Emulation of the Effect of Inclisiran in LDL-C Reduction in an Unselected Regional Portuguese Population

Speaker(s)

ABSTRACT WITHDRAWN

OBJECTIVES:

To emulate inclisiran phase III trials, ORION-10 (Atherosclerotic Cardiovascular Disease patients [ASCVD]) and 11 (ASCVD or ASCVD risk equivalent patients), effects in LDL-C reduction in an unselected 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 of adult patient population from 14 primary care centers linked to 1 public hospital in northern Portugal. We identified patients with ≥1 primary care appointment in the 3 years before index date that met eligibility criteria for ORION-10&11 at 31-12-2021 (index date) and characterized their LDL-C levels. ORION-10 reported an LDL-C reduction, at 540 days of 52.3% [95% confidence interval (95%CI) 48.8-55.7], and ORION-11 a reduction of 49.9% [95%CI 46.6-53.1]. We modeled the mentioned relative reductions in LDL-C using a Gaussian distribution using the point estimates as means, and standard deviations derived from the reported 95%CI. We applied this model to the baseline LDL-C (most near index date value) of the matching patient populations to estimate the potential LDL-C reductions and LDL-C targets achievement (according to the ESC/EAS’19 guidelines) at 540 days of continued therapy with inclisiran.

RESULTS:

From a universe of 189,720 adult patients, we identified 4,643 (2.5%) eligible patients for ORION-10 and 13,628 (7.2%) for ORION-11. Median [P25-P75] baseline LDL-C was 102 [86-126] mg/dL for ORION-10, and 132 [114-159] mg/dL for ORION-11 patients. Emulated reductions for ORION-10 and ORION-11 patients would translate in a median [P25-P75] LDL-C of 49 [41-60] mg/dL and 66 [57-80] mg/dL, respectively, with 65% and 39% of patients reaching LDL-c targets.

CONCLUSIONS:

We found sizable proportions of patients fulfilling criteria for ORION-10&11 in an unselected adult patient population in Northern Portugal, to whom inclisiran therapy could potentially translate into substantial LDL-C reductions and consequently, high LDL-C targets achievements.

Code

RWD74

Topic

Methodological & Statistical Research, Study Approaches

Topic Subcategory

Electronic Medical & Health Records

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory), No Additional Disease & Conditions/Specialized Treatment Areas