505-P: Real-World Use of Inclisiran in Outpatient Physician Clinics
Authors: GRAHAM TIMOTHY E. , VARISCO TYLER J. , BALLANTYNE CHRISTIE M. , ITELD BRUCE J. , SEROTA HARVEY , MCELLIGOTT SEAN , NIU XIAOLI , VAN ANGLEN LUCINDA J. 
Published: June 2023

Objective: In clinical trials, inclisiran, a novel siRNA therapy, reduced LDL-C equally among diabetic and nondiabetic patients. This study aimed to characterize a cohort of obese, prediabetic, and diabetic patients prior to initiating inclisiran in outpatient clinics.

Methods: This was a retrospective, longitudinal cohort study of patients referred for treatment with inclisiran between February and November 2022 in 23 clinics in 11 states. Patients with obesity (BMI&gt;30 kg/m2), prediabetes (5.7≤ HbA1c≤ 6.5%), or diagnosed diabetes at the time of referral were assessed. The log rank test was used to identify differences in time from referral to first administration between above groups.

Results: Of 81 identified patients, 48.2% were diabetic, 27.2% obese, and 24.7% prediabetic. Median age was 71 (IQR: 68-75) years, 60.5% were male, and 60.5% were Medicare beneficiaries. At referral, 81.4% had a primary diagnosis of atherosclerotic cardiovascular disease (ASCVD), 30.9% were on concurrent statins, 30.9% on ezetimibe, 66.7% had documented statin intolerance, 50.6% had prior PCSK9 monoclonal antibody use, and the median Elixhauser comorbidity score was 6.0 (IQR: 2-15). Elixhauser score was notably higher among the diabetic group (Median: 9, IQR: 3-18) compared to the prediabetic (Median: 4, IQR: 0-13) and obese (Median: 3, IQR: -3-12) patient groups. Median baseline LDL-C was 135 (IQR: 99-166) mg/dL with no differences between groups. Median time to initiation was 27 (IQR: 16-49) days with no notable difference between obese, prediabetic, and diabetic patients.

Conclusion: Inclisiran can be promptly initiated in the clinic setting for the management of LDL-C in obese, prediabetic, and diabetic patients. Future work will focus on measuring real-world effectiveness and adherence to inclisiran in each of these groups.

Disclosure

T.E. Graham: None. T.J. Varisco: Consultant; HEALIX. C.M. Ballantyne: Research Support; Abbott Diagnostics, Akcea, Amgen Inc., Arrowhead Pharmaceuticals, Inc., ESPERION Therapeutics, Inc., Ionis Pharmaceuticals, Merck & Co., Inc., Novartis, Novo Nordisk, Regeneron, Roche Diagnostics. Consultant; Alnylam Pharmaceuticals, Inc., Althera Pharmaceuticals, Amarin Corporation, Amgen Inc., Arrowhead Pharmaceuticals, Inc., AstraZeneca, ESPERION Therapeutics, Inc., 89bio, Inc., Abbott Diagnostics, Denka Seiken, Genentech, Inc., Gilead Sciences, Inc., Illumina, Matinas BioPharma Inc, Merck & Co., Inc., New Amsterdam Pharma, Novartis, Novo Nordisk, Pfizer Inc., Regeneron, Roche Diagnostics. B.J. Iteld: Speaker's Bureau; Amgen Inc. Research Support; Amgen Inc., Novartis AG, Bayer Inc. Speaker's Bureau; ESPERION Therapeutics, Inc. Research Support; BMS. Speaker's Bureau; Boehringer-Ingelheim. H. Serota: Speaker's Bureau; Amarin Corporation. Advisory Panel; Bayer Inc. Speaker's Bureau; Janssen Pharmaceuticals, Inc., Boehringer Ingelheim and Eli Lilly Alliance. S. McElligott: Employee; Novartis. Stock/Shareholder; Janssen Pharmaceuticals, Inc. Employee; Sanofi. Stock/Shareholder; Merck & Co., Inc. X. Niu: Employee; Novartis, Sunovion Pharmaceuticals Inc. L.J. Van Anglen: Research Support; Novartis Pharmaceuticals Corporation, Merck & Co., Inc., ADMA Biologics, Inc., Octapharma USA, Paratek Pharmaceuticals.

Funding

Novartis Pharmaceuticals Corporation