Estimation of the Effect of Inclisiran in LDL-C Reduction in a Regional Portuguese Population

Speaker(s)

Araújo F1, Gavina C2, Afonso-Silva M3, Ferreira C4, Freitas AS5, Seabra D2, Lopes R6, Costa I7, Gomes-da-Costa J8
1Hospital Lusíadas, Lisboa, Lisboa, Portugal, 2Pedro Hispano Hospital, Matosinhos, Matosinhos, Portugal, 3Novartis Farma, Produtos Farmacêuticos SA, Porto Salvo, 11, Portugal, 4Novartis Farma - Produtos Farmacêuticos SA, Porto Salvo, Oeiras, Portugal, 5Novartis Farma, Produtos Farmacêuticos SA, Porto Salvo, Porto Salvo, Portugal, 6MTG Research and Development Lab, Porto, Porto, Portugal, 7Novartis Farma, Produtos Farmacêuticos SA, Porto Salvo, Oeiras, Portugal, 8Novartis Farma - Produtos Farmacêuticos SA, Porto Salvo, 11, Portugal

Presentation Documents

OBJECTIVES: Low-density lipoprotein-cholesterol (LDL-C) is the main target for lipid control for cardiovascular disease prevention. Inclisiran provided sustained and clinically meaningful reductions of LDL-C in ORION 10/11 in patients with ASCVD and ASCVD risk equivalent in addition to high intensity statin therapy. This study aims to extrapolate ORION-10/11 effects in LDL-C reduction to a Portuguese adult patient population and estimate its impact in reaching LDL-C targets.

METHODS: We scanned relevant eligibility criteria for ORION-10/11 in a complete electronic health record database (EHRD) of adult patient population from 14 primary care (PC) centers and 1 public hospital in northern Portugal. We identified patients with ≥1 PC visit in the 3 years before index date. LDL-C reductions of 52.3% and 49.9% were reported, at day 510, for ORION-10/11, respectively. Relative reductions were transposed to the population of interest, using a Gaussian distribution (point estimates as means and standard deviations, derived from the reported 95%CI). This model was applied to the baseline LDL-C of the EHRD population to estimate the potential LDL-C reduction and target achievement according to the ESC/EAS’19 guidelines, at day 510, of continued therapy with Inclisiran.

RESULTS: From 189,720 adult patients, we identified 4,643 (2.5%) similar patients for ORION-10 (median LDL-C baseline: 102 mg/dL) and 13,628 (7.2%) for ORION-11 (median LDL-C baseline: 132 mg/dL). Extrapolated reductions of ORION-10/11 would translate in a median LDL-C of 49 and 66 mg/dL, respectively, (expected reduction of 50 and 52%, respectively) with 65% and 39% of patients reaching LDL-C targets at day 510.

CONCLUSIONS: We found a proportion of patients fulfilling criteria for ORION-10/11 in a regional adult patient population in Northern Portugal, to whom Inclisiran therapy, despite older patients, with higher baseline LDL-C and different prevalence of other comorbidities, could potentially translate into LDL-C reductions and target achievement as achieved in pivotal RCT.

Code

CO55

Topic

Clinical Outcomes

Topic Subcategory

Clinical Outcomes Assessment, Performance-based Outcomes

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory)