessed LDL‐C lowering during 1 year of evolocumab therapy. Methods This retrospective cohort study used linked laboratory (Prognos) and medical claims (IQVIA Dx/LRx and PharMetrics Plus®) data. Patients with a first fill for evolocumab between 7/1/2015 and 10/31/2019 (index event) and LDL‐C ≥ 70 mg/dL were included (overall cohort; N = 5897). Additionally, a patient subgroup with a recent myocardial infarction (MI) within 12 months (median 130 days) before the first evolocumab fill was identified (N = 152). Reduction from baseline LDL‐C was calculated based on the lowest LDL‐C value recorded during a 12‐month follow‐up period. Results The mean (SD) age was 65 (10) years; 61.9% of patients had ASCVD diagnoses and 70.7% of patients were in receipt of lipid‐lowering therapy. Following evolocumab treatment, changes in LDL‐C from baseline were −60% in the overall cohort (median [interquartile range (IQR)] 146 [115–180] mg/dL to 58 [36–84] mg/dL) and −65% in the recent MI subgroup (median [IQR] 137 [109–165] mg/dL to 48 [30–78] mg/dL). In the overall cohort and recent MI subgroup, 62.1% and 69.7% of patients achieved LDL‐C < 70 mg/dL, respectively. Conclusions In this real‐world analysis, evolocumab was associated with significant reductions in LDL‐C comparable to that seen in the FOURIER clinical trial, which were durable over 1 year of treatment.

The First Report of a Real-world Experience With a PCSK9 Inhibitor in a Large Familial Hyperlipidemia and Very-high-risk Middle Eastern Population

“…Although up to a 70% reduction in LDL-C was reported in Phase III clinical trials, 25 and an expected up to 85% in triple LLT combination as stated in the ESC/EAS guidelines, 5 other real-world experience studies performed following regulatory approval of evolocumab reported LDL-C reductions averaging from 40% to 60%, [27][28][29][30][31][32][33] which is comparable to our findings. LDL-C reductions of 39%, 52.3%, 54.9%, and 60% were observed in PCSK9 treatment groups in reports by Sarsam et al, 26 Koren et al, 27 Santos et al, 28 and Desai et al 29 In the present study, introduction pf evolocumab helped attain the ACC/AHA guidelines-recommended reduction in LDL-C ( ≥30% reduction or LDL-C < 2.6 mmol/L in primary prevention or ≥50% reduction or LDL-C < 1.8 mmol/L in secondary prevention) not only as add-on therapy to statins but also as a combination with other LLTs in statin-intolerant patients. Voutyritsa et al 34 reported greater (up to 70%) reductions in LDL-C with evolocumab when administered with other LLTs.…”

“…Voutyritsa et al 34 reported greater (up to 70%) reductions in LDL-C with evolocumab when administered with other LLTs. Desai et al 29 observed an LDL-C reduction of up to 60% in a real-world setting. Gürgöze et al 17 reported that the addition of evolocumab to other LLTs lowered LDL-C levels by ∼60%.…”

Novel Insights into the Management of Patients with Very High Cardiovascular Risk Eligible for PCSK9 Inhibitor Treatment: Baseline Findings from the PERI-DYS Study

“…In the newly treated PCSK9i receivers, we assume that the PCSK9i LDL-C lowering is not yet fully effective at enrolment due to a short period between laboratory measurement and patient enrolment. This result is in line with other reports but varied in comparison to the data from Switzerland (75% of patients < 70 mg/dl) [ 24 ] and data from Phar Metrics observations (62.1–69.7% < 70 mg/dl) [ 25 ]. Importantly, our study shows that PCSK9i are preferentially used in patients with considerably higher baseline LDL-C compared to the clinical development studies.…”

Assessment of the Quality of Drug Therapy in Patients with Stable Coronary Artery Disease in the Second Stage of the ALIGN Study

“…Desai и соавт. [8], где на амбулаторном этапе исследования до усиления терапии эвалокумабом прием гиполипидемической терапии зарегистрирован лишь у 70,7% больных. В исследовании ALIGN среди пациентов, перенесших инфаркт миокарда, при первичном обращении только 27 из 33 (81,8%) получали или ингибиторы ангиотензинпревращающего фермента (ИАПФ) или блокаторы рецепторов ангиотензина II (БРА), а бета-адреноблокаторы (ББ) -29 из 33 (87,9%) больных.…”